Any requirement established by or under section 387b, 387c, 387e, or 387i of this title applicable to a tobacco product shall apply to such tobacco product until the applicability of the requirement 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.
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 reasons for such action, and each publication of findings required to be made in connection with rulemaking under any such section shall set forth-
Any information reported to or otherwise obtained by the Secretary or the Secretary's representative under section 387c, 387d, 387g, 387h, 387i, 387j, 387k, or 374 of this title, or under subsection (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 information may be disclosed to other officers or employees concerned with carrying out this subchapter, or when relevant in any proceeding under this subchapter.
The Secretary may by regulation require restrictions on the sale and distribution of a tobacco product, including restrictions on the access to, and the advertising and promotion of, the tobacco product, if the Secretary determines that such regulation would be appropriate for the protection of the public health. The Secretary may by regulation impose restrictions 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 determined 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-
No such regulation may require that the sale or distribution of a tobacco product be limited to the written or oral authorization of a practitioner licensed by law to prescribe medical products.
The label of a tobacco product shall bear such appropriate statements of the restrictions required by a regulation under subsection (a) as the Secretary may in such regulation prescribe.
No restrictions under paragraph (1) may-
For purposes of any regulations issued by the Secretary, matchbooks of conventional size containing not more than 20 paper matches, and which are customarily given away for free with the purchase of tobacco products, shall be considered as adult-written publications which shall be permitted to contain advertising. Notwithstanding the preceding sentence, if the Secretary finds that such treatment of matchbooks is not appropriate for the protection of the public health, the Secretary may determine by regulation that matchbooks shall not be considered adult-written publications.
The Secretary shall-
Nothing in this paragraph limits the authority of the Secretary to take additional actions under the other paragraphs of this subsection.
It shall be unlawful for any retailer to sell a tobacco product to any person younger than 21 years of age.
In applying manufacturing restrictions to tobacco, the Secretary shall, in accordance with subparagraph (B), prescribe regulations (which may differ based on the type of tobacco product involved) requiring that the methods used in, and the facilities and controls used for, the manufacture, preproduction design validation (including a process to assess the performance of a tobacco product), packing, and storage of a tobacco product conform to current good manufacturing practice, or hazard analysis and critical control point methodology, as prescribed in such regulations to assure that the public health is protected and that the tobacco product is in compliance with this subchapter. Such regulations may provide for the testing of raw tobacco for pesticide chemical residues regardless of whether a tolerance for such chemical residues has been established.
The Secretary shall-
Any person subject to any requirement prescribed under paragraph (1) may petition the Secretary for a permanent or temporary exemption or variance from such requirement. Such a petition shall be submitted to the Secretary in such form and manner as the Secretary shall prescribe and shall-
The Secretary may refer to the Tobacco Products Scientific Advisory Committee any petition submitted under subparagraph (A). The Tobacco Products Scientific Advisory Committee shall report its recommendations to the Secretary with respect to a petition referred to it within 60 days after the date of the petition's referral. Within 60 days after-
whichever occurs later, the Secretary shall by order either deny the petition or approve it.
The Secretary may approve-
An order of the Secretary approving a petition for a variance shall prescribe such conditions respecting the methods used in, and the facilities and controls used for, the manufacture, packing, and storage of the tobacco product to be granted the variance under the petition as may be necessary to assure that the tobacco product will be in compliance with this subchapter.
After the issuance of an order under subparagraph (B) respecting a petition, the petitioner shall have an opportunity for an informal hearing on such order.
Compliance with requirements under this subsection shall not be required before the end of the 3-year period following June 22, 2009.
The Secretary may enter into contracts for research, testing, and demonstrations respecting tobacco products and may obtain tobacco products for research, testing, and demonstration purposes.
1So in original. Probably should be "are".
21 U.S.C. § 387f
EDITORIAL NOTES
PRIOR PROVISIONSA prior section 906 of act June 25, 1938, was renumbered section 1006 and is classified to section 396 of this title.
AMENDMENTS2019-Subsec. (d)(3)(A)(ii). Pub. L. 116-94, §603(a)(1), substituted "21 years" for "18 years".Subsec. (d)(5). Pub. L. 116-94, §603(a)(2), added par. (5).
STATUTORY NOTES AND RELATED SUBSIDIARIES
REGULATIONS Pub. L. 116-94, div. N, title I, §603(b), Dec. 20, 2019, 133 Stat. 3123, provided that: "(1) IN GENERAL.-Not later than 180 days after the date of enactment of this Act [Dec. 20, 2019], the Secretary of Health and Human Services (referred to in this section as the 'Secretary') shall publish in the Federal Register a final rule to update the regulations issued under chapter IX of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387 et seq.) as appropriate, only to carry out the amendments made by subsection (a) [amending this section], including to update all references to persons younger than 18 years of age in subpart B of part 1140 of title 21, Code of Federal Regulations, and to update the relevant age verification requirements under such part 1140 to require age verification for individuals under the age of 30. Such final rule shall-"(A) take full effect not later than 90 days after the date on which such final rule is published; and"(B) be deemed to be in compliance with all applicable provisions of chapter 5 of title 5, United States Code[,] and all other provisions of law relating to rulemaking procedures."(2) OTHER REGULATIONS.-Prior to making amendments to part 1140 of title 21, Code of Federal Regulations[,] other than the amendments described in paragraph (1), the Secretary shall promulgate a proposed rule in accordance with chapter 5 of title 5, United States Code."
MODIFICATION OF DEADLINES FOR SECRETARIAL ACTIONWith 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 calculation 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 reduce the duration of one or more such time periods, except 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.