[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]
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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Products; Draft Guidance for Industry; Availability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.
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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availability of a draft guidance for industry entitled ``Modifications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 The draft
guidance discusses changes to the compliance policies for premarket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DATES: Submit either electronic or written comments on the draft
guidance by April 15, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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: [email protected].
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]
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