---
kind: "section"
citation: "21 U.S.C. § 387b"
title: "21"
title_heading: "Food and Drugs"
number: "387b"
heading: "Adulterated tobacco products"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/387b"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter IX — Tobacco Products"
---

# §387b. Adulterated tobacco products


A [tobacco product](/usc/21/321.md?p=rr-1) 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](/usc/21/360eee.md?p=13) 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](/usc/21/387.md?p=13) is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health;
- (4) the [manufacturer](/usc/21/360hh.md?p=3) or importer of the [tobacco product](/usc/21/321.md?p=rr-1) fails to pay a user fee assessed to such [manufacturer](/usc/21/360hh.md?p=3) or importer pursuant to [section 387s of this title](/usc/21/387s.md) by the date specified in [section 387s of this title](/usc/21/387s.md) 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](/usc/21/321.md?p=rr-1) which is subject to a [tobacco product](/usc/21/321.md?p=rr-1) standard established under [section 387g of this title](/usc/21/387g.md) unless such [tobacco product](/usc/21/321.md?p=rr-1) is in all respects in conformity with such standard;
- (6)
  - (A) it is required by [section 387j(a) of this title](/usc/21/387j.md?p=a) to have premarket review and does not have an order in effect under [section 387j(c)(1)(A)(i) of this title](/usc/21/387j.md?p=c-1-A-i); or
  - (B) it is in violation of an order under [section 387j(c)(1)(A) of this title](/usc/21/387j.md?p=c-1-A);
- (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](/usc/21/387f.md?p=e-1) or an applicable condition prescribed by an order under [section 387f(e)(2) of this title](/usc/21/387f.md?p=e-2); or
- (8) it is in violation of [section 387k of this title](/usc/21/387k.md).

## 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.)

## Notes

### 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.