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

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 Page 2122 TITLE 15—COMMERCE AND TRADE § 4405 chapter shall be considered a violation of sec- tion 45 of this title. (2) Any person who is found to violate any pro- vision of section 4402 or 4403(a) of this title shall be guilty of a misdemeanor and shall on convic- tion thereof be subject to a fine of not more than $10,000. (b) Regulations under section 4402 of this title (1) Regulations issued by the Federal Trade Commission under section 4402 of this title shall be issued in accordance with section 553 of title 5. (2) Not later than 180 days after February 27, 1986, the Federal Trade Commission shall pro- mulgate such regulations as it may require to implement section 4402 of this title. (c) Construction Nothing in this chapter (other than the re- quirements 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 prac- tices in the advertising of smokeless tobacco products. (Pub. L. 99–252, § 5, Feb. 27, 1986, 100 Stat. 33.) Statutory Notes and Related Subsidiaries EFFECTIVE DATE Subsecs. (a) and (c) effective one year after Feb. 27, 1986, see section 11(a) of Pub. L. 99–252, set out as a note under section 4401 of this title. § 4405. Injunctions The several district courts of the United States are vested with jurisdiction, for cause shown, to prevent and restrain violations of sec- tions 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 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. (Pub. L. 99–252, § 6, Feb. 27, 1986, 100 Stat. 33.) Statutory Notes and Related Subsidiaries EFFECTIVE DATE Section effective one year after Feb. 27, 1986, see sec- tion 11(a) of Pub. L. 99–252, set out as a note under sec- tion 4401 of this title. § 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 prod- ucts and health, other than the statements re- quired by section 4402 of this title, shall be re- quired by any Federal agency to appear on any package or in any advertisement (unless the ad- vertisement is an outdoor billboard advertise- ment) 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, 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 per- son from liability at common law or under State statutory law to any other person. (Pub. L. 99–252, § 7, Feb. 27, 1986, 100 Stat. 34; Pub. L. 111–31, div. A, title II, § 205(b), June 22, 2009, 123 Stat. 1849.) Editorial Notes REFERENCES IN TEXT The Family Smoking Prevention and Tobacco Con- trol Act, referred to in subsec. (a), is div. A of Pub. L. 111–31, June 22, 2009, 123 Stat. 1776. For complete classi- fication of this Act to the Code, see Short Title of 2009 Amendment note set out under section 301 of Title 21, Food and Drugs, and Tables. AMENDMENTS 2009—Subsec. (a). Pub. L. 111–31 substituted ‘‘Except as provided in the Family Smoking Prevention and To- bacco Control Act (and the amendments made by that Act), no’’ for ‘‘No’’. § 4407. Omitted Editorial Notes CODIFICATION Section, Pub. L. 99–252, § 8, Feb. 27, 1986, 100 Stat. 34, which required the Secretary of Health and Human Services and the Federal Trade Commission to trans- mit biennial reports to Congress on smokeless tobacco products, terminated, effective May 15, 2000, pursuant to section 3003 of Pub. L. 104–66, as amended, set out as a note under section 1113 of Title 31, Money and Fi- nance. See, also, pages 95 and 173 of House Document No. 103–7. § 4408. Definitions For purposes of this chapter: (1) The term ‘‘smokeless tobacco’’ has the meaning given such term by section 387(18) of title 21. (2) The term ‘‘commerce’’ means (A) com- merce between any State, the District of Co- lumbia, the Commonwealth of Puerto Rico, Guam, the Virgin Islands, American Samoa, Wake Island, Midway Islands, Kingman Reef, or Johnston Island and any place outside thereof; (B) commerce between points in any State, the District of Columbia, the Common- wealth of Puerto Rico, Guam, the Virgin Is- lands, American Samoa, Wake Island, Midway Islands, Kingman Reef, or Johnston Island, but through any place outside thereof; or (C) commerce wholly within the District of Co- lumbia, Guam, the Virgin Islands, American Samoa, Wake Island, Midway Islands, King- man Reef, or Johnston Island. (3) The term ‘‘United States’’, when used in a geographical sense, includes the several States, the District of Columbia, the Common- wealth of Puerto Rico, Guam, the Virgin Is- lands, American Samoa, Wake Island, Midway Islands, Kingman Reef, Johnston Island, and installations of the Armed Forces.