[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
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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]
BILLING CODE 4164-01-P