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21 U.S.C. § 387b — Adulterated tobacco products
Federal law — U.S. Code and appendices · legal_authorities
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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387s&num=0&edition=prelim) by the date specified in [section 387s of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387s&num=0&edition=prelim) 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387g&num=0&edition=prelim) 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387j/a&num=0&edition=prelim) to have premarket review and does not have an order in effect under [section 387j(c)(1)(A)(i) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:
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Stable record: federal_law:legal_authorities:record_usc_baa91081f07081f47bf06a23
Source file: Laws/federal/codes/united-states-code/title-21/section-387b-adulterated-tobacco-products--ef98be7e77.md
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Passage SHA-256: 02af72fa21ea5c5c18ca45a100ce294ccce9e67347853811ad89ef7885687a8c
Source location: Title 21, Chapter 9, § 387b; chapter-009-federal-food-drug-and-cosmetic-act.md
Stored source content
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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387s&num=0&edition=prelim) by the date specified in [section 387s of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387s&num=0&edition=prelim) 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387g&num=0&edition=prelim) 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387j/a&num=0&edition=prelim) to have premarket review and does not have an order in effect under [section 387j(c)(1)(A)(i) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387j/c/1/A/i&num=0&edition=prelim); or
(B) it is in violation of an order under [section 387j(c)(1)(A) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387j/c/1/A&num=0&edition=prelim);
(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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387f/e/1&num=0&edition=prelim) or an applicable condition prescribed by an order under [section 387f(e)(2) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387f/e/2&num=0&edition=prelim); or
(8) it is in violation of [section 387k of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387k&num=0&edition=prelim).
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Establishment of quarterly fee** Beginning on June 22, 2009, the Secretary shall in accordance with this section assess user fees on, and collect such fees from, each manufacturer and importer of tobacco products subject to this subchapter. The fees shall be assessed and collected with respect to each quarter of each fiscal year, and the total amount assessed and collected for a fiscal year shall be the amount specified in subsection (b)(1) for such year, subject to subsection (c).
**(b) Assessment of user fee**
(1) **Amount of assessment** — The total amount of user fees authorized to be assessed and collected under subsection (a) for a fiscal year is the following, as applicable to the fiscal year involved:
(A) For fiscal year 2009, $85,000,000 (subject to subsection (e)).
(B) For fiscal year 2010, $235,000,000.
(C) For fiscal year 2011, $450,000,000.
(D) For fiscal year 2012, $477,000,000.
(E) For fiscal year 2013, $505,000,000.
(F) For fiscal year 2014, $534,000,000.
(G) For fiscal year 2015, $566,000,000.
(H) For fiscal year 2016, $599,000,000.
(I) For fiscal year 2017, $635,000,000.
(J) For fiscal year 2018, $672,000,000.
(K) For fiscal year 2019 and each subsequent fiscal year, $712,000,000.
(2) **Allocations of assessment by class of tobacco products**
(A) *In general* — The total user fees assessed and collected under subsection (a) each fiscal year with respect to each class of tobacco products shall be an amount that is equal to the applicable percentage of each class for the fiscal year multiplied by the amount specified in paragraph (1) for the fiscal year.
(B) *Applicable percentage*
(i) *In general* — For purposes of subparagraph (A), the applicable percentage for a fiscal year for each of the following
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 387s
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Federal law — U.S. Code and appendices · legal_authorities
This chapter may be cited as the Federal Food, Drug, and Cosmetic Act.
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 301
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Federal law — U.S. Code and appendices · legal_authorities
**(a) In general**
(1) **Special rules**
(A) *Special rule for cigarettes* — Beginning 3 months after June 22, 2009, a cigarette or any of its component parts (including the tobacco, filter, or paper) shall not contain, as a constituent (including a smoke constituent) or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice, including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee, that is a characterizing flavor of the tobacco product or tobacco smoke. Nothing in this subparagraph shall be construed to limit the Secretary’s authority to take action under this section or other sections of this chapter applicable to menthol or any artificial or natural flavor, herb, or spice not specified in this subparagraph.
(B) *Additional special rule* — Beginning 2 years after June 22, 2009, a tobacco product manufacturer shall not use tobacco, including foreign grown tobacco, that contains a pesticide chemical residue that is at a level greater than is specified by any tolerance applicable under Federal law to domestically grown tobacco.
(2) **Revision of tobacco product standards** — The Secretary may revise the tobacco product standards in paragraph (1) in accordance with subsection (c).
(3) **Tobacco product standards**
(A) *In general* — The Secretary may adopt tobacco product standards in addition to those in paragraph (1) if the Secretary finds that a tobacco product standard is appropriate for the protection of the public health.
(B) *Determinations*
(i) *Considerations* — In making a finding described in subparagraph (A), the Secretary shall consider scientific evidence concerning—
(I) the risks and benefits to the population as a whole,
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 387g
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Law determinative of exemption** Meats and meat food products shall be exempt from the provisions of this chapter to the extent of the application or the extension thereto of the Meat Inspection Act, approved March 4, 1907, as amended [[21 U.S.C. 601](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section601&num=0&edition=prelim) et seq.].
**(b) Laws unaffected** Nothing contained in this chapter shall be construed as in any way affecting, modifying, repealing, or superseding the provisions of section 351 of Public Health Service Act [[42 U.S.C. 262](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim)] (relating to viruses, serums, toxins, and analogous products applicable to man); the virus, serum, toxin, and analogous products provisions, applicable to domestic animals, of the Act of Congress approved March 4, 1913 (37 Stat. 832–833) [[21 U.S.C. 151](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section151&num=0&edition=prelim) et seq.]; the Filled Cheese Act of June 6, 1896 (U.S.C., 1934 ed., title 26, ch. 10), the Filled Milk Act of March 4, 1923 [[21 U.S.C. 61](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section61&num=0&edition=prelim) et seq.]; or the Import Milk Act of February 15, 1927 [[21 U.S.C. 141](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section141&num=0&edition=prelim) et seq.].
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 392
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Federal law — U.S. Code and appendices · legal_authorities
**(a) In general** No person may introduce or deliver for introduction into interstate commerce any modified risk tobacco product unless an order issued pursuant to subsection (g) is effective with respect to such product.
**(b) Definitions** In this section:
(1) **Modified risk tobacco product** — The term “modified risk tobacco product” means any tobacco product that is sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products.
(2) **Sold or distributed**
(A) *In general* — With respect to a tobacco product, the term “sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products” means a tobacco product—
(i) the label, labeling, or advertising of which represents explicitly or implicitly that—
(I) the tobacco product presents a lower risk of tobacco-related disease or is less harmful than one or more other commercially marketed tobacco products;
(II) the tobacco product or its smoke contains a reduced level of a substance or presents a reduced exposure to a substance; or
(III) the tobacco product or its smoke does not contain or is free of a substance;
(ii) the label, labeling, or advertising of which uses the descriptors “light”, “mild”, or “low” or similar descriptors; or
(iii) the tobacco product manufacturer of which has taken any action directed to consumers through the media or otherwise, other than by means of the tobacco product’s label, labeling, or advertising, after June 22, 2009, respecting the product that would be reasonably expected to result in consumers believing that the tobacco product or its smoke may present a lower risk of disease or is less harmful than
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 387k
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Federal law — U.S. Code and appendices · legal_authorities
Page 671
TITLE 21—FOOD AND DRUGS
§ 387c
(2) The document titled ‘‘Nicotine in Ciga-
rettes and Smokeless Tobacco Products is a
Drug and These Products Are Nicotine Deliv-
ery Devices Under the Federal Food, Drug, and
Cosmetic Act’’ (60 Fed. Reg. 41453–41787 (Au-
gust 11, 1995)).
(3) The preamble to the final rule in the doc-
ument 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 Ciga-
rettes 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)).
(Pub. L. 111–31, div. A, title I, § 102, June 22, 2009,
123 Stat. 1830.)
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 Pre-
vention 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.
Sectio
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 387b
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