[Federal Register Volume 90, Number 116 (Wednesday, June 18, 2025)]
[Notices]
[Pages 26053-26055]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-10821]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0835]
Modified Risk Tobacco Product Application: Applications for ZYN
Products Submitted by Swedish Match U.S.A., Inc.
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for comments.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity to provide public comment on modified risk tobacco
product applications (MRTPAs) submitted by Swedish Match U.S.A., Inc.
for ZYN oral pouch products containing nicotine derived from tobacco.
DATES: Electronic or written comments on the applications may be
submitted beginning June 18, 2025. FDA will establish a closing date
for the comment period as described in section I.
ADDRESSES: You may submit comments 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-2025-N-0835 for ``Modified Risk
[[Page 26054]]
Tobacco Product Applications: Applications for ZYN oral pouch products
containing nicotine derived from tobacco submitted by Swedish Match
U.S.A., Inc.'' 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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read 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.
FOR FURTHER INFORMATION CONTACT: Erin Ellis, Office of Science, 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: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Section 911 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 387k) addresses the marketing and distribution of modified
risk tobacco products (MRTPs). MRTPs are tobacco products that are sold
or distributed for use to reduce harm or the risk of tobacco-related
disease associated with commercially marketed tobacco products. Section
911(a) of the FD&C Act prohibits the introduction or delivery for
introduction into interstate commerce of any MRTP unless an order
issued by FDA pursuant to section 911(g) of the FD&C Act is effective
with respect to such product.
Section 911(d) of the FD&C Act describes the information that must
be included in a MRTPA, which must be filed and evaluated by FDA before
an applicant can receive an order from FDA. FDA is required by section
911(e) of the FD&C Act to make a MRTPA available to the public (except
for matters in the application that are trade secrets or otherwise
confidential commercial information) and to request comments by
interested persons on the information contained in the application and
on the label, labeling, and advertising accompanying the application.
The determination of whether an order is appropriate under section 911
of the FD&C Act is based on the scientific information submitted by the
applicant as well as the scientific evidence and other information that
is made available to the Agency, including through public comments.
Section 911(g) of the FD&C Act describes the demonstrations
applicants must make to obtain an order from FDA under either section
911(g)(1) or (2). The applicant, Swedish Match U.S.A., Inc., is seeking
a modified risk granted order under section 911(g)(1) of the FD&C Act.
FDA may issue an order under section 911(g)(1) of the FD&C Act, if
FDA has determined that the applicant has demonstrated that the
proposed MRTP, as it is actually used by consumers, will:
Significantly reduce harm and the risk of tobacco-related
disease to individual tobacco users; and
Benefit the health of the population as a whole taking
into account both users of tobacco products and persons who do not
currently use tobacco products.
Section 911(g)(4) of the FD&C Act describes factors that FDA must
take into account in evaluating whether a tobacco product benefits the
health of individuals and the population as a whole.
FDA is issuing this notice to inform the public that the MRTPAs for
the following products submitted by Swedish Match U.S.A., Inc. have
been filed and are being made available for public comment:
MR0000268.PD1: ZYN Cool Mint 3 mg
MR0000268.PD2: ZYN Cool Mint 6 mg
MR0000268.PD3: ZYN Peppermint 3 mg
MR0000268.PD4: ZYN Peppermint 6 mg
MR0000268.PD5: ZYN Spearmint 3 mg
MR0000268.PD6: ZYN Spearmint 6 mg
MR0000268.PD7: ZYN Wintergreen 3 mg
MR0000268.PD8: ZYN Wintergreen 6 mg
MR0000268.PD9: ZYN Citrus 3 mg
MR0000268.PD10: ZYN Citrus 6 mg
MR0000268.PD11: ZYN Coffee 3 mg
MR0000268.PD12: ZYN Coffee 6 mg
MR0000268.PD13: ZYN Cinnamon 3 mg
MR0000268.PD14: ZYN Cinnamon 6 mg
MR0000268.PD15: ZYN Smooth 3 mg \1\
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\1\ Product may also be marketed as ZYN Original 3 mg.
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MR0000268.PD16: ZYN Smooth 6 mg \2\
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\2\ Product may also be marketed as ZYN Original 6 mg.
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MR0000268.PD17: ZYN Chill 3 mg \3\
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\3\ Product may also be marketed as ZYN Classic 3 mg.
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MR0000268.PD18: ZYN Chill 6 mg \4\
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\4\ Product may also be marketed as ZYN Classic 6 mg.
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MR0000268.PD19: ZYN Menthol 3 mg \5\
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\5\ Product may also be marketed as ZYN Fresh 3 mg.
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MR0000268.PD20: ZYN Menthol 6 mg.\6\
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\6\ Product may also be marketed as ZYN Fresh 6 mg.
FDA will post the application documents, including any amendments,
to its website for the MRTPAs (see section II) for public comment on a
rolling basis as they are redacted in accordance with applicable laws.
In this document, FDA is announcing the availability of the first batch
of application documents for public comment. FDA intends to establish a
closing date for the comment period that is both at least 180 days
after the date of this notice and at least 30 days after the final
documents from the application are made available for public comment.
FDA will announce the closing date at least 30 days in advance. FDA
believes that this comment period is appropriate given
[[Page 26055]]
the volume and complexity of the applications being posted.
FDA will notify the public about the availability of additional
application documents and comment period closing date via the Agency's
web page for the MRTPAs (see section II) and by other means of public
communication, such as by email to individuals who have signed up to
receive email alerts. To receive email alerts, visit FDA's email
subscription service management website (https://www.fda.gov/about-fda/contact-fda/get-email-updates), provide an email address, scroll down
to the ``Tobacco'' heading, select ``Modified Risk Tobacco Product
Application Update'', and click ``Submit''. To encourage public
participation consistent with section 911(e) of the FD&C Act, FDA is
making the redacted MRTPAs that are the subject of this notice
available electronically (see section II).
II. Electronic Access
Persons with access to the internet may obtain the document(s) at
https://www.fda.gov/tobacco-products/advertising-and-promotion/swedish-match-usa-inc-modified-risk-tobacco-product-mrtp-applications-zyn-products.
Dated: June 9, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-10821 Filed 6-17-25; 8:45 am]
BILLING CODE 4164-01-P