[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,
[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 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