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

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 Page 677 TITLE 21—FOOD AND DRUGS § 387f (B) the increased or decreased likelihood that those who do not use tobacco products will start using such products. No such regulation may require that the sale or distribution of a tobacco product be limited to the written or oral authorization of a prac- titioner licensed by law to prescribe medical products. (2) Label statements The label of a tobacco product shall bear such appropriate statements of the restric- tions required by a regulation under sub- section (a) as the Secretary may in such regu- lation prescribe. (3) Limitations (A) In general No restrictions under paragraph (1) may— (i) prohibit the sale of any tobacco prod- uct in face-to-face transactions by a spe- cific category of retail outlets; or (ii) establish a minimum age of sale of tobacco products to any person older than 21 years of age. (B) Matchbooks 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-writ- ten 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 reg- ulation that matchbooks shall not be consid- ered adult-written publications. (4) Remote sales (A) In general The Secretary shall— (i) within 18 months after June 22, 2009, promulgate regulations regarding the sale and distribution of tobacco products that occur through means other than a direct, face-to-face exchange between a retailer and a consumer in order to prevent the sale and distribution of tobacco products to individuals who have not attained the minimum age established by applicable law for the purchase of such products, in- cluding requirements for age verification; and (ii) within 2 years after June 22, 2009, issue regulations to address the promotion and marketing of tobacco products that are sold or distributed through means other than a direct, face-to-face exchange between a retailer and a consumer in order to protect individuals who have not at- tained the minimum age established by ap- plicable law for the purchase of such prod- ucts. (B) Relation to other authority Nothing in this paragraph limits the au- thority of the Secretary to take additional actions under the other paragraphs of this subsection. (5) Minimum age of sale It shall be unlawful for any retailer to sell a tobacco product to any person younger than 21 years of age. (e) Good manufacturing practice requirements (1) Methods, facilities, and controls to conform (A) In general In applying manufacturing restrictions to tobacco, the Secretary shall, in accordance with subparagraph (B), prescribe regulations (which may differ based on the type of to- bacco product involved) requiring that the methods used in, and the facilities and con- trols used for, the manufacture, preproduction design validation (including a process to assess the performance of a to- bacco product), packing, and storage of a to- bacco product conform to current good man- ufacturing practice, or hazard analysis and critical control point methodology, as pre- scribed 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. (B) Requirements The Secretary shall— (i) before promulgating any regulation under subparagraph (A), afford the To- bacco Products Scientific Advisory Com- mittee an opportunity to submit rec- ommendations with respect to the regula- tion proposed to be promulgated; (ii) before promulgating any regulation under subparagraph (A), afford oppor- tunity for an oral hearing; (iii) provide the Tobacco Products Sci- entific Advisory Committee a reasonable time to make its recommendation with re- spect to proposed regulations under sub- paragraph (A); (iv) in establishing the effective date of a regulation promulgated under this sub- section, take into account the differences in the manner in which the different types of tobacco products have historically been produced, the financial resources of the different tobacco product manufacturers, and the state of their existing manufac- turing facilities, and shall provide for a reasonable period of time for such manu- facturers to conform to good manufac- turing practices; and (v) not require any small tobacco prod- uct manufacturer to comply with a regula- tion under subparagraph (A) for at least 4 years following the effective date estab- lished by the Secretary for such regula- tion. (2) Exemptions; variances (A) Petition Any person subject to any requirement prescribed under paragraph (1) may petition the Secretary for a permanent or temporary exemption or variance from such require- Page 678 TITLE 21—FOOD AND DRUGS § 387f ment. Such a petition shall be submitted to the Secretary in such form and manner as the Secretary shall prescribe and shall— (i) in the case of a petition for an exemp- tion from a requirement, set forth the basis for the petitioner’s determination that compliance with the requirement is not required to assure that the tobacco product will be in compliance with this subchapter; (ii) in the case of a petition for a vari- ance from a requirement, set forth the methods proposed to be used in, and the fa- cilities and controls proposed to be used for, the manufacture, packing, and storage of the tobacco product in lieu of the meth- ods, facilities, and controls prescribed by the requirement; and (iii) contain such other information as the Secretary shall prescribe. (B) Referral to the Tobacco Products Sci- entific Advisory Committee 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— (i) the date the petition was submitted to the Secretary under subparagraph (A); or (ii) the day after the petition was re- ferred to the Tobacco Products Scientific Advisory Committee, whichever occurs later, the Secretary shall by order either deny the petition or approve it. (C) Approval The Secretary may approve— (i) a petition for an exemption for a to- bacco product from a requirement if the Secretary determines that compliance with such requirement is not required to assure that the tobacco product will be in compliance with this subchapter; and (ii) a petition for a variance for a to- bacco product from a requirement if the Secretary determines that the methods to be used in, and the facilities and controls to be used for, the manufacture, packing, and storage of the tobacco product in lieu of the methods, facilities, and controls prescribed by the requirement are suffi- cient to assure that the tobacco product will be in compliance with this subchapter. (D) Conditions An order of the Secretary approving a pe- tition 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 to- bacco 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. (E) Hearing After the issuance of an order under sub- paragraph (B) respecting a petition, the peti- tioner shall have an opportunity for an in- formal hearing on such order. (3) Compliance Compliance with requirements under this subsection shall not be required before the end of the 3-year period following June 22, 2009. (f) Research and development The Secretary may enter into contracts for re- search, testing, and demonstrations respecting tobacco products and may obtain tobacco prod- ucts for research, testing, and demonstration purposes. (June 25, 1938, ch. 675, § 906, as added Pub. L. 111–31, div. A, title I, § 101(b)(3), June 22, 2009, 123 Stat. 1795; amended Pub. L. 116–94, div. N, title I, § 603(a), Dec. 20, 2019, 133 Stat. 3123.) Editorial Notes PRIOR PROVISIONS A prior section 906 of act June 25, 1938, was renum- bered section 1006 and is classified to section 396 of this title. AMENDMENTS 2019—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 Sec- retary of Health and Human Services (referred to in this section as the ‘Secretary’) shall publish in the Fed- eral 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 ref- erences to persons younger than 18 years of age in sub- part B of part 1140 of title 21, Code of Federal Regula- tions, and to update the relevant age verification re- quirements 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 appli- cable 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 amend- ments to part 1140 of title 21, Code of Federal Regulations[,] other than the amendments described in paragraph (1), the Secretary shall promulgate a pro- posed rule in accordance with chapter 5 of title 5, United States Code.’’ 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- Page 679 TITLE 21—FOOD AND DRUGS § 387g 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–1. Enforcement action plan for advertising and promotion restrictions (a) Action plan (1) Development Not later than 6 months after June 22, 2009, the Secretary of Health and Human Services (in this section referred to as the ‘‘Secretary’’) shall develop and publish an action plan to en- force restrictions adopted pursuant to section 387f of this title, as added by section 101(b) of this division, or pursuant to section 387a–1(a) of this title, on promotion and advertising of menthol and other cigarettes to youth. (2) Consultation The action plan required by paragraph (1) shall be developed in consultation with public health organizations and other stakeholders with demonstrated expertise and experience in serving minority communities. (3) Priority The action plan required by paragraph (1) shall include provisions designed to ensure en- forcement of the restrictions described in paragraph (1) in minority communities. (b) State and local activities (1) Information on authority Not later than 3 months after June 22, 2009, the Secretary shall inform State, local, and tribal governments of the authority provided to such entities under section 1334(c) of title 15, as added by section 203 of this division, or preserved by such entities under section 387p of this title, as added by section 101(b) of this division. (2) Community assistance At the request of communities seeking as- sistance to prevent underage tobacco use, the Secretary shall provide such assistance, in- cluding assistance with strategies to address the prevention of underage tobacco use in communities with a disproportionate use of menthol cigarettes by minors. (Pub. L. 111–31, div. A, title I, § 105, June 22, 2009, 123 Stat. 1841.) Editorial Notes CODIFICATION Section was enacted as part of the Family Smoking Prevention and Tobacco Control Act, and not as part of the Federal Food, Drug, and Cosmetic Act which com- prises this chapter. Statutory Notes and Related Subsidiaries MODIFICATION OF DEADLINES FOR SECRETARIAL ACTION With respect to any time periods specified in 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 fis- cal 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. § 387g. Tobacco product standards (a) In general (1) Special rules (A) Special rule for cigarettes Beginning 3 months after June 22, 2009, a cigarette or any of its component parts (in- cluding the tobacco, filter, or paper) shall not contain, as a constituent (including a smoke constituent) or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice, including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee, that is a charac- terizing flavor of the tobacco product or to- bacco smoke. Nothing in this subparagraph shall be construed to limit the Secretary’s authority to take action under this section or other sections of this chapter applicable to menthol or any artificial or natural fla- vor, herb, or spice not specified in this sub- paragraph. (B) Additional special rule Beginning 2 years after June 22, 2009, a to- bacco product manufacturer shall not use tobacco, including foreign grown tobacco, that contains a pesticide chemical residue that is at a level greater than is specified by any tolerance applicable under Federal law to domestically grown tobacco. (2) Revision of tobacco product standards The Secretary may revise the tobacco prod- uct standards in paragraph (1) in accordance with subsection (c). (3) Tobacco product standards (A) In general The Secretary may adopt tobacco product standards in addition to those in paragraph (1) if the Secretary finds that a tobacco product standard is appropriate for the pro- tection of the public health. (B) Determinations (i) Considerations In making a finding described in sub- paragraph (A), the Secretary shall con- sider scientific evidence concerning— (I) the risks and benefits to the popu- lation as a whole, including users and nonusers of tobacco products, of the pro- posed standard; (II) the increased or decreased likeli- hood that existing users of tobacco prod- ucts will stop using such products; and (III) the increased or decreased likeli- hood that those who do not use tobacco products will start using such products. (ii) Additional considerations In the event that the Secretary makes a determination, set forth in a proposed to-