
[Federal Register Volume 84, Number 57 (Monday, March 25, 2019)]
[Notices]
[Pages 11108-11109]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-05656]



[[Page 11108]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-0120]


Interpretation of and Compliance Policy for Certain Label 
Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic 
Act Requirements to Vape Shops; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a final guidance for industry entitled ``Interpretation 
of and Compliance Policy for Certain Label Requirement; Applicability 
of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape 
Shops.'' This guidance provides FDA's interpretation of, and a 
compliance policy for, the requirement that the label of tobacco 
products contain an accurate statement of the percentage of foreign and 
domestic grown tobacco under the Federal Food, Drug, and Cosmetic Act 
(FD&C Act). This guidance document is also intended to assist retailers 
who sell deemed products by explaining whether engaging in certain 
activities subjects such establishments to additional requirements of 
the FD&C Act and the limited circumstances under which FDA does not 
intend to enforce compliance.

DATES: The announcement of the guidance is published in the Federal 
Register on March 25, 2019.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

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-2017-D-0120 for ``Interpretation of and Compliance Policy for 
Certain Label Requirement; Applicability of Certain Federal Food, Drug, 
and Cosmetic Act Requirements to Vape Shops.'' 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.
     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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    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.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the 
Center for Tobacco Products, Food and Drug Administration, Document 
Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver 
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist 
that office in processing your request or include a Fax number to which 
the guidance document may be sent. See the SUPPLEMENTARY INFORMATION 
section for information on electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT: Gerie Voss or Annette Marthaler, 
Center for Tobacco Products, Food and Drug Administration, Document 
Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver 
Spring, MD 20993-0002, 1-877-287-1373, email: 
CTPRegulations@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    We are announcing the availability of a guidance for industry 
entitled ``Interpretation of and Compliance Policy for Certain Label 
Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic 
Act Requirements to Vape Shops.'' This guidance finalizes the draft 
guidance of the same title, which was made available for public comment 
as noted in the Federal Register of January 17, 2017 (82 FR 4893).
    This guidance document provides FDA's interpretation of, and a 
compliance policy for, the label requirement under section 903(a)(2)(C) 
of the FD&C Act (21 U.S.C. 387c(a)(2)(C)). This guidance document is 
also intended to assist retailers who

[[Page 11109]]

sell deemed products by explaining whether engaging in certain 
activities subjects such establishments to additional requirements of 
the FD&C Act and the limited circumstances under which FDA does not 
intend to enforce compliance.
    The Family Smoking Prevention and Tobacco Control Act (Pub. L. 111-
31) (Tobacco Control Act), enacted on June 22, 2009, amends the FD&C 
Act and provides FDA with the authority to regulate the manufacture, 
marketing, and distribution of tobacco products to protect the public 
health generally and to reduce tobacco use by minors.
    Cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless 
tobacco were immediately covered by FDA's tobacco product authorities 
in chapter IX of the FD&C Act, when the Tobacco Control Act went into 
effect. As for other types of tobacco products, section 901(b) of the 
FD&C Act (21 U.S.C. 387a(b)) grants FDA authority to deem those 
products subject to chapter IX of the FD&C Act. Pursuant to that 
authority, FDA issued a rule deeming all other products that meet the 
statutory definition of ``tobacco product,'' set forth in section 
201(rr) of the FD&C Act (21 U.S.C. 321(rr)), except for accessories of 
those products, as subject to chapter IX of the FD&C Act (21 U.S.C. 387 
through 387u) (81 FR 28974). FDA published the final rule on May 10, 
2016, and it became effective on August 8, 2016.
    Section 903(a)(2)(C) of the FD&C Act provides that a tobacco 
product in package form is misbranded unless its label contains ``an 
accurate statement of the percentage of tobacco used in the product 
that is domestically grown tobacco and the percentage that is foreign 
grown tobacco.'' The guidance provides FDA's interpretation of, and a 
compliance policy for, this label requirement.
    Retail establishments, such as vape shops, which engage in certain 
activities may also be subject to certain requirements of the FD&C Act 
that apply to tobacco product manufacturers and to establishments that 
engage in the manufacture, preparation, compounding, or processing of 
tobacco products. These activities may also include modifying a product 
so that it is a new tobacco product requiring compliance with the 
premarket authorization requirements. This guidance explains which 
activities subject vape shops to these FD&C Act requirements and the 
limited circumstances under which FDA does not intend to enforce 
compliance.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on this topic. It does not establish any rights 
for any person and is not binding on FDA or the public. You can use an 
alternative approach if it satisfies the requirements of the applicable 
statutes and regulations. This guidance is not subject to Executive 
Order 12866.

III. Electronic Access

    Persons with access to the internet may obtain an electronic 
version of the guidance at either https://www.regulations.gov or 
https://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm.

    Dated: March 20, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-05656 Filed 3-22-19; 8:45 am]
 BILLING CODE 4164-01-P


