View all text of Subchapter IX [§ 387 - § 387v]
§ 387e. Annual registration
(a) DefinitionsIn this section:
(1) Manufacture, preparation, compounding, or processing
(2) Name
(b) Registration by owners and operators
(c) Registration by new owners and operators
(d) Registration of added establishments
(e) Uniform product identification system
(f) Public access to registration information
(g) Biennial inspection of registered establishments
(h) Registration by foreign establishments
(i) Registration information
(1) Product listEvery person who registers with the Secretary under subsection (b), (c), (d), or (h) shall, at the time of registration under any such subsection, file with the Secretary a list of all tobacco products which are being manufactured, 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 paragraph (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 contained 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 marketing of such tobacco product and a copy of all labeling for such tobacco product;
(B) in the case of any other tobacco product 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 Secretary for good cause, a copy of all advertisements for a particular tobacco product; and
(C) if the registrant filing a list has determined 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 determination if the Secretary requests such a statement with respect to that particular tobacco product.
(2) Consultation with respect to forms
(3) Biannual report of any change in product listEach person who registers with the Secretary under this section shall report to the Secretary once during the month of June of each year and once during the month of December of each year the following:
(A) A list of each tobacco product introduced by the registrant for commercial distribution which has not been included in any list previously filed by that person with the Secretary under this subparagraph or paragraph (1). A list under this subparagraph shall list a tobacco product by its established 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 person has discontinued the manufacture, preparation, compounding, or processing for commercial distribution of a tobacco product included in a list filed under subparagraph (A) or paragraph (1), notice of such discontinuance, the date of such discontinuance, and the identity of its established name.
(C) If since the date the registrant reported 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 information required by paragraph (1), unless the registrant has previously reported such resumption to the Secretary under this subparagraph.
(D) Any material change in any information previously submitted under this paragraph or paragraph (1).
(j) Report preceding introduction of certain substantially equivalent products into interstate commerce
(1) In generalEach 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 distribution of a tobacco product intended for human use that was not commercially marketed (other than for test marketing) in the United States as of February 15, 2007, shall, at least 90 days prior to making such introduction or delivery, report to the Secretary (in such form and manner as the Secretary shall prescribe)—
(A) the basis for such person’s determination that—
(i) the tobacco product is substantially equivalent, within the meaning of section 387j of this title, to a tobacco product commercially marketed (other than for test marketing) in the United States as of February 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 requirements of this chapter; or
(ii) the tobacco product is modified within the meaning of paragraph (3), the modifications are to a product that is commercially marketed and in compliance with the requirements of this chapter, and all of the modifications are covered by exemptions 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
(3) Exemptions
(A) In generalThe Secretary may exempt from the requirements of this subsection relating to the demonstration that a tobacco product is substantially equivalent within the meaning of section 387j of this title, tobacco products that are modified by adding or deleting a tobacco 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 appropriate.
(B) Regulations
(