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 such programs, materials, and an- nouncements available to States, local govern- ments, school systems, the media, and such other entities as the Secretary determines ap- propriate to further the purposes of this chap- ter; (C) conduct and support research on the ef- fect of smokeless tobacco on human health; and (D) collect, analyze, and disseminate infor- mation and studies on smokeless tobacco and health. (2) In developing programs, materials, and an- nouncements 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 appro- priate 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 edu- cational programs and materials and public service announcements respecting the dangers to human health from the use of smokeless to- bacco, (2) to assist in the distribution of such pro- grams, materials, and announcements throughout the States, and (3) to establish 18 as the minimum age for the purchase of smokeless tobacco. (Pub. L. 99–252, § 2, Feb. 27, 1986, 100 Stat. 30.) Statutory Notes and Related Subsidiaries EFFECTIVE DATE Pub. L. 99–252, § 11, Feb. 27, 1986, 100 Stat. 35, provided that: ‘‘(a) IN GENERAL.—Except as provided in sections 3(f) and 5(b) [sections 4402(f) and 4404(b) of this title] and subsection (b), this Act [enacting this chapter and amending section 342 of Title 21, Food and Drugs] shall take effect one year after the date of enactment of this Act [Feb. 27, 1986]. ‘‘(b) EXCEPTION.—Sections 2, 3(b), 3(c), 3(d), 3(e), 4(b), 7, 8, 9 [sections 4401, 4402(b) to (e), 4403(b), and 4406 to 4408 of this title], and 10 [amending section 342 of Title 21] shall take effect on the date of the enactment of this Act [Feb. 27, 1986].’’ SHORT TITLE Pub. L. 99–252, § 1, Feb. 27, 1986, 100 Stat. 30, provided that: ‘‘This Act [enacting this chapter and amending section 342 of Title 21, Food and Drugs] may be cited as the ‘Comprehensive Smokeless Tobacco Health Edu- cation Act of 1986’.’’ § 4402. Smokeless tobacco warning (a) General rule (1) It shall be unlawful for any person to man- ufacture, 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 dis- ease and tooth loss. WARNING: This product is not a safe alter- native to cigarettes. WARNING: Smokeless tobacco is addictive. (2) Each label statement required by para- graph (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 dis- play 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 pack- age, 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 Page 2120 TITLE 15—COMMERCE AND TRADE § 4402 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 con- currently into the distribution chain of such products. (4) The provisions of this subsection do not apply to a tobacco product manufacturer or dis- tributor of any smokeless tobacco product that does not manufacture, package, or import smokeless tobacco products for sale or distribu- tion 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 prod- uct manufacturer, packager, importer, dis- tributor, or retailer of smokeless tobacco prod- ucts to advertise or cause to be advertised with- in the United States any smokeless tobacco product unless its advertising bears, in accord- ance with the requirements of this section, one of the labels specified in subsection (a). (2)(A) Each label statement required by sub- section (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 re- quired 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 cap- ital letters, and each label statement shall ap- pear 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 state- ments. (F) The text of such label statements shall be in a typeface pro rata to the following require- ments: 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 tab- loid 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 ad- vertisement. (G) The label statements shall be in English, except that— (i) in the case of an advertisement that ap- pears 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 ap- pear in the same language as that principally used in the advertisement. (3)(A) The label statements specified in sub- section (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 to- bacco product manufacturer, importer, dis- tributor, or retailer and approved by the Sec- retary. (B) The label statements specified in sub- section (a)(1) shall be rotated quarterly in alter- nating sequence in advertisements for each brand of smokeless tobacco product in accord- ance with a plan submitted by the tobacco prod- uct manufacturer, importer, distributor, or re- tailer to, and approved by, the Secretary. (C) The Secretary shall review each plan sub- mitted under subparagraphs (A) and (B) and ap- prove it if the plan— (i) will provide for the equal distribution and display on packaging and the rotation re- quired in advertising under this subsection; and (ii) assures that all of the labels required under this section will be displayed by the to- bacco product manufacturer, importer, dis- tributor, 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 pub- lic, 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, 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 con- stituent 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 et seq.]. The text of any such label statements or disclosures shall be required to appear only within the 20 percent area of adver- tisements provided by paragraph (2). The Sec- retary shall promulgate regulations which pro- vide 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 Com- munications Commission. Page 2121 TITLE 15—COMMERCE AND TRADE § 4404 (d) Authority to revise warning label statements The Secretary may, by a rulemaking con- ducted under section 553 of title 5, adjust the format, type size, and text of any of the label re- quirements, require color graphics to accom- pany 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 for- mat, type size, and text of any other disclosures required under the Federal Food, Drug, and Cos- metic Act, if the Secretary finds that such a change would promote greater public under- standing of the risks associated with the use of smokeless tobacco products. (Pub. L. 99–252, § 3, Feb. 27, 1986, 100 Stat. 30; Pub. L. 111–31, div. A, title II, §§ 204(a), 205(a), June 22, 2009, 123 Stat. 1846, 1848.) Editorial Notes REFERENCES IN TEXT The Federal Food, Drug, and Cosmetic Act, referred to in subsecs. (b)(4) and (d), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§ 301 et seq.) of Title 21, Food and Drugs. For complete classification of this Act to the Code, see section 301 of Title 21 and Tables. AMENDMENTS 2009—Pub. L. 111–31, § 204(a), amended section gen- erally. Prior to amendment, section consisted of sub- secs. (a) to (f) relating to smokeless tobacco warning labels and television and radio advertising. Subsec. (d). Pub. L. 111–31, § 205(a), amended section as amended by Pub. L. 111–31, § 204, by adding subsec. (d). Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 2009 AMENDMENT Pub. L. 111–31, div. A, title II, § 204(b), June 22, 2009, 123 Stat. 1848, provided that: ‘‘The amendment made by subsection (a) [amending this section] shall take effect 12 months after the date of enactment of this Act [June 22, 2009]. Such effective date shall be with respect to the date of manufacture, provided that, in any case, be- ginning 30 days after such effective date, a manufac- turer shall not introduce into the domestic commerce of the United States any product, irrespective of the date of manufacture, that is not in conformance with section 3 of the Comprehensive Smokeless Tobacco Health Education Act of 1986 (15 U.S.C. 4402), as amend- ed by subsection (a).’’ EFFECTIVE DATE Subsec. (a) effective one year after Feb. 27, 1986, and subsecs. (b) to (e) effective Feb. 27, 1986, see section 11 of Pub. L. 99–252, set out as a note under section 4401 of this title. § 4403. Ingredient reporting (a) In general (1) Each person who manufactures, packages, or imports smokeless tobacco products shall an- nually provide the Secretary with— (A) a list of the ingredients added to tobacco in the manufacture of smokeless tobacco prod- ucts which does not identify the company which uses the ingredients or the brand of smokeless tobacco which contains the ingredi- ents; and (B) a specification of the quantity of nico- tine contained in each such product. (2) A person or group of persons required to provide information by this subsection may des- ignate an individual or entity to provide the in- formation required by this subsection. (b) Report (1) At such times as the Secretary considers appropriate, the Secretary shall transmit to the Congress a report, based on the information pro- vided under subsection (a), respecting— (A) a summary of research activities and proposed research activities on the health ef- fects of ingredients added to tobacco in the manufacture of smokeless tobacco products and the findings of such research; (B) information pertaining to any such in- gredient which in the judgment of the Sec- retary poses a health risk to users of smoke- less tobacco; and (C) any other information which the Sec- retary determines to be in the public interest. (2)(A) Any information provided to the Sec- retary under subsection (a) shall be treated as a trade secret or confidential information subject to section 552(b)(4) of title 5 and shall not be re- vealed, except as provided in paragraph (1), to any person other than those authorized by the Secretary in carrying out their official duties under this section. (B) Subparagraph (A) does not authorize the withholding of information provided under sub- section (a) of this section from any duly author- ized subcommittee or committee of the Con- gress. If a subcommittee or committee of the Congress requests the Secretary to provide it such information, the Secretary shall make the information available to the subcommittee or committee and shall, at the same time, notify in writing the person who provided the information of such request. (C) The Secretary shall establish written pro- cedures to assure the confidentiality of informa- tion provided under subsection (a) of this sec- tion. Such procedures shall include the designa- tion of a duly authorized agent to serve as cus- todian of such information. The agent— (i) shall take physical possession of the in- formation and, when not in use by any person authorized to have access to such information, shall store it in a locked cabinet or file; and (ii) shall maintain a complete record of any person who inspects or uses the information. Such procedures shall require that any person permitted access to the information shall be in- structed in writing not to disclose the informa- tion to anyone who is not entitled to have ac- cess to the information. (Pub. L. 99–252, § 4, Feb. 27, 1986, 100 Stat. 32.) Statutory Notes and Related Subsidiaries EFFECTIVE DATE Subsec. (a) effective one year after Feb. 27, 1986, and subsec. (b) effective Feb. 27, 1986, see section 11 of Pub. L. 99–252, set out as a note under section 4401 of this title. § 4404. Enforcement, regulations, and construc- tion (a) Enforcement (1) A violation of section 4402 of this title or the regulations promulgated pursuant to this