[Federal Register Volume 87, Number 86 (Wednesday, May 4, 2022)]
[Proposed Rules]
[Pages 26311-26313]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-09302]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 1162 and 1166
[Docket Nos. FDA-2021-N-1349 and FDA-2021-N-1309]
Proposed Regulations To Establish Tobacco Product Standards for
Menthol in Cigarettes and Characterizing Flavors in Cigars: Listening
Sessions; Public Meeting; Request for Comments
AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).
ACTION: Notification of public meeting; request for comments.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the following virtual listening sessions entitled ``Proposed
Regulations to Establish Tobacco Product Standards for Menthol in
Cigarettes and Characterizing Flavors in Cigars: Listening Sessions.''
The purpose of the listening sessions is to discuss two proposed
regulations that are published elsewhere in this issue of the Federal
Register, a tobacco product standard that would prohibit menthol as a
characterizing flavor in cigarettes (``Tobacco Product Standard for
Menthol in Cigarettes''; Docket No. FDA-2021-N-1349) and a tobacco
product standard that would prohibit characterizing flavors (other than
tobacco) in all cigars (``Tobacco Product Standard for Characterizing
Flavors in Cigars''; Docket No. FDA-2021-N-1309). FDA will provide
information on the proposed rules to the public and provide the public
an opportunity to provide open public comment.
DATES: The listening sessions will be held on two separate days on June
13 and 15, 2022. All requests to make open public comment must be
received by June 6, 2022, at 11:59 p.m. Eastern Time.
FDA reminds the public that, in addition to providing comments
through these meetings, commenters may submit either electronic or
written comments on one or both of the proposed rules set out in the
SUMMARY by July 5, 2022. See the SUPPLEMENTARY INFORMATION section for
registration date and information.
ADDRESSES: Additional details, such as the time of the listening
sessions and registration information, will be posted soon at https://www.fda.gov/tobacco-products. The listening sessions will be held
virtually and more information will be posted here: https://www.fda.gov/tobacco-products.
You may submit written comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of July 5, 2022. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
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
[[Page 26312]]
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-2021-N-1349 for ``Tobacco Product Standard for Menthol in
Cigarettes'' and/or Docket No. FDA-2021-N-1309 for ``Tobacco Product
Standard for Characterizing Flavors in Cigars.'' Received comments,
those filed in a timely manner (see ADDRESSES), 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 dockets 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.
FOR FURTHER INFORMATION CONTACT: May Nelson, Center for Tobacco
Products, Food and Drug Administration, 10903 New Hampshire Ave.,
Silver Spring, MD 20993-0002, 877-287-1373, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Published elsewhere in this issue of the Federal Register, FDA is
proposing two product standards: (1) A tobacco product standard that
would prohibit menthol as a characterizing flavor in cigarettes
(``Tobacco Product Standard for Menthol in Cigarettes''; Docket No.
FDA-2021-N-1349) and (2) a tobacco product standard that would prohibit
characterizing flavors (other than tobacco) in all cigars (``Tobacco
Product Standard for Characterizing Flavors in Cigars''; Docket No.
FDA-2021-N-1309). Characterizing flavors in tobacco products, including
menthol, enhance taste and make them easier to use. Menthol's flavor
and sensory effects reduce the harshness of cigarette smoking and make
it easier for new users, particularly youth and young adults, to
continue experimenting and progress to regular use. Characterizing
flavors in cigars, such as strawberry, grape, cocoa, and fruit punch,
increase appeal and make the cigars easier to use, particularly among
youth and young adults. FDA is proposing these two tobacco product
standards because they would significantly reduce disease and death
from combusted tobacco product use, the leading cause of preventable
death in the United States.
There are over 18.5 million menthol cigarette smokers ages 12 and
older in the United States. The proposed ``Tobacco Product Standard for
Menthol in Cigarettes'' rule would reduce the appeal of cigarettes,
particularly to youth and young adults, and thereby decrease the
likelihood that nonusers who would otherwise experiment with menthol
cigarettes would progress to regular smoking. In addition, this
proposed tobacco product standard would improve the health and reduce
the mortality risk of current menthol cigarette smokers by decreasing
cigarette consumption and increasing the likelihood of cessation.
Over a half million youth in the United States use flavored cigars.
The proposed ``Tobacco Product Standard for Characterizing Flavors in
Cigars'' rule would reduce the appeal of cigars, particularly to youth
and young adults, and thereby decrease the likelihood of
experimentation, development of nicotine dependence, and progression to
regular use. This proposed standard also would improve public health by
increasing the likelihood that existing users of flavored cigars would
quit.
FDA is issuing both proposed product standards to reduce the
tobacco-related death and disease associated with menthol cigarette and
flavored cigar use. The proposed standards also are expected to reduce
tobacco-related health disparities and advance health equity.
II. Topics for Discussion at the Listening Sessions
The listening sessions will provide the public an opportunity to
provide open public comment on the proposed product standard rules.
Both proposed rules will be discussed at each session. Although the
public can submit their questions and comments directly to the dockets,
the listening sessions will enable FDA to share public information
(i.e., what is contained in the rules and related documents) and
facilitate comment on the proposed rules.
After introductions, FDA will begin each listening session with an
overview of both proposed rules. Then the registered speakers will have
approximately 5 minutes each to share their comments on any topics
related to the product standards. FDA is particularly interested in the
areas where we specifically requested comment in the proposed rules and
the associated preliminary regulatory impact analyses.
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III. Participating in the Listening Sessions
Registration: To register to attend the free listening sessions,
please visit the following website: https://www.fda.gov/tobacco-products. Registration information will be posted soon.
Live closed captioning will be provided during the listening
sessions. Additional information on requests for special accommodations
due to a disability will be provided during registration.
Requests to Provide Open Public Comment: During online registration
you may indicate if you wish to make open public comments during the
listening sessions. All requests to make open public comment must be
received by June 6, 2022, at 11:59 p.m. Eastern Time. We will do our
best to accommodate requests to make public comments. We are seeking to
have a broad representation of ideas and perspectives presented at the
meeting. FDA is especially interested to hear from those individuals or
communities who may be less likely or less able to provide formal
written comments through the standard process of docket submission.
Individuals and organizations with common interests are urged to
consolidate or coordinate their comments and request time for a joint
presentation. FDA will determine the approximate time open public
comments are to be provided and will notify all registrants who
requested to make public comment ahead of the listening session. FDA
will not accept presentation materials for the listening sessions.
Instead, any materials can be submitted to the respective docket noted
in the ``Docket'' section of this document before the end of the
comment period.
Transcripts: Please be advised that as soon as transcripts of the
listening sessions are available, they will be accessible at https://www.regulations.gov. They may be viewed at the Dockets Management Staff
(see ADDRESSES). A link to the transcripts and recordings will also be
available on the internet at https://www.fda.gov/tobacco-products.
Dated: April 26, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-09302 Filed 4-28-22; 11:15 am]
BILLING CODE 4164-01-P