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

(a) Definitions: (1) "Manufacture, preparation, compounding, or processing" includes repackaging or relabeling a tobacco product on its way from the factory to the person who finally sells or delivers it to the consumer. (2) "Name" includes, for a partnership, every partner's name; for a corporation, every officer's and director's name plus the state of incorporation. (b) Registration by owners and operators: By December 31 of each year, anyone who owns or runs a factory in any state that manufactures, prepares, compounds, or processes tobacco products must register their name, business address, and every such factory with the Secretary. If this law was enacted in the second half of a calendar year, the Secretary must set a deadline no later than 6 months into the following year. (c) Registration by new owners and operators: Anyone starting this kind of business for the first time must register immediately. (d) Registration of added establishments: Anyone already registered under (b) or (c) who opens an additional factory doing this work in any state must register that new factory immediately too. (e) Uniform product identification system: The Secretary may create, by regulation, a standard system for identifying tobacco products, and can require registrants to use it when listing their products under subsection (i). (f) Public access to registration information: The Secretary must let any member of the public inspect a filed registration on request. (g) Biennial inspection of registered establishments: Every registered establishment that manufactures, compounds, or processes tobacco products must be inspected at least once every 2 years, starting from its registration date. (h) Registration by foreign establishments: Foreign factories that manufacture, prepare, compound, or process tobacco products must also register, under regulations the Secretary sets. Those regulations must require the same information as subsection (i), and must let the Secretary arrange — through the foreign government or otherwise — to determine whether the factory's products should be refused entry into the United States for any of the usual legal reasons. (i) Registration information: (1) Product list — When registering under (b), (c), (d), or (h), a business must file a list of every tobacco product it is making for commercial distribution that it hasn't already listed. This list must come with: (A) for a product already covered by a tobacco product standard or a substantial-equivalence order, a reference to that authority and a copy of its labeling; (B) for any other listed product, a copy of its consumer labeling, a representative sample of its ads, and — if the Secretary asks for good cause — copies of all its ads; and (C) if the registrant has decided a listed product isn't subject to a product standard, a brief explanation of that decision if the Secretary requests one. (2) Consultation with respect to forms — The Secretary must work with the Treasury Department's Tax and Trade Bureau when designing registration forms, to minimize duplicate paperwork for businesses that must register with both agencies. (3) Biannual report of any change in product list — Every June and every December, each registrant must report: (A) any new product introduced for commercial distribution since its last list, described by its established name with the same details required under paragraph (1); (B) if it has stopped making a listed product, notice of that discontinuance and the date; (C) if it later resumes making a discontinued product, notice of the resumption, the date, the product's established name, and the paragraph (1) details, unless already reported; and (D) any material change to information filed earlier under this paragraph or paragraph (1). (j) Report preceding introduction of certain substantially equivalent products into interstate commerce: (1) Anyone required to register who plans to sell a tobacco product not commercially marketed in the United States as of February 15, 2007, must, at least 90 days before doing so, report to the Secretary either: (A) the basis for believing the product is "substantially equivalent" (as defined in section 387j) to a product marketed as of February 15, 2007, or to a product the Secretary has already ruled equivalent and compliant, and the steps taken to meet section 387g's product standards; or (B) that the product is a modified version, covered by an exemption granted under paragraph (3). (2) For a product first introduced between February 15, 2007 and roughly 21 months after June 22, 2009, this report is due by that 21-month deadline instead. (3) Exemptions — (A) The Secretary may exempt certain minor additive changes from this equivalence-report requirement if a report isn't needed to protect public health and an exemption is otherwise appropriate. (B) The Secretary must issue regulations implementing this exemption within 15 months of June 22, 2009.