21 U.S.C. § 387d — Submission of health information to the

Page 673 TITLE 21—FOOD AND DRUGS § 387d date of manufacture, provided that, in any case, begin- ning 30 days after such effective date, a manufacturer 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 903(a)(2), (3), and (4) and section 920(a) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 387t(a)]. ‘‘(6) ADVERTISING REQUIREMENTS.—The advertising re- quirements of section 903(a)(8) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 387c(a)(8)] (as amend- ed by this division) shall take effect on the date that is 12 months after the date of enactment of this Act [June 22, 2009].’’ § 387d. Submission of health information to the Secretary (a) Requirement Each tobacco product manufacturer or im- porter, or agents thereof, shall submit to the Secretary the following information: (1) Not later than 6 months after June 22, 2009, a listing of all ingredients, including to- bacco, substances, compounds, and additives that are, as of such date, added by the manu- facturer to the tobacco, paper, filter, or other part of each tobacco product by brand and by quantity in each brand and subbrand. (2) A description of the content, delivery, and form of nicotine in each tobacco product measured in milligrams of nicotine in accord- ance with regulations promulgated by the Sec- retary in accordance with section 1333(e) of title 15. (3) Beginning 3 years after June 22, 2009, a listing of all constituents, including smoke constituents as applicable, identified by the Secretary as harmful or potentially harmful to health in each tobacco product, and as ap- plicable in the smoke of each tobacco product, by brand and by quantity in each brand and subbrand. Effective beginning 3 years after June 22, 2009, the manufacturer, importer, or agent shall comply with regulations promul- gated under section 387o of this title in report- ing information under this paragraph, where applicable. (4) Beginning 6 months after June 22, 2009, all documents developed after June 22, 2009 that relate to health, toxicological, behav- ioral, or physiologic effects of current or fu- ture tobacco products, their constituents (in- cluding smoke constituents), ingredients, components, and additives. (b) Data submission At the request of the Secretary, each tobacco product manufacturer or importer of tobacco products, or agents thereof, shall submit the fol- lowing: (1) Any or all documents (including under- lying scientific information) relating to re- search activities, and research findings, con- ducted, supported, or possessed by the manu- facturer (or agents thereof) on the health, tox- icological, behavioral, or physiologic effects of tobacco products and their constituents (in- cluding smoke constituents), ingredients, components, and additives. (2) Any or all documents (including under- lying scientific information) relating to re- search activities, and research findings, con- ducted, supported, or possessed by the manu- facturer (or agents thereof) that relate to the issue of whether a reduction in risk to health from tobacco products can occur upon the em- ployment of technology available or known to the manufacturer. (3) Any or all documents (including under- lying scientific or financial information) re- lating to marketing research involving the use of tobacco products or marketing practices and the effectiveness of such practices used by tobacco manufacturers and distributors. An importer of a tobacco product not manufac- tured in the United States shall supply the in- formation required of a tobacco product manu- facturer under this subsection. (c) Time for submission (1) In general At least 90 days prior to the delivery for in- troduction into interstate commerce of a to- bacco product not on the market on June 22, 2009, the manufacturer of such product shall provide the information required under sub- section (a). (2) Disclosure of additive If at any time a tobacco product manufac- turer adds to its tobacco products a new to- bacco additive or increases the quantity of an existing tobacco additive, the manufacturer shall, except as provided in paragraph (3), at least 90 days prior to such action so advise the Secretary in writing. (3) Disclosure of other actions If at any time a tobacco product manufac- turer eliminates or decreases an existing addi- tive, or adds or increases an additive that has by regulation been designated by the Sec- retary as an additive that is not a human or animal carcinogen, or otherwise harmful to health under intended conditions of use, the manufacturer shall within 60 days of such ac- tion so advise the Secretary in writing. (d) Data list (1) In general Not later than 3 years after June 22, 2009, and annually thereafter, the Secretary shall publish in a format that is understandable and not misleading to a lay person, and place on public display (in a manner determined by the Secretary) the list established under sub- section (e). (2) Consumer research The Secretary shall conduct periodic con- sumer research to ensure that the list pub- lished under paragraph (1) is not misleading to lay persons. Not later than 5 years after June 22, 2009, the Secretary shall submit to the ap- propriate committees of Congress a report on the results of such research, together with rec- ommendations on whether such publication should be continued or modified. (e) Data collection Not later than 24 months after June 22, 2009, the Secretary shall establish, and periodically revise as appropriate, a list of harmful and po- tentially harmful constituents, including smoke constituents, to health in each tobacco product Page 674 TITLE 21—FOOD AND DRUGS § 387e by brand and by quantity in each brand and subbrand. The Secretary shall publish a public notice requesting the submission by interested persons of scientific and other information con- cerning the harmful and potentially harmful constituents in tobacco products and tobacco smoke. (June 25, 1938, ch. 675, § 904, as added Pub. L. 111–31, div. A, title I, § 101(b)(3), June 22, 2009, 123 Stat. 1790.) Editorial Notes PRIOR PROVISIONS A prior section 904 of act June 25, 1938, was renum- bered section 1004 and is classified to section 394 of this title. Statutory Notes and Related Subsidiaries MODIFICATION OF DEADLINES FOR SECRETARIAL ACTION With respect to any time periods specified in an amendment by div. A of Pub. L. 111–31 that begin on June 22, 2009, within which the Secretary of Health and Human Services is required to carry out and complete specified activities, with certain limitations, the cal- culation of such time periods shall commence on the first day of the first fiscal quarter following the initial 2 consecutive fiscal quarters of fiscal year 2010 for which the Secretary has collected fees under section 387s of this title, and the Secretary may extend or re- duce the duration of one or more such time periods, ex- cept that no such period shall be extended for more than 90 days, see section 6 of Pub. L. 111–31, set out as a note under section 387 of this title. § 387e. Annual registration (a) Definitions In this section: (1) Manufacture, preparation, compounding, or processing The term ‘‘manufacture, preparation, compounding, or processing’’ shall include re- packaging or otherwise changing the con- tainer, wrapper, or labeling of any tobacco product package in furtherance of the dis- tribution of the tobacco product from the original place of manufacture to the person who makes final delivery or sale to the ulti- mate consumer or user. (2) Name The term ‘‘name’’ shall include in the case of a partnership the name of each partner and, in the case of a corporation, the name of each corporate officer and director, and the State of incorporation. (b) Registration by owners and operators On or before December 31 of each year, every person who owns or operates any establishment in any State engaged in the manufacture, prepa- ration, compounding, or processing of a tobacco product or tobacco products shall register with the Secretary the name, places of business, and all such establishments of that person. If enact- ment of the Family Smoking Prevention and Tobacco Control Act occurs in the second half of the calendar year, the Secretary shall designate a date no later than 6 months into the subse- quent calendar year by which registration pur- suant to this subsection shall occur. (c) Registration by new owners and operators Every person upon first engaging in the manu- facture, preparation, compounding, or proc- essing of a tobacco product or tobacco products in any establishment owned or operated in any State by that person shall immediately register with the Secretary that person’s name, place of business, and such establishment. (d) Registration of added establishments Every person required to register under sub- section (b) or (c) shall immediately register with the Secretary any additional establishment which that person owns or operates in any State and in which that person begins the manufac- ture, preparation, compounding, or processing of a tobacco product or tobacco products. (e) Uniform product identification system The Secretary may by regulation prescribe a uniform system for the identification of tobacco products and may require that persons who are required to list such tobacco products under sub- section (i) shall list such tobacco products in ac- cordance with such system. (f) Public access to registration information The Secretary shall make available for inspec- tion, to any person so requesting, any registra- tion filed under this section. (g) Biennial inspection of registered establish- ments Every establishment registered with the Sec- retary under this section shall be subject to in- spection under section 374 of this title or sub- section (h), and every such establishment en- gaged in the manufacture, compounding, or processing of a tobacco product or tobacco prod- ucts shall be so inspected by 1 or more officers or employees duly designated by the Secretary at least once in the 2-year period beginning with the date of registration of such establishment under this section and at least once in every successive 2-year period thereafter. (h) Registration by foreign establishments Any establishment within any foreign country engaged in the manufacture, preparation, compounding, or processing of a tobacco product or tobacco products, shall register under this section under regulations promulgated by the Secretary. Such regulations shall require such establishment to provide the information re- quired by subsection (i) and shall include provi- sions for registration of any such establishment upon condition that adequate and effective means are available, by arrangement with the government of such foreign country or other- wise, to enable the Secretary to determine from time to time whether tobacco products manu- factured, prepared, compounded, or processed in such establishment, if imported or offered for import into the United States, shall be refused admission on any of the grounds set forth in sec- tion 381(a) of this title. (i) Registration information (1) Product list Every person who registers with the Sec- retary under subsection (b), (c), (d), or (h) shall, at the time of registration under any