[Federal Register Volume 85, Number 84 (Thursday, April 30, 2020)]
[Notices]
[Pages 23973-23974]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-09164]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Enforcement Priorities for Electronic Nicotine Delivery Systems 
and Other Deemed Products on the Market Without Premarket Authorization 
(Revised); 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 final guidance for industry entitled ``Enforcement 
Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other 
Deemed Products on the Market Without Premarket Authorization 
(Revised).'' This is a revision to the guidance which describes, among 
other things, how FDA intends to prioritize its enforcement resources 
with regard to the marketing of ENDS products that do not have 
premarket authorization. FDA is revising this guidance to change the 
date required to submit premarket authorization applications to the 
Agency from May 12, 2020, to September 9, 2020.

DATES: The announcement of the guidance is published in the Federal 
Register on April 30, 2020.

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-2019-D-0661 for ``Enforcement Priorities for Electronic Nicotine 
Delivery Systems (ENDS) and Other Deemed Products on the Market Without 
Premarket Authorization (Revised).'' 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.govinfo.gov/content/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, 10903 New 
Hampshire Ave., Document Control Center, 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, Center for Tobacco 
Products, Food and Drug Administration, 10903 New Hampshire Ave., 
Document Control Center, Bldg. 71, Rm. G335, Silver Spring, MD 20993-

[[Page 23974]]

0002, email: CTPRegulations@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Enforcement Priorities for Electronic Nicotine Delivery 
Systems (ENDS) and Other Deemed Products on the Market Without 
Premarket Authorization (Revised).''
    On June 22, 2009, the President signed the Family Smoking 
Prevention and Tobacco Control Act (Pub. L. 111-31) (Tobacco Control 
Act) into law. The Tobacco Control Act grants FDA authority to regulate 
the manufacture, marketing, and distribution of 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 ENDS, cigars, waterpipe (hookah) tobacco, pipe 
tobacco, nicotine gels, and dissolvables that were not already subject 
to the FD&C Act (81 FR 28974 at 28976, May 10, 2016).
    The requirements in chapter IX of the FD&C Act (21 U.S.C. 387 
through 387u) now apply to deemed tobacco products. This includes 
section 910 (21 U.S.C. 387j), which imposes 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. 
Accordingly, after the rule's effective date, deemed new tobacco 
products were required to obtain premarket authorization under section 
910 of the FD&C Act. Deemed new tobacco products that remain on the 
market without marketing authorization are marketed unlawfully in 
contravention of the Tobacco Control Act.
    On January 2, 2020, FDA issued a final guidance entitled 
``Enforcement Priorities for Electronic Nicotine Delivery Systems 
(ENDS) and Other Deemed Products on the Market Without Premarket 
Authorization'' to communicate its enforcement priorities with respect 
to ENDS products (January 7, 2020; 85 FR 720) (available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-priorities-electronic-nicotine-delivery-system-ends-and-other-deemed-products-market). It also stated that manufacturers of 
other deemed tobacco products would be required to submit marketing 
applications for those products by May 12, 2020.
    On April 22, 2020, the court granted a motion for a 120-day 
extension (until September 9, 2020) in light of the global outbreak of 
respiratory illness caused by a new coronavirus.\1\ Accordingly, FDA is 
revising the guidance to change the date required to submit premarket 
authorization applications to the Agency from May 12, 2020, to 
September 9, 2020.
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    \1\ American Academy of Pediatrics, et al. v. Food and Drug 
Administration, et al., Case No. 8:18-cv-883 (PWG), (D. Md. April 
22, 2020), Dkt. No. 182.
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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 the Agency's enforcement priorities with respect to 
ENDS products and the submission of marketing applications for other 
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.

III. Paperwork Reduction Act of 1995

    This final guidance refers to previously approved FDA collections 
of information. 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. 3501-3521). The collections of 
information in 21 CFR 1107.1(b) and (c) have been approved under OMB 
control number 0910-0684; the collections of information under section 
910 of the FD&C Act 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 guidance at either https://www.regulations.gov or 
https://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm.

    Dated: April 24, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-09164 Filed 4-29-20; 8:45 am]
 BILLING CODE 4164-01-P


