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.

Rules and Regulations Federal Register

74831 

Vol. 89, No. 178 

Friday, September 13, 2024 

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. 

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, AskCTP@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Enforcement Policy for Required 


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74832 Federal Register / Vol. 89, No. 178 / Friday, September 13, 2024 / Rules and Regulations 

1R.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). 

2R.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). 

3R.J. Reynolds Tobacco Co., No. 6:20–cv–00176 

(E.D. Tex. December 7, 2022) (opinion and order; 

final judgment), Docs. No. 106; 107. 

4R.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. 

5R.J. Reynolds Tobacco Co. et al., No. 23–40076 

(5th Cir. May 21, 2024) (order denying petition for 

rehearing), Doc. No. 162–2. 

6R.J. Reynolds Tobacco Co. et al., No. 23–40076 

(5th Cir. May 29, 2024) (mandate), Doc. No. 163– 

2. 

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 (§ 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. 

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/rulesregulations-and-guidance/guidance, or 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments. 

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 

DEPARTMENT OF THE TREASURY 

Office of Foreign Assets Control 

31 CFR Part 501 

Reporting, Procedures and Penalties 

AGENCY: Office of Foreign Assets 

Control, Treasury. 

ACTION: Interim final rule; request for 

comments. 

SUMMARY: The Department of the 

Treasury’s Office of Foreign Assets 

Control (OFAC) is issuing this interim 

final rule to amend the Reporting, 

Procedures and Penalties Regulations 

(the ‘‘Regulations’’), extending 

recordkeeping requirements for certain 

transactions from five to 10 years, 

consistent with the statute of limitations 


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