U.S. Code » Title 21 » Chapter CHAPTER 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter SUBCHAPTER IX— TOBACCO PRODUCTS

21 U.S.C. § 387b

Adulterated tobacco products

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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.(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.)Editorial NotesPrior 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.

Notes of Decisions
Cited in 7 cases (4 in the last 5 years), 2017–2025 · leading case: Nicopure Labs, LLC v. Food & Drug Admin., 266 F. Supp. 3d 360 (D.D.C. 2017).
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Nicopure Labs, LLC v. Food & Drug Admin., 266 F. Supp. 3d 360 (D.D.C. 2017). “See 21 U.S.C. § 387b (finding that a tobacco product is adulterated if it is required to have a premarket review order but does not have one); 21 U.”
In re Santa Fe Nat. Tobacco Co. Mktg. & Sales Practices & Prods. Liab. Litig., 288 F. Supp. 3d 1087 (D.N.M. 2017). “§ 387k(g) ), these products are adulterated under section 902(8) of the FD & C Act (21 U.S.C. § 387b(8) ) .... The violations discussed in this letter do not necessarily constitute an exhaustive list.”
Swisher Int'l, Inc. v. United States Food & Drug Admin. (D.D.C. 2023). “at 3 (citing 21 U.S.C. §§ 387b(6), 387j(a)(1)). According to Swisher, this requirement applies to nearly its entire portfolio of products.”
Big Time Vapes, Inc. v. Food & Drug Admin. (S.D. Miss. 2019). “See 21 U.S.C. § 387b; 21 U.S.C. § 387c. The deeming rule went into effect on August 8, 2016, but the FDA provided time periods during which the FDA did not intend to enforce compliance with premarket review requirements.”
Swisher Int'l, Inc. v. United States Food & Drug Admin. (D.D.C. 2024). “” 21 U.S.C. §§ 387b(6), 387j(a)(1). The TCA created three pathways for premarket approval.”
Vape Cent. Grp., LLC v. Food & Drug Admin. (D.D.C. 2025). “” 21 U.S.C. § 387b(6). The “introduction or delivery for introduction into interstate commerce of any .”
Shenzhen Youme v. FDA (5th Cir. 2025). “21 U.S.C. § 387b(6)(A). As a matter of enforcement discretion, _____________________ 2 https://tinyurl.”
— 21 U.S.C. § 387b(6) — 3 cases
Swisher Int'l, Inc. v. United States Food & Drug Admin. (D.D.C. 2023). “at 3 (citing 21 U.S.C. §§ 387b(6), 387j(a)(1)). According to Swisher, this requirement applies to nearly its entire portfolio of products.”
Swisher Int'l, Inc. v. United States Food & Drug Admin. (D.D.C. 2024). “” 21 U.S.C. §§ 387b(6), 387j(a)(1). The TCA created three pathways for premarket approval.”
Vape Cent. Grp., LLC v. Food & Drug Admin. (D.D.C. 2025). “” 21 U.S.C. § 387b(6). The “introduction or delivery for introduction into interstate commerce of any .”
— 21 U.S.C. § 387b(6)(A) — 1 case
Shenzhen Youme v. FDA (5th Cir. 2025). “21 U.S.C. § 387b(6)(A). As a matter of enforcement discretion, _____________________ 2 https://tinyurl.”
— 21 U.S.C. § 387b(8) — 1 case
In re Santa Fe Nat. Tobacco Co. Mktg. & Sales Practices & Prods. Liab. Litig., 288 F. Supp. 3d 1087 (D.N.M. 2017). “§ 387k(g) ), these products are adulterated under section 902(8) of the FD & C Act (21 U.S.C. § 387b(8) ) .... The violations discussed in this letter do not necessarily constitute an exhaustive list.”
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