On the first day of publication of the Federal Register that is 180 days or more after June 22, 2009, the Secretary of Health and Human Services shall publish in the Federal Register a final rule regarding cigarettes and smokeless tobacco, which-
Except as provided in this subsection, the final rule published under paragraph (1),2 shall be identical in its provisions to part 897 of the regulations promulgated by the Secretary of Health and Human Services in the August 28, 1996, issue of the Federal Register (61 Fed. Reg. 44615-44618). Such rule shall-
Prior to making amendments to the rule published under paragraph (1), the Secretary shall promulgate a proposed rule in accordance with chapter 5 of title 5.
Except as provided in paragraph (3), nothing in this section shall be construed to limit the authority of the Secretary to amend, in accordance with chapter 5 of title 5, the regulation promulgated pursuant to this section, including the provisions of such regulation relating to distribution of free samples.
The Secretary of Health and Human Services shall ensure that the provisions of this division, the amendments made by this division, and the implementing regulations (including such provisions, amendments, and regulations relating to the retail sale of tobacco products) are enforced with respect to the United States and Indian tribes.
A qualified adult-only facility (as such term is defined in section 897.16(d) of the final rule published under paragraph (1)) that is also a retailer and that commits a violation as a retailer shall not be subject to the limitations in section 103(q)3 and shall be subject to penalties applicable to a qualified adult-only facility.
Section 801 of title 5 shall not apply to the final rule published under paragraph (1).
As of June 22, 2009, the following documents issued by the Food and Drug Administration shall not constitute advisory opinions under section 10.85(d)(1) of title 21, Code of Federal Regulations, except as they apply to tobacco products, and shall not be cited by the Secretary of Health and Human Services or the Food and Drug Administration as binding precedent:
1So in original. Probably should be "chapter IX".
2So in original. The comma probably should not appear.
3So in original. See References in Text note below.
21 U.S.C. § 387a-1
EDITORIAL NOTES
REFERENCES IN TEXTThe Federal Food, Drug, and Cosmetic Act, referred to in subsec. (a)(1)(A), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§301 et seq.) of this title. Chapter 9 [IX] of the Act is classified generally to this subchapter. For complete classification of this Act to the Code, see section 301 of this title and Tables.This division, referred to in subsec. (a)(2)(A), (5), is div. A of Pub. L. 111-31, 123 Stat. 1776, known as the Family Smoking Prevention and Tobacco Control Act. For complete classification of division A to the Code, see Short Title of 2009 Amendment note set out under section 301 of this title and Tables. The date of enactment of the Family Smoking Prevention and Tobacco Control Act, referred to in subsec. (a)(2)(G), is the date of enactment of Pub. L. 111-31 which was approved June 22, 2009.Section 103(q), referred to in subsec. (a)(6), is section 103(q) of Pub. L. 111-31 which enacted provisions set out as notes under sections 333 and 387c of this title.
CODIFICATIONSection was enacted as part of the Family Smoking Prevention and Tobacco Control Act and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.
STATUTORY NOTES AND RELATED SUBSIDIARIES
MODIFICATION OF DEADLINES FOR SECRETARIAL ACTIONFor provision deeming reference to "180 days" in subsec. (a)(1) to be "270 days", see section 6 of Pub. L. 111-31 set out as a note under section 387 of this title.