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21 U.S.C. § 387c — Misbranded tobacco products

Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 387c — Misbranded tobacco products

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Source location: Title 21, Chapter 9, § 387c; chapter-009-federal-food-drug-and-cosmetic-act.md

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**(a) In general** A tobacco product shall be deemed to be misbranded— (1) if its labeling is false or misleading in any particular; (2) if in package form unless it bears a label containing— (A) the name and place of business of the tobacco product manufacturer, packer, or distributor; (B) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count; (C) an accurate statement of the percentage of the tobacco used in the product that is domestically grown tobacco and the percentage that is foreign grown tobacco; and (D) the statement required under [section 387t(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387t/a&num=0&edition=prelim), except that under subparagraph (B) reasonable variations shall be permitted, and exemptions as to small packages shall be established, by regulations prescribed by the Secretary; (3) if any word, statement, or other information required by or under authority of this subchapter to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, or designs in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use; (4) if it has an established name, unless its label bears, to the exclusion of any other nonproprietary name, its established name prominently printed in type as required by the Secretary by regulation; (5) if the Secretary has issued regulations requiring that its labeling bear adequate directions for use, or adequate warnings against use by children, that are necessary for the protection of users unless its labeling conforms in all respects to such regulations; (6) if it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 387e(b), 387e(c), 387e(d), or 387e(h) of this title, if it was not included in a list required by [section 387e(i) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387e/i&num=0&edition=prelim), if a notice or other information respecting it was not provided as required by such section or [section 387e(j) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387e/j&num=0&edition=prelim), or if it does not bear such symbols from the uniform system for identification of tobacco products prescribed under [section 387e(e) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387e/e&num=0&edition=prelim) as the Secretary by regulation requires; (7) if, in the case of any tobacco product distributed or offered for sale in any State— (A) its advertising is false or misleading in any particular; or (B) it is sold or distributed in violation of [section 387f(d)(5) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387f/d/5&num=0&edition=prelim) or of regulations prescribed under [section 387f(d) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387f/d&num=0&edition=prelim); (8) unless, in the case of any tobacco product distributed or offered for sale in any State, the manufacturer, packer, or distributor thereof includes in all advertisements and other descriptive printed matter issued or caused to be issued by the manufacturer, packer, or distributor with respect to that tobacco product— (A) a true statement of the tobacco product’s established name as described in paragraph (4), printed prominently; and (B) a brief statement of— (i) the uses of the tobacco product and relevant warnings, precautions, side effects, and contraindications; and (ii) in the case of specific tobacco products made subject to a finding by the Secretary after notice and opportunity for comment that such action is appropriate to protect the public health, a full description of the components of such tobacco product or the formula showing quantitatively each ingredient of such tobacco product to the extent required in regulations which shall be issued by the Secretary after an opportunity for a hearing; (9) if it is a tobacco product 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 it bears such labeling as may be prescribed in such tobacco product standard; or (10) if there was a failure or refusal— (A) to comply with any requirement prescribed under section 387d or 387h of this title; or (B) to furnish any material or information required under [section 387i of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387i&num=0&edition=prelim). **(b) Prior approval of label statements** The Secretary may, by regulation, require prior approval of statements made on the label of a tobacco product to ensure that such statements do not violate the misbranding provisions of subsection (a) and that such statements comply with other provisions of the Family Smoking Prevention and Tobacco Control Act (including the amendments made by such Act). No regulation issued under this subsection may require prior approval by the Secretary of the content of any advertisement, except for modified risk tobacco products as provided in [section 387k of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387k&num=0&edition=prelim). No advertisement of a tobacco product published after June 22, 2009, shall, with respect to the language of label statements as prescribed under [section 1333 of title 15](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section1333&num=0&edition=prelim) and [section 4402 of title 15](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section4402&num=0&edition=prelim) or the regulations issued under such sections, be subject to the provisions of sections 52 through 55 of title 15.

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 301 — Short title

This chapter may be cited as the Federal Food, Drug, and Cosmetic Act.

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15 U.S.C. § 1333 — Labeling

**(a) Label requirements** (1) **In general** — It shall be unlawful for any person to manufacture, package, sell, offer to sell, distribute, or import for sale or distribution within the United States any cigarettes the package of which fails to bear, in accordance with the requirements of this section, one of the following labels: WARNING: Cigarettes are addictive. WARNING: Tobacco smoke can harm your children. WARNING: Cigarettes cause fatal lung disease. WARNING: Cigarettes cause cancer. WARNING: Cigarettes cause strokes and heart disease. WARNING: Smoking during pregnancy can harm your baby. WARNING: Smoking can kill you. WARNING: Tobacco smoke causes fatal lung disease in nonsmokers. WARNING: Quitting smoking now greatly reduces serious risks to your health. (2) **Placement; typography; etc.** — Each label statement required by paragraph (1) shall be located in the upper portion of the front and rear panels of the package, directly on the package underneath the cellophane or other clear wrapping. Each label statement shall comprise the top 50 percent of the front and rear panels of the package. The word “WARNING” shall appear in capital letters and all text shall be in conspicuous and legible 17-point type, unless the text of the label statement would occupy more than 70 percent of such area, in which case the text may be in a smaller conspicuous and legible type size, provided that at least 60 percent of such area is occupied by required text. The text shall be black on a white background, or white on a black background, in a manner that contrasts, by typography, layout, or color, with all other printed material on the package, in an alternating fashion under the plan submitted under subsection (c). (3) **Does not apply to foreign distribution** — The provisio

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21 U.S.C. § 387g — Tobacco product standards

**(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,

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21 U.S.C. § 387k — Modified risk tobacco products

**(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

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21 U.S.C. § 394 — Scientific review groups

Without regard to the provisions of title 5 governing appointments in the competitive service and without regard to the provisions of chapter 51 and subchapter III of chapter 53 of such title relating to classification and General Schedule pay rates, the Commissioner of Food and Drugs may— (1) establish such technical and scientific review groups as are needed to carry out the functions of the Food and Drug Administration (including functions prescribed under this chapter); and (2) appoint and pay the members of such groups, except that officers and employees of the United States shall not receive additional compensation for service as members of such groups.

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Federal law — U.S. Code and appendices · legal_authorities

15 U.S.C. § 4402 — Smokeless tobacco warning

**(a) General rule** (1) It shall be unlawful for any person to manufacture, package, sell, offer to sell, distribute, or import for sale or distribution within the United States any smokeless tobacco product unless the product package bears, in accordance with the requirements of this chapter, one of the following labels:WARNING: This product can cause mouth cancer. WARNING: This product can cause gum disease and tooth loss. WARNING: This product is not a safe alternative to cigarettes. WARNING: Smokeless tobacco is addictive. (2) Each label statement required by paragraph (1) shall be— (A) located on the 2 principal display panels of the package, and each label statement shall comprise at least 30 percent of each such display panel; and (B) in 17-point conspicuous and legible type and in black text on a white background, or white text on a black background, in a manner that contrasts by typography, layout, or color, with all other printed material on the package, in an alternating fashion under the plan submitted under subsection (b)(3), except that if the text of a label statement would occupy more than 70 percent of the area specified by subparagraph (A), such text may appear in a smaller type size, so long as at least 60 percent of such warning area is occupied by the label statement. (3) The label statements required by paragraph (1) shall be introduced by each tobacco product manufacturer, packager, importer, distributor, or retailer of smokeless tobacco products concurrently into the distribution chain of such products. (4) The provisions of this subsection do not apply to a tobacco product manufacturer or distributor of any smokeless tobacco product that does not manufacture, package, or import smokeless tobacco products for sale or distribution withi

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21 U.S.C. § 387i — Records and reports on tobacco products

**(a) In general** Every person who is a tobacco product manufacturer or importer of a tobacco product shall establish and maintain such records, make such reports, and provide such information, as the Secretary may by regulation reasonably require to assure that such tobacco product is not adulterated or misbranded and to otherwise protect public health. Regulations prescribed under the preceding sentence— (1) may require a tobacco product manufacturer or importer to report to the Secretary whenever the manufacturer or importer receives or otherwise becomes aware of information that reasonably suggests that one of its marketed tobacco products may have caused or contributed to a serious unexpected adverse experience associated with the use of the product or any significant increase in the frequency of a serious, expected adverse product experience; (2) shall require reporting of other significant adverse tobacco product experiences as determined by the Secretary to be necessary to be reported; (3) shall not impose requirements unduly burdensome to a tobacco product manufacturer or importer, taking into account the cost of complying with such requirements and the need for the protection of the public health and the implementation of this subchapter; (4) when prescribing the procedure for making requests for reports or information, shall require that each request made under such regulations for submission of a report or information to the Secretary state the reason or purpose for such request and identify to the fullest extent practicable such report or information; (5) when requiring submission of a report or information to the Secretary, shall state the reason or purpose for the submission of such report or information and identify to the fullest extent practicabl

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21 U.S.C. § 393 — Food and Drug Administration

**(a) In general** There is established in the Department of Health and Human Services the Food and Drug Administration (hereinafter in this section referred to as the “Administration”). **(b) Mission** The Administration shall— (1) promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner; (2) with respect to such products, protect the public health by ensuring that— (A) foods are safe, wholesome, sanitary, and properly labeled; (B) human and veterinary drugs are safe and effective; (C) there is reasonable assurance of the safety and effectiveness of devices intended for human use; (D) cosmetics are safe and properly labeled; and (E) public health and safety are protected from electronic product radiation; (3) participate through appropriate processes with representatives of other countries to reduce the burden of regulation, harmonize regulatory requirements, and achieve appropriate reciprocal arrangements; and (4) as determined to be appropriate by the Secretary, carry out paragraphs (1) through (3) in consultation with experts in science, medicine, and public health, and in cooperation with consumers, users, manufacturers, importers, packers, distributors, and retailers of regulated products. **(c) Interagency collaboration** The Secretary shall implement programs and policies that will foster collaboration between the Administration, the National Institutes of Health, and other science-based Federal agencies, to enhance the scientific and technical expertise available to the Secretary in the conduct of the duties of the Secretary with respect to the development, clinical investigation, evaluation, and postmarket monitoring of emerging

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21 U.S.C. § 331 — Prohibited acts

The following acts and the causing thereof are prohibited: **(a)** The introduction or delivery for introduction into interstate commerce of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded. **(b)** The adulteration or misbranding of any food, drug, device, tobacco product, or cosmetic in interstate commerce. **(c)** The receipt in interstate commerce of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise. **(d)** The introduction or delivery for introduction into interstate commerce of any article in violation of section 344, 350d, 355,,11 So in original. 360bbb–3, or 364c of this title. **(e)** The refusal to permit access to or copying of any record as required by section 350a, 350c, 350f(j), 350e, 354, 360bbb–3, 364a, 373, 374(a), 379aa, or 379aa–1 of this title; or the failure to establish or maintain any record, or make any report, required under section 350a, 350c(b), 350f, 350e, 354, 355(i) or (k), 360b(a)(4)(C), 360b(j), (l) or (m), 360ccc–1(i), 360e(f), 360i, 360bbb–3, 364a, 364g, 379aa, 379aa–1, 387i, or 387t of this title or the refusal to permit access to or verification or copying of any such required record; or the violation of any recordkeeping requirement under section 2223 22 See References in Text note below. of this title (except when such violation is committed by a farm). **(f)** The refusal to permit entry or inspection as authorized by [section 374 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section374&num=0&edition=prelim). **(g)** The manufacture within any Territory of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded. *

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21 U.S.C. § 387c — Misbranded tobacco products

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

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