[Federal Register Volume 85, Number 104 (Friday, May 29, 2020)]
[Rules and Regulations]
[Pages 32293-32294]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-11462]


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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: In accordance with 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, from June 18, 2021, to October 16, 2021.

DATES: The effective date of the rule amending 21 CFR part 1141 
published at 85 FR 15638, March 18, 2020, is delayed until October 16, 
2021.

FOR FURTHER INFORMATION CONTACT: Courtney Smith, Office of Regulations, 
Center for Tobacco Products, Food and Drug Administration, Document 
Control Center, Bldg. 71, Rm. G335, 10903 New

[[Page 32294]]

Hampshire Ave., Silver Spring, MD 20993-0002, 1-877-287-1373, 
AskCTPRegulations@fda.hhs.gov.

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 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\ Due to the COVID-
19 pandemic and its impacts, 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\ The court ordered that the new 
effective date of the final rule is postponed to October 16, 2021. 
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.
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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 120-day postponement of the effective date, 
until October 16, 2021, is required by court order in accordance with 
the court's authority to postpone a rule's effective date ``on such 
conditions as may be required and to the extent necessary to prevent 
irreparable injury'' 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 issue and implementation of regulations.

    Dated: May 22, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-11462 Filed 5-28-20; 8:45 am]
BILLING CODE 4164-01-P


