21 U.S.C. § 387f — General provisions respecting control of tobacco products

(a) In general: Rules made under sections 387b, 387c, 387e, or 387i keep applying to a tobacco product until they're changed by action taken under section 387g (product standards), 387j (equivalence review), 387k (modified risk products), or subsection (d) below. If one of those older rules conflicts with a newer requirement imposed under 387g, 387j, 387k, or (d), the older rule stops applying to that product. (b) Information on public access and comment: Any proposed rule or other notice published under sections 387g, 387h, 387i, 387j, or 387k, or under this section — and any other Federal Register notice explaining the reasons for an action taken under those sections — must state: (1) how interested people can review the underlying data, and (2) how long they have to comment, orally or in writing — at least 60 days and no more than 90, unless the Secretary extends it for good cause explained in a Federal Register notice. (c) Limited confidentiality of information: Information the Secretary collects under several tobacco-related sections that qualifies as exempt from public disclosure as a trade secret or confidential commercial information must be kept confidential. It may be shared only with other officers or employees working on this subchapter, or when relevant to a proceeding under this subchapter. (d) Restrictions: (1) In general — The Secretary may, by regulation, restrict how a tobacco product is sold and distributed, including limiting access to it and its advertising and promotion, if that restriction would protect public health. Advertising and promotion restrictions must stay within First Amendment limits. Whether a restriction protects public health is judged by weighing the risks and benefits to the whole population, users and non-users alike, including (A) whether it makes existing users more or less likely to quit, and (B) whether it makes non-users more or less likely to start. No such restriction may require that a tobacco product be sold only with a prescription from a licensed medical practitioner. (2) Label statements — The tobacco product's label must carry any restriction-related statements the Secretary requires by regulation. (3) Limitations — (A) No restriction under paragraph (1) may ban face-to-face sales of a tobacco product by a specific category of retail outlet, or set a minimum sale age above 21. (B) Ordinary matchbooks (20 or fewer paper matches, customarily given away free with a tobacco purchase) count as "adult-written publications" that may carry advertising — unless the Secretary decides by regulation that this treatment isn't appropriate for public health. (4) Remote sales — (A) The Secretary must, within 18 months of June 22, 2009, issue regulations on sales and distribution that don't happen face-to-face (to prevent underage sales, including age-verification requirements), and within 2 years, issue regulations on how such remote sales are promoted and marketed, to protect people under the legal purchase age. (B) This doesn't limit the Secretary's other powers under this subsection. (5) Minimum age of sale — No retailer may sell a tobacco product to anyone younger than 21. (e) Good manufacturing practice requirements: (1) Methods, facilities, and controls to conform — (A) The Secretary must issue regulations (which may differ by product type) requiring that tobacco manufacturing methods, facilities, and controls — covering manufacture, preproduction design testing, packing, and storage — follow current good manufacturing practice or similar hazard-control methods, to protect public health and ensure compliance with this subchapter; these regulations may require testing raw tobacco for pesticide residue. (B) Before issuing such a regulation, the Secretary must let the Tobacco Products Scientific Advisory Committee submit recommendations and give it reasonable time to do so, hold an oral hearing, set an effective date that accounts for how different tobacco products have historically been made and manufacturers' resources (giving them reasonable time to comply), and exempt small manufacturers from compliance for at least 4 years after the regulation's effective date. (2) Exemptions; variances — Anyone subject to a manufacturing requirement may petition the Secretary for a permanent or temporary exemption (arguing compliance isn't needed for safety) or a variance (proposing different methods, facilities, and controls that still ensure safety). The Secretary may refer the petition to the Advisory Committee, which must report back within 60 days of referral. The Secretary must then approve or deny the petition within 60 days of either the filing date or the Committee's report, whichever is later. The Secretary may approve an exemption if compliance isn't needed for safety, or a variance if the proposed alternative is good enough; a variance approval must set the conditions needed to ensure safety. The petitioner may request an informal hearing after the Secretary's decision. (3) Compliance — No one has to comply with these manufacturing-practice rules before the end of the 3-year period following June 22, 2009. (f) Research and development: The Secretary may contract for research, testing, and demonstrations on tobacco products, and may obtain tobacco products for those purposes.