[Federal Register Volume 91, Number 47 (Wednesday, March 11, 2026)]
[Notices]
[Pages 11980-11981]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-04732]
[[Page 11980]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-D-1817]
Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket
Applications--Considerations Related to Youth Risk; Draft Guidance for
Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability; request for comment.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft document entitled ``Flavored Electronic
Nicotine Delivery Systems (ENDS) Premarket Applications--Considerations
Related to Youth Risk; Draft Guidance for Industry.'' The draft
document describes FDA's current thinking and provides recommendations
regarding evidentiary considerations for premarket tobacco product
applications (PMTAs) for flavored ENDS submitted under section 910 of
the Federal Food, Drug, and Cosmetic Act (FD&C Act).
DATES: Submit either electronic or written comments on the draft
guidance by May 11, 2026 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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-2026-D-1817 for ``Flavored Electronic Nicotine Delivery Systems
(ENDS) Premarket Applications--Considerations Related to Youth Risk;
Draft Guidance for Industry.'' 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, 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 electronic access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Samantha Rivera, Food and Drug
Administration, Document Control Center, Bldg. 71, Rm. G335, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002, 877-287-1373,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft document entitled
``Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket
Applications--Considerations Related to Youth Risk; Draft Guidance for
Industry.''
This draft guidance, when final, is intended to assist persons
submitting premarket tobacco product applications (PMTAs) for
electronic nicotine delivery systems (ENDS) under section 910 of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 387j). The
draft guidance, when final, will describe FDA's current thinking on
evidentiary considerations relevant to determining whether the
marketing of a flavored ENDS product would be ``appropriate for the
protection of the public health'' (APPH), including how FDA generally
evaluates the risks and benefits of flavored ENDS to the population as
a whole, with particular attention to youth initiation and use.
The draft guidance reflects FDA's concerns regarding the known and
substantial risk of youth initiation and use associated with certain
flavored ENDS products, especially fruit and candy/dessert/other sweet
flavored
[[Page 11981]]
products, and it is intended to provide additional clarity regarding
FDA's risk-proportionate, product-specific approach to assessing non-
tobacco flavors. FDA recognizes that ENDS products with flavors other
than tobacco may, in certain circumstances, provide benefits to adults
who smoke combusted cigarettes, including by facilitating switching
away from combusted tobacco products, increasing quit attempts,
supporting sustained smoking abstinence, and reducing cigarette
consumption among adults who would otherwise continue smoking. Emerging
evidence indicates that many adult smokers who use ENDS products to
transition away from combusted cigarettes report a preference for non-
tobacco flavors. The draft guidance discusses the scientific evidence
FDA may consider regarding differential youth appeal and initiation
risks across flavor categories and the types of evidence that may be
relevant to demonstrating adult benefit (e.g., complete switching or
substantial reduction in combusted cigarette use), including examples
of study designs and methods that may help characterize youth appeal
and adult orientation of flavors. As FDA gains experience that would be
broadly applicable, FDA will consider issuing further guidance in this
area, which may include generating scientifically valid evidence
characterizing the relative appeal of non-tobacco flavors.
This draft guidance is being issued 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 ``Flavored
Electronic Nicotine Delivery Systems (ENDS) Premarket Applications--
Considerations Related to Youth Risk.'' 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.
As we develop any final guidance on this topic, FDA will consider
comments on costs or cost savings the guidance may generate, relevant
for Executive Order 14192.
II. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
in 21 CFR 1114 relating to the submission of Premarket Tobacco Product
Applications have been approved under OMB control number 0910-0879.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at https://www.regulations.gov, https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/guidance, or https://www.fda.gov/regulatory-information/search-fda-guidance-documents.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-04732 Filed 3-9-26; 11:15 am]
BILLING CODE 4164-01-P