§ 387a–1. Final rule

(a) Cigarettes and smokeless tobacco

(1) In general 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—

(A) is deemed to be issued under chapter 9 and shall be subject to penalties applicable to a qualified adult-only facility.

(7) Congressional review provisions

Section 801 of title 5 shall not apply to the final rule published under paragraph (1).

(b) Limitation on advisory opinions 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:

(1) The preamble to the proposed rule in the document titled “Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco Products to Protect Children and Adolescents” (60 Fed. Reg. 41314–41372 (August 11, 1995)).

(2) The document titled “Nicotine in Cigarettes and Smokeless Tobacco Products is a Drug and These Products Are Nicotine Delivery Devices Under the Federal Food, Drug, and Cosmetic Act” (60 Fed. Reg. 41453–41787 (August 11, 1995)).

(3) The preamble to the final rule in the document titled “Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents” (61 Fed. Reg. 44396–44615 (August 28, 1996)).

(4) The document titled “Nicotine in Cigarettes and Smokeless Tobacco is a Drug and These Products are Nicotine Delivery Devices Under the Federal Food, Drug, and Cosmetic Act; Jurisdictional Determination” (61 Fed. Reg. 44619–45318 (August 28, 1996)).

(Pub. L. 111–31, div. A, title I, § 102, June 22, 2009, 123 Stat. 1830.)

References In Text

References in Text

The 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, June 22, 2009, 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.

Codification

Codification

Section 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.

Miscellaneous

Modification of Deadlines for Secretarial Action

For 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.