[Federal Register Volume 88, Number 47 (Friday, March 10, 2023)]
[Proposed Rules]
[Pages 15174-15263]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-04591]



[[Page 15173]]

Vol. 88

Friday,

No. 47

March 10, 2023

Part III





Department of Health and Human Services





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Food and Drug Administration





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21 CFR Part 1120





Requirements for Tobacco Product Manufacturing Practice; Proposed Rule

  Federal Register / Vol. 88 , No. 47 / Friday, March 10, 2023 / 
Proposed Rules  

[[Page 15174]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1120

[Docket No. FDA-2013-N-0227]
RIN 0910-AH91


Requirements for Tobacco Product Manufacturing Practice

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA, we, or Agency) is 
proposing to establish tobacco product manufacturing practice 
requirements for manufacturers of finished and bulk tobacco products. 
This proposed rule, if finalized, would set forth the requirements with 
which finished and bulk tobacco product manufacturers must comply in 
the manufacture, preproduction design validation, packing, and storage 
of finished and bulk tobacco products, to assure that the public health 
is protected and that tobacco products are in compliance with chapter 
IX of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

DATES: Either electronic or written comments on the proposed rule must 
be submitted by September 6, 2023. Submit written comments (including 
recommendations) on the collection of information under the Paperwork 
Reduction Act of 1995 (PRA) by April 10, 2023 (see section ``VI. 
Paperwork Reduction Act of 1995'' of this document). See section V of 
this document for the proposed effective date of a final rule based on 
this proposed rule.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of September 6, 2023. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are received on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2013-N-0227 for ``Requirements for Tobacco Product Manufacturing 
Practice.'' Received comments will be placed in the docket and, except 
for those submitted as ``Confidential Submissions,'' publicly viewable 
at https://www.regulations.gov or at the Dockets Management Staff 
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.
    Submit comments on information collection issues to the Office of 
Management and Budget (OMB) in the following ways:
     Fax to the Office of Information and Regulatory Affairs, 
OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or email to 
[email protected]. All comments should be identified with the 
title, ``Requirements for Tobacco Product Manufacturing Practice.''

FOR FURTHER INFORMATION CONTACT: Matthew Brenner, Office of 
Regulations, or Rear Admiral Emil Wang, Office of Compliance and 
Enforcement, Center for Tobacco Products, Food and Drug Administration, 
Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, 
Silver Spring, MD 20993, 877-287-1373, [email protected].

SUPPLEMENTARY INFORMATION: 

Table of Contents

I. Executive Summary
    A. Purpose of the Proposed Rule
    B. Summary of the Major Provisions of the Proposed Rule
    C. Legal Authority
    D. Costs and Benefits
II. Table of Abbreviations/Commonly Used Acronyms in This Document
III. Background
    A. Legal Authority
    B. Rationale for the Proposed Regulation
    C. Development of the Proposed Regulation
IV. Description of the Proposed Regulation
    A. General Provisions
    B. Management System Requirements
    C. Buildings, Facilities, and Equipment
    D. Design and Development Controls
    E. Process Controls

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    F. Packaging and Labeling Controls
    G. Handling, Storage, and Distribution
    H. Recordkeeping and Document Controls
    I. Small Tobacco Product Manufacturers
    J. Exemptions and Variances
V. Proposed Effective and Compliance Dates
VI. Preliminary Economic Analysis of Impacts
VII. Paperwork Reduction Act of 1995
VIII. Analysis of Environmental Impact
IX. Federalism
X. Consultation and Coordination With Indian Tribal Governments
XI. References

I. Executive Summary

A. Purpose of the Proposed Rule

    This proposed regulation--proposed part 1120 (21 CFR part 1120)--
sets forth requirements for tobacco product manufacturing practice 
(TPMP) and provides a framework for manufacturers of finished or bulk 
tobacco products to follow that would include: (1) establishing tobacco 
product design and development controls to prevent or minimize certain 
risks; (2) ensuring that finished and bulk tobacco products are 
manufactured in conformance with established specifications; (3) 
minimizing the likelihood of the manufacture and distribution of 
nonconforming tobacco products; (4) requiring investigation and 
identification of nonconforming products, including those that have 
been distributed in order to institute appropriate corrective actions, 
such as conducting a recall as needed; (5) requiring manufacturers to 
take appropriate measures to prevent contamination of tobacco products; 
and (6) establishing traceability to account for all components or 
parts, ingredients, additives, and materials, as well as each batch of 
finished or bulk tobacco product, to aid in investigations of 
nonconforming tobacco products. Therefore, this proposed regulation 
would establish requirements for the control of tobacco product 
manufacturing activities and the treatment of contaminated or otherwise 
nonconforming tobacco products, including the investigation, 
evaluation, and corrective and preventive actions (CAPA) necessary to 
protect the public health.
    These provisions are generally similar to many existing industry 
practices and are drafted to provide tobacco product manufacturers with 
flexibility in the manner they comply with the proposed requirements 
while assuring the protection of public health. This proposal is 
intended to ensure that tobacco products conform to established 
specifications and to help prevent the manufacture and distribution of 
contaminated or otherwise nonconforming products, thereby assuring that 
the public health is protected and that tobacco products comply with 
the requirements in chapter IX of the FD&C Act.

B. Summary of the Major Provisions of the Proposed Rule

    The proposed regulation is divided into 10 subparts. This proposed 
regulation is intended to provide a framework that requires all 
finished and bulk tobacco product manufacturers subject to the rule 
(including specification developers, contract manufacturers, and 
repackagers/relabelers) to establish and maintain procedures for 
various aspects of the manufacturing, preproduction design validation, 
packing, and storage processes, while allowing flexibility to establish 
procedures that are unique to the manufacturer's facilities and 
activities, and appropriate for a given tobacco product. The proposed 
requirements are written in general terms to allow manufacturers to 
establish procedures appropriate for their specific products and 
operations. The extent of the procedures necessary to meet the 
regulation requirements may vary with the size and complexity of the 
design and manufacturing operations. Tobacco product manufacturers who 
have a complex manufacturing process would likely need to establish 
more detailed procedures to comply with the rule, while tobacco product 
manufacturers who have a less complex manufacturing process may need 
less extensive procedures.
1. Subpart A--General Provisions
    Subpart A contains two proposed sections: scope and definitions. 
The scope section describes the purpose of this proposed regulation and 
the products and activities to which it applies. This proposed 
regulation would apply to manufacturers (foreign and domestic) of 
finished and bulk tobacco products. The definitions section defines the 
terminology applicable to the proposed requirements laid out in this 
notice of proposed rulemaking (NPRM). The proposed rule would define 
``tobacco product manufacturer'' to mean ``any person(s), including a 
repacker or relabeler, who: manufactures, fabricates, assembles, 
processes, or labels a tobacco product, or imports a finished or bulk 
tobacco product for sale or distribution in the United States. The 
manufacture of a tobacco product includes establishing the 
specifications of or the requirements for a tobacco product.''
2. Subpart B--Management System Requirements
    Subpart B contains three proposed sections: organization and 
personnel; tobacco product complaints; and CAPA. The organization and 
personnel section would require finished and bulk tobacco product 
manufacturers to establish and maintain an organizational structure; 
have sufficient personnel; designate personnel with appropriate 
responsibility, including management with executive responsibility; 
train personnel; and maintain certain records of these activities. The 
tobacco product complaints section would require finished and bulk 
tobacco product manufacturers to establish and maintain complaint 
handling procedures for the receipt, evaluation, investigation, and 
documentation of all complaints. The CAPA section would require 
finished and bulk tobacco product manufacturers to establish and 
maintain procedures for implementing CAPA and to maintain records of 
the activities required under this subpart.
3. Subpart C--Buildings, Facilities, and Equipment
    Subpart C contains four proposed sections: personnel practices; 
buildings, facilities, and grounds; equipment; and environmental 
controls. The personnel practices section would require finished and 
bulk tobacco product manufacturers to establish and maintain procedures 
related to personnel practices to reduce the risk of contamination with 
filth biological materials, chemical hazards, or other deleterious 
substances, including rocks or metal shavings. The buildings, 
facilities, and grounds section would require such manufacturers to 
ensure that buildings and facilities are of suitable construction, 
design, and location to facilitate cleaning and sanitation, 
maintenance, and proper operations. In addition, manufacturers would be 
required to ensure that facility grounds are maintained in a condition 
to prevent contamination and to control the water used in the 
manufacturing process. The proposed requirements would also require 
such manufacturers to establish and maintain procedures for proper 
cleaning and sanitation and animal and pest control, and maintain 
records of these activities to demonstrate compliance with this 
proposed rule. The equipment section would provide requirements for 
design, construction, and maintenance of equipment as well as certain 
additional requirements (e.g., calibration) for testing, monitoring, 
and measuring equipment used in the tobacco product manufacturing 
processes and for major

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equipment and processing line identification. Lastly, the environmental 
controls section would require that environmental control systems be 
maintained and monitored to verify that environmental controls, 
including necessary equipment, are adequate and functioning properly. 
This subpart would also require manufacturers to maintain certain 
records to demonstrate compliance with this proposed rule.
4. Subpart D--Design and Development Controls
    Subpart D contains two proposed sections: design and development 
activities and master manufacturing record (MMR). The design and 
development activities section would require finished and bulk tobacco 
product manufacturers to establish and maintain procedures to control 
the design and development of tobacco products, including the control 
of risks associated with the product, production process, packing, and 
storage, as well as procedures for design verification and validation. 
These requirements would include developing a process for 
identification, analysis, and evaluation of known and reasonably 
foreseeable risks associated with the tobacco product and its packaging 
as well as taking appropriate measures to reduce or eliminate risks 
using recognized tools for risk management. Manufacturers would also be 
required to maintain records of all activities required under this 
section.
    The proposed MMR section would require manufacturers to establish 
and maintain an MMR for each finished and bulk tobacco product they 
manufacture for distribution. The proposed section would require each 
MMR to include tobacco product specifications, the manufacturing 
methods and production process procedures, and all packaging, labeling, 
and labels approved for use with the product. Additionally, the 
proposed MMR section includes requirements for the review and approval 
of the MMR, including any changes after initial approval.
5. Subpart E--Process Controls
    Subpart E contains nine proposed sections: purchasing controls; 
acceptance activities; production processes and controls; laboratory 
controls; production record; sampling; nonconforming tobacco product; 
returned tobacco product; and reprocessing and rework. The purchasing 
controls section would require finished and bulk tobacco product 
manufacturers to establish and maintain procedures for ensuring that 
purchased or otherwise received products and services related to the 
manufacture of a finished or bulk tobacco product are from qualified 
suppliers and conform to established specifications. The acceptance 
activities section would require finished and bulk tobacco product 
manufacturers to establish and maintain procedures for incoming and for 
in-process and/or final acceptance activities, including acceptance 
criteria, to ensure that products meet established specifications. The 
production processes and controls section would require finished and 
bulk tobacco product manufacturers to establish and maintain procedures 
for production processes, including process specifications and process 
controls, process validation, and manual methods and manufacturing 
material. The laboratory controls section would require finished and 
bulk tobacco product manufacturers to demonstrate laboratory competency 
to perform laboratory activities associated with the manufacture of 
finished and bulk tobacco products and to establish and maintain 
laboratory control procedures for any laboratory activities conducted 
under proposed part 1120. The production record section would require 
finished and bulk tobacco product manufacturers to establish and 
maintain procedures for ensuring that a production record is prepared 
for each batch of finished or bulk product to demonstrate conformity 
with the requirements established under the MMR. The sampling section 
would require finished and bulk tobacco product manufacturers to 
establish and maintain an adequate sampling plan that uses 
representative samples based on a valid scientific rationale for any 
sampling performed under proposed part 1120. The nonconforming tobacco 
product section would require finished and bulk tobacco product 
manufacturers to establish and maintain procedures for control and 
disposition of nonconforming tobacco product, including specific 
requirements for identification and segregation, investigation, and 
disposition and followup. The proposed returned tobacco product section 
would require procedures for the control and disposition of returned 
tobacco product, including specific requirements for identification, 
segregation, evaluation, and disposition. The reprocessing and rework 
section would require procedures for reprocessing and reworking tobacco 
products, including specific requirements for evaluation of the tobacco 
product to determine that it is appropriate for reprocessing or rework, 
authorization of the reprocessing or rework, and production processes, 
including process controls, to ensure that reprocessed and reworked 
tobacco product conforms to MMR specifications. Manufacturers also 
would be required to maintain records of all activities required under 
this subpart.
6. Subpart F--Packaging and Labeling Controls
    Subpart F contains four proposed sections: packaging and labeling 
controls; repackaging and relabeling; manufacturing code; and warning 
plans. The packaging and labeling controls section would require 
finished and bulk tobacco product manufacturers to establish and 
maintain procedures for ensuring that the correct packaging and 
labeling is used to prevent mixups and that all packaging and labeling 
is approved for use by the manufacturer and complies with all 
requirements of the MMR as well as other applicable requirements of the 
FD&C Act, the Comprehensive Smokeless Tobacco Health Education Act 
(CSTHEA), and the Federal Cigarette Labeling and Advertising Act 
(FCLAA) and their implementing regulations. The section would also 
require the packaging and labeling control procedures to ensure that 
labels are indelibly printed on or permanently affixed to finished and 
bulk tobacco product packages; and that the packaging, labeling, 
storage, and shipping cases do not contaminate or otherwise render the 
tobacco product adulterated or misbranded. The repackaging and 
relabeling requirements would require finished tobacco product 
manufacturers to establish and maintain procedures for repackaging and 
relabeling operations. The manufacturing code section would require 
finished and bulk tobacco product manufacturers to apply a 
manufacturing code that contains the manufacturing date and batch 
number to the packaging or label of all finished and bulk tobacco 
products. The warning plans section would require manufacturers of 
finished tobacco products that are required to comply with a warning 
plan for tobacco product packaging, to establish and maintain 
procedures for implementing the requirements of such plan. 
Manufacturers would also be required to maintain records of all 
activities required under this subpart.
7. Subpart G--Handling, Storage and Distribution
    Subpart G contains two proposed sections: handling and storage and 
distribution. The handling and storage

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section would require finished and bulk tobacco product manufactures to 
establish and maintain procedures to ensure that tobacco products are 
handled and stored under appropriate conditions to prevent 
nonconforming products as well as mixups, deterioration, contamination, 
adulteration, and misbranding of tobacco products. The distribution 
section would require finished and bulk tobacco product manufacturers 
to establish and maintain procedures to ensure that tobacco products 
are distributed to the initial consignee under appropriate conditions 
and that only those finished and bulk tobacco products approved for 
release are distributed. The distribution section would also require 
finished and bulk tobacco product manufacturers to maintain 
distribution records and a list of direct accounts.
8. Subpart H--Recordkeeping and Document Controls
    The recordkeeping and document control requirements section 
establishes certain requirements for documents and records required by 
this rule. This section would require that all documents and records be 
maintained at the manufacturing establishment or another location that 
is readily accessible to responsible individuals of the manufacturer 
and to FDA and that they be written in English or an English 
translation be made available upon request. Documents and records 
required under this section that are associated with a batch of 
finished or bulk tobacco product must be retained for a period of not 
less than 4 years from the date of distribution of the batch or until 
the product reaches its expiration date if one exists, whichever is 
later. Documents and records required under this section that are not 
associated with a batch of finished or bulk tobacco product must be 
retained for a period of not less than 4 years from the date they were 
last in effect. FDA is soliciting comment on whether the timeframe for 
manufacturers to retain the documents and records under this section is 
sufficient for FDA's inspections and compliance activities or if it 
should be extended for an additional 1 or 2 years after the tobacco 
product reaches its expiration date if one exists. They also must be 
made readily accessible to FDA during the retention period for 
inspection and photocopying or other means of reproduction. This 
section also would require finished and bulk tobacco product 
manufacturers to ensure that all records are attributable to a 
responsible individual, legible, contemporaneously recorded, original, 
and accurate and to establish and maintain procedures for the approval 
and distribution of documents and for making changes to documents.
9. Subpart I--Small Tobacco Product Manufacturers
    Subpart I explains that small tobacco product manufacturers of 
finished and bulk tobacco products would not have to comply with the 
TPMP regulation until 4 years after the effective date of the final 
rule.
10. Subpart J--Exemptions and Variances
    Subpart J consists of five sections, and it sets forth the proposed 
procedures and requirements for petitioning for an exemption or 
variance from a TPMP requirement. Pursuant to section 906(e)(2)(B) of 
the FD&C Act (21 U.S.C. 387f), this subpart also would establish that a 
petition for an exemption or variance may be referred to the Tobacco 
Products Scientific Advisory Committee (TPSAC) and describe how FDA 
would make a determination on a petition for an exemption or variance. 
Finally, pursuant to section 906(e)(2)(E) of the FD&C Act, this subpart 
would provide that the petitioner has an opportunity for a hearing 
after the issuance of an order denying or approving a petition for an 
exemption or variance.

C. Legal Authority

    Section 906(e) of the FD&C Act (21 U.S.C. 387f) states that in 
applying manufacturing restrictions to tobacco, FDA shall prescribe 
regulations requiring that the methods used in, and the facilities and 
controls used for, the manufacture, preproduction design validation 
(including a process to assess the performance of a tobacco product), 
packing, and storage of a tobacco product conform to current good 
manufacturing practice (cGMP) or hazard analysis and critical control 
point (HACCP) methodology as prescribed in such regulations to assure 
that the public health is protected and that the tobacco product is in 
compliance with chapter IX of the FD&C Act (21 U.S.C. 387 through 
387u). The proposed requirements flow from this authority and serve 
these goals of protecting public health and assuring compliance with 
chapter IX of the FD&C Act.
    The proposed rule is also being issued based upon: FDA's 
authorities related to adulterated and misbranded tobacco products 
under sections 902 and 903 (21 U.S.C. 387c); FDA's authorities related 
to records and reports under section 909 (21 U.S.C. 387i); and FDA's 
rulemaking and inspection authorities under sections 701 (21 U.S.C. 
371), 704 (21 U.S.C. 374), and 905(g) (21 U.S.C. 387e(g)) of the FD&C 
Act.

D. Costs and Benefits

    The proposed rule, if finalized, would establish requirements for 
manufacturers of finished and bulk tobacco products on the methods used 
in, and the facilities and controls used for, the manufacture, pre-
production design validation, packing, and storage of tobacco products. 
The TPMP requirements described in the proposed rule are expected to 
ensure that tobacco product manufacturers control the design and 
specifications of finished and bulk tobacco products, providing a level 
of assurance of conformity in the production of tobacco products to 
established and required specifications that does not occur in the 
existing market for tobacco products, to prevent the adulteration and 
misbranding of finished and bulk tobacco products, and establish 
controls for traceability purposes.
    Estimated quantified benefits of the proposed rule arise from the 
value of reduced adverse events due to nonconforming finished and bulk 
tobacco products and from the reduction of costs associated with 
reduced product recalls and market withdrawals. We estimate the mean 
present value of benefits annualized over ten years using a seven and 
three percent discount rate to be $27.2 million and $29.9 million.
    There are other potential benefits associated with the proposed 
rule which we have not quantified. First, the proposed recordkeeping 
provisions would support FDA's regulatory compliance activities and 
help FDA implement and enforce other provisions of the FD&C Act which 
will likely generate government cost savings. Second, the proposed 
rule, if finalized, may further reduce losses to health and property 
for users and nonusers associated with nonconforming tobacco products, 
beyond those estimated in the quantified benefits. Third, the proposed 
rule's risk assessment, CAPA, tobacco product complaints, and related 
provisions will facilitate investigation and identification of causes 
and root causes of consumer complaints and other reports of adverse 
events. Other benefits include avoided spillover costs to capital 
markets.\1\
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    \1\ Estimated quantified benefits of avoided recalls include 
reduced external costs in the supply chain of the recalled or 
withdrawn products (or they exclude reduced recall costs to 
manufacturers). Estimated external costs of conducting a recall or 
market withdrawal include lost sales to retailers and wholesalers, 
expenses associated with notifying tobacco retailers (for 
wholesalers) and consumers, removal and storage of inventory costs 
collection and shipping costs, disposal costs, and legal costs, 
among others. Estimated quantified benefits do not include avoided 
spillover costs to capital markets.

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    Initial and recurring costs from this proposed rule arise from 
conducting tasks associated with establishing and maintaining 
procedures for various aspects of the manufacturing, preproduction 
design validation, packing and storage processes. We estimate the mean 
present value of costs annualized over ten years using a seven and 
three percent discount rate to be $27.0 million and $28.2 million.

II. Table of Abbreviations/Commonly Used Acronyms in This Document

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     Abbreviation/acronym                    What it means
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AAMI.........................  Advancement of Medical Instrumentation.
ALCOA........................  Attributable, Legible, Contemporaneously
                                Recorded, Original, and Accurate.
ANSI.........................  American National Standards Institute.
ASTM.........................  American Society for Testing and
                                Materials.
ASQ..........................  American Society for Quality.
CAPA.........................  Corrective and Preventive Actions.
CDC..........................  Centers for Disease Control and
                                Prevention.
cGMP.........................  Current Good Manufacturing Practice.
CoA..........................  Certificate of Analysis.
CORESTA......................  Cooperation Centre for Scientific
                                Research Relative to Tobacco.
CSTHEA.......................  Comprehensive Smokeless Tobacco Health
                                Education Act.
Deeming Rule.................  Deeming Tobacco Products To Be Subject to
                                the Food, Drug, and Cosmetic Act, as
                                Amended by the Family Smoking Prevention
                                and Tobacco Control Act; Regulations
                                Restricting the Sale and Distribution of
                                Tobacco Products and Required Warning
                                Statements for Tobacco Product Packages
                                and Advertisements.
EA...........................  Environmental Assessment.
E. coli......................  Escherichia coli.
EIS..........................  Environmental Impact Statement.
ENDS.........................  Electronic Nicotine Delivery Systems.
E.O..........................  Executive Order.
FCLAA........................  Federal Cigarette Labeling and
                                Advertising Act.
FCTC.........................  Framework Convention on Tobacco Control.
FDA or Agency................  Food and Drug Administration.
FD&C Act.....................  Federal Food, Drug, and Cosmetic Act.
FR...........................  Federal Register.
HACCP........................  Hazard Analysis and Critical Control
                                Point.
HHS..........................  Health and Human Services.
HVAC.........................  Heating, Ventilation, and Cooling.
IARC.........................  International Agency for Research on
                                Cancer.
IEC..........................  International Electrotechnical
                                Commission.
ISO..........................  International Organization for
                                Standardization.
MITC.........................  Manufacturer Detected Methyl
                                Isothiocyanate.
MMR..........................  Master Manufacturing Record.
MRTPs........................  Modified Risk Tobacco Products.
MRTPA........................  Modified Risk Tobacco Product
                                Application.
NNK..........................  4-(methylnitrosamino)-1-(3-pyridyl)-1-
                                butanone.
NNN..........................  N-nitrosonornicotine.
NPRM.........................  Notice of Proposed Rulemaking.
NTRMs........................  Nontobacco Related Materials.
OMB..........................  Office of Management and Budget.
OOS..........................  Out-Of-Specification.
SE...........................  Substantial Equivalence.
PMTA.........................  Premarket Tobacco Product Application.
PRA..........................  Paperwork Reduction Act of 1995.
PRIA.........................  Proposed Regulatory Impact Analysis.
QMS..........................  Quality Management System.
QSR..........................  Quality System Regulation.
RYO..........................  Roll-Your-Own.
Tobacco Control Act..........  Family Smoking Prevention and Tobacco
                                Control Act.
TPMP.........................  Tobacco Product Manufacturing Practice.
TPSAC........................  Tobacco Products Scientific Advisory
                                Committee.
TSNAs........................  Tobacco-Specific Nitrosamines.
UPC..........................  Universal Product Code.
USB..........................  Universal Serial Bus.
U.S.C........................  United States Code.
WHO..........................  World Health Organization.
------------------------------------------------------------------------

III. Background

A. Legal Authority

    The Family Smoking Prevention and Tobacco Control Act (Tobacco 
Control Act) was enacted on June 22, 2009, amending the FD&C Act and 
providing FDA with the authority to regulate tobacco products (Pub. L. 
111-31). Specifically, section 101(b) of the Tobacco Control Act 
amended the FD&C Act by adding chapter IX, which provides FDA with the 
authority to regulate tobacco products and imposes certain obligations 
on tobacco product

[[Page 15179]]

manufacturers (including importers), distributors, and retailers.
    Section 901(b) of the FD&C Act establishes FDA's immediate 
authority over cigarettes, cigarette tobacco, roll-your-own (RYO) 
tobacco, smokeless tobacco, and tobacco products containing nicotine 
that is not made or derived from tobacco,\2\ and permits FDA, by 
regulation, to deem additional tobacco products subject to chapter IX 
of the FD&C Act. In the Federal Register of May 10, 2016 (81 FR 28973), 
FDA published a final rule entitled ``Deeming Tobacco Products To Be 
Subject to the Food, Drug, and Cosmetic Act, as Amended by the Family 
Smoking Prevention and Tobacco Control Act; Regulations Restricting the 
Sale and Distribution of Tobacco Products and Required Warning 
Statements for Tobacco Product Packages and Advertisements'' (Deeming 
Rule) deeming all tobacco products meeting the statutory definition of 
``tobacco product,'' except accessories of deemed tobacco products, to 
be subject to chapter IX of the FD&C Act. FDA intends for this proposed 
rule to apply to manufacturers of all finished and bulk tobacco 
products that are subject to chapter IX of the FD&C Act, except 
finished and bulk accessories of cigarettes, cigarette tobacco, RYO 
tobacco, smokeless tobacco, and tobacco products containing nicotine 
that is not made or derived from tobacco.
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    \2\ See Consolidated Appropriations Act, 2022, Public Law 117-
103, div. P, tit. I, subtit. A, sec. 111(b) (March 15, 2022).
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    Section 906(e) of the FD&C Act provides that in applying 
manufacturing restrictions to tobacco, FDA shall prescribe regulations 
requiring that the methods used in, and the facilities and controls 
used for, the manufacture, preproduction design validation (including a 
process to assess the performance of a tobacco product), packing, and 
storage of a tobacco product conform to cGMP or HACCP methodology, as 
prescribed in such regulations to assure that the public health is 
protected and that the tobacco product is in compliance with chapter IX 
of the FD&C Act. The requirements in proposed part 1120, including 
management system requirements; buildings, facilities, and equipment 
requirements; design and development controls; process controls; 
packaging and labeling controls; handling, storage, and distribution 
requirements; and recordkeeping and document controls, are derived from 
this authority. Section 902(7) of the FD&C Act provides that a tobacco 
product shall be deemed to be adulterated if the methods used in, or 
the facilities or controls used for, its manufacture, packing, or 
storage are not in conformity with applicable requirements under 
section 906(e)(1) of the FD&C Act or an applicable condition prescribed 
by an order under section 906(e)(2) of the FD&C Act. As a result, a 
product will be adulterated if a manufacturer fails to comply with the 
requirements prescribed in this proposed regulation. Violations 
relating to section 906(e) of the FD&C Act are subject to regulatory 
action by FDA, including seizure and injunction.
    In addition, section 909 of the FD&C Act authorizes FDA, by 
regulation, to require manufacturers and importers of tobacco products 
to establish and maintain records, make reports, and provide 
information to assure that such tobacco products are not adulterated or 
misbranded, and to otherwise protect public health. Section 909 thus 
provides additional legal authority for the proposed rule's 
recordkeeping, reporting, and related requirements. In addition, under 
section 701(a) of the FD&C Act (21 U.S.C. 371(a)), FDA has the 
authority to issue regulations for the efficient enforcement of the 
FD&C Act. The proposed rule will help assure that tobacco products are 
not adulterated or misbranded under other provisions of the FD&C Act 
and will assist in the efficient enforcement of those other provisions. 
For example, section 902 of the FD&C Act provides that a tobacco 
product is adulterated in several circumstances including: (1) if a 
tobacco product consists in whole or in part of any filthy, putrid, or 
decomposed substance, or is otherwise contaminated by any added 
poisonous or added deleterious substance that may render the product 
injurious to health; (2) it has been prepared, packed, or held under 
insanitary conditions whereby it may have been contaminated with filth, 
or whereby it may have been rendered injurious to health; or (3) its 
package is composed, in whole or in part, of any poisonous or 
deleterious substance which may render the contents injurious to 
health. (Section 902(1)-(3) of the FD&C Act.) The proposed rule will 
help ensure that tobacco products are not adulterated in these ways, 
and that appropriate records, reports, and information will be 
available to enforce section 902's adulteration provisions. To similar 
effect, section 903 provides that a tobacco product is misbranded if, 
for example, its labeling is false or misleading in any particular or 
if the product does not bear labeling that is required by an applicable 
tobacco product standard established under section 907 (section 
903(a)(1) and (a)(9) of the FD&C Act). The proposed rule's labeling 
requirements will help prevent tobacco products from being misbranded 
in violation of section 903.
    Further, section 801(a) of the FD&C Act gives FDA authority to 
refuse admission of tobacco products imported or offered for import 
into the United States in situations where it appears such products: 
(1) have been manufactured, processed, or packed under insanitary 
conditions; (2) are forbidden or restricted in sale in the country in 
which they were produced or from which they were exported; or (3) are 
adulterated or misbranded. As noted earlier, section 701(a) of the FD&C 
Act (21 U.S.C. 371(a)) authorizes FDA to issue regulations for the 
efficient enforcement of the FD&C Act. The proposed rule will assist in 
the efficient enforcement of the FD&C Act's import requirements under 
section 801(a) by requiring manufacturers of finished and bulk tobacco 
products to implement certain controls over their product 
manufacturing, preproduction design validation, packing, and storage 
activities, including recordkeeping, to prevent the import of tobacco 
products that appear to be adulterated or misbranded.
    Finally, the proposed rule will assist in the performance of FDA 
inspections under section 704 (21 U.S.C. 374) and 905(g) (21 U.S.C. 
387e(g)) of the FD&C Act.

B. Rationale for the Proposed Regulation

    While all tobacco products have inherent risks to the public 
health, FDA is proposing TPMP requirements to minimize or prevent 
product problems, as well as health issues not normally associated with 
use of a tobacco product. For example, these requirements would help 
minimize or prevent the manufacture and distribution of tobacco 
products contaminated with foreign substances (e.g., nontobacco related 
materials (NTRMs) such as metal, glass, nails, pins, wood, dirt, sand, 
stones, rocks, fabric, cloth, and plastics) which have been found in 
finished tobacco products as will be discussed further below. These 
requirements also would help minimize or prevent the manufacture and 
distribution of nonconforming electronic nicotine delivery systems 
(ENDS) e-liquids that contain nicotine concentration levels that vary 
from the labeled amount and vary from one ENDS product to another 
within the same brand (Ref. 1, Ref. 178). As explained elsewhere in 
this document, this potential variability in nicotine concentration, in 
which an e-liquid product contains significantly higher

[[Page 15180]]

levels of nicotine than what is stated on the label, could be 
misleading to consumers concerned about nicotine delivery levels, 
potentially intensifying or prolonging their addiction and potentially 
exposing users to increased toxins (Refs. 4 and 5). Tobacco products 
may introduce preventable harms not normally associated with use of 
tobacco products due to inadequate design or manufacturing controls; 
for example, defective solder joints from an ENDS cartomizer (atomizer 
plus replaceable fluid-filled cartridge) may cause respiratory distress 
due to metallic particles in the aerosol (Ref. 2). This proposed 
regulation would help to assure that the public health is protected 
from these, and other, types of hazards and that tobacco products 
comply with chapter IX of the FD&C Act.
    FDA is proposing a TPMP regulation under section 906(e) of the FD&C 
Act that employs a Quality Management System (QMS) approach. QMS 
approaches are well established and have been required (e.g., 21 CFR 
part 820) or utilized by FDA (e.g., ``FDA Guidance for Industry--
Quality Systems Approach to Pharmaceutical CGMP Regulations'') in other 
product categories. A QMS can protect the public health in several 
ways. First, a QMS can enable the manufacturer to demonstrate its 
ability to consistently produce products that meet applicable statutory 
and regulatory requirements. Second, a QMS can enable a manufacturer to 
establish and maintain a robust design and development process for its 
product and to adequately identify and control nonconforming products 
to prevent their distribution and related potential harm. Finally, if 
nonconforming products are discovered, a QMS can provide the 
manufacturer with a recognized framework to effectively investigate and 
identify the nonconforming products in order to institute appropriate 
corrective actions such as conducting a recall as needed. If a firm is 
manufacturing a tobacco product that is contaminated or inconsistent 
with the specifications identified in an application under which it has 
received marketing authorization, the tobacco product may be 
adulterated or misbranded pursuant to section 902 or section 903 of the 
FD&C Act and subject to regulatory action. Thus, the proposed 
regulation based on a QMS approach, if finalized, would help assure 
that the public health is protected and that tobacco products are in 
compliance with chapter IX of the FD&C Act.
1. Assuring That the Public Health Is Protected
    The proposed regulation would help assure that the public health is 
protected by, among other things, minimizing the likelihood of the 
manufacture and distribution of nonconforming tobacco products. A 
``nonconforming tobacco product'' is proposed to be defined as any 
tobacco product that: (1) does not meet a product specification as set 
by the MMR (see proposed Sec.  1120.44(a)(1)); (2) has packaging, 
labeling, or labels other than those included in the MMR (see proposed 
Sec.  1120.44(a)(3)); or (3) is a contaminated tobacco product 
(proposed Sec.  1120.3). Nonconforming products occur for many 
different reasons, including inadequate sanitation practices, design 
issues, failures of or problems with purchasing controls, inadequate 
process controls, improper facilities or equipment, inadequate 
personnel training, inadequate manufacturing methods and procedures, 
the introduction or presence of hazards, or improper handling or 
storage of the tobacco product. A tobacco product that does not conform 
to established specifications, has incorrect packaging, labeling, or 
labels, or is contaminated could increase the product's risk compared 
to what would normally be associated with use of the product.
    Tobacco products with contaminants that could have been prevented 
with the implementation of this proposed TPMP rule have been 
identified. For example, consumer complaints of foreign metal material, 
including sharp metal objects, in a manufacturer's smokeless tobacco 
(e.g., chewing) products ultimately led the manufacturer to issue a 
voluntary recall of certain products on January 31, 2017 (Ref. 3). In 
other instances, smokeless tobacco products have contained rocks or 
metal shavings as well as other NTRMs (e.g., glass, nails, pins, wood, 
dirt, sand, fabric, cloth, and plastics) in finished tobacco products. 
These NTRMs can cause cuts or lacerations to the lips and gums or 
result in broken teeth. This proposed regulation includes measures that 
will help avoid such contamination, in addition to provisions for how 
manufacturers would be required to handle complaints in similar 
situations, as well as the subsequent investigation, evaluation, and 
CAPA they would need to take to address such issues.
    Consumers have reported additional substances not ordinarily 
contained in tobacco products such as biological materials (e.g., mold, 
mildew, hair, fingernails) and chemical hazards (e.g., ammonia, 
cleaning agents, and kerosene). Caustic cleaning chemicals may cause 
vomiting, nausea, allergic reactions, dizziness, numbness, or 
headaches.
    Even when nonconforming tobacco products are not contaminated with 
foreign objects or substances, they may contain higher levels of a 
constituent than the consumer is expecting, which can have negative 
health effects not normally associated with the tobacco product. For 
example, researchers have reported on the variability of nicotine in 
certain ENDS e-liquids and that the labeling of these products did not 
accurately reflect the actual nicotine levels. For example, there have 
been reports of wide variability in e-cigarette manufacturing, 
including nicotine concentrations in e-liquid, that were inconsistent 
with the information contained on the product label (Ref. 178). In one 
study, researchers found that actual nicotine amounts differed from 
label amounts by more than 20 percent in 9 out of 20 original e-
cigarette cartridges tested, and in 3 out of 15 refill cartridges 
tested (Ref. 1). In a second study, 9 of 21 samples had nicotine levels 
that deviated from the labeled value by more than 10%, with 
inconsistencies ranging from -21 percent to +22.1 percent (Ref. 4). 
Nicotine delivery varies not only across brands, but also within brands 
(Refs. 178-180). A finished ENDS that contains a nicotine concentration 
higher than the established specification can be more addictive. 
Similarly, a cigarette that does not conform to its pH specification 
can affect the amount of nicotine that is delivered to the user and its 
rate of absorption that can increase the tobacco product's toxicity and 
addictiveness (Ref. 6).
    Nonconforming products may also occur because of design issues, 
which can cause the tobacco product to be more harmful. For example, an 
ENDS product, as designed, may have a design feature that contributes 
to an increased risk of fire and/or explosion. The ENDS product, during 
use or foreseeable misuse, can expose consumers to increased harm if 
the product catches fire or explodes resulting in serious burns that 
would not be expected from use of the product (e.g., Ref. 7).
    Given the dangers associated with contaminated and otherwise 
nonconforming tobacco products, FDA is proposing this regulation to 
help assure that the public health is protected by requiring that 
finished and bulk tobacco product manufacturers establish and maintain 
certain controls to prevent the manufacture and distribution of 
nonconforming products

[[Page 15181]]

that may have an adverse effect on public health.
2. Ensuring Compliance With Chapter IX of the FD&C Act
    The proposed regulation would help assure that tobacco products are 
in compliance with the requirements of chapter IX of the FD&C Act 
pursuant to section 906(e) of the FD&C Act. In particular, by requiring 
controls over the manufacturing process, the proposed regulation would 
help assure that tobacco products are manufactured in accordance with 
the specifications provided in their applications authorized by FDA. 
Specifications generally are included in four types of applications:
     Substantial equivalence (SE) report--To request marketing 
authorization for a new tobacco product, manufacturers may submit a 
report pursuant to section 905(j) of the FD&C Act (21 U.S.C. 387e) to 
demonstrate that the new tobacco product has the same characteristics 
as a predicate tobacco product, or has different characteristics than 
the predicate tobacco product but the information submitted 
demonstrates that it is not appropriate to regulate the product under 
section 910 because the product does not raise different questions of 
public health.
     Exemption from SE--To request marketing authorization for 
a new tobacco product that is modified by adding or deleting a tobacco 
additive, or increasing or decreasing the quantity of an existing 
tobacco additive, manufacturers may request an exemption from 
demonstrating SE under certain circumstances (see 21 CFR 1107.1 and 
section 905(j) of the FD&C Act).
     Premarket tobacco product application (PMTA)--To request 
marketing authorization for a new tobacco product, manufacturers may 
submit a PMTA, which must include, among other things, a full statement 
of the components, ingredients, additives, and properties of the 
product as well as a full description of the methods used in, and the 
facilities and controls used for, the manufacture, processing, and when 
relevant, packing and installation of the product. This pathway 
requires the applicant to demonstrate that marketing the new tobacco 
product is appropriate for the protection of public health pursuant to 
section 910 of the FD&C Act.
     Modified risk tobacco product application (MRTPA)--To 
request that a product be sold or distributed for use to reduce harm or 
the risk of tobacco-related diseases associated with commercially 
marketed tobacco products, manufacturers may submit an MRTPA, which 
must include, among other things, a description of the product and the 
formulation of the product. Applicants must demonstrate that, among 
other things, the product will or is expected to benefit the health of 
the population as a whole.
    If a firm is manufacturing a tobacco product that is inconsistent 
with the specifications identified in the application under which it 
has received marketing authorization, the tobacco product may be 
adulterated or misbranded pursuant to section 902 or section 903 of the 
FD&C Act and subject to regulatory action. Such a product could have 
negative effects on public health. For example, a cigarette that does 
not meet its specifications for ventilation such that ventilation is 
reduced can pose public health risk through the resulting higher 
delivery of harmful and potentially harmful constituents (HPHCs) 
including nicotine (Refs. 8-9, 106, 173, and 183). FDA believes that 
the proposed TPMP rule (if finalized) would help ensure that tobacco 
products conform to the specifications in their authorized marketing 
applications and do not provide a more addictive or toxic product to 
consumers.
    Pursuant to section 910(a)(1) of the FD&C Act, tobacco products 
that were commercially marketed (other than exclusively in test 
markets) in the United States as of February 15, 2007 (``pre-existing 
products''), are not considered ``new tobacco products'' and thus are 
not subject to the premarket requirements of the FD&C Act. These 
products are subject to other provisions of the FD&C Act, including 
proposed TPMP requirements. The proposed rule would help manufacturers 
ensure that pre-existing tobacco products are manufactured to their 
original specifications, and thus do not undergo any modification that 
would render them ``new'' and in violation of the requirements of 
chapter IX of the FD&C Act because they lack proper marketing 
authorization. It would also help FDA identify and determine if any 
changes to established specifications or manufacturing methods and 
procedures result in a modification that would render the tobacco 
product ``new.''
    Manufacturers must also ensure that their tobacco products are in 
compliance with tobacco product standards under section 907 of the FD&C 
Act. Tobacco product standards may reduce the death and disease caused 
by tobacco use, encourage cessation, decrease initiation, or reduce the 
harms not normally associated with tobacco use, such as nicotine 
poisoning. The proposed requirements would help a finished or bulk 
tobacco product manufacturer to ensure that, and FDA to review whether, 
the tobacco products conform to applicable tobacco product standards.
    In addition to helping assure that tobacco products are 
manufactured in accordance with the specifications provided in their 
marketing applications authorized by FDA and that products are 
manufactured in accordance with applicable product standards, the 
proposed TPMP rule would help tobacco product manufacturers assure 
compliance with other requirements in chapter IX of the FD&C Act. For 
example, tobacco product manufacturers must submit a listing of 
ingredients, additives, and harmful and potentially harmful 
constituents to FDA under section 904 and applicable regulations under 
section 915 of the FD&C Act. The proposed TPMP recordkeeping 
requirements, including the MMR and production record requirements, 
could help FDA verify that the ingredients of these products are 
consistent with the listing of ingredients reported to FDA under 
section 904(a)(1) of the FD&C Act.
    Similarly, under section 905(i) of the FD&C Act, copies of all 
labeling, and section 910(b)(1)(F) of the FD&C Act, specimens of 
labeling, must be submitted by tobacco product manufacturers to FDA. 
This helps the Agency determine if a manufacturer has included 
unauthorized modified risk claims on product labels or labeling or if 
product labeling is false or misleading or otherwise renders the 
product misbranded under section 903 of the FD&C Act. The recordkeeping 
requirements in the proposed regulation related to packaging and 
labeling would help the Agency make similar assessments, as well as 
identify variations between the submitted labeling and actual packaging 
and labeling.
    Finally, the proposed contamination and risk management controls 
would help prevent products from becoming contaminated. Finished or 
bulk tobacco products that contain substances such as physical, 
chemical, and/or biological hazards may be adulterated under sections 
902(1) to (3) of the FD&C Act. The proposed requirements for facilities 
and controls covering the manufacture, packing, and storage of tobacco 
products would help minimize the occurrence of these kinds of hazards 
and would therefore help ensure that products are in compliance with 
the requirements of chapter IX of the FD&C Act.

[[Page 15182]]

C. Development of the Proposed Regulation

    FDA's development of this proposed regulation reflects its 
experience in regulating tobacco products, including the inspections 
and facility visits of tobacco manufacturing facilities it has 
conducted, recommendations for good manufacturing practice requirements 
for ENDS submitted by tobacco product manufacturers, and public 
comments filed in response to these recommendations (Docket No. FDA-
2013-N-0227). FDA is also drawing on its experience with cGMP and HACCP 
regulations for other regulated products, such as foods, medical 
devices, drugs, and dietary supplements.
    FDA's experience with biennial inspections of tobacco products has 
informed this proposal. Pursuant to section 905(g) of the FD&C Act, FDA 
has conducted hundreds of inspections of establishments engaged in the 
manufacture of regulated tobacco products, including cigarettes, 
cigarette tobacco, RYO tobacco, and smokeless tobacco since October 1, 
2011. FDA believes that this experience is also relevant to 
establishments that manufacture deemed products, which engage in many 
similar activities and processes. Beginning in 2017, the Agency also 
began inspecting manufacturing establishments of deemed tobacco 
products, including ENDS products.
    In August 2012, FDA issued a notice in the Federal Register 
announcing an invitation to participate in its Tobacco Product 
Manufacturing Facility Visits program (77 FR 48992, August 15, 2012). 
The purpose of the program was to provide an opportunity for tobacco 
product manufacturing facilities, including facilities related to 
laboratory testing, to invite FDA staff to visit these facilities and 
observe their manufacturing operations. As part of this program, FDA 
staff visited tobacco product manufacturers, including small tobacco 
product manufacturers, of cigarettes, smokeless tobacco products, and 
cigarette papers, as well as facilities that conduct laboratory testing 
services for the tobacco industry. In response to a similar notice 
issued in 2016 (81 FR 39053, June 15, 2016), FDA staff also visited 
manufacturing facilities of domestic and foreign manufacturers, 
including small tobacco product manufacturers, of deemed tobacco 
products including cigars, ENDS, and e-liquids. FDA's experiences 
during these visits have helped to inform this proposal.
    In addition, on January 10, 2012, 13 tobacco companies and a trade 
association of tobacco product manufacturers submitted to FDA their 
recommendations for regulations on cGMP. This group of industry 
stakeholders included manufacturers of a variety of tobacco products 
including cigarettes, smokeless tobacco, and snus. On May 2, 2012, 
representatives of the tobacco companies met with the Agency to present 
an overview of the recommendations and their approach to developing 
them. FDA established a public docket requesting public comment on 
these industry recommendations (78 FR 16824, March 19, 2013). These 
industry GMP recommendations included proposed requirements for an 
extensive range of manufacturing practices including: qualification of 
personnel; complaints and recordkeeping; procedures for nonconforming 
product; contamination prevention; buildings, facilities, and 
equipment; MMR; acceptance activities; supplier evaluation; 
manufacturing records; packaging and labeling; handling and storage; 
and general recordkeeping and document control procedures. We received 
comments on the industry recommendations from a variety of stakeholders 
including manufacturers of cigarettes, cigars, smokeless tobacco, and 
snus, as well as from public health advocates.
    Further, on June 7, 2017, a group of 13 tobacco companies, a trade 
coalition representing small tobacco product manufacturers, and a 
standards organization representing vaping manufacturers and retailers 
submitted updated supplemental industry recommendations in order to 
provide additional cGMP recommendations for ENDS products. The 
supplemental industry GMP recommendations were generally similar to 
industry manufacturing practices that the Agency has observed through 
its biennial inspections. Among the cGMP requirements that industry 
recommended for ENDS products were specific ENDS design process and 
procedures, process qualification requirements to ensure that products 
consistently meet specifications, procedures to validate and approve 
test methods, and requirements for stability testing, reserve samples, 
and sampling plans.
    FDA established a public docket requesting comment on these updated 
industry recommendations for good manufacturing practice requirements 
for ENDS (82 FR 55613, November 22, 2017). FDA received additional 
comments from manufacturers of a variety of tobacco products, public 
health advocates, and individuals sharing their experiences with ENDS. 
In developing this regulation, FDA reviewed and considered the 
recommendations from both industry proposals, as well as the comments 
submitted to the public docket.
    FDA is proposing many requirements similar to those included in the 
industry GMP recommendations, particularly in the areas of personnel; 
contamination prevention; requirements for buildings, facilities, and 
equipment; development of an MMR; purchasing controls; process 
controls; production records; procedures for nonconforming tobacco 
product; complaints; packaging and labeling; distribution; and document 
control procedures.
    However, FDA's proposal deviates from the industry GMP 
recommendations in several ways. First, the proposed TPMP regulation 
generally includes more robust provisions for procedures and records 
than provisions in the industry GMP recommendations. For example, the 
industry recommendations do not propose requirements for design and 
development activities generally, returned tobacco product, and warning 
plans, as discussed throughout this preamble. Such provisions are 
critical for the efficient enforcement of the FD&C Act.
    Second, FDA's proposal includes additional provisions that are 
necessary to assure that the public health is protected and that 
manufacturers' tobacco products are in compliance with chapter IX of 
the FD&C Act. As noted, the industry GMP recommendations do not propose 
requirements for returned tobacco product and warning plans (see 
sections IV.E and IV.F.3 for a discussion of these FDA proposals and 
why FDA believes they will help assure the protection of the public 
health). In addition, to ensure that tobacco product manufacturers can 
demonstrate that their tobacco products consistently conform to 
established specifications, an important public health objective, the 
proposed rule includes additional requirements for environmental 
controls, process validation, laboratory controls, and sampling. 
Moreover, this document includes proposed requirements for design and 
development activities, as well as complaint, CAPA, and nonconforming 
product investigations. To address risks not normally associated with 
use of tobacco products, FDA is also proposing manufacturing code and 
distribution record requirements to facilitate the traceability of 
nonconforming products and enable tobacco product manufacturers and FDA 
to take appropriate corrective actions to protect the public health.

[[Page 15183]]

    FDA also has chosen not to propose certain requirements in the 
industry cGMP recommendations which, in some cases, would have been 
more burdensome than FDA's proposed requirements. For example, FDA 
considered industry recommendations stating that TPMP requirements 
should be modified for ENDS given that they are different from other 
tobacco products. FDA's proposed rule, instead, utilizes an 
``umbrella'' approach with flexible requirements, similar to other cGMP 
regulations, that would apply to the wide variety of tobacco products 
offered for sale or distribution. For example, the scope of covered 
tobacco products in the 2017 supplemental industry cGMP recommendations 
covers manufacturers and suppliers of ENDS components and parts and 
included an additional requirement for stability tests to determine 
appropriate storage conditions and expiration dates for finished ENDS 
products. However, FDA believes that such requirements are unnecessary 
and that the FDA proposal to cover bulk tobacco product manufacturers 
and the proposed requirements for design and development controls, 
process controls, and handling and storage requirements are sufficient 
to address the design, manufacture, and storage of ENDS products.
    Further, the industry GMP recommendations include a requirement for 
a HACCP analysis for ENDS and e-liquids. While the Agency considered 
requiring HACCP plans in this proposal, as discussed in section IV.D.1, 
FDA determined that use of a risk management process would be more 
flexible for manufacturers while still assuring that the public health 
was protected.
    FDA also did not include the industry's proposed GMP recommendation 
to require reserve samples of the e-liquid-containing component/product 
from each lot or batch of finished ENDS products, similar to the 
reserve samples that are required for medical products. While reserve 
samples could be useful for determining a root cause for any 
nonconforming products or addressing any customer complaints, we 
believe that the proposed documentation and recordkeeping requirements 
are sufficient to address any investigation required under the proposed 
rule. For example, for a released product found to be nonconforming 
because of its nicotine concentration, under the proposed rule, the 
manufacturer and/or FDA could review the MMR and the purchasing, 
acceptance activities, and production records to determine the nicotine 
concentration of the released product as well as who conducted the 
testing and signed off on the release of the product. FDA's request for 
comments includes comments both on industry GMP recommendations that 
FDA is proposing in these requirements, and industry GMP 
recommendations that FDA is not proposing.
    In addition to the industry GMP recommendation, FDA considered its 
existing cGMP regulations for other regulated products and evaluated 
them for their suitability and applicability to tobacco products. 
Specifically, FDA considered the medical device quality system 
regulation (QSR) (part 820), and the food, dietary supplement, and drug 
cGMP regulations (21 CFR parts 110, 111, 210, and 211, respectively). 
In addition, FDA examined its regulations on HACCP systems, such as 
preventive controls for human foods, juice HACCP regulations, and fish 
and fishery products HACCP regulations (21 CFR parts 117, 120, and 123, 
respectively).
    FDA also considered voluntary industry cGMP and quality system 
standards in developing this proposal. For example, FDA evaluated the 
American E-Liquid Manufacturing Standards Association's voluntary E-
Liquid Manufacturing Standards (Ref. 10). The Agency also considered 
the International Organization for Standardization (ISO) ISO 
9001:2015--Quality management systems--Requirements (Ref. 11); ISO 
31000: 2018--Risk Management--Principles and Guidelines (Ref. 12).
    FDA considered the quality systems and QMS requirements in FDA's 
medical device QSR and pharmaceutical cGMP for the 21st century (Ref. 
13) in designing the proposed rule. The Agency believes certain aspects 
of those regulations are informative but not wholly applicable to 
tobacco products because of certain key differences between tobacco 
products and medical products regulated by FDA. For example, marketing 
applications for medical products are evaluated to determine whether 
they are ``safe and effective.'' Unlike medical products, tobacco 
products cannot be ``safe and effective'' even if used as intended and, 
therefore, the FD&C Act requires that marketing applications for 
tobacco products be evaluated under different standards (see, e.g., the 
``appropriate for the protection of the public health'' standard under 
section 910 of the FD&C Act). FDA has taken these differences into 
account in developing the proposed rule. For example, while the Agency 
has included requirements for CAPA, it has decided not to propose 
continuous process improvement requirements as part of this rule.
    The Agency's proposed rule utilizes an ``umbrella'' approach to the 
regulation of all types of finished and bulk tobacco products, which is 
similar to the approach taken by the other cGMPs and voluntary 
standards considered in the development of this proposal. Because this 
regulation would apply to many different types of tobacco products, the 
proposal does not prescribe in detail how a manufacturer must produce a 
specific tobacco product. Rather, the proposed regulation provides the 
framework that all manufacturers would follow by requiring that 
manufacturers establish and maintain procedures and fill in the details 
that are appropriate to a given tobacco product.

V. Description of the Proposed Regulation

A. General Provisions

1. Scope
    The Tobacco Control Act gave FDA immediate authority over 
cigarettes, cigarette tobacco, RYO tobacco, and smokeless tobacco. In 
addition, the Tobacco Control Act gave FDA the authority to promulgate 
regulations deeming other tobacco products subject to its authorities 
in chapter IX of the FD&C Act. In the Federal Register of May 10, 2016, 
FDA issued the Deeming Rule deeming all other products meeting the 
statutory definition of tobacco product to be subject to FDA's 
regulatory authority under chapter IX of the FD&C Act, except 
accessories of deemed products. 81 FR 28974. That rule became effective 
on August 8, 2016.
    As discussed in proposed Sec.  1120.1(a), FDA is proposing TPMP 
requirements that would apply to manufacturers of all finished and bulk 
tobacco products that are subject to chapter IX of the FD&C Act (e.g., 
cigarettes, cigarette tobacco, RYO tobacco, smokeless tobacco, ENDS, e-
liquids, pipe tobacco, cigars, hookah tobacco, nicotine gels, and 
dissolvable tobacco products) but not their related accessories.
    FDA proposes to define a ''finished tobacco product'' as a tobacco 
product, including any component or part, sealed in final packaging 
(e.g., a pack of cigarettes, a can of moist snuff). For the purposes of 
the ``finished tobacco product'' definition, a ``package'' is a pack, 
box, carton, or container of any kind or, if no other container, any 
wrapping, including cellophane, in which a finished tobacco product is 
offered for sale, sold, or otherwise distributed to consumers. As 
discussed in more detail below, the proposed

[[Page 15184]]

definition of finished tobacco product also includes components or 
parts of tobacco products sealed in final packaging (e.g., rolling 
papers, filters, filter tubes, or e-liquids sold separately to 
consumers or as part of kits). FDA intends for this TPMP rule to cover 
manufacturers of finished tobacco products to help assure that the 
public health is protected and that those products are in compliance 
with chapter IX of the FD&C Act.
    FDA proposes to define a ``bulk tobacco product'' as any tobacco 
product that is not sealed in final packaging but is otherwise suitable 
for consumer use as a tobacco product (e.g., bulk cigarettes, bulk RYO 
tobacco, bulk pipe tobacco). As discussed in more detail below, the 
proposed definition of bulk tobacco product also includes components or 
parts of tobacco products that are not sealed in final packaging but 
are otherwise suitable for consumer use as tobacco products (e.g., bulk 
filters, bulk e-liquids). Products that are suitable for consumer use 
as tobacco products are those products that do not require further 
processing by a tobacco product manufacturer, such as mixing, cutting, 
curing, blending, or adding components or parts, ingredients, additives 
and materials, before they can be used by a consumer. For example, an 
e-liquid not sealed in final packaging is suitable for consumer use as 
a tobacco product because it requires no additional processing by a 
tobacco product manufacturer before it can be used by a consumer in an 
ENDS device; it requires only final packaging and labeling to be a 
finished tobacco product. A product can be suitable for consumer use as 
a tobacco product even if it could undergo additional processing by a 
manufacturer, such as blending, as long as it does not require further 
processing by a manufacturer before use by a consumer. For example, 
coconut and pineapple e-liquids not sealed in final packaging would be 
considered bulk tobacco products because they are suitable for consumer 
use as tobacco products, even if they might later be blended together 
by a manufacturer to make pi[ntilde]a colada e-liquid.
    FDA is including bulk manufacturers within the scope of this 
proposed rule in order to cover critical regulatory gaps that would 
occur if the rule were to only cover manufacturers of finished tobacco 
products. Bulk manufacturers provide bulk tobacco products, such as 
bulk cigarettes, bulk RYO or pipe tobacco, and bulk e-liquids, to 
finished tobacco product manufacturers who merely package and/or label 
the products for consumer use. Bulk tobacco products are suitable for 
consumer use as tobacco products with no additional processing by a 
tobacco product manufacturer and, therefore, should be regulated in the 
same manner as finished tobacco products. If the scope of the rule were 
limited to finished tobacco product manufacturers, then entities that 
perform key manufacturing steps other than final packaging and labeling 
for consumer use, such as design and development, blending, mixing, 
cutting, processing, assembling, and compounding, might not be subject 
to any TPMP requirements. Inadequate controls in earlier stages of 
manufacturing could result in contaminated or otherwise nonconforming 
bulk tobacco products that would not be detected by a finished tobacco 
product manufacturer during packaging and labeling operations. In 
addition, a finished tobacco product manufacturer that packages or 
labels a bulk tobacco product may not be able to conduct adequate 
investigations of product complaints and implementing CAPA for issues 
related to product design or production processes.
    As noted above, the proposed definitions of finished and bulk 
tobacco products would include finished and bulk components or parts of 
tobacco products. FDA proposes to define ``component or part'' for 
purposes of proposed part 1120 consistent with the definition of 
``component or part'' in the Deeming Rule, codified at 21 CFR 1143.1. 
Accordingly, a component or part would mean any software or assembly of 
materials intended or reasonably expected: (1) to alter or affect the 
tobacco product's performance, composition, constituents, or 
characteristics, or (2) to be used with or for the human consumption of 
a tobacco product; but would exclude anything that is an accessory of a 
tobacco product. The requirements of proposed part 1120 would apply to 
manufacturers of finished and bulk components or parts of tobacco 
products. This would include manufacturers of finished or bulk RYO 
tobacco, papers, and filters, ENDS e-liquids, atomizers, batteries 
(with or without variable voltage), and cartomizers (atomizer plus 
replaceable fluid-filled cartridge).
    In determining whether software or an assembly of materials might 
be ``intended or reasonably expected'' to alter or affect a tobacco 
product's performance, composition, constituents, or characteristics, 
or to be used with or for the human consumption of a tobacco product 
(and, therefore, whether the software or assembly of materials is a 
``component or part''), the manufacturer's subjective claims of intent 
are not controlling. Rather, FDA considers all relevant evidence, 
including direct and circumstantial objective evidence, which 
encompasses a variety of factors, such as circumstances surrounding the 
distribution of the product or the context in which it is sold, sales 
data, and how the product is used by consumers.
    The requirements of proposed part 1120 would also apply to 
manufacturers of finished or bulk products for general consumer use 
(i.e., products not specifically designed for use with tobacco 
products) that meet the definition of finished or bulk tobacco products 
(including finished or bulk components or parts). For example, the 
requirements of proposed part 1120 would apply to manufacturers of 
finished or bulk batteries who intend them to be used in an ENDS 
device, for example by labeling or co-packaging the batteries with an 
ENDS device. Similarly, the rule would apply to manufacturers of 
finished or bulk food grade flavors who intend the flavors to be used 
with e-liquids. Likewise, the rule would apply to the manufacturer of a 
screen sold at a hardware store for a variety of general uses if that 
manufacturer labels the screen for use with a tobacco product, such as 
an ENDS, or co-packages the screen with a tobacco product.
    The proposed rule would not apply to manufacturers of accessories 
of finished or bulk tobacco products. FDA proposes to define an 
``accessory'' as any product that is intended or reasonably expected to 
be used with or for the human consumption of a tobacco product; does 
not contain tobacco and is not made or derived from tobacco; and meets 
either of the following: (1) is not intended or reasonably expected to 
affect or alter the performance, composition, constituents, or 
characteristics of a tobacco product or (2) is intended or reasonably 
expected to affect or maintain the performance, composition, 
constituents, or characteristics of a tobacco product but (i) solely 
controls moisture and/or temperature of a stored tobacco product; or 
(ii) solely provides an external heat source to initiate but not 
maintain combustion of a tobacco product. This proposed definition is 
the same as the definition of ``accessory'' under 21 CFR 1100.3 and 
under 21 CFR 1143.1. Examples of accessories of finished and bulk 
tobacco products include ashtrays, spittoons, hookah tongs, cigar clips 
and stands, and pipe pouches, because they do not contain tobacco, are 
not derived from tobacco, and do not affect or alter the performance, 
composition, constituents, or characteristics of a

[[Page 15185]]

tobacco product. Examples of accessories also include humidors or 
refrigerators that solely control the moisture and/or temperature of a 
stored product and conventional matches and lighters that solely 
provide an external heat source to initiate but not maintain combustion 
of a tobacco product. An electric heater or charcoal used for prolonged 
heating of waterpipe tobacco is not an accessory because it is 
maintaining the combustion of the tobacco. Accessories of deemed 
products are not currently subject to chapter IX of the FD&C Act. At 
this time, FDA believes that the proposed requirements of this rule 
assure that the public health is protected and that tobacco products 
are in compliance with chapter IX of the FD&C Act without applying the 
requirements to manufacturers of accessories of cigarettes, cigarette 
tobacco, RYO tobacco, smokeless tobacco, and deemed tobacco products.
2. Umbrella Approach
    This proposed rule utilizes an ``umbrella'' approach to the 
regulation of all types of finished and bulk tobacco products, which is 
similar to the approach taken by the other cGMPs and voluntary 
standards considered in the development of this proposal. Thus, the 
proposed regulation provides the framework that requires all finished 
and bulk tobacco product manufacturers subject to the rule (including 
specification developers, contract manufacturers, and repackagers/
relabelers) to establish and maintain procedures that are unique to the 
manufacturer's facilities and activities, and appropriate for a given 
tobacco product. The proposed requirements are written in general terms 
to allow manufacturers to establish procedures appropriate for their 
specific products and operations. The extent of the procedures 
necessary to meet the regulation requirements may vary with the size 
and complexity of the design and manufacturing operations. Tobacco 
product manufacturers who have a complex manufacturing process would 
likely need to establish more detailed procedures to comply with the 
rule, while tobacco product manufacturers who have a less complex 
manufacturing process may need less extensive procedures.
3. Specification Developers
    As discussed in proposed Sec.  1120.1(a), manufacturers of finished 
and bulk tobacco products include specification developers, contract 
manufacturers, and repackagers and relabelers. If a specification 
developer designs and establishes tobacco product specifications of a 
finished or bulk tobacco product and provides the specifications to a 
contract manufacturer to physically manufacture the product, both the 
specification developer and the contract manufacturer would be engaged 
in the manufacture and/or preproduction design validation of finished 
or bulk tobacco products for purposes of this rule and would be 
required to comply with this proposed rule. This approach is similar to 
other cGMP and HACCP regulations that have been applied to other FDA-
regulated products, such as part 820, QSR for medical devices, and part 
211, cGMP for finished pharmaceuticals.
    A specification developer is a person who controls the design and 
development of a tobacco product and/or initiates or creates the 
specifications for the product. Such activities are important steps in 
the manufacture and preproduction design validation of a tobacco 
product. A specification developer is, in concept, like an architect 
who creates a ``blueprint'' of a tobacco product. A specification 
developer may be the same party that physically manufactures the 
tobacco product or a separate entity that only provides specification 
development services to another manufacturer, who then physically 
manufactures the tobacco product. FDA is aware that some tobacco 
product manufacturers have established an organizational structure that 
places the specification development functions in an entity separate 
from the entity in charge of physically manufacturing the finished or 
bulk tobacco product; these entities develop and usually control 
changes to the specifications of the tobacco product. Such entities are 
specification developers under the proposed rule.
    A tobacco product manufacturer may utilize a specification 
developer to initiate or create the specifications of a finished or 
bulk tobacco product when the manufacturer lacks knowledge or expertise 
in product design and development. Specifically, a manufacturer may 
want to produce a tobacco product with certain features but lack the 
knowledge needed to design such a product and translate the desired 
features into particular product specifications. For example, a 
cigarette manufacturer who wants to manufacture a cigarette with 
certain constituent yields and consumer sensory qualities may use a 
specification developer to create appropriate specifications for the 
product, such as the specific tobacco blend, paper type and grade, 
filter ventilation, additives, and other features. A tobacco product 
manufacturer who intends to manufacture a dissolvable lozenge, orb, or 
strip smokeless tobacco product may similarly involve a specification 
developer to create appropriate product specifications such as tobacco 
mixtures, pH, additives, colorants, size and shape, and packaging 
materials. A tobacco product manufacturer who wants to commercially 
market an e-cigarette with certain performance features such as 
particular power levels, aerosol particle size, pressure drop, airflow, 
and puff count may similarly use a specification developer who can 
design a product with such features and translate them into appropriate 
specifications, including cartridge, atomizer, heating element, 
battery, and circuit board/software specifications.
    FDA proposes to regulate specification developers under this rule 
because product design and the development of product specifications 
are integral parts of the manufacturing and preproduction design 
validation process. Product design and specification development are 
important because these can affect the level of risk or harm (e.g., 
toxicity, addictiveness) a tobacco product consumer may be exposed to 
when using tobacco products, and, in the absence of proper controls, 
can also result in harm not normally associated with the use of a 
tobacco product.
    FDA has authority to include requirements about product design in 
its TPMP regulation. Specifically, section 906(e) of the FD&C Act 
provides, in part, that FDA shall prescribe regulations requiring that 
the methods used in and the facilities and controls used for tobacco-
product manufacture and preproduction design validation (including a 
process to assess the performance of a tobacco product) conform to 
current good manufacturing practice, or HACCP methodology. Requiring 
specification developers to comply with TPMP provisions is consistent 
with that authority.
    FDA believes that it is necessary to apply the proposed TPMP 
regulation to specification developers because of their key role in the 
manufacture and preproduction design validation of finished and bulk 
tobacco products and because, under certain circumstances, a 
specification developer may be the most appropriate party or even the 
only capable party, to adequately perform certain activities required 
under the proposed regulation. Design and development frequently 
involve knowledge of trade secrets and/or other confidential commercial 
information, and a specification developer may not

[[Page 15186]]

share such information with the entity that physically manufactures the 
finished or bulk tobacco product.
    Such activities include, for example, conducting adequate 
investigations of product complaints and implementing CAPA for issues 
related to product design. For example, if complaints are received that 
users are experiencing respiratory distress from the aerosol of an ENDS 
product, only a specification developer may be able to conduct an 
adequate investigation to determine the cause of problems and implement 
the necessary actions to correct and prevent the problems. The finished 
or bulk ENDS manufacturer who physically manufactures the product may 
be able to rule out a manufacturing problem (e.g., defectively 
manufactured solder joints), but it may not be able to determine the 
cause of the problem if the issue relates to design (e.g., metallic 
particles that result from improper material selection for the 
cartomizer wires). In that case, only the specification developer may 
have the unique knowledge regarding the product's design and history of 
specification development necessary to determine the cause of the 
problem and how to address it.
    Similarly, if complaints are received that the software of an ENDS 
product that controls the heat and temperature functions is being 
altered or hacked by users and causing malfunctions that result in 
overheating, fires, or explosions, the specification developer--not the 
manufacturer who physically manufactures the product--would have the 
expertise to conduct a thorough investigation and initiate a CAPA to 
redesign the software to prevent this user misuse.
    Specification developers are also the only party capable of 
adequately performing certain activities included in the proposed 
product development control requirements, such as identifying known or 
reasonably foreseeable risks associated with the design of the tobacco 
product and/or package as well as design verification and validation 
activities. With product design and development knowledge, the 
specification developer would be in the best position to identify and 
take appropriate measures to treat risks associated with the design of 
the tobacco product and package that are not normally associated with 
the use of the tobacco product and package, or that it determines 
constitute an unacceptable level of risk. For example, a specification 
developer of a dissolvable tobacco product (e.g., a tobacco lozenge) 
would have the knowledge to address possible misuse of the product by a 
child that could cause choking or inadvertent exposure and to take 
appropriate measures to redesign the size and shape of the tobacco 
product or redesign the packaging. As another example, a specification 
developer of a heat-not-burn tobacco product would have the knowledge 
to assess whether the product could reach temperatures that could cause 
burns and to take appropriate measures to reduce this risk.
    Accordingly, FDA believes that requiring specification developers 
to comply with the proposed TPMP requirements is essential to ensure 
that the proposed TPMP regulation operates as intended.
4. Foreign Manufacturers
    Further, FDA is proposing that foreign manufacturers of finished or 
bulk tobacco products that are imported or offered for import into the 
United States be covered under this TPMP rule. In accordance with 
section 906(e) of the FD&C Act, FDA believes that covering foreign 
manufacturers is necessary to assure the protection of the public 
health. The risks associated with the tobacco product, production 
process, packaging, and storage are the same for all tobacco products 
covered by this proposed rule, regardless of where they are 
manufactured, and all can be addressed by the same types of controls. 
For example, the proposed design and development controls (proposed 
subpart D) would address these risks, including risks associated with 
the design of ENDS products that are primarily designed and 
manufactured in China and for which there have been numerous reports of 
battery fires and explosions (e.g., Ref. 7).
    In addition, having the proposed rule apply to foreign 
manufacturers of finished or bulk tobacco products would be necessary 
to ensure that imported tobacco products comply with chapter IX of the 
FD&C Act. For example, the proposed controls (e.g., design and 
development controls, MMR, acceptance activities, and production record 
requirements) would help to ensure that imported tobacco products meet 
all applicable tobacco product standards, and thus avoid being 
adulterated or misbranded. A tobacco product which is subject to a 
tobacco product standard is adulterated under section 902(5) of the 
FD&C Act unless the product is in all respects in conformity with the 
standard. Similarly, a tobacco product subject to a tobacco product 
standard is misbranded under section 903(a)(9) of the FD&C Act unless 
it bears such labeling as may be prescribed in the standard.
5. Vape Shops Engaged in the Manufacture of Tobacco Products
    Vape shops are establishments that generally, among other things, 
sell a variety of products including ENDS, replacement pieces, 
hardware, custom mixed e-liquids, and other related accessories. Sales 
of such products, standing alone, would not constitute finished or bulk 
tobacco product manufacturing. However, some vape shops are also 
tobacco product manufacturers under the Deeming Rule, 81 FR at 29044, 
because they also (for example) mix or prepare e-liquids or create or 
modify aerosolizing apparatuses for direct sale to consumers for use in 
ENDS. Under the proposed regulation, vape shops engaged in these 
additional activities would be manufacturers of finished or bulk 
tobacco products. When such vape shops are engaged in the manufacture, 
preproduction design validation, packing, and storage of finished or 
bulk tobacco products within the meaning of the proposed rule, they 
would be subject to the requirements in this proposed TPMP rule. 
Requiring such manufacturers to comply with TPMP requirements, as 
proposed, is important for protecting the public health because 
products manufactured at the retail level pose many of the same public 
health risks as those manufactured upstream, and possibly additional 
risks related to the lack of standard manufacturing practices and 
controls. A vape shop that does not engage in the activities described 
above would not be a finished or bulk tobacco product manufacturer 
subject to the requirements of this proposed part 1120. In addition, as 
set out immediately below, proposed Sec.  1120.1(b) would require a 
finished and bulk tobacco product manufacturer to comply only with 
requirements applicable to its finished and bulk tobacco product 
manufacturing operations. Therefore, smaller tobacco product 
manufacturers (such as vape shops that engage in some but not all of 
the activities described above) would be able to tailor their 
procedures to suit their smaller operations while still complying with 
the proposed TPMP requirements.
6. Compliance With Requirements Applicable to Operations
    Proposed Sec.  1120.1(b) clarifies that if a tobacco product 
manufacturer engages in some operations subject to the requirements of 
proposed part 1120, but not others, the manufacturer need only comply 
with those requirements applicable to the operations in which it is 
engaged. This is the same approach

[[Page 15187]]

used in the drug cGMP regulation at Sec.  210.2(b) and the device QSR 
at Sec.  820.1(a)(1).
    For example, a manufacturer of finished e-liquids would not need to 
comply with the warning plan requirements in proposed Sec.  1120.98 
because e-liquids are only required to bear a single warning. 
Similarly, a finished cigarette manufacturer who does not engage in 
repackaging or relabeling operations would not need to comply with the 
repackaging and relabeling requirements in proposed Sec.  1120.94. 
Likewise, a specification developer who only designs/creates the MMR 
for another manufacturer's tobacco product and does not engage in any 
physical manufacturing would not be subject to, for example, the 
proposed requirements in subparts C (Buildings, Facilities, and 
Equipment), E (Production Processes and Controls), and G (Handling, 
Storage, and Distribution). If manufacturers believe a requirement is 
not appropriate or necessary to ensure that the public health is 
protected and that the tobacco product will be in compliance with this 
chapter, they may petition for an exemption or variance from all or 
part of the regulation pursuant to proposed Sec.  1120.142.
    Proposed Sec.  1120.1(c) clarifies the term ``where appropriate,'' 
which appears several times in proposed part 1120. As discussed in 
proposed Sec.  1120.1(c), when a requirement is qualified with ``where 
appropriate,'' it is deemed to be appropriate unless the tobacco 
product manufacturer documents in writing (on paper or electronically) 
an adequate justification prior to abstaining from implementing the 
requirement. An adequate justification would address why abstaining 
from the requirement would not result in a nonconforming tobacco 
product or in the manufacturer not being able to carry out necessary 
corrective actions. In this circumstance, the manufacturer need not 
petition for or receive an exemption or variance under Sec.  1120.140. 
Proposed Sec.  1120.1(d) notes that requirements in proposed part 1120 
are intended to protect the public health and assure that tobacco 
products are in compliance with the relevant provisions of the FD&C Act 
and explains that the failure to comply with any applicable provision 
in proposed part 1120 would render the tobacco product adulterated 
under section 902(7) of the FD&C Act.
7. Other Manufacturers and Request for Comment
    At this time, FDA is not proposing to apply these proposed TPMP 
requirements to manufacturers of tobacco products other than finished 
and bulk tobacco products. In particular, the proposed regulation will 
not reach manufacturers of components or parts that are not offered for 
sale, sold, or otherwise distributed to consumers, i.e., components or 
parts for further manufacture. For example, the rule would not apply to 
manufacturers of filter tow material and cigarette tipping paper that 
are intended or reasonably expected to be used to manufacture a 
cigarette, because those products are not sold to consumers. The 
proposed rule's current scope does not reach such components or parts 
directly, but rather requires incoming tobacco product components or 
parts, ingredients, additives, and materials to be subject to 
purchasing controls and acceptance activities implemented by finished 
and bulk tobacco product manufacturers to ensure that they meet 
established specifications. In addition, FDA is not currently proposing 
to apply these proposed requirements to manufacturers of accessories.
    FDA is soliciting comment on the scope of the proposed rule, as 
well as whether the scope of this regulation should be expanded to 
reach more than finished and bulk tobacco products. If you believe that 
FDA should expand the scope of this proposed rule to reach additional 
tobacco products, please explain why you believe FDA should take that 
approach; which proposed requirements, if any, should apply to other 
manufacturers; whether the regulation should cover manufacturers of all 
regulated tobacco products, including all components or parts, or only 
manufacturers of certain products; as well as any public health data 
and information that would support what you believe would be the 
appropriate scope of this rule. Alternatively, if you believe that FDA 
should limit the scope of the proposed regulation, please explain why 
you believe the scope of the rule should be more limited than finished 
and bulk tobacco product manufacturers and provide any data or 
information that would support that such a limited scope would still 
assure that the public health is protected and that tobacco products 
are in compliance with chapter IX of the FD&C Act.
8. Definitions
    Proposed Sec.  1120.3 sets forth the meaning of terms used in 
proposed part 1120.
     Accessory. We propose to define ``accessory'' as any 
product that is intended or reasonably expected to be used with or for 
the human consumption of a tobacco product; does not contain tobacco 
and is not made or derived from tobacco; and meets either of the 
following: (1) is not intended or reasonably expected to affect or 
alter the performance, composition, constituents, or characteristics of 
a tobacco product or (2) is intended or reasonably expected to affect 
or maintain the performance, composition, constituents, or 
characteristics of a tobacco product but (i) solely controls moisture 
and/or temperature of a stored tobacco product; or (ii) solely provides 
an external heat source to initiate but not maintain combustion of a 
tobacco product. Examples of accessories are ashtrays, spittoons, 
hookah tongs, cigar clips and stands and pipe pouches, because they do 
not contain tobacco, are not derived from tobacco, and do not affect or 
alter the performance, composition, constituents, or characteristics of 
a tobacco product. Examples of accessories also include humidors or 
refrigerators that solely control the moisture and/or temperature of a 
stored product and conventional matches and lighters that solely 
provide an external heat source to initiate but not maintain combustion 
of a tobacco product. An electric heater or charcoal used for prolonged 
heating of waterpipe tobacco is not an accessory because it is used to 
maintain the combustion of the tobacco.
     Additive. We propose to define ``additive'' as any 
substance the intended use of which results or may reasonably be 
expected to result, directly or indirectly, in its becoming a component 
or otherwise affecting the characteristic of any tobacco product 
(including any substances intended for use as a flavoring or coloring 
or in producing, manufacturing, packing, processing, preparing, 
treating, packaging, transporting, or holding), except that such term 
does not include tobacco or a pesticide chemical residue in or on raw 
tobacco or a pesticide chemical. An additive can be a type of 
ingredient in a tobacco product; an example is methyl salicylate in 
smokeless tobacco, which can serve as an absorption enhancer and affect 
the characteristics of the tobacco product by changing the rate of 
absorption into the body.
     Batch. We propose to define ``batch'' as a specific 
identified amount of tobacco product produced in a unit of time or 
quantity and that is intended to have the same specifications. FDA 
proposes to give tobacco product manufacturers flexibility to determine 
what unit of time or quantity is appropriate for their product, and how 
batches would be designated. For example, manufacturers likely would 
define a batch for cigarette production, which is almost continuous, 
differently

[[Page 15188]]

than a batch for smokeless tobacco, which likely would be defined based 
on the amount processed in a vat through the fermentation process.
     Brand. We propose to define ``brand'' as a variety of 
tobacco product distinguished by the tobacco used, tar content, 
nicotine content, flavoring used, size, filtration, packaging, logo, 
registered trademark, brand name, identifiable pattern of colors, or 
any combination of such attributes.
     Bulk tobacco product. We proposed to define ``bulk tobacco 
product'' as a tobacco product not sealed in final packaging but 
otherwise suitable for consumer use as a tobacco product. Products that 
are suitable for consumer use as a tobacco product are those products 
that do not require further processing by a tobacco product 
manufacturer before they can be used by a consumer, such as mixing, 
cutting, curing, blending, and adding components or parts, ingredients, 
additives and materials. A tobacco product can be suitable for use even 
if it could undergo additional processing by a manufacturer as long as 
it does not require further processing by a manufacturer before use by 
a consumer. Examples of bulk tobacco products include bulk RYO tobacco, 
bulk pipe tobacco, bulk RYO filters, and bulk e-liquids. However, 
cigarette paper that is supplied on a bobbin roll would not be 
considered a bulk tobacco product because it would need to be cut into 
rolling paper sizes or combined/glued with filters to make cigarette 
tubes. The terms ``bulk tobacco product'' and ``finished tobacco 
product'' are distinguishable because bulk tobacco products are not 
sealed in final packaging, whereas finished tobacco products are sealed 
in final packaging.
     Characteristic. We propose to define ``characteristic'' as 
the materials, ingredients, design, composition, heating source, or 
other features of a tobacco product.
     Component or Part. We propose to define ``component or 
part'' as any software or assembly of materials intended or reasonably 
expected: (1) to alter or affect the tobacco product's performance, 
composition, constituents, or characteristics or (2) to be used with or 
for the human consumption of a tobacco product. Component or part 
excludes anything that is an accessory of a tobacco product.
     Contaminated tobacco product. We propose to define 
``contaminated tobacco product'' as a tobacco product that contains a 
substance not ordinarily contained in that tobacco product. ``Not 
ordinarily contained'' refers to a substance that is not intended or 
expected to be in that tobacco product. As stated in proposed Sec.  
1120.3, an example of a contaminated tobacco product is a smokeless 
tobacco product with metal fragments in the tobacco filler.
     Design. We propose to define ``design'' as the form and 
structure concerning and the manner in which components or parts, 
ingredients, additives, and materials are integrated to produce a 
tobacco product.
     Direct accounts. We propose to define ``direct accounts'' 
as all persons who are customers of the tobacco product manufacturer 
that receive finished or bulk tobacco products directly from the 
manufacturer or from any person under control of the manufacturer. 
Direct accounts may include wholesalers, distributors, and retailers. 
Direct accounts do not include individual purchasers of tobacco 
products for personal consumption.
     Establish and maintain. We propose to define ``establish 
and maintain'' as to define, document in writing (on paper or 
electronically), implement, follow, and update. Multiple requirements 
in the proposed regulation direct manufacturers to ``establish and 
maintain'' certain procedures. For example, proposed Sec.  
1120.12(e)(1) would require tobacco product manufacturers to establish 
and maintain procedures for identifying training needs and establishing 
training frequency for personnel based on the work the employee 
performs. Therefore, to comply with proposed Sec.  1120.12(e)(1), a 
manufacturer would be required to create written procedures for 
identifying and meeting training needs, implement and follow the 
written procedures, and update the procedures as needed.
     Equipment. We propose to define ``equipment'' as any 
machinery, tool, instrument, utensil, or other similar or related 
article, used in the manufacture, preproduction design validation, 
packing, or storage of a tobacco product. Equipment used during testing 
and laboratory activities conducted as part of the manufacturing 
process would be covered under this proposed definition.
     Finished tobacco product. We propose to define ``finished 
tobacco product'' as a tobacco product, including any component or 
part, sealed in final packaging. Additional examples of finished 
tobacco products include a pack of cigarettes, a can of moist snuff, 
and rolling papers, filters, filter tubes, or e-liquids sold to 
consumers. One finished tobacco product may contain others. For 
example, a carton of cigarette packs (which are finished tobacco 
products) is also a finished tobacco product, because, like a cigarette 
pack, a carton is a tobacco product sealed in final packaging. As noted 
below, final packaging means a pack, box, carton, or container of any 
kind or, if no other container, any wrapping (including cellophane), in 
which a finished tobacco product is offered for sale, sold, or 
otherwise distributed to consumers. (See definition of packaging).
     Ingredient. We propose to define ``ingredient'' as 
tobacco, substances, compounds, or additives contained within or added 
to the tobacco, paper, filter, or any other component or part of a 
tobacco product, including substances and compounds reasonably expected 
to be formed through chemical action during tobacco product 
manufacturing.
    For example, an ingredient may be a single chemical substance, leaf 
tobacco, or the product of a reaction, such as a chemical reaction, in 
manufacturing. Examples of substances and compounds (ingredients) 
reasonably expected to be formed through a chemical reaction during 
tobacco product manufacturing include the following:

--The reaction of sugars with amines to form families of compounds with 
new carbon-nitrogen bonds, including Maillard reaction products and 
Amadori compounds;
--the reaction of sodium hydroxide with citric acid to form sodium 
citrate;
--the production of ethyl alcohol, a residual solvent, from ethyl 
acetate during production of tipping paper adhesive;
--products of thermolytic reactions,
--such as the production of carboxylic acids from sugar esters;
--products of enzymatically or nonenzymatically catalyzed reactions, 
such as the hydrolytic production of flavor or aroma precursors from 
nonvolatile glucosides; and
--products of acid-base reactions, such as removal of a proton from 
protonated nicotine to generate the basic form of nicotine (``free'' 
nicotine). 86 FR 55300 at 55313 (Oct. 5, 2021).

     Label. We propose to define ``label'' as a display of 
written, printed, or graphic matter upon the immediate container of any 
article. For finished tobacco products, the term label means a display 
of written, printed, or graphic matter upon the immediate container of 
any finished tobacco product. Likewise, for a bulk tobacco product, the 
term label means a display of written, printed, or graphic matter upon 
the immediate container of any bulk tobacco product.
     Labeling. We propose to define ``labeling'' as all labels 
and other

[[Page 15189]]

written, printed, or graphic matter: (1) upon any article or any of its 
containers or wrappers or (2) accompanying such article.
     Management with executive responsibility. We propose to 
define ``management with executive responsibility'' as one or more 
designated personnel who have the authority and responsibility to 
ensure compliance with TPMP requirements, including allocating 
resources and making changes to the organizational structure, 
buildings, facilities, equipment or the manufacture, preproduction 
design validation, packing, and storage of a tobacco product. These 
employees are typically senior employees with the authority to 
establish or make changes to tobacco product manufacturing policies. 
Such person(s) also would be responsible for ensuring that TPMP 
requirements are communicated, understood, implemented, and followed at 
all levels of the organization.
     Manual method, process, or procedure. We propose to define 
``manual method, process, or procedure'' as any nonautomated method, 
process, or procedure, including processes performed by hand with or 
without the use of equipment.
     Manufacturing. We propose to define ``manufacturing'' as 
the manufacturing, fabricating, assembling, processing, or labeling, 
including the repackaging or relabeling, of a tobacco product. The term 
``manufacturing'' includes establishing the specifications of a 
finished or bulk tobacco product. Examples of manufacturing activities 
include expanding (a process used with the tobacco leaf, typically dry 
ice expanded tobacco), homogenizing, mixing, and formulating a tobacco 
product.
     Manufacturing code. We propose to define ``manufacturing 
code'' as any distinctive sequence or combination of letters, numbers, 
or symbols that begins with the manufacturing date followed by the 
batch number. The purpose of the manufacturing code is to allow 
manufacturers and FDA to identify the production batch of a particular 
finished or bulk product that has been released for distribution. This 
information is intended to help determine the product's history (e.g., 
batch production records) and assist manufacturers and FDA in the event 
of a nonconforming product investigation and any corrective actions to 
be taken as a result of the investigation.
     Manufacturing date. We propose to define ``manufacturing 
date'' as the month, day, and year in 2-digit numerical values in the 
format (MMDDYY) that a finished or bulk tobacco product is packaged for 
distribution. The manufacturing date is included in the manufacturing 
code.
     Manufacturing material. We propose to define 
``manufacturing material'' as material used in or used to facilitate 
the manufacturing process that is not equipment and is not intended to 
be part of the product. Such material would have to contact the tobacco 
product or tobacco product-contact surface. An example of manufacturing 
material would be a mold release agent used to facilitate the release 
of a tobacco product from a mold.
     Master manufacturing record (MMR). We propose to define 
``master manufacturing record'' as a document or designated compilation 
of documents containing the established specifications for a tobacco 
product including acceptance criteria for those specifications, all 
relevant manufacturing methods and production process procedures for 
the tobacco product, and all approved packaging, labeling, and labels 
for the tobacco product. Tobacco product specifications, as used in 
this definition, may be established by the manufacturer or required by 
FDA. The MMR may be prepared either as a single document (or single 
file of documents) or as a product-specific index system that 
references and includes the location of all the required information.
     Nonconforming tobacco product. We propose to define 
``nonconforming tobacco product'' as any tobacco product that does not 
meet a product specification in the MMR (see proposed Sec.  
1120.44(a)(1)); has packaging, labeling, or labels other than those 
included in the MMR (see proposed Sec.  1120.44(a)(3)); or is a 
contaminated tobacco product.
     Not normally associated. We propose to define ``not 
normally associated'' as not an inherent risk of using the tobacco 
product. In this context, the inherent risk would be associated with 
using the specific category of tobacco product. For example, inherent 
risks of using cigarettes include cancers of the mouth, throat, larynx, 
esophagus, trachea, lung, stomach, liver, pancreas, kidney, bladder, 
cervix, and colon/rectum, as well as one form of leukemia (Ref. 14). 
Other examples of inherent risks of using cigarettes include stroke, 
heart disease, peripheral vascular disease, COPD, tuberculosis, asthma, 
pneumonia and other respiratory diseases (id.). Examples of inherent 
risks of cigars include oral, laryngeal, pharyngeal, and esophageal 
cancers, as well as lung cancer and heart disease (Ref. 15). Examples 
of inherent risks of smokeless tobacco include oral and pancreatic 
cancers (Ref. 16).
    Examples of risks not normally associated with tobacco products 
include lacerations of the gums or lips due to metal fragments found in 
chewing tobacco; broken teeth caused by rocks found in chewing tobacco; 
bodily injury caused by an exploding battery of an ENDS product; 
vomiting, nausea, allergic reactions, dizziness, numbness, or headaches 
caused by toxic chemical compounds found in nonconforming products; a 
serious illness caused by a tobacco product contaminated by aflatoxin 
from a fungus; and acute breathing difficulties associated with an 
allergic reaction to a contaminated tobacco product (e.g., Ref. 17).
     Package or packaging. We propose to define ``package'' or 
``packaging'' as a pack, box, carton, or container of any kind or, if 
no other container, any wrapping (including cellophane), in which a 
finished tobacco product is offered for sale, sold, or otherwise 
distributed to consumers (this is also referred to as final package or 
final packaging), or in which a bulk tobacco product is offered for 
sale, sold, or otherwise distributed (including commercial distribution 
and interplant transfers). For example, under the proposed definition, 
a carton offered for sale to consumers, which holds individual 
cigarette packages, would be considered a ``package'' or ``packaging.'' 
However, a shipping crate that holds multiple cartons of cigarettes, or 
other multiple quantities of finished tobacco products, for 
distribution to retailers would not be considered ``packages'' or 
``packaging,'' because such shipping crates for distribution to 
retailers are not containers or wrapping in which a finished tobacco 
product is offered for sale, sold, or otherwise distributed to 
consumers. We use the terms ``package'' and ``packaging'' 
interchangeably throughout this proposed rule.
     Personnel. We propose to define ``personnel'' as all 
persons, including managers, staff, consultants, contractors, and 
third-party entities, performing services for the manufacturer subject 
to proposed part 1120. The term ``personnel'' includes independent 
contractors performing services for the manufacturer.
     Relabeling. We propose to define ``relabeling'' as 
operations in which the labeling of a finished tobacco product is 
subsequently changed or replaced. This may be performed by the same 
person who originally labeled the product. For example, if a finished 
tobacco product fails an acceptance activity because it bears the wrong 
label, the manufacturer

[[Page 15190]]

may relabel the product with the correct label.
     Repackaging. We propose to define ``repackaging'' as 
operations in which the packaging of a finished tobacco product is 
subsequently changed or replaced. This may be performed by the same 
person who originally packaged the product. For example, if the package 
of a finished tobacco product is damaged during storage, the 
manufacturer may repackage the finished product in a new package.
     Representative sample. We propose to define 
``representative sample'' as a sample that consists of a number of 
units that are drawn based on a valid scientific rationale (such as 
random sampling) and intended to ensure that the sample accurately 
reflects the material being sampled.
     Reprocessing. We propose to define ``reprocessing'' as 
using tobacco product that has been previously recovered from 
manufacturing in the subsequent manufacture of a finished or bulk 
tobacco product. FDA has observed that reprocessing is a routine 
manufacturing process. An example of reprocessing would be using 
tobacco recovered through a ripper short process for cigarettes (where 
tobacco is removed from rejected cigarettes using equipment such as 
feeders, shakers, and separators) to make other cigarettes. Similar 
reprocessing occurs for smokeless tobacco, where the tobacco is 
recovered from rejected finished or bulk tobacco products, for example, 
due to incorrect weight or defective packaging/labels, and then used to 
make other smokeless tobacco products.
     Returned tobacco product. We propose to define ``returned 
tobacco product'' as commercially distributed finished or bulk tobacco 
product returned to the tobacco product manufacturer by any person not 
under the control of the tobacco product manufacturer, including a 
wholesaler/distributor, retailer, consumer, or member of the public. 
Individuals may return tobacco products to the manufacturer for a 
number of reasons, including improper weight or taste.
     Rework. We propose to define ``rework'' as action taken on 
a nonconforming or returned tobacco product to ensure that the product 
meets the specifications and other requirements in the MMR of a 
subsequently manufactured tobacco product before it is released for 
further manufacturing or distribution. For example, a smokeless tobacco 
product that fails an acceptance activity for pH level can be reworked 
by further fermentation.
     Small tobacco product manufacturer. We propose to define 
``small tobacco product manufacturer'' as a tobacco product 
manufacturer that employs fewer than 350 employees. For purposes of 
this definition, the number of employees of a manufacturer includes 
those employees and personnel of each entity that controls, is 
controlled by, or is under common control with such manufacturer.
     Specification. We propose to define ``specification'' as 
any requirement with which a product, process, service, or other 
activity must conform. A tobacco product specification is a requirement 
established by the manufacturer (including specification developer, 
contract manufacturer, or repackager/relabeler), including a 
requirement established to ensure that the tobacco product meets any 
applicable product standard under section 907 of the FD&C Act. Tobacco 
product specifications can include physical, chemical, and biological 
specifications. Examples of physical specifications include length, 
circumference, and pressure drop for cigarettes, and cut size and 
weight for smokeless tobacco products. An example of a chemical 
specification is a pH level for smokeless tobacco products, and an 
example of a biological specification is a specification related to the 
use of a biological fermentation agent used during the manufacturing 
process for smokeless tobacco products. Examples of a production 
process specification are the upper and lower temperature and humidity 
limits for specified durations, as part of the fermentation process for 
a smokeless tobacco product. An example of a service specification is a 
requirement with which a pest control service must conform.
    This proposed rule would require that the tobacco product 
specifications and acceptance criteria for those specifications be 
included in the MMR for each finished and bulk tobacco product. For 
example, if an ENDS manufacturer establishes a voltage specification 
for an adjustable, variable voltage product with a range of 3-6V, the 
MMR would have to indicate the voltage acceptance criteria that reflect 
the tolerance that is established around the upper and lower 
specifications.
     Tobacco product. The term ``tobacco product'' means any 
product made or derived from tobacco, or containing nicotine from any 
source, that is intended for human consumption, including any 
component, part, or accessory of a tobacco product (except for raw 
materials other than tobacco used in manufacturing a component, part, 
or accessory of a tobacco product). The term ``tobacco product'' does 
not mean an article that is a drug under section 201(g)(1) (21 U.S.C. 
321(g)(1)), a device under section 201(h) (21 U.S.C. 321(h)), or a 
combination product described in section 503(g) of the FD&C Act (21 
U.S.C. 353(g)). The term ``tobacco product'' does not mean an article 
that is a food under section 201(f) (21 U.S.C. 321(f)), if such article 
contains no nicotine, or no more than trace amounts of naturally 
occurring nicotine.
     Tobacco product-contact surface. We propose to define 
``tobacco product-contact surface'' to mean a surface that comes into 
contact with a tobacco product or a surface from which drainage (or 
other transfer) ordinarily occurs onto the tobacco product or onto 
surfaces that come into contact with the tobacco product during the 
normal course of operations. This definition would include surfaces of 
equipment that come into contact with the tobacco product.
     Tobacco product manufacturer. We propose to define the 
term ``tobacco product manufacturer'' as any person(s), including any 
repacker or relabeler, who: manufactures, fabricates, assembles, 
processes, or labels a tobacco product; or imports a finished tobacco 
product for sale or distribution in the United States. Tobacco product 
manufacturer includes any person(s) who establishes the specifications 
for a tobacco product.
    FDA does not propose to define ``tobacco product manufacturer'' to 
include third-party laboratories. A finished or bulk tobacco product 
manufacturer who uses a third-party laboratory is responsible for 
ensuring that the laboratory is qualified to provide services under 
proposed Sec.  1120.62 and is competent to perform laboratory 
activities associated with the manufacture of a finished or bulk 
tobacco product under proposed Sec.  1120.68. A finished or bulk 
tobacco product manufacturer who uses a third-party laboratory is also 
responsible for ensuring that it receives from the third-party 
laboratory all the documents and records (including all metadata) 
needed to comply with the proposed TPMP requirements, including, for 
example, proposed Sec. Sec.  1120.68(c) and 1120.122. It is the 
finished or bulk tobacco product manufacturer, not the laboratory, that 
is required to comply with the laboratory control requirements in 
proposed Sec.  1120.68.
     Unique identifier. We propose to define ``unique 
identifier'' as information, such as a code or number, that is 
maintained for each accepted incoming product that would enable the

[[Page 15191]]

tobacco product manufacturer and FDA to identify the supplier and 
unique shipment of the incoming product.
     Validation. We propose to define ``validation'' as 
confirmation by examination and objective evidence that the particular 
requirements can be consistently fulfilled. An example of a validation 
activity would be the validation of the smokeless tobacco fermentation 
process, which would demonstrate that when key parameters (e.g., 
temperature, pH, oven volatiles, and number of turns) are met, 
conforming product will be produced in that batch. The relevant 
parameters would be monitored to confirm that the batch was produced 
within the validated ranges for the fermentation process.
     Verification. We propose to define ``verification'' as 
confirmation by examination and objective evidence that specified 
requirements have been fulfilled. Examples of verification activities 
would include measuring a dimension such as the length or circumference 
of a cigarette or cigar to confirm it meets a specified requirement, 
conducting a laboratory analysis of a pH level to confirm it is within 
a specified range, and performing a visual comparison of a hand-rolled 
cigar against a standard or approved model to confirm the proper shape 
and dimensions of that finished cigar.

B. Management System Requirements

1. Organization and Personnel
    Proposed Sec.  1120.12 describes the proposed requirements for 
finished and bulk tobacco product manufacturers' organization and 
personnel. This section forms the foundation for manufacturers to 
adequately perform and comply with the proposed requirements under 
proposed part 1120. These proposed requirements are generally similar 
to the organization and personnel requirements in the industry 
recommendations, and similar practices that FDA has observed during 
establishment inspections.
    Specifically, proposed Sec.  1120.12(a) would require finished and 
bulk tobacco product manufacturers to establish and maintain an 
organizational structure that will ensure that their manufacturing 
operations meet the requirements of part 1120. The organizational 
structure should clearly delineate the parts of the organization and 
personnel responsible for complying with the proposed requirements. FDA 
has observed that it is standard industry practice to maintain an 
organizational structure, position descriptions, and employee training 
programs.
    Proposed Sec.  1120.12(b) would require finished and bulk tobacco 
product manufacturers to employ sufficient personnel to carry out the 
requirements of proposed part 1120. Personnel must have the background, 
education, training, and experience, or any combination thereof, needed 
to carry out the requirements of proposed part 1120. Each manufacturer 
should determine the appropriate background and necessary education for 
personnel to carry out these requirements. A manufacturer may determine 
that appropriate certifications and job-related trainings are necessary 
for a particular job function. For example, employees responsible for 
quality assurance could take classes or coursework relevant to their 
role auditing the production process and evaluating the final product 
for conformance to tobacco product specifications and other 
requirements established in the MMR. FDA recommends that such training 
be updated on a regular basis so that responsible employees are aware 
of current procedures and controls to ensure that they can consistently 
meet the requirements of proposed part 1120. Proposed Sec.  1120.12(b) 
would also require manufacturers to maintain appropriate written 
records of the background, education, training, and experience of its 
personnel in the format described in proposed Sec.  1120.12(f) and 
discussed in more detail below.
    Proposed Sec.  1120.12(c) would require each finished and bulk 
tobacco product manufacturer to designate, in writing (on paper or 
electronically), the appropriate responsibility and authority for all 
personnel who perform an activity subject to proposed part 1120. 
Therefore, while proposed Sec.  1120.12(a) would require manufacturers 
to establish an organizational structure, this provision would require 
manufacturers to specifically designate the responsibilities and 
authority for those personnel who would be responsible for performing 
the activities required under proposed part 1120. This provision would 
help manufacturers to ensure that their tobacco products conform to 
their established specifications and reduce the likelihood that 
nonconforming products would be distributed to consumers.
    Proposed Sec.  1120.12(d) would require finished and bulk tobacco 
product manufacturers to designate, in writing (on paper or 
electronically), management with executive responsibility that has the 
duty, power, and responsibility to implement the proposed requirements 
under proposed part 1120. Management with executive responsibility 
refers to those individual(s) who are ultimately responsible for 
ensuring compliance with proposed part 1120. This responsibility would 
include the allocation of resources, including facilities, equipment, 
materials, controls, and personnel used for the manufacture, 
preproduction design validation, packing, and storage of a tobacco 
product. These employees are typically senior employees with the 
authority to establish or make changes to tobacco product manufacturing 
policies and ensure that they are effectively communicated throughout 
the organization. Management with executive responsibility would be 
required to establish and maintain required processes and procedures to 
ensure compliance with requirements under proposed part 1120. Such 
person(s) also would be required to ensure that TPMP requirements are 
communicated, understood, implemented, and followed at all levels of 
the organization. FDA believes that this proposed requirement is 
generally similar to existing industry practice.
    Proposed Sec.  1120.12(e) would require finished and bulk tobacco 
product manufacturers to establish and maintain training procedures. 
This provision would require that training procedures identify training 
needs and establish training frequency for personnel based on the work 
the employee performs. Under this provision, manufacturers should 
assess whether employees need periodic or refresher training. FDA is 
not proposing to prescribe the extent and frequency of training or type 
of training, but rather the Agency believes that manufacturers should 
have the flexibility to determine how to adequately train their 
personnel to perform their assigned responsibilities in accordance with 
proposed part 1120. For example, some tobacco manufacturing facilities 
are only open for portions of the year and staffed with seasonal 
personnel. In this case, a manufacturer may opt to train its personnel 
at the start of each new manufacturing season.
    Proposed Sec.  1120.12(e) would also require finished and bulk 
tobacco product manufacturers to train personnel on their assigned 
responsibility and on the TPMP requirements relevant to their 
responsibility. Under this provision, manufacturers would not be 
required to train personnel on all the requirements of the proposed 
regulation, but rather on the provisions of the regulation that are 
relevant to their assigned responsibility,

[[Page 15192]]

including their understanding of the relevant procedures and how to 
maintain applicable records. Training should also cover the 
consequences of improper performance so that personnel will be apprised 
of nonconformities that can result if they do not adequately perform 
their assigned responsibility and implement the tobacco product 
manufacturing requirements relevant to their responsibility.
    Proposed Sec.  1120.12(f) establishes the format for training 
records required by Sec.  1120.12(b). These training records would be 
required to include the type and description of the training, the 
training date, the names of the parties performing and taking the 
training, and documentation supporting completion. Training records 
should demonstrate which personnel were trained, identify the training 
completed, and illustrate whether that personnel received the proper 
training for their job functions. Documentation supporting completion 
may include the results of an assessment or examination given to 
personnel upon completion of the training.
    The Agency believes that the proposed organization and personnel 
requirements would assure that the public health is protected by 
requiring that the responsible individuals at all levels of the 
organization have the knowledge, experience, and training to ensure 
that the establishment manufactures and distributes tobacco products 
that conform to established specifications and are not contaminated 
during the manufacturing process. Deficiencies in personnel 
qualification and training could increase the likelihood that a company 
manufactures and distributes nonconforming tobacco products. For 
example, one company found that spotting and staining of nonconforming 
finished cigarettes was due to improper training, when personnel used 
plasticizer instead of casing in the manufacturing process (Ref. 18). 
In addition, if an employee responsible for analyzing samples in the 
lab is not properly trained on the techniques for sample preparation 
and extraction to measure for pH in smokeless tobacco, the results may 
be unreliable and could lead to products that do not conform to the 
established specifications for distribution. The pH can influence the 
availability of nicotine and increase the risk to consumers beyond 
those normally associated with the product (Ref. 19).
    In addition, the Agency believes that the proposed personnel 
requirements would help assure that tobacco products are in compliance 
with the requirements of chapter IX of the FD&C Act. In particular, the 
proposed requirements would help ensure that personnel with proper 
background and expertise are participating in and monitoring the 
production process, thus ensuring that the tobacco product does not 
become adulterated or misbranded under section 902 or section 903 of 
the FD&C Act. The proposed requirements also would help ensure that new 
and modified risk tobacco products (MRTPs) are manufactured consistent 
with the specifications provided in their applications (i.e., SE 
Report, request for SE exemption, PMTA, MRTPA) and that pre-existing 
products are manufactured consistent with their original 
characteristics. For example, for an SE product, qualified personnel 
are needed to ensure that tobacco products are manufactured to the 
specifications described in the SE report. Similarly, these proposed 
personnel requirements would help ensure that tobacco products that 
were commercially marketed in the United States as of February 15, 2007 
(pre-existing products), continue to be manufactured consistently with 
their original characteristics.
    Qualified and trained personnel are vital to a controlled 
production process. Requiring manufacturers to have qualified personnel 
with designated roles and who are appropriately trained would help 
ensure that personnel are competent in their assigned roles. This, in 
turn, would help ensure that manufacturing operations are performed 
correctly and would reduce the chances of adulteration during the 
manufacturing process. For example, qualified personnel with specific 
responsibilities to clean tobacco product-contact surfaces would help 
decrease the likelihood that products contain filthy, putrid, or 
decomposed substances, or are otherwise contaminated by added poisonous 
or deleterious substances that may render the product injurious to 
health. This would also help ensure that products are not prepared or 
held under insanitary conditions.
2. Tobacco Product Complaints
    Proposed Sec.  1120.14 sets forth the requirements for the receipt, 
evaluation, investigation, and documentation of all complaints. FDA 
considers a ``complaint,'' in this context, to be any communication 
(including written, electronic, and oral communication) that the 
tobacco product does not meet expectations, is unsatisfactory or 
unacceptable, or appears to be a nonconforming product. Tobacco product 
complaints may come from any source, including healthcare 
professionals, consumers, the public, and businesses (e.g., retailers, 
other tobacco product manufacturers).
    The proposed requirements are generally similar to complaint 
handling processes that FDA has observed during establishment 
inspections. For example, FDA is aware that tobacco product 
manufacturers generally maintain complaint records containing 
information about nonconforming tobacco products, such as incorrectly 
packaged tobacco products, filters that fall off the filter rod of a 
cigarette, broken or torn cigarettes, filter plug problems, and 
irregular and improper burning of cigarettes. FDA is also aware of 
complaint records containing information about contaminants and hazards 
in finished tobacco products such as NTRMs (e.g., metal, glass, nails, 
pins, wood, dirt, sand, stones, rocks, fabric, cloth, plastics), 
biological materials (e.g., mold, mildew, hair, fingernails), oil or 
greasy spots on cigarettes, chemicals (e.g., ammonia, cleaning agents, 
kerosene), and the presence or infestation of tobacco beetles or 
insects. Further, FDA is aware that manufacturers maintain reports of 
complaints such as exploding e-cigarettes, excessive heating during use 
and charging of ENDS, as well as cuts and lacerations, broken teeth, 
vomiting, nausea, burns, allergic reactions, dizziness, numbness, 
headaches, and other personal or property damage reported to tobacco 
product manufacturers. These experiences and records have informed the 
proposed complaint requirements.
    Given the clear importance of tobacco product complaints in 
alerting manufacturers and FDA to product problems, proposed Sec.  
1120.14(a) would require finished and bulk tobacco product 
manufacturers to establish and maintain procedures for the receipt, 
evaluation, investigation, and documentation of all tobacco product 
complaints. FDA believes it is necessary for manufacturers to establish 
and maintain procedures to address all activities related to complaints 
(i.e., receipt and processing; evaluation, investigation, and 
documentation) in order to ensure that manufacturers properly handle 
complaints.
    Proposed Sec.  1120.14(a)(1) through (3) would require that the 
tobacco product complaint procedures ensure that each complaint is: (1) 
processed upon receipt in a uniform and timely manner; (2) evaluated 
and, if necessary, investigated, in accordance with Sec.  1120.14(b) 
and (c); and (3) documented in accordance with Sec.  1120.14(e). All 
complaints would need to be processed upon receipt by the

[[Page 15193]]

manufacturer. Even complaints that may not appear to be directly 
related to illness or injury (such as failure to meet a specification, 
defective packaging, mixup of products, product bearing wrong labeling/
warning, or incorrect quantity of product) may be important in 
identifying a nonconforming product or other manufacturing issue. Such 
complaints may indicate that the product is adulterated or misbranded 
and that a corrective action, such as a recall, is needed. Moreover, 
even a complaint regarding a side effect that appears to be normally 
associated with tobacco use may indicate a nonconforming product or a 
product design issue and, therefore, would be required to be 
investigated. For example, a complaint about respiratory distress could 
be determined to be attributed to a nonconforming product due to 
defective solder joints from an ENDS cartomizer that results in 
metallic particles in the aerosol (Ref. 2). Similarly, a complaint 
about dizziness or nausea could be due to the addition of too many 
ammonia compounds and other substances to reconstituted tobacco in a 
cigarette, which can affect free nicotine levels.
    FDA is aware that some manufacturers have a corporate complaint 
department that handles complaints for all establishments and others 
have different complaint handling units for different product types and 
different establishments, which could result in multiple processes for 
handling complaints. Therefore, under proposed Sec.  1120.14, 
manufacturers should designate in their procedures which individual(s) 
are responsible for coordinating and performing all complaint handling 
functions to ensure consistent handling, categorization, and 
evaluation/investigation of complaints across the corporation and 
establishments.
    Proposed Sec.  1120.14(b) elaborates on the evaluation requirement 
found in proposed Sec.  1120.14(a)(2). Proposed Sec.  1120.14(b) would 
require that personnel evaluate each complaint to determine whether it 
could be related to: (1) a nonconforming tobacco product; (2) a product 
design issue; or (3) any adverse experience that is required to be 
reported under a regulation issued under section 909(a) of the FD&C Act 
or implementing regulations.\3\
---------------------------------------------------------------------------

    \3\ We note that, currently, there are no adverse events 
required to be reported under section 909(a) of the FD&C Act; 
however, this provision would trigger automatically should FDA issue 
a regulation based on section 909(a).
---------------------------------------------------------------------------

    Complaint information may need to be incorporated into the risk 
management process in proposed Sec.  1120.42 to inform the 
manufacturer's risk assessment and risk treatment. For example, a 
manufacturer that previously determined in its risk assessment that a 
dissolvable tobacco product is unlikely to cause a safety hazard to 
users would be required to reassess its risks, pursuant to proposed 
Sec.  1120.42(a)(1)(iii), if it receives complaints alleging choking 
adverse experiences that could change the previous risk assessment.
    Proposed Sec.  1120.14(c)(1) states that if the evaluation 
determines that the complaint could be related to the circumstances 
identified in proposed Sec.  1120.14(b)(1) through (3), an 
investigation must be performed (unless it is subject to the exception 
as provided in proposed Sec.  1120.14(d). For example, if a complaint 
evaluation indicates that an ENDS product explosion could be related to 
an issue with the product's design, the tobacco product manufacturer 
would be required to perform an investigation under Sec.  1120.14(c). 
Records of previously received complaints may be relevant to this 
evaluation. The evaluation phase would not be required to include an 
analysis regarding the veracity of the complaint.
    Accordingly, this proposed section would require that all 
complaints be processed and evaluated. However, only certain complaints 
would need to be investigated (i.e., complaints that could be related 
to a nonconforming product, a product design issue, or reportable 
adverse experience). For example, a complaint regarding the price of 
the product or the size offerings distributed by the manufacturer (for 
example, customer complaints that the manufacturer should offer a 
larger package size) would need to be processed and evaluated but would 
not need to be investigated under the proposed rule. However, 
complaints regarding an exploding battery, metal or rocks found in the 
tobacco, or nicotine poisoning of the user (or nonuser) would need to 
be investigated.
    As stated in proposed Sec.  1120.14(c)(2), the complaint 
investigation would be required to identify the scope and cause of the 
issue and the risk of illness or injury it poses. If a manufacturer's 
investigation shows that the scope and cause of the issue cannot be 
determined without the involvement of another entity, such as a 
specification developer, contract manufacturer, or other entity or 
establishment that performs a manufacturing operation for the product, 
then the manufacturer should work together with the other entity to 
determine the scope and cause of the issue. This would include the 
timely reporting to other entities of all relevant information related 
to the complaint.
    For example, if complaints are reported to a contract manufacturer 
and, after investigation, are determined to pertain to a possible 
product design issue, the contract manufacturer should report these 
complaints to the specification developer for further investigation. 
The specification developer has the specific knowledge of the design 
and development information of the finished tobacco product and would 
be required to conduct an investigation of the product complaints and 
implement CAPA, as needed pursuant to proposed Sec.  1120.16, including 
potential redesign of the product. The contract manufacturer, in turn, 
should continue to work with the specification developer to ensure that 
the complaint is resolved in accordance with the proposed requirements 
in this section. Similarly, if a finished tobacco product manufacturer 
that only packages or labels bulk tobacco products receives complaints 
of nonconforming products that may be related to the design or 
manufacture of the incoming bulk tobacco product, it should report 
these complaints to the bulk manufacturer who must then also conduct an 
investigation into the scope and cause of the issue, the risk of 
illness or injury posed by the issue, and whether any followup action 
is necessary, and implement CAPA, as needed pursuant to proposed Sec.  
1120.16. The finished tobacco product manufacturer should follow up 
with the bulk manufacturer as needed to ensure that the product 
complaints have been resolved in accordance with these proposed 
requirements. This would include the finished tobacco product 
manufacturer documenting the evaluation, investigation, and any 
associated followup action regarding the complaint, including any 
information provided by the bulk manufacturer.
    A complaint investigation also must determine whether any followup 
action is necessary, including whether a CAPA is necessary under 
proposed Sec.  1120.16. Followup action could include, for example, 
updating a procedure, requiring refresher training, making a 
manufacturing process change, or other action to correct and prevent a 
nonconforming product or design problem; initiating a recall; reporting 
an adverse experience under a section 909(a) regulation; or beginning 
to monitor the issue to see if there is a trend that might require 
further action. This proposed requirement is necessary to ensure that 
finished and bulk tobacco product manufacturers adequately

[[Page 15194]]

investigate complaints that could relate to nonconforming tobacco 
products, issues related to product design, and reportable adverse 
experiences to protect consumers, correct the issue, and prevent the 
same or similar problems from occurring in the future.
    A complaint investigation may lead the tobacco product manufacturer 
to initiate a corrective action, such as a recall or a change to the 
manufacturing process. For example, in one case, FDA received a 
consumer complaint that an ENDS product created thick and searing smoke 
that caused an unexpected health problem, specifically, sore, raw, and 
swollen throat that persisted for several days (Ref. 20). If, during 
the investigation, the manufacturer determined that the user's health 
problem was due to excess voltage causing the atomizer coil to burn, 
these proposed requirements would ensure that manufacturers investigate 
the scope of such an issue, the risk of illness or injury it poses, and 
whether any followup action, such as a CAPA, is necessary. A tobacco 
product manufacturer may initiate a CAPA under proposed Sec.  1120.16, 
to implement a design change to control the maximum voltage output to 
prevent coil overheating. While some tobacco product manufacturers may 
initiate such actions on their own, FDA believes that these 
requirements are needed to ensure that all manufacturers take these 
steps to assure the public health is protected.
    Complaints could also identify a reasonably foreseeable risk not 
previously known to the manufacturer, including risks that may occur 
with normal use and reasonably foreseeable misuse of the tobacco 
product, which could relate to a design issue. FDA acknowledges that a 
manufacturer cannot possibly foresee every single potential misuse 
during the design of a tobacco product, but should the manufacturer 
become aware through a complaint of information about risks posed by 
the product due to misuse, the corrective and preventive action 
requirements under proposed Sec.  1120.16 and the risk management 
requirements under proposed Sec.  1120.42 would be triggered, which 
would include reassessing and treating the risk pursuant to proposed 
Sec.  1120.42(a)(1)(iii). For example, an ENDS manufacturer may receive 
complaints of respiratory distress for an ENDS product and determine in 
its investigation that users are modifying the heating element to 
increase voltage in order to produce greater clouds of vapor, resulting 
in higher aerosol temperatures than designed that generate harmful 
constituents such as formaldehyde, acetaldehyde, and acrolein (Ref. 
21). Knowing that information, the manufacturer would reassess and 
treat the risk and initiate appropriate corrective action, which may 
include implementing design changes to prevent a user from 
disassembling and modifying the heating element.
    When conducting investigations, tobacco product manufacturers 
should also review available records related to the complaint (e.g., 
acceptance records, nonconforming product records, or CAPA records). 
For example, a tobacco product manufacturer may receive complaints 
about an ENDS overheating. Even if the product is not returned, the 
manufacturer may review other complaint files and determine that 
complaints related to other ENDS models have been received. An 
investigation and review of acceptance records (see proposed Sec.  
1120.64) may reveal an increase in the number of heating element 
components being rejected from a particular supplier. As a result of 
the investigation, the tobacco product manufacturer may initiate a CAPA 
to increase monitoring of the supplier and require additional testing 
to ensure that received components meet established specifications.
    Proposed Sec.  1120.14(d) provides an exception to the requirement 
to conduct an investigation under Sec.  1120.14(c). This paragraph 
would provide that a tobacco product manufacturer is not required to 
complete an investigation if it has already conducted an investigation 
of a similar complaint and the tobacco product manufacturer determines 
and documents that the previous investigation results apply and another 
investigation is not necessary. FDA interprets a similar complaint to 
be one related to the same type of nonconformity or issue and likely to 
have the same cause or source. Therefore, a tobacco product 
manufacturer would not need to conduct an investigation if its 
documentation includes a reference to a previous investigation and a 
statement explaining why the complaints were sufficiently similar such 
that the previous investigation results apply and another investigation 
is not necessary. This analysis would be based on the particular facts 
and circumstances at issue. For example, a tobacco product manufacturer 
may determine and document that it need not investigate a complaint of 
an ENDS overheating, because it had previously investigated a complaint 
and found that a particular component caused the overheating and the 
production record shows that the product at issue used the same 
component from the same supplier, before the problem was corrected.
    Proposed Sec.  1120.14(e) would require a manufacturer of finished 
or bulk tobacco products to maintain complaint records containing the 
information required by Sec.  1120.14(e)(1) through (14). Complaints 
requiring investigation that may result in a risk of illness, injury, 
or death not normally associated with tobacco product use must be 
clearly identified or separated. Additional discussion of the meaning 
of ``not normally associated'' can be found in section II.A.2. This 
proposed requirement would enable tobacco product manufacturers to 
recognize these types of complaints and prioritize appropriate followup 
action.
    Proposed Sec.  1120.14(e)(1) through (14) states that the complaint 
record must include the following information, if available: the name 
of the product, including brand and sub-brand; a description of the 
product; manufacturing code; date the complaint was received; format of 
complaint (i.e., oral or written); name, address, and phone number of 
complainant; nature and details of the complaint, including how the 
product was used; identification of individual(s) receiving complaint; 
record of evaluation by the manufacturer, including the name of the 
individual(s) performing the evaluation; if no investigation is 
undertaken, the name of the individual(s) responsible for that decision 
and the rationale for the decision; investigation date(s); record of 
investigational activities performed and personnel who performed the 
activities; results of investigation; and any follow up action taken, 
including any reply to the complainant or any corrective and preventive 
action taken. Some of this information would be obtained during the 
evaluation stage while other information would be obtained during the 
investigation stage, if an investigation is required. The complaint 
record would also include activities performed by other entities that 
assist in the investigation. For example, if a manufacturer reports a 
complaint to another entity, such as a specification developer, or 
contract manufacturer, because the manufacturer's investigation shows 
that the scope and cause of the issue cannot be determined without the 
involvement the other entity, then the manufacturer should include in 
the complaint record information regarding the investigation performed 
by the other entity, if available.
    The information in proposed Sec.  1120.14(e) is basic information 
that is

[[Page 15195]]

essential to any complaint investigation and necessary to ensure a 
thorough complaint investigation and facilitate an appropriate 
followup. The manufacturer should make a reasonable effort to obtain 
the information listed in proposed Sec.  1120.14(e)(1) through (14). 
For example, should some of the basic information in proposed Sec.  
1120.14(e)(1) through (14) be missing with respect to a particular 
complaint, a single unsuccessful attempt to reach the complainant would 
not be considered by FDA to be a reasonable effort to obtain 
information related to the complaint. If the information described in 
proposed Sec.  1120.14(e)(1) through (14) cannot be obtained, this 
provision would require the manufacturer to document the attempts to 
obtain this information and explain why the information was not 
included, as described in proposed Sec.  1120.14(f).
    FDA believes that these proposed requirements would assure that the 
public health is protected by requiring tobacco product manufacturers 
to systematically handle the receipt, evaluation, investigation, and 
documentation of all complaints to determine if there is a problem with 
the tobacco product, a related tobacco product, or the manufacturing 
process, and take appropriate action. If a tobacco product manufacturer 
does not have a written complaint procedure, the manufacturer may not 
properly evaluate and if necessary, investigate the received complaint 
and may fail to identify a nonconforming tobacco product, a product 
design issue, or a reportable adverse experience. For example, if a 
customer reports to a manufacturer that there are metal objects in a 
can of smokeless tobacco (e.g., Ref. 3), and the complaint procedures 
do not describe how to perform an investigation, the manufacturer may 
not conduct an adequate investigation and take an appropriate followup 
action, including a corrective and preventive action that would prevent 
consumer illness or injury from such contaminants.
    Complaints from users and nonusers are an invaluable source of 
information for tobacco product manufacturers. The evaluation and 
investigation of complaints can help a tobacco product manufacturer 
identify problems with a tobacco product's design, established 
specifications, or production process. For example, if a manufacturer 
is receiving complaints alleging explosions of ENDS, this proposed rule 
would require the manufacturer to investigate the scope and cause of 
the issue to determine if, for example, it is due to a design problem 
or manufacturing problem. The investigation may determine that the 
problem is due to use of a non-Original Equipment Manufacturer battery 
charger that does not meet the manufacturer's established 
specification. The U.S. Fire Administration has found that nearly 25 
percent of e-cigarette fires occurred when the battery was being 
charged (Ref. 22). Many e-cigarettes are charged using an ordinary 
universal serial bus (USB) port charging connection that allows users 
to connect the e-cigarette to power adapters that are not provided by 
the original manufacturer of the device. Because the voltage and 
current provided by USB ports can vary significantly between 
manufacturers, use of a USB port or power adapter not supplied by the 
original manufacturer may subject the battery to a higher current than 
is safe, leading to thermal runaway that results in an explosion and/or 
fire. As a result of this complaint information, the manufacturer may 
initiate a CAPA pursuant to proposed Sec.  1120.16 (and further 
discussed in section IV.B.3) to redesign the battery to have a 
proprietary connection that could only be connected to a charging unit 
designed to be compatible or redesign the battery management system to 
detect an incompatible power adapter and prevent the battery from 
charging. New information on increased likelihood of occurrence or 
severity of harm obtained from tobacco product complaints should be 
incorporated into the manufacturer's ongoing risk management activities 
(i.e., review of new information that could change the original risk 
assessment and risk treatment) under proposed Sec.  1120.42.
    In addition, FDA believes that the proposed tobacco product 
complaint requirements would help assure that tobacco products are in 
compliance with the requirements of chapter IX of the FD&C Act. 
Consumer complaints about adverse experiences or product problems may 
indicate nonconforming tobacco products that are not being manufactured 
to established specifications. Therefore, these proposed complaint 
requirements would help tobacco product manufacturers to ensure that 
new tobacco products and MRTPs are manufactured consistent with the 
specifications provided in their applications (i.e., SE Report, request 
for SE exemption, PMTA, MRTPA) and that pre-existing products are 
manufactured consistent with their original characteristics. For 
example, if numerous complaints are received about a product, the 
manufacturer may investigate and learn that the product does not have 
the same characteristics it had as of the pre-existing date.
    Complaints can also indicate that distributed tobacco products are 
adulterated or misbranded under section 902 or 903 of the FD&C Act. For 
example, complaints could indicate that products have been ``prepared, 
packed, or held under insanitary conditions'' (section 902(2) of the 
FD&C Act). In addition, as noted previously, complaints can uncover 
cross-contamination in a production process that resulted in an adverse 
experience to the user, necessitating a change in the manufacturing 
process to prevent the further production of cross-contaminated 
products. The proposed requirements in this rule that would require 
manufacturers to process, evaluate, investigate, and document 
complaints would help them to address and prevent recurrence of such 
adulteration.
    These proposed complaint requirements also may help ensure that the 
packaging, labeling, or labels of finished and bulk tobacco products 
comply with applicable statutory and regulatory requirements. For 
example, a complaint may note that tobacco products are missing labels 
with required warning statements causing the products to be misbranded 
under section 903 of the FD&C Act. The investigation may determine that 
adequate acceptance activities are not being performed during the 
packaging and labeling operations. This provision would enable the 
manufacturer to ensure that required warning statements are applied to 
prevent misbranded products from being commercially marketed.
3. Corrective and Preventive Actions
    Proposed Sec.  1120.16 sets forth the requirements for CAPA. CAPA, 
for purposes of proposed Sec.  1120.16, is a systematic assessment of 
nonconforming tobacco products and design problems to determine the 
cause and implement appropriate changes to the product specifications, 
relevant manufacturing methods and production process procedures, and/
or packaging, labeling, and labels to correct and prevent the cause of 
the nonconformity or design problem. CAPA also helps prevent the 
distribution of identified nonconforming product and helps identify 
design problems. These proposed requirements are generally similar to 
the industry recommendations and to practices of tobacco product 
manufacturing establishments that follow ISO 9001-2015 (Ref. 11). 
Tobacco product manufacturers have utilized CAPA in

[[Page 15196]]

the past to take appropriate actions to correct and prevent identified 
causes of nonconformities and design problems (e.g., Refs. 23-27). FDA 
believes that all tobacco product manufacturers should implement CAPA 
procedures.
    Proposed Sec.  1120.16(a) would require finished and bulk tobacco 
product manufacturers to establish and maintain procedures for 
implementing CAPAs. Specifically, proposed Sec.  1120.16(a)(1) would 
require such manufacturers to review and analyze processes, process 
control records, complaints, production records, returned products, 
reprocessed products, reworked products, and other sources of data to 
identify existing and potential causes of nonconforming tobacco product 
and design problems. These sources would help manufacturers identify 
possible causes of nonconformities and design problems and may also 
help manufacturers identify previously undetected problems.
    Under the proposed rule, FDA expects that manufacturers would 
periodically examine manufacturing processes to look for causes of 
nonconforming tobacco products or design problems, and take steps to 
prevent their occurrence. For example, under proposed Sec.  
1120.16(a)(1) (and the proposed production processes and controls 
provision discussed further below (see Sec.  1120.66)), a finished or 
bulk e-liquid manufacturer would periodically review the mixing process 
for an e-liquid to determine if it has been trending towards the upper 
control limit for the nicotine concentration. Such an issue would 
require a corrective action to maintain the mixing operation within the 
control limits so as not to produce nonconforming product. Further, 
records associated with other tobacco products manufactured using the 
same equipment or production process, including records of tobacco 
complaints, acceptance activities, nonconforming product, and returned 
products could help determine if a repeated nonconformity is associated 
with a manufacturing method or procedure.
    Appropriate statistical methodology must be employed where 
necessary to detect recurring problems. Statistical techniques (e.g., 
Ref. 28) are useful to identify trends of nonconforming product or 
processes and records that indicate systemic problems that contribute 
to nonconformities. Appropriate statistical tools, such as trend 
analysis, can be used to review tobacco product complaints, process 
controls, nonconforming product, acceptance activities, and production 
records. It may be necessary to employ statistical techniques such as 
trend analysis to identify recurring problems across multiple batches 
and identify potential causes of nonconforming product or design 
problems, which is an important part of preventive action.
    Proposed Sec.  1120.16(a)(2) would require finished and bulk 
tobacco product manufacturers to investigate the cause of design 
problems or nonconformities relating to the tobacco product or the 
manufacturing process. For example, if a validated cigarette-making 
process has a normal 2 percent rejection rate and that rate rises to 10 
percent, this provision (along with proposed Sec.  1120.74(b)) would 
require the manufacturer to perform an investigation into the 
nonconformance of the process. In this example, we would expect the 
investigation to include an assessment of production batches 
manufactured before and after the suspect batch, including records of 
monitoring of the process control parameters required by proposed Sec.  
1120.66(a)(2) and continued process verification results required by 
proposed Sec.  1120.66(b)(3) to determine if other batches have been 
affected and whether there are process deviations that require 
revalidation of the manufacturing process pursuant to proposed Sec.  
1120.66(a)(3).
    If a manufacturer's investigation shows that the cause of the 
design problem or nonconformity cannot be determined without the 
involvement of another entity, such as a specification developer, 
contract manufacturer, or other entity that performs a manufacturing 
operation for the product, then the manufacturer should work together 
with the other entity to determine the cause of the design problem or 
nonconformity. This would include the timely reporting to other 
entities of all relevant information related to the design problem or 
nonconformity. For example, if a contract manufacturer investigates the 
cause of a nonconformity in accordance with proposed Sec. Sec.  
1120.16(a)(2) and 1120.74(b) and determines that it does not pertain to 
its contract manufacturing process, the contract manufacturer should 
report the information to the specification developer for 
investigation. The specification developer has knowledge of, and 
controls the design and development information of, the finished 
tobacco product and may be in the best position to investigate whether 
the nonconformity relates to a design problem, and to implement CAPA 
for issues related to product design. Similarly, if a finished tobacco 
product manufacturer who repackages or relabels tobacco products 
performs a CAPA investigation and determines that the cause of a 
nonconformity does not relate to its repackaging or relabeling process, 
it should report the nonconformity to the other manufacturer(s), who 
then can conduct an adequate investigation, determine the cause of the 
nonconformity, and implement appropriate CAPA, for example changes to 
process controls.
    Proposed Sec.  1120.16(a)(3) would require finished and bulk 
tobacco product manufacturers to identify and take actions needed to 
correct and prevent the recurrence of design problems and 
nonconformities and other related problems found in the investigation. 
Correction and prevention of inadequate procedures and practices should 
result in fewer tobacco product nonconformities. To comply with this 
provision, for example, a manufacturer could decide to revise and 
update inadequate procedures, identify and correct improper personnel 
training, or require refresher training on a procedure to address 
employees' failure to follow such procedure. When identifying such 
actions, manufacturers should take into account the risk of illness or 
injury posed by the design problem or nonconformance. The degree of 
corrective and preventive action taken to eliminate or minimize design 
problems or nonconformities should be appropriate to the magnitude of 
the problem and commensurate with the associated risks. For example, to 
address a more serious problem such as a design problem resulting in a 
fire or explosion, the manufacturer may need to take a more significant 
corrective and preventive action, such as a product redesign. When 
performing the CAPA in such a scenario, the manufacturer may need to 
incorporate its risk management process (see proposed Sec.  
1120.42(a)(1)) to assess and treat the risk.
    Proposed Sec.  1120.16(a)(4) would require finished and bulk 
tobacco product manufacturers to verify or validate CAPAs to ensure 
that the actions are effective and do not adversely affect the product. 
Verification, as defined in proposed Sec.  1120.3, would refer to 
confirmation by examination and objective evidence that specified 
requirements have been fulfilled. Examples of verification activities 
would include measuring a dimension such as the length or circumference 
of a cigarette or cigar to confirm it meets a specified requirement, 
conducting a laboratory analysis of a pH level to confirm it is within 
a specified range, and performing a visual comparison of a hand-rolled 
cigar against a standard or

[[Page 15197]]

approved model to confirm the proper shape and dimensions of that 
finished cigar. Validation, as defined in proposed Sec.  1120.3, would 
refer to confirmation by examination and objective evidence that the 
particular requirements can be consistently fulfilled. An example of a 
validation activity would be the validation of the smokeless tobacco 
fermentation process, which would be used to demonstrate that when key 
parameters (e.g., temperature, pH, oven volatiles, and number of turns) 
are met, conforming product will be produced in that batch. The 
relevant parameters would be monitored to confirm that the batch was 
produced within the validated ranges for the fermentation process.
    Verification and validation could also include the collection and 
analysis of data, such as from acceptance activities and nonconforming 
products, to confirm that a CAPA has effectively addressed the problem. 
Moreover, if a tobacco product manufacturer determines that a process 
change is required because the existing process cannot be maintained, 
proposed Sec.  1120.16(a)(4) would require the manufacturer to verify 
or validate that this CAPA does not adversely affect the tobacco 
product by, for example, modifying an established specification. 
Verification and validation activities provide an opportunity to 
demonstrate through examination and objective evidence that the 
proposed corrective and preventive action is effective and does not 
introduce new or increased risks associated with the product, 
production process, packing, and storage. For example, if a 
manufacturer receives complaints about the presence of mold in finished 
tobacco product, it may decide to initiate a CAPA to address this issue 
by changing the packaging to control the moisture content of the 
tobacco product. The manufacturer must verify or validate the newly 
redesigned packaging, for example, by confirming that the new packaging 
material's moisture barrier meets specified requirements or conducting 
shelf life testing, respectively.
    Proposed Sec.  1120.16(a)(5) would require finished and bulk 
tobacco product manufacturers to implement and document changes to 
tobacco product specifications, manufacturing methods and production 
process procedures, and packaging, labeling, and labels needed to 
correct and prevent identified causes of the design problem or the 
nonconformity. A tobacco product manufacturer could comply with this 
provision in many different ways. For example, a tobacco product 
manufacturer that receives consumer complaints regarding respiratory 
distress, may redesign an ENDS cartomizer to minimize metal and 
silicate particles in the aerosol (Ref. 2). Similarly, a cigarette 
manufacturer may determine that calibration procedures need to be 
revised to correct the improper application of casings applied to cut 
filler and prevent the recurrence of nonconforming product (Ref. 29). 
Another example is a manufacturer that may change solvents used on 
packaging (e.g., benzene, toluene, methyl ethyl ketone, methyl 
cellosolve, cellosolve) that are found to contaminate cigarettes (Ref. 
30).
    Proposed Sec.  1120.16(a)(6) would require that information related 
to the design problem or nonconformity and the CAPA taken be 
disseminated to management with executive responsibility, those 
responsible for acceptance activities of a tobacco product, and 
personnel responsible for identifying training needs in accordance with 
proposed Sec.  1120.12(e). This requirement would help ensure that 
designated individuals who are responsible for implementing TPMP 
requirements are notified about design problems, nonconformities, and 
CAPAs and can adjust procedures accordingly.
    Proposed Sec.  1120.16(b) would require that finished and bulk 
tobacco product manufacturers maintain records of all activities 
conducted under this section and that these records include the date 
and time, the individual performing the activity, any information that 
demonstrates the requirement was met, and any data or calculations 
necessary to reconstruct the results. For purposes of this proposed 
part 1120, FDA interprets ``reconstruct,'' in this context, to mean the 
ability to re-create the results by analyzing all data, including 
source and metadata data, and records, including calculations. Although 
FDA is not proposing to prescribe a particular format to document CAPA 
activities, this provision would require tobacco product manufacturers 
to document all of the actions taken to address the requirements under 
this section (e.g., Refs. 24-26).
    The proposed Sec.  1120.16 requirements would help assure that the 
public health is protected by requiring tobacco product manufacturers 
to perform a systematic assessment of nonconforming products and design 
problems to determine and address the cause. For example, nonconforming 
product can result from inadequate or nonexistent tobacco product or 
process specifications; failures of or problems with purchasing 
controls; inadequate process controls; improper facilities or 
equipment; inadequate training; and inadequate manufacturing methods 
and procedures.
    The proposed requirements would help ensure that nonconformities 
and design problems are thoroughly investigated and effective CAPA are 
taken to eliminate or minimize them and potential harms to the 
consumer. For example, under this proposed section, an ENDS 
manufacturer that receives complaints about respiratory distress and 
metallic aftertaste from use of an ENDS product may initiate a CAPA 
investigation. The manufacturer may determine that the cartomizer 
aerosol contains traces of tin, copper, nickel, and silver metals 
attributed to poor solder joints from the cartomizer supplier (Ref. 2), 
and take a CAPA to change suppliers, use different cartomizer 
materials, and implement solder joint reliability testing as an 
acceptance activity (see Sec.  1120.64). While individual tobacco 
product manufacturers may have used CAPA in the past, these proposed 
requirements would ensure that all finished and bulk manufacturers take 
these actions to prevent harms that could occur as a result of design 
problems and nonconforming products.
    CAPA can also help minimize or prevent contamination of finished or 
bulk tobacco product. For example, due to increased consumer complaints 
of plastic or Styrofoam material in finished tobacco products, a 
manufacturer may initiate a CAPA to implement an optical sorter to 
prevent the introduction of non-ferrous NTRMs into finished and bulk 
tobacco products.
    The proposed CAPA requirements would also help assure that tobacco 
products are in compliance with the requirements of chapter IX of the 
FD&C Act by establishing procedures for the manufacturer to follow in 
taking appropriate action on nonconforming and contaminated tobacco 
products both prior to, and after the manufacturer starts, marketing 
the products. For example, a CAPA to prevent the introduction of non-
ferrous NTRMs into finished or bulk tobacco products, as discussed 
above, would help ensure that the product is not adulterated under 
section 902(a)(1) of the FD&C Act. Moreover, these provisions would 
help ensure that appropriate measures are taken to address new or MRTPs 
that do not conform to the specifications provided by the manufacturer 
to FDA in the relevant tobacco product applications (i.e., SE Report, 
SE exemption request, PMTA, MRTPA) and that pre-existing tobacco 
products are manufactured consistent with their original 
characteristics.

[[Page 15198]]

C. Buildings, Facilities, and Equipment

1. Personnel Practices
    Proposed Sec.  1120.32 would require finished and bulk tobacco 
product manufacturers to establish and maintain procedures for the 
cleanliness, personal practices, and apparel of personnel. Under this 
proposed requirement, the procedures must include requirements to 
ensure that contact between the personnel and the tobacco product 
manufacturer or the environment would not result in contamination of 
the tobacco product. These proposed requirements are generally similar 
to personnel practices that FDA has observed during establishment 
inspections. Personnel can contaminate tobacco products by 
unintentionally transferring bacteria, viruses, or disease through the 
handling of tobacco products, and contamination (e.g., physical or 
microbial) may occur at any time during the manufacturing process. 
Therefore, this proposed rule would require each tobacco product 
manufacturer to set up appropriate, consistent, and effective measures 
to prevent personnel from contaminating tobacco products. Examples of 
such measures for ``cleanliness, personal practices, and apparel'' can 
include outer garment requirements, personal cleanliness, restrictions 
on jewelry and other loose items, adequate hand washing before handling 
a tobacco product, use of gloves, head coverings, or other protective 
equipment, and daily checks on these practices.
    This proposed requirement would help ensure that the public health 
is protected by helping to prevent tobacco products from becoming 
contaminated, which can adversely affect public health over and above 
the risk normally associated with the use of the product. The proposed 
requirements also would help assure that tobacco products are in 
compliance with the requirements of chapter IX of the FD&C Act. These 
measures would prevent a likely source of contamination and 
nonconformity and help ensure that products are not manufactured under 
insanitary conditions. Therefore, the requirements would help ensure 
that products are not adulterated under section 902 of the FD&C Act.
2. Buildings, Facilities, and Grounds
    Proposed Sec.  1120.34(a) would require finished and bulk tobacco 
product manufacturers to ensure that any buildings and facilities used 
in or for the manufacture, packaging, or storage of a tobacco product 
are of suitable construction, design, and location to facilitate 
cleaning and sanitation, maintenance, and proper operations. These 
proposed requirements are generally similar to the controls for 
buildings, facilities, and grounds in the industry recommendations, and 
to practices that FDA has observed during establishment inspections.
    The construction, design, and location of the physical plant 
provide the infrastructure that enables a tobacco product manufacturer 
to conduct its manufacturing operations. Therefore, this proposed rule 
would require that each building and facility be maintained in an 
appropriate condition to prevent tobacco product contamination. The 
term ``suitable,'' as used in this provision, would mean that the 
construction, design, and location of facilities would enable proper 
cleaning and sanitizing, maintenance, and operation. Examples of 
buildings and facilities that are inadequately constructed, designed or 
located would include facilities that are constructed of particle board 
that have exposed wood chips or flakes that could become a physical 
hazard, facilities that are constructed of porous material and cannot 
be adequately cleaned and sanitized, and buildings and facilities whose 
equipment is so tightly placed that it prevents adequate cleaning and 
maintenance of the building or facility. For the buildings and 
facilities to facilitate ``proper operations'', they should be 
constructed, designed, and located in a manner to facilitate the 
logical flow of manufacturing activities from receipt and storage of 
incoming materials, processing, packaging, and warehousing. FDA is not 
proposing to require specific activities to satisfy this requirement; 
rather the proposed rule is intended to provide flexibility for 
manufacturers to determine what is appropriate based on the specific 
manufacturing activities performed at the establishment.
    Proposed Sec.  1120.34(a)(1) would require that buildings and 
facilities have adequate lighting. FDA would consider this requirement 
satisfied if lighting conditions enable the tobacco product 
manufacturer to perform necessary manufacturing operations, including 
cleaning, sanitation, and maintenance. Among other things, this 
requirement is necessary to identify insanitary conditions that may not 
be visible with inadequate lighting. For example, tobacco product 
manufacturers may utilize visual inspection to remove NTRMs from the 
production area and inadequate lighting may make it difficult for 
personnel to identify and remove these materials. Manufacturers should 
also take measures to make sure that lighting is not a source of 
contamination. For example, lighting should not attract pests that can 
contaminate or otherwise render the tobacco products adulterated or 
misbranded under section 902 or 903 of the FD&C Act. Manufacturers 
should cover lighting fixtures or use shatter-proof bulbs to prevent 
tobacco products from becoming contaminated with glass shards if the 
light bulbs shatter.
    Proposed Sec.  1120.34(a)(2) would require that buildings and 
facilities have adequate heating, ventilation, and cooling (HVAC). HVAC 
equipment and systems are used to maintain the environmental conditions 
of buildings and facilities. For example, a manufacturer may establish 
temperature, relative humidity, and air flow conditions necessary for 
storage, handling, or processing (such as mixing, cutting, or blending) 
of tobacco product. Use of fans and other air-blowing equipment can 
maintain air ventilation to minimize odors and vapors (including steam 
and noxious fumes) in areas where they may contaminate product or 
otherwise render product adulterated. This requirement would help 
ensure that the HVAC equipment is designed and maintained to prevent 
contamination of tobacco products. For example, manufacturers should 
prevent conditions such as damaged or exposed HVAC duct insulation 
hanging over processing equipment or leakage of hydraulic fluid from an 
HVAC system on tobacco products that may contaminate tobacco products 
(e.g., Ref. 31). While some tobacco product manufacturers may already 
take such actions to control environmental conditions, these proposed 
requirements would ensure that all manufacturers take these actions to 
prevent contamination that could occur due to an inadequate HVAC 
system.
    Proposed Sec.  1120.34(a)(3) would require finished and bulk 
tobacco product manufacturers to utilize adequate plumbing (including 
control of drainage, backflow, sewage, and waste) to avoid being a 
source of contamination or creating insanitary conditions. For example, 
water pipes should be designed so condensation does not fall on the 
tobacco product or tobacco product-contact surfaces, which can cause 
contamination. In addition, floors cleaned with water (or water-soluble 
products) should be designed with floor drains to facilitate adequate 
drainage. Water by-products, sewage, and waste can be a source of 
contamination if they touch a tobacco product-contact surface or become 
a part of the tobacco product. Improper control of drainage, sewage, 
and waste also can result in pooling and create insanitary conditions 
or attract

[[Page 15199]]

pests that may contaminate tobacco products with filth. Filthy 
conditions from improper control of drainage, sewage, and waste can be 
transferred throughout the facility on shoes and equipment.
    Proposed Sec.  1120.34(a)(4) would require that buildings and 
facilities have adequate waste collection, storage, and disposal. 
Adequate waste collection, storage, and disposal includes not creating 
malodors that contaminate tobacco products or result in an attraction, 
harborage, or breeding places for animals and pests. Trash bins should 
have lids and be periodically emptied to help reduce the potential for 
insanitary conditions from microbial contamination and pests.
    Proposed Sec.  1120.34(a)(5) would require finished and bulk 
tobacco product manufacturers to provide adequate readily accessible 
handwashing and toilet facilities. The facilities must provide for 
water at suitable temperatures and appropriate cleaning and sanitation 
materials. FDA considers adequate hand-washing and toilet facilities to 
have hand-cleaning and sanitizing preparation areas, towel service or 
suitable drying stations, water control valves, appropriate signs, 
shelving or hooks on which to rest garments while using the toilet, and 
trash bins that are properly constructed and maintained. Handwashing 
and sanitizing, when used with water at suitable temperatures and with 
appropriate cleaning and sanitation materials, are an important means 
of preventing tobacco product contamination by personnel.
    Proposed Sec.  1120.34(b) would require finished and bulk tobacco 
product manufacturers to maintain the facility grounds in a condition 
to prevent contamination. The grounds consist of the actual physical 
property where the buildings and facilities are located. Inadequately 
maintained grounds can, for example, present a pest harborage area that 
can be a source of contamination.
    Proposed Sec.  1120.34(c) would require finished and bulk tobacco 
product manufacturers to ensure that water used in the manufacturing 
process, including water that is or may become part of the tobacco 
product (e.g., water used as an ingredient or water used on a tobacco 
product-contact surface) is potable, will not contaminate the tobacco 
product, is maintained under positive pressure (e.g., to prevent back 
siphonage that can draw water from a contaminated source into the water 
supply system due to leaks or gaps in the mains, cross-connections, or 
valves), and is supplied from sources that comply with all applicable 
Federal, State, and local requirements. Water is commonly used in the 
manufacture of tobacco products, and water that is untreated may be 
contaminated with Escherichia coli (E. coli) and coliform bacteria. All 
piping systems, hydrants, taps, faucets, hoses, buckets, and other 
equipment used for the delivery of water that is used as an ingredient 
or for use on tobacco product-contact surfaces, should be designed, 
constructed, maintained, and operated in such a manner as to prevent 
contamination of the water.
    Under this proposal, the manufacturer's water supply should come 
from a source for which adequate controls exist for testing, treatment, 
and removal of contaminants (e.g., microbes and heavy metals).
    Therefore, proposed Sec.  1120.34(c) would require that the water 
be supplied from sources that comply with all applicable Federal, 
State, and local requirements. For example, state governments have 
water departments that administer the public water system and have 
specific requirements to ensure that the water is safe for consumption 
and use.
    Proposed Sec.  1120.34(d) would require finished and bulk tobacco 
product manufacturers to establish and maintain procedures for the 
cleaning and sanitation of buildings, facilities, and grounds, 
including procedures for the use of any cleaning compounds, sanitizing 
agents, pesticide chemicals, rodenticides, insecticides, fungicides, 
fumigating agents, and other toxic materials. An establishment's poor 
cleaning and sanitation practices can increase the likelihood of 
tobacco product contamination. A tobacco product manufacturer should 
take into account the construction, design, and location of the 
buildings and facilities as well as the manufacturing operations, when 
establishing cleaning and sanitation procedures.
    Specifically, proposed Sec.  1120.34(d)(1) would require that 
manufacturers' cleaning and sanitation procedures detail the cleaning 
schedules, equipment, and materials to be used in the cleaning and 
sanitization, as appropriate, of the buildings, facilities, and 
grounds.
    Proposed Sec.  1120.34(d)(2) would require that these procedures 
include measures to ensure that materials used for cleaning and 
sanitation are identified, held, used, and stored in a manner to 
protect against contamination of tobacco products and tobacco product-
contact surfaces. For example, FDA has observed on inspections that 
cleaning and sanitation materials are sometimes stored in unmarked 
containers in the manufacturing area (e.g., Ref. 32) and, consequently, 
may be inadvertently used or mixed with tobacco product ingredients, 
additives, or materials. This proposed provision would help prevent 
this potential source of contamination. To help ensure that the use of 
cleaning and sanitation materials are used in a manner that protects 
against contamination, manufacturers should ensure that such materials 
are appropriate for their intended purpose and nontoxic where possible.
    Proposed Sec.  1120.34(d)(3) also would require that the use of 
cleaning and sanitation materials comply with all applicable Federal, 
State, and local requirements related to their application, use, or 
storage. For example, hazardous cleaning and sanitation chemicals must 
be handled, used, and stored in a manner consistent with the 
information contained in their safety data sheets in accordance with 
the hazard communication standard at 29 CFR 1910.1200(g).
    Proposed Sec.  1120.34(e) would require finished and bulk tobacco 
product manufacturers to establish and maintain procedures for 
monitoring, controlling, and minimizing the presence of animals and 
pests in the buildings, facilities, and grounds to protect against 
contamination of tobacco products. This proposed requirement would be 
limited to manufacturing activities and not extend to agricultural 
activities including growing, cultivation, or curing of raw tobacco (21 
U.S.C. 387). FDA acknowledges that tobacco is an agricultural crop and, 
therefore, there is the likelihood that there will be a certain level 
of animals and pests (such as tobacco beetles) in the tobacco. However, 
it is important that manufacturers take appropriate action to control 
these animals and pests, which can cause contamination (e.g., Refs. 33-
35). FDA is proposing that these procedures include requirements for 
establishing threshold criteria for animals and pests. This provision 
is intended to provide manufacturers with flexibility to quantitatively 
establish acceptable levels of animals or pests, such as insects, that 
may be present and the levels that would necessitate action to control 
and minimize infestation in order to avoid contamination. Manufacturers 
may employ pest control or fumigation to minimize the presence of 
animals or pests (e.g., Ref. 36). This approach is recognized in the 
Cooperation Centre for Scientific Research Relative to Tobacco's 
(CORESTA's) Good Agricultural Practices Guidelines (Ref. 37).

[[Page 15200]]

    This paragraph also would require that the procedures include a 
requirement that any pesticide, including rodenticides, insecticides, 
or fungicides used in the buildings, facilities, and grounds be 
registered in accordance with the Federal Insecticide, Fungicide, and 
Rodenticide Act (7 U.S.C. 136 et seq.) and used in accordance with its 
label, as applicable and used in a manner that protects against 
contamination. Pesticides, such as rodenticides, insecticides, or 
fungicides are useful to manufacturers to monitor, control, and 
minimize animals and pests effectively. The tobacco product 
manufacturer should follow all applicable pesticide labels, identify 
proper compounds to be used, use the correct concentration, and apply 
it as directed to avoid contamination (e.g., Refs. 38-40). Use of 
inappropriate pest control chemicals or use in an inappropriate manner 
can contaminate tobacco products (e.g., Refs. 39-41).
    Proposed Sec.  1120.34(f) would require finished and bulk tobacco 
product manufacturers to maintain records of cleaning and sanitation 
and animal and pest control activities required under this section. 
These records would be required to include the date and time, the 
individual performing the activity, the type of activity performed, any 
information demonstrating the requirement was met, and any data or 
calculations necessary to reconstruct the results. We believe these 
records are necessary for tobacco product manufacturers to ensure that 
the required activities have been conducted and for FDA to verify that 
the activities have been adequately performed.
    The proposed requirements for buildings, facilities, and grounds 
would help assure that the public health is protected by helping to 
prevent tobacco product contamination by, among other things, toxic 
cleaning compounds, inadequate maintenance, or cross-contamination from 
inadequate cleaning (e.g., Refs. 42-44). Insanitary conditions can 
create the potential for growth of microorganisms that may render 
tobacco products injurious to health beyond what is normally associated 
with tobacco products (e.g., Refs. 45 and 46).
    These proposed requirements also would help assure that tobacco 
products are in compliance with the requirements of chapter IX of the 
FD&C Act by helping to ensure that tobacco products are not ``prepared, 
packed, or held under insanitary conditions'' that may contaminate 
tobacco products and render them adulterated under section 902 of the 
FD&C Act. As discussed above, inadequate or inappropriate maintenance, 
cleaning and sanitizing procedures, or animal and pest control may 
result in conditions that can adulterate tobacco products.
3. Equipment
    Proposed Sec.  1120.36(a) would require finished and bulk tobacco 
product manufacturers to ensure all equipment is appropriately designed 
and constructed, and is suitable for its intended purpose. These 
proposed requirements are generally similar to the equipment controls 
in the industry recommendations and to controls that FDA has observed 
during establishment inspections. The term ``equipment'' means any 
machinery, tool, instrument, utensil, or other similar or related 
article, used in the manufacture, preproduction design validation, 
packing, or storage of a tobacco product. Equipment that is 
appropriately designed, constructed, and suitable for its intended 
purpose is designed and constructed in a manner that facilitates its 
function, use, maintenance, and cleaning. For example, under this 
proposal, a tobacco cutter would be required to be designed and 
constructed to enable use, cleaning, and maintenance (e.g., inspection 
and replacement of its cutting blade). It would also be required to be 
suitable for its intended purpose to cut tobacco to particular 
specifications (e.g., different cut sizes).
    Proposed Sec.  1120.36(b) would require finished and bulk tobacco 
product manufacturers to establish and maintain procedures, including 
the methods and schedules, for the routine cleaning and maintenance of 
equipment, to ensure proper performance of equipment and prevent 
contamination. This provision is intended to give each tobacco product 
manufacturer the flexibility to determine the appropriate methods and 
frequency of cleaning and maintenance of equipment based on their 
manufacturing practices. For example, a manufacturer may require that 
cutting equipment be cleaned after each batch of tobacco is produced, 
using approved sanitizing agents that will not contaminate the tobacco 
product. The manufacturer also could schedule maintenance involving 
disassembling, inspection, and replacement of the cutting blade to be 
performed every 6 months. Proposed Sec.  1120.36(b) would also require 
that the procedures provide for any change-over of tobacco product and 
account for changes, limitations, or adjustment to the equipment. For 
example, if a manufacturer uses the same equipment to manufacture 
flavored and nonflavored tobacco products,\4\ the cleaning and 
maintenance procedures must address the change-over activities to 
prevent mixups or cross-contamination (e.g., Refs. 47 and 48).
---------------------------------------------------------------------------

    \4\ FDA recently issued proposed tobacco product standards that 
would prohibit menthol as a characterizing flavor in cigarettes, 87 
FR 26454 (May 4, 2022), and characterizing flavors (other than 
tobacco) in all cigars and their components and parts, 87 FR 26396 
(May 4, 2022).
---------------------------------------------------------------------------

    Proposed Sec.  1120.36(c) would require finished and bulk tobacco 
product manufacturers to identify (electronically, by signage, or other 
method of identification), if applicable, all processing lines and 
major equipment to be used during manufacturing to prevent mixups and 
contamination. The intent of this identification requirement is to 
prevent mixups (e.g., flavored vs. nonflavored, regular vs. 
mentholated) and distribution of nonconforming product. FDA is also 
proposing that related information (i.e., which major equipment and 
processing line was used in the manufacture of a batch of finished or 
bulk tobacco product) be maintained in the production record, pursuant 
to proposed Sec.  1120.70(b)(3) to establish traceability and assist 
with, for example, nonconforming tobacco product investigations.
    FDA recognizes that it is impractical to identify every piece of 
equipment used during manufacturing. Thus, the Agency proposes to 
require identification of major equipment only. Major equipment 
includes blending silos, conditioning cylinders, makers, filling 
machines, assembly equipment (for cartridge production), and packers. 
For example, if a manufacturer has multiple blending silos to hold 
different blends, conditioning cylinders at different stages that add 
different moisture levels, dedicated makers for different cigarette 
lengths/circumferences, filling machines for dry vs. moist snuff, and 
packers for soft vs. hard packs, this provision would require all such 
equipment to be appropriately identified. Examples of equipment that 
would not need to be identified under this proposed provision include a 
portable hand-held mixer, optical detectors (to remove foreign matter), 
metal detectors, string doffers (to remove string), and moisture 
meters/detectors. In addition, manufacturers would be required to 
identify all processing lines. For example, if there are dedicated 
maker and packer lines for regular and mentholated products, these 
processing lines would be required to bear appropriate identification 
to prevent mixups and contamination. If a

[[Page 15201]]

manufacturer does not have multiple or dedicated processing lines or 
major equipment that could lead to product mixup, it should document 
this as a justification for not implementing these proposed 
identification requirements.
    Manufacturers may also choose to include in the identification of 
the processing line or major equipment the identification of the 
product being processed. FDA has observed that some manufacturers place 
designated, color coded, indicator to identify the flavor of the 
product (for example, pink for cherry flavor) being manufactured with 
that equipment. This requirement is intended to work in conjunction 
with the requirements for identification and acceptance status 
established in proposed Sec.  1120.64. Identifying the product as well 
as major manufacturing equipment, will help minimize or eliminate 
mixups during the manufacturing process.
    Proposed Sec.  1120.36(d) sets out additional requirements for 
testing, monitoring, and measuring equipment. Testing, monitoring, and 
measuring equipment is used in all stages of manufacturing. Examples of 
testing, monitoring, and measuring equipment include pH meters, 
moisture meters, and weight or measurement scales that are used to 
verify established tobacco product specifications.
    Proposed Sec.  1120.36(d)(1) would require finished and bulk 
tobacco product manufacturers to establish and maintain procedures for 
all testing, monitoring, and measuring equipment to ensure such 
equipment is capable of producing accurate and reliable results. For 
example, if a manufacturer uses a pH meter, this proposal would require 
procedures for the use of such a meter to address how its reference and 
pH electrodes are to be maintained in order to produce accurate 
results; otherwise, it could result in unstable and off-scale readings 
(Ref. 49). In addition, if an ingredient specification is measured by 
weight in grams, the scale would need to be sensitive enough to 
accurately and reliably provide these measurements to ensure the 
correct amount of the ingredient is added to the tobacco product.
    Proposed Sec.  1120.36(d)(2) would require that all testing, 
monitoring, and measuring equipment be identified and disabled, 
removed, replaced, or repaired when it is no longer suitable for its 
intended purpose or when it is no longer capable of producing accurate 
and reliable results. Defective equipment is not suitable for use in 
the manufacturing process and can result in nonconforming or 
contaminated tobacco product.
    Proposed Sec.  1120.36(d)(3) would require finished and bulk 
tobacco product manufacturers to establish and maintain procedures for 
the routine calibration of testing, monitoring and measuring equipment. 
Calibration provides assurance that equipment is properly performing 
and providing accurate and reliable measurements. Under this proposal, 
the procedures must describe an appropriate reference standard and 
include specific directions and acceptance criteria for the limits of 
accuracy and precision. Testing, monitoring, and measuring equipment 
must be calibrated before first use; thereafter, at a frequency 
determined by the equipment manufacturer or at intervals necessary to 
ensure accurate and reliable results; and after repair or maintenance. 
The appropriate frequency of calibration would likely depend on the 
particular equipment, the equipment manufacturer's recommendation, the 
activity the equipment is used for, and the individual calibration 
process. Calibration should be performed at suitable intervals in 
accordance with an established procedure containing specific 
directions, schedules, and limits for accuracy and precision based on 
the type of instrument being used and other factors such as operating 
environment and wear and tear.
    Proposed Sec.  1120.36(e) would require finished and bulk tobacco 
product manufacturers to maintain records of all activities required 
under this section. Records would be required to include the date and 
time, the individual performing the activity, the type of activity 
performed, any information that demonstrates the requirement was met, 
and any data or calculations necessary to reconstruct the results.
    The proposed equipment requirements would assure that the public 
health is protected, by helping to prevent the use of malfunctioning 
equipment that can produce nonconforming product. For example, if a 
tobacco cutter is not designed, constructed, or maintained properly, it 
can result in tobacco strips that do not conform to established 
specifications for cut size. The size of the cuttings of tobacco is a 
physical design specification that can influence the release of 
nicotine in a tobacco product (Ref. 6). Maintenance of equipment is 
also necessary to prevent contamination of tobacco product. For 
example, a finished tobacco product manufacturer previously recalled 
tobacco products due to heavy oil spots from a cutter head oil leak 
(Ref. 50). While some manufacturers may already have controls similar 
to the proposed requirements in place, FDA believes it is important 
that all manufacturers comply with these requirements to help protect 
against the manufacturing and distributing of contaminated or otherwise 
nonconforming product. The proposed identification requirement would 
help assure that the public health is protected by preventing mixups 
and contamination of tobacco products that could have an adverse impact 
on public health.
    The proposed equipment requirements also would help assure that 
tobacco products are in compliance with the requirements of chapter IX 
of the FD&C Act. For example, the equipment requirements would help 
ensure that tobacco products meet applicable statutory requirements 
under sections 905, 907, 910, and 911 of the FD&C Act. Equipment that 
functions properly and produces accurate and reliable results is 
necessary to ensure that new tobacco products and MRTPs are 
manufactured consistent with the specifications described in their 
applications (i.e., SE Report, request for SE exemption, PMTA, MRTPA); 
that the specifications for pre-existing tobacco products continue to 
be consistent with their original characteristics; and that tobacco 
products subject to tobacco product standards are manufactured in 
accordance with those standards.
    For example, consider a cigarette product marketed pursuant to an 
SE Report. If laboratory equipment used in the cigarette manufacturing 
provides a check on the nicotine content in the manufactured products, 
improperly functioning equipment may allow higher nicotine content in 
the manufactured products. Such products would not conform to the 
specifications described in the SE Report. Because FDA authorizes the 
marketing of tobacco products based on the specifications described in 
the relevant marketing application, nonconforming products, such as the 
cigarette in this example, would be on the market without FDA 
authorization in violation of chapter IX of the FD&C Act.
    In addition, a bulk manufacturer that does not properly maintain or 
calibrate its testing, monitoring, and measuring equipment can produce 
nonconforming bulk tobacco products. For example, cutting equipment 
that has not been properly maintained can result in bulk cigarette 
tobacco, RYO, or pipe tobacco products with an incorrect cut size. 
Similarly, filling equipment that has not been properly calibrated can 
produce bulk e-liquids with nicotine concentration that exceeds the 
labeled concentration.

[[Page 15202]]

4. Environmental Controls
    Proposed Sec.  1120.38(a) would require finished and bulk tobacco 
product manufacturers to establish and maintain procedures to 
adequately control environmental conditions where appropriate. In 
addition, under the proposed requirement, environmental control systems 
would have to be maintained and monitored to verify that environmental 
controls, including necessary equipment, are adequate and functioning 
properly. Environmental control systems include associated equipment 
(e.g., HVAC equipment, humidifier, air filters) that manages the 
facility's environmental conditions (e.g., temperature, humidity, 
ventilation, filtration). These proposed requirements, which are 
intended to ensure that the tobacco product meets its specifications 
and is not adversely affected by environmental conditions, complement 
those in proposed Sec.  1120.34, which are intended, in part, to ensure 
that buildings and facilities have adequate controls to prevent 
contamination. These proposed requirements are generally similar to the 
practices of manufacturing establishments that follow ISO 9001-2015 
(Ref. 11).
    The appropriate environmental control procedures needed to comply 
with this proposed requirement can vary by product, manufacturing 
process, and other factors. For example, if a tobacco product 
manufacturer uses a sterilization process for a moist snuff product to 
achieve a product stability specification, it should establish 
environmental controls for temperature, moisture, and time (Ref. 51). 
If a tobacco product manufacturer determines that specific conditions 
are necessary to minimize mold growth, it would need to establish 
appropriate environmental controls, such as controlling the relative 
humidity (Ref. 52). In addition, if an ENDS manufacturer determines 
that airborne particulates can contaminate e-liquids, appropriate 
environmental controls, such as use of air filters or precautions 
against potential sources of airborne contaminants, should be taken 
(e.g., Ref. 10).
    Proposed Sec.  1120.38(a) also would require that environmental 
control systems be maintained and monitored to verify that 
environmental controls, including necessary equipment, are adequate and 
functioning properly. Monitoring of these systems can be performed by 
recording data, using alarms to determine if the environmental controls 
deviate from the operating range or fail, or other means to ensure that 
environmental controls are operating as intended.
    Proposed Sec.  1120.38(b) would require finished and bulk tobacco 
product manufacturers to maintain records regarding environmental 
controls, including maintenance and monitoring. Records would be 
required to include the date and time, individual performing the 
activity, type of activity performed, any information that demonstrates 
the requirement was met, and any data or calculations necessary to 
reconstruct the results. We believe these records are necessary to 
ensure that the required activities have been conducted and for FDA to 
verify that the activities have been adequately performed.
    The proposed environmental controls requirements would help assure 
that the public health is protected by maintaining proper environmental 
conditions to protect products from contamination and to ensure they 
meet specifications. For example, improper humidity and temperature 
during storage of tobacco can result in spoilage and the growth of mold 
(Ref. 53). Studies have shown that mold can grow on reconstituted 
tobacco at certain humidity and temperature conditions (Ref. 54). FDA 
is aware that some tobacco product manufacturers have a microbiological 
monitoring plan and perform environmental monitoring of water and air 
in accordance with that plan and assess the effectiveness of their 
sanitation procedures (Ref. 55). As an example of how environmental 
controls can also be important to ensure that products meet 
specifications, if a smokeless tobacco product uses a heat treatment 
process (Ref. 56) or a cigar uses a fermentation process (Ref. 57) to 
achieve a pH specification, the tobacco product would not conform to 
its established specification if the manufacturer does not establish 
and maintain environmental controls for the temperature, moisture, and 
time. As explained in more detail in the discussion of proposed Sec.  
1120.74 (see section II.E below), a specification such as pH can affect 
the speed and amount of nicotine that is delivered to a user (Refs. 6 
and 19). Moisture and pH also can be associated with concentrations of 
nicotine in smokeless tobacco (Refs. 58 and 59). While some 
manufacturers may already have similar controls in place, this proposed 
rule would help ensure that all manufacturers establish such controls 
to help protect against the manufacturing and distributing of 
contaminated or otherwise nonconforming product.
    In addition, the proposed environmental controls would help assure 
that tobacco products are in compliance with the requirements of 
chapter IX of the FD&C Act. As discussed, specific controlled 
environmental conditions may be necessary to manufacture a tobacco 
product that conforms to established specifications, including 
specifications described in any relevant tobacco product applications 
(i.e., SE Report, request for SE exemption, PMTA, MRTPA), and to ensure 
that the specifications for pre-existing tobacco products continue to 
be consistent with their original characteristics.

D. Design and Development Controls

1. Design and Development Activities
    Proposed Sec.  1120.42 addresses risks associated with design and 
development activities by requiring finished and bulk tobacco product 
manufacturers to establish and maintain procedures to control the 
design and development of each finished and bulk tobacco product and 
its package, including the control of risks associated with the 
product, production process, packing, and storage. Procedures to 
control the design and development of finished and bulk tobacco 
products would need to address risk management as well as design 
verification and validation. The proposed requirements incorporate 
principles similar to those found in, for example, ISO 9001; the QSR 
for medical devices; current good manufacturing practice, hazard 
analysis, and risk-based preventive controls for human food; and HACCP 
regulations.
    Proposed Sec.  1120.42(a) would require finished and bulk tobacco 
product manufacturers to establish and maintain procedures to control 
the design and development of each product and its package, including 
the control of risks associated with the product, production process, 
packing, and storage. While FDA is aware that some tobacco product 
manufacturers already engage in a wide variety of activities to control 
the design and development of tobacco products, including chemistry, 
toxicology, and nonclinical testing; clinical assessment and 
investigations; and consumer and market research (e.g., Ref. 55), the 
Agency believes that these requirements are needed to ensure that all 
manufacturers address risks associated with design and development 
activities. A manufacturer's procedures may vary based on the type of 
tobacco product and may be specific to one or multiple products. 
Therefore, FDA is proposing a flexible framework to allow manufacturers 
to implement procedures that best suit their specific design and 
development approach.

[[Page 15203]]

    Design activities can be performed by different parts of a tobacco 
product manufacturer's organization, (e.g., manufacturing, marketing, 
purchasing, and regulatory affairs). Procedures to control the design 
and development of a tobacco product should establish the roles that 
any groups have in process and describe the information that they 
should receive and transmit, including any approvals that may be 
necessary.
    Under proposed Sec.  1120.42(a), design and development controls 
must control for risks associated with each finished and bulk tobacco 
product and its package, production process, packing, and storage. 
Specifically, proposed Sec.  1120.42(a)(1) would require that the 
design and development procedures include a risk management process. 
For purposes of this rule, a risk management process is a preventive 
means to identify and control for potential risks throughout the 
product lifecycle (i.e., during design, manufacturing, distribution, 
and use of products). Risk management is an established practice used 
by manufacturers in many industries, including in the manufacture of 
FDA-regulated products such as foods, drugs, biologics, and medical 
devices. General risk management standards such as ISO 31000:2018--Risk 
Management--Principles and Guidelines (Ref. 12) can be used by 
manufacturers to provide guidance in establishing and maintaining a 
risk management system. In some industries, industry-specific risk 
management standards have been developed (e.g., Refs. 60 and 61), 
whereas other industries use a more broadly developed framework (e.g., 
Ref. 62). While FDA is not proposing to require compliance with a 
particular risk management framework or standard, FDA recommends that 
finished and bulk tobacco product manufacturers use an established risk 
management framework such as a standard or guideline.
    The proposed provision would give manufacturers flexibility in 
devising their risk management process and the type of risk assessment 
technique(s) employed; however, at a minimum, proposed Sec.  
1120.42(a)(1) would require that the risk management process include 
the following steps: risk assessment (including risk identification, 
risk analysis, and risk evaluation), risk treatment, and reassessment. 
A tobacco product manufacturer can perform their risk management 
process for categories, types, or families of products that share 
similar specifications and design characteristics. During inspections, 
the Agency has observed that some tobacco product manufacturers 
currently use a risk management framework (including, e.g., HACCP 
plans) that is consistent with these proposed requirements (Ref. 63).
    Under proposed Sec.  1120.42(a)(1)(i), each finished and bulk 
manufacturer must perform a risk assessment that includes risk 
identification, risk analysis, and risk evaluation. Manufacturers can 
utilize various risk assessment techniques to help ensure compliance 
with this section, such as preliminary hazard analysis, Delphi, 
scenario analysis, fault tree analysis, cause-and-effect analysis, 
failure mode and effect analysis, hazard and operability studies, and 
hazard analysis and critical control points (Ref. 62). Risk assessment 
for risks associated with the tobacco product would need to be 
performed for each tobacco product manufactured, packed, or stored, 
taking into account the individual attributes of each product, its 
package, and manufacturing process. For example, a manufacturer 
performing a risk assessment for e-liquids would need to consider 
potential risks associated with access of e-liquid by children or 
leakage of e-liquid from cartridges during and after use, which can 
cause acute nicotine toxicity to users and nonusers.
    The first step of risk assessment that would be required under 
proposed Sec.  1120.42(a)(1)(i) is risk identification. At this step, 
manufacturers would be required to identify all known or reasonably 
foreseeable risks associated with the tobacco product and its package, 
as well as its production process, packing, and storage (see Refs. 12 
and 62). In identifying all known or reasonably foreseeable risks 
associated with the tobacco product, a manufacturer would be required 
to identify known or reasonably foreseeable risks that may occur 
naturally or be introduced, intentionally or unintentionally, in the 
growing, harvesting, curing, leaf processing, and warehousing of 
tobacco leaf, and during primary production, manufacturing, packing, or 
storage of finished or bulk tobacco products. These risks may include 
biological, chemical, or physical hazards in a tobacco product, such as 
harmful bacteria, pesticides, and NTRMs. Risk identification would also 
need to take into account risks associated with product design. An 
example of a risk associated with product design is a dissolvable 
tobacco product whose size and shape resembles candy, resulting in 
potential misuse by and harm to children.
    ``Known'' risks refer to those risks that a tobacco product 
manufacturer knows about through, for example, its manufacturing and 
distribution experience, records, and reports (such as complaints, 
returned products, nonconforming product, and CAPA). ``Reasonably 
foreseeable'' risks are those risks that a reasonably prudent tobacco 
product manufacturer would become aware of through scientific 
literature, publications, or public information, such as an industry 
standard or FDA guidance document. To identify risks, the manufacturer 
should evaluate relevant information, such as complaint file 
investigations, published literature, articles, and reports. For 
example, in identifying reasonably foreseeable risks associated with an 
ENDS product with a lithium battery, a manufacturer should take into 
consideration, among other things, available information regarding 
design features of lithium ion batteries that could cause overheating, 
fires, and explosions (e.g., Refs. 64-69).
    Proposed Sec.  1120.42(a)(1)(i) would also require that risk 
identification include risks that may occur with normal use (i.e., 
labeled and customary uses) and with reasonably foreseeable misuse 
(i.e., any use not intended by the manufacturer, including user error) 
of a tobacco product. Risks that may occur with normal use and with 
reasonably foreseeable misuse are discussed in greater detail below.
    The concept of ``reasonably foreseeable misuse'' is well-
established and utilized in risk management. For example, the American 
National Standards Institute (ANSI)/Advancement of Medical 
Instrumentation (AAMI)/International Electrotechnical Commission (IEC) 
62304:2006 regarding medical device software, states that manufacturers 
must identify potential causes of hazardous situations, including 
reasonably foreseeable misuse (Ref. 70). Since misuse of a product can 
be a source of harm, FDA believes it is appropriate to consider 
reasonably foreseeable misuse when completing risk management 
activities for tobacco products. An example of a risk related to 
reasonably foreseeable misuse would include a child accessing an e-
liquid container that does not have a secure container closure system 
and ingesting the product, which could lead to serious injury or death 
due to nicotine toxicity.
    Proposed Sec.  1120.42(a)(1)(i) would require each finished and 
bulk tobacco product manufacturer to identify all known or reasonably 
foreseeable risks associated with the tobacco product and its package, 
as well as its production process, packing, and storage. Risks 
associated with a tobacco product under proposed Sec.  1120.42(a)(1)(i) 
would include risks associated with finished or bulk tobacco product 
specifications,

[[Page 15204]]

including product risks attributable to components or parts, 
ingredients, additives and materials; product design; and issues 
addressed in a tobacco product standard under section 907 of the FD&C 
Act. For example, use of an improper charger on a rechargeable e-
cigarette may result in a battery fire or explosion due to differences 
in specifications. Similarly, use of e-liquid flavors containing 
diacetyl may cause acute-onset bronchiolitis obliterans, a severe and 
irreversible obstructive lung disease (Ref. 71).
    Risk identification would also need to be performed for known or 
reasonably foreseeable risks associated with the tobacco product 
package. Risks associated with a tobacco product package would include 
substances that may render the contents injurious to health and cause 
the tobacco product to become adulterated under section 902(3) of the 
FD&C Act or a package design which can cause or expose users and 
nonusers to harm. For example, an e-liquid manufacturer would need to 
consider potential risks of leakage of e-liquid from cartridges, which 
can cause product malfunction (Ref. 72) or skin irritation (Ref. 73), 
as well as risks to nonusers such as children who can access the e-
liquid and experience acute nicotine toxicity (Refs. 74-76).
    Risk identification would also need to be performed for all known 
or reasonably foreseeable risks associated with the production process, 
packing, and storage. Risks associated with the production process, 
packing, and storage would include substances and conditions that can 
contaminate and/or render the tobacco product injurious to health and 
thereby cause the tobacco product to become adulterated under section 
902(1) and (2) of the FD&C Act, including but not limited to, 
biological, chemical, and physical hazards described below. Risk 
identification should take into account the type of tobacco product 
being manufactured, the manufacturing processes, and the facility where 
the product is manufactured, packed, or stored. Risks identified in one 
facility may not be significant in another facility, even if it 
manufactures the same or a similar product, due to differences in 
equipment, process controls, and/or maintenance programs. Additionally, 
risks associated with a facility's tobacco products may differ based on 
the type of tobacco product manufactured, packed, or stored.
    Risk identification should take into account biological, chemical, 
and physical hazards. For example, biological hazards such as bacteria, 
mold, yeast, microbes, and other biological organisms can grow on 
tobacco and tobacco products as a result of environmental conditions in 
their warehousing, packing, and storage. These hazards vary widely in 
their prevalence, mode of action, infectious dose, growth and survival 
specifications, and resistance to heating, chemical agents, and other 
processes or treatments. The Agency has observed on inspection that a 
cigarette manufacturer identified potential mold on incoming ``tobacco 
with yellow spots'' during visual inspection that was determined by 
microbiological analysis to be Aspergillus flavus (the major producer 
of aflatoxin, which is associated with an increased risk of liver 
cancer) (Ref. 77). In addition, microbes that can be found on tobacco 
and tobacco products include bacteria, bacterial spores, fungi (yeast 
and mold), fungal spores, cell wall components (certain glucans and 
flagellum), and diverse microbial toxins that include exotoxins and 
endotoxins (Ref. 78). Examples of bacterial-derived toxins include 
endotoxins (lipopolysaccharide, LPS; inflammatory factor) and mold-
derived mycotoxins (Ref. 78).
    Similarly, risk identification should include chemical hazards. 
Chemical hazards, including pesticide residues, can be naturally 
occurring or intentionally, unintentionally, or incidentally added to 
tobacco, tobacco products, or tobacco-product contacting surfaces. For 
example, pesticide chemical residues have been found on commercially 
available cigarettes. In 2003, the European Commission's Joint Research 
Centre investigated the content of organochlorine pesticides in a 
selection of commercially available cigarette brands and found that 
they contained pesticide chemical residues (Ref. 79). Organochlorine 
pesticides act on the nervous system to prevent the normal flow of 
nerve impulses to muscles that control both voluntary movement, such as 
walking, and involuntary movement, such as breathing and heartbeat 
(Ref. 80). These classes of pesticides are also associated with a range 
of adverse health effects that could result in immediate and life-
threatening effects, such as respiratory failure, or conditions that do 
not appear immediately, such as cancer (Ref. 80).
    When identifying chemical hazards, tobacco product manufacturers 
should assess the chemicals that are used in the manufacturing 
establishment for cleaning, sanitation, and pest control purposes that 
may be associated with the manufacturing, packing, and storage of 
tobacco products, including rodenticides, insecticides, fungicides, and 
fumigating agents. For example, FDA is aware of situations where 
packaging solvents, cleaning solutions, hydraulic oil leakage, and 
machine grease may have caused contamination (Refs. 50 and 81).
    Risk identification should also take into account any physical 
hazards that may be associated with the tobacco product. These hazards 
include animals, animal parts and excrement, insects and insect 
excrement, such as tobacco beetles and insect parts; rocks, stones, and 
sand; plastic string, plastic sheet, foam, and rubber; metal, glass, 
hessian/burlap, wood products, cloth, and cotton strings; and other 
forms of NTRMs that may be introduced on the farm, during harvesting, 
and during the manufacturing process. The facility and equipment also 
can be a source of physical hazards (e.g., metal fragments such as nuts 
and bolts from equipment used in manufacturing and processing, glass 
pieces from overhead light bulbs, or debris from overhead equipment). 
FDA is aware that glass shards have been found in smokeless tobacco 
products (Ref. 81). If glass is present in chewing tobacco, it may 
lacerate the gums or lips of the user of the tobacco product. FDA 
believes it is critical to identify NTRMs that may be introduced 
throughout the supply chain (Ref. 37).
    FDA is proposing that the risk management process require 
identification of all known and reasonably foreseeable risks associated 
with the tobacco product, including risks that cause illness, injury, 
or death normally associated with the use of tobacco products. 
Identifying risks normally associated with the use of the tobacco 
product is necessary to perform an adequate risk analysis and 
evaluation. Some symptoms or health effects of risks not normally 
associated with the use of the tobacco product can be similar to the 
symptoms or health effects of risks normally associated with the use of 
the tobacco product, and therefore this requirement would help ensure 
that risks that may appear to be normally associated with the use of 
tobacco products, but are not, are included in the risk analysis and 
evaluation. In addition, identifying symptoms or health effects of 
risks normally associated with the use of the tobacco product and their 
likelihood and consequence of occurrence will help inform the 
investigation of user reports and complaints about such symptoms or 
health effects, because they may also point to risks not normally 
associated with the use of the tobacco product. For example, an 
increase of reported frequency or severity of respiratory distress from 
use of an ENDS product may help a

[[Page 15205]]

manufacturer detect a previously unidentified risk of metallic 
particles in the cartomizer aerosol due to defective solder joints from 
the cartomizer (Ref. 2). Similarly, increased complaints of pneumonia, 
exacerbation of asthma, bronchitis, chronic obstructive pulmonary 
disease, eosinophilic pneumonitis, and laryngitis may be associated 
with chemical contamination of a tobacco product (Ref. 82).
    After risk identification, the next step of risk assessment is risk 
analysis. Risk analysis is an analysis of the nature and level of the 
risk for each identified known or reasonably foreseeable risk that 
takes into account the likelihood of occurrence of the risk and the 
consequences of occurrence of the risk (i.e., severity of the potential 
harm). When considering the likelihood of occurrence of the risk, the 
manufacturer should consider the frequency that such risk may occur in 
the type of product, the production process, and the particular 
manufacturing establishment. When considering the consequences of the 
occurrence of the risk, the manufacturer should consider the health 
effects of the risk, including the severity, immediacy, or near-term 
onset of any potential injury or illness, and long-term effects from 
chronic or cumulative exposure, on both users and nonusers.
    For example, FDA is aware that some manufacturers have identified 
styrene (Styrofoam) as a risk that requires risk control. Styrene is a 
chemical hazard that can be introduced in tobacco products as an NTRM 
such as via food containers that contaminate tobacco products during 
manufacturing or via a packaging coating that can be transferred to the 
tobacco product (Ref. 83). Styrene can enter into the body of consumers 
by inhalation or ingestion. Styrene consumption can affect the nervous 
system, resulting in changes in color vision, tiredness, feeling drunk, 
slowed reaction times, concentration problems, and balance problems 
(Ref. 84). The International Agency for Research on Cancer (IARC) has 
determined that styrene is a possible carcinogen (Ref. 85). Under the 
proposed rule, a manufacturer performing a risk analysis for styrene 
would consider the likelihood of styrene being introduced into the 
tobacco product and reaching consumers. It would also consider the 
health effects of styrene exposure on users and nonusers. For example, 
storage conditions such as temperature and duration can affect 
microbial growth and nitrite formation, which can influence tobacco-
specific N-nitrosamines (TSNA) content in processed and packaged 
smokeless tobacco products. (See Ref. 16, Ref. 181-182). Under the 
proposed rule, a manufacturer should perform a risk analysis of the 
tobacco product using the expected storage period and conditions and 
determine the likelihood of changes to TSNA content that may result in 
an increased risk to public health as the product sits in storage.
    Following risk analysis, the last step of risk assessment is risk 
evaluation. The proposed risk evaluation requirement would require an 
evaluation of each identified risk. Risk evaluation is a determination 
of the significance of the risk and the type of risk treatment needed 
(e.g., avoiding the risk, mitigating the risk, or choosing to retain 
the risk), including the priority of the risk treatment. A 
comprehensive risk evaluation demonstrates that the manufacturer has 
considered all relevant information about the tobacco products being 
manufactured, packed, or stored and determined the significance of the 
identified risks and what type of risk treatment is needed.
    In this context, determining the significance of the risk means 
evaluating whether the risk and its magnitude are acceptable, 
tolerable, or unacceptable. In determining the significance of the 
risk, manufacturers should develop criteria against which the risk and 
its magnitude can be evaluated. For example, a manufacturer may 
determine that, based on its risk criteria, a risk of nonusers 
ingesting e-liquids resulting in toxic nicotine exposure is not 
tolerable and must be controlled. The manufacturer may similarly 
determine that, based on its risk criteria, a nicotine concentration 
that is a certain percentage higher than the established specification 
is not tolerable and must be controlled through additional 
manufacturing controls such as acceptance testing. Determining the 
significance of a risk would inform the manufacturer's decision 
regarding what type of risk treatment is appropriate and the priority 
of that risk treatment. FDA is aware that during the evaluation stage 
of a risk assessment, manufacturers across industries sort risks into 
categories based on established risk criteria to determine whether risk 
control/mitigation is required, should be considered, or is not 
necessary (Ref. 12).
    Proposed Sec.  1120.42(a)(1)(ii) would require that each finished 
and bulk manufacturer treat all identified risks, including risks 
addressed in applicable tobacco product standards. Risk treatment can 
include implementing controls to avoid or remove the risk, or making an 
informed decision to retain the identified risk (Ref. 12). The proposed 
risk treatment requirements would require the manufacturer to 
significantly minimize or prevent risks identified in proposed Sec.  
1120.42(a)(1)(i) that are reasonably likely to occur and that may cause 
serious illness, injury, or death not normally associated with the use 
of the tobacco product, or that the manufacturer determines constitute 
an unacceptable level of risk. Additionally, risks addressed in any 
applicable tobacco product standards would be required to be treated in 
a manner that ensures the tobacco product will conform to the 
specifications and requirements established in the tobacco product 
standard. FDA requests comment on whether these are the appropriate 
risks for which risk prevention or mitigation should be required.
    FDA's application of risk management concepts acknowledges that the 
use and consumption of tobacco products entails some degree of risk 
inherent to tobacco use. Therefore, the risk mitigation and prevention 
requirements in the proposed rule focus on reducing or eliminating 
those risks associated with the tobacco product, its design and 
packaging, and its associated production process, packing, and storage 
that are reasonably likely to occur and may cause an illness, injury, 
or death not normally associated with the use of tobacco products. 
These requirements are also intended to address issues that the 
manufacturer determines constitute an unacceptable level of risk. This 
proposed provision would, therefore, require tobacco product 
manufacturers to, at a minimum, undertake risk treatment to 
significantly minimize or prevent such risks. Additionally, any risks 
identified in an applicable tobacco product standard would need to be 
treated in a manner that ensures the tobacco product will conform to 
the tobacco product standard.
    For example, a manufacturer may determine that NTRMs such as glass, 
metal, rocks, and stones are introduced on the farm, during harvesting, 
or during the manufacturing process, and that, as a result, hard or 
sharp NTRMs are reasonably likely to occur in a tobacco product. The 
manufacturer may also determine that, when these hard or sharp NTRMs 
are present in a tobacco product, they may cause traumatic injury, 
including laceration and perforation of tissues of the mouth, tongue, 
throat, stomach, and intestine as well as damage to the teeth and gums. 
Based on this information, the manufacturer would be required to 
significantly minimize or prevent the risk under Sec.  
1120.42(a)(1)(ii) of the proposed rule.

[[Page 15206]]

    Risk treatment measures will vary based on the type of product and 
the risks identified as well as the manufacturing facility. Risk 
treatment can include manufacturing controls, redesigning the tobacco 
product, clarifying user instructions, or ordering a component or part 
from a different supplier. Risk treatment also may include personnel 
requirements (e.g., health, cleanliness, personal practices, and 
apparel of personnel), cleaning and sanitation controls, animal and 
pest controls, maintenance of equipment, environmental controls, 
purchasing controls (e.g., Good Agricultural Practices, supplier 
guarantee, testing raw tobacco for pesticide chemical residues (Ref. 
86)), acceptance activities (e.g., visual inspection, tests, and other 
verification activities), and process controls (e.g., metal detectors, 
x-rays, optical sorters). For example, FDA has noted on inspections 
that certain manufacturers have implemented manufacturing policies that 
include a requirement to use pens that do not have caps, are color-
coded, and contain ferrous material to prevent physical hazards from 
being introduced in the tobacco product during the production process 
and enable the hazard to be readily identified by metal detectors and 
magnets if necessary (Ref. 87).
    Where risk treatment measures required by proposed Sec.  
1120.42(a)(1)(ii) are implemented to significantly minimize or prevent 
a risk associated with the production process, packing, and storage 
that is reasonably likely to occur and may cause serious illness, 
injury, or death not normally associated with the use of the tobacco 
product and package, or that the manufacturer determines constitutes an 
unacceptable level of risk, the manufacturer should incorporate these 
measures in the relevant procedure(s) under proposed part 1120. For 
example, the manufacturer may need to incorporate the risk treatment 
measures into its procedures for personnel practices under proposed 
Sec.  1120.32, buildings, facilities, and grounds under proposed Sec.  
1120.34, environmental controls under proposed Sec.  1120.38, 
purchasing controls under Sec.  1120.62, acceptance activities under 
proposed Sec.  1120.64, and production processes and controls under 
proposed Sec.  1120.66. Manufacturers also would be required to 
validate or verify their production process in accordance with proposed 
Sec.  1120.66.
    A manufacturer may determine that a risk is unacceptable if it 
occurs infrequently but the consequences are severe. Likewise, a risk 
may be unacceptable if the risk occurs frequently, even if it is not 
associated with serious illness or injury. For example, if a cigarette 
manufacturer uses a new filter supplier that uses methyl isothiocyanate 
(which can cause throat irritation) in its filter processing, it may 
determine that this is an unacceptable level of risk if it occurs 
frequently, even though the severity of the risk is moderate or low.
    Although testing alone is rarely considered an effective risk 
treatment, testing can be useful to verify that control measures are 
effectively minimizing or preventing risks. For example, microbial 
testing of raw materials may verify that suppliers have controlled for 
biological hazards. Environment testing also may verify whether 
sanitation or environmental controls have addressed the potential for 
environmental pathogens to contaminate tobacco products. For example, 
during acceptance moisture testing, a manufacturer may determine a 
finished product has excessive moisture content during the packing 
process that has resulted in spoilage of cigarettes due to growth of 
Aspergillus restrictus and Aspergillus glaucus mold, a biological 
hazard (Ref. 88).
    Where a manufacturer has identified a risk associated with consumer 
misuse of a product, the manufacturer may need to redesign the product 
in order to comply with this proposed provision. If there is a 
potential for misuse that causes harm and such misuse could be 
prevented, the manufacturer should address it. For example, a tobacco 
product manufacturer may determine that a package redesign could reduce 
choking hazards associated with dissolvable tobacco products or toxic 
exposure to e-liquids (e.g., Refs. 89 and 90). Similarly, an ENDS 
manufacturer could redesign a battery charger connection if the 
manufacturer identifies the risk that users are misusing the USB 
charging connection port and using a nonstandard USB power source that 
does not match the manufacturer's specifications. Depending on the 
manufacturer's assessment of the risk, a redesign may not always be 
necessary. However, if new information suggests that risk treatment 
short of redesign has not been effective, the proposed rule would 
require the manufacturer to reassess their risk treatment activities 
pursuant to proposed Sec.  1120.42(a)(1)(iii) and consider additional 
mitigation.
    Proposed Sec.  1120.42(a)(1)(iii) would require each finished and 
bulk tobacco product manufacturer to reassess the risks whenever the 
manufacturer becomes aware of new information that could change the 
risk assessment and risk treatment, including information about 
previously unidentified risks or the adequacy of risk treatment 
measures.
    The risk management process FDA is proposing is an ongoing process 
whereby manufacturers update their risk assessment as new information 
is learned. The purpose of the reassessment requirement is to determine 
if existing risk assessment and risk treatment need to be updated in 
light of new information that bears on the effectiveness of the risk 
management process. New information can inform the scientific 
understanding of a previously assessed risk or identify a new risk. A 
finished or bulk tobacco product manufacturer may become aware of new 
information in a variety of ways, including user and nonuser reports of 
adverse experiences, records and reports (such as complaints, returned 
products, nonconforming product, and CAPA), and through scientific 
literature, publications, or public information, such as an industry 
standard or FDA document.
    Proposed Sec.  1120.42(a)(1)(iii) would specifically require 
finished and bulk tobacco product manufacturers to reassess risks 
whenever the manufacturer becomes aware of new information that 
indicates a previously unidentified risk. For example, an ENDS 
manufacturer may become aware that the ENDS product's power settings 
can result in carbonyl generation which can increase cancer potency 
(Refs. 91 and 92). Under these circumstances, the ENDS manufacturer 
would have to undertake the risk assessment and risk treatment steps 
for the newly identified risk.
    Additionally, this provision would also require the manufacturer to 
reassess the risks when it becomes aware of new information that 
indicates that a previously identified risk they did not believe was 
reasonably likely to occur is, in fact, reasonably likely to occur. For 
example, a tobacco product manufacturer may have previously identified 
metal fragments in chewing tobacco as a risk that was not reasonably 
likely to occur. If the manufacturer begins to receive consumer 
complaints about metal fragments being found in its chewing tobacco, 
this new information would necessitate a reassessment of the risk to 
determine whether the initial risk analysis and evaluation must be 
updated and new risk treatment measures must be implemented.
    In addition, this provision would also require manufacturers to 
reassess risks when they become aware of new information that indicates 
the existing risk treatment measures are ineffective.

[[Page 15207]]

For example, if consumer complaints report that finished tobacco 
products continue to have NTRM after risk treatment measures have been 
implemented, the tobacco product manufacturer would need to reassess 
the risk and modify the treatment measures as necessary.
    FDA recognizes that batteries and other components may be a source 
of risk. Therefore, FDA is proposing that finished and bulk tobacco 
product manufacturers, which are responsible for component selection 
and design (e.g., an ENDS manufacturer responsible for the selection of 
the battery and the manner in which it operates in the ENDS product), 
would need to do a risk assessment of the risks associated with the 
finished or bulk tobacco product, including risks attributable to such 
components. For example, an ENDS manufacturer should perform a risk 
assessment of the battery design (such as an internal or a commercially 
available off-the-shelf external battery), safety rating, and suppliers 
to consider potential risks associated with use of the battery with 
their ENDS product that may occur during normal use (e.g., charging) 
and during reasonably foreseeable misuse (e.g., customer replacement 
with a non-OEM battery).
    FDA is aware that not all tobacco product manufacturers design the 
tobacco products they manufacture. Under this proposed rule, contract 
manufacturers who are not responsible for product design would not be 
required to assess the design risks associated with the products' 
specifications. For example, if a contract manufacturer does not engage 
in design activities but only manufactures a tobacco product for 
another party based on specifications provided by that party, the 
contract manufacturer would not be responsible for assessing the design 
risks associated with the product's specifications.
    For finished and bulk tobacco products first commercially marketed 
or modified after the effective date of this rule, proposed Sec.  
1120.42(a)(2) would require finished and bulk tobacco product 
manufacturers to perform design verification to confirm that the 
tobacco product and its packaging meet specifications and design 
validation to assess the performance of the tobacco product. These 
activities would be informed by the risk management process in proposed 
Sec.  1120.42(a)(1). Process verification and process validation would 
be separate requirements and are found in proposed Sec.  1120.66. 
Design verification confirms that the product and packaging meet their 
specifications. Design verification activities can include testing and 
studies, and reviewing design documents before their release as 
specifications in the MMR. For example, an ENDS manufacturer may 
establish that the specification for a battery is a power of 4 volts, 
temperature range of 200 [deg]C to 300 [deg]C, it must be charged in 
less than 90 minutes, and that it can be recharged 1,000 times. Under 
the proposed rule, the manufacturer would be required to perform 
battery testing to verify that the battery performance meets those 
specifications.
    Design validation is a process to assess the product performance to 
confirm that it consistently performs or functions as intended. For 
example, a manufacturer could perform testing of child resistant 
packaging to validate the effectiveness of the package design in 
preventing children from accessing the tobacco product while allowing 
adult users to open the package.
    For finished and bulk tobacco products first commercially marketed 
or modified after the effective date of this rule, proposed Sec.  
1120.42(a)(3) would require that the product and packaging design be 
approved by a designated, authorized individual. The review and 
approval would be required to ensure that the product and packaging 
specifications are supported by the product design verification and 
validation activities and that appropriate risk treatment measures have 
been implemented.
    For finished and bulk tobacco products first commercially marketed 
or modified after the effective date of this rule, proposed Sec.  
1120.42(a)(4) would require finished and bulk tobacco product 
manufacturers to transfer the approved product and packaging 
specifications to the MMR. Proposed Sec.  1120.42(a)(5) would require 
finished and bulk tobacco product manufacturers, where appropriate, to 
utilize the processes under proposed Sec.  1120.42(a)(2) through (4) 
for design changes before the changes are implemented.
    Proposed Sec.  1120.42(b) would require finished and bulk tobacco 
product manufacturers to maintain records of all activities required 
under this section. These records would be required to include the date 
and time, individual performing the activity, type of activity 
performed, any information that demonstrates the requirement was met, 
and any data or calculations necessary to reconstruct the results. 
Manufacturers would have flexibility to determine the format in which 
these records are maintained. For example, these records may be 
maintained in a single record or single file of records, or as part of 
a product- or product-type-specific index system that references and 
includes the location of all the required information. The results of 
the design and development activities would produce the information 
documented in the MMR, including specifications, manufacturing methods 
and procedures, and packaging and labeling (see proposed Sec.  
1120.44(a)).
    The proposed requirements for design verification and validation, 
design approval, and design transfer under Sec.  1120.42(a)(2) through 
(4) would not apply to existing tobacco products already commercially 
marketed before the effective date of this rule, including, for 
example, pre-existing tobacco products commercially marketed in the 
United States as of February 15, 2007. Finished and bulk tobacco 
product manufacturers would not be required to perform retroactive 
design verification to confirm that such tobacco products and their 
packages meet specifications, or retroactive design validation to 
assess their performance. Similarly, finished and bulk tobacco product 
manufacturers would not be required to perform retroactive design 
approval and design transfer for such products under proposed Sec.  
1120.42(b)(3) and (4). However, the proposed Sec.  1120.42(a)(2)-(4) 
requirements would apply to finished and bulk tobacco products first 
commercially marketed after the effective date of the rule, and to any 
finished and bulk tobacco products that are modified after the 
effective date of the rule, including changes made in order to comply 
with a tobacco product standard. When changes are made to finished or 
bulk tobacco products commercially marketed before the effective date 
of any final TPMP rule, the proposed requirements of Sec.  
1120.42(a)(2) must be followed to confirm that the tobacco product and 
its package, as modified, meet specifications and that the tobacco 
product will perform as intended.
    The proposed design and development activities requirements would 
help assure that the public health is protected by helping to prevent 
illness, injury, or death not normally associated with the use of the 
tobacco product, including to users and nonusers. The proposed 
provisions would require finished and bulk tobacco product 
manufacturers to perform an assessment of the known and reasonably 
foreseeable risks associated with the tobacco product, its package, and 
its production process, packing, and storage that may occur with normal 
use of the tobacco product or with any reasonably foreseeable misuse of 
the product, including user error. For

[[Page 15208]]

example, ENDS can overheat, resulting in fires and explosions (e.g., 
Refs. 64, 93 and 94). Under these proposed requirements, an ENDS 
manufacturer would be required to assess the risk the battery poses in 
the design of its finished tobacco product, as lithium batteries can 
contribute to ``thermal runaway'' and cause a battery fire or explosion 
(Ref. 67). If the ENDS manufacturer determines that this risk is 
reasonably likely to occur and that it may cause serious illness, 
injury, or death not normally associated with the use of the tobacco 
product, it would then be required to take appropriate treatment 
measures to significantly minimize or prevent the risk, such as use of 
overcharging protection circuits, thermal power cutoffs, and internal 
overpressure relief mechanisms that can help prevent and mitigate 
thermal runaway. The proposed provision would then require 
manufacturers to verify and validate the design of the product taking 
into account these risk treatment measures.
    FDA believes that engaging in a risk management process is the most 
effective and efficient way to proactively ensure that risks associated 
with finished and bulk tobacco products, their package, and their 
production process, packing, and storage, are adequately assessed and 
treated. FDA believes such an approach is more effective than 
identifying and controlling risks through finished product testing or 
sanitation controls alone (Ref. 95). Additionally, other TPMP 
requirements such as product complaints, acceptance activities, 
nonconforming product, and returned product may not be sufficient to 
address all risks.
    The requirement to maintain records of required design and 
development activities could help FDA understand how a tobacco product 
manufacturer has established the specifications in the MMR for the 
finished or bulk tobacco product and their impact on public health. In 
addition, in the event of a recall, FDA could use these records to 
learn information that may be related to the recall and ascertain the 
appropriate way to address the issue. For example, FDA is aware of 
instances where contamination of cigarettes with a suspected chemical 
hazard resulted in a recall. One cigarette manufacturer announced a 
voluntary recall of approximately 8 billion cigarettes because the 
company detected unusual tastes and peculiar odors in 36 product lines 
(Ref. 82). Consumers who smoked the affected cigarettes reportedly 
suffered from pneumonia, exacerbation of asthma, bronchitis, chronic 
obstructive pulmonary disease, eosinophilic pneumonitis, and laryngitis 
(Ref. 82). The manufacturer detected methyl isothiocyanate (MITC) in 
the cigarette filters (Ref. 82). Adverse health effects from MITC 
exposure (e.g., mucosal irritation of the respiratory and 
gastrointestinal tracts, conjunctival irritation, and neurologic 
symptoms) have been documented, although it was not established in this 
recall event that the reported illnesses were associated with users 
smoking contaminated cigarettes (Ref. 82). In such a scenario, if MITC 
was not previously an identified risk but was subsequently determined 
to pose a risk because it was used in the production of cigarette 
filters by the filter supplier, this provision would have required the 
manufacturer to reassess the risk and to take appropriate risk 
treatment steps. The risk assessment and risk treatment steps could 
include notifying the filter supplier to cease the use of this 
substance to minimize or prevent this risk if the manufacturer 
determined the level of risk to be unacceptable. Alternatively, the 
manufacturer could use the updated risk assessment to choose an 
alternate filter supplier who does not use MITC in the manufacture of 
filters.
    The proposed design and development activities requirements also 
would help assure that the finished or bulk tobacco product is in 
compliance with the requirements of chapter IX of the FD&C Act. For 
example, finished or bulk tobacco products that pose risks such as 
physical, chemical, and/or biological hazards may be adulterated under 
section 902 of the FD&C Act. While some finished and bulk tobacco 
product manufacturers may already have similar controls in place, FDA 
believes that manufacturers should be required to engage in a risk 
management process and perform design validation and verification to 
help protect against the manufacture and distribution of nonconforming 
and/or contaminated product.
3. Master Manufacturing Record
    Proposed Sec.  1120.44(a) would require finished and bulk tobacco 
product manufacturers to establish and maintain an MMR for each 
finished and bulk tobacco product they manufacture for distribution. 
These proposed requirements are similar to those in other FDA-regulated 
industry manufacturing regulations (e.g., Sec.  820.181). An MMR is a 
document or a designated compilation of documents containing the 
established specifications for a tobacco product, including acceptance 
criteria for those specifications, all relevant manufacturing methods 
and production process procedures for the tobacco product, and all 
approved packaging, labeling, and labels for the tobacco product.
    Under proposed Sec.  1120.44(a)(1), the MMR must include the 
tobacco product specifications and acceptance criteria for those 
specifications. A tobacco product specification is any requirement 
established by the manufacturer (including specifications necessary to 
ensure that the tobacco product meets any applicable product standard) 
with which a product must conform. Tobacco product specifications can 
include physical, chemical, and biological specifications. Examples of 
physical specifications include length, circumference, and pressure 
drop for cigarettes and cut size and weight for smokeless tobacco 
products. An example of a chemical specification is a pH level for 
smokeless tobacco products, and an example of a biological 
specification is a specification related to the use of a biological 
fermentation agent used during the manufacturing process for smokeless 
tobacco products.
    Tobacco product specifications in the MMR could include 
specifications for the finished or bulk tobacco products as well as 
specifications for incoming components and in-process tobacco products. 
For example, a tobacco product manufacturer may establish 
specifications for the cut size of incoming tobacco cut filler or the 
length, diameter, and tow of incoming filters. Tobacco product 
manufacturers may also establish specifications for in-process tobacco 
products, for example, a specification for the pH of fermented tobacco 
before it is packaged as a finished smokeless tobacco product or a 
specification for the length, circumference, and pressure drop of 
cigarette filter rods before they are packaged as finished cigarettes. 
In addition, tobacco product manufacturers may establish specifications 
for finished tobacco products, for example, specifications for the 
length, circumference, and pressure drop for cigarettes, or cut size 
and weight for smokeless tobacco products.
    Proposed Sec.  1120.44(a)(1) also would require that the MMR 
include acceptance criteria for the tobacco product specifications. The 
acceptance criteria should indicate if there is a particular value, 
range, minimum or maximum value, and/or standard deviation associated 
with a specification for an incoming component, in-process product, or 
finished or bulk tobacco product. For example, if a smokeless

[[Page 15209]]

tobacco product manufacturer establishes a pH and a weight 
specification for a finished smokeless tobacco product, proposed Sec.  
1120.44(a)(1) would require that the MMR for the product indicate the 
specific pH and weight acceptance criteria, for example, 7.2 0.5 pH and 3g 0.2 gram (g), respectively. Similarly, 
if an ENDS manufacturer establishes a voltage specification for an 
adjustable, variable voltage product, the MMR would have to indicate 
the voltage acceptance criteria, for example, a range of 3-6 V. While 
this proposed rule would require acceptance criteria, the tobacco 
product manufacturer would determine the specific acceptance criteria 
that are appropriate for each established specification.
    Under the proposed requirement, it would generally be up to 
manufacturers to determine what specifications to include in the MMR 
for each particular product they manufacture. However, proposed Sec.  
1120.44(a)(1)(i) through (iv) would require that, at a minimum, tobacco 
product specifications in the MMR include certain specifications 
related to product content, design, any applicable product standards 
established by FDA under section 907 of the FD&C Act, and pesticide 
chemical residues for raw tobacco.
    Proposed Sec.  1120.44(a)(1)(i) would require the product 
specifications in the MMR to include the identity and amount of any 
components or parts, ingredients, additives, and materials in the 
finished or bulk tobacco product. This information could be presented, 
for example, in a bill of materials that describes the identity and 
amount of the ingredients, additives, and materials in a finished 
tobacco product. The identity of all components or parts, ingredients, 
additives, and materials in the finished or bulk tobacco product should 
include a uniquely identifying name and/or number information. The 
proposed approach for uniquely identifying information is intended to 
be consistent with FDA's current thinking on listing of ingredients 
under section 904 of the FD&C Act as articulated in FDA's guidance 
entitled ``Listing of Ingredients in Tobacco Products.'' For example, 
for ingredients that are single chemical substances, uniquely 
identifying information should be a unique scientific name or code, 
such as the FDA Unique Ingredient Identifier code, Chemical Abstracts 
Service number, or International Union of Pure and Applied Chemistry 
name. Leaf tobacco (i.e., whole leaf or parts) that has been prepared 
solely by mechanical processing that involves no chemical, additive, or 
substance other than potable water should be uniquely identified by, if 
known: the type (e.g., burley, bright, oriental); the variety; the cure 
method (e.g., flue, fire, sun, steam, air) and heat source (e.g., 
propane, wood); and a description of any recombinant DNA technology 
used to engineer the tobacco. Complex purchased ingredients, as 
described in FDA's revised guidance, ``Listing of Ingredients in 
Tobacco Products,'' should be identified by: the complete name of the 
manufacturer of the complex purchased ingredient and the uniquely 
identifying item name and/or number (e.g., catalog number or Universal 
Product Code (UPC)) used by that manufacturer. Complex ingredients made 
by the tobacco product manufacturer or made to the tobacco product 
manufacturer's specifications should be included in the MMR in a manner 
that uniquely identifies each individual ingredient.
    We recognize that some tobacco product manufacturers obtain certain 
components or parts for their products from other manufacturers or 
suppliers and may not be in a position to know every individual 
ingredient in those components or parts. This is especially true if the 
component or part is, for example, a proprietary blend. In these 
instances, the tobacco product manufacturer could comply with proposed 
Sec.  1120.44(a)(1)(i) by including the complete name of the 
manufacturer of the component or part and a uniquely identifying item 
name and/or number (e.g., catalog number or UPC) used by that 
manufacturer. The tobacco product manufacturer, however, would have to 
comply with additional requirements intended to ensure awareness of any 
changes to purchased components or parts that may affect the tobacco 
product (see proposed Sec.  1120.62(c), Purchasing controls).
    Proposed Sec.  1120.44(a)(1)(ii) would require the MMR to include 
the finished or bulk tobacco product design, meaning the form and 
structure concerning and the manner in which components or parts, 
ingredients, additives, and materials are integrated to produce a 
tobacco product. For example, a cigarette's design could include design 
features such as ventilation, paper porosity, tobacco cut width, and 
filter efficiency and the manner in which the tobacco cut filler, 
filter, cigarette paper, tipping paper, and plug wrap are assembled to 
produce a finished cigarette.
    Under proposed Sec.  1120.44(a)(1)(ii), a manufacturer must also 
include an identification of the product's heating source, if any 
(e.g., burning coal, electric, chemical reaction, carbon tip), a 
discussion of the intended user operation (how the tobacco product will 
be used or operated by a user), and any relevant product drawings or 
schematics. For example, a discussion of the intended user operation of 
an ENDS product could include the appropriate and intended methods to 
charge the ENDS battery or how to handle, refill, and store the e-
liquids for the ENDS product.
    Proposed Sec.  1120.44(a)(1)(iii) would require the MMR to include 
any specification necessary to ensure that the tobacco product meets 
any applicable product standard established under section 907 of the 
FD&C Act. For example, under section 907 of the FD&C Act, FDA could 
establish a product standard requiring the reduction of an additive or 
constituent in a tobacco product. In this case, the tobacco product 
manufacturer would be required to include any specification necessary 
to ensure that the product meets the established standard for that 
additive or constituent. Finally, proposed Sec.  1120.44(a)(1)(iv) 
would require the MMR to include specifications for pesticide chemical 
residues for raw tobacco.
    Proposed Sec.  1120.44(a)(2) would require the MMR to include all 
relevant manufacturing methods and production process procedures. This 
requirement is intended to capture all the manufacturing steps involved 
in making the tobacco product, from receipt of incoming materials to 
distribution of the finished or bulk product. Under this requirement, 
the tobacco product manufacturer would be required to include any 
process controls, production process specifications with relevant 
acceptance criteria, and monitoring and acceptance activities 
(inspections, testing, evaluation, and other verification activities). 
For example, a smokeless tobacco product manufacturer may control its 
fermentation process by using a specific amount of a biological agent, 
controlling temperature and humidity, and setting turn cycle 
specifications. Under the proposed requirements, the manufacturer must 
include these production process specifications and activities in the 
MMR for the finished or bulk tobacco product. The manufacturer would 
also be required to include any established acceptance criteria 
associated with these activities and process specifications, for 
example, acceptable temperature and humidity ranges for the 
fermentation process.
    The manufacturing methods and production process procedures in the 
MMR would also be required to include any monitoring and acceptance

[[Page 15210]]

activities. These are the activities the manufacturer performs to 
ensure that the production process meets the established process 
specifications. Acceptance and monitoring activities may include 
inspections, tests, evaluation, and other verification activities. 
Under proposed Sec.  1120.44(a)(2), the manufacturer would be required 
to document all these activities in the MMR.
    Specific aspects of the requirement in proposed Sec.  1120.44(a)(2) 
and related requirements are further discussed in the proposed sections 
that follow, including proposed Sec. Sec.  1120.64 (Acceptance 
activities), 1120.66 (Production processes and controls), and 1120.68 
(Laboratory controls).
    Proposed Sec.  1120.44(a)(3) would require the MMR to include all 
packaging, labeling, and labels approved by the manufacturer for use 
with the finished or bulk tobacco product. To satisfy this requirement, 
a tobacco product manufacturer could maintain actual copies of the 
packaging, labeling, and labels approved for use with the finished and 
bulk tobacco products. Alternatively, a manufacturer could maintain 
artwork files that describe the design, layout, and content of the 
packaging, labeling, and labels approved for use with the products. For 
example, a finished tobacco product manufacturer may have packaging and 
labeling materials with different warning statements or different 
product package inserts or onserts. Under the proposed requirement, the 
MMR for the finished tobacco product would have to include or reference 
the location of these materials so that they can be readily accessible 
to FDA during inspections.
    The MMR could be prepared either as a single document (or single 
file of documents) or as a product-specific index system that 
references and includes the location of all the required information. 
For example, if a specific manufacturing procedure is relevant to 
multiple tobacco products, the manufacturer would not need to reproduce 
that procedure in the MMR file for each product; instead the MMR file 
for each product could simply list and cross-reference the procedure 
(e.g., identify it by a name and/or number) and indicate where the 
procedure can be found. Similarly, MMR files for multiple products 
could be included in one single document, as long as it is clear from 
the document what information pertains to each specific finished or 
bulk tobacco product.
    Proposed Sec.  1120.44(b) would require finished and bulk tobacco 
product manufacturers to establish and maintain procedures for the 
review and approval of the MMR, including any changes made to the MMR 
after initial approval. Under these procedures, a designated, qualified 
individual would be required to review and approve all MMR information 
before it is implemented in the manufacture of finished or bulk tobacco 
products for distribution. The designated, qualified individual's 
approval of the MMR would be required to be documented by date of 
approval and name and signature of the individual(s) approving the 
document.
    When reviewing and approving the MMR for a tobacco product, the 
designated, qualified individual would be required to confirm that any 
design activities conducted to support the tobacco product 
specifications have been completed in accordance with the product 
design and development procedures established by the manufacturer under 
Sec.  1120.42 and that the resulting production specifications are 
correctly transferred into the established MMR. These proposed 
requirements are intended to ensure that the tobacco product 
manufacturer has adequate control over the MMR, including changes to 
the MMR, and therefore over the product, prior to its release for 
distribution.
    Proposed Sec.  1120.44(c) would require that the MMR describe which 
methods and procedures established under Sec.  1120.44(a)(2) and 
related sections, including Sec. Sec.  1120.62 (Purchasing controls), 
1120.64 (Acceptance activities), 1120.66 (Production processes and 
controls), and 1120.68 (Laboratory controls), are used to ensure that 
the tobacco product is manufactured in conformance with each tobacco 
product specification established under Sec.  1120.44(a)(1). Thus, 
under proposed Sec.  1120.44(a)(1), the MMR would include all 
established product specifications; under proposed Sec.  1120.44(a)(2), 
the MMR would include all relevant manufacturing methods and production 
process procedures; and under proposed Sec.  1120.44(c), the MMR would 
link the methods and procedures with the specifications by indicating 
which method or procedure would be used to ensure that each particular 
specification is met.
    For example, under proposed Sec.  1120.44(a)(1) a finished 
cigarette manufacturer may establish specifications for the porosity, 
ink type and color, and burn properties of a cigarette paper. If the 
manufacturer receives the paper from a qualified cigarette paper 
supplier (consistent with the purchasing controls in proposed Sec.  
1120.62) and ensures that the paper meets its specifications by relying 
on a Certificate of Analysis (CoA) from the supplier that addresses 
these specifications, under proposed Sec.  1120.44(c), the manufacturer 
would be required to indicate in the MMR that a supplier's CoA is used 
to ensure that the cigarette paper meets specifications for porosity, 
ink type and color, and burn properties. Similarly, a smokeless tobacco 
product manufacturer may use a laboratory test as its acceptance 
activity (consistent with the acceptance activity requirements in 
proposed Sec.  1120.64) to ensure that a smokeless product meets its pH 
specification, or a cigarette manufacturer may use a validated cutting 
process (consistent with the production processes and controls in 
proposed Sec.  1120.66 and laboratory controls in proposed Sec.  
1120.68) to demonstrate that the tobacco cut filler meets its cut size 
specification. Under proposed Sec.  1120.44(c), the manufacturers would 
be required to indicate the link between these activities and controls 
and the tobacco product specifications in the MMR.
    The Agency believes that the proposed requirements would help 
assure that the public health is protected and that tobacco products 
are in compliance with the requirements of chapter IX of the FD&C Act. 
The proposed requirements would accomplish this by requiring 
manufacturers to establish specifications for each finished or bulk 
tobacco product and follow manufacturing methods and procedures that 
ensure that those specifications are met and, therefore, that products 
are manufactured in a controlled and consistent manner. The proposed 
MMR requirements provide a foundation for several of the requirements 
in part 1120. Building on the specifications established in the MMR, 
the purchasing controls, acceptance activities, process controls, and 
production record requirements would help ensure that each batch of 
tobacco product is manufactured in conformance with its established 
specifications. A manufacturer that fails to maintain control over its 
production process could manufacture and distribute nonconforming 
tobacco products, which could adversely affect public health. Because 
the MMR forms the foundation for the process controls that ensure that 
the production process operates as intended, the proposed MMR 
requirements would help ensure that nonconforming tobacco products are 
not manufactured and released for distribution.
    Under the proposed MMR requirements, manufacturers would be 
required to establish specifications

[[Page 15211]]

related to the content and design of their finished and bulk tobacco 
products. Content and design are two critical parameters of finished 
and bulk tobacco products that can have a direct effect on public 
health. The physical design specifications of a tobacco product 
interact with its chemical composition to influence its function and 
effect on consumers. Thus, the content and design of finished and bulk 
tobacco products can impact the health consequences and addictiveness 
of the product. For example, the design of a cigarette filter's 
ventilation impacts the level of tar, nicotine, and carbon monoxide 
produced in the cigarette's smoke (Ref. 96). If a cigarette deviates 
from this ventilation design, the amount of tar, nicotine, and carbon 
monoxide delivered to the user may vary, affecting the tobacco 
product's toxicity and addictiveness. Because the content and design of 
a tobacco product can directly (e.g., by increasing harmful emissions) 
or indirectly (e.g., by increasing the addictiveness and the amount of 
use) contribute to the harm of a product, tobacco products that are 
manufactured inconsistently with established specifications may cause 
increased harm to the public health beyond what is normally associated 
with the product (Ref. 6). Requiring manufacturers to establish product 
specifications and manufacture products that meet those specifications 
helps minimize harm to public health associated with nonconforming 
products.
    In addition, the Agency believes that the proposed MMR requirements 
would help assure that tobacco products are in compliance with the 
requirements of chapter IX of the FD&C Act. For example, the proposed 
requirements would enable the Agency to monitor and confirm that 
tobacco products are not manufactured in a manner that causes them to 
become adulterated or misbranded in violation of section 902(1) through 
(3) or 903 of the FD&C Act.
    By requiring manufacturers to establish product specifications and 
manufacturing methods and procedures, the proposed requirements would 
reduce the chances of adulteration during the production process. For 
example, maintaining a state of control would help decrease the 
likelihood that products contain filthy, putrid, or decomposed 
substances, or are otherwise contaminated by added poisonous or 
deleterious substances that may render the product injurious to health. 
A controlled production process would also help ensure that products 
are not prepared, packed, or held under insanitary conditions.
    The proposed MMR requirements, in particular proposed Sec.  
1120.44(a)(3), would also help ensure that the packaging, labeling, or 
labels of finished tobacco products comply with applicable statutory 
and regulatory requirements. For example, the packaging and labeling 
information maintained in the MMR would help FDA ascertain whether 
manufacturers are adulterating or misbranding products by approving and 
using packaging or labeling that is false or misleading, lacks required 
health warnings, or contains unauthorized modified risk claims.
    The proposed MMR requirements, together with the proposed process 
controls, also would enable tobacco product manufacturers to ensure, 
and FDA to verify, that tobacco products are manufactured in compliance 
with the applicable premarket requirements under sections 905 and 910 
of the FD&C Act. Specifically, the proposed requirements would enable 
FDA to verify that the established specifications for new or MRTPs are 
consistent with the tobacco product specifications provided by the 
manufacturer to FDA in the relevant tobacco product applications (i.e., 
SE Report, request for SE exemption, PMTA, MRTPA) and that the 
specifications for pre-existing tobacco products are consistent with 
their original characteristics. The proposed MMR requirements would 
also help manufacturers to ensure, and FDA to verify, that 
manufacturers are not making changes to tobacco products that may 
render the products new and adulterated under section 902(6) of the 
FD&C Act or misbranded under section 903(a)(6) of the FD&C Act.
    The MMR requirements would also help ensure that tobacco products 
are manufactured in compliance with any tobacco product standards 
established under section 907 of the FD&C Act. Under section 907, the 
Agency can adopt a tobacco product standard if it finds that the 
standard is appropriate for the protection of the public health. 
Proposed Sec.  1120.44(a)(1)(iii) would require the manufacturer to 
establish in the MMR any specifications necessary to ensure that the 
tobacco product meets any applicable product standard. For example, 
under section 907, FDA could require a reduction or elimination of an 
additive or constituent. In such an instance, proposed Sec.  
1120.44(a)(1)(iii) would require manufacturers to establish 
specifications in the MMR to ensure that the additive or constituent is 
reduced or eliminated in accordance with the standard.

E. Process Controls

1. Purchasing Controls
    Proposed Sec.  1120.62 would require manufacturers to ensure that 
purchased or otherwise received products and services from suppliers 
conform to established specifications and that suppliers are qualified. 
Specifically, proposed Sec.  1120.62(a) would require finished and bulk 
tobacco product manufacturers to establish and maintain procedures to 
ensure that each purchased or otherwise received product or service 
related to the manufacture of a finished or bulk tobacco product is 
from a qualified supplier and conforms to established specifications. 
In this context, ``products or services related to the manufacture of a 
finished or bulk tobacco product'' means products or services that are 
used in the manufacture of the product or that could impact the 
performance, composition, constituents or characteristics of the 
product.
    A purchased or otherwise received product related to the 
manufacture of a finished or bulk tobacco product would include a 
component or part, ingredient, additive, or other material purchased or 
received for use in the manufacture of a finished or bulk tobacco 
product. It also would include manufacturing materials as well as other 
materials purchased or received for use in the manufacture, packing, 
and storage of tobacco products, on tobacco product contact surfaces, 
or for the manufacturing operation, including cleaning and sanitation, 
of buildings, facilities, and grounds.
    A supplier of such product may be internal (from an establishment 
within the manufacturer's organization; e.g., a sister facility) or 
external (from an entity outside of the manufacturer; e.g., an external 
third-party entity that supplies tobacco blends or flavorings). For 
example, a cigarette manufacturer may establish filter specifications 
for circumference, length, and pressure drop in the MMR in accordance 
with proposed Sec.  1120.44(a)(1) and purchase filters from an external 
supplier. The proposed purchasing controls provision would require that 
the cigarette manufacturer establish and maintain procedures to ensure 
that the filter supplier is qualified and that the filters purchased 
and received from the external filter supplier conform to the 
established specifications. Such purchasing control procedures would be 
required whether payment for the products or services occurs or not. 
Thus, for example, a cigarette manufacturer would be required to comply 
with these requirements even when it receives

[[Page 15212]]

filters from an internal supplier, such as a ``sister facility'' or 
another corporate or financial affiliate.
    A ``purchased or otherwise received service related to the 
manufacture of a finished or bulk tobacco product'' would include any 
activity associated with a manufacturing method or production process 
procedure established in Sec.  1120.44(a)(2) as well as any activity 
regulated under proposed part 1120. Such services would include 
manufacturing or other activities (e.g., specification development, 
laboratory testing, packaging and labeling) that are contracted to 
others. For example, a tobacco product manufacturer may contract with a 
third-party laboratory to perform laboratory tests, or contract with 
others to perform certain activities required under proposed part 1120, 
such as complaint handling, facility cleaning, or pest control. 
Purchasing controls for such outsourcing services would be an 
additional requirement to help ensure that any service purchased or 
otherwise received from a supplier complies with the relevant 
requirements in proposed part 1120 (e.g., Sec. Sec.  1120.44(a)(2), 
1120.68, 1120.14, 1120.34) and meets specified requirements. In such 
cases, the finished or bulk tobacco product manufacturer would still be 
responsible for complying with all applicable requirements under 
proposed part 1120, even though it has chosen to outsource certain 
activities.
    Proposed Sec.  1120.62(b) would require finished and bulk tobacco 
product manufacturers to establish and maintain procedures for 
qualifying their suppliers. It is important that suppliers be qualified 
to demonstrate their ability to provide products and services to 
tobacco product manufacturers that meet established specifications. 
Proposed Sec.  1120.62(b)(1) would require the qualification procedures 
to include evaluating and selecting potential suppliers based on their 
ability to meet requirements set by the manufacturer in writing (on 
paper or electronically). Supplier evaluation and selection may be 
based, in part, on a supplier's past performance (i.e., a supplier's 
historical ability to meet a manufacturer's specifications or 
requirements consistently). Qualification could also include onsite 
visits, audits of the supplier's practices or records, or periodic 
testing or sampling of the supplier's products or services to determine 
if they conform to established specifications and if the supplier 
complies with applicable requirements under proposed part 1120. It 
would be the finished and bulk tobacco product manufacturer's 
responsibility to establish the appropriate supplier evaluation and 
selection process to ensure that purchased or otherwise received 
products and services related to the manufacture of a finished or bulk 
tobacco product meet established requirements.
    Proposed Sec.  1120.62(b)(2) would require the qualification 
procedures to include provisions that define the type and extent of 
control to be exercised over selected suppliers and their product or 
service, based on evaluation results. Manufacturers should determine 
the degree of control necessary based on the specific product or 
service purchased or otherwise received. When determining the type and 
extent of control to be exercised over qualified suppliers, 
manufacturers should use an appropriate mix of evaluations, which can 
include audits and acceptance activities, to ensure that products and 
services conform to established specifications. Factors such as the 
tobacco product manufacturer's knowledge or control of the supplier's 
manufacturing practices, the supplier's history of providing acceptable 
products or services, history or trends of delivering products or 
services that do not meet specifications, and the impact of the product 
or service on the finished or bulk tobacco product meeting its 
established specifications, can inform the type and extent of control 
needed for a particular supplied product or service. For example, if a 
tobacco product manufacturer determines that a component supplier has a 
history of providing acceptable product that meets established 
specifications, it may determine that a CoA is an adequate control. 
However, if the tobacco product manufacturer observes a trend that a 
supplier has been providing nonconforming products that have been 
rejected and returned, it may determine that increased audits or 
incoming product acceptance activities such as testing may be needed to 
comply with these proposed requirements. FDA has observed on 
inspections that manufacturers may implement more rigorous control over 
those suppliers that are determined to have a ``critical'' impact on 
product specifications and controls (Ref. 97).
    Proposed Sec.  1120.62(b)(3) would require the qualification 
procedures to include developing a list of qualified suppliers and 
their product(s) or service(s) and updating this information 
periodically. This list of qualified suppliers is intended to help 
provide assurance to the manufacturer and FDA that each supplier has 
been evaluated and selected based on its ability to meet established 
requirements.
    Proposed Sec.  1120.62(b)(4) would require that, as part of the 
qualification procedures, finished and bulk tobacco product 
manufacturers monitor qualified suppliers to ensure they meet specified 
requirements and perform reevaluation as needed. This requirement could 
be met by periodic testing or sampling, or through periodic 
reevaluation of the types of information considered for initial 
evaluation and selection of a supplier (e.g., records of nonconforming 
product, onsite audits, independent test results) under proposed Sec.  
1120.62(b)(1). Thus, the same kinds of information or records could be 
used for both initial qualification and ongoing monitoring of 
suppliers. For example, a manufacturer may use records of a supplier's 
performance (e.g., records showing that a product meets established 
specifications) to initially qualify suppliers as well as to monitor 
their continued ability to meet specified requirements and determine 
whether any adjustments to the type and extent of control over 
qualified suppliers are necessary (see proposed Sec.  1120.62(b)(2)). A 
manufacturer may determine that a supplier with a history of deficient 
auditing results or that repeatedly fails to meet established 
requirements should no longer be a qualified supplier.
    FDA notes that this proposed rule would allow for different 
approaches to monitoring suppliers. While some suppliers might warrant 
onsite visits depending on the products at issue, some products could 
be monitored through acceptance activities. For example, if a supplier 
supplies a manufacturer with labels bearing the required warnings for 
its finished tobacco product and the historical rejection rate of the 
labels at receipt is 1 percent, but that rate has recently risen to 25 
percent, the manufacturer may consider that supplier no longer 
qualified. Given that manufacturers are required to establish and 
maintain records of acceptance activities under proposed Sec.  
1120.64(e), reviewing trend lines across these activities would be an 
acceptable way to comply with this provision.
    Proposed Sec.  1120.62(c) would require finished and bulk tobacco 
product manufacturers to maintain records of all activities conducted 
under proposed Sec.  1120.62. Records must include the date and time, 
individual performing the activity, type of activity performed, any 
information that demonstrates the requirement was met, and any data or 
calculations necessary to reconstruct the results.

[[Page 15213]]

    The records described in this proposed provision would include all 
types of purchasing records. Purchasing records are those records 
associated with any supplier contract, the established specifications 
for the product or service being provided, and any activities 
undertaken to qualify, requalify, and monitor suppliers. Purchasing 
records contain information on the specifications or requirements for a 
specific product or service. They could include a purchasing contract 
between a manufacturer and supplier, documents and records that set 
forth the quality requirements (i.e., procedures and controls) that the 
supplier must comply with, documents and records that reflect the 
activities that the manufacturer uses to control and monitor the 
supplier (e.g., audits), and documents and records provided by the 
supplier that indicate the established specifications for the product 
or service (e.g., certificate of analysis (CoA), drawings, 
specifications sheets, catalogue numbers, engineering change order). 
Some types of purchasing records also may demonstrate compliance with 
other provisions of this proposed rule. For example, a CoA that 
documents the specified requirements for filters purchased from a 
supplier may constitute a purchasing record for purposes of this 
section, but it could also be used as an acceptance activity record to 
verify that a received batch of filters meets established 
specifications. Similarly, a finished tobacco product manufacturer 
using a contract pest control service to comply with the proposed 
animal and pest control requirement in Sec.  1120.34(e) would be 
required to maintain the invoice documenting purchase of this service 
to satisfy the recordkeeping requirements under proposed Sec.  
1120.62(c) as well as the recordkeeping requirements under proposed 
Sec.  1120.34(f).
    Proposed Sec.  1120.62(c) would also require that records 
maintained under this section include a written agreement (e.g., 
purchase order, contractual agreement) that the supplier will notify 
the manufacturer of any change in the product or service so that the 
manufacturer can determine whether the change may affect the 
specifications of the finished or bulk tobacco product established in 
accordance with Sec.  1120.44(a)(1). This provision is necessary to 
ensure that a supplier does not make any changes to the product or 
service without the knowledge of the finished or bulk tobacco product 
manufacturer that would result in a change to a finished or bulk 
tobacco product's specifications, rendering it a nonconforming product.
    If a tobacco product manufacturer conducts audits to address the 
supplier qualification requirements at proposed Sec.  1120.62(b), FDA, 
as a matter of policy, generally would not request to review or copy 
such audit records during routine inspections. Instead, FDA would 
consider a written certification by the manufacturer's management with 
executive responsibility stating that the audits have been performed 
and documented, the dates on which they were performed, and that any 
action taken in response to the audit results has been completed, as 
sufficient to meet the recordkeeping requirement under proposed Sec.  
1120.62(c). Nevertheless, this provision would not limit the Agency's 
ability to request for review or copy any procedures created to meet 
the requirement at proposed Sec.  1120.62(b).
    A tobacco product manufacturer could contract out certain 
activities required under proposed part 1120. To ensure purchased or 
otherwise received products or services conform to specified 
requirements, each tobacco product manufacturer would need to establish 
and maintain procedures to ensure that purchasing is carried out 
subject to adequate controls, including the evaluation and selection of 
suppliers, and the clear and unambiguous specification of requirements 
for such suppliers. In addition, the manufacturer would be required to 
have acceptance activities in accordance with proposed Sec.  1120.64. 
These controls would help ensure that only suppliers that meet the 
specified requirements are used.
    The finished or bulk tobacco product manufacturer would have the 
ultimate responsibility for ensuring that all applicable requirements 
under proposed part 1120 are met. For example, if a finished or bulk 
tobacco product manufacturer outsources laboratory testing services 
performed as part of an acceptance activity to a contractor, the 
manufacturer would be required to use purchasing controls to help 
ensure that the contract laboratory's procedures, processes, and 
records comply with the proposed laboratory controls requirements. The 
finished or bulk tobacco product manufacturer would be responsible if 
the contract laboratory does not adequately implement laboratory 
control processes. Additionally, the finished or bulk tobacco product 
manufacturer would be responsible for ensuring it receives all the 
documents and records needed to comply with proposed Sec.  1120.122, 
including all relevant metadata. A supplier (including a contractor or 
consultant) would be directly responsible for complying with part 1120 
to the extent that it is a finished or bulk tobacco product 
manufacturer under this proposed rule. For example, if a finished 
tobacco product manufacturer sends ENDS products to a contract packager 
to package and label the products for consumer use, the finished 
tobacco product manufacturer would be required to use purchasing 
controls to help ensure that the contract packager's packaging and 
labeling activities meet specified requirements; additionally, the 
contract packager would be covered under the proposed rule as a 
finished tobacco product manufacturer and would be directly responsible 
for the packaging and labeling requirements under the proposed rule 
(see the discussion of proposed subpart F in section IV.F).
    The proposed regulation is intended to allow flexibility in the way 
finished and bulk tobacco product manufacturers ensure the 
acceptability of products and services. Under the proposed purchasing 
control requirements, manufacturers would be required to establish and 
maintain procedures that clearly define the type and extent of control 
they intend to apply to suppliers and their products and services. A 
finished or bulk tobacco product manufacturer may choose to provide 
greater in-house controls such as additional acceptance activities (see 
discussion of proposed Sec.  1120.64 in section IV.F.2) to ensure that 
products and services meet specified requirements, or the manufacturer 
may require that the supplier adopt measures necessary to ensure 
acceptability, as appropriate, for example, batch testing. FDA believes 
that a mix of purchasing controls and in-house manufacturing controls 
will generally be necessary to ensure acceptability of received 
products and services. A manufacturer could review and approve the 
supplier's procedures or perform supplier audits to assess the 
supplier's continued capability to provide acceptable product. The 
manufacturer could also review historical data, monitor and look for 
trends in data such as acceptance and nonconforming product records, 
and perform inspection and testing of received products.
    FDA has observed that tobacco product manufacturers use a variety 
of different purchasing controls to ensure that received products and 
services conform to established specifications. For example, a 
manufacturer may use different purchasing controls based on the degree 
of impact that the supplied product or service may have on the

[[Page 15214]]

finished or bulk tobacco product. A manufacturer may determine that a 
supplier of liquid nicotine would need to provide a certificate of 
analysis of the nicotine concentration for each batch, undergo a yearly 
audit, and send every fifth batch for an independent laboratory 
analysis to confirm a nonconformance rate of less than 1 percent. In 
contrast, the manufacturer may determine that a supplier of outer 
packaging for shipping (that does not come into contact with the 
tobacco product) only needs to be initially qualified and to maintain 
production records for review by the manufacturer as requested. In 
addition, these proposed requirements are generally similar to the 
practices of manufacturing establishments that follow ISO 9001.
    The proposed purchasing controls requirements would help assure 
that the public health is protected by ensuring that suppliers are 
capable of providing products and services that conform to established 
specifications and other specified requirements set by the 
manufacturer. A change in a received product may impact one or more of 
the established specifications of the finished or bulk tobacco product, 
rendering it nonconforming. For example, a menthol supplier may change 
its menthol formulation by using a different chemical compound, such as 
L-menthol instead of D-menthol stereoisomer. This change in formulation 
may affect the specification for this ingredient and cause the finished 
tobacco product not to meet the specifications for menthol established 
in the MMR. This change is formulation may also impact public health as 
the change from D-menthol to L-menthol may promote smoking initiation 
and nicotine addiction (Ref. 98).
    A change in service also may impact an established specification. 
For example, if a contract laboratory changes the sampling plan for 
product acceptance, the test results may no longer be representative of 
the product, which may result in a nonconforming product. Use of 
components or parts, ingredients, additives, and materials that do not 
meet specifications may result in the manufacture of a nonconforming 
tobacco product. In addition, use of an unqualified laboratory to 
perform testing and sampling may result in a failure to conduct 
adequate product acceptance activities and in the manufacture of a 
nonconforming tobacco product.
    The proposed purchasing controls requirements would also help 
assure that tobacco products are in compliance with chapter IX of the 
FD&C Act. For example, purchasing controls would help ensure that 
products meet relevant requirements under sections 905 and 910 of the 
FD&C Act and that such products are not adulterated under section 
902(6) or misbranded under section 903(a)(6) of the FD&C Act. The 
proposed requirements would enable the tobacco product manufacturer to 
be aware of any change to supplied products so that it may determine 
whether the change may affect the established specifications of the 
finished or bulk tobacco product in the MMR. A change in an established 
tobacco product specification can result in a modification and the 
creation of a new tobacco product under section 910(a)(1)(B) of the 
FD&C Act for which premarket review is required. For example, a change 
in the denier per filament specification of the acetate tow material of 
a cigarette filter would change the filter's pressure drop, rendering 
it a new tobacco product (Ref. 99). Therefore, this section would help 
manufacturers to ensure, and FDA to verify, that manufacturers are not 
making changes to their tobacco products that may render the products 
adulterated under section 902(6) or misbranded under section 903(a)(6) 
of the FD&C Act. In addition, if a tobacco product standard establishes 
requirements respecting a component of a tobacco product, the proposed 
purchasing controls requirement would help a finished tobacco product 
manufacturer that obtains such component from a supplier to ensure that 
the purchased or received component conforms to the standard. Likewise, 
if a tobacco product standard establishes requirements for testing of a 
tobacco product and the testing is performed by a contract laboratory, 
the proposed requirement would help ensure that the purchased or 
received service results in a product that conforms to the tobacco 
product standard.
    The proposed purchasing controls requirements would also help 
ensure that tobacco products are not adulterated under section 902 of 
the FD&C Act by ensuring that purchased or received products are not 
contaminated or held under insanitary conditions. For example, a bulk 
manufacturer may require through purchasing controls that leaf 
producers follow a Good Agricultural Practice program, including the 
use of approved pesticides. This would help ensure that purchased leaf 
tobacco is not treated with unapproved pesticides that may contain 
``any added poisonous or added deleterious substance that may render 
the product injurious to health'' and, therefore, adulterated under 
section 902(1) of the FD&C Act.
2. Acceptance Activities
    Proposed Sec.  1120.64(a) would require tobacco product 
manufacturers to establish and maintain procedures for acceptance 
activities, including acceptance criteria. Acceptance activities can be 
used throughout the production process--incoming, during the receipt of 
incoming materials; in-process, during the manufacturing process; and 
final, prior to the release of the finished or bulk product for 
distribution. These proposed requirements are generally similar to the 
practices of manufacturing establishments that follow ISO 9001.
    Acceptance activities could include inspections, tests, 
evaluations, and other verification activities. Inspections could 
include visual inspection of incoming, finished, or bulk tobacco 
products (Refs. 100 and 101). Testing could include laboratory testing, 
such as testing the resistance to draw of a cigarette (Ref. 102). Other 
verification activities could include, for example, review of a 
supplier's CoA to ensure that an ingredient meets its specification for 
purity (e.g., Ref. 103), or use of worksheets or programs to determine 
that the correct amount or weight of materials, ingredients, and 
additives has been used. In addition, tobacco product acceptance 
activities could include use of a validated production process with 
appropriate continued process verification under proposed Sec.  
1120.66(b).
    Although a manufacturer could rely on the review of purchasing 
records during incoming acceptance such as a CoA, there may be 
circumstances where testing or inspection may be necessary for 
accepting incoming product. For example, if a manufacturer determines 
that a supplier's product is close to the outer parameters of 
acceptability, the manufacturer could establish a testing requirement 
to audit the supplier under Sec.  1120.62(b)(2) to confirm the 
information that is supplied in the CoA. Manufacturers would have the 
flexibility to choose which acceptance activity method(s) is most 
suitable to their needs, products, and manufacturing process.
    Proposed Sec.  1120.64(a) also would require that procedures for 
all acceptance activities include acceptance criteria. Acceptance 
criteria could be expressed as values, ranges, or tolerances or may 
include criteria such as appearance, color, or specific gravity (e.g., 
Ref. 104). For example, under these proposed requirements, an e-liquid 
manufacturer who uses liquid

[[Page 15215]]

nicotine to make e-liquids could perform laboratory testing as an 
acceptance activity to verify that a specification for the 
concentration of incoming liquid nicotine is met. If the manufacturer's 
MMR establishes the specification at 90 percent nicotine and the 
specification's acceptance criteria is designated with a tolerance of 
0.40 percent, the laboratory testing results would need to 
show that the concentration of nicotine is between 89.6 percent and 
90.4 percent to meet the established specification. Under the proposed 
requirements, if the incoming liquid nicotine has a nicotine 
concentration of less than 89.6 percent or greater than 90.4 percent, 
the manufacturer would need to treat the incoming liquid nicotine as a 
nonconforming product in accordance with proposed Sec.  1120.74.
    In addition, acceptance activities that involve sampling would be 
required to use representative sampling under proposed Sec.  1120.72. 
Representative samples are frequently used to determine whether a batch 
of tobacco product meets specifications. While FDA is aware that some 
tobacco product manufacturers use sampling plans for acceptance 
activities, the Agency believes that this requirement is needed to 
ensure that all manufacturers who perform sampling in their acceptance 
activities use representative samples to demonstrate that a batch meets 
established specifications. CORESTA has also developed recommended 
methods for sampling plans for the preparation of samples of different 
types of tobacco products, such as cigarettes, smokeless tobacco, fine-
cut tobacco, and cigars (Refs. 105, 107, 108).
    Proposed Sec.  1120.64(b)(1) would require that the acceptance 
activity procedures address acceptance activities for all incoming 
products to ensure that any specifications established under Sec.  
1120.44 or through purchasing controls under Sec.  1120.62 are met and 
that such products are not contaminated or deteriorated. The term 
``incoming products'' would include not only incoming tobacco products, 
but also any incoming equipment that is used in the manufacturing of 
tobacco products, such as cigarette makers, as well as any other 
materials that may be used, such as cleaning agents that may be used to 
clean the tobacco contacting equipment and may leave residues that 
might contaminate the tobacco. Some tobacco product manufacturers 
already use acceptance activities to verify that incoming products meet 
established specifications. For example, organic solvents such as 
toluene often are used for the printing of cigarette packages. A 
tobacco product manufacturer could evaluate a CoA for incoming 
cigarette packages that indicates an upper limit for the acceptance 
criteria of each organic solvent. The tobacco product manufacturer 
could review the analysis results in the CoA showing the actual 
measurement of the organic solvent to determine whether these incoming 
materials are acceptable for use in manufacturing (e.g., Ref. 109). A 
tobacco product manufacturer could also conduct its own laboratory 
testing of incoming material to determine that it meets established 
specifications (e.g., Ref. 110).
    Proposed Sec.  1120.64(b)(1) also states that each accepted 
incoming tobacco product would need to be designated by a unique 
identifier, which must be maintained throughout manufacturing and 
documented in accordance with Sec.  1120.70(b)(5). Incoming acceptance 
would apply to all incoming products, but the unique identifier 
requirement would be limited to those products that meet the definition 
of a tobacco product. Once the tobacco product manufacturer accepts an 
incoming tobacco product for use in the manufacturing process, a unique 
identifier would be assigned. A unique identifier is information, such 
as a code or number that is maintained for each accepted incoming 
tobacco product, that would enable the tobacco product manufacturer and 
FDA to identify the supplier and unique shipment (e.g., purchase order) 
of the incoming tobacco product. The proposed unique identifier 
requirement would establish traceability for all components or parts, 
ingredients, additives, and materials in a finished or bulk tobacco 
product and would aid in investigations related to tobacco product 
complaints, CAPAs, and nonconforming products. For example, during an 
investigation of a nonconforming product, the unique identifiers of all 
components or parts, ingredients, additives, and materials in a 
finished or bulk tobacco product would enable the manufacturer to 
determine the scope and cause of the nonconformance. If a nonconformity 
is attributed to a nonconforming component or part, ingredient, 
additive, or material, the manufacturer could take appropriate 
corrective action with respect to any other affected finished or bulk 
tobacco product that uses the affected tobacco product. For an incoming 
finished or bulk tobacco product, the unique identifier would be 
required to include, or be traceable to, the manufacturing code on the 
packaging or label of the incoming finished or bulk tobacco product. 
This could be a separate unique identifier or it could incorporate the 
manufacturing code of the incoming finished or bulk tobacco product. 
This requirement would be important for tobacco product manufacturers 
who perform only packaging and labeling, including repackaging and 
relabeling, as the unique identifier would establish traceability to 
the specific batch of the incoming finished or bulk tobacco product.
    FDA is not proposing to prescribe the format or mechanism (e.g., 
affixing a batch or control number to the immediate container or 
product label) of the unique identifier requirement. Rather, 
manufacturers would have the flexibility to determine the method that 
they would use to track and identify the received and accepted incoming 
tobacco products that are used in the manufacture of finished and bulk 
tobacco products. On inspections, FDA has observed manufacturers using 
various means of implementing unique identifiers, including 
programmable and scannable bar codes and tags affixed to the immediate 
container.
    FDA is proposing that the unique identifier for each accepted 
incoming component or part, ingredient, additive, and material used in 
the manufacture of finished and bulk tobacco products would need to be 
documented in the production record in accordance with proposed Sec.  
1120.70(b)(5). Although not required by this proposed rule, as 
components and parts undergo further manufacturing and become a new 
component or part, ingredient, additive, or material, a manufacturer 
may choose to assign a new unique identifier to the combined product, 
subassembly, or batch of tobacco product. The new unique identifier 
would establish more accurate traceability to account for all 
components or parts, ingredients, additives, and materials in a 
finished or bulk tobacco product and would aid in investigations 
related to tobacco product complaints, CAPAs, and nonconforming 
products. However, any original unique identifier would need to be 
maintained in the production record, even if a subsequent unique 
identifier is assigned to the product after further manufacturing. For 
example, if an e-liquid manufacturer assigns a unique identifier for 
banana and vanilla flavor ingredients under Sec.  1120.64(b)(1) and 
further processes these ingredients to make a batch of banana 
cr[egrave]me flavor, it may assign a new identifier for the new flavor. 
If this approach is used, traceability to the unique identifiers of the 
new, as well as the original, individual components and parts, 
ingredients, additives, and materials would need to be maintained in

[[Page 15216]]

accordance with proposed Sec.  1120.70(b)(5).
    This provision also would require that the results of incoming 
acceptance activities be reviewed and approved to ensure that the 
incoming tobacco product specifications established under proposed 
Sec.  1120.44 or through purchasing controls under proposed Sec.  
1120.62 are met and that the product is not contaminated or 
deteriorated. Therefore, prior to using incoming product in the 
manufacturing process, a designated qualified individual would be 
required to review the results of the incoming tobacco product 
acceptance activities, determine that the specifications established in 
the MMR and through purchasing controls are met and that the product is 
not contaminated or deteriorated, and approve the release of the 
product for manufacturing. The acceptance status of the released 
tobacco product would be maintained under proposed Sec.  1120.64(d). 
FDA has observed on inspections that the number of personnel or the 
complexity of the manufacturing process may determine whether the 
review and approval of incoming acceptance activities is performed by 
the individual who conducted the acceptance activity or a designated 
quality assurance employee who reviews and approves acceptance activity 
results conducted by others. The proposed rule would afford the 
manufacturer flexibility to determine how it would perform this 
activity, as long as it occurs prior to the release of incoming product 
for manufacturing.
    Proposed Sec.  1120.64(b)(2) would require that acceptance 
activities procedures address the testing and acceptance of raw tobacco 
to ensure that raw tobacco from suppliers (internal and external to the 
organization) complies with established specifications for pesticide 
chemical residue(s). The specifications for pesticide chemical 
residue(s) would need to be established by the manufacturer and comply 
with any applicable tolerance(s) established under Federal law.\5\ FDA 
considers raw tobacco to include tobacco leaf and tobacco cut rag that 
is received from importers, wholesalers, and distributors.
---------------------------------------------------------------------------

    \5\ Under 907(a)(1)(B) of the FD&C Act, a tobacco product 
manufacturer cannot use tobacco, including foreign grown tobacco, 
that contains a pesticide chemical residue that is at a level 
greater than is specified by any tolerance applicable under Federal 
law to domestically grown tobacco. As of publication of this 
proposed rule, such a tolerance level has not been established by 
Federal statute or regulation.
---------------------------------------------------------------------------

    Manufacturers would be required to comply with this requirement for 
all tobacco products containing raw tobacco. A tobacco product 
manufacturer could comply with this proposed requirement by performing 
its own testing or accepting a CoA from the supplier of the raw tobacco 
showing that relevant specifications for pesticide chemical residue(s) 
are met (e.g., Refs. 111 and 112). On inspections, FDA has observed 
that several tobacco product manufacturers have established 
specifications for pesticide chemical residues for raw tobacco, taking 
into account recommendations in CORESTA's Guide No. 1--The Concept and 
Implementation of CPA (crop protection agent) Guidance Residue Levels 
(Ref. 86), and voluntary U.S. Department of Agriculture pesticide 
residue standards at 7 CFR 29.427.
    Proposed Sec.  1120.64(b)(3) would require that all incoming 
tobacco products, i.e., components or parts, ingredients, additives, 
and materials, be evaluated during incoming acceptance activities to 
ensure that they are not contaminated or deteriorated. FDA is aware 
that tobacco product manufacturers have considered and used different 
methods to evaluate products for physical and some biological 
contamination including metal detectors, x-rays, and optical sorters 
(e.g., Refs. 113 and 114). Tobacco product manufacturers could 
establish procedures to visually inspect incoming product for 
contamination or sources of potential contamination (e.g., Refs. 115 
and 116). Any of these methods could be suitable for compliance with 
this proposed section, depending on the product being inspected. 
Deterioration of components or parts, ingredients, additives, and 
materials could result in nonconforming product or otherwise render the 
product adulterated or misbranded. Examples of possible deterioration 
include discoloration, spotting, and staining of components (such as 
packaging, labels, filters) or flavors or additives that have passed 
their expiration date.
    Proposed Sec.  1120.64(c) would require finished and bulk tobacco 
product manufacturers to establish and maintain procedures for in 
process and/or final acceptance activities to ensure that each finished 
or bulk tobacco product meets the specifications established under 
proposed Sec.  1120.44. Tobacco product manufacturers could comply with 
proposed Sec.  1120.64(c) in process or after manufacturing a finished 
or bulk tobacco product. A manufacturer could comply with this 
provision by performing batch testing on finished or bulk product. Any 
acceptance activities that involve sampling would be required to comply 
with proposed Sec.  1120.72. On inspections, FDA has observed that 
tobacco product manufacturers may perform acceptance activities at 
discrete points in the production process or use a stage-gate approach 
to accept tobacco product and release it to the next stage of 
processing (e.g., Ref. 117). For example, acceptance activities could 
be performed on tobacco blends after primary processing, on smokeless 
tobacco blends after fermentation, and on cigarettes or smokeless 
tobacco product after making. Acceptance activities could also be 
performed after the tobacco product is packaged; for example, testing 
the finished tobacco product to ensure that it meets established 
specifications (e.g., Ref. 118) and inspecting the product packaging to 
determine it meets all packaging and labeling requirements.
    This provision also would require that the results of in-process 
and final acceptance activities be reviewed and approved to ensure that 
the finished and bulk tobacco product specifications established under 
Sec.  1120.44 are met. Therefore, a designated qualified individual 
would need to review the results of the tobacco product acceptance 
activities to determine that the specifications established in the MMR 
are met, and approve the release of the finished or bulk tobacco 
product for distribution. As discussed previously regarding proposed 
Sec.  1120.64, the proposed rule would afford the manufacturer 
flexibility to determine how it would perform this activity, as long as 
it occurs prior to distribution.
    Proposed Sec.  1120.64(d) would require tobacco product 
manufacturers to identify, by suitable means, the acceptance status of 
a tobacco product throughout the different stages of the manufacturing 
process, indicating whether the tobacco product is a conforming or 
nonconforming tobacco product. The identification of the acceptance 
status would need to be maintained from receipt of incoming products 
throughout manufacturing and until the finished or bulk tobacco product 
passes required acceptance activities and is released for distribution. 
FDA considers ``suitable means'' to mean that the acceptance status of 
a tobacco product can be readily determined. For example, tobacco 
product manufacturers could use various methods to identify the 
acceptance status of tobacco products, including scannable barcodes, 
labels, markings and other methods (e.g., Refs. 119 and 120). This 
requirement is intended to ensure that manufacturers can effectively 
identify the acceptance status of tobacco products and prevent mixups.

[[Page 15217]]

    This provision seeks to ensure that the acceptance status of all 
tobacco products, including incoming tobacco products, in-process 
tobacco products, and finished and bulk tobacco products is properly 
identified throughout manufacturing to ensure that only tobacco 
products that pass required acceptance activities are incorporated into 
the finished or bulk tobacco product and ultimately released for 
distribution. This requirement is intended to prevent nonconforming 
tobacco product from being used in the manufacture of a finished or 
bulk tobacco product. For example, if a smokeless tobacco blend does 
not conform to a fermentation specification during a tobacco product 
acceptance activity, its nonconforming acceptance status would need to 
be identified so that it would not be used in the manufacture of a 
finished smokeless tobacco product.
    Proposed Sec.  1120.64(e) would require finished and bulk tobacco 
product manufacturers to maintain records of all activities required 
under this section. This provision would require records to include the 
date and time, individual performing the activity, type of activity 
performed, acceptance criteria, any information that demonstrates the 
requirement was met, equipment used if applicable, and any data or 
calculations necessary to reconstruct the results. This provision is 
necessary to help ensure that acceptance activities are performed 
according to established procedures and that the tobacco product meets 
the specifications established in proposed Sec.  1120.44. The date and 
time when the acceptance activities were conducted and the name of the 
individual who performed the activities could help manufacturers and 
FDA identify the scope of any nonconformity.
    The proposed acceptance activities requirements would help assure 
that the public health is protected. Tobacco product specifications 
could impact the toxicity and addictiveness of the product, and 
acceptance activities would help ensure that tobacco products do not 
exceed established specifications that affect these parameters. For 
example, if a tobacco product manufacturer establishes a nicotine 
concentration level for an ENDS product, acceptance activities would 
help ensure that the tobacco product meets that specification. This 
would be important because a finished ENDS that contains a nicotine 
concentration higher than the established specification could be more 
addictive (Refs. 4 and 5).
    In addition, the physical design specifications of a tobacco 
product interact with its chemical composition to influence its 
function and effect on consumers, which can impact the toxicity and 
addictiveness of the product (Ref. 6). For example, the design of a 
cigarette filter's ventilation impacts the level of nicotine in the 
cigarette's smoke (Ref. 96). If a cigarette's filter deviates from its 
established ventilation design specification, the amount of nicotine 
delivered to the user may be affected, which can increase 
addictiveness. A tobacco product's operating and design specifications 
and features can affect the toxicity and addictiveness of the product. 
For example, a variable voltage ENDS product can enable a user to 
control the power input. The electrical power input--which is 
proportional to the square of the voltage and inversely proportional to 
the heater resistance--influences the temperature at which the aerosol 
is produced, which may influence nicotine and other toxicant emissions 
(Ref. 121). Acceptance activities would verify that the tobacco product 
conforms to its established design specification and, therefore, help 
to minimize additional harm associated with nonconforming products.
    The proposed acceptance activities requirements also would help 
assure that tobacco products are in compliance with the requirements of 
chapter IX of the FD&C Act. Acceptance activities would help tobacco 
product manufacturers to verify, and enable FDA to confirm, that 
finished and bulk tobacco products conform to established 
specifications. These provisions would help ensure that new tobacco 
products and MRTPs are manufactured consistent with the specifications 
provided in their applications (i.e., SE Report, request for SE 
exemption, PMTA, MRTPA) and that pre-existing products are manufactured 
consistent with their original characteristics. The acceptance 
activities requirements also would help ensure that the packaging, 
labeling, and labels of finished tobacco products comply with 
applicable statutory and regulatory requirements. For example, by 
ensuring that correct packaging, labeling, and labels are used with 
each product, the acceptance activities and associated records would 
help ensure that labeling does not contain false or misleading 
statements, that packages and labels bear required health warnings or 
statements, and that the labeling or labels do not contain unauthorized 
modified risk claims. Additionally, the acceptance activities 
requirements and associated records would help ensure that a product is 
compliant with any product standards established by FDA under section 
907 of the FD&C Act. For example, under section 907, FDA could require 
a reduction or elimination of an additive or constituent. The 
acceptance activity records would help enable FDA to verify that the 
amount of the additive or constituent in the manufacturers' products 
meets the product standard.
    The proposed requirements also would help ensure that tobacco 
products do not contain a contaminant or hazard that may cause the 
product to be adulterated under section 902(1)-(3) of the FD&C Act. For 
example, visual inspection of incoming tobacco leaf for mold or NTRM 
(including glass or metal fragments) or use of metal detectors, x-rays, 
optical sorters, and other methods would help minimize the likelihood 
that tobacco products contain such substances.
3. Production Processes and Controls
    Proposed Sec.  1120.66(a) would require finished and bulk tobacco 
product manufacturers to establish and maintain procedures for their 
production processes, including process controls, to ensure that 
tobacco products conform to requirements established in the MMR in 
accordance with proposed Sec.  1120.44. Production processes include 
the methods, activities, or steps that a tobacco product manufacturer 
uses to manufacture a tobacco product. Production processes may include 
primary processing such as blending, casing, and cutting tobacco; 
fermenting tobacco; mixing flavors and liquid nicotine; and assembling 
components or parts.
    Under proposed Sec.  1120.66(a)(1), production process procedures 
would be required to address production process specifications with 
relevant acceptance criteria. For example, a manufacturer could 
establish production specifications for moisture with relevant 
acceptance criteria at different points in the production process to 
ensure that the tobacco product moisture specification is met at the 
point of each acceptance activity. Similarly, a manufacturer could 
establish time, temperature, and humidity production process 
specifications with relevant acceptance criteria to ensure that the 
tobacco product pH specification is met.
    Proposed Sec.  1120.66(a)(2) would also require that the production 
process procedures include relevant process controls such as monitoring 
and acceptance activities (inspection, testing, evaluation, and other 
verification activities). For example, if a

[[Page 15218]]

manufacturer established production process specifications with 
acceptance criteria, such as time, temperature, and humidity, the 
manufacturer would be required to implement relevant process controls 
such as monitoring or testing tobacco product to verify that such 
production process specifications are met. Under proposed Sec.  
1120.66(a)(2), such process controls would be included in the 
production process procedures. The proposed requirements are intended 
to provide tobacco product manufacturers with the flexibility to 
establish the production process procedures that are appropriate for 
their particular manufacturing operations and type of tobacco products 
to ensure that manufactured tobacco products conform to the 
requirements established in the MMR in accordance with proposed Sec.  
1120.44.
    Proposed Sec.  1120.66(a)(1) and (2) are intended to help ensure 
that the production process is controlled so that tobacco products meet 
their product specifications at the appropriate acceptance activity 
stage. For example, the fermentation of smokeless tobacco must occur 
under specific environmental conditions to assure that at the end of 
fermentation desired specifications, such as pH and oven volatiles are 
met. The production process procedures required by this proposed 
provision would, therefore, specify that fermentation occur in an 
environmentally-controlled room. The manufacturer would need to 
establish time, temperature, and humidity ranges for the room to ensure 
that the room is maintained within the environmental ranges required to 
meet product specifications. In this example, the production process 
specifications would be the upper and lower temperature and humidity 
limits for specified durations. The manufacturer would also use 
relevant process controls such as monitoring activities to confirm that 
the process occurred within the required time, temperature, and 
humidity ranges and to alert staff if these conditions are not met, for 
example, if the room temperature is drifting towards a temperature that 
does not meet the established production process specification.
    Proposed Sec.  1120.66(a)(3) would require that the production 
process procedures include a requirement for investigating any 
deviations from the production process specifications and established 
acceptance criteria, or from relevant process controls, to determine if 
the deviation results in a nonconforming product. Process deviations 
can be identified from process and product sources, such as process 
monitoring, acceptance activities, production records, and records of 
nonconforming products. For example, if the fermentation of a tobacco 
blend deviates from established production processes and controls for 
fermentation, such as maintaining temperature and humidity through 
specified turn cycles necessary to meet a pH specification, the tobacco 
product manufacturer would be required to perform an investigation to 
determine if the deviation results in a nonconforming product. Proposed 
Sec.  1120.66(a)(3) would also require that the manufacturer document 
the disposition of any product affected by the deviation. A product 
manufactured under conditions that deviate from the process 
specifications could be released for further processing or distribution 
if the investigation determines that the product conforms to product 
specifications, for example, if data from process validation activities 
demonstrates that product produced within those process specifications 
still conforms to product specifications. Product found to be 
nonconforming would need to be handled in accordance with proposed 
Sec.  1120.74.
    If a manufacturer finds that its originally established process 
specifications are difficult to maintain (i.e., result in many process 
deviations), the manufacturer may decide to use a wider range of 
process specifications for future production where it is supported by 
the original process validation activities, rather than investigating 
each time a product is produced outside the narrower range. In such a 
case, the proposed rule would require that the updated process 
specifications be documented in the MMR in accordance with the 
procedures established under Sec.  1120.44. If the manufacturer decides 
to adopt new ranges beyond the originally validated process 
specifications, the manufacturer would need to evaluate the change 
under proposed Sec.  1120.66(a)(4) and revalidate the process, where 
appropriate.
    Proposed Sec.  1120.66(a)(4) would require that the production 
process procedures include a requirement for evaluating all changes to 
production processes, including process controls, to determine their 
impact on the tobacco product specifications in the MMR. If any 
production process changes result in a change to the tobacco product 
specifications, the proposed rule would require that the manufacturer 
ensure that procedures applicable to the changes in tobacco product 
specifications are followed in accordance with Sec. Sec.  1120.42 and 
1120.44 and update the tobacco product specifications in the MMR as 
needed. This requirement is intended to ensure that the manufacturer 
identifies changes to a production process that may affect a tobacco 
product specification and, therefore, lead to a nonconforming product. 
For example, if a manufacturer uses a 3-turn fermentation process to 
manufacture a smokeless tobacco product with an established pH 
specification, and the tobacco product manufacturer changes the 
fermentation process to a 2-turn process, under this proposed 
provision, the manufacturer would need to evaluate the production 
process change to determine if it results in a change to the pH (or any 
other specifications) of the smokeless tobacco product. If it does, 
then the manufacturer could decide against making the process change or 
could change the tobacco product specifications in accordance with 
proposed Sec. Sec.  1120.42 and 1120.44.
    Proposed Sec.  1120.66(a)(4) would also require that any changes to 
validated processes be revalidated before implementation, where 
appropriate. For example, if a tobacco product manufacturer makes a 
change to the validated forming and drying process for reconstituted 
leaf tobacco by adjusting the thickness and pressure of the size press, 
these changes would need to be evaluated and revalidated, where 
appropriate, before being implemented.
    In addition to the requirements in proposed Sec.  1120.66(a), 
proposed Sec.  1120.66(b) would require that the production process 
procedures include requirements for process validation, if applicable. 
Specifically, if the results of a process cannot be fully verified 
(including any automated processes), this provision would require 
finished and bulk tobacco product manufacturers to validate the process 
to demonstrate that the process will produce a tobacco product that 
conforms to the tobacco product specifications established under Sec.  
1120.44(a)(1). The results of a process cannot be fully verified, for 
example, where the manufacturer cannot demonstrate that the tobacco 
product meets established specifications through acceptance activities 
using representative samples (e.g., automated cigarettes manufactured 
with millions or tens of millions of cigarettes in a batch, because the 
size of the batch is too large) or where acceptance activities cannot 
fully determine whether the product meets established specifications 
(e.g., laser welding of an ENDS atomizer to a tolerance of 0.0002 inches)). Although this provision would not require 
processes to be validated where the results can be fully verified, the

[[Page 15219]]

Agency encourages manufacturers to validate all processes.
    Process validation includes activities to establish scientific 
evidence that a process is capable of consistently producing product 
that conforms to established specifications. FDA is aware that some 
tobacco product manufacturers use validation master plans to validate 
the processes and equipment for the manufacturing and packaging of 
tobacco products; these plans cover the criteria for review and 
approval of the processes, specific methods and procedures to qualify 
the process, methods for continued process verification through 
monitoring and measurement of the processes, and revalidation.
    This proposal would require process validation to use appropriate 
objective measures and valid scientific tools and analyses to maintain 
the process in a state of control. Examples of valid scientific tools 
and analyses used in process validation would include a capability 
study to measure the ability of the process to consistently meet 
specifications, challenge tests to demonstrate where nonconformities 
are due to variation and off-target processes under worst-case 
conditions, and acceptance sampling plans to determine the number of 
samples to be tested to provide a gross check for defect rate increase 
with respect to a predetermined acceptable quality level (e.g., Ref. 
122). Acceptance sampling can be based on standards (e.g., ISO 
28590:2017, ISO 3951:2013, ANSI Z1.4, ANSI Z1.9) (Refs. 123-126).
    Proposed Sec.  1120.66(b)(1) would require finished and bulk 
tobacco product manufacturers, as part of process validation, to design 
a production process for manufacturing a tobacco product. The process 
design would need to address the capability and functionality of the 
production process. The process design also would establish a strategy 
for process control to develop operational limits and monitoring of the 
production process that should take into account the building, 
facility, and equipment and possible sources of variability posed by 
personnel and environmental conditions. This provision is intended to 
help ensure that products conform to established specifications.
    For example, a cigarette maker can operate at speeds up to 20,000 
cigarettes per minute and manufacture cigarettes to specifications of 
weight, length, and diameter. In this case, proposed Sec.  
1120.66(b)(1) would require a manufacturer to address the capability 
and functionality of its production process at various operational 
speeds and establish a strategy for process control. The tobacco 
product manufacturer may determine that the cigarette maker operates at 
an optimal speed of 16,000 cigarettes per minute and the process 
control could consist of samples being taken every 30 minutes to 
monitor the production process. However, if the maker operates at its 
maximum 20,000 cigarettes per minute speed, a process control could 
consist of samples being taken more frequently (e.g., every 15 minutes) 
to assure that the tobacco product remains conforming at the increased 
production speed.
    Alternatively, in a case where the product attribute is not readily 
measurable due to limitations of sampling or detectability, operational 
limits and in-process monitoring parameters could be established for 
process control. For example, a manufacturer may establish process 
specifications for manufacturing cigarette filter rods. The 
manufacturer would have to validate the process used by the automated 
filter rod maker to ensure that filters meet product specifications. 
For this process, the manufacturer could establish a target 
specification for parameters such as the pressure drop. The lower 
specification and upper specification limits or tolerances would also 
need to be developed around the target specification. The manufacturer 
would then be required to determine lower and upper process control 
limits for parameters such as the speed of cellulose acetate fiber that 
is fed into the rod maker. These process control limits would be at 
values between the target and lower and upper specification limits. 
Based on the results obtained by a predetermined sampling plan, the 
values would be used to adjust the machine to ensure that filters are 
manufactured in accordance with the product specifications.
    For any required process validation activities, proposed Sec.  
1120.66(b)(2)(i) would require finished and bulk tobacco product 
manufacturers to perform process qualification to determine if the 
process is capable of reproducible manufacturing. Manufacturers would 
need to demonstrate that the design of the facility is appropriate and 
qualify the equipment to confirm that it is suitable for its intended 
purposes and will perform properly. This could involve qualifying that 
the equipment is appropriate for its specific use, verifying that 
equipment is built and installed in conformance with its design 
specifications, and verifying that equipment operates properly in all 
anticipated operating ranges. Proposed Sec.  1120.66(b)(2)(ii) would 
require manufacturers to perform process performance qualification to 
confirm the process design and to demonstrate that the manufacturing 
process performs as expected in accordance with established criteria, 
which would need to be documented in a written protocol. This could 
involve utilizing the qualified equipment with trained personnel and 
production process procedures, including process controls, to confirm 
the process design and demonstrate that the commercial manufacturing 
process performs as expected.
    Proposed Sec.  1120.66(b)(3) would require finished and bulk 
tobacco product manufacturers to monitor the production process using 
data collected from records required under proposed part 1120 and valid 
scientific tools to detect variability and ensure that the process 
remains in a state of control. This proposed requirement is intended to 
help prevent process deviations. A manufacturer could accomplish this 
by monitoring for undesired process variability and determining the 
appropriate actions to correct, anticipate, and prevent problems. 
Relevant process and product data must be collected from records 
covered under proposed part 1120, and would include data regarding 
acceptance activities (proposed Sec.  1120.64) and reviews of 
nonconforming product (proposed Sec.  1120.74).
    Valid scientific tools can include statistical process control 
techniques, control charts, recognized standards such as American 
Society for Testing and Materials (ASTM) E2281-03 ``Standard Practice 
for Process and Measurement Capability Indices'' and ASTM E2709-09 
``Standard Practice for Demonstrating Capability to Comply with a Lot 
Acceptance Procedure'' (e.g., Refs. 127-130). The collection and 
analysis of data and use of valid scientific tools can detect trends 
caused by process deviations.
    If continued process verification under proposed Sec.  
1120.66(b)(3) reveals that the process is no longer operating in a 
state of control and requires a change to the existing validated 
production process, such as to its method, procedure, or process 
control, revalidation under proposed Sec.  1120.66(a)(4) would be 
required.
    Proposed Sec.  1120.66(c) would require that the production process 
procedures include certain additional requirements, if applicable. 
Under proposed Sec.  1120.66(c)(1), if a production process includes a 
manual method or process, the production process procedures would be 
required to describe the manual method or process in sufficient detail 
to ensure that the tobacco product

[[Page 15220]]

meets established specifications and include, if applicable, the 
criteria for workmanship using a standard or approved model sample. An 
actual or diagrammatic representation of a model sample could show the 
design and construction of a tobacco product. For example, a hand-
rolled cigar could be represented by a model sample that defines the 
type and size of tobacco leaf to be used for the wrapper, the type and 
amount of filler tobacco to be used, the brand label to be applied, and 
the size/shape/length/diameter of the finished, rolled cigar. 
Similarly, a documented standard could establish specific length, gauge 
width, and shapes of certain types of standardized cigars (e.g., 
Corona, Churchill, and Panetela) (Ref. 131).
    Proposed Sec.  1120.66(c)(2) would require that the production 
process procedures address the use and removal of manufacturing 
material if such material could reasonably be expected to contaminate a 
tobacco product or otherwise result in a nonconforming tobacco product. 
For example, if a tobacco product manufacturer uses a mold release 
agent for an injection molding process for smokeless tobacco 
containers, and that agent contains volatile solvents that can 
contaminate the tobacco product and be toxic to users, the production 
process procedures would need to address how to clean and remove the 
manufacturing material (e.g., Refs. 132-134).
    Proposed Sec.  1120.66(d) would require finished and bulk tobacco 
product manufacturers to maintain records of all activities required 
under this section. Under this proposed provision, records must include 
the date and time, individual performing the activity, type of activity 
performed, any information that demonstrates the requirement was met, 
and any data or calculations necessary to reconstruct the results. 
These records could include drawings of the process validation process, 
a general outline of steps for process validation, or meeting agendas 
and notes regarding the validation process (e.g., Refs. 135-137).
    The proposed production processes and controls requirements would 
help assure that the public health is protected because they can 
prevent, monitor, and detect variability in the manufacturing process. 
Variability in the manufacturing process may result in the manufacture 
of tobacco product that does not conform to established specifications. 
For example, many tobacco product manufacturers establish moisture 
specifications for finished and bulk tobacco products. The regulation 
of moisture throughout the production process is important because of 
the influence of moisture on tobacco and other components and parts, 
their processing properties, and on the finished tobacco product itself 
(Ref. 138). Moisture also can affect the properties of tobacco and 
other components and parts (e.g., paper, filters), such as the level of 
micro-organisms and mass, hardness, circumference, pressure drop, and 
filter ventilation (id.). In addition, the moisture content of a 
finished cigarette is one of the physical variables that can affect the 
level of total particulate matter and the chemical composition of 
particulate phase smoke, such as during the initial puffs (Ref. 139). 
Similarly, many tobacco product manufacturers establish a pH 
specification for smokeless tobacco products using production processes 
such as curing, fermentation, or pasteurization. An increase in pH can 
result in an increase in the speed of nicotine absorption, which is 
associated with the development of tolerance and physical dependence to 
nicotine (Ref. 19). Inadequate production processes and controls may 
also contribute to substantial variability in actual nicotine 
concentration as compared to labeled nicotine concentration in e-
liquids intended to be used with ENDS (Ref. 1). This variability could 
be particularly problematic for users seeking to limit or cease tobacco 
product use. Therefore, these proposed provisions are needed to prevent 
the manufacture and distribution of nonconforming products that may 
have an adverse effect on public health.
    In addition, the proposed requirements for production processes and 
controls would help assure that tobacco products are in compliance with 
the requirements of chapter IX of the FD&C Act. If tobacco products are 
not consistently manufactured to conform to established specifications, 
new tobacco products and MRTPs may not conform to the specifications 
that are described in their applications (i.e., SE Report, request for 
SE exemption, PMTA, MRTPA) and pre-existing tobacco products may not be 
manufactured consistent with their original characteristics. Relatedly, 
the proposed requirements would help manufacturers to ensure, and FDA 
to verify, that manufacturers are not making changes to tobacco 
products that may render them new and adulterated under section 902(6) 
of the FD&C Act or misbranded under section 903(a)(6) of the FD&C Act. 
Further, a finished or bulk tobacco product whose contents, such as 
nicotine concentration, are not consistent with its labels or labeling 
also may be deemed misbranded and subject to regulatory action.
4. Laboratory Controls
    Proposed Sec.  1120.68 establishes requirements for laboratory 
controls. Under proposed Sec.  1120.68(a), finished and bulk tobacco 
product manufacturers would be required to demonstrate laboratory 
competence when using a laboratory (either in-house or contract 
laboratory) to conduct activities under proposed part 1120. Under 
proposed Sec.  1120.68(b), finished and bulk tobacco product 
manufacturers would also be required to establish and maintain 
laboratory control procedures for any laboratory activities that are 
conducted under proposed part 1120. Laboratory activities conducted 
under proposed part 1120 may include, for example, those used for 
design and development activities, acceptance activities, and process 
controls, and for the calibration of testing, monitoring, and measuring 
equipment. The requirements under proposed Sec.  1120.68(a) are 
intended to ensure that the facilities and personnel of in-house 
laboratories, as well as those of contract laboratories, are competent 
to perform the laboratory testing conducted under proposed part 1120. 
The requirements under proposed Sec.  1120.68(b) establish the specific 
requirements that the laboratory control procedures would be required 
to address in order to ensure that the laboratory testing is adequately 
performed.
    Proposed Sec.  1120.68(a) would require finished and bulk tobacco 
product manufacturers, when using a laboratory (either in-house or 
contract) to conduct activities under proposed part 1120, to 
demonstrate the laboratory's competence to perform laboratory 
activities associated with the manufacture of finished and bulk tobacco 
products. This proposed requirement is intended to ensure that tobacco 
product manufacturers confirm that laboratories are technically 
competent and able to produce precise and accurate data to comply with 
proposed part 1120. While manufacturers would have the flexibility to 
determine how they would demonstrate a laboratory's competency, they 
would be required to have appropriate documentation. Tobacco product 
manufacturers could utilize various means to show their laboratory's 
competency to carry out its activities such as a standard 
accreditation, such as ISO 17025:2005 (Ref. 140), or otherwise 
documenting a laboratory QMS (i.e., standard operating procedures for 
test methods, equipment maintenance and calibration logs, quality 
control

[[Page 15221]]

sampling protocols, and personnel training).
    Proposed Sec.  1120.68(b) would require finished and bulk tobacco 
product manufacturers to establish and maintain laboratory control 
procedures for any laboratory activities that are conducted under 
proposed part 1120. The laboratory control procedure requirements in 
proposed Sec.  1120.68(b)(1) through (3) are inter-related and intended 
to ensure that manufacturers utilize appropriate laboratory facilities 
and equipment, and that laboratory activities associated with the 
manufacture of tobacco products are performed with controls sufficient 
to ensure accurate and reliable results. For example, a manufacturer 
may use a laboratory to test pH levels of smokeless tobacco products to 
ensure that the pH levels meet the product specifications (Ref. 141). 
The laboratory control requirements in this section would help ensure 
that the data from such laboratory testing are accurate and precise, 
for example, by helping ensure that the laboratory uses properly 
calibrated pH meters, nonexpired pH check solutions, and a valid test 
method (Ref. 141).
    If a tobacco product manufacturer contracts its laboratory 
activities to an outside entity, the manufacturer would remain 
responsible for complying with the proposed laboratory control 
requirements. However, we note that these proposed requirements would 
not apply to laboratory activities outside the scope of manufacturing 
activities. For example, the proposed requirements would not apply to 
testing for harmful and potentially harmful constituents performed 
solely to comply with section 904(a)(3) of the FD&C Act.
    Proposed Sec.  1120.68(b) would require the laboratory control 
procedures to include several specific laboratory control requirements. 
First, proposed Sec.  1120.68(b)(1) would require the laboratory 
controls to include the use of scientifically valid laboratory methods 
that are accurate, precise, and appropriate for their intended purpose. 
A laboratory method can be scientifically valid if it is based on 
scientific data or results published in, for example, scientific 
journals, references, or text books.
    Second, proposed Sec.  1120.68(b)(2) would require laboratory 
controls to include the use of representative samples based on valid 
scientific rationale, in accordance with proposed Sec.  1120.72. As 
further described in proposed Sec.  1120.72, samples for laboratory 
control activities required under Sec.  1120.68(b)(2) would need to 
follow an established sampling plan to ensure that samples being tested 
or evaluated are representative of the material being sampled (i.e., 
the batch or part of the batch).
    Third, proposed Sec.  1120.68(b)(3) would require laboratory 
controls to include demonstration of analytical control, which means a 
laboratory must be able to show that its laboratory method and 
instrumentation reliably generate accurate and valid results. 
Demonstration of analytical control can be shown using a variety of 
quality control activities including but not limited to the use of 
certified reference materials, positive and negative controls, 
replicate testing, and/or internal standards. Quality control 
activities should be appropriate for the type and frequency of testing, 
suitable to monitor the analytical performance of the method and 
instrumentation used by the laboratory, and enable the laboratory to 
determine if the test yielded the expected result or response. One way 
to demonstrate compliance with this requirement would be to generate 
and maintain a quality control chart, which tracks and assesses results 
of quality control sample analysis with known amounts, to demonstrate 
analytical control of the equipment and test method. Demonstration of 
analytical control allows a tobacco product manufacturer to have 
confidence in the test sample measurements and investigate any 
anomalies early in the production process (e.g., Refs. 142 and 143).
    Under this proposed provision, for example, if a tobacco product 
manufacturer uses a laboratory to test or measure the moisture content 
of a cigarette as part of its acceptance activities to ensure that the 
product meets established specifications, a scientifically valid 
laboratory method would have to be used, such as the Weighing-Drying-
Method with Oven and Balance, described in the Tobacco Moisture, Water 
and Oven Volatiles CORESTA Technical Report (Ref. 138). In addition, a 
sampling plan would have to be used to collect representative samples 
based on a valid scientific rationale, such as ISO 8243:2013 (e.g., 
Ref. 144).
    Proposed Sec.  1120.68(c) would require finished and bulk tobacco 
product manufacturers to maintain records of all activities required 
under proposed Sec.  1120.68. Under this paragraph, records would be 
required to include the date and time, individual performing the 
activity, type of activity performed, any information that demonstrates 
the requirement was met, and any data or calculation necessary to 
reconstruct the results. As stated elsewhere in this preamble, for 
purposes of proposed part 1120, FDA interprets ``reconstruct'' to mean 
the ability to re-create the results by analyzing all data, including 
source and metadata data, and records, including calculations. Whether 
the laboratory control activities are conducted by the tobacco product 
manufacturer or contracted out to another facility, the manufacturer 
would be responsible for ensuring laboratory records, including 
results, are maintained in compliance with proposed Sec. Sec.  
1120.68(c) and 1120.122. These records could be included directly in 
the relevant production record or cross-referenced in another record 
that is readily accessible for inspection.
    This proposed provision would help assure that the public health is 
protected. Laboratory controls, such as those used for acceptance 
activities, are important analytical tools for evaluating and testing a 
tobacco product to determine if it conforms to specifications 
established in the MMR, which could help to minimize the harm to public 
health associated with nonconforming products. For example, a smokeless 
tobacco product that does not conform to established pH specifications 
could adversely affect public health because it may have a more rapid 
rate of nicotine delivery and absorption, which can lead to increased 
dependence (Refs. 6 and 19).
    This proposed provision also would require tobacco product 
manufacturers to control the laboratory activities that are part of the 
production process, which would further help to protect against the 
manufacture of a nonconforming product. For example, a tobacco product 
manufacturer may determine that monitoring the water content by 
measuring oven volatiles in the production process is necessary to 
control the level of microorganisms. Laboratory controls would ensure 
that the laboratory method used to monitor and control the moisture 
content in the production process is maintained within production 
process specifications, minimizing the chance for development of 
potentially harmful microorganisms.
    In addition, the Agency believes that the proposed laboratory 
controls requirements would help assure that tobacco products are in 
compliance with the requirements of chapter IX of the FD&C Act. These 
proposed requirements would enable the Agency to monitor and confirm 
that tobacco products are not manufactured in a manner that causes them 
to become adulterated under section 902(1) through (3) of the FD&C Act, 
that

[[Page 15222]]

tobacco products conform to specifications established in their MMRs, 
that new tobacco products and MRTPs are manufactured consistent with 
the specifications provided in their applications (i.e., SE Report, 
request for exemption from SE, PMTA, MRTPA), and that pre-existing 
products are manufactured consistent with their original 
characteristics.
5. Production Record
    Proposed Sec.  1120.70(a) would require finished and bulk tobacco 
product manufacturers to establish and maintain procedures to ensure 
that a production record is prepared for each batch of finished or bulk 
tobacco products to demonstrate conformity with the requirements 
established in the MMR in accordance with Sec.  1120.44. These proposed 
requirements are generally consistent with the practices of 
manufacturing establishments that follow ISO 9001. The production 
record could consist of a single record or compilation of records that 
represent the complete production history of the finished or bulk 
tobacco product by batch, including identification of all of its 
components or parts, ingredients, additives, and materials (e.g., Ref. 
145).
    Proposed Sec.  1120.70(a) also would require that designated 
personnel review and approve the production record for release of each 
batch of finished and bulk tobacco products into distribution. This 
requirement is intended to ensure that each batch is acceptable for 
release into distribution (e.g., that the products conform to MMR 
specifications; there were no unaddressed nonconformities as a result 
of deviations from process specifications or process controls; and the 
manufacturer has completed all acceptance activities and the results 
demonstrate that the acceptance criteria were met). The review and 
approval could take place at the end of manufacturing or at the end of 
stages of the production process such as, for example, primary, making, 
and packing stages in cigarette production.
    Proposed Sec.  1120.70(b)(1) through (7) would require that the 
production record include, or refer to the location of, certain 
information. Proposed Sec.  1120.70(b)(1) would require the production 
record to include the manufacturing code of the finished or bulk 
tobacco product, which is defined in proposed Sec.  1120.3 to include 
the manufacture date and batch number (see also proposed Sec.  
1120.96). This information is needed to identify affected tobacco 
product, for example, during a tobacco product complaint and/or 
nonconforming product investigation. A tobacco product manufacturer 
could also choose to include manufacturing time in the production 
record to further narrow the scope of any nonconforming product 
investigation. In this context, ``manufacturing time'' generally refers 
to the time that the finished or bulk tobacco product was packaged 
(e.g., designated by year/month/date/hour/minute).
    Proposed Sec.  1120.70(b)(2) would require the production record to 
include the quantity of finished or bulk tobacco product manufactured 
in the batch. This information would be helpful for conducting tobacco 
product complaint and nonconforming product investigations because it 
would help determine how many tobacco products may be affected and, 
therefore, the scope of the investigation.
    Proposed Sec.  1120.70(b)(3) would require the production record to 
identify the major equipment and processing lines used in manufacturing 
the batch of finished or bulk tobacco product. If a tobacco product 
manufacturer has more than one piece of major equipment and/or 
processing line, this provision would require the manufacturer to 
document the specific major equipment and/or processing line that was 
used in the manufacture of the batch. This information would help to 
determine whether a nonconforming product is attributable to an issue 
with a particular piece of equipment or processing line and help 
determine the scope of product that might be affected.
    Proposed Sec.  1120.70(b)(4) would require that the production 
record also include records of any activities performed under proposed 
part 1120 necessary to demonstrate that the batch of finished or bulk 
tobacco product was manufactured to conform with the MMR requirements 
established under proposed Sec.  1120.44. The records to be maintained 
in a production record under paragraph (b)(4) include purchasing 
records, acceptance activity records, continued process verification 
records, laboratory testing records, reprocessing and rework records, 
and packaging and labeling records. To the extent that these records 
may overlap with other records required under proposed part 1120, the 
manufacturer need not maintain duplicate copies in the production 
record but may instead simply cross-reference the location of the 
relevant records. We note, relatedly, that the records would not have 
to be physically located in the same place but the location of all 
relevant records must be included in the production record, and the 
records must comply with the requirements in proposed Sec.  1120.122 
(e.g., the records must be readily accessible to responsible officials 
of the tobacco product manufacturer and to FDA).
    Proposed Sec.  1120.70(b)(5) would require the production record to 
include all unique identifiers of all accepted incoming tobacco 
products, including components or parts, ingredients, additives, and 
materials, used in the manufacture of the batch of finished or bulk 
tobacco product. This information could help a tobacco product 
manufacturer or FDA to determine if there is a problem with a 
particular component or part, ingredient, additive, or material and to 
establish traceability to identify other affected tobacco products.
    Proposed Sec.  1120.70(b)(6) would require that, if any finished or 
bulk tobacco product was used in the manufacture of the batch, the 
manufacturing code for that finished or bulk tobacco product must be 
included in the production record. For example, if a finished tobacco 
product manufacturer uses bulk tobacco product from a supplier, under 
Sec.  1120.70(b)(6), the production record for the batch of finished 
tobacco product must include the manufacturing code for the bulk 
tobacco product (as received from the supplier and provided on the 
label of the bulk product). Similarly, if returned and reworked 
finished product is used in the subsequent manufacture of another 
finished product, under Sec.  1120.70(b)(6), the production record for 
the subsequent finished product must include the manufacturing code of 
the incorporated returned and reworked product. We note that the 
requirement in proposed Sec.  1120.70(b)(6) is distinct from and in 
addition to the requirement in proposed Sec.  1120.70(b)(1) that the 
production record for each batch of finished or bulk tobacco product 
include the manufacturing code assigned by the manufacturer for that 
finished or bulk tobacco product. This information is needed to 
establish traceability and help identify affected tobacco products 
during a tobacco product complaint and/or nonconforming product 
investigation.
    Proposed Sec.  1120.70(b)(7) would require actual or copies of the 
packaging, labeling, and labels (as defined in proposed Sec.  1120.3) 
used with the finished and bulk tobacco product, including inserts and 
onserts that accompany the product.
    Finally, proposed Sec.  1120.70(b)(8) would require the name(s) and 
signature(s) of the designated individual(s) reviewing and approving 
the production record for release of the batch of finished or bulk 
tobacco

[[Page 15223]]

product into distribution. The designated individual can perform the 
function of a gatekeeper by conducting a final review and approval of 
the production record for the batch for release into distribution. 
Alternatively, review and approval of the relevant portions of the 
production record can be conducted in stages. If review and approval is 
performed in stages throughout the production process, the manufacturer 
could also perform a final review and approval of the production record 
to verify that approvals of all production process stages had been made 
and documented.
    The proposed production record requirements would help assure that 
the public health is protected. The proposed requirements would ensure 
that tobacco product manufacturers review and approve the production 
record prior to the release of each batch of finished and bulk tobacco 
product. The manufacturer would ensure that all records required to be 
included in the production record (e.g., records from acceptance 
activities) have been included, or their location referenced, and that 
the production record demonstrates that the batch of finished or bulk 
tobacco product conforms to the MMR. These requirements would help 
prevent the distribution of nonconforming product.
    In addition, the proposed production record contents are essential 
to the conduct of adequate tobacco product complaint and nonconforming 
product investigations to identify the scope and cause of an issue and 
ensure traceability to determine affected tobacco products. For 
example, if there are complaints that report a particular problem, 
review of the relevant production records (e.g., manufacturing code, 
identification of major equipment and processing lines) can help 
determine the scope of the problem (e.g., whether it is limited to a 
specific piece of equipment or processing line or certain production 
batches, or whether it includes all products from the establishment), 
the cause, and the quantity of affected tobacco product manufactured. 
If a manufacturer has to initiate a corrective action such as a recall, 
the manufacturing code included in the production record could also be 
used to identify the corresponding distribution records to help 
determine where the affected products were distributed.
    The proposed production record requirements would also help assure 
that tobacco products are in compliance with the requirements of 
chapter IX of the FD&C Act. For example, information regarding the 
identity and amount of all components or parts, ingredients, additives, 
and materials used in the manufacture of a finished or bulk tobacco 
product could be used to confirm ingredient listings submitted to FDA 
under section 904(a)(1) of the FD&C Act. Documenting in the production 
record the packaging, labeling, and labels used with finished tobacco 
products also would help enable FDA to determine if the tobacco 
products display required warning statements and are in compliance with 
the MRTP provisions in section 911 of the FD&C Act (21 U.S.C. 387k) and 
relevant requirements of section 903(a)(2) of the FD&C Act.
6. Sampling
    For any sampling performed under proposed part 1120, proposed Sec.  
1120.72 would require finished and bulk tobacco product manufacturers 
to establish and maintain an adequate sampling plan using 
representative samples. These proposed requirements are similar to 
those in other FDA-regulated industry manufacturing regulations. To 
comply with this requirement, each manufacturer would be required to 
create a written sampling plan using representative samples, implement 
and follow the sampling plan, and update the sampling plan as needed. 
The proposed sampling requirements in proposed Sec.  1120.72 would 
apply to all sampling performed under proposed part 1120, including 
sampling used for acceptance activities, process control monitoring, 
and continued process verification. Acceptance sampling is performed to 
determine the disposition of products tested (e.g., accept, reject) 
whereas statistical process control and the sampling associated with 
monitoring a process are used to distinguish between variation that is 
inherent in the process and variation induced by some external factor 
that would result in nonconforming product.
    A sampling plan is a written, detailed document that describes: (1) 
the purpose of the sampling, (2) the scientific technique or method 
used to establish the number of samples, including an explanation of 
how the sample size is representative of the material being sampled, 
and (3) the method of sampling. A sampling plan is essential to ensure 
that sampling is reliable, consistent, replicable, and suitable for its 
intended purpose. Under the proposed rule, manufacturers could tailor 
their sampling plans to specific activities and purposes. For example, 
a sampling plan for an acceptance activity could be different than one 
for monitoring whether a production process remains in a state of 
control or for continued process verification to detect sources of 
variability.
    The basic principles of an adequate sampling plan include the 
following: the samples are representative of the batch or quantity 
being sampled, the number of samples is based on a valid scientific 
rationale, and the number of samples is sufficient for the intended 
purpose. ``Valid scientific rationale'' refers to scientific techniques 
or methods used to establish the number of representative samples and 
should take into account tolerance for variability, confidence levels, 
and the degree of precision required (Refs. 105, 107, 108). FDA 
believes that requiring the number of samples to be based on a ``valid 
scientific rationale'' would provide manufacturers with the flexibility 
to determine the appropriate number of representative samples for any 
sampling plan. While FDA is proposing this flexibility, this provision 
would require that manufacturers have support for the scientific 
technique or methods used to establish the number of representative 
samples used and to show that the sampling size is representative of 
the material being sampled.
    Proposed Sec.  1120.72(a) through (c) specifies the required 
elements of a sampling plan. First, proposed Sec.  1120.72(a) would 
require the sampling plan to describe the intended purpose of the 
sampling (e.g., product acceptance, monitor a production process, or 
detect sources of variability). Second, proposed Sec.  1120.72(b) would 
require the plan to describe the scientific technique or method used to 
establish the sample size, including an explanation of how the sample 
size is representative of the material being sampled. Examples of 
scientific techniques or methods for sampling can include the ``ISO 
2859 series of standards for sampling procedures for inspection by 
attributes,'' as well as ANSI/American Society for Quality (ASQ) Z1.4 
(Refs. 146 and 125). Information regarding the scientific techniques 
and methods used would be required to include an explanation of the 
sample size (i.e., the quantity or amount of product to be sampled) and 
how the sample size is representative of the material being sampled. 
The sample size would need to be sufficient for the intended purpose of 
the sampling plan and analysis to be performed. Third, proposed Sec.  
1120.72(c) would require the plan to describe the method of sampling. 
This refers to when and how samples are collected. For example, CORESTA 
Recommended Method No 24--Cigarettes--Sampling, A.3 states that samples 
should be drawn from one or more cartons of cigarettes at random from 
each sampling point to form the necessary gross and there should be at

[[Page 15224]]

least 10 sampling points distributed between factories where the 
cigarettes are made (Ref. 105).
    The proposed representative sample requirements would help assure 
that the public health is protected by ensuring that any sampling 
performed under proposed part 1120 is scientifically sound and 
appropriate for its intended purpose and does not erroneously support 
the release of a batch containing tobacco products that do not conform 
to established specifications. If a sampling plan is not adequate, the 
results of an acceptance activity may not accurately demonstrate 
whether the batch meets established specifications, the established 
production process may not be properly controlled, and a validated 
process may not be adequately monitored to detect sources of 
variability, all of which could result in the manufacture and 
distribution of nonconforming product.
    The proposed sampling requirements would also help assure that 
tobacco products are in compliance with the requirements of chapter IX 
of the FD&C Act. Appropriate sampling methods would help manufacturers 
ensure that the new tobacco products and MRTPs they manufacture meet 
the specifications described in their applications (i.e., SE report, 
request for exemption from SE, PMTA, MRTPA) and that the specifications 
for pre-existing tobacco products continue to be consistent with their 
original characteristics.
7. Nonconforming Tobacco Product
    Proposed Sec.  1120.74 would require finished and bulk tobacco 
product manufacturers to establish and maintain procedures for the 
control and disposition of nonconforming tobacco product. A 
nonconforming tobacco product is defined as any tobacco product that 
does not meet a product specification as set by the MMR (see proposed 
Sec.  1120.44(a)(1)); has packaging, labeling, or labels other than 
those included in the MMR (see proposed Sec.  1120.44(a)(3)); or is a 
contaminated tobacco product. These procedures are necessary to help 
prevent the distribution of nonconforming tobacco products, which could 
pose risks not normally associated with tobacco products, by ensuring 
that all potential nonconforming products are identified, segregated, 
and investigated, and that appropriate disposition and followup is 
taken for products determined to be nonconforming. These provisions are 
also intended to help manufacturers determine the extent of any 
nonconformity and, in cases in which nonconforming product has already 
been released for distribution, determine where it was distributed. 
These proposed requirements are generally consistent with the practices 
of manufacturing establishments that follow ISO 9001 and the industry 
recommendations.
    These proposed requirements would be applicable throughout the 
manufacturing process. For example, if an ENDS manufacturer determines 
through its in-process product acceptance activities that the liquid 
nicotine contains contaminants such as metal or silicate particles 
(known to cause respiratory disease and distress), the liquid nicotine 
would be a nonconforming product and would have to be handled according 
to the procedures outlined in proposed Sec.  1120.74 (Ref. 2). 
Similarly, if an ENDS manufacturer determines through its process 
controls that the liquid nicotine concentration does not meet the 
concentration specification established in its MMR, the liquid nicotine 
would be a nonconforming product and the manufacturer would have to 
identify, segregate, investigate, and determine its disposition (e.g., 
rework as appropriate or discard) in accordance with proposed Sec.  
1120.74(c) (Ref. 5). As another example, if a smokeless tobacco product 
manufacturer determines through its tobacco product acceptance 
activities that its chewing tobacco is contaminated with aflatoxins 
(Ref. 17), the manufacturer would be required to follow its 
nonconforming product procedures in accordance with this provision.
    Proposed Sec.  1120.74(a) would require finished and bulk tobacco 
product manufacturers to identify and segregate potential nonconforming 
product in a manner that prevents mixups and use of potential 
nonconforming product prior to investigation and disposition. This 
requirement would be triggered upon discovery of a potential 
nonconforming product. For example, if a manufacturer establishes 
acceptance activities to visually inspect incoming tobacco for the 
presence of mold, and a product appears to be discolored or blighted, 
the manufacturer would determine that the tobacco may be nonconforming 
and therefore subject to this provision. If an ENDS manufacturer 
performs laboratory testing on the nicotine concentration of an e-
liquid as part of acceptance activities and the testing results do not 
conform to the established specification and acceptance criteria, the 
manufacturer would determine that the e-liquid is a potential 
nonconforming product that must be identified and segregated. If a 
tobacco product was manufactured under conditions outside of an 
established production process specification where failure to meet the 
process specification is reasonably likely to cause the tobacco product 
to fail to meet a product specification, the product should be treated 
as a potential nonconforming product.
    Identification of potential nonconforming product can be 
accomplished in many ways (e.g., applying a label with the relevant 
information directly to the product container; or, if an electronic 
system is utilized, associating the nonconforming product information 
with the relevant barcode). Identification is a critical first step to 
preventing further processing, production, or distribution of potential 
nonconforming tobacco product.
    Proposed Sec.  1120.74(a) would also require finished and bulk 
tobacco product manufacturers to segregate potential nonconforming 
product in a manner that prevents mixups and use of potential 
nonconforming product prior to investigation and disposition. This 
provision would require potential nonconforming product to remain 
segregated pending an investigation until it is determined to be 
conforming. If a potential nonconforming product is determined to be 
nonconforming, it would need to remain segregated throughout 
investigation and disposition, including any rework. For purposes of 
proposed part 1120, ``segregation'' means setting the identified 
potential nonconforming product apart from other product (i.e., placing 
it away from conforming in-process material). This segregation could be 
accomplished by placing it in a quarantined or specifically marked-off 
area. Manufacturers should use prudence and segregate potential 
nonconforming tobacco product in a manner that is appropriate, given 
the nature of the potential nonconformity. For example, if a product is 
potentially nonconforming because it may be contaminated with pests, 
pathogens, or other substances that are likely to spread, it should be 
segregated and stored in a manner that prevents contamination of other 
tobacco products.
    Proposed Sec.  1120.74(b) would require finished and bulk tobacco 
product manufacturers to investigate all potential nonconforming 
tobacco products. The purpose of the investigation is to determine 
whether the product is in fact nonconforming and, if it is found to be 
nonconforming, to determine the scope and cause of the nonconformity, 
and the risk of illness or injury it poses. Under proposed Sec.  
1120.74(b)(1), in order to determine if

[[Page 15225]]

the product is nonconforming, FDA is proposing to require that the 
investigation include an examination of relevant production processes 
and controls, laboratory testing, complaints, and any other relevant 
records and sources of information.
    For example, in accordance with proposed Sec. Sec.  1120.66(a)(3) 
and 1120.74(b), if there was a deviation from a production process, a 
tobacco product manufacturer would be required to conduct an 
investigation to determine if the production process deviation resulted 
in a nonconforming product. For example, if the fermentation of a 
tobacco blend deviates from established production processes and 
controls for fermentation, such as maintaining temperature and humidity 
through specified turn cycles necessary to meet a pH specification, the 
tobacco product manufacturer would be required to perform an 
investigation to determine if the deviation resulted in a nonconforming 
product.
    Similarly, if a manufacturer uses a laboratory to perform product 
acceptance activities, and there is an out-of-specification (OOS) 
laboratory test result, the manufacturer would need to investigate the 
OOS test result under proposed Sec.  1120.74(b) to determine whether 
the product is nonconforming or the OOS result is due to another cause 
such as laboratory error. Under proposed Sec.  1120.74(b)(1), the 
investigation would be required to include an examination of relevant 
production processes and controls and any other relevant records and 
sources of information such as the laboratory method and review of 
initial testing and calibration of the laboratory equipment. Such an 
investigation could determine that the OOS test results came from an 
aberration of the measurement process (e.g., laboratory error, 
defective testing equipment, or deviation from an established 
laboratory test method) and that the potential nonconforming product is 
not nonconforming. Alternatively, an investigation could conclude that 
the OOS test result was valid and that the product was nonconforming as 
a result of the manufacturing process.
    If a tobacco product is determined to be nonconforming, under 
proposed Sec.  1120.74(b)(2), the investigation also would be required 
to determine the scope and cause of the nonconformance and the risk of 
illness or injury posed by the nonconformance. Examination of relevant 
production processes and controls and any other relevant records and 
sources of information could help a manufacturer determine if any other 
batches are affected or if nonconforming product has been distributed. 
For example, if the investigation of a nonconforming product determines 
that the cause is due to fragments from a cutting blade, the 
manufacturer may need to investigate other batches on which the cutting 
blade was used since it was last inspected and take appropriate follow 
up action. For any product determined to be nonconforming, 
documentation of the investigation activities under proposed Sec.  
1120.74(d) should include the product name (brand and sub-brand), 
additional product identification, and quantity of nonconforming 
tobacco product. The additional product identification should include 
all unique identifiers associated with the tobacco product and, if 
applicable, the manufacturing code of the finished or bulk tobacco 
product.
    The proposed rule would also require that, for products determined 
to be nonconforming, the investigation include an examination of the 
risk of illness or injury posed by the nonconformance, because this 
risk would be relevant to the manufacturer's disposition decision under 
proposed Sec.  1120.74(c). Furthermore, this information can feed into 
the manufacturer's risk management process under proposed Sec.  
1120.42.
    Under proposed Sec.  1120.74(b), an investigation would be required 
to be performed for all potential nonconforming products. However, if a 
previous investigation has been completed and it is determined to be 
applicable to the current investigation, the results and followup of 
the previous investigation could be cross-referenced and applied to the 
current investigation. In other words, if the cause of a nonconforming 
product is determined to be the same as that of a previous 
nonconforming product, the manufacturer could cross-reference the 
results of the previous investigation and would not need to repeat 
aspects of the investigation that would be redundant.
    Proposed Sec.  1120.74(c) would require finished and bulk tobacco 
product manufacturers to determine the disposition of all nonconforming 
tobacco products and to conduct any necessary follow up action. Under 
proposed Sec.  1120.74(c), nonconforming product could not be released 
for distribution without rework or an adequate justification. Thus, 
nonconforming product could be reworked as appropriate under proposed 
Sec.  1120.78, distributed with an adequate justification (as explained 
below), or discarded. If a manufacturer determines that nonconforming 
product can be reworked, the disposition decision should address how 
the rework will correct the nonconformity without adversely affecting 
the product. For example, if an ENDS manufacturer decides to rework a 
nonconforming circuit board by resoldering a joint, the manufacturer 
should document how such rework does not adversely affect the circuit 
board by melting or delaminating board components.
    A manufacturer may determine that a nonconforming tobacco product 
can be released for distribution without rework; however, proposed 
Sec.  1120.74(c) would require the manufacturer to provide an adequate 
written justification before releasing such product. An adequate 
written justification would be required to address why releasing the 
product would not result in an increased risk of illness or injury or 
in the tobacco product being adulterated or misbranded. For example, if 
a manufacturer determines that a product is nonconforming because of a 
minor discrepancy in the color of its packaging (e.g., Pantone 2415 C 
vs. an established specification of Pantone 2415 CP) and that the 
product can be released for distribution without rework, the 
manufacturer could provide an adequate written justification (i.e., 
explain that the minor color discrepancy will not increase the risk of 
illness or injury or render the product adulterated or misbranded) and 
release the nonconforming product. However, nonconforming product that 
would increase the risk of illness or injury, or that would result in 
the tobacco product being adulterated or misbranded would not be 
acceptable for release without rework. For example, if a nonconformity 
results in a modification of a product that would require a new 
marketing application under section 905 or 910 of the FD&C Act and make 
the product misbranded under section 903(a)(6) of the FD&C Act or 
adulterated under section 902(6)(A) of the FD&C Act, the nonconforming 
product could not be released for distribution without rework. 
Similarly, a tobacco product that becomes contaminated by glass 
fragments from an unprotected light fixture would present an increased 
risk of injury to the user that would warrant discarding the product as 
it may not be possible for it to be reworked.
    Proposed Sec.  1120.74(c) would also require finished and bulk 
tobacco product manufacturers to conduct any necessary followup 
actions. Follow up actions could include initiating a CAPA under 
proposed Sec.  1120.16 and taking appropriate corrective action on 
other affected batches. If nonconforming product has already been 
distributed, the manufacturer could initiate a recall.

[[Page 15226]]

Necessary followup should be informed by the results of the 
investigation under proposed Sec.  1120.74(b); for example, the risk of 
illness or injury posed by the nonconformance may affect the type of 
CAPA to be taken.
    Proposed Sec.  1120.74(d) would require finished and bulk tobacco 
product manufacturers to maintain records of all activities required 
under this section. This provision would require that such records 
include the date and time of the activity, the individual performing 
the activity, type of activity performed, any information that 
demonstrates the requirement was met, and any data or calculations 
necessary to reconstruct the results. As stated elsewhere in this 
preamble, for purposes of this proposed part 1120, FDA interprets 
``reconstruct'' to mean the ability to re-create the results by 
analyzing all data, including source and metadata data, and records, 
including calculations. For any product determined to be nonconforming, 
the records should document the product name (brand and sub-brand), any 
additional product identification information (e.g., manufacturing 
code(s), batch number, or unique ID as applicable), and the quantity of 
nonconforming tobacco product. This information is important for 
verifying that all potential nonconforming product is properly handled, 
that nonconforming product investigations are appropriately thorough 
and complete, and that disposition decisions are made to prevent the 
release of nonconforming product for distribution and are properly 
justified.
    In addition to helping to prevent the distribution of nonconforming 
product, the proposed nonconforming product requirements would help 
assure that the public health is protected by requiring tobacco product 
manufacturers to perform a systematic assessment of nonconforming 
product and take appropriate followup. Nonconforming product can result 
from a design problem, failure to meet tobacco product specifications, 
failures of or problems with purchasing controls, inadequate process 
controls, improper facilities or equipment, inadequate training, 
inadequate manufacturing methods and procedures, or improper handling 
of the tobacco product. The proposed provisions would require 
manufacturers to investigate the cause of nonconforming product and 
take appropriate followup, such as CAPAs, to eliminate or minimize 
future nonconformities. For example, if a cigarette manufacturer 
determined that a cigarette did not meet its filter pressure drop 
specification (a nonconformity that can expose consumers to increased 
risk of exposure to constituents compared to what would normally be 
expected from cigarette use (Ref. 147), these provisions would require 
that the manufacturer undertake a systematic assessment to determine 
the cause of the nonconformity and the need for CAPAs to be taken, 
which would help prevent the manufacture and sale of similar 
nonconforming product. If the results of acceptance activities 
demonstrate that the product does not meet the specification, the 
manufacturer would be required to take the steps to address 
nonconformities in accordance with proposed Sec.  1120.74. 
Specifically, the manufacturer would need to identify and segregate the 
nonconforming product to prevent mixups and distribution of 
nonconforming product, investigate the nonconformity, and determine the 
disposition of the product.
    As another example, where a tobacco product manufacturer determines 
that its product does not conform to established pH specifications, it 
would be required to comply with this proposed provision. The amount 
and speed of nicotine delivered by a tobacco product is related to the 
proportion of nicotine in a tobacco product and/or its emissions that 
is in the unprotonated or ``free-base'' form (also known as the un-
ionized free-base form); therefore, a product that delivers more 
unprotonated nicotine at a faster rate is more addictive and toxic than 
other tobacco products. Because the pH scale is logarithmic, the 
proportion of unprotonated nicotine increases or decreases sharply with 
relatively small changes in pH. For example, at a pH of 7, about 7 
percent of the nicotine is free; at a pH of 9 or more, 80 percent of 
the nicotine is in the free form. Tobacco and smoke pH appear to be 
controlled primarily by the use of ammonia compounds and other 
substances used in tobacco processing and final cigarette production, 
which serve to optimize the free nicotine levels (Ref. 6). Accordingly, 
a tobacco product's specifications (including the amount of 
ingredients, additives, and materials such as ammonia compounds) can 
affect the product's pH. A manufacturer's investigation and disposition 
of such nonconforming product would help to ensure that such products 
are not placed into distribution and that such nonconformities do not 
occur in the future, thereby helping ensure that consumers are not 
exposed to greater risks than those normally associated with the use of 
the product.
    The proposed nonconforming product requirements would help assure 
that tobacco products are in compliance with the requirements of 
chapter IX of the FD&C Act by providing thorough steps and actions to 
be taken on nonconforming tobacco products. These measures would help 
ensure that tobacco products that are nonconforming are either not 
placed into distribution or are reworked so that they conform to 
established specifications, including those provided by the 
manufacturer to FDA in any relevant tobacco product applications (i.e., 
SE Report, request for exemption from SE, PMTA, MRTPA). In addition, 
they would help manufacturers to ensure, and FDA to verify, that 
manufacturers are not making changes to finished tobacco products that 
may render them new tobacco products adulterated under section 902(6) 
of the FD&C Act or misbranded under section 903(a)(6) of the FD&C Act.
8. Returned Tobacco Product
    Proposed Sec.  1120.76(a) would require each finished and bulk 
tobacco product manufacturer to establish and maintain procedures for 
the control and disposition of returned tobacco product. Returned 
tobacco products are commercially distributed finished or bulk tobacco 
products returned to the tobacco product manufacturer by any person not 
under the control of the tobacco product manufacturer, including a 
wholesaler/distributor, retailer, consumer, or a member of the public. 
These proposed requirements are generally similar to practices of 
manufacturing establishments that follow ISO 9001.
    Proposed Sec.  1120.76(a)(1) would require finished and bulk 
tobacco product manufacturers to identify returned tobacco product with 
the product name, manufacturing code, quantity returned, date the 
manufacturer received the returned product, and reason for return. 
Returned tobacco products should be identified using appropriate means 
such as a tag or label to prevent mixups and inadvertent use or 
distribution.
    Proposed Sec.  1120.76(a)(2) would require finished and bulk 
tobacco product manufacturers to segregate the identified returned 
tobacco product in a manner that prevents mixups and use of returned 
tobacco product prior to evaluation and disposition. Returned tobacco 
products could be segregated by being placed in a quarantined area or 
in an identified location that prevents mixups.
    Proposed Sec.  1120.76(a)(3) would require finished and bulk 
tobacco product manufacturers to evaluate identified returned tobacco 
product and determine its disposition (i.e., discard,

[[Page 15227]]

rework, release for distribution). Evaluation is necessary to determine 
whether the returned product should be discarded, whether it is 
appropriate for rework under proposed Sec.  1120.78, or whether the 
product can be released for distribution. If during an evaluation, a 
manufacturer determines that returned tobacco product is potentially 
nonconforming, the manufacturer would be required to follow its 
nonconforming product procedures in accordance with proposed Sec.  
1120.74. Under proposed Sec.  1120.76(a)(3), tobacco product 
manufacturers would have flexibility to determine how to evaluate 
returned tobacco product. A tobacco product manufacturer could use 
inspection, testing, or other verification methods to evaluate the 
returned tobacco product and make an appropriate disposition 
determination. Returned tobacco product would be required to be 
discarded unless the manufacturer determines that it can be reworked, 
or released for distribution based on an adequate written 
justification. An adequate written justification would show that the 
returned product is not nonconforming or explain why releasing 
nonconforming returned product would not result in an increased risk of 
illness or injury or in the tobacco product being adulterated or 
misbranded (see also proposed Sec.  1120.74(c)).
    In some circumstances, a manufacturer could determine that returned 
nonconforming product can be reworked to meet established 
specifications. For example, if a tobacco product is returned because 
the package contained an incorrect quantity, the manufacturer could 
repackage the product with the correct quantity. The release of 
nonconforming returned product for distribution should not occur except 
in limited circumstances where the manufacturer can provide an adequate 
written justification that addresses why releasing the product would 
not result in an increased risk of illness or injury or in the tobacco 
product being adulterated or misbranded (see proposed Sec.  
1120.74(c)). For example, a manufacturer could release a returned 
product for distribution without rework if the product was mistakenly 
sent to a distributor or retailer and returned in unopened and intact 
packaging with no visible signs of damage or contamination.
    FDA notes that when returned products are determined to be 
potentially nonconforming under proposed Sec.  1120.74, or are 
associated with complaints under proposed Sec.  1120.14 or with a CAPA 
under proposed Sec.  1120.16, the requirements in those sections, 
including all investigation requirements, would apply and take 
precedence. If returned products are needed (e.g., for product testing) 
in order to conduct an adequate investigation under those sections, a 
manufacturer should complete the investigation before discarding the 
returned product under proposed Sec.  1120.76. For example, if a 
manufacturer determines that a returned product might contain a 
contaminant, it should keep the product and complete an investigation 
on the nature and scope of the contamination before the returned 
product is discarded.
    If a tobacco product manufacturer's disposition decision is to 
rework the returned tobacco product, the rework would need to be 
performed in accordance with proposed Sec.  1120.78.
    Proposed Sec.  1120.76(b) would require finished and bulk tobacco 
product manufacturers to maintain records of all activities required 
under this section. Under this proposed provision, records must include 
the date and time, individual performing the activity, type of activity 
performed, any information that demonstrates the requirement was met, 
and any data or calculations necessary to reconstruct the results. As 
stated elsewhere in the preamble, FDA interprets ``reconstruct'' to 
mean the ability to re-create the results by analyzing all data, 
including source and metadata data, and records, including 
calculations. In addition, records of evaluation and disposition would 
be required to include the product name, manufacturing code, quantity 
returned, date the manufacturer received the returned product, reason 
for the return, disposition decision and any justification, and the 
name of the individual making the decision.
    The industry GMP recommendations do not include returned product 
provisions. The Agency believes the proposed returned tobacco product 
requirements would help assure that the public health is protected by 
requiring that manufacturers of finished and bulk tobacco products 
evaluate returned tobacco products and adequately justify their 
disposition decisions. For example, FDA has learned that some tobacco 
products have been contaminated with insecticides, gasoline or diesel 
fuel, or other toxic substances during shipment (e.g., Refs. 148 and 
149). In addition, FDA is aware that tobacco products such as ENDS may 
be altered or customized by a vape shop, resulting in nonconformity, 
including contamination. If these products are returned to the 
manufacturer, this provision would help ensure that they are handled 
appropriately and that any subsequent distribution of the products is 
adequately justified.
    The proposed returned tobacco product requirements would assure 
that the public health is protected and that products are in compliance 
with chapter IX of the FD&C Act by helping to prevent contamination and 
adulteration of tobacco products. Contaminated and adulterated tobacco 
products can adversely affect public health over and above the risk 
normally associated with the use of the product.
9. Reprocessing and Rework
    Proposed Sec.  1120.78 would require finished and bulk tobacco 
product manufacturers to establish and maintain procedures for 
reprocessing and reworking tobacco product. These proposed requirements 
are similar to practices that are already being implemented by the 
tobacco industry, as FDA has observed during inspections, and to the 
practices of manufacturing establishments that follow ISO 9001. FDA has 
found that tobacco product manufacturers use reprocessing procedures in 
their manufacturing process (Refs. 150-154).
    Proposed Sec.  1120.3 defines ``reprocessing'' as using tobacco 
product that has been previously recovered from manufacturing in the 
subsequent manufacture of a finished or bulk tobacco product. An 
example of reprocessing would be using tobacco recovered during the 
production process, such as cigarette tobacco recovered from the ripper 
short process (e.g., Ref. 155) or tobacco recovered from smokeless 
tobacco cans that are rejected for being the incorrect weight, in the 
subsequent manufacture of cigarettes or smokeless tobacco cans that use 
the same tobacco blend. Proposed Sec.  1120.3 defines ``rework'' as 
action taken on a nonconforming or returned tobacco product to ensure 
the product meets the specifications and other requirements in the MMR 
of a subsequently manufactured product before it is released for 
further manufacturing or distribution. An example of rework would be 
the repackaging or relabeling of a finished tobacco product due to 
nonconforming packaging or labeling.
    Specifically, proposed Sec.  1120.78(a)(1) would require the 
reprocessing and rework procedures to include evaluation of the tobacco 
product to determine whether the product is appropriate for 
reprocessing or rework and authorization of any reprocessing or rework 
by a designated individual. Under proposed Sec.  1120.78(a)(1), tobacco

[[Page 15228]]

product would be appropriate for reprocessing if it is uncontaminated 
and has the same specifications as those in the MMR of the subsequently 
manufactured tobacco product. For example, tobacco recovered through a 
ripper short process would be appropriate for reprocessing if it is 
uncontaminated and has the same tobacco blend/type, size, and length, 
as specified in the MMR of the subsequently manufactured tobacco 
product. Tobacco recovered from one brand of a finished or bulk tobacco 
product could be reprocessed for use in the subsequent manufacture of 
another brand/sub-brand of a finished or bulk tobacco product if it has 
the same tobacco blend/types, cut size, and length and otherwise meets 
the MMR specifications for the other brand/sub-brand. However, 
mentholated tobacco, for example, would not be appropriate for 
reprocessing in the subsequent manufacture of a nonmentholated finished 
or bulk tobacco product.
    A tobacco product would be appropriate for rework if further 
manufacturing can correct the nonconformity and the product could meet 
the specifications and other requirements in the MMR of a subsequently 
manufactured tobacco product. For example, if a tobacco product is 
nonconforming because of a contaminant, it would be appropriate for 
rework if further manufacturing could eliminate the contaminant and the 
tobacco product could meet the specifications and other requirements in 
the MMR for the subsequently manufactured product.
    The evaluation required under proposed Sec.  1120.78(a)(1) could be 
done by conducting testing or other inspection or verification 
activities, or by providing an adequate written justification for why 
the tobacco product is appropriate for reprocessing or rework. FDA has 
observed on inspections that reprocessing often occurs in the following 
in-line situations: incomplete cigarettes produced by a maker machine 
(e.g., loose ends, ripper shorts, paper damage, or empty tip (no filter 
attached)); and smokeless tobacco cans that are rejected for missing or 
having an incorrect label or being the incorrect weight. In these types 
of situations, manufacturers typically determine that the tobacco is 
appropriate for reprocessing without further investigation or testing 
because it is uncontaminated and can be directly recovered from 
manufacturing for use in the subsequent manufacture of finished or bulk 
tobacco products. For example, if the manufacturer decides to reprocess 
tobacco from unformed cigarettes that are rejected by the maker 
equipment, under proposed Sec.  1120.78(a)(1), the manufacturer would 
be required to evaluate the tobacco to ensure that it is appropriate 
for reprocessing. The evaluation could determine that the recovered 
tobacco is appropriate for reprocessing because these unformed 
cigarettes were collected directly from the maker and, therefore, 
further testing is not necessary to show that the tobacco is not 
contaminated and conforms to the specifications established in the MMR 
for the subsequently manufactured product. The manufacturer should 
provide an adequate written justification for its determination that is 
appropriate to reprocess the recovered tobacco, either in its 
reprocessing procedure or on an ad hoc basis. If the manufacturer 
chooses to reprocess tobacco products out-of-line (i.e., tobacco not 
recovered directly from the production line), it should determine 
whether the evaluation should include testing the product to ascertain 
eligibility for reprocessing (e.g., testing to ensure that the product 
is not contaminated).
    A manufacturer would also have to perform an evaluation under 
proposed Sec.  1120.78(a)(1) to determine whether tobacco product is 
appropriate for rework. For example, if finished packages of cigars are 
rejected for being the incorrect weight, a manufacturer would have to 
evaluate the nonconforming product to determine if it is appropriate 
for rework. The evaluation could determine that the nonconformity is 
due to the package having four cigars instead of the required five 
cigars, and that the product can undergo repackaging to address the 
nonconformity and meet the specifications and other requirements in the 
MMR for the subsequently manufactured product. In some cases, an 
evaluation may show that a product is not appropriate for rework. For 
example, an evaluation of returned tobacco product may determine that 
it is not appropriate for rework because further manufacturing cannot 
remove a contaminant, such as an insecticide (e.g., Ref. 148).
    Proposed Sec.  1120.78(a)(2) would require the reprocessing and 
rework procedures to detail the production processes, including process 
controls, in accordance with proposed Sec.  1120.66(a), and acceptance 
activities, in accordance with Sec.  1120.64(c), used to ensure the 
reprocessed or reworked tobacco conforms to the requirements 
established in the MMR for the subsequently manufactured product. 
Usually, the production processes and controls used for reprocessing 
and rework would be the same as those used for the subsequently 
manufactured product under proposed Sec.  1120.66(a) and reflected in 
its MMR under proposed Sec.  1120.44(a)(2). However, there may be 
instances in which a manufacturer uses different production processes 
or process controls when reprocessing or reworking tobacco product. If 
reprocessing or rework involves different production processes and 
controls, proposed Sec.  1120.78(a)(2) would require that reprocessing 
and rework procedures include these different production processes and 
controls. For example, if a manufacturer recovers tobacco product from 
a packing and labeling machine, determines that the product is 
nonconforming because it has incorrect labels, and decides to rework it 
using a manual relabeling process, the manufacturer would be required 
to include in its reworking procedures the production processes and 
controls for the manual relabeling process used to ensure that the 
subsequent reworked finished tobacco product conforms to the MMR 
specifications.
    Proposed Sec.  1120.78(b) would establish the requirement to 
maintain records of all activities required under this section. Under 
this proposed provision, records must include the date and time, 
individual performing the activity, type of activity performed, any 
information that demonstrates the requirement was met, and any data or 
calculations necessary to reconstruct the results. As stated elsewhere 
in this preamble, FDA interprets ``reconstruct'' to mean the ability to 
recreate the results by analyzing all data, including source and 
metadata data, and records, including calculations.
    Additionally, proposed Sec.  1120.78(b) would require that the 
production record of any finished or bulk tobacco product that includes 
reprocessed or reworked product include the amount, any unique 
identifier(s) assigned under proposed Sec.  1120.64(b), any batch 
number, and any manufacturing code associated with the reprocessed or 
reworked product. These requirements are necessary to enable the 
tobacco product manufacturer to trace tobacco products consisting of 
(in whole or in part) reprocessed or reworked material and take 
appropriate corrective action, such as a recall or changes to 
procedures, if these products are determined to be nonconforming 
following reprocessing or rework. Reprocessing or rework records would 
be required to be maintained in the tobacco product's production record 
to show that the product conforms to the MMR.

[[Page 15229]]

    The proposed reprocessing and rework requirements would assure that 
the public health is protected and that tobacco products are in 
compliance with chapter IX of the FD&C Act by helping to ensure that 
reprocessed or reworked tobacco products are not contaminated or 
adulterated or misbranded and meet the requirements in the MMR for the 
subsequently manufactured product. They would also help maintain 
traceability in case there is nonconformity as a result of ineffective 
reprocessing or reworking processes or procedures and corrective action 
is needed.

F. Packaging and Labeling Controls

1. Packaging and Labeling, and Repackaging and Relabeling, Controls
    Proposed Sec.  1120.92 would require finished and bulk tobacco 
product manufacturers to establish and maintain procedures to control 
packaging and labeling activities to prevent mixups and to ensure that 
all packaging and labeling are approved for use by the manufacturer and 
comply with all requirements of the MMR (see proposed Sec.  1120.44) as 
well as all other applicable requirements of the FD&C Act, CSTHEA, 
FCLAA and their implementing regulations. These proposed requirements 
are generally similar to the practices of manufacturing establishments 
that follow ISO 9001 and to the proposed packaging and labeling 
controls in the industry recommendations.
    Other applicable requirements of the FD&C Act, CSTHEA, FCLAA, and 
their implementing regulations include, among others: requirements 
related to false or misleading labeling of tobacco products under 
section 903(a)(1); requirements for including certain information on 
the label of tobacco products in package form under section 903(a)(2) 
of the FD&C Act; and package warning statement requirements for 
cigarettes under section 4 of FCLAA, for smokeless tobacco under 
section 3(a) of CSTHEA, for cigarette tobacco, RYO tobacco, and covered 
tobacco products other than cigars under Sec.  1143.3(a) (21 CFR 
1143.3(a)), and for cigars under Sec.  1143.5(a). This includes warning 
rotation plan requirements for packages pursuant to section 4(c)(1) of 
FCLAA, section 3(b)(3)(C) of CSTHEA and Sec.  1143.5(c). For example, 
under Sec.  1143.5, packaging for cigars is required to contain certain 
warning statements in accordance with an FDA-approved warning plan. 
Accordingly, under this proposed provision, finished cigar 
manufacturers would have to establish and maintain procedures to 
control packaging and labeling activities to ensure that the correct 
required warning statement is applied to the cigar package, that the 
formatting requirements are met, and that the warnings on the package 
label follow the approved warning plan (Sec.  1143.5). See also 
proposed Sec.  1120.98 for related requirements about warning plans.
    As set forth in proposed Sec.  1120.44(a)(3), the MMR would be 
required to include all packaging, labeling, and labels approved by the 
manufacturer for use with the finished or bulk tobacco product. The 
packaging and labeling control procedure requirement proposed in this 
section would ensure that only the approved packaging, labeling, and 
labels are used on finished and bulk tobacco products.
    A tobacco product manufacturer could control packaging and labeling 
operations to prevent mixups using a variety of techniques. For 
example, a manufacturer could release approved and accepted packaging 
and labeling for each production batch (i.e., a manufacturer could 
release the packaging and labeling in the same manner as it would 
release received components from a supplier that pass acceptance 
activities). Product acceptance could utilize verification activities, 
such as visual inspection and optical scanners, to inspect finished and 
bulk tobacco products to ensure the use of correct packaging and 
labeling, including correct package warning statements on finished 
products. Outdated or obsolete packaging and labeling should be 
destroyed.
    Proposed Sec.  1120.92(a)(1) would require that the packaging and 
labeling control procedures address label integrity. Specifically, this 
provision would require that labels be indelibly printed on or 
permanently affixed to finished and bulk tobacco product packages so 
they remain legible, prominent, and conspicuous during the customary 
conditions of processing, packing, storage, handling, distribution, and 
use. For a finished tobacco product, permanently affixed means the 
label must remain on the product package through the expected duration 
of use of the tobacco product by the consumer. For a bulk tobacco 
product, permanently affixed means the label must remain on the product 
package until the receipt by the subsequent manufacturer (e.g., 
finished tobacco product manufacturer, packager or labeler). These 
label integrity requirements are intended to ensure that labels remain 
affixed to the tobacco product, and that the information contained on 
the label remains visible and readable and is not adversely affected by 
conditions such as ink bleeding, adhesion loss, or fading.
    Proposed Sec.  1120.92(a)(2) establishes design and construction 
requirements for packaging and labeling and for storage and shipping 
cases and containers. Specifically, proposed Sec.  1120.92(a)(2)(i) 
would require that a manufacturer has procedures that ensure that a 
product's packaging and labeling do not contaminate or otherwise render 
the tobacco product adulterated or misbranded. To comply with this 
requirement, as part of its packaging and labeling procedures, a 
tobacco product manufacturer could evaluate the packaging materials to 
assess toxicological issues and verify that the material would not 
contaminate the tobacco product (Ref. 156). For example, packaging or 
label solvents such as benzene, toluene, methyl ethyl ketone, methyl 
cellosolve, and cellosolve are among the chemicals that can transfer 
from packaging materials to tobacco products and cause contamination 
(e.g., Refs. 157-159). This proposed provision is intended to ensure 
that, among other things, a product's packaging and labeling do not 
render the product adulterated due to the use of these types of 
chemicals.
    Proposed Sec.  1120.92(a)(2)(ii) would require that the 
manufacturer has procedures that ensure storage and shipping cases or 
containers of finished or bulk tobacco products are designed and 
constructed to protect against contamination and adulteration of 
finished and bulk tobacco products during the customary conditions of 
storage, handling, and distribution. For example, if tobacco products 
are customarily stored, handled, or shipped in conditions where the 
tobacco product can be exposed to oils, hazardous materials, or 
insanitary conditions, the storage and shipping cases or containers 
would have to be able to protect the products from becoming 
contaminated or adulterated. Also, if customary environmental 
conditions of storage, handling, and distribution (such as temperature, 
moisture, and humidity) can contaminate or adulterate the tobacco 
products (e.g., mold contamination), the storage and shipping cases or 
containers would have to protect the products from these conditions 
adequately.
    Proposed Sec.  1120.92(b) would require finished and bulk tobacco 
product manufacturers to maintain records of all activities required 
under this section. According to this provision, records must include 
the date and time, individual performing the activity, type of activity 
performed, any information that demonstrates the requirement was

[[Page 15230]]

met, and any data or calculations necessary to reconstruct the results.
    These proposed requirements would help assure that the public 
health is protected and that tobacco products are in compliance with 
chapter IX of the FD&C Act. Proper packaging and labeling of finished 
and bulk tobacco products are necessary to avoid mixups and to ensure 
that the packaging and labeling do not contaminate or otherwise render 
the tobacco product adulterated or misbranded. If a manufacturer 
applies the wrong label to a tobacco product, the label may be false or 
misleading, rendering the product misbranded under section 903(a)(1) of 
the FD&C Act. Such a product could impact public health. For example, 
in the case of a mixup, if a manufacturer applies the wrong nicotine 
concentration label to an e-liquid such that the product contains 
significantly higher levels of nicotine than what is stated on the 
label, this can increase the risk of addictiveness.
    Proper packaging and labeling of tobacco products play an important 
role in FDA's comprehensive public health approach to tobacco control. 
The Tobacco Control Act contains a number of provisions related to the 
packaging and labeling of tobacco products. For example, certain 
tobacco product labeling must be submitted to FDA when tobacco 
manufacturers register under section 905(i)(1) of the FD&C Act. 
Specimens of tobacco product labeling must also be submitted with PMTAs 
under section 910(b)(1)(F) of the FD&C Act. Similarly, sample product 
labels and labeling must be included in MRTP applications under section 
911(d)(4) of the FD&C Act. Additionally, section 903(a)(1) of the FD&C 
Act includes provisions related to false or misleading labeling of 
tobacco products, such as, for example, labeling that fails to bear 
required health warning statements (see section 201(n) of the FD&C 
Act). In addition, FDA's Deeming Rule requires warning statements on 
the packages of all covered tobacco products, cigarette tobacco, and 
RYO tobacco, with limited exceptions (see part 1143). The packaging and 
labeling of tobacco products contain required warning statements that 
promote greater understanding of the risks associated with the use of 
tobacco products (Ref. 160). For a discussion regarding why health 
warnings are appropriate for the protection of the public health and 
the effectiveness of warning statements, please see the analysis in the 
proposed Deeming Rule (79 FR 23142 at 23163-65). Requiring that tobacco 
product manufacturers establish and maintain procedures to control 
packaging and labeling activities would help to ensure that the 
manufacturers successfully carry out the labeling requirements in the 
Tobacco Control Act.
    Proposed Sec.  1120.94(a) would require finished tobacco product 
manufacturers to establish and maintain procedures to control 
repackaging and relabeling activities. These procedures would be 
required to address all requirements described in proposed Sec.  
1120.92. The terms ``repackaging'' and ``relabeling'' describe 
activities in which the package or label of a finished tobacco product 
is subsequently changed or replaced. Repackaging and relabeling may be 
performed by the same person who originally packaged and labeled the 
product or by someone other than the original packager/labeler. For 
example, if a manufacturer receives returned tobacco products and 
determines that the products could be distributed with new packages or 
labels, the manufacturer would have to comply with this provision, 
among others. In addition, this proposed provision would apply to an 
importer that changes or replaces the packages or labels of imported 
finished tobacco products. These proposed requirements are generally 
similar to the practices of manufacturing establishments that follow 
ISO 9001, and to the proposed repackaging and relabeling provision in 
the industry recommendations.
    Proposed Sec.  1120.94(b) would require finished tobacco product 
manufacturers to maintain records of all activities required under this 
section. According to this provision, records must include the date and 
time, the individual performing the activity, the type of activity 
performed, any information that demonstrates the requirement was met, 
and any data or calculations necessary to reconstruct the results.
    Like the proposed packaging and labeling control requirements 
(discussed in the preceding section), these proposed requirements would 
help assure that the public health is protected and that tobacco 
products are in compliance with the requirements of chapter IX of the 
FD&C Act. If a manufacturer applies the wrong label to the tobacco 
product, the product may be misbranded under section 903. In addition, 
if a finished tobacco product manufacturer recalls a product because 
the product was distributed with the wrong label, and determines that 
rework of that product is possible through repackaging or relabeling, 
the proposed requirements would help ensure that the reworked tobacco 
product conforms to the established specifications and other applicable 
requirements.
    Proper packaging and labeling of tobacco products play an important 
role in FDA's comprehensive public health approach to tobacco control. 
The Tobacco Control Act contains a number of provisions related to the 
packaging and labeling of tobacco products (e.g., sections 905(i)(1), 
910(b)(1)(F), and 911(d)(4) of the FD&C Act), including provisions 
related to false or misleading labeling (section 903(a)(1) of the FD&C 
Act), such as labeling that fails to bear required health warning 
statements (see section 201(n) of the FD&C Act). For a discussion 
regarding why health warnings are appropriate for the protection of the 
public health and the effectiveness of warning statements, please see 
the analysis in the proposed Deeming Rule (79 FR 23142 at 23162). 
Requiring that tobacco product manufacturers establish and maintain 
procedures for repackaging and relabeling activities would help to 
ensure that the manufacturers successfully carry out the labeling 
requirements in the Tobacco Control Act.
2. Manufacturing Code
    Proposed Sec.  1120.96(a) would require that each finished and bulk 
tobacco product manufacturer apply a manufacturing code to the 
packaging or label of all finished and bulk tobacco products. These 
proposed requirements are generally similar to the practices of 
manufacturing establishments that follow ISO 9001 and practices that 
FDA has observed during establishment inspections, as well as to the 
proposed requirements of the industry recommendations.
    For a finished tobacco product, the manufacturing code would need 
to be applied in a manner that assures it would remain on the packaging 
or label through the expected duration of a consumer's use of the 
tobacco product. For a bulk tobacco product, the manufacturing code 
would need to be applied in a manner that assures it would remain on 
the packaging or label until receipt by the subsequent tobacco product 
manufacturer.
    For example, under this proposed provision, a finished cigarette 
manufacturer, who sells individual packs of cigarettes as well as 
cartons of cigarettes, would be required to apply a manufacturing code 
to each carton and to each pack of cigarettes. Similarly, a smokeless 
manufacturer who sells individual cans of smokeless tobacco as well as 
multiple cans packaged together in a plastic sleeve would need to apply 
a manufacturing code to the sleeve and to each individual can. Some 
cigarette manufacturers already apply similar

[[Page 15231]]

codes on cartons of cigarettes, and some smokeless tobacco product 
manufacturers apply similar codes on the plastic sleeve that holds 
individual and multiple cans of smokeless tobacco. Since the carton and 
the sleeve are typically discarded by the consumer during use, this 
section also would require that the manufacturing code be applied on 
the individual cigarette pack and smokeless can. FDA has observed on 
inspections that many manufacturers apply a code to the packaging, 
labeling, or shipping containers of finished tobacco products, which 
may be discarded prior to a consumer's use or immediately upon opening 
by the consumer, but FDA believes this practice is not sufficient. 
Under the proposed provisions, if a user stores the tobacco product and 
then later experiences an injury or illness due to a hazard or 
contaminant, or has another health-related problem, the user would be 
able to notify the manufacturer of the affected product using the 
product's manufacturing code, even if the packaging sleeve has been 
discarded.
    Proposed Sec.  1120.96(b) would require that the manufacturing code 
for each finished and bulk tobacco product be permanently affixed, 
legible, conspicuous, and prominent. The code should be easily visible, 
and it should not be obscured or be able to be mutilated or removed in 
whole or in part. For example, a manufacturing code that is partially 
smudged and cannot be read in its entirety would not meet the proposed 
requirement. This proposed requirement would allow for ready 
identification of the manufacturing code during distribution and sale. 
It also would help FDA to identify and trace nonconforming or violative 
tobacco products and perform relevant inspections to determine the 
scope of the problem and recommend or require appropriate corrective 
action such as a recall or stock recovery.
    Proposed Sec.  1120.96(c) would require that the manufacturing code 
contain the following information listed in the following order: (1) 
the manufacturing date in two-digit numerical values in the month-day-
year format (MMDDYY), and (2) the finished or bulk tobacco product 
batch number. FDA proposes to require the manufacturing code to include 
the batch number because the batch number is the common identifier for 
the product in the production and distribution records. Because the 
batch number would be documented in the production record (see proposed 
Sec.  1120.70) and the production record would include all the relevant 
manufacturing information for the batch (e.g., unique identifiers of 
incoming components, acceptance activities results, identification of 
major equipment and processing lines used in the manufacturing of the 
batch), the manufacturing code on the product package or label would 
establish a link to the manufacturing history of the product and, as 
discussed in proposed Sec.  1120.104, to certain records of 
distribution.
    The proposed manufacturing code requirement would help assure that 
the public health is protected by providing for tobacco product 
traceability. The manufacturing code would enable tobacco product 
manufacturers to determine the manufacturing and distribution history 
of finished and bulk tobacco products. If a product user becomes ill or 
injured due to a hazard or contaminant, or otherwise has a tobacco-
related health problem, the user would be able to notify the 
manufacturer of the affected product using the product's manufacturing 
code. The manufacturer could use this information to review the 
production record as part of a complaint, nonconforming product, or 
CAPA investigation to determine the scope and cause of the issue. In 
addition, the manufacturing code would help the manufacturer determine 
the distribution history of the affected tobacco product if it needs to 
take a corrective action, such as a recall or stock recovery.
    In addition, the proposed requirement would help assure that 
tobacco products are in compliance with the requirements of chapter IX 
of the FD&C Act. If adulterated or misbranded products have been 
manufactured and distributed, the Agency can identify affected batches 
and take appropriate actions. For example, the manufacturing code would 
help FDA effectuate an order under section 908(a) of the FD&C Act to 
provide notification about tobacco products that present an 
unreasonable risk of substantial harm to the public health in order to 
eliminate such risk. This information would also help to effectuate an 
order under section 908(c) to recall tobacco products, where FDA finds 
that there is a reasonable probability that the tobacco product 
contains a manufacturing or other problem not ordinarily contained in 
tobacco products on the market that would cause serious, adverse health 
consequences or death. In addition, if FDA tests tobacco products at 
retail locations and determines that the products are adulterated or 
misbranded, it would be able to use the manufacturing code to conduct 
relevant inspections or investigations (e.g., review production and 
distribution records) to determine the scope and cause of the issue and 
take appropriate action.
3. Warning Plans
    Proposed Sec.  1120.98(a) would require each finished tobacco 
product manufacturer that is required to comply with a warning plan for 
tobacco product packaging (under the FD&C Act, FCLAA, CSTHEA, or their 
implementing regulations) to establish and maintain procedures to 
implement the requirements of such warning plan. For example, under 
Sec.  1143.5(c), certain cigar packages must bear warning statements 
that are randomly displayed in each 12-month period, in as equal a 
number of times as is possible on each brand of cigar, and randomly 
distributed in all areas of the United States in which the product is 
marketed in accordance with a plan submitted by the cigar manufacturer, 
importer, distributor, or retailer to, and approved by, FDA. Proposed 
Sec.  1120.98(a) would require cigar manufacturers that are required to 
comply with an FDA-approved plan under Sec.  1143.5(c) to establish and 
maintain procedures to ensure that such a plan is implemented and 
followed. Similarly, finished cigarette and smokeless tobacco product 
manufacturers would have to establish and maintain procedures to ensure 
that warning plans for cigarette and smokeless tobacco product 
packaging required under FCLAA and CSTHEA are implemented and followed.
    Under section 903(a)(1) of the FD&C Act, a tobacco product is 
deemed to be misbranded if its labeling is false or misleading in any 
particular. This could include, for example, a case in which a 
manufacturer includes the same single warning on all product packages, 
when there is a requirement to rotate a number of different warnings 
(see section 201(n) of the FD&C Act). This provision would help the 
Agency to ensure that tobacco product packaging displays all applicable 
required health warning statements. FDA has observed that some 
manufacturers do engage in activities that address warning plans but we 
have also found, during inspections, that some manufacturers do not 
have proper procedures in place at the manufacturing facility to ensure 
the warning statements are randomly displayed in each 12-month period, 
in as equal a number of times as is possible on each brand of product, 
and randomly distributed in all areas of the United States in which the 
product is marketed (e.g., Refs. 55 and 161) (see 15 U.S.C. 4402).
    Manufacturers could adopt a number of practices to comply with 
applicable warning plans. For example,

[[Page 15232]]

manufacturers could order labels on which the warnings are printed in 
sequence on the label rolls such that, for a given production run, each 
of the warnings is applied equally. Alternatively, manufacturers could 
use multiple label rolls that contain one of the required warning 
labels and have a supervisor tasked with calculating and documenting 
when to switch the roll to ensure that the required warning labels are 
equally applied in a batch. Further, manufacturers could establish 
procedures that define the specific number of each of the required 
warning statements needed for printing or affixing to the label of each 
brand of product during the manufacturing process and outline 
procedures for shipment of the products to ensure random distribution. 
Such practices could be included in the procedures required in this 
proposed provision.
    Under proposed Sec.  1120.98(a), the warning plan procedures would 
be required to include the inspection of the packaging before 
distribution to ensure that finished tobacco product labels bear the 
required warning statements in accordance with the warning plan. For 
example, FDA is aware that some manufacturers use visual inspection or 
electronic optical scanners to perform inspection of packaging and 
labeling to confirm that the correct warning statements have been 
applied.
    Proposed Sec.  1120.98(b) would require finished tobacco product 
manufacturers that are required to comply with a warning plan for 
tobacco product packaging (under the FD&C Act, FCLAA, CSTHEA, or their 
implementing regulations) to maintain records that demonstrate that 
they are in compliance with the warning plan. For example, if the 
manufacturer must comply with a cigar warning plan under Sec.  1143.5, 
this provision would require the manufacturer to maintain records that 
demonstrate that the required warning statements are randomly displayed 
in each 12-month period, in as equal number of times as possible on 
each brand of cigar packaging. Such records also would need to 
demonstrate that the required warning statements on packaging are 
randomly distributed in all areas of the United States in which the 
cigar is marketed. Records required under this proposed provision could 
include a copy of the relevant FDA approved warning plan, copies of the 
product labels maintained in the production records (see proposed Sec.  
1120.70(b)(6)), distribution records maintained under proposed Sec.  
1120.104(b), and any additional records demonstrating compliance with 
any requirements for random distribution and random and equal display.
    The Agency has observed that many tobacco product manufacturers 
have adopted a number of different practices that would meet the 
requirements in proposed Sec.  1120.98(b). For example, FDA is aware 
that some smokeless tobacco manufacturers keep records from audits or 
an accounting of each of the four required warning statements that are 
ordered for and applied to smokeless tobacco product packaging to 
confirm that over a 12-month period, each of the four required warning 
statements are randomly displayed, in as equal a number of times as is 
possible for each brand of product. FDA is aware that other 
manufacturers have used a quality audit, to verify the production of 
required warning statements on packaging within a 12-month period (Ref. 
162). Other manufacturers document in their production, inventory, or 
shipment records the specific warning statements that have been used or 
applied to packaging, and demonstrate through distribution records that 
the required warning statements have been randomly distributed.
    The industry GMP recommendations do not call for warning plans. The 
Agency believes that the proposed requirements would help assure that 
the public health is protected. This provision would help ensure that 
manufacturers who produce finished tobacco products that are subject to 
a warning plan establish and maintain packaging procedures to ensure 
compliance with applicable laws and regulations to warn users of known 
health risks. The World Health Organization (WHO)'s Framework 
Convention on Tobacco Control (FCTC), an evidence-based treaty, 
provides a regulatory strategy for health warnings on packaging and 
labeling (Ref. 163), for addressing the serious negative impacts of 
tobacco products, calls for rotating health warnings to ensure that 
they do not become stale (Ref. 164). Salient warnings would be more 
visible to consumers, informing them of the consequences associated 
with use of tobacco products. Accordingly, this provision would help 
assure that the public health goals of the warning label requirements 
are met.
    These proposed requirements also would help assure that tobacco 
products are in compliance with chapter IX of the FD&C Act. Under 
section 903(a)(1) of the FD&C Act, a tobacco product is deemed to be 
misbranded if its labeling is false or misleading in any particular. 
This could include, for example, a case in which a manufacturer 
includes the same single warning on all product packages, when there is 
a requirement to rotate a number of different warnings (see section 
201(n) of the FD&C Act). By ensuring that tobacco product manufacturers 
establish and maintain packaging procedures that address required 
warning plans, the proposed provision would help ensure that tobacco 
products are not misbranded.

G. Handling, Storage, and Distribution

1. Handling and Storage
    Proposed Sec.  1120.102 would require finished and bulk tobacco 
product manufacturers to establish and maintain procedures to ensure 
that tobacco products are handled and stored under appropriate 
conditions to prevent nonconforming products as well as mixups, 
deterioration, contamination, adulteration, and misbranding of tobacco 
products. These proposed requirements are generally similar to the 
practices of manufacturing establishments that follow ISO 9001, the 
proposed handling and storage provision in the industry 
recommendations, and controls that are already being implemented by the 
tobacco industry, as observed by FDA during inspections.
    Handling and storage procedures under proposed Sec.  1120.102 could 
include, for example, establishing storage conditions to control 
temperature and humidity to prevent mold growth, and adopting certain 
product segregation practices to prevent mixups. If a manufacturer 
restricts access to designated storage areas through the use of keys, 
bar code readers, or other means, the procedures should detail, among 
other things, who is permitted access and what steps should be followed 
prior to handling. Such procedures are intended to prevent mixups or 
the use of unsuitable materials in manufacturing.
    These proposed requirements would apply to all stages of handling 
and storage in which a manufacturer is involved, including handling and 
storage as part of the production process. The handling and storage 
procedures should complement other procedures required under this 
proposed rule, such as, for example, the procedures required in 
proposed Subpart C--Buildings, Facilities, and Equipment.
    The proposed handling and storage requirements are intended, in 
part, to prevent deterioration of the tobacco product after it has 
undergone product acceptance activities and has been approved for 
release into distribution. For example, the tobacco-specific

[[Page 15233]]

nitrosamines (TSNAs) 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone 
(NNK) and N-nitrosonornicotine (NNN) are formed from tobacco alkaloids 
and nitrosating agents, such as nitrite (Ref. 165). These TSNAs are 
potent carcinogenic agents found in smokeless tobacco products (82 FR 
8004, January 23, 2017). The concentration of NNK and NNN may increase 
in smokeless tobacco when stored at room temperature due to microbial 
action (Refs. 56 and 166). Additionally, high storage temperature of 
cured tobacco has been shown to contribute to TSNA formation (Ref. 
167). However, controls exist that can limit the formation of TSNA, 
including refrigeration of the tobacco products during storage (Ref. 
165). If such handling and storage conditions are necessary to ensure 
that a finished or bulk tobacco product remains within its NNN or NNK 
specification, this provision would require a manufacturer to establish 
and maintain procedures for such handling and storage controls.
    The proposed handling and storage requirements are also intended to 
prevent contamination. For example, in storage, the environment's 
moisture content and relative humidity can support mold growth and 
aflatoxin production by aflatoxigenic molds (Refs. 168 and 169). 
Manufacturers can decrease the likelihood of mold contamination in 
tobacco products by controlling the temperature and humidity during 
storage. Additionally, FDA is aware that tobacco products in many 
countries contain numerous contaminant by-products attributed to 
storage practices (Ref. 165). These storage practices can introduce 
NTRMs, including manufacturing materials, pesticides, cleaning 
compounds, microorganisms, and animal or insect excrement or parts into 
the tobacco product (Refs. 6 and 170). A tobacco product can also 
become contaminated if it is stored close to highly aromatic liquids or 
materials, such as kerosene, oils, grease, and paraffin (Ref. 171). The 
proposed requirements in this section are intended to ensure that 
tobacco product manufacturers adopt handling and storage practices that 
prevent such contamination.
    The proposed handling and storage requirements are also intended to 
protect against problems that could occur from product or ingredient 
mixups. For example, if the manufacturer does not implement these 
handling and storage requirements and ingredients are mishandled during 
the manufacturing process without detection, a label might not 
accurately reflect the content of ingredients of the product.
    The Agency believes that the proposed handling and storage 
requirements would help assure that the public health is protected and 
that tobacco products are in compliance with the requirements of 
chapter IX of the FD&C Act. Establishing and maintaining procedures for 
handling and storage is an important step in preventing nonconforming 
products and mixups, contamination, deterioration, adulteration, and 
misbranding.
2. Distribution
    Proposed Sec.  1120.104 would require finished and bulk tobacco 
product manufacturers to establish and maintain procedures related to 
the distribution of finished and bulk tobacco products. These proposed 
requirements would apply only to tobacco product distribution within 
the manufacturer's control (i.e., to the initial consignee and direct 
account). These proposed requirements are generally similar to the 
practices of manufacturing establishments that follow ISO 9001, the 
distribution provision in the industry recommendations, and practices 
that are already being implemented by the tobacco industry, as observed 
by FDA during inspections.
    Specifically, proposed Sec.  1120.104(a)(1) would require finished 
and bulk tobacco product manufacturers to establish and maintain 
distribution procedures to ensure that finished and bulk tobacco 
products are distributed to the initial consignee under appropriate 
conditions to prevent nonconforming product as well as mixups, 
deterioration, contamination, adulteration, and misbranding of tobacco 
products. FDA intends for this provision to provide manufacturers 
flexibility in determining what conditions are appropriate for 
protecting their tobacco products against mixups, deterioration, 
contamination, adulteration, or misbranding. For example, a tobacco 
product manufacturer could seek to ensure that distribution conditions 
are appropriate by inspecting the integrity of shipping containers to 
make sure that there are no problematic conditions such as holes or 
gaps, checking the cleanliness and environmental conditions of 
transport containers, and making sure that there are no conditions that 
can attract insects and rodents. Additionally, a tobacco product 
manufacturer could establish distribution requirements to prohibit the 
distribution of finished and bulk tobacco products in transport 
containers that ship agricultural products, such as livestock and 
manure remnants in the form of organic fertilizer, to prevent tobacco 
products from becoming contaminated with bacteria such as E. coli and 
fecal coliform (Ref. 172). A manufacturer could also establish shipping 
procedures that require inspection of the shipping conditions to 
prevent the shipment of tobacco product in circumstances where they may 
become contaminated by toxic or hazardous substances. For example, 
shipping procedures could address circumstances similar to a reported 
situation where a shipment of cigarettes was contaminated with ant and 
roach spray (Ref. 148).
    Proposed Sec.  1120.104(a)(2) would require finished and bulk 
tobacco product manufacturers to establish and maintain distribution 
procedures to ensure that only those finished and bulk tobacco products 
approved for release are distributed. (See proposed Sec.  1120.70 for 
the proposed requirement for review and approval of the production 
record for release of each batch of finished and bulk tobacco product 
for distribution.) This requirement is intended to prevent the release 
of nonconforming product or products that have not undergone applicable 
product acceptance activities. Tobacco product manufacturers would have 
the flexibility to determine the appropriate procedures and practices 
to control the distribution of their tobacco products. For example, FDA 
has observed on inspections that tobacco product manufacturers have 
used printed or electronically scannable labels, tags, and signs to 
ensure that only tobacco products that have been approved for release 
may be distributed.
    Proposed Sec.  1120.104(b) would require finished and bulk tobacco 
product manufacturers to maintain distribution records. According to 
this paragraph, the distribution records would be required to include 
the name and address of the initial consignee, the identification and 
quantity of finished or bulk tobacco products shipped, date of 
shipment, and the manufacturing code(s) of the tobacco products. The 
meaning of ``consignee'' in this context would be the person to whom 
the tobacco product is delivered, which is consistent with the use of 
consignee in other Agency distribution recordkeeping requirements 
(e.g., Sec.  820.160). The initial consignee is the first person to 
whom the manufacturer (or any person(s) acting on behalf of the 
manufacturer) delivers the tobacco products. The initial consignee can 
be a warehouse, wholesaler, distributor, or retailer, who is a customer 
of the manufacturer. However, the requirement would not include

[[Page 15234]]

individual purchasers of tobacco products for personal consumption. 
This basic information is needed to identify where tobacco products 
have been initially distributed in order, for example, to facilitate a 
corrective action such as a recall or stock recovery.
    Proposed Sec.  1120.104(c) would require finished and bulk tobacco 
product manufacturers to maintain a list of direct accounts. For 
purposes of this rule, ``direct accounts'' means all persons who are 
customers of the tobacco product manufacturer that receive finished or 
bulk tobacco products directly from the tobacco product manufacturer or 
from any person under control of the manufacturer. Direct accounts may 
include wholesalers, distributors, and retailers. Direct accounts do 
not include individual purchasers of tobacco products for personal 
consumption.
    The list of direct accounts would be required to contain the name, 
address, and contact information of each entity. This list is different 
from the distribution record, which only lists the individual initial 
consignee associated with a particular shipment. The list of direct 
account information is necessary, for example, to facilitate 
investigations of nonconforming product. In addition, this information 
would assist in tracing finished or bulk tobacco products to all 
persons to whom the tobacco product manufacturer has distributed or 
sold products. This requirement would be consistent with 21 CFR part 7 
provisions regarding voluntary recalls initiated by manufacturers.
    The proposed distribution requirements would help assure that the 
public health is protected by requiring finished and bulk tobacco 
products to be distributed under appropriate conditions to prevent 
nonconforming tobacco products as well as mixups, deterioration, 
contamination, adulteration and misbranding of tobacco products. A 
finished or bulk tobacco product may deteriorate or be adversely 
affected by distribution conditions (e.g., environmental transport 
conditions).
    The proposed requirements also would help assure that tobacco 
products are in compliance with the requirements of chapter IX of the 
FD&C Act by helping to establish traceability of finished and bulk 
tobacco products. Tracing finished and bulk tobacco products would 
enable tobacco product manufacturers and FDA to identify where tobacco 
products that do not meet the requirements of the FD&C Act have been 
distributed and sold. This information would facilitate notification of 
consignees and persons in the distribution chain in order to 
efficiently conduct a product recall under section 908 of the FD&C Act, 
if necessary. The scope of a product recall would likely be much 
broader than necessary if records of product distribution were not 
available to pinpoint distribution, thus potentially decreasing a 
recall's effectiveness and increasing cost to the tobacco product 
manufacturer.
    The proposed requirements also, in conjunction with the proposed 
unique identifier, production record, and manufacturing code 
requirements, would help enable FDA to assure the integrity of the 
supply chain from suppliers to finished or bulk tobacco product 
manufacturers as well as from finished or bulk tobacco product 
manufacturers to the initial consignees.

H. Recordkeeping and Document Controls

    Proposed Sec.  1120.122 would establish recordkeeping and document 
control requirements.
    For purposes of this proposed part 1120, documents generally refer 
to written (paper or electronic) procedures, forms, work instructions, 
etc., such as the procedures that a finished or bulk tobacco product 
manufacturer establishes and maintains to address a TPMP requirement. 
For example, a tobacco product complaint procedure and complaint form 
template that is established under proposed Sec.  1120.14 are 
considered to be documents. For purposes of this proposed part 1120, 
records generally refer to the written (paper or electronic) output 
from activities undertaken to implement the documents. For example, 
records include written results of complaint and nonconforming product 
investigations, and laboratory testing activities. We note that this 
use of the term ``record'' is specific to proposed part 1120 and does 
not affect how that term is applied in other contexts.
    All documents and records required under the proposed rule would be 
required to meet certain requirements under proposed Sec.  1120.122(a). 
We are proposing additional requirements for records under proposed 
Sec.  1120.122(b) and for documents under proposed Sec.  1120.122(c). 
FDA notes that if a tobacco product manufacturer establishes and 
maintains documents and records required under proposed part 1120 in an 
electronic format, then they are subject to the requirements of 21 CFR 
part 11.
    Specifically, proposed Sec.  1120.122(a) would establish general 
requirements that apply to all documents and records required under 
proposed part 1120. Proposed Sec.  1120.122(a)(1) would require that 
documents and records required under proposed part 1120 be written in 
English, or an accurate English translation must be made available upon 
request. Documents and records (including any associated source data) 
could be maintained in the native language of a foreign tobacco product 
manufacturer as long as a translation is made available upon request. 
FDA expects that a manufacturer would fulfill requests for documents or 
records translations promptly to ensure that there are no delays of 
inspections or investigations. The accuracy of the English translation 
could be demonstrated by, for example, providing a certification of the 
translation, using a certified translator, or providing information on 
the competency of the translator.
    Proposed Sec.  1120.122(a)(2) would require that all documents and 
records required by proposed part 1120, that are associated with a 
batch of finished or bulk tobacco product, must be retained for a 
period of not less than 4 years from the date of distribution of the 
batch or until the product reaches its expiration date if one exists, 
whichever is later. Examples of such records include purchasing, 
acceptance, production, laboratory testing, warning plans, and 
distribution records. FDA has selected 4 years as a means to help 
assure that the records would be available for at least one biennial 
FDA inspection under sections 704 (21 U.S.C. 374) and 905(g) of the 
FD&C Act.
    Documents and records that would be required by proposed part 1120, 
that are not associated with a batch of finished or bulk, would be 
required to be retained for a period of not less than 4 years from the 
date they were last in effect. Examples of these documents and records 
include training, calibration, and pest control procedures and records 
required under proposed Sec. Sec.  1120.12 (Organization and 
personnel), 1120.36 (Equipment) and 1120.34 (Buildings, facilities, and 
grounds), respectively.
    Proposed Sec.  1120.122(a)(3) would require that all documents and 
records required under proposed part 1120 be maintained at the 
manufacturing establishment or another location that is readily 
accessible to responsible officials of the tobacco product manufacturer 
and to FDA. FDA interprets ``readily accessible'' to FDA as the 
documents and records being made available to FDA upon request within 
the course of an inspection. Documents and records, regardless of 
location, would be considered readily accessible to FDA if the tobacco 
product manufacturer can respond to an FDA investigator's request 
promptly and

[[Page 15235]]

without delaying the inspection or investigation.
    The requirement to maintain documents and records at the 
manufacturing establishment or other locations that are readily 
accessible to responsible officials of the tobacco product manufacturer 
is intended to enable the manufacturer to exercise control over the 
documents and records, which will help ensure accountability. FDA would 
consider ``responsible officials'' to include management with executive 
responsibility. The proposed requirement also would help ensure that 
the responsible officials at the manufacturing establishment have ready 
access to those documents and records that are essential for performing 
required activities and making critical decisions.
    This provision would require that the documents and records 
required to be maintained, including those not stored at the 
establishment, be made readily accessible during the 4-year retention 
period to FDA for inspection and photocopying or other means of 
reproduction. Documents and records required under this part may be 
retained either as originals or as true copies such as photocopies, 
microfilm, microfiche or other reproductions which preserve the content 
and meaning of the data, including associated metadata and audit 
trails. Where reduction techniques are used, suitable reader, computer, 
and copying equipment should be readily accessible to FDA during an 
inspection. Documents and records that can be immediately retrieved 
from another location as originals or true copies, including by 
computer or other electronic means, would meet the requirements of this 
paragraph.
    Proposed Sec.  1120.122(b) would establish additional requirements 
that apply to all records required under proposed part 1120. 
Specifically, proposed Sec.  1120.122(b) would require that all 
records, regardless of storage medium, must be attributable, legible, 
contemporaneously recorded, original, and accurate (ALCOA). The ALCOA 
requirements of proposed Sec.  1120.122(b) are basic principles that 
describe minimum standards for how records should be collected and 
maintained in order to protect the integrity of the data they preserve. 
For purposes of this requirement, records include all records required 
to be maintained under proposed part 1120, such as, for example, 
written results from inspections, tests, other verification activities. 
These ALCOA requirements would apply to all records regardless of 
format or storage media, including paper-based and electronic records. 
For example, laboratory test records would be required to include all 
relevant raw data, graphs, and charts. This provision is intended to 
ensure the data integrity of information generated to demonstrate 
compliance with the proposed TPMP rule.
    The ALCOA requirements are defined under proposed Sec.  
1120.122(b)(2) and further explained as follows:
     Attributable means that the data in a record is traceable 
to its source. This means it should be attributable to the originator 
of the data, whether that source is an individual, an automated piece 
of equipment, or individual operating equipment. For example, if an 
ENDS manufacturer conducts an acceptance test of e-liquid, using gas 
chromatography-mass spectrometry, to determine its nicotine 
concentration, the record would have to identify the gas 
chromatography-mass spectrometry equipment used and the personnel who 
performed the test and state the result. This applies to any changes, 
corrections, deletions, or revisions to a record.
     Legible means the record is permanently recorded in a 
readable format. A legible record prevents loss and preserves 
traceability of changes without obscuring the original entry or 
subsequent additions or deletions. For example, if test information is 
recorded on a laboratory notebook or form, it would have to be recorded 
in ink. If any changes are made, the original entry would have to be 
struck out to preserve the first capture of the data and initialed and 
dated for traceability. Electronic data that are first stored in 
temporary memory before creating a permanent record would not comply 
with the proposed requirement, because the process would fail to save 
the first capture of the data and would not preserve the traceability 
of changes. Practices like this, that allow data manipulation prior to 
transfer to the permanent record, compromise the data integrity of the 
record and would not comply with this requirement.
     Contemporaneously recorded means that data is recorded at 
the time the procedure, assessment, observation, or other activity is 
performed.
     Original means the record reflects the first capture of 
the data and all information related to all subsequent changes required 
to fully reconstruct the TPMP activities. An original record preserves 
the record content and the meaning of the data, including associated 
metadata. Original records may be static or dynamic. A static record, 
such as a paper record, is fixed and allows little or no interaction 
between the user and record content. Records in a dynamic state allow 
the user to interact with the information. For example, electronic 
records in database formats that allow the user to track, trend, and 
query data are examples of records in a dynamic state. This provision 
would require that information that is first captured in a dynamic 
state remain available in that state.
     Accurate means that the data in a record is correct, 
truthful, complete, valid, and reliable. All records required under 
this part, including the associated data and metadata, must be 
accurate. Depending on the manufacturing process and record systems 
used, data may be captured manually by human observation or automated 
electronic equipment (e.g., an electronic manufacturing system, 
records, or laboratory system). If errors occur, they should be 
specifically noted. Accurate also would require that there are no 
changes or edits to the recorded data without documented amendments. 
Electronic data that are first stored in temporary memory before 
creating a permanent record would not comply with the proposed 
requirement because such practice allows for data manipulation prior to 
recording, thus compromising the data integrity.
    In order to comply with proposed Sec.  1120.122(b) and other 
requirements of this proposed rule, finished and bulk tobacco 
manufacturers would need to preserve the metadata associated with TPMP 
records. Metadata are the contextual information required to understand 
the data. For example, without metadata the number ``20'' is 
meaningless. With additional context such as the unit of measure (e.g., 
20 mg nicotine/cigarette), the value 20 is given meaning. Metadata are 
structured information that describes, explains, or otherwise makes it 
easier to retrieve, use, or manage data. Metadata include the unit of 
measure, date/time stamp for when the data were acquired, 
identification of the person who conducted the test or analysis that 
generated the data, and identification of the equipment used to capture 
the data. Specific pieces of metadata may be required by other subparts 
of this proposed rule.
    Finished and bulk tobacco product manufacturers also may find that 
audit trails assist them in demonstrating that information or data in a 
record complies with the proposed recordkeeping requirements. An audit 
trail is a form of metadata that contains information associated with 
actions related to the creation, modification, or deletion of a TPMP 
record. An audit trail is a chronology of the ``who, what, when, and 
why'' of a record. For a paper

[[Page 15236]]

record, the audit trail of a change would be recorded via a single line 
cross-out that allows the original entry to remain legible and includes 
the initials of the person making the change, the date of the change, 
and the reason for the change. The audit trail for a paper record 
should be contained within the four corners of the record. For 
electronic records, an audit trail is a secure, computer-generated, 
time-stamped electronic file that that allows for reconstruction of the 
course of events relating to the creation, modification, or deletion of 
a record.
    Finished and bulk tobacco product manufacturers may comply with the 
proposed requirement of Sec.  1120.122(b) that records be ``original'' 
by maintaining original records or true copies of those records through 
the records retention period. A true copy, like the original record, 
would preserve the record content and meaning of the data, including 
associated metadata and any audit trails. A true copy may only be 
retained in lieu of the original if it preserves the static or dynamic 
state of the original and if the copy has been compared to the original 
and verified to contain the entire content and meaning of the original 
record, including all metadata and any audit trails. Consistent with 
the cGMP requirements for other FDA-regulated products, true copies may 
be photocopies, pictures, scanned copies, microfilm, microfiche, 
electronic records, or other equivalent reproductions depending on form 
and content of the original record.
    The extent of what would need to be included in a true copy is 
dependent on the original record. For example, when an individual 
writes a contemporaneous observation in a notebook or on a worksheet or 
scrap of paper, this is the first capture of data; this piece of paper 
would need to be retained unless a true copy is created. If a true copy 
is made, it must capture any written notes, strikeouts, erasure marks, 
and all other alterations to the original record.
    Proposed Sec.  1120.122(c) would require tobacco product 
manufacturers to establish and maintain procedures to control all 
documents established to meet requirements under proposed part 1120. 
For the purposes of proposed part 1120, documents generally refer to 
written procedures (such as standard operating procedures), work 
instructions, and blank forms, such as the procedures that a finished 
and or bulk tobacco product manufacturer establishes and maintains to 
address a TPMP requirement. However, completed forms and testing 
results generated when implementing activities under proposed part 1120 
are considered records and therefore would not be subject to Sec.  
1120.122(c). For example, a pH acceptance testing procedure and blank 
form to record the pH test result are documents that would be subject 
to the general requirements under Sec.  1120.122(a) and to the document 
controls under proposed Sec.  1120.122(c). When pH testing is performed 
according to the testing procedure and the results are recorded on the 
form, this creates a record subject to the requirements under proposed 
Sec.  1120.122(a) and (b). Similarly, a complaint procedure and a 
complaint record template established to comply with proposed Sec.  
1120.14 are documents and would need to comply with the proposed 
requirements in Sec.  1120.122(a) and (c); the record maintained for a 
specific complaint event would be required to comply with the proposed 
requirements in Sec.  1120.122(a) and (b), but it would not be required 
to comply with the proposed requirements in Sec.  1120.122(c).
    Proposed Sec.  1120.122(c)(1) would require the document control 
procedures to include requirements for document approval and 
distribution. To comply with this proposed provision, manufacturers 
would need to assign personnel to review and approve all documents 
established to meet the requirements of proposed part 1120. Such review 
and approval would have to be completed before the document is 
implemented. For example, under proposed Sec.  1120.14, manufacturers 
would be required to establish and maintain procedures for the receipt, 
evaluation, investigation, and documentation of all complaints. 
Personnel must review and approve the complaint procedure prior to the 
issuance and use of the procedure. The approval would be required to 
include the date, name, and signature of the individual(s) approving 
the document. Documents that are established to meet requirements 
proposed part 1120 would be required to be available at all locations 
for which they are designated, used, or otherwise necessary, and all 
such documents that are superseded and obsolete would have to be 
promptly removed from all points of use or otherwise prevented from 
unintended use. On inspections, FDA has observed the use of obsolete 
documents on the production line. Personnel who use an obsolete 
document may not adequately perform a required activity, which can 
result in the manufacture of nonconforming products.
    Proposed Sec.  1120.122(c)(2) would require that the document 
control procedures include requirements related to document changes. 
Specifically, changes to documents would have to be reviewed and 
approved prior to implementation by an individual(s) in the same 
function or part of the organization (e.g., Quality Assurance 
Department) that performed the original review and approval. The 
purpose of this proposed requirement is to ensure that individual(s) in 
the same job function as those who originally reviewed and approved the 
document review any changes because these individuals typically have 
the best insight on the impact of the changes.
    Proposed Sec.  1120.122(c)(2) also would require that approved 
changes be communicated to the appropriate personnel in a timely 
manner. For example, a manufacturer could comply with this requirement 
by making the changed documents readily accessible at all locations for 
which they are designated, used, or otherwise necessary, and by 
retraining affected personnel on the changed documents. FDA has 
observed on inspections instances where manufacturers made changes to 
procedures, but the changes were not communicated in a timely manner to 
the personnel utilizing the documents. Without these proposed 
requirements in place, personnel may not be aware that changes have 
been made to a procedure, which can result in the manufacture of 
nonconforming products.
    In addition, proposed Sec.  1120.122(c)(2) would require that 
superseded and obsolete documents be archived. For purposes of proposed 
part 1120, archiving means that the superseded or obsolete document 
would be retained for historical reference. These documents would have 
to be retained in accordance with the time period in proposed Sec.  
1120.122(a)(2) (e.g., for 4 years after last use, when not associated 
with a batch of finished or bulk tobacco product). These documents may 
be useful to manufacturers when performing an investigation of products 
manufactured and distributed using a previous version of a document. 
For example, an obsolete MMR would provide helpful information on 
specifications when investigating a nonconforming product that was 
manufactured under that version of the MMR.
    Further, proposed Sec.  1120.12(c)(2) would require tobacco product 
manufacturers to maintain records of changes to documents. According to 
this paragraph, document change records must include the following 
information: a description of the change; identification of the 
affected documents; the name and signature of the approving 
individual(s); the approval date; and the

[[Page 15237]]

date the change becomes effective. Maintaining change records on 
computers would be acceptable, provided that appropriate controls are 
implemented to ensure the integrity of the electronic data and 
signatures. Electronic signatures could be used to satisfy this 
requirement. All electronic records are subject to part 11.
    The proposed requirements would help assure that the public health 
is protected. Documents and records are essential to the ability to 
conduct adequate investigations in case of problems (e.g., to determine 
the scope and cause of a nonconforming product issue) and take an 
appropriate corrective action, such as a recall.
    The Agency also believes that the proposed document control 
requirements would help assure that the public health is protected. 
Document controls would establish a formal, documented system that 
defines how and by whom documents will be reviewed and approved. They 
also would include the procedures used for updating documents, for the 
distribution and maintenance of all required documents, and for the 
removal of obsolete and superseded documents. Controlled documents are 
necessary to establish consistent practices in manufacturing operations 
and provide a basis for employee training and supervision. If documents 
are not appropriately approved and current versions distributed for 
use, or if obsolete documents are used to manufacture tobacco products, 
manufacturing operations might proceed in an ad hoc manner that could 
result in the manufacture of nonconforming products. For example, if a 
manufacturer changes an acceptance activity procedure document to 
include a visual inspection of a new type of foreign material to 
address consumers' complaints, this change would have to be reviewed, 
approved, and communicated to the appropriate personnel in a timely 
manner. If personnel who are responsible for conducting this visual 
inspection are not informed of this change, they may fail to perform 
this activity and release products that contain this foreign material.
    The proposed requirements would also help assure that tobacco 
products are in compliance with the requirements of chapter IX of the 
FD&C Act by ensuring that FDA can verify that the activities required 
under proposed part 1120 have been implemented and that the documents 
and records are trustworthy and reliable. Data integrity is an 
essential foundation of the proposed rule and is critical to FDA's 
ability to protect the public health. The proposed ALCOA requirements 
are necessary in order to protect the integrity of TPMP records. Widely 
accepted, the ALCOA requirements are the basic principles of data 
integrity (Refs. 174-177). The effectiveness of FDA inspections depends 
on the veracity of the information provided by regulated entities to 
the Agency. The vast majority of the time, FDA is absent from the 
establishment. The Agency depends on records and documents to 
reconstruct events which it was not present to witness. FDA's 
experiences in other regulated product areas have shown that data-
integrity-related manufacturing violations, including data fraud and 
falsification of records, have led to numerous regulatory actions. 
Other regulatory agencies and public health organizations, like the 
World Health Organization, the European Medicines Agency, the Medicines 
& Healthcare Products Regulatory Agency of the United Kingdom, and the 
Therapeutic Goods Administration of Australia share FDA's view that 
data integrity principles are a core component of good manufacturing 
practice (id.). Because data integrity principles are essential to the 
quality systems and QMS, they are among the portions of those 
approaches adopted by the Agency in this proposed rule. Data integrity 
lapses in the regulated manufacturing environments are critical 
deficiencies because they undermine the ability of FDA to verify if a 
product is manufactured in accordance with its marketing authorization. 
Consequently, the proposed ALCOA requirement helps assure that tobacco 
products are in compliance with the requirements of chapter IX of the 
FD&C Act by giving the Agency confidence in the integrity of the 
records which are at the center of the regulatory scheme envisioned by 
the Tobacco Control Act.
    In addition, the Agency believes that the proposed document control 
requirements would help ensure that tobacco products are in compliance 
with the requirements of chapter IX of the FD&C Act, because, for 
example, documents established to meet the requirements of proposed 
part 1120 are necessary to implement the manufacturing methods and 
procedures specified in the MMR and ensure that a tobacco product 
conforms to its specifications. Thus, these documents would enable FDA 
to help ensure that new tobacco products and MRTPs are manufactured 
consistent with the specifications provided in their applications 
(i.e., SE Report, request for SE exemption, PMTA, MRTPA) and that pre-
existing products are manufactured consistent with their original 
characteristics.

I. Small Tobacco Product Manufacturers

    Proposed Sec.  1120.130 provides for an extended compliance 
deadline that would grant small tobacco product manufacturers of 
finished and bulk tobacco products additional time to implement the 
requirements in part 1120, consistent with section 906(e)(1)(B)(v) of 
the FD&C Act. Instead of being required to comply with part 1120 on the 
effective date of the final rule, small tobacco manufacturers would be 
required to comply with the requirements in part 1120 4 years after the 
effective date of the final rule. FDA believes that this extended 
compliance deadline for small tobacco product manufacturers would 
provide them with sufficient time to implement the proposed 
requirements.

J. Exemptions and Variances

1. Exemptions and Variances
    Proposed Sec.  1120.140 explains that, under section 906(e)(2) of 
the FD&C Act, any person subject to any of the TPMP requirements could 
petition FDA for a permanent or temporary exemption or variance from 
any of these requirements. The petitioner remains subject to the 
relevant requirements unless FDA grants the petition for an exemption 
or variance under proposed Sec.  1120.146. Thus, any person who 
petitions FDA for an exemption or variance would have to follow the 
TPMP requirements in proposed part 1120 unless and until FDA grants the 
petition.
    Section 906(e)(2)(A) of the FD&C Act provides FDA the authority to 
prescribe the form and manner for submission of petitions. Under 
proposed Sec.  1120.140, an individual petitioning for an exemption or 
variance would have to submit the petition, including all information 
supporting the petition, in an electronic format that FDA can process, 
review, and archive. FDA intends to provide information on its website 
on how to provide the electronic submission to FDA (e.g., information 
on electronic media and methods of transmission). Electronic submission 
of information is consistent with the Government Paperwork Elimination 
Act (Pub. L. 105-277, Title VII). Because of the broad availability of 
the internet, FDA does not anticipate any need to submit a petition for 
an exemption or variance, and supporting materials, in a nonelectronic 
format. However, if the petitioner is unable to submit a petition in an 
electronic

[[Page 15238]]

format, the petitioner may submit a written request to FDA asking that 
FDA allow the submission in an alternative format, explaining in detail 
why the petitioner cannot submit the petition in an electronic format 
and why an alternate format is necessary. Proposed Sec.  1120.140 would 
also require that all petitions, including supporting information, and 
all requests to submit a petition in an alternative format, be legible 
and in the English language. These proposed requirements would ensure 
that FDA could review the petitions expeditiously and appropriately.
2. Petition for an Exemption or Variance
    Proposed Sec.  1120.142 would require that a petition for an 
exemption or variance be submitted with supporting documentation and 
contain: (1) the petitioner's name, address, and contact information; 
(2) identification of the tobacco product(s); (3) the requirement(s) in 
part 1120 for which an exemption or variance is requested; a detailed 
explanation of why the exemption or variance is requested, including 
why the tobacco product manufacturer is not able to comply with the 
requirement(s) of proposed part 1120; and (4) the duration of the 
proposed exemption or variance. In addition, for a petition for a 
variance, this section would require a detailed explanation setting 
forth the methods proposed to be used in, and the facilities and 
controls proposed to be used for, the manufacture, packing, and storage 
of the tobacco product in lieu of the requirement(s) in part 1120, as 
well as the basis for the petitioner's determination that the proposed 
methods will be sufficient to assure that the public health will be 
protected and that the tobacco product(s) will be in compliance with 
chapter IX of the FD&C Act. For a petition for an exemption, this 
provision would require a detailed explanation setting forth the basis 
for the petitioner's determination that compliance with the 
requirement(s) is not required to assure that the public health will be 
protected and the tobacco product will be in compliance with chapter IX 
of the FD&C Act. Additional information that would be required with a 
petition for an exemption or a petition for a variance includes: any 
other information justifying the exemption or variance; a statement 
certifying that, to the best of the petitioner's knowledge and belief, 
the information provided in the petition includes all information and 
views on which the petition relies, including representative data, and 
any information known to the petitioner that is unfavorable to the 
petition; and an environmental assessment (EA) under part 25 (21 CFR 
part 25) prepared in accordance with Sec.  25.40.
    FDA expects that the submission of this information, along with 
supporting documentation will enable FDA to determine whether to grant 
a petition for a variance or exemption. FDA is considering including 
additional requirements for the specific contents of petitions for 
variances and exemptions and is seeking comment on the kinds of 
information and/or evidence that would be helpful in determining 
whether a petition should be granted.
3. Referral to the Tobacco Products Scientific Advisory Committee 
(TPSAC)
    Proposed Sec.  1120.144 explains that FDA may refer any petition 
submitted under this subpart to the TPSAC. If FDA refers a petition for 
an exemption or variance to the TPSAC, the TPSAC would be required to 
report its recommendations to FDA with respect to the petition referred 
to it within 60 days after the date of the petition's referral.
4. Petition Determination
    Proposed Sec.  1120.146(a) explains how FDA would make a 
determination on a petition for an exemption. Under proposed Sec.  
1120.146(a)(1), the Agency may, upon review of the information 
submitted and any recommendation from the TPSAC, approve a petition for 
an exemption from a TPMP requirement if it determines that compliance 
with such requirement is not required to assure that the tobacco 
product will be in compliance with chapter IX of the FD&C Act. As 
discussed above, in deciding whether to grant or deny a petition FDA 
will consider all the information provided by the petitioner including 
the basis of the petitioner's determination that compliance with the 
requirement is not needed to assure that the public health is 
protected. Proposed Sec.  1120.146(a)(2) provides that, if FDA 
determines that the information submitted by the petitioner is 
insufficient to enable FDA to make a determination whether an exemption 
is appropriate, the Agency could request additional information from 
the petitioner. Proposed Sec.  1120.146(a)(2) also provides that if the 
petitioner fails to respond by the time specified in the request, FDA 
could consider the exemption request withdrawn. FDA specifically 
requests comments from stakeholders as to what information should be 
included in a petition for exemption and how long it would take for a 
typical firm to gather and prepare the information that would be 
included in the petition for exemption.
    Proposed Sec.  1120.146(b) explains how FDA would make a 
determination on a petition for a variance. Under proposed Sec.  
1120.146(b)(1), the Agency may, upon review of the information 
submitted and any recommendation from the TPSAC, approve a petition for 
a variance if it determines that the methods to be used in, and the 
facilities and controls to be used for, the manufacture, packing, and 
storage of the tobacco product in lieu of the methods, facilities, and 
controls prescribed by the requirements in part 1120 are sufficient to 
assure that the tobacco product will be in compliance with chapter IX 
of the FD&C Act. As discussed above, in deciding whether to grant or 
deny a petition FDA will consider all the information provided by the 
petitioner, including the basis of the petitioner's determination that 
the proposed alternative methods, facilities, and controls are 
sufficient to assure that the public health is protected. Proposed 
Sec.  1120.146(b)(2) provides that, if FDA determines that the 
information submitted by the petitioner is insufficient to enable FDA 
to make a determination whether a variance is appropriate, the Agency 
may request additional information from the petitioner. Proposed Sec.  
1120.146(b)(2) also provides that if the petitioner fails to respond by 
the time specified in the request, FDA may consider the variance 
request withdrawn.
    Proposed Sec.  1120.146(c) explains the timeframe in which FDA 
would make a decision on a petition. Proposed Sec.  1120.146(c) 
provides that FDA would either grant or deny a petition within 60 days 
after the date the complete petition was submitted to FDA under Sec.  
1120.142 or within 60 days after the day after FDA referred the 
petition to TPSAC under Sec.  1120.144, whichever date is later. The 
60-day review period under proposed Sec.  1120.146(c)(1) would begin 
when FDA receives a complete petition. Thus, if FDA receives an 
incomplete petition and requests additional information under Sec.  
1120.146(a)(2) or Sec.  1120.146(b)(2), the 60-day review period would 
not begin until FDA receives the additional information that completes 
the petition. FDA intends to request additional information, if 
necessary, within 60 days after the date the incomplete petition was 
submitted to FDA.
    Proposed Sec.  1120.146(d) provides that an order from FDA granting 
a variance would prescribe such conditions respecting the methods used 
in, and the facilities and controls used for, the manufacture, packing, 
and storage of the tobacco product as may be necessary to assure that 
the tobacco product will be

[[Page 15239]]

in compliance with chapter IX of the FD&C Act.
5. Hearing
    Proposed Sec.  1120.148 explains that after FDA issues an order 
under Sec.  1120.146, the petitioner would have the opportunity for an 
informal hearing under part 16 (21 CFR part 16).

V. Proposed Effective and Compliance Dates

    FDA proposes that any final rule become effective 2 years after the 
date the final rule publishes in the Federal Register. Section 
906(e)(1)(B)(iv) of the FD&C Act specifies that, in establishing the 
effective date of any TPMP regulations, FDA must take into account the 
differences in the manner in which the different types of tobacco 
products have historically been produced, the financial resources of 
the different tobacco product manufacturers, and the state of their 
existing manufacturing facilities, and must provide for a reasonable 
period of time for such manufacturers to conform to any TPMP 
regulations. FDA has considered these factors in determining the 
proposed effective dates for this rule.
    The Agency's proposed rule utilizes a standards-based approach to 
the regulation of all types of finished and bulk tobacco products, 
which is similar to the approach taken by the other cGMPs and voluntary 
standards considered in the development of this proposal. Thus, the 
proposed regulation provides the framework that all manufacturers would 
utilize and apply in a manner that is appropriate to a given tobacco 
product. FDA is proposing this effective date to ensure that 
manufacturers of all types of covered tobacco products will have 
adequate time to comply regardless of the complexity of their 
manufacturing process.
    In addition, FDA inspections have demonstrated that a number of 
manufacturers already have implemented many measures similar to the 
proposed TPMP requirements. FDA also believes that manufacturers other 
than small tobacco product manufacturers have the financial resources 
to comply with the proposed requirements within 2 years, as 
demonstrated by the proposed regulatory impact analysis (PRIA) and the 
fact that a number of manufacturers already have implemented similar 
provisions. Those manufacturers meeting the definition of small tobacco 
product manufacturers will have an additional 4 years to come into 
compliance (see proposed Sec.  1120.130). FDA inspections and facility 
visits have noted that entities that manufacture the originally 
regulated products (i.e., cigarettes, smokeless, cigarette tobacco, and 
RYO) as well as entities that manufacture deemed products generally 
already have some manufacturing controls in place that are similar to 
the proposed rule (e.g., a QMS or some portions of a QMS). FDA believes 
that the proposed effective date is feasible and that different 
effective dates for different types of manufacturers are not needed.
    Accordingly, FDA believes that 2 years is a reasonable period of 
time for manufacturers (other than small tobacco product manufacturers) 
to comply with any final TPMP regulations. During those 2 years, FDA 
expects that manufacturers would take steps to plan and implement 
business operations that will comply with the final rule. FDA 
specifically requests comment regarding this proposed 2-year effective 
date.
    Section 906(e)(1)(B)(v) of the FD&C Act specifies that FDA may not 
require any small tobacco product manufacturer to comply with any TPMP 
regulations for at least 4 years following the effective date of the 
regulation. As discussed in subpart J of the proposed regulation, FDA 
proposes that small tobacco product manufacturers of finished and bulk 
tobacco products not be required to comply with the TPMP regulations 
until 4 years after the effective date of the final rule. This proposed 
compliance date would give small tobacco product manufacturers a total 
of 6 years to comply with the TPMP regulations, and FDA believes that 
this extended compliance date for small tobacco product manufacturers 
would provide them with sufficient time to implement the requirements 
in any final rule. This proposed effective date is consistent with the 
recommendation of some tobacco companies (Docket No. FDA-2013-N-0227). 
FDA requests comment on this proposed effective and compliance dates 
from all interested parties.

VI. Preliminary Economic Analysis of Impacts

A. Introduction

    We have examined the impacts of the proposed rule under Executive 
Order (E.O.) 12866, E.O. 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). E.O. 12866 and 13563 direct us to assess all costs and benefits 
of available regulatory alternatives and, when regulation is necessary, 
to select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). We believe that this 
proposed rule is a significant regulatory action as defined by E.O. 
12866.
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. Because small entities are likely to incur a large portion of 
the costs to comply with the proposed rule, we find that the proposed 
rule would have a significant economic impact on a substantial number 
of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us to prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $158 million, using the most current (2020) Implicit 
Price Deflator for the Gross Domestic Product. This proposed rule would 
not result in an expenditure in any year that meets or exceeds this 
amount.

B. Summary of Costs and Benefits

    The proposed rule, if finalized, would establish requirements for 
manufacturers of finished and bulk tobacco products on the methods used 
in, and the facilities and controls used for, the manufacture, pre-
production design validation, packing, and storage of tobacco products. 
The TPMP requirements described in the proposed rule are expected to 
ensure that tobacco product manufacturers control the design and 
specifications of finished and bulk tobacco products, providing a level 
of assurance of conformity in the production of tobacco products to 
established and required specifications that does not occur in the 
existing market for tobacco products, to prevent the adulteration and 
misbranding of finished and bulk tobacco products, and establish 
controls for traceability purposes.
    We quantify two potential benefits of the proposed rule. First, the 
manufacturing controls required by the proposed regulation are likely 
to reduce the likelihood that nonconforming products are manufactured 
and commercially distributed which, in turn, would reduce social costs 
associated with product recalls and market withdrawals. The social 
costs of a recall, due to inadequate or

[[Page 15240]]

insufficient controls, may extend beyond the costs to the manufacturer 
conducting the recall and may include shareholders as well as 
consumers, retailers, and wholesalers. If a recall or market withdrawal 
were necessary, the records required by the proposed regulation would 
help locate nonconforming products that were commercially distributed, 
which would also be expected to reduce the cost of conducting recalls 
and market withdrawals, both voluntary and involuntary. Since 2009, 
tobacco product manufacturers have initiated eight voluntary recalls, 
resulting in at least three million cans of smokeless tobacco and 62 
million cigarettes recalled or withdrawn from the market. Furthermore, 
we estimate that, if the proposed rule is finalized, the costs of 
product recalls and market withdrawals may fall by between $4 million 
and $213 million per year.
    Another quantified potential benefit of the proposed rule is that 
adverse events due to nonconforming finished and bulk tobacco products 
would decrease as a result of improvements in the control of tobacco 
product manufacturing operations. We use data on exposure calls to 
Poison Control Centers (PCs) throughout the United States to quantify 
the impact of the proposed rule on the number of exposure calls 
reporting clinical effects such as vomiting, nausea, abdominal pain, 
etc. associated with the consumption of tobacco products that, 
according to the PCs Certified Specialists in Poison Information, had 
been tampered with or contaminated. We estimate from 2001 to 2030, a 
total of 11,135 projected exposures, or an annual average of 371 
exposures per year, associated with the consumption of such 
products.\6\ Based just on these data regarding calls to PCs, if the 
proposed rule is finalized, we estimate that the total (undiscounted) 
monetized health losses associated with contaminated tobacco products 
may be reduced by between $908 and $2,723 per year.
---------------------------------------------------------------------------

    \6\ The 11,135 projected exposures are estimated from observed 
2001-2017 exposures (adjusted for under-reporting) and adjusted to 
account for apparent trend of increasing exposure calls from 2018 
through 2030. We used this forecast to estimate a baseline trend of 
what would occur without implementing this proposed rule. Figures 
are also adjusted for underreporting as explained in the Benefits of 
the Proposed Rule, section D.2 of the Preliminary Regulatory Impact 
Analysis (Ref. 184).
---------------------------------------------------------------------------

    There are other potential benefits associated with the proposed 
rule which we have not quantified. First, the proposed recordkeeping 
provisions will also support FDA's regulatory compliance activities and 
help FDA implement and enforce other provisions of the FD&C Act which 
will likely generate government cost savings. Second, the proposed 
rule, if finalized, may further reduce losses to health and property 
for users and nonusers associated with nonconforming tobacco products, 
beyond those estimated in the quantified benefits. Third, the proposed 
rule's risk assessment, CAPA, tobacco products complaints and related 
provisions will facilitate investigation and identification of causes 
and root causes of consumer complaints and other reports of adverse 
events. Other benefits include avoided spillover costs to capital 
markets.\7\
---------------------------------------------------------------------------

    \7\ Estimated quantified benefits of avoided recalls include 
reduced external costs in the supply chain of the recalled or 
withdrawn products (or they exclude reduced recall costs to 
manufacturers). Estimated external costs of conducting a recall or 
market withdrawal include lost sales to retailers and wholesalers, 
expenses associated with notifying tobacco retailers (for 
wholesalers) and consumers, removal and storage of inventory costs 
collection and shipping costs, disposal costs, and legal costs, 
among others. Estimated quantified benefits do not include avoided 
spillover costs to capital markets.
---------------------------------------------------------------------------

    The potential costs of the rule include tasks associated with 
establishing and maintaining procedures for various aspects of the 
manufacturing, preproduction design validation, packing and storage 
processes. Examples of these tasks include conducting new or more 
stringent manufacturing activities, writing and updating standard 
operating procedures (SOPs), training employees to engage in new or 
more stringent manufacturing activities, and keeping new or additional 
records. We estimate that (undiscounted) one-time costs range from $39 
million to $73 million and (undiscounted) recurring costs range from 
$15 million per year to $56 million per year. FDA is also proposing 
that any final rule become effective two years after the date of the 
final rule's publication. FDA is further proposing in Sec.  1120.130 of 
this rule that manufacturers meeting the definition of small tobacco 
product manufacturer would be required to comply with the requirements 
of this rule four years after the effective date of the final rule 
(i.e., six years after the date of the final rule's publication). 
Because small manufacturers would have more time than non-small 
manufacturers to comply with the requirements of this proposed rule, we 
estimate all costs to reflect the staggered compliance dates. We 
estimate learning costs for both non-small and small manufacturers to 
begin one year after publication (year 1). Non-small manufacturers and 
small manufacturers would incur costs one and five years, respectively, 
after the publication date of a final rule as they work to come into 
compliance with the rule two and six years from the date of final 
publication.\8\ We therefore estimate the present value of total 
domestic costs annualized over ten years using a discount rate of seven 
percent is estimated to range from $13 million per year to $54 million 
per year, and from $14 million per year to $43 million per year using a 
discount rate of three percent. Our estimated benefits will begin to 
accrue on the same years as the compliance dates (years 2 and 6). The 
present value of total benefits annualized over ten years using a 
discount rate of seven percent is estimated to range from $1.9 million 
per year to $97.0 million per year, and from $2.1 million per year to 
$106.5 million per year using a discount rate of three percent. Table 1 
summarizes our estimate of the annualized costs and benefits of the 
proposed rule.
---------------------------------------------------------------------------

    \8\ The year of publication is year zero and the effective date 
is year two. In order for non-small manufacturers to comply with the 
requirements of this rule by the effective date (year two), we 
assume they will begin to incur compliance costs on year one. For 
small manufacturers to comply four years after the effective date or 
year six, we assume they will begin to incur compliance costs on 
year five. Benefits from non-small and small manufacturers begin to 
accrue on year two and year six respectively. All values have been 
adjusted to reflect 2020 dollars. Estimated costs in Table 1 
represent estimated costs incurred by domestic manufacturers and 
domestic importers. Estimated benefits in Table 1 are from reduced 
exposure and reduced recall related costs associated with both 
domestic and imported tobacco products sold in the U.S.

[[Page 15241]]



                                   Table 1--Summary of Benefits, Costs and Distributional Effects of the Proposed Rule
                                                                    [$ millions/year]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                 Units
                                                                                ---------------------------------------
                Category                    Primary        Low          High                    Discount      Period                  Notes
                                            estimate     estimate     estimate       Year         rate       covered
                                                                                   dollars     (percent)     (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized Monetized $millions/year.        $27.2         $1.9        $97.0         2020            7           10  Quantified benefits include a
                                                 29.9          2.1        106.5         2020            3           10   summation of potential
                                                                                                                         reductions in (1) cost of
                                                                                                                         recalls and market withdrawals
                                                                                                                         and (2) adverse health effects
                                                                                                                         associated with contaminated or
                                                                                                                         otherwise nonconforming tobacco
                                                                                                                         products.
    Annualized Quantified...............                                                                7           10
                                                                                                        3           10
                                         -----------------------------------------------------------------
    Qualitative.........................  Non-quantified benefits include (1) Government costs savings              10
                                          due to aiding FDA compliance efforts; (2) potentially reducing
                                          losses to health and property for users and nonusers associated
                                          with nonconforming tobacco products; and (3) facilitating the
                                          investigation and identification of causes and root causes of
                                          consumer complaints and other reports of adverse events.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
    Annualized Monetized $millions/year.         27.0         13.3         41.1         2020            7           10  Annualized total costs of
                                                 28.2         13.7         43.0         2020            3           10   compliance with the proposed
                                                                                                                         rule. Range of estimates
                                                                                                                         captures uncertainty.
    Annualized Quantified...............                                                                7           10
                                                                                                        3           10
    Qualitative.........................                                                                            10
--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers:
    Federal Annualized Monetized                                                                        7           10
     $millions/year.                                                                                    3           10
                                         ------------------------------------------------------------------------------
    From/To.............................  From:
                                          To:                                10
                                         ------------------------------------------------------------------------------
    Other Annualized Monetized $millions/                                                               7           10
     year.                                                                                              3           10
                                         ------------------------------------------------------------------------------
    From/To.............................  From:
                                          To:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
    State, Local or Tribal Government:..................................................................................................................
    Small Business:.....................................................................................................................................
    One-time costs per small entity are between 0.06% and 0.11% of their average annual revenue. Due to many missing values from Census data, average
     small-entity impacts are likely subject to large variability, due to the significant amount of heterogeneity in small-entity impacts across
     entities of different sizes (See Ref. 184)..
    Wages:..............................................................................................................................................
    Growth:.............................................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------

    We have developed a comprehensive Preliminary Economic Analysis of 
Impacts that assesses the impacts of the proposed rule. The full 
preliminary analysis of economic impacts is available in the docket for 
this proposed rule (as Ref. 184) and at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

VII. Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that 
are subject to review by the OMB under the PRA (44 U.S.C. 3501-3521). A 
description of these provisions is given in the Description section of 
this document with an estimate of the annual reporting, recordkeeping, 
and third-party disclosure burden. Included in the estimate is the time 
for reviewing instructions, searching existing data sources, gathering 
and maintaining the data needed, and completing and reviewing each 
collection of information.
    FDA invites comments on these topics: (1) whether the proposed 
collection of information is necessary for the proper performance of 
FDA's functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.
    Title: Requirements for Tobacco Product Manufacturing Practice.
    Description: The Tobacco Control Act was enacted on June 22, 2009, 
amending the FD&C Act and providing FDA with the authority to regulate 
tobacco products. Section 101(b) of the Tobacco Control Act amends the 
FD&C Act by adding new chapter IX, which provides FDA with authorities 
to regulate tobacco products and imposes certain obligations on tobacco 
product manufacturers, retailers, and importers. Among the amendments 
are provisions that relate to tobacco product manufacturing practice 
requirements. The proposed provisions include, among other things, the 
authority to issue regulations relating to good manufacturing practice 
requirements; hereinafter TPMP, in order to assure that the public 
health is protected and

[[Page 15242]]

tobacco products are in compliance with the requirements of the FD&C 
Act.
    Description of Respondents: This proposed rule applies to 
manufacturers (foreign and domestic) of finished and bulk tobacco 
products. Finished tobacco products include tobacco products, including 
all components and parts, sealed in final packaging (e.g., rolling 
papers, filters, filter tubes, or e-liquids sold to consumers. Bulk 
tobacco products are tobacco products that are not sealed in final 
packaging but otherwise suitable for consumer use as tobacco products 
(e.g., bulk cigarettes, bulk filters, bulk e-liquids).
    Subpart B prescribes the proposed requirements pertaining to 
finished and bulk tobacco product manufacturers' management systems 
that cover a manufacturer's organization and personnel (Sec.  1120.12), 
tobacco product complaints (Sec.  1120.14), and CAPA (Sec.  1120.16).
    Proposed Sec.  1120.12 would require manufacturers to establish and 
maintain an organizational structure; have sufficient personnel to 
carry out the requirements under part 1120; designate, in writing, 
appropriate responsibility for all personnel who perform an activity 
subject to part 1120 and designate, in writing, management with 
executive responsibility who have the duty, power, and responsibility 
to implement the requirements under part 1120; establish and maintain 
training procedures; and maintain records of personnel qualifications 
and training records. Manufacturers would be required to keep records 
of all activities required under this provision.
    Proposed Sec.  1120.14 would require manufacturers to establish and 
maintain procedures to receive, evaluate, investigate, and document 
complaints. Manufacturers would be required to keep records of all 
activities required under this provision.
    Proposed Sec.  1120.16 would require manufacturers to establish and 
maintain procedures for implementing CAPA. These procedures are to 
require review of various sources of data for identifying and 
investigating existing and potential causes of nonconformities and 
design problems, acting to correct and prevent nonconformities and 
design problems, verifying or validating the CAPAs, implementing and 
documenting the changes needed, and communicating that information to 
specified personnel. Manufacturers must maintain records of all 
activities conducted under this section. Manufacturers would be 
required to keep records of all activities required under this 
provision.
    Subpart C prescribes the proposed requirements that are specific to 
personnel practices (Sec.  1120.32), building, facilities, and grounds 
(Sec.  1120.34), equipment (Sec.  1120.36), and environmental controls 
(Sec.  1120.38).
    Proposed Sec.  1120.32 would require manufacturers to establish and 
maintain procedures for the cleanliness, personal practices, and 
apparel, which must include requirements to ensure that contact between 
personnel and the tobacco product or environment would not result in 
contamination of the tobacco product.
    Proposed Sec.  1120.34 would require manufacturers to ensure each 
building, facility, and grounds is maintained in appropriate condition 
to prevent contamination and ensure that buildings and facilities are 
of suitable construction, design, and location to facilitate 
sanitation, maintenance, and proper operation. The provision also would 
require controls for water quality, and record keeping, as well as 
require manufacturers to establish and maintain procedures for cleaning 
and sanitation and animal and pest control. Manufacturers would be 
required to keep records of all activities required under this 
provision.
    Proposed Sec.  1120.36 would require manufacturers to ensure that 
equipment used in manufacturing operations is appropriately designed, 
constructed, and suitable for its intended purpose, and must establish 
and maintain procedures for the routine cleaning and maintenance of 
equipment, as well as for the routine calibration of testing, 
monitoring, and measuring equipment to ensure proper performance. The 
provision also would require identification of major equipment and all 
processing lines. Manufacturers would be required to keep records of 
all activities required under this provision.
    Proposed Sec.  1120.38 would require manufacturers to establish and 
maintain procedures to adequately control environmental conditions, 
where appropriate, and maintain and monitor environmental control 
systems to verify that the environmental controls are adequate and 
functioning properly. Manufacturers would be required to keep records 
of all activities required under this provision.
    Subpart D of the proposed rule prescribes the requirements for 
design and development activities (Sec.  1120.42) and MMRs (Sec.  
1120.44).
    Proposed Sec.  1120.42 would require manufacturers to establish and 
maintain procedures to control the design and development of each 
finished and bulk tobacco product and its package, including the 
control of risks associated with the product, production process, 
packing, and storage. To control for risks, manufacturers would be 
required to conduct a risk assessment: (1) risk identification of all 
known or reasonably foreseeable risks associated with the tobacco 
product and its package, production process, packing, and storage, 
including risks normally associated with the use of the tobacco 
product; (2) risk analysis of the nature and level of risk for each 
identified known or reasonably foreseeable risk; and (3) risk 
evaluation of each identified risk to determine the significance of the 
risk and the type of risk treatment needed. In addition, manufacturers 
would be required to perform risk treatment to significantly minimize 
or prevent risks identified that are reasonably likely to occur and 
that may cause serious illness, injury, or death not normally 
associated with the use of the tobacco product, or that the 
manufacturer determines constitutes an unacceptable level of risk as 
well as to address risks for any applicable tobacco product standards 
to ensure that the tobacco product will conform to the specifications 
and requirements established in the tobacco product standard. Finally, 
manufacturers would be required to conduct a risk reassessment whenever 
the manufacturer becomes aware of new information that could change the 
risks assessment and risk treatment, including information about 
previously unidentified risks or the adequacy of risk treatment 
measures. Manufacturers would maintain records of all activities 
required under this section.
    Proposed Sec.  1120.44 would require that manufacturers establish 
and maintain an MMR for each tobacco product manufactured. 
Manufacturers would also establish and maintain procedures for the 
review and approval of the MMR.
    Subpart E of the proposed rule prescribes the proposed requirements 
for purchasing controls (Sec.  1120.62), acceptance activities (Sec.  
1120.64), production and process controls (Sec.  1120.66), laboratory 
controls (Sec.  1120.68), production records (Sec.  1120.70), sampling 
(Sec.  1120.72), nonconforming tobacco products (Sec.  1120.74), 
returned tobacco products (Sec.  1120.76), and reprocessing and rework 
(Sec.  1120.78).
    Proposed Sec.  1120.62 would require manufacturers to establish and 
maintain purchasing procedures, purchasing records, and procedures for 
qualifying its suppliers. Manufacturers would be required to keep 
records of all activities required under this provision.
    Proposed Sec.  1120.64 would require manufacturers to establish and 
maintain procedures for acceptance activities

[[Page 15243]]

including inspections, evaluations, tests, and other verification 
methods manufacturers use in the manufacturing process. The written 
procedures would also be required to contain procedures and records for 
ensuring that each accepted incoming tobacco product is designated by a 
unique identifier, which must be maintained throughout the 
manufacturing process and documented in the production record.
    Proposed Sec.  1120.66 would require manufacturers to establish and 
maintain production procedures that describe the process specifications 
and process controls used in the manufacturing of tobacco products. 
Process controls include monitoring and acceptance activities such as 
inspection, testing, evaluation, or other verification activities. The 
procedures should also address removal of manufacturing material if it 
could reasonably be expected to have an adverse effect on the product, 
if applicable; changes to a production process; and process validation 
procedures to demonstrate that the process will be maintained in a 
state of control to ensure that tobacco products conform to their 
established specifications and other requirements when it cannot be 
fully verified that tobacco product specifications conform to the MMR. 
Manufacturers would be required to keep records of all activities 
required under this provision.
    Proposed Sec.  1120.68 would require manufacturers to establish and 
maintain procedures for any laboratory controls employed to satisfy 
requirements in the proposed rule. The procedures include 
scientifically valid laboratory methods that are accurate, precise, and 
appropriate for their intended purpose, sampling plans that comply with 
Sec.  1120.72 of the proposed rule, and demonstration of analytical 
control. Manufacturers would also be required to demonstrate the 
laboratory's competence to perform laboratory activities associated 
with the manufacture of finished or bulk tobacco products. 
Manufacturers would be required to keep records of all activities 
required under this provision.
    Proposed Sec.  1120.70 would require manufacturers to establish and 
maintain procedures for the preparation of a production record for each 
manufactured tobacco product batch.
    Proposed Sec.  1120.72 would require manufacturers to have an 
adequate sampling plan using representative samples.
    Proposed Sec.  1120.74 would require manufacturers to establish and 
maintain procedures for the control and disposition of nonconforming 
tobacco products. These procedures include: (1) identification and 
segregation of potential nonconforming products; (2) investigation of 
all potential nonconforming products, including determination of the 
scope and cause of the nonconformance and the risk of illness or injury 
posed by the nonconformance; and (3) disposition and followup. 
Manufacturers would be required to keep records of all activities 
required under this provision.
    Proposed Sec.  1120.76 would require manufacturers to establish and 
maintain procedures for the control and disposition of returned 
products. These procedures must address identification, segregation, 
evaluation, and disposition of returned products. Returned products 
must be segregated in a manner that prevents mix-ups and use of 
returned products prior to evaluation and disposition. Returned product 
must be evaluated to determine its disposition. Manufacturers would be 
required to keep records of all activities required under this 
provision.
    Proposed Sec.  1120.78 would require manufacturers to establish and 
maintain procedures for reprocessing and reworking tobacco products. 
These procedures would require evaluation of the tobacco product to 
determine whether the product is appropriate for reprocessing or rework 
and authorization of any reprocessing or rework by a designated 
individual; and must include the production processes, including 
process controls, and acceptance activities, used to ensure the 
reprocessed or reworked tobacco product conforms to the requirements 
established in the MMR for the subsequently manufactured tobacco 
product. Manufacturers would be required to maintain records of all 
activities required under this provision.
    Subpart F of the proposed rule prescribes the proposed requirements 
for packaging and labeling activities (Sec.  1120.92), repackaging and 
relabeling activities (Sec.  1120.94), manufacturing codes on the 
packaging or label of tobacco products (Sec.  1120.96), and warning 
plans for packaging (Sec.  1120.98).
    Proposed Sec.  1120.92 would require manufacturers to establish and 
maintain procedures to control packaging and labeling activities. 
Manufacturers would be required to maintain records of all activities 
required under this provision.
    Proposed Sec.  1120.94 would require manufacturers to establish and 
maintain procedures to control repackaging and relabeling activities 
for those establishments engaging in such activities. Manufacturers 
would be required to maintain records of all activities required under 
this provision.
    Proposed Sec.  1120.96 would require manufacturers to apply a 
manufacturing code to the packaging or label of all finished and bulk 
tobacco products. Manufacturers would be required to maintain records 
of all activities required under this provision.
    Proposed Sec.  1120.98 would require finished tobacco product 
manufacturers, who are required to comply with a warning plan for 
tobacco product packaging, to establish and maintain procedures to 
implement the requirements of such warning plan. Manufacturers would be 
required to keep records of all activities required under this 
provision.
    Subpart G of the proposed rule prescribes the proposed requirements 
for activities associated with handling and storage (Sec.  1120.102) 
and distribution (Sec.  1120.104).
    Proposed Sec.  1120.102 would require tobacco product manufacturers 
to establish and maintain procedures for the handling and storage of 
tobacco products.
    Proposed Sec.  1120.104 would require tobacco product manufacturers 
to establish and maintain procedures for the distribution of finished 
and bulk tobacco products and to keep distribution records and records 
of direct accounts.
    Proposed subpart H of the proposed rule prescribes the proposed 
general recordkeeping and document control requirements (Sec.  
1120.122).
    Proposed Sec.  1120.122(a) would establish general requirements 
that apply to all documents and records required under proposed part 
1120. Proposed Sec.  1120.122(a)(1) would require that documents and 
records required under proposed part 1120 be written in English, or an 
accurate English translation must be made available upon request. All 
documents and records required by proposed part 1120, that are 
associated with a batch of finished or bulk tobacco product, must be 
retained for a period of not less than 4 years from the date of 
distribution of the batch or until the product reaches its expiration 
date if one exists, whichever is later. Documents and records not 
associated with a batch must be retained for not less than 4 years from 
the date they were last in effect. Furthermore, all documents and 
records required under proposed part 1120 be maintained at the 
manufacturing establishment or another location that is readily 
accessible to responsible officials of the tobacco product manufacturer 
and to FDA. FDA interprets ``readily accessible'' to FDA as the 
documents and records being made available to FDA upon request within 
the course of an inspection.

[[Page 15244]]

Proposed Sec.  1120.122(b) would require that records required under 
the proposed rule are attributable, legible, contemporaneously 
recorded, original, and accurate. Proposed Sec.  1120.122(c) would 
require tobacco product manufacturers to establish and maintain 
procedures to control all documents established to meet the 
requirements under proposed part 1120.
    As required by section 906(e)(2) of the FD&C Act, subpart J of the 
proposed rule sets forth the procedures and requirements for 
petitioning for an exemption or variance from a TPMP requirement.
    Proposed Sec.  1120.140 explains that, under section 906(e)(2) of 
the FD&C Act, any person subject to any requirement of the TPMP 
regulations may petition FDA for a permanent or temporary exemption or 
variance from such requirement. The requirements under this part remain 
in effect unless FDA grants the petition for an exemption or variance 
under Sec.  1120.146. Thus, any person who petitions FDA for an 
exemption or variance must follow the TPMP regulations while the 
petition is being considered and until FDA grants the petition. Under 
proposed Sec.  1120.140, an individual petitioning for an exemption or 
variance must submit all information supporting the petition in an 
electronic form that FDA can process, review, and archive. Because of 
the broad availability of the internet, FDA does not anticipate any 
need to submit a petition for an exemption or variance and supporting 
materials in a non-electronic format. However, if the petitioner is 
unable to submit a petition in an electronic format, the petitioner may 
submit a written request to FDA requesting that FDA allow the 
submission in an alternative format and explain in detail why the 
petitioner cannot submit the petition in an electronic format.
    Proposed Sec.  1120.142 would require that a petition for an 
exemption or variance contain: (1) the petitioner's name, address, and 
contact information; (2) identification of the tobacco product; (3) the 
requirement in this part for which an exemption or variance is 
requested; (4) a detailed explanation of why the exemption or variance 
is requested; the duration of the proposed exemption or variance; (5) a 
detailed explanation setting forth the methods proposed to be used in, 
and the facilities and controls proposed to be used for, the 
manufacture, packing, and storage of the tobacco product in lieu of the 
requirement in this part as well as the basis for the petitioner's 
determination that the proposed methods will be sufficient to assure 
that the public health is protected and the tobacco product(s) will be 
in compliance with chapter IX of the FD&C Act (for a petition for a 
variance); (6) a detailed explanation setting forth the basis for the 
petitioner's determination that compliance with the requirement is not 
required to assure that the public health is protected and that the 
tobacco product will be in compliance with chapter IX of the FD&C Act 
(for a petition for exemption); (7) any other information justifying 
the exemption or variance; a statement certifying that, to the best of 
the petitioner's knowledge and belief, the petition includes all 
information and views on which the petition relies including 
representative data and information known to the petitioner which are 
unfavorable to the petition; and (8) an EA under part 25 of this 
chapter prepared in accordance with the requirements of Sec.  25.40 of 
this chapter.
    FDA recognizes that many of the proposed provisions of the proposed 
rule are consistent with quality control and manufacturing practices 
that have already been voluntarily adopted by manufacturers. As a part 
of usual and customary business practices, FDA expects some baseline 
level of manufacturer compliance with the provisions of the proposed 
rule.
    FDA's burden estimates are based on the PRIA, FDA inspection 
reports, estimates of the number of deemed tobacco product 
manufacturers published in the Deeming Rule (part 1143), and 2017 data 
on permits issued to tobacco manufacturers by the Alcohol and Tobacco 
Tax and Trade Bureau. The requirements in the proposed rule would apply 
to both domestic and foreign manufacturers of finished and bulk tobacco 
products.
    As discussed in the PRIA, we estimate the number of affected 
entities, by major tobacco product group and size of operation group. 
We estimate that there is a total of 1,935 domestic entities and 3,273 
foreign entities manufacturers potentially affected by the proposed 
rule. For purposes of the PRA estimates, FDA used a weighted average of 
the median hours and entities affected to calculate the respondents and 
burden hours. These estimates are a combination of small and large 
manufacturers and foreign and domestic manufactures. The estimated 
numbers of manufacturers in the tables below represent an estimated 
average portion of all domestic and foreign tobacco product 
manufacturers by the percentage of manufacturers that are currently not 
practicing one or more of the proposed requirements set forth in the 
proposed rule.
    FDA estimates the burden of this collection of information as 
follows:

                                  Table 2--Estimated Annual Reporting Burden 1
----------------------------------------------------------------------------------------------------------------
                                                     Number of
    21 CFR part and activity        Number of      responses per     Total annual    Average burden  Total hours
                                   respondents       respondent       responses       per response
----------------------------------------------------------------------------------------------------------------
1120.40, 1120.142, and 1120.146               1                1                1               59           59
 Petition for Exemption or
 Variance and Environmental
 Assessment (EA)...............
----------------------------------------------------------------------------------------------------------------
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

    Table 2 describes the annual reporting burden as a result of the 
proposed requirements in Sec.  1120.142 for submitting petitions for 
exemption or variance (including EA). FDA believes this will be 
infrequent, so we have assigned 1 token response acknowledging the 
requirement.

[[Page 15245]]



                                                  Table 3--Estimated One-Time Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                             Number of                    Average burden
                21 CFR part and activity                     Number of      records per      One-time           per         Total hours    Total capital
                                                           recordkeepers   recordkeeper       records      recordkeeping                       costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                         One-Time Recordkeeping Burden Subpart B
--------------------------------------------------------------------------------------------------------------------------------------------------------
1120.12 Organization and personnel procedures and                  1,598               3           4,794            4.12          19,751  ..............
 training...............................................
1120.14 Tobacco product complaints......................           1,946               8          15,568            1.82          28,334  ..............
1120.16 Corrective and preventive actions...............           1,814               8          14,512            1.82          26,412  ..............
                                                         -----------------------------------------------------------------------------------------------
    Total Subpart B.....................................  ..............  ..............  ..............  ..............          74,497  ..............
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                         One-Time Recordkeeping Burden Subpart C
--------------------------------------------------------------------------------------------------------------------------------------------------------
1120.32 Personnel.......................................           1,416              67          94,872            0.59          55,974  ..............
1120.34 Buildings, facilities, and grounds..............           1,642              20          32,840            2.62          86,041  ..............
1120.36 Equipment.......................................           1,186              86         101,996            1.62         165,234  ..............
1120.38 Environment controls............................           2,965               8          23,720            2.42          57,402  ..............
                                                         -----------------------------------------------------------------------------------------------
    Total Subpart C.....................................  ..............  ..............  ..............  ..............         364,651  ..............
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                         One-Time Recordkeeping Burden Subpart D
--------------------------------------------------------------------------------------------------------------------------------------------------------
1120.42 Product development controls....................           2,853              12          34,236            2.90          99,284  ..............
1120.44 Master manufacturing record.....................           1,381              14          19,334            1.91          36,928  ..............
                                                         -----------------------------------------------------------------------------------------------
    Total Subpart D.....................................  ..............  ..............  ..............  ..............         136,212  ..............
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                         One-Time Recordkeeping Burden Subpart E
--------------------------------------------------------------------------------------------------------------------------------------------------------
1120.62 Purchasing controls.............................           2,539              17          43,163            3.39         146,323  ..............
1120.64 Acceptance activities...........................           2,029              26          52,754            1.85          97,595  ..............
1120.66 Process controls................................           1,677              35          58,695            1.84         107,999      $1,014,697
1120.68 Laboratory controls.............................           1,293               9          11,637            1.79          20,830      10,996,249
1120.70 Production record...............................           2,163               9          19,467            0.96          18,688  ..............
1120.72 Representative samples..........................           3,631               8          29,048            1.86          54,029  ..............
1120.74 Nonconforming product...........................           1,458               9          13,122            1.80          23,620  ..............
1120.76 Returned product................................           1,594               9          14,346            1.80          25,823  ..............
1120.78 Reprocessing and rework.........................           1,833               8          14,664            1.86          27,275  ..............
                                                         -----------------------------------------------------------------------------------------------
    Total Subpart E.....................................  ..............  ..............  ..............  ..............         522,182      12,010,946
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                         One-Time Recordkeeping Burden Subpart F
--------------------------------------------------------------------------------------------------------------------------------------------------------
1120.92 Packaging and labeling controls.................           1,683               8          13,464            3.34          44,970  ..............
1120.94 Repackaging and Relabeling......................           1,523               8          12,184            3.18          38,745  ..............
1120.98 Warning plans...................................           1,448               8          11,584            3.18          36,837  ..............
                                                         -----------------------------------------------------------------------------------------------
    Total Subpart F.....................................  ..............  ..............  ..............  ..............         120,552  ..............
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                         One-Time Recordkeeping Burden Subpart G
--------------------------------------------------------------------------------------------------------------------------------------------------------
1120.102 Handling and storage...........................           1,855              12          22,260            1.82          40,513  ..............
1120.104 Distribution...................................           2,028              12          24,336            1.82          44,292  ..............
                                                         -----------------------------------------------------------------------------------------------
    Total Subpart G.....................................  ..............  ..............  ..............  ..............          84,805  ..............
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                         One-Time Recordkeeping Burden Subpart H
--------------------------------------------------------------------------------------------------------------------------------------------------------
1120.124 Document controls..............................           3,155               1           3,155            6.99          22,053  ..............
                                                         -----------------------------------------------------------------------------------------------
    Total Subpart H.....................................  ..............  ..............  ..............  ..............          22,053  ..............
    Total One-Time Burden...............................  ..............  ..............  ..............  ..............       1,324,952      12,010,946
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs associated with this collection of information.


                         Table 4--Estimated Annual (Recurring) Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                    Number of                     Average burden
    21 CFR part and activity        Number of      records per    Total annual         per          Total hours
                                  recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
                                      Annual Recordkeeping Burden Subpart B
----------------------------------------------------------------------------------------------------------------
1120.12 Organization and                  1,598               3           4,794                2           9,588
 personnel Procedures and
 training......................
1120.14 Tobacco product                   1,946               8          15,568                4          62,272
 complaints....................
1120.16 Corrective and                    1,814               8          14,512                4          58,048
 preventive actions............
                                --------------------------------------------------------------------------------
    Total Subpart B............  ..............  ..............  ..............  ...............         129,908
----------------------------------------------------------------------------------------------------------------

[[Page 15246]]

 
                                      Annual Recordkeeping Burden Subpart C
----------------------------------------------------------------------------------------------------------------
1120.32 Personnel..............           1,416              67          94,872             0.03           2,846
1120.34 Buildings, facilities,            1,642              20          32,840             0.55          18,062
 and grounds...................
1120.36 Equipment..............           1,186              86         101,996             0.14          14,279
1120.38 Environment controls...           2,965               8          23,720             0.28           6,642
                                --------------------------------------------------------------------------------
    Total Subpart C............  ..............  ..............  ..............  ...............          41,829
----------------------------------------------------------------------------------------------------------------
                                      Annual Recordkeeping Burden Subpart D
----------------------------------------------------------------------------------------------------------------
1120.42 Product development               2,853              12          34,236                1          34,236
 controls......................
1120.44 Master manufacturing              1,381              14          19,334             0.36           6,960
 record........................
                                --------------------------------------------------------------------------------
    Total Subpart D............  ..............  ..............  ..............  ...............          41,196
----------------------------------------------------------------------------------------------------------------
                                      Annual Recordkeeping Burden Subpart E
----------------------------------------------------------------------------------------------------------------
1120.62 Purchasing controls....           2,539              17          43,163             0.27          11,654
1120.64 Acceptance activities..           2,029              26          52,754                1          52,754
1120.66 Process controls.......           1,677              35          58,695                1          58,695
1120.68 Laboratory controls....           1,293               9          11,637                5          58,185
1120.70 Production record......           2,163               9          19,467                3          58,401
1120.72 Representative samples.           3,631               8          29,048             0.27           7,843
1120.74 Nonconforming product..           1,458               9          13,122             4.77          62,592
1120.76 Returned product.......           1,594               9          14,346             4.37          62,692
1120.78 Reprocessing and rework           1,833               8          14,664             0.28           4,106
                                --------------------------------------------------------------------------------
    Total Subpart E............  ..............  ..............  ..............  ...............         376,922
----------------------------------------------------------------------------------------------------------------
                                      Annual Recordkeeping Burden Subpart F
----------------------------------------------------------------------------------------------------------------
1120.92 Packaging and labeling            1,683               8          13,464             0.28           3,770
 controls......................
1120.94 Repackaging and                   1,523               8          12,184             0.27           3,290
 Relabeling....................
1120.98 Warning plans..........           1,448               8          11,584             0.28           3,244
                                --------------------------------------------------------------------------------
    Total Subpart F............  ..............  ..............  ..............  ...............          10,304
----------------------------------------------------------------------------------------------------------------
                                      Annual Recordkeeping Burden Subpart G
----------------------------------------------------------------------------------------------------------------
1120.102 Handling and storage..           1,855              12          22,260             0.15           3,339
1120.104 Distribution..........           2,028              12          24,336             0.15           3,650
                                --------------------------------------------------------------------------------
    Total Subpart G............  ..............  ..............  ..............  ...............           6,989
----------------------------------------------------------------------------------------------------------------
                                      Annual Recordkeeping Burden Subpart H
----------------------------------------------------------------------------------------------------------------
1120.124 Document controls.....           3,155               1           3,155             2.66           8,392
                                --------------------------------------------------------------------------------
    Total Subpart H............  ..............  ..............  ..............  ...............           8,392
    Total Annual Burden........  ..............  ..............  ..............  ...............         615,540
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Table 3 represents the one-time recordkeeping requirements in the 
rule. FDA believes that there will be a total of 5,208 recordkeepers 
(the sum of 1,935 domestic and 3,273 foreign entities) who would keep 
records. Most of the provisions in the proposed rule require tobacco 
manufacturers to establish and maintain procedures. In table 3, the 
columns entitled ``number of recordkeepers'' and ``one-time total 
responses'' is totaled in the text, but not the chart. For economic 
purposes, the numbers in these columns are not additive because the 
numbers representing each section are not mutually exclusive. However, 
for PRA purposes these numbers are additive. We total these columns in 
the narrative for PRA purposes of describing and matching the data that 
will be submitted to OMB for approval.
    Subpart B describes the proposed requirements applicable to 
finished and bulk tobacco product manufacturers' management systems 
that cover a manufacturer's organization and personnel (Sec.  1120.12), 
tobacco product complaints (Sec.  1120.14), and CAPA (Sec.  1120.16). 
FDA estimates that under proposed subpart B 5,358 recordkeepers will 
establish a total of 34,874 one-time records for a total of 74,497 one-
time hours.
    Subpart C of the proposed rule prescribes the proposed requirements 
that are specific to personnel practices (Sec.  1120.32), building, 
facilities, and grounds (Sec.  1120.34), equipment (Sec.  1120.36), and 
environmental controls (Sec.  1120.38). FDA estimates that under 
proposed subpart C 7,209 recordkeepers

[[Page 15247]]

will establish a total of 253,428 one-time records for a total of 
364,651 one-time hours.
    Subpart D of the proposed rule prescribes the proposed requirements 
for design and development activities (Sec.  1120.42) and MMRs (Sec.  
1120.44). FDA estimates that under proposed subpart D 4,234 
recordkeepers will establish a total of 53,570 one-time records for a 
total of 136,212 one-time hours.
    Subpart E of the proposed rule prescribes the proposed requirements 
for purchasing controls (Sec.  1120.62), acceptance activities (Sec.  
1120.64), production and process controls (Sec.  1120.66), laboratory 
controls (Sec.  1120.68), production records (Sec.  1120.70), sampling 
(Sec.  1120.72), nonconforming tobacco products (Sec.  1120.74), 
returned tobacco products (Sec.  1120.76), and reprocessing and rework 
(Sec.  1120.78). FDA estimates that under proposed subpart E 18,217 
recordkeepers will establish a total of 256,896 one-time records for a 
total of 522,182 one-time hours.
    To conduct activities related to Sec. Sec.  1120.64, 1120.66, and 
1120.68, some tobacco product manufacturers may purchase capital 
equipment such as metal detectors, pH meters, thermometers, ultrasonic 
flow meters, scanners, and densimeters. We estimate one-time capital 
costs of $1,014,697 combined under Sec.  1120.64 acceptance activities 
and Sec.  1120.66 Production and process controls, and $10,996,249 
under Sec.  1120.68 Laboratory controls for a total of $12,010,946.
    Subpart F of the proposed rule prescribes the proposed requirements 
for packaging and labeling controls (Sec.  1120.92), repackaging and 
relabeling (Sec.  1120.94), and warning plans (Sec.  1120.98). FDA 
estimates that under proposed subpart F 4,654 respondents will 
establish a total of 37,232 one-time records for a total of 120,552 
one-time hours.
    Subpart G of the proposed rule prescribes the proposed requirements 
for activities associated with handling and storage (Sec.  1120.102) 
and distribution (Sec.  1120.104). FDA estimates that under proposed 
subpart G 3,883 respondents will establish a total of 46,596 one-time 
records for a total of 84,805 one-time hours.
    Proposed subpart H of the proposed rule prescribes the proposed 
general recordkeeping and document control requirements (Sec.  
1120.122). FDA estimates that under proposed subpart H 3,155 
respondents will establish a total of 3,155 one-time records for a 
total of 22,053 one-time hours.
    FDA estimates a total of 1,324,952 one-time hours and $12,010,946 
one-time capital costs.
    Table 4 estimates the annual recurring burden under the proposed 
rule. FDA believes that there will be a total of 5,208 recordkeepers 
(the sum of 1,935 domestic and 3,273 foreign entities) who would keep 
records. In table 4, the columns number of annual recordkeepers, and 
total annual responses is totaled in the text, but not in the chart. 
For economic purposes the numbers in these columns are not additive 
because the numbers representing each section are not mutually 
exclusive. However, for PRA purposes these numbers are additive. We 
total these columns in the narrative for PRA purposes of describing and 
matching the data that will be submitted to OMB for approval.
    FDA estimates that under proposed subpart B (Management System 
Requirements) 5,358 recordkeepers will maintain a total of 34,874 
records annually for a total of 129,908 annual hours.
    FDA estimates that under proposed subpart C (Buildings, Facilities, 
and Equipment) 7,209 recordkeepers will maintain a total of 253,428 
records annually for a total of 41,829 annual hours.
    FDA estimates that under proposed subpart D (Design and Development 
Controls) 4,234 recordkeepers will maintain a total of 53,570 records 
annually for a total of 41,196 annual hours.
    FDA estimates that under proposed subpart E (Process Controls) 
18,217 recordkeepers will maintain a total of 256,896 records annually 
for a total of 376,922 annual hours.
    FDA estimates that under proposed subpart F (Packaging and Labeling 
Controls) 4,654 recordkeepers will maintain a total of 37,232 records 
annually for a total of 10,304 annual hours.
    FDA estimates that under proposed subpart G (Handling, Storage and 
Distribution) 3,883 recordkeepers will maintain a total of 46,596 
records annually for a total of 6,989 annual hours.
    FDA estimates that under proposed subpart H (Recordkeeping and 
Document Controls) 3,155 recordkeepers will maintain a total of 3,155 
records annually for a total of 8,392 annual hours.
    FDA estimates a total of 615,540 annual hours for this proposed 
rule.

                           Table 5--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
   21 CFR part and activity        Number of      disclosures per    Total annual   Average  burden  Total hours
                                  respondents       respondent       disclosures    per  disclosure
----------------------------------------------------------------------------------------------------------------
1120.96 Manufacturing code....               1                 1                1                1            1
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Proposed Sec.  1120.96 would require that manufacturers apply a 
manufacturing code to the packaging and label of tobacco products. FDA 
lacks data on the percentage of manufacturers who apply such codes to 
the packaging and label of tobacco products but based on a cursory 
review of manufactured products it appears that many, if not all, 
manufacturers already apply a manufacturing code to their products. For 
purposes of the PRA, we have assigned one token burden hour for this 
activity.
    Per the requirements of this proposed rule, FDA estimates the total 
burden will be 1,940,552 hours (59 + 1 + 1,324,952 + 615,540) and 
$12,010,946 one-time capital costs.
    To ensure that comments on information collection are received, OMB 
recommends that written comments be faxed to the Office of Information 
and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, 
or emailed to [email protected]. All comments should be 
identified with the title ``Requirements for Tobacco Product 
Manufacturing Practice.''
    In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 
3407(d)), we have submitted the information collection provisions of 
this proposed rule to OMB for review. These information collection 
requirements will not be effective until FDA publishes a final rule, 
OMB approves

[[Page 15248]]

the information collection requirements, and the rule goes into effect. 
FDA will announce OMB approval of these requirements in the Federal 
Register.

VIII. Analysis of Environmental Impact

    The proposed regulation is issued pursuant to section 906(e) of the 
FD&C Act, which directs FDA to prescribe regulations requiring that the 
methods used in, and the facilities and controls used for, the 
manufacture, preproduction design validation, packing, and storage of a 
tobacco product conform to cGMP, or HACCP methodology to assure that 
the public health is protected and that the tobacco product is in 
compliance with chapter IX of the FD&C Act. Under Sec.  25.30(j), 
classes of actions that are categorically excluded include the issuance 
of cGMP and HACCP regulations. As a result, the proposed rule falls 
within a class of actions that are categorically excluded under Sec.  
25.30(j) and, therefore, ordinarily do not require the preparation of 
an EA or environmental impact statement (EIS).
    An EA or EIS is required for categorically excluded actions only if 
extraordinary circumstances indicate that the specific proposed action 
may significantly affect the quality of the human environment (Sec.  
25.21). The proposed action is of a type that does not individually or 
cumulatively have a significant effect on the human environment. The 
proposed action is not anticipated to pose the potential for serious 
harm to the environment or to adversely affect a species or the 
critical habitat of a species described in Sec.  25.21(b). Thus, FDA 
has determined that no extraordinary circumstances exist that would 
require preparation of an EA or an EIS.

IX. Federalism

    We have analyzed this proposed rule in accordance with the 
principles set forth in E.O. 13132. Section 4(a) of the E.O. requires 
Agencies to ``construe . . . a Federal statute to preempt State law 
only where the statute contains an express preemption provision or 
there is some other clear evidence that the Congress intended 
preemption of State law, or where the exercise of State authority 
conflicts with the exercise of Federal authority under the Federal 
statute.''
    Section 916(a)(2) of the FD&C Act (21 U.S.C. 387p) is an express 
preemption provision. Section 916(a)(2) provides that ``no State or 
political subdivision of a State may establish or continue in effect 
with respect to a tobacco product any requirement which is different 
from, or in addition to, any requirement under the provisions of this 
chapter relating to . . . good manufacturing standards.''
    This rule is being issued under section 906(e) of the FD&C Act, 
which directs FDA to prescribe regulations relating to good 
manufacturing practice. Thus, if this proposed rule is made final, the 
final rule would create requirements that fall within the scope of 
section 916(a)(2) of the FD&C Act.

X. Consultation and Coordination With Indian Tribal Governments

    FDA has analyzed this proposed rule in accordance with the 
principles set forth in E.O. 13175. We have tentatively concluded that 
the rule does not contain policies that would have a substantial direct 
effect on one or more Indian tribes, on the relationship between the 
Federal Government and Indian tribes, or on the distribution of power 
and responsibilities between the Federal Government and Indian tribes. 
The Agency solicits comments from tribal officials on any potential 
impact on Indian tribes from this proposed action.

XI. References

    The following references marked with an asterisk (*) are on display 
at the Dockets Management Staff (see ADDRESSES) and are available for 
viewing by interested persons between 9 a.m. and 4 p.m., Monday through 
Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public 
display at https://www.regulations.gov because they have copyright or 
other restrictions. Some may be available at the website address, if 
listed. References without asterisks are available for viewing only at 
the Dockets Management Staff. FDA has verified the website addresses, 
as of the date this document publishes in the Federal Register, but 
websites are subject to change over time.

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[IPCAL]

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List of Subjects in 21 CFR Part 1120

    Smoking, Tobacco, Reporting and recordkeeping requirements.


0
Therefore, under the Federal Food, Drug, and Cosmetic Act [LEGAL 
CITATION] and under authority delegated to the Commissioner of Food and 
Drugs, amend chapter I of title 21 of the Code of Federal Regulations 
by adding part 1120 to subchapter K to read as follows:

PART 1120--REQUIREMENTS FOR TOBACCO PRODUCT MANUFACTURING PRACTICE

Sec.
Subpart A--General Provisions
1120.1 Scope.
1120.3 Definitions.
Subpart B--Management System Requirements
1120.12 Organization and personnel.
1120.14 Tobacco product complaints.
1120.16 Corrective and preventive actions.
Subpart C--Buildings, Facilities, and Equipment
1120.32 Personnel practices.
1120.34 Buildings, facilities, and grounds.
1120.36 Equipment.
1120.38 Environmental controls.
Subpart D--Design and Development Controls
1120.42 Design and development activities.
1120.44 Master manufacturing record.
Subpart E--Process Controls
1120.62 Purchasing controls.
1120.64 Acceptance activities.

[[Page 15253]]

1120.66 Production processes and controls.
1120.68 Laboratory controls.
1120.70 Production record.
1120.72 Sampling.
1120.74 Nonconforming tobacco product.
1120.76 Returned tobacco product.
1120.78 Reprocessing and rework.
Subpart F--Packaging and Labeling Controls
1120.92 Packaging and labeling controls.
1120.94 Repackaging and relabeling.
1120.96 Manufacturing code.
1120.98 Warning plans.
Subpart G--Handling, Storage, and Distribution
1120.102 Handling and storage.
1120.104 Distribution.
Subpart H--Recordkeeping and Document Controls
1120.122 Recordkeeping and document control requirements.
Subpart I--Small Tobacco Product Manufacturers
1120.130 Compliance date for small tobacco product manufacturers.
Subpart J--Exemptions and Variances
1120.140 Exemptions and variances.
1120.142 Petition for an exemption or variance.
1120.144 Referral to the Tobacco Products Scientific Advisory 
Committee.
1120.146 Petition determination.
1120.148 Hearing.

    Authority:  21 U.S.C. 371, 21 U.S.C. 374, 21 U.S.C. 381, 21 
U.S.C. 387b, 21 U.S.C. 387c, 21 U.S.C. 387e(g), 21 U.S.C. 387f(e), 
and 21 U.S.C. 387i.

Subpart A--General Provisions


Sec.  1120.1  Scope.

    (a) This part sets forth the current tobacco product manufacturing 
practice (TPMP) requirements under the Federal Food, Drug, and Cosmetic 
Act. The requirements of this part apply to manufacturers of all 
finished and bulk tobacco products that are subject to chapter IX of 
the Federal Food, Drug, and Cosmetic Act, except finished and bulk 
accessories of cigarettes, cigarette tobacco, roll-your-own tobacco, 
smokeless tobacco, and tobacco products containing nicotine that is not 
made or derived from tobacco. Manufacturers of finished and bulk 
tobacco products include specification developers, contract 
manufacturers, and repackagers/relabelers. The requirements in this 
part govern the methods used in, and the facilities and controls used 
for, the preproduction design validation, manufacture, packing, and 
storage of finished and bulk tobacco products by finished and bulk 
tobacco product manufacturers.
    (b) If a tobacco product manufacturer engages in some operations 
subject to the requirements of this part, and not others, that 
manufacturer need only comply with those requirements applicable to the 
operations in which it is engaged.
    (c) The term ``where appropriate'' is used several times in this 
part. When a requirement is qualified with ``where appropriate,'' it is 
deemed to be appropriate unless the tobacco product manufacturer 
documents in writing an adequate justification prior to abstaining from 
implementing the requirement. An adequate justification would address 
why abstaining from the requirement would not result in a nonconforming 
tobacco product, or in the manufacturer not being able to carry out 
necessary corrective actions.
    (d) The requirements in this part are intended to protect the 
public health and assure that tobacco products are in compliance with 
the relevant provisions of the Federal Food, Drug, and Cosmetic Act. 
The failure to comply with any applicable provision in this part 
renders a product adulterated under section 902(7) of the Federal Food, 
Drug, and Cosmetic Act.


Sec.  1120.3  Definitions.

    For purposes of this part:
    Accessory means any product that is intended or reasonably expected 
to be used with or for the human consumption of a tobacco product; does 
not contain tobacco and is not made or derived from tobacco; and meets 
either of the following:
    (1) Is not intended or reasonably expected to affect or alter the 
performance, composition, constituents, or characteristics of a tobacco 
product; or
    (2) Is intended or reasonably expected to affect or maintain the 
performance, composition, constituents, or characteristics of a tobacco 
product but
    (i) Solely controls moisture and/or temperature of a stored tobacco 
product; or
    (ii) Solely provides an external heat source to initiate but not 
maintain combustion of a tobacco product.
    Additive means any substance the intended use of which results or 
may reasonably be expected to result, directly or indirectly, in its 
becoming a component or otherwise affecting the characteristic of any 
tobacco product (including any substances intended for use as a 
flavoring or coloring or in producing, manufacturing, packing, 
processing, preparing, treating, packaging, transporting, or holding), 
except that such term does not include tobacco or a pesticide chemical 
residue in or on raw tobacco or a pesticide chemical.
    Batch means a specific identified amount of a tobacco product 
produced in a unit of time or quantity and that is intended to have the 
same specifications.
    Brand means a variety of tobacco product distinguished by the 
tobacco used, tar content, nicotine content, flavoring used, size, 
filtration, packaging, logo, registered trademark, brand name(s), 
identifiable pattern of colors, or any combination of such attributes.
    Bulk tobacco product means a tobacco product not sealed in final 
packaging but otherwise suitable for consumer use as a tobacco product.
    Characteristic means the materials, ingredients, design, 
composition, heating source, or other features of a tobacco product.
    Component or part means any software or assembly of materials 
intended or reasonably expected:
    (1) To alter or affect the tobacco product's performance, 
composition, constituents, or characteristics or
    (2) To be used with or for the human consumption of a tobacco 
product. Component or part excludes anything that is an accessory of a 
tobacco product.
    Contaminated tobacco product means a tobacco product that contains 
a substance not ordinarily contained in that tobacco product. An 
example of a contaminated tobacco product is a smokeless tobacco 
product with metal fragments in the tobacco filler.
    Design means the form and structure concerning and the manner in 
which components or parts, ingredients, additives, and materials are 
integrated to produce a tobacco product.
    Direct accounts means all persons who are customers of the tobacco 
product manufacturer that receive finished or bulk tobacco products 
directly from the manufacturer or from any person under control of the 
manufacturer. Direct accounts may include wholesalers, distributors, 
and retailers. Direct accounts do not include individual purchasers of 
tobacco products for personal consumption.
    Establish and maintain means to define, document in writing, 
implement, follow, and update.
    Equipment means any machinery, tool, instrument, utensil, or other 
similar or related article, used in the manufacture, preproduction 
design validation, packing, or storage of a tobacco product.
    Finished tobacco product means a tobacco product, including any 
component or part, sealed in final packaging. Examples of finished 
tobacco products include a pack of cigarettes, a

[[Page 15254]]

can of moist snuff, and rolling papers, filters, filter tubes, or e-
liquids sold to consumers.
    Ingredient means tobacco, substances, compounds, or additives 
contained within or added to the tobacco, paper, filter, or any other 
component or part of a tobacco product, including substances and 
compounds reasonably expected to be formed through chemical action 
during tobacco product manufacturing.
    Label means a display of written, printed, or graphic matter upon 
the immediate container of any article.
    Labeling means all labels and other written, printed, or graphic 
matter:
    (1) Upon any article or any of its containers or wrappers; or
    (2) Accompanying such article.
    Management with executive responsibility means one or more 
designated personnel who have the authority and responsibility to 
ensure compliance with TPMP requirements, including allocating 
resources or making changes to the organizational structure, buildings, 
facilities, equipment, or the manufacture, preproduction design 
validation, packing, and storage of a tobacco product.
    Manual method, process, or procedure means any nonautomated method, 
process, or procedure, including processes performed by hand with or 
without the use of equipment.
    Manufacturing means the manufacturing, fabricating, assembling, 
processing, or labeling, including the repackaging or relabeling, of a 
tobacco product. Manufacturing includes establishing the specifications 
of a finished or bulk tobacco product.
    Manufacturing code means any distinctive sequence or combination of 
letters, numbers, or symbols that begins with the manufacturing date 
followed by the batch number.
    Manufacturing date means the month, day, and year in 2-digit 
numerical values in the format (MMDDYY) that a finished or bulk tobacco 
product is packaged for distribution.
    Manufacturing material means material used in or used to facilitate 
the manufacturing process that is not equipment and is not intended to 
be part of the product.
    Master manufacturing record (MMR) means a document or designated 
compilation of documents containing the established specifications for 
a tobacco product, including acceptance criteria for those 
specifications, all relevant manufacturing methods and production 
process procedures for the tobacco product, and all approved packaging, 
labeling, and labels for the tobacco product.
    Nonconforming tobacco product means any tobacco product that does 
not meet a product specification in the MMR (see Sec.  1120.44(a)(1)); 
has packaging, labeling, or labels other than those included in the MMR 
(see Sec.  1120.44(a)(3)); or is a contaminated tobacco product.
    Not normally associated means not an inherent risk of using the 
tobacco product. For example, bodily injury caused by an exploding 
electronic nicotine delivery system (ENDS) battery would be considered 
not normally associated with the use of ENDS products.
    Package or packaging means a pack, box, carton, or container of any 
kind or, if no other container, any wrapping (including cellophane), in 
which a finished tobacco product is offered for sale, sold, or 
otherwise distributed to consumers (this is also referred to as final 
package or final packaging), or in which a bulk tobacco product is 
offered for sale, sold, or otherwise distributed (including commercial 
distribution and interplant transfers).
    Personnel means all persons, including managers, staff, 
consultants, contractors, and third-party entities, performing services 
for the manufacturer subject to this part. This definition includes 
independent contractors performing services for the manufacturer.
    Relabeling means operations in which the labeling of a finished 
tobacco product is subsequently changed or replaced.
    Repackaging means operations in which the packaging of a finished 
tobacco product is subsequently changed or replaced.
    Representative sample means a sample that consists of a number of 
units that are drawn based on a valid scientific rationale (such as 
random sampling) and intended to ensure that the sample accurately 
reflects the material being sampled.
    Reprocessing means using a tobacco product that has been previously 
recovered from manufacturing in the subsequent manufacture of a 
finished or bulk tobacco product.
    Returned tobacco product means a commercially distributed finished 
or bulk tobacco product returned to the tobacco manufacturer by any 
person not under the control of the tobacco product manufacturer, 
including a wholesaler/distributor, retailer, consumer, or a member of 
the public.
    Rework means action taken on a nonconforming or returned tobacco 
product to ensure the product meets the specifications and other 
requirements of the MMR of a subsequently manufactured tobacco product 
before it is released for further manufacturing or distribution.
    Small tobacco product manufacturer means a tobacco product 
manufacturer that employs fewer than 350 employees. For purposes of 
determining the number of employees of a manufacturer under the 
preceding sentence, the employees of a manufacturer are deemed to 
include the employees of each entity that controls, is controlled by, 
or is under common control with such manufacturer.
    Specification means any requirement with which a product, process, 
service, or other activity must conform.
    Tobacco product means any product made or derived from tobacco, or 
containing nicotine from any source, that is intended for human 
consumption, including any component, part, or accessory of a tobacco 
product (except for raw materials other than tobacco used in 
manufacturing a component, part, or accessory of a tobacco product). 
The term ``tobacco product'' does not mean an article that is a drug 
under section 201(g)(1) (21 U.S.C. 321(g)(1)), a device under section 
201(h) (21 U.S.C. 321(h)), or a combination product described in 
section 503(g) of the FD&C Act (21 U.S.C. 353(g)). The term ``tobacco 
product'' does not mean an article that is a food under section 201(f) 
(21 U.S.C. 321(f)), if such article contains no nicotine, or no more 
than trace amounts of naturally occurring nicotine.
    Tobacco product-contact surface means a surface that comes into 
contact with a tobacco product and a surface from which drainage (or 
other transfer) ordinarily occurs onto the tobacco product or onto 
surfaces that come into contact with the tobacco product during the 
normal course of operations. For example, tobacco product-contact 
surfaces include surfaces of equipment that come into contact with the 
tobacco product.
    Tobacco product manufacturer means any person(s), including a 
repacker or relabeler, who: manufactures, fabricates, assembles, 
processes, or labels a tobacco product; or imports a finished tobacco 
product for sale or distribution in the United States. Tobacco product 
manufacturer includes any person(s) establishing specifications for a 
tobacco product.
    Unique identifier means information, such as a code or number, that 
is maintained for each accepted incoming tobacco product that would 
enable the tobacco product manufacturer and FDA to identify the 
supplier and unique shipment of the incoming product.

[[Page 15255]]

    Validation means confirmation by examination and objective evidence 
that the particular requirements can be consistently fulfilled.
    Verification means confirmation by examination and objective 
evidence that specified requirements have been fulfilled.

Subpart B--Management System Requirements


Sec.  1120.12  Organization and personnel.

    (a) Organization. Each finished and bulk tobacco product 
manufacturer must establish and maintain an organizational structure to 
ensure that manufacturing operations meet the requirements of this 
part.
    (b) Personnel qualifications. Each finished and bulk tobacco 
product manufacturer must have sufficient personnel to carry out the 
requirements of this part. Personnel must have the background, 
education, training, and experience, or any combination thereof, needed 
to carry out the requirements under this part. Each manufacturer must 
maintain appropriate written records of the background, education, 
training, and experience of its personnel.
    (c) Responsibility. Each finished and bulk tobacco product 
manufacturer must designate, in writing, appropriate responsibility and 
authority for all personnel who perform an activity subject to this 
part.
    (d) Management with executive responsibility. Each finished and 
bulk tobacco product manufacturer must designate, in writing, 
management with executive responsibility that has the duty, power, and 
responsibility to implement the requirements under this part. 
Management with executive responsibility must establish and maintain 
required processes and procedures to ensure compliance with the 
requirements under this part. Management with executive responsibility 
must ensure the requirements of this part are communicated, understood, 
implemented, and followed at all levels of the organization.
    (e) Training. Each finished and bulk tobacco product manufacturer 
must establish and maintain training procedures for identifying 
training needs and establishing training frequency for personnel based 
on the work the employee performs. The manufacturer must train 
personnel on their assigned responsibility and on the tobacco product 
manufacturing practice requirements relevant to their responsibility.
    (f) Records. The training records required under Sec.  1120.12(b) 
must include:
    (1) The type and description of the training;
    (2) The training date;
    (3) The names of parties performing and taking the training; and
    (4) Documentation supporting completion.


Sec.  1120.14  Tobacco product complaints.

    (a) Procedures. Each finished and bulk tobacco product manufacturer 
must establish and maintain procedures for the receipt, evaluation, 
investigation, and documentation of all complaints. The procedure must 
ensure that all complaints are:
    (1) Processed upon receipt in a uniform and timely manner;
    (2) Evaluated and, if necessary, investigated with any followup 
action taken, according to paragraphs (b) and (c) of this section; and
    (3) Documented according to paragraph (e) of this section.
    (b) Evaluation. All complaints must be evaluated to determine 
whether the complaint could be related to:
    (1) A nonconforming tobacco product;
    (2) A product design issue; or
    (3) Any adverse experience that is required to be reported under a 
regulation promulgated under section 909(a) of the Federal Food, Drug, 
and Cosmetic Act.
    (c) Investigation. (1) If the evaluation determines that the 
complaint could be related to paragraphs (b)(1) through (3) of this 
section, an investigation must be performed except as provided in 
paragraph (d) of this section.
    (2) The investigation must include:
    (i) The scope and cause of the issue;
    (ii) The risk of illness or injury posed by the issue;
    (iii) Whether any other followup action is necessary, including 
whether a corrective and preventative action is necessary under Sec.  
1120.16.
    (d) Exception. An investigation required under paragraph (c) of 
this section must be completed unless an investigation has already been 
performed for a similar complaint and the tobacco product manufacturer 
determines and documents that the previous investigation results apply 
and another investigation is not necessary.
    (e) Complaint records. Each finished and bulk tobacco product 
manufacturer must maintain complaint records. The record documenting 
the complaint, including all evaluation, investigation, and any 
followup action, must be maintained according to the procedures 
identified under paragraph (a) of this section. Complaints received 
that could be related to a nonconforming tobacco product, design 
issues, or any adverse experience that is required to be reported under 
a regulation promulgated under section 909(a) of the Federal Food, 
Drug, and Cosmetic Act, and that may result in a risk of illness, 
injury, or death not normally associated with the use of tobacco 
products must be clearly identified or separated. Complaint records 
must include the following information, if available:
    (1) Name of the product, including brand and sub-brand;
    (2) Description of the product;
    (3) Manufacturing code;
    (4) Date complaint received;
    (5) Format of complaint (i.e., oral or written);
    (6) Name, address, and phone number of complainant;
    (7) Nature and details of complaint, including how the product was 
used;
    (8) Identification of individual(s) receiving complaint;
    (9) Record of evaluation by the manufacturer including the name of 
the individual(s) performing the evaluation;
    (10) If no investigation is undertaken, the name of the 
individual(s) responsible for that decision and the rationale for the 
decision;
    (11) Investigation date(s);
    (12) Record of investigational activities performed and who 
performed the activity;
    (13) Results of investigation; and
    (14) Followup action taken, including any reply to the complainant 
or any corrective and preventive action.
    (f) Unavailable complaint records. If information identified under 
paragraph (e) of this section is unavailable, the record must include:
    (1) Documentation of the attempt(s) to obtain the information; and
    (2) Why the information is not included.


Sec.  1120.16  Corrective and preventive actions.

    (a) Procedures. Each finished and bulk tobacco product manufacturer 
must establish and maintain procedures for implementing corrective and 
preventive actions. The procedures must include requirements for:
    (1) Reviewing and analyzing processes, process control records, 
complaints, production records, returned products, reprocessed 
products, reworked products, and other sources of data to identify 
existing and potential causes of nonconforming tobacco product and 
design problems. Appropriate statistical methodology must be employed 
where necessary to detect recurring problems;

[[Page 15256]]

    (2) Investigating the cause of design problems or nonconformities 
relating to the product or manufacturing process;
    (3) Identifying and taking the action needed to correct and prevent 
the recurrence of design problems and nonconformities and other related 
problems;
    (4) Verifying or validating the corrective and preventive action to 
ensure that the action taken is effective and does not adversely affect 
the tobacco product;
    (5) Implementing and documenting changes to tobacco product 
specifications, manufacturing methods and production process 
procedures, and packaging, labeling, and labels needed to correct and 
prevent identified causes of the design problem or nonconformity; and
    (6) Disseminating information related to the design problem or 
nonconforming product and the corrective and preventive action taken 
to:
    (i) Management with executive responsibility;
    (ii) Those responsible for acceptance activities of a tobacco 
product; and
    (iii) Personnel responsible for identifying training needs in 
accordance with Sec.  1120.12(e).
    (b) Records. Each finished and bulk tobacco product manufacturer 
must maintain records of all activities conducted under this section. 
Records must include the date and time, individual performing the 
activity, any information that demonstrates the requirement was met, 
and any data or calculations necessary to reconstruct the results.

Subpart C--Buildings, Facilities, and Equipment


Sec.  1120.32  Personnel practices.

    Each finished and bulk tobacco product manufacturer must establish 
and maintain procedures for the cleanliness, personal practices, and 
apparel of personnel. Such procedures must include requirements to 
ensure that contact between the personnel and the tobacco product or 
the environment would not result in contamination of the tobacco 
product.


Sec.  1120.34  Buildings, facilities, and grounds.

    (a) Buildings and facilities. Each finished and bulk tobacco 
product manufacturer must ensure that any buildings and facilities used 
in or for the manufacture, packaging, or storage of a tobacco product 
are of suitable construction, design, and location to facilitate 
cleaning and sanitation, maintenance, and proper operations. Each 
building and facility must be maintained in an appropriate condition to 
prevent contamination. Buildings and facilities must have adequate:
    (1) Lighting;
    (2) Heating, ventilation, and cooling;
    (3) Plumbing (including control of drainage, backflow, sewage, and 
waste) to avoid being a source of contamination or creating insanitary 
conditions;
    (4) Waste collection, storage, and disposal (including not creating 
malodors that contaminate tobacco products or result in an attraction, 
harborage, or breeding place for animals and pests); and
    (5) Readily accessible handwashing and toilet facilities. The 
facilities must provide for water at suitable temperatures and 
appropriate cleaning and sanitation materials.
    (b) Grounds. Each finished and bulk tobacco product manufacturer 
must maintain facility grounds in a condition to prevent contamination.
    (c) Water. Each finished and bulk tobacco product manufacturer must 
ensure water used in the manufacturing process, including water that is 
or may become part of the tobacco product (e.g., water used as an 
ingredient or water used on tobacco product-contact surface) is 
potable, will not contaminate the tobacco product, is maintained under 
positive pressure, and is supplied from sources that comply with all 
applicable Federal, State, and local requirements.
    (d) Cleaning and sanitation. Each finished and bulk tobacco product 
manufacturer must establish and maintain procedures for the cleaning 
and sanitation of buildings, facilities, and grounds, including 
procedures for the use of any cleaning compounds, sanitizing agents, 
pesticide chemicals, rodenticides, insecticides, fungicides, fumigating 
agents, and other toxic materials.
    (1) These procedures must detail the cleaning schedules, equipment, 
and materials to be used in the cleaning and sanitizing, as 
appropriate, of the buildings, facilities, and grounds.
    (2) The procedures must include measures to ensure that materials 
used for cleaning and sanitation are identified, held, used, and stored 
in a manner to protect against contamination of tobacco products and 
tobacco product-contact surfaces.
    (3) The use of cleaning and sanitation materials must also comply 
with all applicable Federal, State, and local requirements related to 
their application, use, or storage.
    (e) Animal and pest control. Each finished and bulk tobacco product 
manufacturer must establish and maintain procedures for monitoring, 
controlling, and minimizing the presence of animals and pests in the 
buildings, facilities, and grounds to protect against contamination of 
tobacco products. These procedures must include requirements for 
establishing threshold criteria for animals and pests. The procedures 
also must include requirements that any pesticide used in the 
buildings, facilities, and grounds be registered in accordance with the 
Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 135) and 
used in accordance with its label, as applicable, and used in a manner 
that protects against contamination of the tobacco product.
    (f) Records. Each finished and bulk tobacco product manufacturer 
must maintain records of cleaning and sanitation, and animal and pest 
control activities required under this section. These records must 
include the date and time, individual performing the activity, type of 
activity performed, any information that demonstrates the requirement 
was met, and any data or calculations necessary to reconstruct the 
results.


Sec.  1120.36  Equipment.

    (a) Design and construction. Each finished and bulk tobacco product 
manufacturer must ensure that all equipment is appropriately designed 
and constructed and is suitable for its intended purpose.
    (b) Maintenance. Each finished and bulk tobacco product 
manufacturer must establish and maintain procedures, including the 
methods and schedules, for the routine cleaning and maintenance of 
equipment, to ensure proper performance of equipment and prevent 
contamination. The procedures must provide for any change over of 
tobacco product and account for changes, limitations, or adjustment to 
the equipment.
    (c) Identification. Each finished and bulk tobacco product 
manufacturer must identify (electronically, by signage, or other method 
of identification), if applicable, all processing lines and major 
equipment to be used during manufacturing to prevent mixups and 
contamination.
    (d) Testing, monitoring, and measuring equipment. (1) Each finished 
and bulk tobacco product manufacturer must establish and maintain 
procedures for all testing, monitoring, and measuring equipment to 
ensure the equipment is capable of producing accurate and reliable 
results.
    (2) All testing, monitoring, and measuring equipment must be 
identified and disabled, removed, replaced, or

[[Page 15257]]

repaired when it is no longer suitable for its intended purpose or when 
it is no longer capable of producing accurate and reliable results.
    (3) Each finished and bulk tobacco product manufacturer must 
establish and maintain procedures for the routine calibration of 
testing, monitoring, and measuring equipment. These procedures must 
describe an appropriate reference standard and include specific 
directions and acceptance criteria for the limits of accuracy and 
precision. Equipment must be calibrated:
    (i) Before its first use;
    (ii) Thereafter, at a frequency determined by the equipment 
manufacturer or at intervals necessary to ensure accurate and reliable 
results; and
    (iii) After repair or maintenance.
    (e) Records. Each finished and bulk tobacco product manufacturer 
must maintain records of all activities required under this section. 
These records must include the date and time, individual performing the 
activity, type of activity performed, any information that demonstrates 
the requirement was met, and any data or calculations necessary to 
reconstruct the results.


Sec.  1120.38  Environmental controls.

    (a) Procedures. Each finished and bulk tobacco product manufacturer 
must establish and maintain procedures to adequately control 
environmental conditions, where appropriate. Environmental control 
systems must be maintained and monitored to verify that the 
environmental controls, including necessary equipment, are adequate and 
functioning properly.
    (b) Records. Each finished and bulk tobacco product manufacturer 
must maintain records of all activities required under this section, 
including maintenance and monitoring. Records must include the date and 
time, individual performing the activity, type of activity performed, 
any information that demonstrates the requirement was met, and any data 
or calculations necessary to reconstruct the results.

Subpart D--Design and Development Controls


Sec.  1120.42  Design and development activities.

    (a) Procedures. Each finished and bulk tobacco product manufacturer 
must establish and maintain procedures to control the design and 
development of each finished and bulk tobacco product and its package, 
including the control of risks associated with the product, production 
process, packing, and storage. These procedures must include the 
following requirements:
    (1) Risk management process. These procedures must use a risk 
management process that includes the following:
    (i) Risk assessment. Each finished and bulk tobacco product 
manufacturer must perform a risk assessment that includes risk 
identification, risk analysis, and risk evaluation. Risk identification 
is identification of all known or reasonably foreseeable risks 
associated with the tobacco product and its package, as well as its 
production process, packing, and storage. Risk identification must 
include risks that may occur with normal use and with reasonably 
foreseeable misuse of a tobacco product. Risk analysis is an analysis 
of the nature and level of risk for each identified known or reasonably 
foreseeable risk that takes into account the likelihood of occurrence 
of the risk and the consequences of occurrence of the risk (i.e., 
severity of the potential harm). Risk evaluation is a determination of 
the significance of the risk and what type of risk treatment is needed.
    (ii) Risk treatment. Each finished and bulk tobacco product 
manufacturer must treat all identified risks, including risks addressed 
in applicable tobacco product standards. Risk treatment must 
significantly minimize or prevent risks:
    (A) That are reasonably likely to occur and that may cause serious 
illness, injury, or death not normally associated with the use of the 
tobacco product, or
    (B) That the manufacturer determines constitute an unacceptable 
level of risk. Risks addressed in any applicable tobacco product 
standards must be treated in a manner that ensures the tobacco product 
will conform to the specifications and requirements established in the 
tobacco product standard.
    (iii) Reassessment. Each finished and bulk tobacco product 
manufacturer must reassess the risks whenever the manufacturer becomes 
aware of new information that could change the risk assessment and risk 
treatment, including information about previously unidentified risks or 
the adequacy of risk treatment measures, in accordance with paragraphs 
(a)(1)(i) and (ii) of this section.
    (2) Design verification and validation. For finished and bulk 
tobacco products first commercially marketed or modified after the 
effective date of this rule, each finished and bulk tobacco product 
manufacturer must perform design verification to confirm that the 
tobacco product and its package meet specifications and design 
validation to assess the performance of the tobacco product;
    (3) Design approval. For finished and bulk tobacco products first 
commercially marketed or modified after the effective date of this 
rule, each finished and bulk tobacco product manufacturer must ensure 
the product and package design is approved by a designated, authorized 
individual;
    (4) Design transfer. For finished and bulk tobacco products first 
commercially marketed or modified after the effective date of this 
rule, each finished and bulk tobacco product manufacturer must transfer 
the approved product and package specifications to the master 
manufacturing record; and
    (5) Design changes. Each finished and bulk tobacco product 
manufacturer must, where appropriate, utilize the processes under 
paragraphs (a)(2) to (4) of this section for design changes before the 
changes are implemented.
    (b) Records. Each finished and bulk tobacco product manufacturer 
must maintain records of all activities required under this section. 
Records must include the date and time, individual performing the 
activity, type of activity performed, any information that demonstrates 
the requirement was met, and any data or calculations necessary to 
reconstruct the results.


Sec.  1120.44  Master manufacturing record.

    (a) Each tobacco product manufacturer must establish and maintain a 
master manufacturing record (MMR) for each finished and bulk tobacco 
product they manufacture for distribution. The MMR must include the 
following information:
    (1) Tobacco product specifications (including any physical, 
chemical, and biological specifications) and acceptance criteria for 
those specifications. The tobacco product specifications must include:
    (i) The identity and amount of any components or parts, 
ingredients, additives, and materials in the finished or bulk tobacco 
product;
    (ii) The finished or bulk tobacco product design, an identification 
of the product's heating source (if any), a discussion of intended user 
operation, and any relevant product drawings or schematics;
    (iii) Any specification necessary to ensure that the tobacco 
product meets any applicable product standard established under section 
907 of the Federal Food, Drug, and Cosmetic Act; and
    (iv) Specification(s) for pesticide chemical residue(s) for raw 
tobacco.
    (2) All relevant manufacturing methods and production process 
procedures. The manufacturing methods

[[Page 15258]]

and production process procedures must include any process controls, 
process specifications with relevant acceptance criteria, and 
monitoring and acceptance activities (inspections, testing, evaluation, 
and other verification activities); and
    (3) All packaging, labeling, and labels approved by the tobacco 
product manufacturer for use with the finished or bulk tobacco product.
    (b) Each finished and bulk tobacco product manufacturer must 
establish and maintain procedures for the review and approval of the 
MMR, including any changes made to the MMR after initial approval. 
Under these procedures, a designated, qualified individual must review 
and approve all MMR information before it is implemented in the 
manufacture of finished and bulk tobacco products for distribution. The 
designated, qualified individual's approval of the MMR must be 
documented by date, name, and signature of the individual(s) approving 
the document. The procedures for MMR review and approval must ensure 
that the designated, qualified individual confirms that any design 
activities conducted to support the tobacco product specifications have 
been completed in accordance with the product design and development 
procedures established by the manufacturer under Sec.  1120.42 and that 
the resulting production specifications are correctly transferred into 
the MMR.
    (c) The MMR must describe which methods and procedures established 
under paragraph (a)(2) of this section and related sections, including 
Sec. Sec.  1120.62 (Purchasing controls), 1120.64 (Acceptance 
activities), 1120.66 (Production processes and controls), and 1120.68 
(Laboratory controls), are used to ensure that the tobacco product is 
in conformance with each tobacco product specification established 
under paragraph (a)(1) of this section.

Subpart E--Process Controls


Sec.  1120.62  Purchasing controls.

    (a) Procedures. Each finished and bulk tobacco product manufacturer 
must establish and maintain procedures to ensure that each purchased or 
otherwise received product or service related to the manufacture of a 
finished or bulk tobacco product is from a qualified supplier and 
conforms to established specifications.
    (b) Qualification. Each finished and bulk tobacco product 
manufacturer must establish and maintain procedures for qualifying its 
suppliers. These procedures must include the following requirements for 
qualification of suppliers:
    (1) Evaluating and selecting potential suppliers based on their 
ability to meet written requirements set by the manufacturer (e.g., 
past history, onsite audits, test results);
    (2) Defining the type and extent of control to be exercised over 
selected suppliers and their product or service, based on evaluation 
results;
    (3) Developing a list of qualified suppliers and the product(s) or 
service(s) they provide, and updating this information periodically; 
and
    (4) Monitoring qualified suppliers to ensure they meet specified 
requirements and performing reevaluations as needed.
    (c) Records. Each finished and bulk tobacco product manufacturer 
must maintain records of all activities conducted under this section. 
Records must include the date and time, individual performing the 
activity, type of activity performed, any information that demonstrates 
the requirement was met, and any data or calculations necessary to 
reconstruct the results. These records also must include a written 
agreement that the supplier will notify the manufacturer of any change 
in the product or service so that the manufacturer can determine 
whether the change may affect the specifications of the finished or 
bulk tobacco product established in accordance with Sec.  
1120.44(a)(1).


Sec.  1120.64  Acceptance activities.

    (a) General. Each finished and bulk tobacco product manufacturer 
must establish and maintain procedures for acceptance activities, 
including acceptance criteria, in accordance with paragraphs (b) 
through (d) of this section.
    (b)(1) Incoming acceptance activities. The acceptance activities 
procedures must address the acceptance activities for all incoming 
products to ensure that any specifications established under Sec.  
1120.44 or through purchasing controls under Sec.  1120.62 are met and 
that such products are not contaminated or deteriorated. The incoming 
acceptance procedures must ensure that each accepted incoming tobacco 
product is designated by a unique identifier, which must be maintained 
throughout manufacturing and documented in accordance with Sec.  
1120.70(b)(5). For incoming finished or bulk tobacco product, the 
unique identifier must include or be traceable to the manufacturing 
code on the packaging or label of the finished or bulk tobacco product. 
The results of incoming acceptance activities must be reviewed and 
approved to ensure the incoming tobacco product specifications 
established under Sec.  1120.44 or through purchasing controls under 
Sec.  1120.62 are met, and that such products are not contaminated or 
deteriorated.
    (2) Pesticide chemical residue. The acceptance activities 
procedures must address the testing and acceptance of raw tobacco to 
ensure that it meets established specifications for pesticide chemical 
residue set by the manufacturer and complies with any applicable 
tolerance under Federal law.
    (3) Contamination. All incoming tobacco products must be evaluated 
for contamination or deterioration.
    (c) In-process and final acceptance activities. The acceptance 
activities procedures must address in-process and/or final acceptance 
activities to ensure that each finished or bulk tobacco product meets 
the specifications established under Sec.  1120.44. The results of 
these acceptance activities must be reviewed and approved to ensure the 
finished and bulk tobacco product specifications established under 
Sec.  1120.44 are met.
    (d) Acceptance status. Each finished and bulk tobacco product 
manufacturer must identify by suitable means the acceptance status of a 
tobacco product, indicating whether the tobacco product is a conforming 
or nonconforming tobacco product. The identification of the acceptance 
status must be maintained from receipt of incoming products throughout 
manufacturing and until the finished or bulk tobacco product passes 
required acceptance activities and is released for distribution.
    (e) Records. Each finished and bulk tobacco product manufacturer 
must maintain records of all activities required under this section. 
Records must include the date and time, individual performing the 
activity, type of activity performed, acceptance criteria, any 
information that demonstrates the requirement was met, equipment used 
if applicable, and any data or calculations necessary to reconstruct 
the results.


Sec.  1120.66  Production processes and controls.

    (a) General. Each finished and bulk tobacco product manufacturer 
must establish and maintain procedures for production processes, 
including process controls, to ensure that tobacco products conform to 
the requirements established in the MMR in accordance with Sec.  
1120.44. Production process procedures must address the following:
    (1) Production process specifications with relevant acceptance 
criteria.

[[Page 15259]]

    (2) Relevant process controls, such as any monitoring and 
acceptance activities (inspection, testing, evaluation, and other 
verification activities).
    (3) Any deviations from the production process specifications and 
established acceptance criteria, or from relevant process controls, 
must be investigated to determine if they result in a nonconforming 
tobacco product. The disposition of any product affected by a deviation 
must be documented.
    (4) All changes to production processes, including process 
controls, must be evaluated to determine their impact on the tobacco 
product specifications in the MMR. If any production process changes 
result in a change to the tobacco product specifications, the 
manufacturer must ensure that procedures applicable to changes in 
tobacco product specifications are followed in accordance with 
Sec. Sec.  1120.42 and 1120.44 and update the tobacco product 
specifications in the MMR as needed. Changes to validated processes 
must be revalidated before implementation, where appropriate.
    (b) Process validation. In addition to the requirements in 
paragraph (a) of this section, the production process procedures must 
include the following requirements for process validation, if 
applicable. If the results of a process, including automated processes, 
cannot be fully verified, a manufacturer must validate the process to 
demonstrate that it will produce a tobacco product that conforms to the 
specifications established under Sec.  1120.44(a)(1). Process 
validation must use appropriate objective measures and valid scientific 
tools and analyses to maintain the process in a state of control. The 
process validation must include the following:
    (1) Process design. Each finished and bulk tobacco product 
manufacturer must design a production process for the manufacture of 
its tobacco products. The process design must address the capability 
and functionality of the production process and establish a strategy 
for process control.
    (2) Process qualification. Each finished and bulk tobacco product 
manufacturer must perform:
    (i) Process qualification to determine if the process is capable of 
reproducible manufacturing; and
    (ii) Process performance qualification to confirm the process 
design and demonstrate that the manufacturing process performs as 
expected in accordance with established criteria, which must be 
documented in a written protocol.
    (3) Continued process verification. Each finished and bulk tobacco 
product manufacturer must monitor the production process using data 
collected from records required under this part and valid scientific 
tools to detect variability and ensure that the process remains in a 
state of control.
    (c) Additional requirements. In addition to the requirements in 
paragraph (a) of this section, the production process procedures must 
include the following requirements, if applicable:
    (1) Manual methods. If a production process includes a manual 
method or process, the production process procedures must describe the 
manual method or process in sufficient detail to ensure that the 
tobacco product meets established specifications and include if 
applicable, the criteria for workmanship using a standard or approved 
model sample.
    (2) Manufacturing material. The production process procedures must 
address the use and removal of manufacturing material if such material 
could reasonably be expected to contaminate the tobacco product or 
otherwise result in a nonconforming tobacco product.
    (d) Records. Each finished and bulk tobacco product manufacturer 
must maintain records of all activities required under this section. 
Records must include the date and time, individual performing the 
activity, type of activity performed, any information that demonstrates 
the requirement was met, and any data or calculations necessary to 
reconstruct the results.


Sec.  1120.68  Laboratory controls.

    (a) Competency. When using a laboratory to conduct activities under 
this part, each finished and bulk tobacco product manufacturer must 
demonstrate, through appropriate documentation, the laboratory's 
competence to perform laboratory activities associated with the 
manufacture of finished and bulk tobacco products.
    (b) Controls. Each finished and bulk tobacco product manufacturer 
must establish and maintain laboratory control procedures for any 
laboratory activities that are conducted under this part. Laboratory 
control procedures must include the following requirements:
    (1) Use of scientifically valid laboratory methods that are 
accurate, precise, and appropriate for their intended purpose;
    (2) Use of representative samples in accordance with Sec.  1120.72; 
and
    (3) Demonstration of analytical control.
    (c) Records. Each finished and bulk tobacco product manufacturer 
must maintain records of all activities required under this section. 
Records must include the date and time, individual performing the 
activity, type of activity performed, any information that demonstrates 
the requirement was met, and any data or calculations necessary to 
reconstruct the results.


Sec.  1120.70  Production record.

    (a) Production record. Each finished and bulk tobacco product 
manufacturer must establish and maintain procedures to ensure that a 
production record is prepared for each batch of finished or bulk 
tobacco product to demonstrate conformity with the requirements 
established in the MMR in accordance with Sec.  1120.44. Designated 
personnel must review and approve the production record for release of 
each batch of finished or bulk tobacco product into distribution.
    (b) Production record content. The production record must include, 
or refer to the location of:
    (1) The manufacturing code;
    (2) The quantity of finished or bulk tobacco product manufactured 
in the batch;
    (3) Identification of major equipment and processing lines used in 
manufacturing the batch of finished or bulk tobacco product;
    (4) Records of any activities performed under this part necessary 
to demonstrate that the batch of finished or bulk tobacco product was 
manufactured to conform with requirements established in the MMR under 
Sec.  1120.44;
    (5) All unique identifiers of all accepted incoming tobacco 
products, including components or parts, ingredients, additives, and 
materials, used in the manufacture of the batch of finished or bulk 
tobacco product;
    (6) If any finished or bulk tobacco product was used in the 
manufacturing of the batch, the manufacturing code for that finished or 
bulk tobacco product;
    (7) Actual or copies of the packaging, labeling, and labels used 
with the finished or bulk tobacco product; and
    (8) The name(s) and signature(s) of the designated individual(s) 
reviewing and approving the production record for release of the batch 
of finished or bulk tobacco product into distribution.


Sec.  1120.72  Sampling.

    For any sampling performed under this part, each tobacco product 
manufacturer must establish and maintain an adequate sampling plan

[[Page 15260]]

using representative samples. The sampling plan must include:
    (a) The intended purpose of the sampling;
    (b) The scientific technique or method used to establish the sample 
size, including an explanation of how the sample size is representative 
of the material being sampled; and
    (c) The method of sampling.


Sec.  1120.74  Nonconforming tobacco product.

    Each finished and bulk tobacco product manufacturer must establish 
and maintain procedures for the control and disposition of 
nonconforming tobacco product. The procedures must include the 
following requirements:
    (a) Identification and segregation. Each finished and bulk tobacco 
product manufacturer must identify and segregate potential 
nonconforming product in a manner that prevents mixups and use of 
potential nonconforming product prior to investigation and disposition.
    (b) Investigation. Each finished and bulk tobacco product 
manufacturer must investigate all potential nonconforming tobacco 
products.
    (1) To determine if the product is nonconforming, the investigation 
must include an examination of relevant production processes and 
controls, laboratory testing, complaints, and any other relevant 
records and sources of information.
    (2) For products determined to be nonconforming, the investigation 
must also determine:
    (i) The scope and cause of the nonconformance; and
    (ii) The risk of illness or injury posed by the nonconformance.
    (c) Disposition and followup. Each finished and bulk tobacco 
product manufacturer must determine the disposition of all 
nonconforming tobacco products and conduct any necessary followup. If 
the disposition decision is that the tobacco product can be released 
for distribution without rework, an adequate written justification must 
be provided. An adequate written justification must address why 
releasing the nonconforming product would not result in an increased 
risk of illness or injury or in the tobacco product being adulterated 
or misbranded. Nonconforming product cannot be released for 
distribution without rework or an adequate justification.
    (d) Records. Each finished and bulk tobacco product manufacturer 
must maintain records of all activities required under this section. 
Records must include the date and time of the activity, the individual 
performing the activity, the type of activity performed, any 
information that demonstrates the requirement was met, and any data or 
calculations necessary to reconstruct the results.


Sec.  1120.76  Returned tobacco product.

    (a) Procedures. Each finished and bulk tobacco product manufacturer 
must establish and maintain procedures for the control and disposition 
of returned tobacco product. The procedures must include the following 
requirements:
    (1) Identification. Each finished and bulk tobacco product 
manufacturer must identify returned tobacco product with the product 
name, manufacturing code, quantity returned, date the manufacturer 
received the returned product, and reason for the return.
    (2) Segregation. Each finished and bulk tobacco product 
manufacturer must segregate identified returned tobacco product in a 
manner that prevents mixups and use of returned product prior to 
evaluation and disposition.
    (3) Evaluation and disposition. Each finished and bulk tobacco 
product manufacturer must evaluate identified returned tobacco product 
and determine its disposition. The returned tobacco product must be 
discarded unless the manufacturer determines that it can be reworked 
under Sec.  1120.78 or released for distribution based on an adequate 
written justification.
    (b) Records. Each finished and bulk tobacco product manufacturer 
must maintain records of all activities required under this section. 
Records must include the date and time, individual performing the 
activity, type of activity performed, any information that demonstrates 
the requirement was met, and any data or calculations necessary to 
reconstruct the results. Records of evaluation and disposition must 
include the product name, manufacturing code, quantity returned, date 
the manufacturer received the returned product and reason for the 
return, disposition decision and any justification, and the name of the 
individual making the decision.


Sec.  1120.78  Reprocessing and rework.

    (a) Procedures. Each finished and bulk tobacco product manufacturer 
must establish and maintain procedures for reprocessing and reworking 
tobacco products. The procedures must include:
    (1) Evaluation of the tobacco product to determine whether the 
product is appropriate for reprocessing or rework and authorization of 
any reprocessing or rework by a designated individual. Tobacco product 
is appropriate for reprocessing if it is uncontaminated and has the 
same specifications as those in the MMR of the subsequently 
manufactured tobacco product. Tobacco product is appropriate for rework 
if further manufacturing can correct the nonconformity and the product 
can meet specifications and other requirements in the MMR of the 
subsequently manufactured tobacco product.
    (2) Production processes, including process controls, in accordance 
with Sec.  1120.66(a), and acceptance activities, in accordance with 
Sec.  1120.64(c), used to ensure the reprocessed or reworked tobacco 
product conforms to the requirements established under Sec.  1120.44 
for the subsequently manufactured tobacco product.
    (b) Records. Each finished and bulk tobacco product manufacturer 
must maintain records of all activities required under this section. 
Records must include the date and time, individual performing the 
activity, type of activity performed, any information that demonstrates 
the requirement was met, and any data or calculations necessary to 
reconstruct the results. The production record of any finished or bulk 
tobacco product that includes reprocessed or reworked product must 
include the amount, any unique identifier(s) assigned under Sec.  
1120.64(b), any batch number, and any manufacturing code associated 
with the reprocessed or reworked product.

Subpart F--Packaging and Labeling Controls


Sec.  1120.92  Packaging and labeling controls.

    (a) Procedures. Each finished and bulk tobacco product manufacturer 
must establish and maintain procedures to control packaging and 
labeling activities to prevent mixups and to ensure that all packaging 
and labeling are approved for use by the manufacturer and comply with 
all requirements of the MMR as well as all other applicable 
requirements of the Federal Food, Drug, and Cosmetic Act, the 
Comprehensive Smokeless Tobacco Health Education Act, and the Federal 
Cigarette Labeling and Advertising Act and their implementing 
regulations. The procedures must address the following:
    (1) Label integrity. Labels must be indelibly printed on or 
permanently affixed to finished and bulk tobacco product packages, so 
they remain legible, prominent, and conspicuous during the customary 
conditions of processing, packing, storage, handling, distribution, and 
use.

[[Page 15261]]

    (2) Design and construction. Each finished and bulk tobacco product 
manufacturer must ensure that:
    (i) Packaging and labeling used do not contaminate or otherwise 
render the tobacco product adulterated or misbranded; and
    (ii) Storage and shipping cases or containers of finished or bulk 
tobacco products are designed and constructed to protect against 
contamination and adulteration of the products during the customary 
conditions of storage, handling, and distribution.
    (b) Records. Each finished and bulk tobacco product manufacturer 
must maintain records of all activities required under this section. 
Records must include the date and time, individual performing the 
activity, type of activity performed, any information that demonstrates 
the requirement was met, and any data or calculations necessary to 
reconstruct the results.


Sec.  1120.94  Repackaging and relabeling.

    (a) Procedures. Each finished tobacco product manufacturer must 
establish and maintain procedures to control repackaging and relabeling 
activities. The procedures must address all requirements described in 
Sec.  1120.92.
    (b) Records. Each finished tobacco product manufacturer must 
maintain records of all activities required under this section. Records 
must include the date and time, individual performing the activity, 
type of activity performed, any information that demonstrates the 
requirement was met, and any data or calculations necessary to 
reconstruct the results.


Sec.  1120.96  Manufacturing code.

    (a) Each finished and bulk tobacco product manufacturer must apply 
a manufacturing code to the packaging or label of all finished and bulk 
tobacco products. For a finished tobacco product, the manufacturing 
code must be applied in a manner that assures it will remain on the 
packaging or label through the expected duration of use of the tobacco 
product by the consumer. For a bulk tobacco product, the manufacturing 
code must be applied in a manner that assures it will remain on the 
packaging or label until the product is received by the finished 
tobacco product manufacturer, including a packager or labeler.
    (b) The manufacturing code for each finished and bulk tobacco 
product must be permanently affixed, legible, conspicuous, and 
prominent.
    (c) The manufacturing code must contain the following information 
listed in the following order:
    (1) The manufacturing date in 2-digit numerical values in the 
month-day-year format (MMDDYY); and
    (2) The finished or bulk tobacco product batch number.


Sec.  1120.98  Warning plans.

    (a) Each finished tobacco product manufacturer required to comply 
with a warning plan for tobacco product packaging must establish and 
maintain procedures to implement the requirements of such warning plan. 
Such procedures must include requirements for inspection of packaging 
before distribution to ensure that the finished tobacco product labels 
bear the required warning statements in accordance with the warning 
plan.
    (b) Each finished tobacco product manufacturer required to comply 
with a warning plan for tobacco product packaging must maintain records 
that demonstrate that the manufacturer is in compliance with the 
warning plan.

Subpart G--Handling, Storage, and Distribution


Sec.  1120.102  Handling and storage.

    Each finished and bulk tobacco product manufacturer must establish 
and maintain procedures to ensure that tobacco products are handled and 
stored under appropriate conditions to prevent nonconforming products 
as well as mixups, deterioration, contamination, adulteration, and 
misbranding of tobacco products.


Sec.  1120.104  Distribution.

    (a) Distribution procedures. Each finished and bulk tobacco product 
manufacturer must establish and maintain procedures to ensure the 
following:
    (1) Finished and bulk tobacco products are distributed to the 
initial consignee under appropriate conditions to prevent nonconforming 
products as well as mixups, deterioration, contamination, adulteration, 
and misbranding of tobacco products; and
    (2) Only those finished and bulk tobacco products approved for 
release are distributed.
    (b) Distribution records. Each finished and bulk tobacco product 
manufacturer must maintain distribution records that include:
    (1) The name and address of the initial consignee;
    (2) The identification and quantity of finished or bulk tobacco 
products shipped;
    (3) The date shipped; and
    (4) The manufacturing code(s).
    (c) Records of direct accounts. Each finished and bulk tobacco 
product manufacturer must maintain a list of direct accounts (including 
wholesalers, distributors, and retailers), including their name, 
address, and contact information.

Subpart H--Recordkeeping and Document Controls


Sec.  1120.122  Recordkeeping and document control requirements.

    (a) All documents and records required by this part must comply 
with the following requirements:
    (1) All documents and records must be written in English, or an 
accurate English translation must be made available upon request.
    (2) All documents and records that are associated with a batch of 
finished or bulk tobacco product must be retained for a period of not 
less than 4 years from the date of distribution of the batch or until 
the product reaches its expiration date if one exists, whichever is 
later. Documents and records that are not associated with a batch of 
finished or bulk tobacco product must be retained for a period of not 
less than 4 years from the date they were last in effect.
    (3) All documents and records must be maintained at the 
manufacturing establishment or another location that is readily 
accessible to responsible officials of the tobacco product manufacturer 
and to FDA. These documents and records, including those not stored at 
the establishment, must be made readily accessible to FDA during the 
retention period for inspection and photocopying or other means of 
reproduction. Original or true copies of documents and records that can 
be immediately retrieved from another location, including by computer 
or other electronic means, meet the requirements of this paragraph.
    (b)(1) All records required by this part, regardless of storage 
medium, must be attributable, legible, contemporaneously recorded, 
original, and accurate.
    (2) For the purposes of this subpart, these terms are defined as 
the following:
    (i) Attributable. Attributable means that the data in a record is 
traceable to its source. This means it should be attributable to the 
originator of the data, whether that source is an individual, an 
automated piece of equipment, or individual operating equipment.
    (ii) Legible. Legible means the record is permanently recorded in a 
readable format. A legible record prevents loss and preserves 
traceability of changes without obscuring the original entry or 
subsequent additions or deletions.
    (iii) Contemporaneously recorded. Contemporaneously recorded means

[[Page 15262]]

that data is recorded at the time the procedure, assessment, 
observation, or other activity is performed.
    (iv) Original. Original means the record reflects the first capture 
of the data and all information related to all subsequent changes 
required to fully reconstruct the TPMP activities. An original record 
preserves the record content and the meaning of the data, including 
associated metadata. Original records may be static or dynamic. A 
static record, such as a paper record, is fixed and allows little or no 
interaction between the user and record content. Records in a dynamic 
state allow the user to interact with the information.
    (v) Accurate. Accurate means that the data in a record is correct, 
truthful, complete, valid, and reliable. All records required under 
this part, including the associated data and metadata, must be 
accurate.
    (c) Each finished and bulk tobacco product manufacturer must 
establish and maintain procedures to control all documents established 
to meet the requirements of this part. The procedures must provide for 
the following:
    (1) Document approval and distribution. Each finished and bulk 
tobacco product manufacturer must review and approve all documents 
established to meet the requirements of this part before 
implementation. The approval must include the date, name, and signature 
of the individual(s) approving the document. Documents established to 
meet the requirements of this part must be available at all locations 
for which they are designated, used, or otherwise necessary, and all 
such documents that are superseded and obsolete documents must be 
promptly removed from all points of use or otherwise prevented from 
unintended use.
    (2) Document changes. Before implementation, changes to documents 
established to meet the requirements of this part must be reviewed and 
approved by an individual(s) in the same function or part of the 
organization that performed the original review and approval. Approved 
changes must be communicated to the appropriate personnel in a timely 
manner. Superseded and obsolete documents established to meet the 
requirements of this part must be archived. Each tobacco product 
manufacturer must maintain records of changes to documents established 
to meet the requirements of this part. Change records must include:
    (i) A description of the change;
    (ii) Identification of the affected documents;
    (iii) The name and signature of the approving individual(s);
    (iv) The approval date; and
    (v) The date the change becomes effective.

Subpart I--Small Tobacco Product Manufacturers


Sec.  1120.130  Compliance date for small tobacco product 
manufacturers.

    Small tobacco product manufacturers of finished and bulk tobacco 
products shall not be required to comply with the requirements in this 
part until [DATE 4 YEARS AFTER EFFECTIVE DATE OF FINAL RULE].

Subpart J--Exemptions and Variances


Sec.  1120.140  Exemptions and variances.

    Under section 906(e)(2) of the Federal Food, Drug, and Cosmetic 
Act, any person subject to any requirement prescribed in this part may 
petition FDA for a permanent or temporary exemption or variance from 
such requirement. The petitioner remains subject to the relevant 
requirement unless FDA grants the petition for an exemption or variance 
under Sec.  1120.146. To petition for an exemption or variance, the 
petitioner must submit all information supporting the petition in an 
electronic format that FDA can process, review, and archive. If the 
petitioner is unable to submit a petition in an electronic format, the 
petitioner may submit a written request to FDA requesting FDA allowance 
of an alternative format and explaining in detail why the petitioner 
cannot submit the petition in an electronic format. Such request must 
include an explanation of why an alternative format is necessary. All 
petitions for exemptions or variances, including all supporting 
information, and all requests to submit petitions in an alternate 
format must be legible and in the English language.


Sec.  1120.142  Petition for an exemption or variance.

    A petition for an exemption or variance from a requirement in this 
part must contain:
    (a) The petitioner's name, address, and contact information;
    (b) Identification of the tobacco product(s);
    (c) The requirement(s) in this part for which an exemption or 
variance is requested;
    (d) A detailed explanation of why the exemption or variance is 
requested, including why the tobacco product manufacturer is not able 
to comply with the requirement(s) of this part;
    (e) The duration of the proposed exemption or variance;
    (f) For a petition for a variance, a detailed explanation setting 
forth the methods proposed to be used in, and the facilities and 
controls proposed to be used for, the manufacture, packing, and storage 
of the tobacco product in lieu of the requirement(s) in this part, as 
well as the basis for the petitioner's determination that the proposed 
methods will be sufficient to assure that the public health is 
protected, the tobacco product(s) will be in compliance with chapter IX 
of the Federal Food, Drug, and Cosmetic Act;
    (g) For a petition for an exemption, a detailed explanation setting 
forth the basis for the petitioner's determination that compliance with 
the requirement(s) is not required to assure that: the public health is 
protected, the tobacco product will be in compliance with chapter IX of 
the Federal Food, Drug, and Cosmetic Act;
    (h) Any other information justifying the exemption or variance;
    (i) A statement certifying that, to the best of the petitioner's 
knowledge and belief, the information provided in the petition includes 
all information and views on which the petition relies, including 
representative data, and any information known to the petitioner that 
is unfavorable to the petition; and
    (j) An environmental assessment under part 25 of this chapter 
prepared in accordance with the requirements of Sec.  25.40 of this 
chapter.


Sec.  1120.144  Referral to the Tobacco Products Scientific Advisory 
Committee.

    FDA may refer to the Tobacco Products Scientific Advisory Committee 
any petition submitted under Sec.  1120.142. The Tobacco Products 
Scientific Advisory Committee must report its recommendations to FDA 
with respect to a petition referred to it within 60 days after the date 
of the petition's referral.


Sec.  1120.146  Petition determination.

    (a) Petition for an exemption. Upon review of the information 
submitted and any recommendation from the Tobacco Products Scientific 
Advisory Committee:
    (1) FDA may approve the petition for an exemption from a 
requirement if it determines that compliance with such requirement is 
not required to assure that the tobacco product will be in compliance 
with chapter IX of the Federal Food, Drug, and Cosmetic Act.
    (2) FDA may request additional information if necessary to make a 
determination. FDA may consider the exemption request withdrawn if the 
information is not received by the time specified in the request.

[[Page 15263]]

    (b) Petition for a variance. Upon review of the information 
submitted and any recommendation from the Tobacco Products Scientific 
Advisory Committee:
    (1) FDA may approve the petition for a variance if it determines 
that the methods to be used in, and the facilities and controls to be 
used for, the manufacture, packing, and storage of the tobacco product 
in lieu of the methods, facilities, and controls prescribed by the 
requirements in this part are sufficient to assure that the tobacco 
product will be in compliance with chapter IX of the Federal Food, 
Drug, and Cosmetic Act.
    (2) FDA may request additional information if necessary to make a 
determination. FDA may consider the variance request withdrawn if the 
information is not received by the time specified in the request.
    (c) Timeframe. FDA will either grant or deny the petition within 60 
days after:
    (1) The date the complete petition was submitted to FDA under Sec.  
1120.142; or
    (2) The day after FDA referred the petition to the Tobacco Products 
Scientific Advisory Committee under Sec.  1120.144, whichever is later.
    (d) Order granting a petition for variance. An order from FDA 
granting a variance will prescribe such conditions respecting the 
methods used in, and the facilities and controls used for, the 
manufacture, packing, and storage of the tobacco product as may be 
necessary to assure that the tobacco product will be in compliance with 
chapter IX of the Federal Food, Drug, and Cosmetic Act.


Sec.  1120.148  Hearing.

    After the issuance of an order under Sec.  1120.146 respecting a 
petition, the petitioner will have an opportunity for a hearing under 
part 16 of this chapter.

    Dated: February 28, 2023.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2023-04591 Filed 3-8-23; 8:45 am]
BILLING CODE 4164-01-P


