[Federal Register Volume 87, Number 226 (Friday, November 25, 2022)]
[Rules and Regulations]
[Pages 72384-72385]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-25650]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1141

[Docket No. FDA-2019-N-3065]
RIN 0910-AI39


Tobacco Products; Required Warnings for Cigarette Packages and 
Advertisements; Delayed Effective Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; delay of effective date.

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SUMMARY: As required by an order issued by the U.S. District Court for 
the Eastern District of Texas, this action delays the effective date of 
the final rule (``Tobacco Products; Required Warnings for Cigarette 
Packages and Advertisements''), which published on March 18, 2020. The 
new effective date is November 6, 2023.

DATES: The effective date of the rule amending 21 CFR part 1141 
published at 85 FR 15638, March 18, 2020, and delayed at 85 FR 32293, 
May 29, 2020; 86 FR 3793, January 15, 2021; 86 FR 36509, July 12, 2021; 
86 FR 50855, September 13, 2021; 86 FR 70052, December 9, 2021; 87 FR 
11295, March 1, 2022; 87 FR 32990, June 1, 2022; and 87 FR 50765, 
August 18, 2022, is further delayed until November 6, 2023.

FOR FURTHER INFORMATION CONTACT: Courtney Smith, Office of Regulations, 
Center for Tobacco Products, Food and Drug Administration, Document 
Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver 
Spring, MD 20993-0002, 1-877-287-1371, email: 
[email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of March 18, 2020, 
the Food and Drug Administration (FDA or Agency) 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 label statements. The Tobacco Control Act 
amends the Federal Cigarette Labeling and Advertising Act of 1965 (Pub. 
L. 89-92) 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. 
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\ On May 8, 2020, 
the court granted a joint motion to govern proceedings in that case and 
postpone the effective date of the final rule by 120 days.\2\ On 
December 2, 2020, the court granted a new motion by the plaintiffs to 
postpone the effective date of the final rule by an additional 90 
days.\3\ On March 2, 2021, the court granted another motion by the 
plaintiffs to postpone the effective date of the

[[Page 72385]]

final rule by an additional 90 days.\4\ On May 21, 2021, the court 
granted another motion by the plaintiffs to postpone the effective date 
of the final rule by an additional 90 days.\5\ On August 18, 2021, the 
court issued an order to postpone the effective date of the final rule 
by an additional 90 days.\6\ On November 12, 2021, the court issued 
another order to postpone the effective date of the final rule by an 
additional 90 days.\7\ On February 10, 2022, the court issued another 
order to postpone the effective date of the final rule by an additional 
90 days.\8\ On May 10, 2022, the court issued another order to postpone 
the effective date of the final rule by an additional 90 days.\9\ On 
August 10, 2022, the court granted a motion by the plaintiffs to 
postpone the effective date of the final rule by an additional 90 
days.\10\ On November 7, 2022, the court issued another order to 
postpone the effective date of the final rule by an additional 31 
days.\11\ The court ordered that the new effective date of the final 
rule is November 6, 2023. Pursuant to the court order, any obligation 
to comply with a deadline tied to the effective date is similarly 
postponed, and those obligations and deadlines are now tied to the 
postponed effective date.
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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. May 
8, 2020) (order granting joint motion and establishing schedule), 
Doc. No. 33.
    \3\ R.J. Reynolds Tobacco Co., No. 6:20-cv-00176 (E.D. Tex. 
December 2, 2020) (order granting Plaintiffs' motion and postponing 
effective date), Doc. No. 80.
    \4\ R.J. Reynolds Tobacco Co., No. 6:20-cv-00176 (E.D. Tex. 
March 2, 2021) (order granting Plaintiffs' motion and postponing 
effective date), Doc. No. 89.
    \5\ R.J. Reynolds Tobacco Co., No. 6:20-cv-00176 (E.D. Tex. May 
21, 2021) (order granting Plaintiffs' motion and postponing 
effective date), Doc. No. 91.
    \6\ R.J. Reynolds Tobacco Co., No. 6:20-cv-00176 (E.D. Tex. 
August 18, 2021) (order postponing effective date), Doc. No. 92.
    \7\ R.J. Reynolds Tobacco Co., No. 6:20-cv-00176 (E.D. Tex. 
November 12, 2021) (order postponing effective date), Doc. No. 93.
    \8\ R.J. Reynolds Tobacco Co., No. 6:20-cv-00176 (E.D. Tex. 
February 10, 2022) (order postponing effective date), Doc. No. 94.
    \9\ R.J. Reynolds Tobacco Co., No. 6:20-cv-00176 (E.D. Tex. May 
10, 2022) (order postponing effective date), Doc. No. 96.
    \10\ R.J. Reynolds Tobacco Co., No. 6:20-cv-00176 (E.D. Tex. 
August 10, 2022) (order granting Plaintiffs' motion and postponing 
effective date), Doc. No. 100.
    \11\ R.J. Reynolds Tobacco Co., No. 6:20-cv-00176 (E.D. Tex. 
November 7, 2022) (order postponing effective date), Doc. No. 104.
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    To the extent that 5 U.S.C. 553 applies to this action, the 
Agency's implementation of this action without opportunity for public 
comment, effective immediately upon publication today in the Federal 
Register, is based on the good cause exception in 5 U.S.C. 553(b)(B). 
Seeking public comment is impracticable, unnecessary, and contrary to 
the public interest. The 31-day postponement of the effective date, 
until November 6, 2023, is required by court order in accordance with 
the court's authority to postpone a rule's effective date pending 
judicial review (5 U.S.C. 705). Seeking prior public comment on this 
postponement would have been impracticable, as well as contrary to the 
public interest in the orderly issuance and implementation of 
regulations.

    Dated: November 18, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-25650 Filed 11-23-22; 8:45 am]
BILLING CODE 4164-01-P