
[Federal Register Volume 84, Number 50 (Thursday, March 14, 2019)]
[Notices]
[Pages 9345-9346]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-04765]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-0661]


Modifications to Compliance Policy for Certain Deemed Tobacco 
Products; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Modifications 
to Compliance Policy for Certain Deemed Tobacco Products.'' The draft 
guidance discusses changes to the compliance policies for premarket 
review requirements for certain deemed tobacco products and describes 
how FDA intends to prioritize its enforcement resources with regard to 
the marketing of certain deemed tobacco products that do not have 
premarket authorization.

DATES: Submit either electronic or written comments on the draft 
guidance by April 15, 2019 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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-2019-D-0661 for ``Modifications to Compliance Policy for Certain 
Deemed Tobacco Products.'' 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 draft 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

[[Page 9346]]

adhesive label to assist that office in processing your request or 
include a fax number to which the draft guidance may be sent. See the 
SUPPLEMENTARY INFORMATION section for information on electronic access 
to the draft guidance.

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

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Modifications to Compliance Policy for Certain Deemed 
Tobacco Products.''
    The Family Smoking Prevention and Tobacco Control Act (Pub. L. 111-
31) (Tobacco Control Act) granted FDA the authority to regulate the 
manufacture, marketing, and distribution of cigarettes, cigarette 
tobacco, roll-your-own (RYO) tobacco, and smokeless tobacco products to 
protect public health generally and to reduce tobacco use by minors. 
The Tobacco Control Act also gave FDA the authority to issue 
regulations deeming other products that meet the statutory definition 
of a tobacco product to be subject to chapter IX of the Federal Food, 
Drug, and Cosmetic Act (FD&C Act).
    In accordance with that authority, on May 10, 2016, FDA issued a 
final rule entitled ``Deeming Tobacco Products to be Subject to the 
Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking 
Prevention and Tobacco Control Act; Restrictions on the Sale and 
Distribution of Tobacco Products and Required Warning Statements for 
Tobacco Products'' (the final deeming rule) deeming all products that 
meet the statutory definition of a tobacco product, except accessories 
of deemed tobacco products, to be subject to FDA's tobacco product 
authority. This included electronic nicotine delivery systems (ENDS), 
cigars, waterpipe (hookah) tobacco, pipe tobacco, nicotine gels, and 
dissolvables that were not already subject to the FD&C Act, and other 
tobacco products that may be developed in the future (81 FR 28974 at 
28976, May 10, 2016).
    Among other requirements, these statutory provisions and 
implementing regulations prohibit sales of tobacco products to minors 
and impose certain premarket-review requirements for new tobacco 
products--i.e., those that were not commercially marketed in the United 
States as of February 15, 2007. In addition, the preamble to the final 
deeming rule explained that, for deemed tobacco products on the market 
as of August 8, 2016, FDA did not intend to initiate enforcement for 
failure to have premarket authorization during two compliance periods: 
One for submission and FDA receipt of applications and one for 
obtaining premarket authorization (81 FR 28974 at 29011).
    In May 2017, FDA published a guidance document entitled ``Three-
Month Extension of Certain Tobacco Product Compliance Deadlines Related 
to the Final Deeming Rule'' under which the Agency, as a matter of 
enforcement discretion, stated its intention not to begin enforcement 
for an additional 3 months for all future compliance dates for 
requirements under the final deeming rule. In July 2017, FDA announced 
a new comprehensive plan for tobacco and nicotine regulation that would 
serve as a multiyear roadmap. In an effort to strike an appropriate 
balance between regulation and encouraging development of innovative 
tobacco products that may be less dangerous than cigarettes, the Agency 
announced that it would be providing targeted relief on some timelines 
described in the preamble to the final deeming rule. In accordance with 
this comprehensive plan announcement, in August 2017, FDA stated its 
intention to further extend the period during which it would not 
initiate enforcement action for requirements under the final deeming 
rule (``August 2017 Compliance Policy'').
    Recent data has documented a significant increase in youth use of 
ENDS products. Data from the 2018 National Youth Tobacco Survey, as 
described in the guidance, reveals the magnitude in the increase of 
youth use of ENDS products. In addition, evidence from the 2016-2017 
(Wave 4) Population Assessment of Tobacco and Health (PATH) Study and 
other studies, as described in the guidance, indicates that minors are 
attracted to flavored ENDS products. In light of this public health 
threat, FDA has reconsidered and, in its discretion, plans to modify 
the August 2017 Compliance Policy as to the premarket authorization 
requirements for certain flavored ENDS products that were on the market 
on August 8, 2016, and to replace it with a new policy as described in 
the draft guidance.
    The draft guidance is intended to discuss how FDA plans to 
prioritize its enforcement resources with regard to certain deemed 
tobacco products in the United States that do not have the required FDA 
premarket authorization for marketing. Goals of the guidance are to 
encourage more prompt filing of premarket submissions for certain ENDS 
products, to focus the Agency's enforcement resources where there is a 
greater threat to public health, and to balance that public health 
threat against the potential benefit to providing adult smokers 
noncombustible options to allow them to completely switch from the use 
of combustible products.

II. Significance of Draft Guidance

    FDA is issuing this draft guidance consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on the compliance 
policy for certain deemed tobacco products. 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. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR 1107.1(b) and (c) have been 
approved under 0910-0684; the collections of information under section 
910 of the FD&C Act (21 U.S.C. 387j) have been approved under OMB 
control number 0910-0768. The collections of information in section 
905(j) of the FD&C Act (21 U.S.C. 387e(j)) have been approved under OMB 
control number 0910-0673.

IV. Electronic Access

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

    Dated: March 11, 2019.
Scott Gottlieb,
Commissioner of Food and Drugs.
[FR Doc. 2019-04765 Filed 3-13-19; 8:45 am]
BILLING CODE 4164-01-P


