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

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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Stable record: federal_law:legal_authorities:record_usc_959fe3303c2077f9336c64b4
Source file: Laws/federal/codes/united-states-code/title-15/section-4402-smokeless-tobacco-warning--7a9efc567f.md
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Source location: Title 15, Chapter 70, § 4402; chapter-070-comprehensive-smokeless-tobacco-health-education.md

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**(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 within the United States. (5) A retailer of smokeless tobacco products shall not be in violation of this subsection for packaging that— (A) contains a warning label; (B) is supplied to the retailer by a license- or permit-holding tobacco product manufacturer, importer, or distributor; and (C) is not altered by the retailer in a way that is material to the requirements of this subsection. **(b) Required labels** (1) It shall be unlawful for any tobacco product manufacturer, packager, importer, distributor, or retailer of smokeless tobacco products to advertise or cause to be advertised within the United States any smokeless tobacco product unless its advertising bears, in accordance with the requirements of this section, one of the labels specified in subsection (a). (2) (A) Each label statement required by subsection (a) in smokeless tobacco advertising shall comply with the standards set forth in this paragraph. (B) For press and poster advertisements, each such statement and (where applicable) any required statement relating to tar, nicotine, or other constituent yield shall comprise at least 20 percent of the area of the advertisement. (C) The word “WARNING” shall appear in capital letters, and each label statement shall appear in conspicuous and legible type. (D) The text of the label statement shall be black on a white background, or white on a black background, in an alternating fashion under the plan submitted under paragraph (3). (E) The label statements shall be enclosed by a rectangular border that is the same color as the letters of the statements and that is the width of the first downstroke of the capital “W” of the word “WARNING” in the label statements. (F) The text of such label statements shall be in a typeface pro rata to the following requirements: 45-point type for a whole-page broadsheet newspaper advertisement; 39-point type for a half-page broadsheet newspaper advertisement; 39-point type for a whole-page tabloid newspaper advertisement; 27-point type for a half-page tabloid newspaper advertisement; 31.5-point type for a double page spread magazine or whole-page magazine advertisement; 22.5-point type for a 28 centimeter by 3 column advertisement; and 15-point type for a 20 centimeter by 2 column advertisement. (G) The label statements shall be in English, except that— (i) in the case of an advertisement that appears in a newspaper, magazine, periodical, or other publication that is not in English, the statements shall appear in the predominant language of the publication; and (ii) in the case of any other advertisement that is not in English, the statements shall appear in the same language as that principally used in the advertisement. (3) (A) The label statements specified in subsection (a)(1) shall be randomly displayed in each 12-month period, in as equal a number of times as is possible on each brand of the product and be randomly distributed in all areas of the United States in which the product is marketed in accordance with a plan submitted by the tobacco product manufacturer, importer, distributor, or retailer and approved by the Secretary. (B) The label statements specified in subsection (a)(1) shall be rotated quarterly in alternating sequence in advertisements for each brand of smokeless tobacco product in accordance with a plan submitted by the tobacco product manufacturer, importer, distributor, or retailer to, and approved by, the Secretary. (C) The Secretary shall review each plan submitted under subparagraphs (A) and (B) and approve it if the plan— (i) will provide for the equal distribution and display on packaging and the rotation required in advertising under this subsection; and (ii) assures that all of the labels required under this section will be displayed by the tobacco product manufacturer, importer, distributor, or retailer at the same time. (D) This paragraph applies to a retailer only if that retailer is responsible for or directs the label statements under this section, unless the retailer displays, in a location open to the public, an advertisement that does not contain a warning label or has been altered by the retailer in a way that is material to the requirements of this subsection. (4) The Secretary may, through a rulemaking under [section 553 of title 5](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title5-section553&num=0&edition=prelim), adjust the format and type sizes for the label statements required by this section; the text, format, and type sizes of any required tar, nicotine yield, or other constituent disclosures; or the text, format, and type sizes for any other disclosures required under the Federal Food, Drug, and Cosmetic Act [[21 U.S.C. 301](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section301&num=0&edition=prelim) et seq.]. The text of any such label statements or disclosures shall be required to appear only within the 20 percent area of advertisements provided by paragraph (2). The Secretary shall promulgate regulations which provide for adjustments in the format and type sizes of any text required to appear in such area to ensure that the total text required to appear by law will fit within such area. **(c) Television and radio advertising** It is unlawful to advertise smokeless tobacco on any medium of electronic communications subject to the jurisdiction of the Federal Communications Commission. **(d) Authority to revise warning label statements** The Secretary may, by a rulemaking conducted under [section 553 of title 5](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title5-section553&num=0&edition=prelim), adjust the format, type size, and text of any of the label requirements, require color graphics to accompany the text, increase the required label area from 30 percent up to 50 percent of the front and rear panels of the package, or establish the format, type size, and text of any other disclosures required under the Federal Food, Drug, and Cosmetic Act, if the Secretary finds that such a change would promote greater public understanding of the risks associated with the use of smokeless tobacco products.

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

15 U.S.C. § 4401 — Public education

**(a) Development** (1) The Secretary of Health and Human Services shall establish and carry out a program to inform the public of any dangers to human health resulting from the use of smokeless tobacco products. In carrying out such program the Secretary shall— (A) develop educational programs and materials and public service announcements respecting the dangers to human health from the use of smokeless tobacco; (B) make such programs, materials, and announcements available to States, local governments, school systems, the media, and such other entities as the Secretary determines appropriate to further the purposes of this chapter; (C) conduct and support research on the effect of smokeless tobacco on human health; and (D) collect, analyze, and disseminate information and studies on smokeless tobacco and health. (2) In developing programs, materials, and announcements under paragraph (1) the Secretary shall consult with the Secretary of Education, medical and public health entities, consumer groups, representatives of manufacturers of smokeless tobacco products, and other appropriate entities. **(b) Assistance** The Secretary of Health and Human Services may provide technical assistance and may make grants to States— (1) to assist in the development of educational programs and materials and public service announcements respecting the dangers to human health from the use of smokeless tobacco, (2) to assist in the distribution of such programs, materials, and announcements throughout the States, and (3) to establish 18 as the minimum age for the purchase of smokeless tobacco.

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

5 U.S.C. § 553 — Rule making

**(a)** This section applies, according to the provisions thereof, except to the extent that there is involved— (1) a military or foreign affairs function of the United States; or (2) a matter relating to agency management or personnel or to public property, loans, grants, benefits, or contracts. **(b)** General notice of proposed rule making shall be published in the Federal Register, unless persons subject thereto are named and either personally served or otherwise have actual notice thereof in accordance with law. The notice shall include— (1) a statement of the time, place, and nature of public rule making proceedings; (2) reference to the legal authority under which the rule is proposed; (3) either the terms or substance of the proposed rule or a description of the subjects and issues involved; and (4) the Internet address of a summary of not more than 100 words in length of the proposed rule, in plain language, that shall be posted on the Internet website under section 206(d) of the E-Government Act of 2002 ([44 U.S.C. 3501](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title44-section3501&num=0&edition=prelim) note) (commonly known as regulations.gov). Except when notice or hearing is required by statute, this subsection does not apply— (A) to interpretative rules, general statements of policy, or rules of agency organization, procedure, or practice; or (B) when the agency for good cause finds (and incorporates the finding and a brief statement of reasons therefor in the rules issued) that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest. **(c)** After notice required by this section, the agency shall give interested persons an opportunity to participate in the rule making through subm

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

15 U.S.C. § 4404 — Enforcement, regulations, and construction

**(a) Enforcement** (1) A violation of [section 4402 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section4402&num=0&edition=prelim) or the regulations promulgated pursuant to this chapter shall be considered a violation of [section 45 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section45&num=0&edition=prelim). (2) Any person who is found to violate any provision of section 4402 or 4403(a) of this title shall be guilty of a misdemeanor and shall on conviction thereof be subject to a fine of not more than $10,000. **(b) Regulations under [section 4402 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section4402&num=0&edition=prelim)** (1) Regulations issued by the Federal Trade Commission under [section 4402 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section4402&num=0&edition=prelim) shall be issued in accordance with [section 553 of title 5](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title5-section553&num=0&edition=prelim). (2) Not later than 180 days after February 27, 1986, the Federal Trade Commission shall promulgate such regulations as it may require to implement [section 4402 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section4402&num=0&edition=prelim). **(c) Construction** Nothing in this chapter (other than the requirements of sections 4402 and 4403 of this title) shall be construed to limit, restrict, or expand the authority of the Federal Trade Commission with respect to unfair or deceptive acts or practices in the advertising of smokeless tobacco products.

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

15 U.S.C. § 4405 — Injunctions

The several district courts of the United States are vested with jurisdiction, for cause shown, to prevent and restrain violations of sections 4402 and 4403 of this title upon application of the Federal Trade Commission in the case of a violation of [section 4402 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section4402&num=0&edition=prelim) or upon application of the Attorney General of the United States acting through the several United States attorneys in their several districts in the case of a violation of section 4402 or 4403 of this title.

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

15 U.S.C. § 4406 — Preemption

**(a) Federal action** Except as provided in the Family Smoking Prevention and Tobacco Control Act (and the amendments made by that Act), no statement relating to the use of smokeless tobacco products and health, other than the statements required by [section 4402 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section4402&num=0&edition=prelim), shall be required by any Federal agency to appear on any package or in any advertisement (unless the advertisement is an outdoor billboard advertisement) of a smokeless tobacco product. **(b) State and local action** No statement relating to the use of smokeless tobacco products and health, other than the statements required by [section 4402 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section4402&num=0&edition=prelim), shall be required by any State or local statute or regulation to be included on any package or in any advertisement (unless the advertisement is an outdoor billboard advertisement) of a smokeless tobacco product. **(c) Effect on liability law** Nothing in this chapter shall relieve any person from liability at common law or under State statutory law to any other person.

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

19 U.S.C. § 1681a — Requirements for entry of certain cigarettes and smokeless tobacco products

**(a) General rule** Except as provided in subsection (b), cigarettes or smokeless tobacco products may be imported into the United States only if— (1) the original manufacturer of those cigarettes or smokeless tobacco products has timely submitted, or has certified that it will timely submit, to the Secretary of Health and Human Services the lists of the ingredients added to the tobacco in the manufacture of such cigarettes or smokeless tobacco products as described in [section 1335a of title 15](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section1335a&num=0&edition=prelim) or [section 4403 of title 15](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section4403&num=0&edition=prelim), as the case may be; (2) the precise warning statements in the precise format specified in [section 1333 of title 15](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section1333&num=0&edition=prelim) or [section 4402 of title 15](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section4402&num=0&edition=prelim), as the case may be, are permanently imprinted on both— (A) the primary packaging of all those cigarettes or smokeless tobacco products; and (B) any other pack, box, carton, or container of any kind in which those cigarettes or smokeless tobacco products are to be offered for sale or otherwise distributed to consumers; (3) the manufacturer or importer of those cigarettes or smokeless tobacco products is in compliance with respect to those cigarettes or smokeless tobacco products being imported into the United States with a rotation plan approved by the Federal Trade Commission pursuant to section 1333(c) 11 See References in Text note below. of title 15 or section 4402(d) 1 of title 15, a

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

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

**(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 regula

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

21 U.S.C. § 387n — Jurisdiction of and coordination with the Federal Trade Commission

**(a) Jurisdiction** (1) **In general** — Except where expressly provided in this subchapter, nothing in this subchapter shall be construed as limiting or diminishing the authority of the Federal Trade Commission to enforce the laws under its jurisdiction with respect to the advertising, sale, or distribution of tobacco products. (2) **Enforcement** — Any advertising that violates this subchapter or a provision of the regulations referred to in [section 387a–1 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387a-1&num=0&edition=prelim), is an unfair or deceptive act or practice under [section 45(a) of title 15](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section45/a&num=0&edition=prelim) and shall be considered a violation of a rule promulgated under [section 57a of title 15](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section57a&num=0&edition=prelim). **(b) Coordination** With respect to the requirements of section 4 of the Federal Cigarette Labeling and Advertising Act [[15 U.S.C. 1333](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section1333&num=0&edition=prelim)] and section 3 of the Comprehensive Smokeless Tobacco Health Education Act of 1986 [[15 U.S.C. 4402](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section4402&num=0&edition=prelim)]— (1) the Chairman of the Federal Trade Commission shall coordinate with the Secretary concerning the enforcement of such Act as such enforcement relates to unfair or deceptive acts or practices in the advertising of cigarettes or smokeless tobacco; and (2) the Secretary shall consult with the Chairman of such Commission in revising the label statements and requirements under such section

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

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

Page 2119 TITLE 15—COMMERCE AND TRADE § 4402 tional Cooperative Research and Production Act of 1993 [15 U.S.C. 4305(a)(3)] at any time.’’ § 4306. Application of section 4303 protections to production of products, processes, and serv- ices Notwithstanding sections 4303 and 4305 of this title, the protections of section 4303 of this title shall not apply with respect to a joint venture’s production of a product, process, or service, as referred to in section 4301(a)(6)(D) of this title, unless— (1) the principal facilities for such produc- tion are located in the United States or its territories, and (2) each person who controls any party to such venture (including such party itself) is a United States person, or a foreign person from a country whose law accords antitrust treat- ment no less favorable to United States per- sons than to such country’s domestic persons with respect to participation in joint ventures for production. (Pub. L. 98–462, § 7, as added Pub. L. 103–42, § 3(g), June 10, 1993, 107 Stat. 119.) CHAPTER 70—COMPREHENSIVE SMOKELESS TOBACCO HEALTH EDUCATION Sec. 4401. Public education. 4402. Smokeless tobacco warning. 4403. Ingredient reporting. 4404. Enforcement, regulations, and construction. 4405. Injunctions. 4406. Preemption. 4407. Omitted. 4408. Definitions. § 4401. Public education (a) Development (1) The Secretary of Health and Human Serv- ices shall establish and carry out a program to inform the public of any dangers to human health resulting from the use of smokeless to- bacco products. In carrying out such program the Secretary shall— (A) develop educational programs and mate- rials and public service announcements re- specting the dangers to human health from the use of smokeless tobacco; (B) make suc

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