[Federal Register Volume 89, Number 178 (Friday, September 13, 2024)]
[Rules and Regulations]
[Pages 74831-74832]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-20850]
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Rules and Regulations
Federal Register
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This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
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Federal Register / Vol. 89, No. 178 / Friday, September 13, 2024 /
Rules and Regulations
[[Page 74831]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1141
[Docket No. FDA-2024-D-3742]
Enforcement Policy for Required Warnings for Cigarette Packages
and Advertisements; Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of availability.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the availability of a final guidance for industry entitled
``Enforcement Policy for Required Warnings for Cigarette Packages and
Advertisements.'' This guidance describes FDA's enforcement policy for
the final rule, ``Tobacco Products; Required Warnings for Cigarette
Packages and Advertisements,'' which established new required cigarette
health warnings for cigarette packages and advertisements. The guidance
is intended to assist entities required to comply with the rule.
DATES: The announcement of the guidance is published in the Federal
Register on September 13, 2024.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances 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-2024-D-3742 for ``Enforcement Policy for Required Warnings for
Cigarette Packages and Advertisements.'' 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 information on electronic access to the guidance.
FOR FURTHER INFORMATION CONTACT: Beth Buckler, Center for Tobacco
Products, Food and Drug Administration, Document Control Center, 10903
New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993-0002,
877-287-1373, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Enforcement Policy for Required
[[Page 74832]]
Warnings for Cigarette Packages and Advertisements.'' This guidance
describes FDA's enforcement policy for the final rule, ``Tobacco
Products; Required Warnings for Cigarette Packages and Advertisements''
(85 FR 15638, March 18, 2020; codified at 21 CFR part 1141), which
established new required cigarette health warnings for cigarette
packages and advertisements. The guidance is intended to assist
entities required to comply with the rule. We are issuing this guidance
consistent with our good guidance practices (GGP) regulation (21 CFR
10.115). We are implementing this guidance without prior public comment
because we have determined that prior public participation is not
feasible or appropriate (Sec. 10.115(g)(2)). We made this
determination because FDA needs to communicate its enforcement policy
in a timely manner given that the rule is now in effect due to
developments in litigation, as explained below. Although this guidance
document is being implemented immediately, it remains subject to
comment in accordance with FDA's GGP regulation.
In the Federal Register of March 18, 2020, FDA issued a final rule
establishing new cigarette health warnings for cigarette packages and
advertisements. The final rule implements a provision of the Family
Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Pub.
L. 111-31) that requires FDA to issue regulations requiring color
graphics depicting the negative health consequences of smoking to
accompany new textual warning statements. The Tobacco Control Act
amends the Federal Cigarette Labeling and Advertising Act (15 U.S.C.
1333) to require each cigarette package and advertisement to bear one
of the new required warnings. The final rule specifies the 11 new
textual warning label statements and accompanying color graphics.
Additionally, the final rule requires the random and equal display and
distribution of the required warnings for cigarette packages and
quarterly rotation of the required warnings for cigarette
advertisements in accordance with an FDA-approved plan (referred to as
cigarette plans), consistent with the Tobacco Control Act. Pursuant to
section 201(b) of the Tobacco Control Act, the rule was published with
an effective date of June 18, 2021, 15 months after the date of
publication of the final rule.
On April 3, 2020, the final rule was challenged in the U.S.
District Court for the Eastern District of Texas.\1\ The District Court
issued multiple orders postponing the effective date of the rule, the
most recent of which postponed the effective date to November 6,
2023.\2\ On December 7, 2022, the District Court issued an order
vacating the rule.\3\ On March 21, 2024, the U.S. Court of Appeals for
the Fifth Circuit issued an opinion reversing the District Court and
concluding that FDA's rule is consistent with the First Amendment.\4\
The opinion remanded the case to the District Court for consideration
of plaintiffs' remaining claims. A petition for rehearing en banc was
denied on May 21, 2024,\5\ and the court's mandate issued on May 29,
2024.\6\ Accordingly, the rule is no longer vacated. Because the
November 6, 2023, date in the District Court's most recent order
postponing the rule's effective date has passed, the rule is now in
effect.
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\1\ R.J. Reynolds Tobacco Co. et al., v. United States Food and
Drug Administration et al., No. 6:20-cv-00176 (E.D. Tex. filed April
3, 2020).
\2\ R.J. Reynolds Tobacco Co., No. 6:20-cv-00176 (E.D. Tex.
November 7, 2022) (order postponing effective date), Doc. No. 104.
See also ``Tobacco Products; Required Warnings for Cigarette
Packages and Advertisements; Delayed Effective Date,'' 87 FR 72384
(November 25, 2022).
\3\ R.J. Reynolds Tobacco Co., No. 6:20-cv-00176 (E.D. Tex.
December 7, 2022) (opinion and order; final judgment), Docs. No.
106; 107.
\4\ R.J. Reynolds Tobacco Co. et al., v. United States Food and
Drug Administration et al., No. 23-40076 (5th Cir. March 21, 2024)
(panel opinion), Doc. No. 140-1.
\5\ R.J. Reynolds Tobacco Co. et al., No. 23-40076 (5th Cir. May
21, 2024) (order denying petition for rehearing), Doc. No. 162-2.
\6\ R.J. Reynolds Tobacco Co. et al., No. 23-40076 (5th Cir. May
29, 2024) (mandate), Doc. No. 163-2.
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FDA recognizes that some manufacturers, distributors, and retailers
already may have begun to prepare to implement the rule's requirements.
For instance, some manufacturers, distributors, and retailers already
have submitted and obtained approval of cigarette plans. Even so, FDA
recognizes that entities may need time to implement the rule's
requirements. In the guidance, FDA sets out its enforcement policy for
the final rule. As discussed in the guidance, FDA intends to exercise
enforcement discretion and generally not enforce requirements of the
final rule for 15 months after the issuance of this guidance, until
December 12, 2025. FDA also intends to exercise enforcement discretion
and generally not enforce requirements of the final rule for an
additional 30 days, until January 12, 2026, with respect to products
manufactured before December 12, 2025. These time periods are
consistent with section 201(b) of the Tobacco Control Act and the
effective date of the final rule upon its publication. As FDA
recommended at the time of publication of the final rule, FDA
recommends that entities that do not already have approved cigarette
plans submit such plans as soon as possible, but in any event, within 5
months, by February 10, 2025.
The guidance represents the current thinking of FDA on this topic.
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.
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 (PRA) (44 U.S.C. 3501-3521). The collections of information in 21
CFR 1141.10 have been approved under OMB control number 0910-0877.
III. Electronic Access
Persons with access to the internet may obtain an electronic
version of the 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.
Dated: September 10, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-20850 Filed 9-12-24; 8:45 am]
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