[Federal Register Volume 91, Number 91 (Tuesday, May 12, 2026)]
[Notices]
[Pages 25892-25894]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-09368]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-D-5083]
Enforcement Priorities for Certain New Tobacco Products Marketed
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, Agency, or we) is
announcing the availability of a final guidance for industry entitled
``Enforcement Priorities for Certain New Tobacco Products Marketed
Without Premarket Authorization.'' This guidance document describes
certain enforcement policies with regard to the marketing of certain
electronic nicotine delivery systems and oral nicotine pouch products
that do not have premarket authorization.
DATES: The announcement of the guidance is published in the Federal
Register on May 12, 2026.
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'').
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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-2026-D-5083 for ``Enforcement Priorities for Certain New Tobacco
Products Marketed 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, 240-402-7500.
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, 240-402-7500.
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 may be sent. See the SUPPLEMENTARY INFORMATION section for
information on electronic access to the guidance.
FOR FURTHER INFORMATION CONTACT: Samantha Rivera, Food and Drug
Administration, 10903 New Hampshire Ave., Document Control Center,
Bldg. 71, Rm. G335, Silver Spring, MD 20993-0002, 877-287-1373,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a final guidance for industry
entitled ``Enforcement Priorities for Certain New Tobacco Products
Marketed Without Premarket Authorization; Guidance for Industry.'' We
are issuing this guidance consistent with our good guidance practices
(GGP) regulation (Sec. 10.115 (21 CFR 10.115)). We are implementing
this guidance without prior public comment because we have determined
that prior public participation is not feasible or appropriate (Sec.
10.115(g)(2)). We made this determination because this guidance is
necessary to promote transparency, and to assist FDA in efficiently
allocating enforcement resources by focusing regulatory oversight on
products that are more likely to meet the applicable public health
standard. FDA's approach is intended to facilitate an orderly shift
toward a regulated market in which compliant products, supported by
appropriate evidence and subject to meaningful oversight, can replace
unauthorized offerings. FDA expects this approach to encourage the
development of applications for potentially less harmful tobacco
products and support more timely evaluation and marketing authorization
decisions for products that may benefit public health. Although this
guidance document is immediately in effect, it remains subject to
comment in accordance with FDA's GGP regulation.
The Federal Food, Drug, and Cosmetic Act (FD&C Act) provides that
new tobacco products \1\ may not legally be marketed without premarket
authorization. Accordingly, all new tobacco products, including those
that are ENDS and nicotine pouch products, on the market without
authorization are illegally marketed products. This guidance document
describes certain enforcement policies with regard to the marketing of
certain electronic nicotine delivery systems and nicotine pouch
products that do not have premarket authorization.
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\1\ Section 910 of the Federal Food, Drug, and Cosmetic Act
defines the term ``new tobacco product'' to mean ``(A) any tobacco
product (including those products in test markets) that was not
commercially marketed in the United States as of February 15, 2007;
or (B) any modification (including a change in design, any
component, any part, or any constituent, including a smoke
constituent, or in the content, delivery or form of nicotine, or any
other additive or ingredient) of a tobacco product where the
modified product was commercially marketed in the United States
after February 15, 2007.'' 21 U.S.C. 387j(a)(1).
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The guidance represents the current thinking of FDA on
``Enforcement Priorities for Certain New Tobacco Products Marketed
Without Premarket Authorization; Guidance for Industry.'' 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.
II. Paperwork Reduction Act of 1995
This 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 0910-0879. 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.
III. Electronic Access
Persons with access to the internet may obtain an electronic
version of the guidance at https://www.fda.gov/tobacco-products/rules-regulations-and-guidance-related-tobacco-products/guidance-related-tobacco-products, https://www.fda.gov/regulatory-
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information/search-fda-guidance-documents, or https://www.regulations.gov.
Lowell M. Zeta,
Deputy Commissioner for Strategic Initiatives.
[FR Doc. 2026-09368 Filed 5-8-26; 8:45 am]
BILLING CODE 4164-01-P