[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