21 U.S.C. § 387e — Annual registration

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 Page 675 TITLE 21—FOOD AND DRUGS § 387e such subsection, file with the Secretary a list of all tobacco products which are being manu- factured, prepared, compounded, or processed by that person for commercial distribution and which have not been included in any list of tobacco products filed by that person with the Secretary under this paragraph or para- graph (2) before such time of registration. Such list shall be prepared in such form and manner as the Secretary may prescribe and shall be accompanied by— (A) in the case of a tobacco product con- tained in the applicable list with respect to which a tobacco product standard has been established under section 387g of this title or which is subject to section 387j of this title, a reference to the authority for the mar- keting of such tobacco product and a copy of all labeling for such tobacco product; (B) in the case of any other tobacco prod- uct contained in an applicable list, a copy of all consumer information and other labeling for such tobacco product, a representative sampling of advertisements for such tobacco product, and, upon request made by the Sec- retary for good cause, a copy of all adver- tisements for a particular tobacco product; and (C) if the registrant filing a list has deter- mined that a tobacco product contained in such list is not subject to a tobacco product standard established under section 387g of this title, a brief statement of the basis upon which the registrant made such determina- tion if the Secretary requests such a state- ment with respect to that particular tobacco product. (2) Consultation with respect to forms The Secretary shall consult with the Sec- retary of the Treasury in developing the forms to be used for registration under this section to minimize the burden on those persons re- quired to register with both the Secretary and the Tax and Trade Bureau of the Department of the Treasury. (3) Biannual report of any change in product list Each person who registers with the Sec- retary under this section shall report to the Secretary once during the month of June of each year and once during the month of De- cember of each year the following: (A) A list of each tobacco product intro- duced by the registrant for commercial dis- tribution which has not been included in any list previously filed by that person with the Secretary under this subparagraph or para- graph (1). A list under this subparagraph shall list a tobacco product by its estab- lished name and shall be accompanied by the other information required by paragraph (1). (B) If since the date the registrant last made a report under this paragraph that per- son has discontinued the manufacture, prep- aration, compounding, or processing for commercial distribution of a tobacco prod- uct included in a list filed under subpara- graph (A) or paragraph (1), notice of such discontinuance, the date of such discontinu- ance, and the identity of its established name. (C) If since the date the registrant re- ported under subparagraph (B) a notice of discontinuance that person has resumed the manufacture, preparation, compounding, or processing for commercial distribution of the tobacco product with respect to which such notice of discontinuance was reported, notice of such resumption, the date of such resumption, the identity of such tobacco product by established name, and other in- formation required by paragraph (1), unless the registrant has previously reported such resumption to the Secretary under this sub- paragraph. (D) Any material change in any informa- tion previously submitted under this para- graph or paragraph (1). (j) Report preceding introduction of certain sub- stantially equivalent products into interstate commerce (1) In general Each person who is required to register under this section and who proposes to begin the introduction or delivery for introduction into interstate commerce for commercial dis- tribution of a tobacco product intended for human use that was not commercially mar- keted (other than for test marketing) in the United States as of February 15, 2007, shall, at least 90 days prior to making such introduc- tion or delivery, report to the Secretary (in such form and manner as the Secretary shall prescribe)— (A) the basis for such person’s determina- tion that— (i) the tobacco product is substantially equivalent, within the meaning of section 387j of this title, to a tobacco product com- mercially marketed (other than for test marketing) in the United States as of Feb- ruary 15, 2007, or to a tobacco product that the Secretary has previously determined, pursuant to subsection (a)(3) of section 387j of this title, is substantially equivalent and that is in compliance with the require- ments of this chapter; or (ii) the tobacco product is modified with- in the meaning of paragraph (3), the modi- fications are to a product that is commer- cially marketed and in compliance with the requirements of this chapter, and all of the modifications are covered by exemp- tions granted by the Secretary pursuant to paragraph (3); and (B) action taken by such person to comply with the requirements under section 387g of this title that are applicable to the tobacco product. (2) Application to certain post–February 15, 2007, products A report under this subsection for a tobacco product that was first introduced or delivered for introduction into interstate commerce for commercial distribution in the United States after February 15, 2007, and prior to the date that is 21 months after June 22, 2009, shall be submitted to the Secretary not later than 21 months after June 22, 2009. Page 676 TITLE 21—FOOD AND DRUGS § 387f 1 So in original. Probably should be ‘‘are’’. (3) Exemptions (A) In general The Secretary may exempt from the re- quirements of this subsection relating to the demonstration that a tobacco product is sub- stantially equivalent within the meaning of section 387j of this title, tobacco products that are modified by adding or deleting a to- bacco additive, or increasing or decreasing the quantity of an existing tobacco additive, if the Secretary determines that— (i) such modification would be a minor modification of a tobacco product that can be sold under this chapter; (ii) a report under this subsection is not necessary to ensure that permitting the tobacco product to be marketed would be appropriate for protection of the public health; and (iii) an exemption is otherwise appro- priate. (B) Regulations Not later than 15 months after June 22, 2009, the Secretary shall issue regulations to implement this paragraph. (June 25, 1938, ch. 675, § 905, as added Pub. L. 111–31, div. A, title I, § 101(b)(3), June 22, 2009, 123 Stat. 1792.) Editorial Notes REFERENCES IN TEXT The Family Smoking Prevention and Tobacco Con- trol Act, referred to in subsec. (b), 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 this title and Tables. PRIOR PROVISIONS A prior section 905 of act June 25, 1938, was renum- bered section 1005 and is classified to section 395 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. § 387f. General provisions respecting control of tobacco products (a) In general Any requirement established by or under sec- tion 387b, 387c, 387e, or 387i of this title applica- ble to a tobacco product shall apply to such to- bacco product until the applicability of the re- quirement to the tobacco product has been changed by action taken under section 387g of this title, section 387j of this title, section 387k of this title, or subsection (d) of this section, and any requirement established by or under section 387b, 387c, 387e, or 387i of this title which is inconsistent with a requirement imposed on such tobacco product under section 387g of this title, section 387j of this title, section 387k of this title, or subsection (d) of this section shall not apply to such tobacco product. (b) Information on public access and comment Each notice of proposed rulemaking or other notification under section 387g, 387h, 387i, 387j, or 387k of this title or under this section, any other notice which is published in the Federal Register with respect to any other action taken under any such section and which states the rea- sons for such action, and each publication of findings required to be made in connection with rulemaking under any such section shall set forth— (1) the manner in which interested persons may examine data and other information on which the notice or findings is 1 based; and (2) the period within which interested per- sons may present their comments on the no- tice or findings (including the need therefore) orally or in writing, which period shall be at least 60 days but may not exceed 90 days un- less the time is extended by the Secretary by a notice published in the Federal Register stating good cause therefore. (c) Limited confidentiality of information Any information reported to or otherwise ob- tained by the Secretary or the Secretary’s rep- resentative under section 387c, 387d, 387g, 387h, 387i, 387j, 387k, or 374 of this title, or under sub- section (e) or (f) of this section, which is exempt from disclosure under subsection (a) of section 552 of title 5 by reason of subsection (b)(4) of that section shall be considered confidential and shall not be disclosed, except that the informa- tion may be disclosed to other officers or em- ployees concerned with carrying out this sub- chapter, or when relevant in any proceeding under this subchapter. (d) Restrictions (1) In general The Secretary may by regulation require re- strictions on the sale and distribution of a to- bacco product, including restrictions on the access to, and the advertising and promotion of, the tobacco product, if the Secretary deter- mines that such regulation would be appro- priate for the protection of the public health. The Secretary may by regulation impose re- strictions on the advertising and promotion of a tobacco product consistent with and to full extent permitted by the first amendment to the Constitution. The finding as to whether such regulation would be appropriate for the protection of the public health shall be deter- mined with respect to the risks and benefits to the population as a whole, including users and nonusers of the tobacco product, and taking into account— (A) the increased or decreased likelihood that existing users of tobacco products will stop using such products; and