21 U.S.C. § 387g — Tobacco product standards

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- Page 680 TITLE 21—FOOD AND DRUGS § 387g bacco product standard in a proposed rule, that it is appropriate for the protection of public health to require the reduction or elimination of an additive, constituent (in- cluding a smoke constituent), or other component of a tobacco product because the Secretary has found that the additive, constituent, or other component is or may be harmful, any party objecting to the pro- posed standard on the ground that the pro- posed standard will not reduce or elimi- nate the risk of illness or injury may pro- vide for the Secretary’s consideration sci- entific evidence that demonstrates that the proposed standard will not reduce or eliminate the risk of illness or injury. (4) Content of tobacco product standards A tobacco product standard established under this section for a tobacco product— (A) shall include provisions that are appro- priate for the protection of the public health, including provisions, where appro- priate— (i) for nicotine yields of the product; (ii) for the reduction or elimination of other constituents, including smoke con- stituents, or harmful components of the product; or (iii) relating to any other requirement under subparagraph (B); (B) shall, where appropriate for the protec- tion of the public health, include— (i) provisions respecting the construc- tion, components, ingredients, additives, constituents, including smoke constitu- ents, and properties of the tobacco prod- uct; (ii) provisions for the testing (on a sam- ple basis or, if necessary, on an individual basis) of the tobacco product; (iii) provisions for the measurement of the tobacco product characteristics of the tobacco product; (iv) provisions requiring that the results of each or of certain of the tests of the to- bacco product required to be made under clause (ii) show that the tobacco product is in conformity with the portions of the standard for which the test or tests were required; and (v) a provision requiring that the sale and distribution of the tobacco product be restricted but only to the extent that the sale and distribution of a tobacco product may be restricted under a regulation under section 387f(d) of this title; (C) shall, where appropriate, require the use and prescribe the form and content of la- beling for the proper use of the tobacco prod- uct; and (D) shall require tobacco products con- taining foreign-grown tobacco to meet the same standards applicable to tobacco prod- ucts containing domestically grown tobacco. (5) Periodic reevaluation of tobacco product standards The Secretary shall provide for periodic evaluation of tobacco product standards estab- lished under this section to determine whether such standards should be changed to reflect new medical, scientific, or other technological data. The Secretary may provide for testing under paragraph (4)(B) by any person. (6) Involvement of other agencies; informed persons In carrying out duties under this section, the Secretary shall endeavor to— (A) use personnel, facilities, and other technical support available in other Federal agencies; (B) consult with other Federal agencies concerned with standard setting and other nationally or internationally recognized standard-setting entities; and (C) invite appropriate participation, through joint or other conferences, work- shops, or other means, by informed persons representative of scientific, professional, in- dustry, agricultural, or consumer organiza- tions who in the Secretary’s judgment can make a significant contribution. (b) Considerations by Secretary (1) Technical achievability The Secretary shall consider information submitted in connection with a proposed standard regarding the technical achievability of compliance with such standard, including with regard to any differences related to the technical achievability of compliance with such standard for products in the same class containing nicotine not made or derived from tobacco and products containing nicotine made or derived from tobacco. (2) Other considerations The Secretary shall consider all other infor- mation submitted in connection with a pro- posed standard, including information con- cerning the countervailing effects of the to- bacco product standard on the health of ado- lescent tobacco users, adult tobacco users, or nontobacco users, such as the creation of a significant demand for contraband or other to- bacco products that do not meet the require- ments of this subchapter and the significance of such demand. (c) Proposed standards (1) In general The Secretary shall publish in the Federal Register a notice of proposed rulemaking for the establishment, amendment, or revocation of any tobacco product standard. (2) Requirements of notice A notice of proposed rulemaking for the es- tablishment or amendment of a tobacco prod- uct standard for a tobacco product shall— (A) set forth a finding with supporting jus- tification that the tobacco product standard is appropriate for the protection of the pub- lic health; (B) invite interested persons to submit a draft or proposed tobacco product standard for consideration by the Secretary; (C) invite interested persons to submit comments on structuring the standard so that it does not advantage foreign-grown to- bacco over domestically grown tobacco; and Page 681 TITLE 21—FOOD AND DRUGS § 387g (D) invite the Secretary of Agriculture to provide any information or analysis which the Secretary of Agriculture believes is rel- evant to the proposed tobacco product stand- ard. (3) Finding A notice of proposed rulemaking for the rev- ocation of a tobacco product standard shall set forth a finding with supporting justification that the tobacco product standard is no longer appropriate for the protection of the public health. (4) Comment The Secretary shall provide for a comment period of not less than 60 days. (d) Promulgation (1) In general After the expiration of the period for com- ment on a notice of proposed rulemaking pub- lished under subsection (c) respecting a to- bacco product standard and after consider- ation of comments submitted under sub- sections (b) and (c) and any report from the Tobacco Products Scientific Advisory Com- mittee, the Secretary shall— (A) if the Secretary determines that the standard would be appropriate for the pro- tection of the public health, promulgate a regulation establishing a tobacco product standard and publish in the Federal Register findings on the matters referred to in sub- section (c); or (B) publish a notice terminating the pro- ceeding for the development of the standard together with the reasons for such termi- nation. (2) Effective date A regulation establishing a tobacco product standard shall set forth the date or dates upon which the standard shall take effect, but no such regulation may take effect before 1 year after the date of its publication unless the Secretary determines that an earlier effective date is necessary for the protection of the pub- lic health. Such date or dates shall be estab- lished so as to minimize, consistent with the public health, economic loss to, and disruption or dislocation of, domestic and international trade. In establishing such effective date or dates, the Secretary shall consider informa- tion submitted in connection with a proposed product standard by interested parties, includ- ing manufacturers and tobacco growers, re- garding the technical achievability of compli- ance with the standard, and including infor- mation concerning the existence of patents that make it impossible to comply in the timeframe envisioned in the proposed stand- ard. If the Secretary determines, based on the Secretary’s evaluation of submitted com- ments, that a product standard can be met only by manufacturers requiring substantial changes to the methods of farming the domes- tically grown tobacco used by the manufac- turer, the effective date of that product stand- ard shall be not less than 2 years after the date of publication of the final regulation es- tablishing the standard. (3) Limitation on power granted to the Food and Drug Administration Because of the importance of a decision of the Secretary to issue a regulation— (A) banning all cigarettes, all smokeless tobacco products, all little cigars, all cigars other than little cigars, all pipe tobacco, or all roll-your-own tobacco products; or (B) requiring the reduction of nicotine yields of a tobacco product to zero, the Secretary is prohibited from taking such actions under this chapter. (4) Amendment; revocation (A) Authority The Secretary, upon the Secretary’s own initiative or upon petition of an interested person, may by a regulation, promulgated in accordance with the requirements of sub- section (c) and paragraph (2), amend or re- voke a tobacco product standard. (B) Effective date The Secretary may declare a proposed amendment of a tobacco product standard to be effective on and after its publication in the Federal Register and until the effective date of any final action taken on such amendment if the Secretary determines that making it so effective is in the public inter- est. (5) Referral to Advisory Committee (A) In general The Secretary may refer a proposed regu- lation for the establishment, amendment, or revocation of a tobacco product standard to the Tobacco Products Scientific Advisory Committee for a report and recommendation with respect to any matter involved in the proposed regulation which requires the exer- cise of scientific judgment. (B) Initiation of referral The Secretary may make a referral under this paragraph— (i) on the Secretary’s own initiative; or (ii) upon the request of an interested per- son that— (I) demonstrates good cause for the re- ferral; and (II) is made before the expiration of the period for submission of comments on the proposed regulation. (C) Provision of data If a proposed regulation is referred under this paragraph to the Tobacco Products Sci- entific Advisory Committee, the Secretary shall provide the Advisory Committee with the data and information on which such pro- posed regulation is based. (D) Report and recommendation The Tobacco Products Scientific Advisory Committee shall, within 60 days after the re- ferral of a proposed regulation under this paragraph and after independent study of the data and information furnished to it by the Secretary and other data and informa- tion before it, submit to the Secretary a re- port and recommendation respecting such Page 682 TITLE 21—FOOD AND DRUGS § 387h regulation, together with all underlying data and information and a statement of the reason or basis for the recommendation. (E) Public availability The Secretary shall make a copy of each report and recommendation under subpara- graph (D) publicly available. (e) Menthol cigarettes (1) Referral; considerations Immediately upon the establishment of the Tobacco Products Scientific Advisory Com- mittee under section 387q(a) of this title, the Secretary shall refer to the Committee for re- port and recommendation, under section 387q(c)(4) of this title, the issue of the impact of the use of menthol in cigarettes on the pub- lic health, including such use among children, African-Americans, Hispanics, and other ra- cial and ethnic minorities. In its review, the Tobacco Products Scientific Advisory Com- mittee shall address the considerations listed in subsections (a)(3)(B)(i) and (b). (2) Report and recommendation Not later than 1 year after its establish- ment, the Tobacco Product Scientific Advi- sory Committee shall submit to the Secretary the report and recommendations required pur- suant to paragraph (1). (3) Rule of construction Nothing in this subsection shall be con- strued to limit the Secretary’s authority to take action under this section or other sec- tions of this chapter applicable to menthol. (f) Dissolvable tobacco products (1) Referral; considerations The Secretary shall refer to the Tobacco Products Scientific Advisory Committee for report and recommendation, under section 387q(c)(4) of this title, the issue of the nature and impact of the use of dissolvable tobacco products on the public health, including such use among children. In its review, the Tobacco Products Scientific Advisory Committee shall address the considerations listed in subsection (a)(3)(B)(i). (2) Report and recommendation Not later than 2 years after its establish- ment, the Tobacco Product Scientific Advi- sory Committee shall submit to the Secretary the report and recommendations required pur- suant to paragraph (1). (3) Rule of construction Nothing in this subsection shall be con- strued to limit the Secretary’s authority to take action under this section or other sec- tions of this chapter at any time applicable to any dissolvable tobacco product. (June 25, 1938, ch. 675, § 907, as added Pub. L. 111–31, div. A, title I, § 101(b)(3), June 22, 2009, 123 Stat. 1799; amended Pub. L. 117–103, div. P, title I, § 111(f), Mar. 15, 2022, 136 Stat. 790.) Editorial Notes PRIOR PROVISIONS A prior section 907 of act June 25, 1938, was renum- bered section 1007 and is classified to section 397 of this title. AMENDMENTS 2022—Subsec. (b)(1). Pub. L. 117–103 inserted before pe- riod at end ‘‘, including with regard to any differences related to the technical achievability of compliance with such standard for products in the same class con- taining nicotine not made or derived from tobacco and products containing nicotine made or derived from to- bacco’’. § 387h. Notification and other remedies (a) Notification If the Secretary determines that— (1) a tobacco product which is introduced or delivered for introduction into interstate com- merce for commercial distribution presents an unreasonable risk of substantial harm to the public health; and (2) notification under this subsection is nec- essary to eliminate the unreasonable risk of such harm and no more practicable means is available under the provisions of this sub- chapter (other than this section) to eliminate such risk, the Secretary may issue such order as may be necessary to assure that adequate notification is provided in an appropriate form, by the persons and means best suited under the circumstances involved, to all persons who should properly re- ceive such notification in order to eliminate such risk. The Secretary may order notification by any appropriate means, including public serv- ice announcements. Before issuing an order under this subsection, the Secretary shall con- sult with the persons who are to give notice under the order. (b) No exemption from other liability Compliance with an order issued under this section shall not relieve any person from liabil- ity under Federal or State law. In awarding damages for economic loss in an action brought for the enforcement of any such liability, the value to the plaintiff in such action of any rem- edy provided under such order shall be taken into account. (c) Recall authority (1) In general If the Secretary finds that there is a reason- able probability that a tobacco product con- tains a manufacturing or other defect not or- dinarily contained in tobacco products on the market that would cause serious, adverse health consequences or death, the Secretary shall issue an order requiring the appropriate person (including the manufacturers, import- ers, distributors, or retailers of the tobacco product) to immediately cease distribution of such tobacco product. The order shall provide the person subject to the order with an oppor- tunity for an informal hearing, to be held not later than 10 days after the date of the issuance of the order, on the actions required by the order and on whether the order should be amended to require a recall of such tobacco product. If, after providing an opportunity for such a hearing, the Secretary determines that inadequate grounds exist to support the ac- tions required by the order, the Secretary shall vacate the order.