§387a–1 — Title 21 Food and Drugs | U.S. Code

Summary

The Secretary of Health and Human Services must publish a final rule about cigarettes and smokeless tobacco in the Federal Register on the first Federal Register day that is at least 180 days after June 22, 2009. That rule will count as issued under the Federal Food, Drug, and Cosmetic Act and as already following rulemaking procedures. The rule will mostly match the regulations at 61 Fed. Reg. 44615–44618 (August 28, 1996) but with changes: updated jurisdiction rules; removal of the Labels Subpart C and one related section; replacement of some definitions with the ones in section 900 of the Federal Food, Drug, and Cosmetic Act; addition of roll-your-own paper to the covered items; possible changes to one advertising rule to reflect First Amendment case law, including Lorillard Tobacco Co. v. Reilly (533 U.S. 525 (2001)); and it will take effect one year after June 22, 2009. The rule also bans free samples of cigarettes, smokeless tobacco, and other tobacco products except that smokeless tobacco samples may be given only in a tightly limited “qualified adult-only facility” (requirements include checking government photo ID for age, no alcohol on site, not next to youth-focused areas, a temporary enclosed area with opaque barriers and limited exterior signs). Samples taken out must be one package per adult per day, no more than 0.53 ounces (15 grams) total, and no more than 8 individual portions if portions are used. No free samples may be given to sports teams or at sporting or entertainment events listed (including football, basketball, baseball, soccer, hockey) or as the Secretary decides. The Secretary must run a compliance program and report to Congress not later than 18 months after the Family Smoking Prevention and Tobacco Control Act was enacted. Nothing allows giving samples to anyone under the legal purchasing age. As of June 22, 2009, the following FDA documents do not count as advisory opinions under 21 C.F.R. 10.85(d)(1) and cannot be cited by HHS or FDA as binding precedent except where they apply to tobacco products: the August 11, 1995 preamble to the proposed rule on restricting sale and distribution of cigarettes and smokeless tobacco (60 Fed. Reg. 41314–41372); the August 11, 1995 document titled about nicotine being a drug and these products being nicotine delivery devices (60 Fed. Reg. 41453–41787); the August 28, 1996 preamble to the final rule on restricting sale and distribution (61 Fed. Reg. 44396–44615); and the August 28, 1996 jurisdictional determination on nicotine and tobacco (61 Fed. Reg. 44619–45318).

Title 21, §387a–1

Food and Drugs — Source: USLM XML via OLRC

(a)(1)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 11 So in original. Probably should be “chapter IX”. of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 387 et seq.], as added by section 101 of this division; and

(B)shall be deemed to be in compliance with all applicable provisions of chapter 5 of title 5 and all other provisions of law relating to rulemaking procedures.

(2)Except as provided in this subsection, the final rule published under paragraph (1),22 So in original. The comma probably should not appear. 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—

(A)provide for the designation of jurisdictional authority that is in accordance with this subsection in accordance with this division and the amendments made by this division;

(B)strike Subpart C—Labels and section 897.32(c);

(C)strike paragraphs (a), (b), and (i) of section 897.3 and insert definitions of the terms “cigarette”, “cigarette tobacco”, and “smokeless tobacco” as defined in section 900 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 387];

(D)insert “or roll-your-own paper” in section 897.34(a) after “other than cigarettes or smokeless tobacco”;

(E)include such modifications to section 897.30(b), if any, that the Secretary determines are appropriate in light of governing First Amendment case law, including the decision of the Supreme Court of the United States in Lorillard Tobacco Co. v. Reilly (533 U.S. 525 (2001));

(F)become effective on the date that is 1 year after June 22, 2009; and

(G)amend paragraph (d) of section 897.16 to read as follows:

“(d)(1)Except as provided in subparagraph (2), no manufacturer, distributor, or retailer may distribute or cause to be distributed any free samples of cigarettes, smokeless tobacco, or other tobacco products (as such term is defined in section 201 of the Federal Food, Drug, and Cosmetic Act).

“(2)(A)Subparagraph (1) does not prohibit a manufacturer, distributor, or retailer from distributing or causing to be distributed free samples of smokeless tobacco in a qualified adult-only facility.

“(B)This subparagraph does not affect the authority of a State or local government to prohibit or otherwise restrict the distribution of free samples of smokeless tobacco.

“(C)For purposes of this paragraph, the term ‘qualified adult-only facility’ means a facility or restricted area that—

“(i)requires each person present to provide to a law enforcement officer (whether on or off duty) or to a security guard licensed by a governmental entity government-issued identification showing a photograph and at least the minimum age established by applicable law for the purchase of smokeless tobacco;

“(ii)does not sell, serve, or distribute alcohol;

“(iii)is not located adjacent to or immediately across from (in any direction) a space that is used primarily for youth-oriented marketing, promotional, or other activities;

“(iv)is a temporary structure constructed, designated, and operated as a distinct enclosed area for the purpose of distributing free samples of smokeless tobacco in accordance with this subparagraph;

“(v)is enclosed by a barrier that—

“(I)is constructed of, or covered with, an opaque material (except for entrances and exits);

“(II)extends from no more than 12 inches above the ground or floor (which area at the bottom of the barrier must be covered with material that restricts visibility but may allow airflow) to at least 8 feet above the ground or floor (or to the ceiling); and

“(III)prevents persons outside the qualified adult-only facility from seeing into the qualified adult-only facility, unless they make unreasonable efforts to do so; and

“(vi)does not display on its exterior—

“(I)any tobacco product advertising;

“(II)a brand name other than in conjunction with words for an area or enclosure to identify an adult-only facility; or

“(III)any combination of words that would imply to a reasonable observer that the manufacturer, distributor, or retailer has a sponsorship that would violate section 897.34(c).

“(D)Distribution of samples of smokeless tobacco under this subparagraph permitted to be taken out of the qualified adult-only facility shall be limited to 1 package per adult consumer containing no more than 0.53 ounces (15 grams) of smokeless tobacco. If such package of smokeless tobacco contains individual portions of smokeless tobacco, the individual portions of smokeless tobacco shall not exceed 8 individual portions and the collective weight of such individual portions shall not exceed 0.53 ounces (15 grams). Any manufacturer, distributor, or retailer who distributes or causes to be distributed free samples also shall take reasonable steps to ensure that the above amounts are limited to one such package per adult consumer per day.

“(3)Notwithstanding subparagraph (2), no manufacturer, distributor, or retailer may distribute or cause to be distributed any free samples of smokeless tobacco—

“(A)to a sports team or entertainment group; or

“(B)at any football, basketball, baseball, soccer, or hockey event or any other sporting or entertainment event determined by the Secretary to be covered by this subparagraph.

“(4)The Secretary shall implement a program to ensure compliance with this paragraph and submit a report to the Congress on such compliance not later than 18 months after the date of enactment of the Family Smoking Prevention and Tobacco Control Act.

“(5)Nothing in this paragraph shall be construed to authorize any person to distribute or cause to be distributed any sample of a tobacco product to any individual who has not attained the minimum age established by applicable law for the purchase of such product.”.

(b)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)).

Notes & Related Subsidiaries

Editorial Notes

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 section 333 and 387c of this title. 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.

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.

§387a–1 Final rule