PRIA, Government Policy, Made Personal

Summary

A tobacco product is treated as adulterated if it is unsafe, contaminated, or not following required rules. This includes being made of or mixed with filthy, rotten, or poisonous material; being prepared, packed, or stored in unsanitary ways that could contaminate it; having packaging that is poisonous; the maker or importer failing to pay a required user fee by the date set or by the 30th day after a final agency decision on a fee dispute; claiming to meet a tobacco product standard but not doing so; needing premarket approval but lacking an approved order or violating such an order; using manufacturing, packing, or storage methods or controls that do not meet required conditions; or violating section 387k.

Title 21, §387b

Food and Drugs, Source: USLM XML via OLRC

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.

Notes & Related Subsidiaries

Editorial Notes

Prior Provisions

A prior section 902 of act June 25, 1938, was renumbered section 1002. Subsec. (a) of section 1002 is set out as a note under section 301 of this title. Subsecs. (b) and (c) of section 1002 are classified to section 392 of this title. Subsec. (d) of section 1002 is set out as a note under section 392 of this title.

§387b Adulterated Tobacco Products

Summary

Title 21, §387b

Notes & Related Subsidiaries

Editorial Notes

Prior Provisions

Citations & Metadata