[Federal Register Volume 85, Number 4 (Tuesday, January 7, 2020)]
[Notices]
[Pages 720-722]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-28539]


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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; 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.'' The 
guidance 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.

DATES: The announcement of the guidance is published in the Federal 
Register on January 7, 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 ``Marketing of Unauthorized Deemed Tobacco 
Products: Enforcement Priorities for Certain Deemed Products on the 
Market Without Premarket Authorization.'' 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

[[Page 721]]

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, 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, 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 guidance for industry 
entitled ``Enforcement Priorities for Electronic Nicotine Delivery 
Systems (ENDS) and Other Deemed Products on the Market Without 
Premarket Authorization.''
    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 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 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. In addition, the preamble to 
the final deeming rule explained that, for deemed tobacco products on 
the market as of August 8, 2016, FDA intended to defer 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 to defer enforcement of 
any future compliance dates for requirements under the final deeming 
rule for an additional 3 months. 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 significantly reduce tobacco-
related disease and death. One aspect of the plan involved striking a 
balance between regulation and encouraging development of innovative 
tobacco products that may be potentially less harmful than cigarettes. 
The Agency announced that it planned to issue an updated compliance 
policy further deferring some enforcement timelines described in the 
final deeming rule. In accordance with this comprehensive plan, in 
August 2017, FDA stated its intention to further extend the period 
during which it did not intend to initiate enforcement action for the 
premarket review requirements under the final deeming rule (``August 
2017 Compliance Policy'').
    In March 2018, in American Academy of Pediatrics, et al. v. Food 
and Drug Administration, et al., the August 2017 Compliance Policy was 
challenged in the U.S. District Court for the District of Maryland, and 
on May 15, 2019, the court issued an order that vacated the 
guidance.\1\ On July 12, 2019, the court issued a further order 
directing FDA to require that premarket authorization applications for 
all new deemed tobacco products be submitted to the Agency within 10 
months, by May 12, 2020, and providing for a 1-year period during which 
products with timely applications might remain on the market pending 
FDA review.\2\ As required by the court's order, deemed new tobacco 
products on the market as of August 8, 2016, for which premarket 
authorization applications are not filed by May 12, 2020, are subject 
to FDA enforcement actions, in the Agency's discretion. The court 
subsequently clarified that its order did not restrict FDA's authority 
to enforce the premarket review provisions against deemed products, or 
categories of

[[Page 722]]

deemed products, prior to May 12, 2020, or during the one-year review 
period.
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    \1\ American Academy of Pediatrics, et al. v. Food and Drug 
Administration, et al., 379 F. Supp. 3d 461, 496 (D. Md. 2019).
    \2\ American Academy of Pediatrics, et al. v. Food and Drug 
Administration, et al., No. 8:18-cv-883 (PWG), 2019 WL 3067492, at 
*7 (D. Md. July 12, 2019) (Dkt. No. 127).
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    Since issuing the August 2017 Compliance Policy, FDA has received 
information underscoring the problem of youth use of ENDS products, as 
well as evidence of other new and continued public health concerns 
related to ENDS products. For example, data from the 2018 National 
Youth Tobacco Survey (NYTS), as described throughout the guidance, 
documented a significant increase in youth use of ENDS products and 
revealed the magnitude of the problem. These data prompted FDA to issue 
a draft guidance regarding the continued marketing of deemed tobacco 
products that had not obtained premarket authorization, and to call on 
industry to do more to keep their products out of the hands of minors. 
In March 2019, FDA published a draft guidance entitled ``Modifications 
to Compliance Policy for Certain Deemed Tobacco Products'' (``March 
2019 Draft Guidance''), which discussed the Agency's plan to modify the 
August 2017 Compliance Policy and prioritize enforcement of the 
premarket authorization requirements for certain deemed tobacco 
products.
    Recent data show a second consecutive year with an alarming 
increase in youth use of ENDS products. In 2019, two of the largest 
surveys of tobacco use among youth found that e-cigarette use has 
reached the highest levels ever recorded. The 2019 Monitoring the 
Future Study shows that e-cigarette use among 8th, 10th, and 12th 
graders who had used ENDS products during the previous 12 months and 
those who had ever used ENDS products significantly increased from 2018 
to 2019. Data from the 2019 NYTS also show that 2019 was the second 
consecutive year in which current (past 30-day) e-cigarette use among 
youth reached unprecedented levels. Evidence from the 2016-2017 (Wave 
4) Population Assessment of Tobacco and Health Study and other studies, 
as described in the guidance, further confirms these trends, including 
that youth are particularly attracted to flavored ENDS products.
    Moreover, recent data indicate that youth overwhelmingly prefer 
cartridge-based ENDS products, which FDA has found are easy to conceal, 
can be used discreetly, may have a high nicotine content, and are 
manufactured on a large scale. The 2019 NYTS survey instrument included 
a measure for the ``usual brand'' of e-cigarette used in the past 30 
days, and the majority of youth who were current e-cigarette users 
reported a cartridge-based e-cigarette as their usual brand.
    Finally, FDA remains concerned about health and safety issues 
connected to ENDS products--e.g., cases of lung injuries associated 
with use of vaping products as well as battery explosions with ENDS 
products--particularly given that all of these products have been 
marketed without premarket authorization. These current public health 
issues affirm the importance of the premarket review process, as 
contemplated by the Tobacco Control Act, to scientifically evaluate 
products based on a public health standard. For example, FDA review of 
premarket tobacco product applications considers the risks and benefits 
of the product to the population as a whole, including tobacco product 
users and non-users. In reviewing premarket tobacco product 
applications, FDA will consider, among other things: The product's 
components, ingredients, additives, and properties; manufacturing 
practices; and any studies or investigations into the health risks of 
the tobacco product.
    The Agency views the dramatic increase in youth use of these 
products as a problem that requires an urgent response. Accordingly, 
FDA is issuing this final guidance to communicate its enforcement 
priorities with respect to ENDS products. FDA would adopt these 
enforcement priorities for ENDS regardless of the decision of the U.S. 
District Court for the District of Maryland in American Academy of 
Pediatrics, et al. v. Food and Drug Administration, et al.\3\ 
Additionally, as described in the guidance, consistent with the court's 
order, manufacturers of other deemed new tobacco products will be 
required to submit marketing applications for those products by May 12, 
2020.\4\
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    \3\ American Academy of Pediatrics, et al. v. Food and Drug 
Administration, et al., 379 F. Supp. 3d 461, 496 (D. Md. 2019).
    \4\ American Academy of Pediatrics, et al. v. Food and Drug 
Administration, et al., No. 8:18-cv-883 (PWG), 2019 WL 3067492, at 
*7 (D. Md. July 12, 2019) (Dkt. No. 127).
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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 for premarket 
review requirements for certain deemed tobacco products and describes 
how the Agency intends to prioritize its enforcement resources with 
regard to the marketing of certain deemed tobacco products that do not 
have premarket authorization. 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 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. 3501-3521). 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/tobacco-products/products-guidance-regulations/rules-regulations-and-guidance.

    Dated: December 31, 2019.
Stephen M. Hahn,
Commissioner of Food and Drugs.
[FR Doc. 2019-28539 Filed 1-3-20; 8:45 am]
 BILLING CODE 4164-01-P