21 U.S.C. § 387b — Adulterated tobacco products

submitted 88 years ago by Pub. L. 111-31 to r/title-21-FOOD-AND-DRUGS · 304 words · no verdicts yet

in plain englishAI-generated · not legal advice

A tobacco product is "adulterated" if it's contaminated, unsanitary, or its package could harm users. It's also adulterated if the maker skips required fees or fails a safety standard. The same is true if it lacks required premarket review, breaks manufacturing rules, or violates section 387k.

A tobacco product counts as "adulterated" if any of these apply. (1) It contains filthy, rotten, or decomposed material. Or it is contaminated with an added poisonous substance that could harm health. (2) It was made, packed, or stored under dirty conditions. These conditions could contaminate it with filth or make it harmful. (3) Its package contains a poisonous or harmful substance. That substance could hurt anyone who uses the contents. (4) The maker or importer misses a deadline to pay a required user fee under section 387s. This includes thirty days after any fee dispute is resolved. (5) It is supposed to meet a tobacco product standard set under section 387g. But it does not fully match that standard. (6) It needed premarket review under section 387j(a) but lacks an order allowing it. Or it violates an order that was issued. (7) The way it is made, packed, or stored does not follow the manufacturing rules in section 387f(e)(1). Or it violates a condition set by an order under section 387f(e)(2). (8) It violates section 387k, which sets other tobacco-product requirements.

facts

- Codified at 21 U.S.C. § 387b, titled "Adulterated tobacco products," part of the Federal Food, Drug, and Cosmetic Act (originally ch. 675, § 902). - Added by Pub. L. 111–31, div. A, title I, § 101(b)(3), enacted June 22, 2009, 123 Stat. 1787. - The statute contains 304 words and lists eight distinct grounds for a tobacco product being deemed adulterated. - Source credit reflects a single amendment count, reflecting its original enactment with no subsequent modifications noted. - Cross-references several related sections (387s, 387g, 387j, 387f, 387k) within the same subchapter.

the actual law source: uscode.house.gov ↗public domain

A tobacco product shall be deemed to be adulterated if—

(1)

it consists in whole or in part of any filthy, putrid, or decomposed substance, or is otherwise contaminated by any added poisonous or added deleterious substance that may render the product injurious to health;

(2)

it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health;

(3)

its package is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health;

(4)

the manufacturer or importer of the tobacco product fails to pay a user fee assessed to such manufacturer or importer pursuant to section 387s of this title by the date specified in section 387s of this title or by the 30th day after final agency action on a resolution of any dispute as to the amount of such fee;

(5)

it is, or purports to be or is represented as, a tobacco product which is subject to a tobacco product standard established under section 387g of this title unless such tobacco product is in all respects in conformity with such standard;

(6)

(A)

it is required by section 387j(a) of this title to have premarket review and does not have an order in effect under section 387j(c)(1)(A)(i) of this title; or

(B)

it is in violation of an order under section 387j(c)(1)(A) of this title;

(7)

the methods used in, or the facilities or controls used for, its manufacture, packing, or storage are not in conformity with applicable requirements under section 387f(e)(1) of this title or an applicable condition prescribed by an order under section 387f(e)(2) of this title; or

(8)

it is in violation of section 387k of this title.

Source credit: (June 25, 1938, ch. 675, § 902, as added Pub. L. 111–31, div. A, title I, § 101(b)(3), June 22, 2009, 123 Stat. 1787.)

history & why it existsrecord from the source credit

1938Enacted · Pub. L. 111-31 · 123 Stat. 1787

The record. According to the source credit, this section derives from the Federal Food, Drug, and Cosmetic Act of June 25, 1938 (ch. 675), codified as § 902 of that Act. The specific provision, however, was not part of the original 1938 enactment; it was added by Public Law 111-31, division A, title I, § 101(b)(3), enacted June 22, 2009, and appearing at 123 Stat. 1787. The source credit reflects a single amendment event—the 2009 addition—with no further amendments noted. Historical context. Public Law 111-31 is commonly known as the Family Smoking Prevention and Tobacco Control Act. This Act is generally understood to have granted the Food and Drug Administration regulatory authority over tobacco products for the first time, extending the framework of the 1938 Food, Drug, and Cosmetic Act to a category of products previously outside FDA's jurisdiction. The broader legislative effort is commonly associated with public health concerns about tobacco use, particularly among minors, and with longstanding debate over whether and how tobacco products should be subject to federal safety and manufacturing standards. Beyond this general understanding of the 2009 Act's purpose, the record does not establish the specific legislative reasoning behind the particular adulteration criteria enumerated in this section, including the choice of these eight specific grounds. Any more detailed account of congressional intent for this precise provision would go beyond what the available materials support.

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