Federal & State Lawfederalstatelaw.com
Home/Federal/Federal Register/2025-23851
Notice2025-23851

Roundtable on Premarket Tobacco Application Submissions for Electronic Nicotine Delivery Systems Products; Notice of Meeting; Establishment of a Public Docket; Request for Comments

Primary source

Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.

Published
December 29, 2025

Issuing agencies

Health and Human Services DepartmentFood and Drug Administration

Abstract

The Food and Drug Administration (FDA, the Agency, or we) is announcing a roundtable discussion with small tobacco product manufacturers to solicit input on premarket tobacco product application (PMTA) submissions for electronic nicotine delivery systems (ENDS) products. The topics to be discussed will include certain components of PMTAs such as product characterization, manufacturing controls, pharmacological profile (e.g., pharmacokinetic studies), studies of adult benefit (e.g., longitudinal cohort/randomized controlled trial (RCT) studies), and toxicological profile (e.g., estimated lifetime cancer risk). The purpose of the roundtable is to provide manufacturers an opportunity to share their experience with, and other opinions about, the premarket application process. This notice provides information on meeting participation and selection. FDA is establishing a docket for public comments related to the roundtable meeting.

Full Text

<html>
<head>
<title>Federal Register, Volume 90 Issue 245 (Monday, December 29, 2025)</title>
</head>
<body><pre>
[Federal Register Volume 90, Number 245 (Monday, December 29, 2025)]
[Notices]
[Pages 60715-60717]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-23851]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2025-N-7022]


Roundtable on Premarket Tobacco Application Submissions for 
Electronic Nicotine Delivery Systems Products; Notice of Meeting; 
Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of roundtable discussion; establishment of a public 
docket; request for comments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing a roundtable discussion with small tobacco product 
manufacturers to solicit input on premarket tobacco product application 
(PMTA) submissions for electronic nicotine delivery systems (ENDS) 
products. The topics to be discussed will include certain components of 
PMTAs such as product characterization, manufacturing controls, 
pharmacological profile (e.g., pharmacokinetic studies), studies of 
adult benefit (e.g., longitudinal cohort/randomized controlled trial 
(RCT) studies), and toxicological profile (e.g., estimated lifetime 
cancer risk). The purpose of the roundtable is to provide manufacturers 
an opportunity to share their experience with, and other opinions 
about, the premarket application process. This notice provides 
information on meeting participation and selection. FDA is establishing 
a docket for public comments related to the roundtable meeting.

DATES: The roundtable meeting will be held on February 10, 2026, 9:00 
a.m. to 5 p.m., Eastern Time. Electronic or written comments on the 
roundtable may be submitted beginning December 29, 2025. See the 
SUPPLEMENTARY INFORMATION section for registration date and 
information.

ADDRESSES: The roundtable meeting will be held in the White Oak Great 
Room and virtually. Entrance for the roundtable panelists (non-FDA 
employees) is through Building 1 where routine security check 
procedures will be performed. For parking and security information, 
please refer to <a href="https://www.fda.gov/about-fda/visitor-information">https://www.fda.gov/about-fda/visitor-information</a>.
    You may submit comments as follows. Please note that late, untimely 
filed comments will not be considered. Electronic comments must be 
submitted on or before February 3, 2026, to be considered for the 
roundtable discussion. All other electronic comments must be submitted 
on or before March 12, 2026. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic 
filing system will accept comments until 11:59 p.m. Eastern Time at the 
end of March 12, 2026. Comments received by mail/hand delivery/courier 
(for written/paper submissions) will be considered timely if they are 
received on or before these dates.
    The public can submit comments on the roundtable topics during the 
open comment period; the request for comments is not limited to small 
tobacco product manufacturers.
    You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
    <bullet> 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:
    <bullet> 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.
    <bullet> 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-2025-N-7022 for ``Roundtable on Premarket Tobacco Application 
Submissions for Electronic Nicotine Delivery Systems Products; Notice 
of Meeting; Establishment of a Public Docket; Request for Comments.'' 
Received, timely comments (see ADDRESSES) will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
    <bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 
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: <a href="https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
    Docket: For access to the docket to read the electronic and 
written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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.

[[Page 60716]]


FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of 
Regulations, Center for Tobacco Products, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993-
0002, 1-877-287-1373, email: <a href="/cdn-cgi/l/email-protection#b1f2e5e1e3d4d6c4ddd0c5d8dedfc2f1d7d5d09fd9d9c29fd6dec7"><span class="__cf_email__" data-cfemail="27647377754240524b46534e48495467414346094f4f5409404851">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Background

    Tobacco products that meet the definition of a ``new tobacco 
product,'' and that an applicant intends to market in the United 
States, including ENDS, are subject to the requirements for a PMTA set 
forth in section 910(b) of the Federal Food, Drug, and Cosmetic Act 
(FD&C Act). When reviewing PMTAs, the Agency evaluates, among other 
things, a tobacco product's components, ingredients, additives, 
constituents, design, harmful and potentially harmful constituents 
(HPHCs), and health risks, as well as how the product is manufactured, 
packaged, and labeled. After reviewing a company's PMTA, FDA determines 
if the application includes or lacks sufficient evidence to demonstrate 
that permitting the marketing of the products would be appropriate for 
the protection of the public health (APPH), which is the applicable 
legal standard required by the FD&C Act (see section 910(c) of the FD&C 
Act).
    Through this notice, FDA announces a roundtable discussion to 
gather feedback from small tobacco product manufacturers (see 21 U.S.C. 
387(16)) about their experience with, and other opinions about, the 
premarket application process. The topics to be discussed will include 
certain components of PMTAs such as product characterization, 
manufacturing controls, pharmacological profile (e.g., pharmacokinetic 
studies), studies of adult benefit (e.g., longitudinal cohort/
randomized controlled trial (RCT) studies), and toxicological profile 
(e.g., estimated lifetime cancer risk (ELCR)). FDA also is establishing 
a public docket to solicit comment on these topics.

II. Topics for Discussion at the Roundtable and for the Request for 
Comments

    The purpose of the roundtable is to provide small ENDS 
manufacturers an opportunity to share their experience and other 
opinions about the premarket application process. Roundtable topics to 
be discussed include certain components of ENDS PMTAs, such as product 
characterization, manufacturing controls, pharmacological profile 
(e.g., pharmacokinetic studies), studies of adult benefit (e.g., 
longitudinal cohort/RCT studies), and toxicological profile (e.g., 
ELCR).

A. Product Characterization

    The foundational information necessary to evaluate the quality and 
consistency of a new tobacco product is based on an understanding of 
the product as delivered to the user. One of the critical pieces of 
information is a complete product listing and description, including 
details of the product design. Also included in ENDS product 
characterization is the measurement of constituents in the aerosol, 
including HPHCs, which provide details of a user's exposure to nicotine 
and other potentially harmful ingredients. This roundtable will discuss 
the types of information needed to fully characterize a product in an 
application and can cover topics including product formulation, 
validation of analytical measurements, and the assessment of leachables 
and extractables, where appropriate.

B. Manufacturing Controls

    In addition to product characterization, a complete understanding 
of a manufacturer's internal controls and practices is important for 
FDA to ensure that products delivered to a user will be sufficiently 
similar to the products that were tested and that form the basis of our 
scientific assessment of nicotine and potential toxic constituent 
exposure from the new product. This information includes standard 
operating procedures (SOPs); work instructions; certificates of 
analysis; the linkage between label claim and actual measured nicotine 
delivery; and stability of new products during storage, transport, and 
shelf life, and these are all topics which may be covered and discussed 
in the roundtable.

C. Pharmacological Profile (e.g., Pharmacokinetic Studies)

    One of the most important aspects of FDA's evaluation of APPH for a 
new tobacco product focuses on the abuse liability of the new tobacco 
product including the delivery and uptake of nicotine by a user of the 
product. Nicotine exposure typically is evaluated through clinical 
studies that evaluate nicotine pharmacokinetics after use of the new 
tobacco product. Occasionally, it is possible to bridge the findings of 
one ENDS product to another, thus allowing a reduction in the number of 
studies needed to support a product. However, the proper designs of 
these clinical studies for ENDS products can be complex and need to be 
highly developed before work is initiated. This roundtable will address 
criteria that could improve the quality of the clinical studies for 
ENDS products submitted by applicants and provide participants an 
opportunity to ask questions about design basics to inform their 
applications.

D. Studies of Adult Benefit (e.g., Longitudinal Cohort/RCT Studies)

    The understanding of the potential benefits that a new ENDS tobacco 
product may offer to users of combusted tobacco products by switching 
to the new ENDS tobacco product is critical to FDA's APPH 
determination. Examples of population studies to assess switching 
include longitudinal cohort studies or randomized controlled trials of 
the new tobacco product with adult users. This roundtable will include 
a discussion of the critical considerations in the design and 
administration of these adult benefit studies.

E. Toxicological Profile (e.g., ELCR)

    The toxicological assessment of a new tobacco product application 
for APPH includes a careful evaluation of critical elements of 
potential and actual risk posed by the use of the product. These 
critical elements typically include, among other topics, the hazard 
identification and associated risk assessment of HPHCs found in the 
aerosol of ENDS products and the risks associated with constituents in 
a new product. This roundtable will discuss approaches that an 
applicant could use to evaluate their products for potential risks from 
a genotoxicity approach (ELCR), inhalation toxicity, and HPHC exposure.

III. Participating in the Roundtable and Selection of Participants

    Registration for the roundtable is open to small tobacco product 
manufacturers as defined in section 900(16) of the FD&C Act. The term 
``small tobacco product manufacturer'' means a tobacco product 
manufacturer that employs fewer than 350 employees. For purposes of 
determining the number of employees of a manufacturer under the 
preceding sentence, the employees of a manufacturer are deemed to 
include the employees of each entity that controls, is controlled by, 
or is under common control with such manufacturer. For example, if a 
parent company owns two subsidiaries, the total number of employees 
would include the employees in the parent company plus the number of 
employees in the two subsidiaries. Additionally, registration for 
participation in the roundtable will be limited to 30 participants

[[Page 60717]]

representing manufacturers who have previously submitted an ENDS PMTA, 
including those with a PMTA currently pending with FDA. Final 
eligibility for attendance will be determined by FDA. Participants 
should be at a sufficiently senior level with significant scientific 
and/or regulatory responsibility to be knowledgeable about their 
company's PMTA.
    Registration: Registration is free. For information on how to 
register for the roundtable as a panelist, please visit the following 
website: <a href="https://www.fda.gov/tobacco-products/ctp-newsroom/february-10-2026-roundtable-premarket-tobacco-application-submissions-electronic-nicotine-delivery">https://www.fda.gov/tobacco-products/ctp-newsroom/february-10-2026-roundtable-premarket-tobacco-application-submissions-electronic-nicotine-delivery</a>, by January 27, 2026, 11:59 p.m. Eastern Time. 
Registrants should include the following information for the attendee 
in their request to participate in the roundtable:
    <bullet> Name of proposed attendee, job title, address, email, and 
telephone number
    <bullet> Name of company and brief company description
    <bullet> How many people the company employs (including 
subsidiaries)
    <bullet> Indicate which of the 5 topics you wish to discuss as a 
panel member (you may select multiple topics):
    A. Product Characterization
    B. Manufacturing Controls
    C. Pharmacological Profile
    D. Studies of Adult Benefit
    E. Toxicological Profile
    Registration for panelists is on a rolling basis determined by 
space availability, with priority given to early registrants. FDA will 
evaluate registrations based on the submitted information until a 
maximum of 30 participants have been selected for the roundtable and 
will then inform applicants of selection decisions. Due to time and 
space constraints, there is a limit of one person to represent and 
speak on behalf of each company. Panel registrants will receive 
confirmation as to whether they have been accepted. If panelist 
registration closes prior to the submission deadline, we will update 
the website to reflect that change. For persons interested in viewing 
the roundtable virtually, information will be provided on our website: 
<a href="https://www.fda.gov/tobacco-products/ctp-newsroom/february-10-2026-roundtable-premarket-tobacco-application-submissions-electronic-nicotine-delivery">https://www.fda.gov/tobacco-products/ctp-newsroom/february-10-2026-roundtable-premarket-tobacco-application-submissions-electronic-nicotine-delivery</a>.
    If you need special accommodations due to a disability, please 
email: <a href="/cdn-cgi/l/email-protection#f3b0a7a3debca0deb2b0a0b3959792dd9b9b80dd949c85"><span class="__cf_email__" data-cfemail="793a2d2954362a54383a2a391f1d185711110a571e160f">[email&#160;protected]</span></a> no later than February 3, 2026.
    Virtual Participation and Live Streaming of the Roundtable: This 
roundtable will also be available for virtual attendance. If you have 
been accepted to participate in the roundtable meeting as a panelist 
but will attend virtually, you will receive details prior to the 
roundtable. For non-panelist attendees interested in viewing the 
roundtable virtually, information will be provided on our website: 
<a href="https://www.fda.gov/tobacco-products/ctp-newsroom/february-10-2026-roundtable-premarket-tobacco-application-submissions-electronic-nicotine-delivery">https://www.fda.gov/tobacco-products/ctp-newsroom/february-10-2026-roundtable-premarket-tobacco-application-submissions-electronic-nicotine-delivery</a>.
    Transcripts: Please be advised that as soon as a transcript of the 
roundtable is available, it will be accessible at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. It may be viewed at the Dockets Management Staff 
(see ADDRESSES). A link to the transcript will also be available on the 
internet at <a href="https://www.fda.gov/tobacco-products/ctp-newsroom/february-10-2026-roundtable-premarket-tobacco-application-submissions-electronic-nicotine-delivery">https://www.fda.gov/tobacco-products/ctp-newsroom/february-10-2026-roundtable-premarket-tobacco-application-submissions-electronic-nicotine-delivery</a>.
    Notice of this meeting is given pursuant to 21 CFR 10.65.

Lowell M. Zeta,
Acting Deputy Commissioner for Policy, Legislation, and International 
Affairs.
[FR Doc. 2025-23851 Filed 12-23-25; 8:45 am]
BILLING CODE 4164-01-P


</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>
View on FederalRegister.gov →Plain-text source
Indexed from Federal Register on December 29, 2025.

This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.