1. U.S. Code
  2. title 21
  3. chapter 9
  4. subchapter IX
  5. § 387l

Collapse to view only § 387l. Judicial review

§ 387. DefinitionsIn this subchapter:
(1) Additive
(2) Brand
(3) CigaretteThe term “cigarette”—
(A) means a product that—
(i) is a tobacco product; and
(ii) meets the definition of the term “cigarette” in section 1332(1) of title 15; and
(B) includes tobacco, in any form, that is functional in the product, which, because of its appearance, the type of tobacco used in the filler, or its packaging and labeling, is likely to be offered to, or purchased by, consumers as a cigarette or as roll-your-own tobacco.
(4) Cigarette tobacco
(5) Commerce
(6) Counterfeit tobacco product
(7) Distributor
(8) Illicit trade
(9) Indian country
(10) Indian tribe
(11) Little cigarThe term “little cigar” means a product that—
(A) is a tobacco product; and
(B) meets the definition of the term “little cigar” in section 1332(7) of title 15.
(12) Nicotine
(13) Package
(14) Retailer
(15) Roll-your-own tobacco
(16) Small tobacco product manufacturer
(17) Smoke constituent
(18) Smokeless tobacco
(19) State; Territory
(20) Tobacco product manufacturerThe term “tobacco product manufacturer” means any person, including any repacker or relabeler, who—
(A) manufactures, fabricates, assembles, processes, or labels a tobacco product; or
(B) imports a finished tobacco product for sale or distribution in the United States.
(21) Tobacco warehouse
(A) Subject to subparagraphs (B) and (C), the term “tobacco warehouse” includes any person—
(i) who—(I) removes foreign material from tobacco leaf through nothing other than a mechanical process;(II) humidifies tobacco leaf with nothing other than potable water in the form of steam or mist; or(III) de-stems, dries, and packs tobacco leaf for storage and shipment;
(ii) who performs no other actions with respect to tobacco leaf; and
(iii) who provides to any manufacturer to whom the person sells tobacco all information related to the person’s actions described in clause (i) that is necessary for compliance with this chapter.
(B) The term “tobacco warehouse” excludes any person who—
(i) reconstitutes tobacco leaf;
(ii) is a manufacturer, distributor, or retailer of a tobacco product; or
(iii) applies any chemical, additive, or substance to the tobacco leaf other than potable water in the form of steam or mist.
(C) The definition of the term “tobacco warehouse” in subparagraph (A) shall not apply to the extent to which the Secretary determines, through rulemaking, that regulation under this subchapter of the actions described in such subparagraph is appropriate for the protection of the public health.
(22) United States
(June 25, 1938, ch. 675, § 900, as added Pub. L. 111–31, div. A, title I, § 101(b)(3), June 22, 2009, 123 Stat. 1784.)

CITE AS: 21 USC 387

§ 387a. FDA authority over tobacco products
(a) In general
(b) Applicability
(c) Scope
(1) In general
(2) Limitation of authority
(A) In general
(B) Exception
(C) Rule of construction
(d) Rulemaking procedures
(e) Center for tobacco products
(f) Office to assist small tobacco product manufacturers
(g) Consultation prior to rulemaking
(June 25, 1938, ch. 675, § 901, as added Pub. L. 111–31, div. A, title I, § 101(b)(3), June 22, 2009, 123 Stat. 1786; amended Pub. L. 117–103, div. P, title I, § 111(b), Mar. 15, 2022, 136 Stat. 789.)

CITE AS: 21 USC 387a

§ 387a–1. Final rule
(a) Cigarettes and smokeless tobacco
(1) In generalOn the first day of publication of the Federal Register that is 180 days or more after June 22, 2009, the Secretary of Health and Human Services shall publish in the Federal Register a final rule regarding cigarettes and smokeless tobacco, which—
(A) is deemed to be issued under chapter 9 1
1 So in original. Probably should be “chapter IX”.
of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 387 et seq.], as added by section 101 of this division; and
(B) shall be deemed to be in compliance with all applicable provisions of chapter 5 of title 5 and all other provisions of law relating to rulemaking procedures.
(2) Contents of ruleExcept as provided in this subsection, the final rule published under paragraph (1),2
2 So in original. The comma probably should not appear.
shall be identical in its provisions to part 897 of the regulations promulgated by the Secretary of Health and Human Services in the August 28, 1996, issue of the Federal Register (61 Fed. Reg. 44615–44618). Such rule shall—
(A) provide for the designation of jurisdictional authority that is in accordance with this subsection in accordance with this division and the amendments made by this division;
(B) strike Subpart C—Labels and section 897.32(c);
(C) strike paragraphs (a), (b), and (i) of section 897.3 and insert definitions of the terms “cigarette”, “cigarette tobacco”, and “smokeless tobacco” as defined in section 900 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 387];
(D) insert “or roll-your-own paper” in section 897.34(a) after “other than cigarettes or smokeless tobacco”;
(E) include such modifications to section 897.30(b), if any, that the Secretary determines are appropriate in light of governing First Amendment case law, including the decision of the Supreme Court of the United States in Lorillard Tobacco Co. v. Reilly (533 U.S. 525 (2001));
(F) become effective on the date that is 1 year after June 22, 2009; and
(G) amend paragraph (d) of section 897.16 to read as follows:
“(d)
(1) Except as provided in subparagraph (2), no manufacturer, distributor, or retailer may distribute or cause to be distributed any free samples of cigarettes, smokeless tobacco, or other tobacco products (as such term is defined in section 201 of the Federal Food, Drug, and Cosmetic Act).
“(2)
(A) Subparagraph (1) does not prohibit a manufacturer, distributor, or retailer from distributing or causing to be distributed free samples of smokeless tobacco in a qualified adult-only facility.
“(B) This subparagraph does not affect the authority of a State or local government to prohibit or otherwise restrict the distribution of free samples of smokeless tobacco.
“(C) For purposes of this paragraph, the term ‘qualified adult-only facility’ means a facility or restricted area that—
“(i) requires each person present to provide to a law enforcement officer (whether on or off duty) or to a security guard licensed by a governmental entity government-issued identification showing a photograph and at least the minimum age established by applicable law for the purchase of smokeless tobacco;
“(ii) does not sell, serve, or distribute alcohol;
“(iii) is not located adjacent to or immediately across from (in any direction) a space that is used primarily for youth-oriented marketing, promotional, or other activities;
“(iv) is a temporary structure constructed, designated, and operated as a distinct enclosed area for the purpose of distributing free samples of smokeless tobacco in accordance with this subparagraph;
“(v) is enclosed by a barrier that—“(I) is constructed of, or covered with, an opaque material (except for entrances and exits);“(II) extends from no more than 12 inches above the ground or floor (which area at the bottom of the barrier must be covered with material that restricts visibility but may allow airflow) to at least 8 feet above the ground or floor (or to the ceiling); and“(III) prevents persons outside the qualified adult-only facility from seeing into the qualified adult-only facility, unless they make unreasonable efforts to do so; and
“(vi) does not display on its exterior—“(I) any tobacco product advertising;“(II) a brand name other than in conjunction with words for an area or enclosure to identify an adult-only facility; or“(III) any combination of words that would imply to a reasonable observer that the manufacturer, distributor, or retailer has a sponsorship that would violate section 897.34(c).
“(D) Distribution of samples of smokeless tobacco under this subparagraph permitted to be taken out of the qualified adult-only facility shall be limited to 1 package per adult consumer containing no more than 0.53 ounces (15 grams) of smokeless tobacco. If such package of smokeless tobacco contains individual portions of smokeless tobacco, the individual portions of smokeless tobacco shall not exceed 8 individual portions and the collective weight of such individual portions shall not exceed 0.53 ounces (15 grams). Any manufacturer, distributor, or retailer who distributes or causes to be distributed free samples also shall take reasonable steps to ensure that the above amounts are limited to one such package per adult consumer per day.
“(3) Notwithstanding subparagraph (2), no manufacturer, distributor, or retailer may distribute or cause to be distributed any free samples of smokeless tobacco—
“(A) to a sports team or entertainment group; or
“(B) at any football, basketball, baseball, soccer, or hockey event or any other sporting or entertainment event determined by the Secretary to be covered by this subparagraph.
“(4) The Secretary shall implement a program to ensure compliance with this paragraph and submit a report to the Congress on such compliance not later than 18 months after the date of enactment of the Family Smoking Prevention and Tobacco Control Act.
“(5) Nothing in this paragraph shall be construed to authorize any person to distribute or cause to be distributed any sample of a tobacco product to any individual who has not attained the minimum age established by applicable law for the purchase of such product.”.
(3) Amendments to rule
(4) Rule of construction
(5) Enforcement of retail sale provisions
(6) Qualified adult-only facility
(7) Congressional review provisions
(b) Limitation on advisory opinionsAs of June 22, 2009, the following documents issued by the Food and Drug Administration shall not constitute advisory opinions under section 10.85(d)(1) of title 21, Code of Federal Regulations, except as they apply to tobacco products, and shall not be cited by the Secretary of Health and Human Services or the Food and Drug Administration as binding precedent:
(1) The preamble to the proposed rule in the document titled “Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco Products to Protect Children and Adolescents” (60 Fed. Reg. 41314–41372 (August 11, 1995)).
(2) The document titled “Nicotine in Cigarettes and Smokeless Tobacco Products is a Drug and These Products Are Nicotine Delivery Devices Under the Federal Food, Drug, and Cosmetic Act” (60 Fed. Reg. 41453–41787 (August 11, 1995)).
(3) The preamble to the final rule in the document titled “Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents” (61 Fed. Reg. 44396–44615 (August 28, 1996)).
(4) The document titled “Nicotine in Cigarettes and Smokeless Tobacco is a Drug and These Products are Nicotine Delivery Devices Under the Federal Food, Drug, and Cosmetic Act; Jurisdictional Determination” (61 Fed. Reg. 44619–45318 (August 28, 1996)).
(Pub. L. 111–31, div. A, title I, § 102, June 22, 2009, 123 Stat. 1830.)

CITE AS: 21 USC 387a-1

§ 387b. Adulterated tobacco products
A tobacco product shall be deemed to be adulterated if—
(1) it consists in whole or in part of any filthy, putrid, or decomposed substance, or is otherwise contaminated by any added poisonous or added deleterious substance that may render the product injurious to health;
(2) it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health;
(3) its package is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health;
(4) the manufacturer or importer of the tobacco product fails to pay a user fee assessed to such manufacturer or importer pursuant to section 387s of this title by the date specified in section 387s of this title or by the 30th day after final agency action on a resolution of any dispute as to the amount of such fee;
(5) it is, or purports to be or is represented as, a tobacco product which is subject to a tobacco product standard established under section 387g of this title unless such tobacco product is in all respects in conformity with such standard;
(6)
(A) it is required by section 387j(a) of this title to have premarket review and does not have an order in effect under section 387j(c)(1)(A)(i) of this title; or
(B) it is in violation of an order under section 387j(c)(1)(A) of this title;
(7) the methods used in, or the facilities or controls used for, its manufacture, packing, or storage are not in conformity with applicable requirements under section 387f(e)(1) of this title or an applicable condition prescribed by an order under section 387f(e)(2) of this title; or
(8) it is in violation of section 387k of this title.
(June 25, 1938, ch. 675, § 902, as added Pub. L. 111–31, div. A, title I, § 101(b)(3), June 22, 2009, 123 Stat. 1787.)

CITE AS: 21 USC 387b

§ 387c. Misbranded tobacco products
(a) In generalA tobacco product shall be deemed to be misbranded—
(1) if its labeling is false or misleading in any particular;
(2) if in package form unless it bears a label containing—
(A) the name and place of business of the tobacco product manufacturer, packer, or distributor;
(B) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count;
(C) an accurate statement of the percentage of the tobacco used in the product that is domestically grown tobacco and the percentage that is foreign grown tobacco; and
(D) the statement required under section 387t(a) of this title,
except that under subparagraph (B) reasonable variations shall be permitted, and exemptions as to small packages shall be established, by regulations prescribed by the Secretary;
(3) if any word, statement, or other information required by or under authority of this subchapter to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, or designs in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use;
(4) if it has an established name, unless its label bears, to the exclusion of any other nonproprietary name, its established name prominently printed in type as required by the Secretary by regulation;
(5) if the Secretary has issued regulations requiring that its labeling bear adequate directions for use, or adequate warnings against use by children, that are necessary for the protection of users unless its labeling conforms in all respects to such regulations;
(6) if it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 387e(b), 387e(c), 387e(d), or 387e(h) of this title, if it was not included in a list required by section 387e(i) of this title, if a notice or other information respecting it was not provided as required by such section or section 387e(j) of this title, or if it does not bear such symbols from the uniform system for identification of tobacco products prescribed under section 387e(e) of this title as the Secretary by regulation requires;
(7) if, in the case of any tobacco product distributed or offered for sale in any State—
(A) its advertising is false or misleading in any particular; or
(B) it is sold or distributed in violation of section 387f(d)(5) of this title or of regulations prescribed under section 387f(d) of this title;
(8) unless, in the case of any tobacco product distributed or offered for sale in any State, the manufacturer, packer, or distributor thereof includes in all advertisements and other descriptive printed matter issued or caused to be issued by the manufacturer, packer, or distributor with respect to that tobacco product—
(A) a true statement of the tobacco product’s established name as described in paragraph (4), printed prominently; and
(B) a brief statement of—
(i) the uses of the tobacco product and relevant warnings, precautions, side effects, and contraindications; and
(ii) in the case of specific tobacco products made subject to a finding by the Secretary after notice and opportunity for comment that such action is appropriate to protect the public health, a full description of the components of such tobacco product or the formula showing quantitatively each ingredient of such tobacco product to the extent required in regulations which shall be issued by the Secretary after an opportunity for a hearing;
(9) if it is a tobacco product subject to a tobacco product standard established under section 387g of this title, unless it bears such labeling as may be prescribed in such tobacco product standard; or
(10) if there was a failure or refusal—
(A) to comply with any requirement prescribed under section 387d or 387h of this title; or
(B) to furnish any material or information required under section 387i of this title.
(b) Prior approval of label statements
(June 25, 1938, ch. 675, § 903, as added Pub. L. 111–31, div. A, title I, § 101(b)(3), June 22, 2009, 123 Stat. 1788; amended Pub. L. 116–94, div. N, title I, § 603(d)(3), Dec. 20, 2019, 133 Stat. 3124.)

CITE AS: 21 USC 387c

§ 387d. Submission of health information to the Secretary
(a) Requirement
Each tobacco product manufacturer or importer, or agents thereof, shall submit to the Secretary the following information:
(1) Not later than 6 months after June 22, 2009, a listing of all ingredients, including tobacco, substances, compounds, and additives that are, as of such date, added by the manufacturer to the tobacco, paper, filter, or other part of each tobacco product by brand and by quantity in each brand and subbrand.
(2) A description of the span, delivery, and form of nicotine in each tobacco product measured in milligrams of nicotine in accordance with regulations promulgated by the Secretary in accordance with section 1333(e) of title 15.
(3) Beginning 3 years after June 22, 2009, a listing of all constituents, including smoke constituents as applicable, identified by the Secretary as harmful or potentially harmful to health in each tobacco product, and as applicable in the smoke of each tobacco product, by brand and by quantity in each brand and subbrand. Effective beginning 3 years after June 22, 2009, the manufacturer, importer, or agent shall comply with regulations promulgated under section 387o of this title in reporting information under this paragraph, where applicable.
(4) Beginning 6 months after June 22, 2009, all documents developed after June 22, 2009 that relate to health, toxicological, behavioral, or physiologic effects of current or future tobacco products, their constituents (including smoke constituents), ingredients, components, and additives.
(b) Data submission
At the request of the Secretary, each tobacco product manufacturer or importer of tobacco products, or agents thereof, shall submit the following:
(1) Any or all documents (including underlying scientific information) relating to research activities, and research findings, conducted, supported, or possessed by the manufacturer (or agents thereof) on the health, toxicological, behavioral, or physiologic effects of tobacco products and their constituents (including smoke constituents), ingredients, components, and additives.
(2) Any or all documents (including underlying scientific information) relating to research activities, and research findings, conducted, supported, or possessed by the manufacturer (or agents thereof) that relate to the issue of whether a reduction in risk to health from tobacco products can occur upon the employment of technology available or known to the manufacturer.
(3) Any or all documents (including underlying scientific or financial information) relating to marketing research involving the use of tobacco products or marketing practices and the effectiveness of such practices used by tobacco manufacturers and distributors.
An importer of a tobacco product not manufactured in the United States shall supply the information required of a tobacco product manufacturer under this subsection.
(c) Time for submission
(1) In general
(2) Disclosure of additive
(3) Disclosure of other actions
(d) Data list
(1) In general
(2) Consumer research
(e) Data collection
(June 25, 1938, ch. 675, § 904, as added Pub. L. 111–31, div. A, title I, § 101(b)(3), June 22, 2009, 123 Stat. 1790.)

CITE AS: 21 USC 387d

§ 387e. Annual registration
(a) DefinitionsIn this section:
(1) Manufacture, preparation, compounding, or processing
(2) Name
(b) Registration by owners and operators
(c) Registration by new owners and operators
(d) Registration of added establishments
(e) Uniform product identification system
(f) Public access to registration information
(g) Biennial inspection of registered establishments
(h) Registration by foreign establishments
(i) Registration information
(1) Product listEvery person who registers with the Secretary under subsection (b), (c), (d), or (h) shall, at the time of registration under any such subsection, file with the Secretary a list of all tobacco products which are being manufactured, prepared, compounded, or processed by that person for commercial distribution and which have not been included in any list of tobacco products filed by that person with the Secretary under this paragraph or paragraph (2) before such time of registration. Such list shall be prepared in such form and manner as the Secretary may prescribe and shall be accompanied by—
(A) in the case of a tobacco product contained in the applicable list with respect to which a tobacco product standard has been established under section 387g of this title or which is subject to section 387j of this title, a reference to the authority for the marketing of such tobacco product and a copy of all labeling for such tobacco product;
(B) in the case of any other tobacco product contained in an applicable list, a copy of all consumer information and other labeling for such tobacco product, a representative sampling of advertisements for such tobacco product, and, upon request made by the Secretary for good cause, a copy of all advertisements for a particular tobacco product; and
(C) if the registrant filing a list has determined that a tobacco product contained in such list is not subject to a tobacco product standard established under section 387g of this title, a brief statement of the basis upon which the registrant made such determination if the Secretary requests such a statement with respect to that particular tobacco product.
(2) Consultation with respect to forms
(3) Biannual report of any change in product listEach person who registers with the Secretary under this section shall report to the Secretary once during the month of June of each year and once during the month of December of each year the following:
(A) A list of each tobacco product introduced by the registrant for commercial distribution which has not been included in any list previously filed by that person with the Secretary under this subparagraph or paragraph (1). A list under this subparagraph shall list a tobacco product by its established name and shall be accompanied by the other information required by paragraph (1).
(B) If since the date the registrant last made a report under this paragraph that person has discontinued the manufacture, preparation, compounding, or processing for commercial distribution of a tobacco product included in a list filed under subparagraph (A) or paragraph (1), notice of such discontinuance, the date of such discontinuance, and the identity of its established name.
(C) If since the date the registrant reported under subparagraph (B) a notice of discontinuance that person has resumed the manufacture, preparation, compounding, or processing for commercial distribution of the tobacco product with respect to which such notice of discontinuance was reported, notice of such resumption, the date of such resumption, the identity of such tobacco product by established name, and other information required by paragraph (1), unless the registrant has previously reported such resumption to the Secretary under this subparagraph.
(D) Any material change in any information previously submitted under this paragraph or paragraph (1).
(j) Report preceding introduction of certain substantially equivalent products into interstate commerce
(1) In generalEach person who is required to register under this section and who proposes to begin the introduction or delivery for introduction into interstate commerce for commercial distribution of a tobacco product intended for human use that was not commercially marketed (other than for test marketing) in the United States as of February 15, 2007, shall, at least 90 days prior to making such introduction or delivery, report to the Secretary (in such form and manner as the Secretary shall prescribe)—
(A) the basis for such person’s determination that—
(i) the tobacco product is substantially equivalent, within the meaning of section 387j of this title, to a tobacco product commercially marketed (other than for test marketing) in the United States as of February 15, 2007, or to a tobacco product that the Secretary has previously determined, pursuant to subsection (a)(3) of section 387j of this title, is substantially equivalent and that is in compliance with the requirements of this chapter; or
(ii) the tobacco product is modified within the meaning of paragraph (3), the modifications are to a product that is commercially marketed and in compliance with the requirements of this chapter, and all of the modifications are covered by exemptions granted by the Secretary pursuant to paragraph (3); and
(B) action taken by such person to comply with the requirements under section 387g of this title that are applicable to the tobacco product.
(2) Application to certain post–February 15, 2007, products
(3) Exemptions
(A) In generalThe Secretary may exempt from the requirements of this subsection relating to the demonstration that a tobacco product is substantially equivalent within the meaning of section 387j of this title, tobacco products that are modified by adding or deleting a tobacco 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 appropriate.
(B) Regulations
(

CITE AS: 21 USC 387e

§ 387f. General provisions respecting control of tobacco products
(a) In general
(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 reasons 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
1 So in original. Probably should be “are”.
based; and
(2) the period within which interested persons may present their comments on the notice or findings (including the need therefore) orally or in writing, which period shall be at least 60 days but may not exceed 90 days unless the time is extended by the Secretary by a notice published in the Federal Register stating good cause therefore.
(c) Limited confidentiality of information
(d) Restrictions
(1) In general
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—
(A) the increased or decreased likelihood that existing users of tobacco products will stop using such products; and
(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 practitioner licensed by law to prescribe medical products.
(2) Label statements
(3) Limitations
(A) In general
No restrictions under paragraph (1) may—
(i) prohibit the sale of any tobacco product in face-to-face transactions by a specific 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
(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, including 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 attained the minimum age established by applicable law for the purchase of such products.
(B) Relation to other authority
(5) Minimum age of sale
(e) Good manufacturing practice requirements
(1) Methods, facilities, and controls to conform
(A) In general
(B) Requirements
The Secretary shall—
(i) before promulgating any regulation under subparagraph (A), afford the Tobacco Products Scientific Advisory Committee an opportunity to submit recommendations with respect to the regulation proposed to be promulgated;
(ii) before promulgating any regulation under subparagraph (A), afford opportunity for an oral hearing;
(iii) provide the Tobacco Products Scientific Advisory Committee a reasonable time to make its recommendation with respect to proposed regulations under subparagraph (A);
(iv) in establishing the effective date of a regulation promulgated under this subsection, 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 manufacturing facilities, and shall provide for a reasonable period of time for such manufacturers to conform to good manufacturing practices; and
(v) not require any small tobacco product manufacturer to comply with a regulation under subparagraph (A) for at least 4 years following the effective date established by the Secretary for such regulation.
(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 requirement. 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 exemption 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 variance from a requirement, set forth the methods proposed to be used in, and the facilities and controls proposed 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; and
(iii) contain such other information as the Secretary shall prescribe.
(B) Referral to the Tobacco Products Scientific 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 referred 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 tobacco 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 tobacco 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 sufficient to assure that the tobacco product will be in compliance with this subchapter.
(D) Conditions
(E) Hearing
(3) Compliance
(f) Research and development
(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.)

CITE AS: 21 USC 387f

§ 387f–1. Enforcement action plan for advertising and promotion restrictions
(a) Action plan
(1) Development
(2) Consultation
(3) Priority
(b) State and local activities
(1) Information on authority
(2) Community assistance
(Pub. L. 111–31, div. A, title I, § 105, June 22, 2009, 123 Stat. 1841.)

CITE AS: 21 USC 387f-1

§ 387g. Tobacco product standards
(a) In general
(1) Special rules
(A) Special rule for cigarettes
(B) Additional special rule
(2) Revision of tobacco product standards
(3) Tobacco product standards
(A) In general
(B) Determinations
(i) ConsiderationsIn making a finding described in subparagraph (A), the Secretary shall consider scientific evidence concerning—(I) the risks and benefits to the population as a whole, including users and nonusers of tobacco products, of the proposed standard;(II) the increased or decreased likelihood that existing users of tobacco products will stop using such products; and(III) the increased or decreased likelihood that those who do not use tobacco products will start using such products.
(ii) Additional considerations
(4) Content of tobacco product standardsA tobacco product standard established under this section for a tobacco product—
(A) shall include provisions that are appropriate for the protection of the public health, including provisions, where appropriate—
(i) for nicotine yields of the product;
(ii) for the reduction or elimination of other constituents, including smoke constituents, or harmful components of the product; or
(iii) relating to any other requirement under subparagraph (B);
(B) shall, where appropriate for the protection of the public health, include—
(i) provisions respecting the construction, components, ingredients, additives, constituents, including smoke constituents, and properties of the tobacco product;
(ii) provisions for the testing (on a sample 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 tobacco 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 span of labeling for the proper use of the tobacco product; and
(D) shall require tobacco products containing foreign-grown tobacco to meet the same standards applicable to tobacco products containing domestically grown tobacco.
(5) Periodic reevaluation of tobacco product standards
(6) Involvement of other agencies; informed personsIn 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, workshops, or other means, by informed persons representative of scientific, professional, industry, agricultural, or consumer organizations who in the Secretary’s judgment can make a significant contribution.
(b) Considerations by Secretary
(1) Technical achievability
(2) Other considerations
(c) Proposed standards
(1) In general
(2) Requirements of noticeA notice of proposed rulemaking for the establishment or amendment of a tobacco product standard for a tobacco product shall—
(A) set forth a finding with supporting justification that the tobacco product standard is appropriate for the protection of the public 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 tobacco over domestically grown tobacco; and
(D) invite the Secretary of Agriculture to provide any information or analysis which the Secretary of Agriculture believes is relevant to the proposed tobacco product standard.
(3) Finding
(4) Comment
(d) Promulgation
(1) In generalAfter the expiration of the period for comment on a notice of proposed rulemaking published under subsection (c) respecting a tobacco product standard and after consideration of comments submitted under subsections (b) and (c) and any report from the Tobacco Products Scientific Advisory Committee, the Secretary shall—
(A) if the Secretary determines that the standard would be appropriate for the protection 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 subsection (c); or
(B) publish a notice terminating the proceeding for the development of the standard together with the reasons for such termination.
(2) Effective date
(3) Limitation on power granted to the Food and Drug AdministrationBecause 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
(B) Effective date
(5) Referral to Advisory Committee
(A) In general
(B) Initiation of referralThe Secretary may make a referral under this paragraph—
(i) on the Secretary’s own initiative; or
(ii) upon the request of an interested person that—(I) demonstrates good cause for the referral; and(II) is made before the expiration of the period for submission of comments on the proposed regulation.
(C) Provision of data
(D) Report and recommendation
(E) Public availability
(e) Menthol cigarettes
(1) Referral; considerations
(2) Report and recommendation
(3) Rule of construction
(f) Dissolvable tobacco products
(1) Referral; considerations
(2) Report and recommendation
(3) Rule of construction
(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.)

CITE AS: 21 USC 387g

§ 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 commerce for commercial distribution presents an unreasonable risk of substantial harm to the public health; and
(2) notification under this subsection is necessary to eliminate the unreasonable risk of such harm and no more practicable means is available under the provisions of this subchapter (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 receive such notification in order to eliminate such risk. The Secretary may order notification by any appropriate means, including public service announcements. Before issuing an order under this subsection, the Secretary shall consult with the persons who are to give notice under the order.
(b) No exemption from other liability
(c) Recall authority
(1) In general
(2) Amendment of order to require recall
(A) In general
(B) Notice
An amended order under subparagraph (A)—
(i) shall not include recall of a tobacco product from individuals; and
(ii) shall provide for notice to persons subject to the risks associated with the use of such tobacco product.
In providing the notice required by clause (ii), the Secretary may use the assistance of retailers and other persons who distributed such tobacco product. If a significant number of such persons cannot be identified, the Secretary shall notify such persons under section 375(b) of this title.
(3) Remedy not exclusive
(June 25, 1938, ch. 675, § 908, as added Pub. L. 111–31, div. A, title I, § 101(b)(3), June 22, 2009, 123 Stat. 1804.)

CITE AS: 21 USC 387h

§ 387i. Records and reports on tobacco products
(a) In general
Every person who is a tobacco product manufacturer or importer of a tobacco product shall establish and maintain such records, make such reports, and provide such information, as the Secretary may by regulation reasonably require to assure that such tobacco product is not adulterated or misbranded and to otherwise protect public health. Regulations prescribed under the preceding sentence—
(1) may require a tobacco product manufacturer or importer to report to the Secretary whenever the manufacturer or importer receives or otherwise becomes aware of information that reasonably suggests that one of its marketed tobacco products may have caused or contributed to a serious unexpected adverse experience associated with the use of the product or any significant increase in the frequency of a serious, expected adverse product experience;
(2) shall require reporting of other significant adverse tobacco product experiences as determined by the Secretary to be necessary to be reported;
(3) shall not impose requirements unduly burdensome to a tobacco product manufacturer or importer, taking into account the cost of complying with such requirements and the need for the protection of the public health and the implementation of this subchapter;
(4) when prescribing the procedure for making requests for reports or information, shall require that each request made under such regulations for submission of a report or information to the Secretary state the reason or purpose for such request and identify to the fullest extent practicable such report or information;
(5) when requiring submission of a report or information to the Secretary, shall state the reason or purpose for the submission of such report or information and identify to the fullest extent practicable such report or information; and
(6) may not require that the identity of any patient or user be disclosed in records, reports, or information required under this subsection unless required for the medical welfare of an individual, to determine risks to public health of a tobacco product, or to verify a record, report, or information submitted under this subchapter.
In prescribing regulations under this subsection, the Secretary shall have due regard for the professional ethics of the medical profession and the interests of patients. The prohibitions of paragraph (6) continue to apply to records, reports, and information concerning any individual who has been a patient, irrespective of whether or when he ceases to be a patient.
(b) Reports of removals and corrections
(1) In general
Except as provided in paragraph (2), the Secretary shall by regulation require a tobacco product manufacturer or importer of a tobacco product to report promptly to the Secretary any corrective action taken or removal from the market of a tobacco product undertaken by such manufacturer or importer if the removal or correction was undertaken—
(A) to reduce a risk to health posed by the tobacco product; or
(B) to remedy a violation of this subchapter caused by the tobacco product which may present a risk to health.
A tobacco product manufacturer or importer of a tobacco product who undertakes a corrective action or removal from the market of a tobacco product which is not required to be reported under this subsection shall keep a record of such correction or removal.
(2) Exception
(June 25, 1938, ch. 675, § 909, as added Pub. L. 111–31, div. A, title I, § 101(b)(3), June 22, 2009, 123 Stat. 1805.)

CITE AS: 21 USC 387i

§ 387j. Application for review of certain tobacco products
(a) In general
(1) New tobacco product definedFor purposes of this section the term “new tobacco product” means—
(A) any tobacco product (including those products in test markets) that was not commercially marketed in the United States as of February 15, 2007; or
(B) any modification (including a change in design, any component, any part, or any constituent, including a smoke constituent, or in the span, delivery or form of nicotine, or any other additive or ingredient) of a tobacco product where the modified product was commercially marketed in the United States after February 15, 2007.
(2) Premarket review required
(A) New productsAn order under subsection (c)(1)(A)(i) for a new tobacco product is required unless—
(i) the manufacturer has submitted a report under section 387e(j) of this title; and the Secretary has issued an order that the tobacco product—(I) is substantially equivalent to a tobacco product commercially marketed (other than for test marketing) in the United States as of February 15, 2007; and(II) is in compliance with the requirements of this chapter; or
(ii) the tobacco product is exempt from the requirements of section 387e(j) of this title pursuant to a regulation issued under section 387e(j)(3) of this title.
(B) Application to certain post-February 15, 2007, productsSubparagraph (A) shall not apply to a tobacco product—
(i) that was first introduced or delivered for introduction into interstate commerce for commercial distribution in the United States after February 15, 2007, and prior to the date that is 21 months after June 22, 2009; and
(ii) for which a report was submitted under section 387e(j) of this title within such 21-month period,
except that subparagraph (A) shall apply to the tobacco product if the Secretary issues an order that the tobacco product is not substantially equivalent.
(3) Substantially equivalent defined
(A) In generalIn this section and section 387e(j) of this title, the term “substantially equivalent” or “substantial equivalence” means, with respect to the tobacco product being compared to the predicate tobacco product, that the Secretary by order has found that the tobacco product—
(i) has the same characteristics as the predicate tobacco product; or
(ii) has different characteristics and the information submitted contains information, including clinical data if deemed necessary by the Secretary, that demonstrates that it is not appropriate to regulate the product under this section because the product does not raise different questions of public health.
(B) Characteristics
(C) Limitation
(4) Health information
(A) Summary
(B) Required information
(b) Application
(1) ContentsAn application under this section shall contain—
(A) full reports of all information, published or known to, or which should reasonably be known to, the applicant, concerning investigations which have been made to show the health risks of such tobacco product and whether such tobacco product presents less risk than other tobacco products;
(B) a full statement of the components, ingredients, additives, and properties, and of the principle or principles of operation, of such tobacco product;
(C) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and, when relevant, packing and installation of, such tobacco product;
(D) an identifying reference to any tobacco product standard under section 387g of this title which would be applicable to any aspect of such tobacco product, and either adequate information to show that such aspect of such tobacco product fully meets such tobacco product standard or adequate information to justify any deviation from such standard;
(E) such samples of such tobacco product and of components thereof as the Secretary may reasonably require;
(F) specimens of the labeling proposed to be used for such tobacco product; and
(G) such other information relevant to the subject matter of the application as the Secretary may require.
(2) Referral to Tobacco Products Scientific Advisory CommitteeUpon receipt of an application meeting the requirements set forth in paragraph (1), the Secretary—
(A) may, on the Secretary’s own initiative; or
(B) may, upon the request of an applicant,
refer such application to the Tobacco Products Scientific Advisory Committee for reference and for submission (within such period as the Secretary may establish) of a report and recommendation respecting the application, together with all underlying data and the reasons or basis for the recommendation.
(c) Action on application
(1) Deadline
(A) In generalAs promptly as possible, but in no event later than 180 days after the receipt of an application under subsection (b), the Secretary, after considering the report and recommendation submitted under subsection (b)(2), shall—
(i) issue an order that the new product may be introduced or delivered for introduction into interstate commerce if the Secretary finds that none of the grounds specified in paragraph (2) of this subsection applies; or
(ii) issue an order that the new product may not be introduced or delivered for introduction into interstate commerce if the Secretary finds (and sets forth the basis for such finding as part of or accompanying such denial) that 1 or more grounds for denial specified in paragraph (2) of this subsection apply.
(B) Restrictions on sale and distribution
(2) Denial of applicationThe Secretary shall deny an application submitted under subsection (b) if, upon the basis of the information submitted to the Secretary as part of the application and any other information before the Secretary with respect to such tobacco product, the Secretary finds that—
(A) there is a lack of a showing that permitting such tobacco product to be marketed would be appropriate for the protection of the public health;
(B) the methods used in, or the facilities or controls used for, the manufacture, processing, or packing of such tobacco product do not conform to the requirements of section 387f(e) of this title;
(C) based on a fair evaluation of all material facts, the proposed labeling is false or misleading in any particular; or
(D) such tobacco product is not shown to conform in all respects to a tobacco product standard in effect under section 387g of this title, and there is a lack of adequate information to justify the deviation from such standard.
(3) Denial information
(4) Basis for findingFor purposes of this section, the finding as to whether the marketing of a tobacco product for which an application has been submitted is 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—
(A) the increased or decreased likelihood that existing users of tobacco products will stop using such products; and
(B) the increased or decreased likelihood that those who do not use tobacco products will start using such products.
(5) Basis for action
(A) Investigations
(B) Other evidence
(d) Withdrawal and temporary suspension
(1) In generalThe Secretary shall, upon obtaining, where appropriate, advice on scientific matters from the Tobacco Products Scientific Advisory Committee, and after due notice and opportunity for informal hearing for a tobacco product for which an order was issued under subsection (c)(1)(A)(i), issue an order withdrawing the order if the Secretary finds—
(A) that the continued marketing of such tobacco product no longer is appropriate for the protection of the public health;
(B) that the application contained or was accompanied by an untrue statement of a material fact;
(C) that the applicant—
(i) has failed to establish a system for maintaining records, or has repeatedly or deliberately failed to maintain records or to make reports, required by an applicable regulation under section 387i of this title;
(ii) has refused to permit access to, or copying or verification of, such records as required by section 374 of this title; or
(iii) has not complied with the requirements of section 387e of this title;
(D) on the basis of new information before the Secretary with respect to such tobacco product, evaluated together with the evidence before the Secretary when the application was reviewed, that the methods used in, or the facilities and controls used for, the manufacture, processing, packing, or installation of such tobacco product do not conform with the requirements of section 387f(e) of this title and were not brought into conformity with such requirements within a reasonable time after receipt of written notice from the Secretary of nonconformity;
(E) on the basis of new information before the Secretary, evaluated together with the evidence before the Secretary when the application was reviewed, that the labeling of such tobacco product, based on a fair evaluation of all material facts, is false or misleading in any particular and was not corrected within a reasonable time after receipt of written notice from the Secretary of such fact; or
(F) on the basis of new information before the Secretary, evaluated together with the evidence before the Secretary when such order was issued, that such tobacco product is not shown to conform in all respects to a tobacco product standard which is in effect under section 387g of this title, compliance with which was a condition to the issuance of an order relating to the application, and that there is a lack of adequate information to justify the deviation from such standard.
(2) Appeal
(3) Temporary suspension
(e) Service of orderAn order issued by the Secretary under this section shall be served—
(1) in person by any officer or employee of the department designated by the Secretary; or
(2) by mailing the order by registered mail or certified mail addressed to the applicant at the applicant’s last known address in the records of the Secretary.
(f) Records
(1) Additional information
(2) Access to records
(g) Investigational tobacco product exemption for investigational use
(June 25, 1938, ch. 675, § 910, as added Pub. L. 111–31, div. A, title I, § 101(b)(3), June 22, 2009, 123 Stat. 1807.)

CITE AS: 21 USC 387j

§ 387k. Modified risk tobacco products
(a) In general
(b) DefinitionsIn this section:
(1) Modified risk tobacco product
(2) Sold or distributed
(A) In generalWith respect to a tobacco product, the term “sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products” means a tobacco product—
(i) the label, labeling, or advertising of which represents explicitly or implicitly that—(I) the tobacco product presents a lower risk of tobacco-related disease or is less harmful than one or more other commercially marketed tobacco products;(II) the tobacco product or its smoke contains a reduced level of a substance or presents a reduced exposure to a substance; or(III) the tobacco product or its smoke does not contain or is free of a substance;
(ii) the label, labeling, or advertising of which uses the descriptors “light”, “mild”, or “low” or similar descriptors; or
(iii) the tobacco product manufacturer of which has taken any action directed to consumers through the media or otherwise, other than by means of the tobacco product’s label, labeling, or advertising, after June 22, 2009, respecting the product that would be reasonably expected to result in consumers believing that the tobacco product or its smoke may present a lower risk of disease or is less harmful than one or more commercially marketed tobacco products, or presents a reduced exposure to, or does not contain or is free of, a substance or substances.
(B) Limitation
(C) Smokeless tobacco product
(3) Effective date
(c) Tobacco dependence products
(d) FilingAny person may file with the Secretary an application for a modified risk tobacco product. Such application shall include—
(1) a description of the proposed product and any proposed advertising and labeling;
(2) the conditions for using the product;
(3) the formulation of the product;
(4) sample product labels and labeling;
(5) all documents (including underlying scientific information) relating to research findings conducted, supported, or possessed by the tobacco product manufacturer relating to the effect of the product on tobacco-related diseases and health-related conditions, including information both favorable and unfavorable to the ability of the product to reduce risk or exposure and relating to human health;
(6) data and information on how consumers actually use the tobacco product; and
(7) such other information as the Secretary may require.
(e) Public availability
(f) Advisory Committee
(1) In general
(2) Recommendations
(g) Marketing
(1) Modified risk productsExcept as provided in paragraph (2), the Secretary shall, with respect to an application submitted under this section, issue an order that a modified risk product may be commercially marketed only if the Secretary determines that the applicant has demonstrated that such product, as it is actually used by consumers, will—
(A) significantly reduce harm and the risk of tobacco-related disease to individual tobacco users; and
(B) benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products.
(2) Special rule for certain products
(A) In generalThe Secretary may issue an order that a tobacco product may be introduced or delivered for introduction into interstate commerce, pursuant to an application under this section, with respect to a tobacco product that may not be commercially marketed under paragraph (1) if the Secretary makes the findings required under this paragraph and determines that the applicant has demonstrated that—
(i) such order would be appropriate to promote the public health;
(ii) any aspect of the label, labeling, and advertising for such product that would cause the tobacco product to be a modified risk tobacco product under subsection (b) is limited to an explicit or implicit representation that such tobacco product or its smoke does not contain or is free of a substance or contains a reduced level of a substance, or presents a reduced exposure to a substance in tobacco smoke;
(iii) scientific evidence is not available and, using the best available scientific methods, cannot be made available without conducting long-term epidemiological studies for an application to meet the standards set forth in paragraph (1); and
(iv) the scientific evidence that is available without conducting long-term epidemiological studies demonstrates that a measurable and substantial reduction in morbidity or mortality among individual tobacco users is reasonably likely in subsequent studies.
(B) Additional findings requiredTo issue an order under subparagraph (A) the Secretary must also find that the applicant has demonstrated that—
(i) the magnitude of the overall reductions in exposure to the substance or substances which are the subject of the application is substantial, such substance or substances are harmful, and the product as actually used exposes consumers to the specified reduced level of the substance or substances;
(ii) the product as actually used by consumers will not expose them to higher levels of other harmful substances compared to the similar types of tobacco products then on the market unless such increases are minimal and the reasonably likely overall impact of use of the product remains a substantial and measurable reduction in overall morbidity and mortality among individual tobacco users;
(iii) testing of actual consumer perception shows that, as the applicant proposes to label and market the product, consumers will not be misled into believing that the product—(I) is or has been demonstrated to be less harmful; or(II) presents or has been demonstrated to present less of a risk of disease than 1 or more other commercially marketed tobacco products; and
(iv) issuance of an order with respect to the application is expected to benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products.
(C) Conditions of marketing
(i) In general
(ii) Agreements by applicant
(iii) Annual submission
(3) BasisThe determinations under paragraphs (1) and (2) shall be based on—
(A) the scientific evidence submitted by the applicant; and
(B) scientific evidence and other information that is made available to the Secretary.
(4) Benefit to health of individuals and of population as a wholeIn making the determinations under paragraphs (1) and (2), the Secretary shall take into account—
(A) the relative health risks to individuals of the tobacco product that is the subject of the application;
(B) the increased or decreased likelihood that existing users of tobacco products who would otherwise stop using such products will switch to the tobacco product that is the subject of the application;
(C) the increased or decreased likelihood that persons who do not use tobacco products will start using the tobacco product that is the subject of the application;
(D) the risks and benefits to persons from the use of the tobacco product that is the subject of the application as compared to the use of products for smoking cessation approved under subchapter V to treat nicotine dependence; and
(E) comments, data, and information submitted by interested persons.
(h) Additional conditions for marketing
(1) Modified risk products
(2) Comparative claims
(A) In general
(B) Quantitative comparisons
(3) Label disclosure
(A) In general
(B) Conditions of use
(4) Time
(5) Advertising
(i) Postmarket surveillance and studies
(1) In general
(2) Surveillance protocol
(j) Withdrawal of authorizationThe Secretary, after an opportunity for an informal hearing, shall withdraw an order under subsection (g) if the Secretary determines that—
(1) the applicant, based on new information, can no longer make the demonstrations required under subsection (g), or the Secretary can no longer make the determinations required under subsection (g);
(2) the application failed to include material information or included any untrue statement of material fact;
(3) any explicit or implicit representation that the product reduces risk or exposure is no longer valid, including if—
(A) a tobacco product standard is established pursuant to section 387g of this title;
(B) an action is taken that affects the risks presented by other commercially marketed tobacco products that were compared to the product that is the subject of the application; or
(C) any postmarket surveillance or studies reveal that the order is no longer consistent with the protection of the public health;
(4) the applicant failed to conduct or submit the postmarket surveillance and studies required under subsection (g)(2)(C)(ii) or subsection (i); or
(5) the applicant failed to meet a condition imposed under subsection (h).
(k) Subchapter IV or V
(l) Implementing regulations or guidance
(1) Scientific evidenceNot later than 2 years after June 22, 2009, the Secretary shall issue regulations or guidance (or any combination thereof) on the scientific evidence required for assessment and ongoing review of modified risk tobacco products. Such regulations or guidance shall—
(A) to the extent that adequate scientific evidence exists, establish minimum standards for scientific studies needed prior to issuing an order under subsection (g) to show that a substantial reduction in morbidity or mortality among individual tobacco users occurs for products described in subsection (g)(1) or is reasonably likely for products described in subsection (g)(2);
(B) include validated biomarkers, intermediate clinical endpoints, and other feasible outcome measures, as appropriate;
(C) establish minimum standards for postmarket studies, that shall include regular and long-term assessments of health outcomes and mortality, intermediate clinical endpoints, consumer perception of harm reduction, and the impact on quitting behavior and new use of tobacco products, as appropriate;
(D) establish minimum standards for required postmarket surveillance, including ongoing assessments of consumer perception;
(E) require that data from the required studies and surveillance be made available to the Secretary prior to the decision on renewal of a modified risk tobacco product; and
(F) establish a reasonable timetable for the Secretary to review an application under this section.
(2) Consultation
(3) Revision
(4) New tobacco products
(m) Distributors
(June 25, 1938, ch. 675, § 911, as added Pub. L. 111–31, div. A, title I, § 101(b)(3), June 22, 2009, 123 Stat. 1812.)

CITE AS: 21 USC 387k

§ 387l. Judicial review
(a) Right to review
(1) In general
Not later than 30 days after—
(A) the promulgation of a regulation under section 387g of this title establishing, amending, or revoking a tobacco product standard; or
(B) a denial of an application under section 387j(c) of this title,
any person adversely affected by such regulation or denial may file a petition for judicial review of such regulation or denial with the United States Court of Appeals for the District of Columbia or for the circuit in which such person resides or has their principal place of business.
(2) Requirements
(A) Copy of petition
(B) Record of proceedings
On receipt of a petition under subparagraph (A), the Secretary shall file in the court in which such petition was filed—
(i) the record of the proceedings on which the regulation or order was based; and
(ii) a statement of the reasons for the issuance of such a regulation or order.
(C) Definition of record
In this section, the term “record” means—
(i) all notices and other matter published in the Federal Register with respect to the regulation or order reviewed;
(ii) all information submitted to the Secretary with respect to such regulation or order;
(iii) proceedings of any panel or advisory committee with respect to such regulation or order;
(iv) any hearing held with respect to such regulation or order; and
(v) any other information identified by the Secretary, in the administrative proceeding held with respect to such regulation or order, as being relevant to such regulation or order.
(b) Standard of review
(c) Finality of judgment
(d) Other remedies
(e) Regulations and orders must recite basis in record
(June 25, 1938, ch. 675, § 912, as added Pub. L. 111–31, div. A, title I, § 101(b)(3), June 22, 2009, 123 Stat. 1819.)

CITE AS: 21 USC 387l

§ 387m. Equal treatment of retail outlets

The Secretary shall issue regulations to require that retail establishments for which the predominant business is the sale of tobacco products comply with any advertising restrictions applicable to retail establishments accessible to individuals under the age of 18.

(June 25, 1938, ch. 675, § 913, as added Pub. L. 111–31, div. A, title I, § 101(b)(3), June 22, 2009, 123 Stat. 1820.)

CITE AS: 21 USC 387m

§ 387n. Jurisdiction of and coordination with the Federal Trade Commission
(a) Jurisdiction
(1) In general
(2) Enforcement
(b) Coordination
With respect to the requirements of section 4 of the Federal Cigarette Labeling and Advertising Act [15 U.S.C. 1333] and section 3 of the Comprehensive Smokeless Tobacco Health Education Act of 1986 [15 U.S.C. 4402]—
(1) the Chairman of the Federal Trade Commission shall coordinate with the Secretary concerning the enforcement of such Act as such enforcement relates to unfair or deceptive acts or practices in the advertising of cigarettes or smokeless tobacco; and
(2) the Secretary shall consult with the Chairman of such Commission in revising the label statements and requirements under such sections.
(June 25, 1938, ch. 675, § 914, as added Pub. L. 111–31, div. A, title I, § 101(b)(3), June 22, 2009, 123 Stat. 1820.)

CITE AS: 21 USC 387n

§ 387o. Regulation requirement
(a) Testing, reporting, and disclosure
(b) Contents of rules
The regulations promulgated under subsection (a)—
(1) shall require testing and reporting of tobacco product constituents, ingredients, and additives, including smoke constituents, by brand and subbrand that the Secretary determines should be tested to protect the public health, provided that, for purposes of the testing requirements of this paragraph, tobacco products manufactured and sold by a single tobacco product manufacturer that are identical in all respects except the labels, packaging design, logo, trade dress, trademark, brand name, or any combination thereof, shall be considered as a single brand; and
(2) may require that tobacco product manufacturers, packagers, or importers make disclosures relating to the results of the testing of tar and nicotine through labels or advertising or other appropriate means, and make disclosures regarding the results of the testing of other constituents, including smoke constituents, ingredients, or additives, that the Secretary determines should be disclosed to the public to protect the public health and will not mislead consumers about the risk of tobacco-related disease.
(c) Authority
(d) Small tobacco product manufacturers
(1) First compliance date
The initial regulations promulgated under subsection (a) shall not impose requirements on small tobacco product manufacturers before the later of—
(A) the end of the 2-year period following the final promulgation of such regulations; and
(B) the initial date set by the Secretary for compliance with such regulations by manufacturers that are not small tobacco product manufacturers.
(2) Testing and reporting initial compliance period
(A) 4-year period
The initial regulations promulgated under subsection (a) shall give each small tobacco product manufacturer a 4-year period over which to conduct testing and reporting for all of its tobacco products. Subject to paragraph (1), the end of the first year of such 4-year period shall coincide with the initial date of compliance under this section set by the Secretary with respect to manufacturers that are not small tobacco product manufacturers or the end of the 2-year period following the final promulgation of such regulations, as described in paragraph (1)(A). A small tobacco product manufacturer shall be required—
(i) to conduct such testing and reporting for 25 percent of its tobacco products during each year of such 4-year period; and
(ii) to conduct such testing and reporting for its largest-selling tobacco products (as determined by the Secretary) before its other tobacco products, or in such other order of priority as determined by the Secretary.
(B) Case-by-case delay
(3) Subsequent and additional testing and reporting
(4) Joint laboratory testing services
(e) Extensions for limited laboratory capacity
(1) In general
The regulations promulgated under subsection (a) shall provide that a small tobacco product manufacturer shall not be considered to be in violation of this section before the deadline applicable under paragraphs (3) and (4), if—
(A) the tobacco products of such manufacturer are in compliance with all other requirements of this subchapter; and
(B) the conditions described in paragraph (2) are met.
(2) Conditions
Notwithstanding the requirements of this section, the Secretary may delay the date by which a small tobacco product manufacturer must be in compliance with the testing and reporting required by this section until such time as the testing is reported if, not later than 90 days before the deadline for reporting in accordance with this section, a small tobacco product manufacturer provides evidence to the Secretary demonstrating that—
(A) the manufacturer has submitted the required products for testing to a laboratory and has done so sufficiently in advance of the deadline to create a reasonable expectation of completion by the deadline;
(B) the products currently are awaiting testing by the laboratory; and
(C) neither that laboratory nor any other laboratory is able to complete testing by the deadline at customary, nonexpedited testing fees.
(3) Extension
(4) Additional extension
(f) Rule of construction
(June 25, 1938, ch. 675, § 915, as added Pub. L. 111–31, div. A, title I, § 101(b)(3), June 22, 2009, 123 Stat. 1820.)

CITE AS: 21 USC 387o

§ 387p. Preservation of State and local authority
(a) In general
(1) Preservation
(2) Preemption of certain State and local requirements
(A) In general
(B) Exception
(b) Rule of construction regarding product liability
(June 25, 1938, ch. 675, § 916, as added Pub. L. 111–31, div. A, title I, § 101(b)(3), June 22, 2009, 123 Stat. 1823.)

CITE AS: 21 USC 387p

§ 387q. Tobacco Products Scientific Advisory Committee
(a) Establishment
(b) Membership
(1) In general
(A) Members
The Secretary shall appoint as members of the Tobacco Products Scientific Advisory Committee individuals who are technically qualified by training and experience in medicine, medical ethics, science, or technology involving the manufacture, evaluation, or use of tobacco products, who are of appropriately diversified professional backgrounds. The committee shall be composed of—
(i) 7 individuals who are physicians, dentists, scientists, or health care professionals practicing in the area of oncology, pulmonology, cardiology, toxicology, pharmacology, addiction, or any other relevant specialty;
(ii) 1 individual who is an officer or employee of a State or local government or of the Federal Government;
(iii) 1 individual as a representative of the general public;
(iv) 1 individual as a representative of the interests of the tobacco manufacturing industry;
(v) 1 individual as a representative of the interests of the small business tobacco manufacturing industry, which position may be filled on a rotating, sequential basis by representatives of different small business tobacco manufacturers based on areas of expertise relevant to the topics being considered by the Advisory Committee; and
(vi) 1 individual as a representative of the interests of the tobacco growers.
(B) Nonvoting members
(C) Conflicts of interest
(2) Limitation
(3) Chairperson
(c) Duties
The Tobacco Products Scientific Advisory Committee shall provide advice, information, and recommendations to the Secretary—
(1) as provided in this subchapter;
(2) on the effects of the alteration of the nicotine yields from tobacco products;
(3) on whether there is a threshold level below which nicotine yields do not produce dependence on the tobacco product involved; and
(4) on its review of other safety, dependence, or health issues relating to tobacco products as requested by the Secretary.
(d) Compensation; support; chapter 10 of title 5
(1) Compensation and travel
(2) Administrative support
(3) Nonapplication of chapter 10 of title 5
(e) Proceedings of advisory panels and committees
(June 25, 1938, ch. 675, § 917, as added Pub. L. 111–31, div. A, title I, § 101(b)(3), June 22, 2009, 123 Stat. 1824; amended Pub. L. 117–286, § 4(a)(160), Dec. 27, 2022, 136 Stat. 4323.)

CITE AS: 21 USC 387q

§ 387r. Drug products used to treat tobacco dependence
(a) In general
The Secretary shall—
(1) at the request of the applicant, consider designating products for smoking cessation, including nicotine replacement products as fast track research and approval products within the meaning of section 356 of this title;
(2) consider approving the extended use of nicotine replacement products (such as nicotine patches, nicotine gum, and nicotine lozenges) for the treatment of tobacco dependence; and
(3) review and consider the evidence for additional indications for nicotine replacement products, such as for craving relief or relapse prevention.
(b) Report on innovative products
(1) In general
Not later than 3 years after June 22, 2009, the Secretary, after consultation with recognized scientific, medical, and public health experts (including both Federal agencies and nongovernmental entities, the Institute of Medicine of the National Academy of Sciences, and the Society for Research on Nicotine and Tobacco), shall submit to the Congress a report that examines how best to regulate, promote, and encourage the development of innovative products and treatments (including nicotine-based and non-nicotine-based products and treatments) to better achieve, in a manner that best protects and promotes the public health—
(A) total abstinence from tobacco use;
(B) reductions in consumption of tobacco; and
(C) reductions in the harm associated with continued tobacco use.
(2) Recommendations
(June 25, 1938, ch. 675, § 918, as added Pub. L. 111–31, div. A, title I, § 101(b)(3), June 22, 2009, 123 Stat. 1825.)

CITE AS: 21 USC 387r

§ 387s. User fees
(a) Establishment of quarterly fee
(b) Assessment of user fee
(1) Amount of assessment
The total amount of user fees authorized to be assessed and collected under subsection (a) for a fiscal year is the following, as applicable to the fiscal year involved:
(A) For fiscal year 2009, $85,000,000 (subject to subsection (e)).
(B) For fiscal year 2010, $235,000,000.
(C) For fiscal year 2011, $450,000,000.
(D) For fiscal year 2012, $477,000,000.
(E) For fiscal year 2013, $505,000,000.
(F) For fiscal year 2014, $534,000,000.
(G) For fiscal year 2015, $566,000,000.
(H) For fiscal year 2016, $599,000,000.
(I) For fiscal year 2017, $635,000,000.
(J) For fiscal year 2018, $672,000,000.
(K) For fiscal year 2019 and each subsequent fiscal year, $712,000,000.
(2) Allocations of assessment by class of tobacco products
(A) In general
(B) Applicable percentage
(i) In general
For purposes of subparagraph (A), the applicable percentage for a fiscal year for each of the following classes of tobacco products shall be determined in accordance with clause (ii):
(I) Cigarettes.(II) Cigars, including small cigars and cigars other than small cigars.(III) Snuff.(IV) Chewing tobacco.(V) Pipe tobacco.(VI) Roll-your-own tobacco.
(ii) Allocations
(iii) Requirement of regulations
(iv) Reallocations
(3) Determination of user fee by company
(A) In general
The total user fee to be paid by each manufacturer or importer of a particular class of tobacco products shall be determined for each quarter by multiplying—
(i) such manufacturer’s or importer’s percentage share as determined under paragraph (4); by
(ii) the portion of the user fee amount for the current quarter to be assessed on all manufacturers and importers of such class of tobacco products as determined under paragraph (2).
(B) No fee in excess of percentage share
(4) Allocation of assessment within each class of tobacco product
(5) Allocation for cigars
(6) Timing of assessment
(7) Memorandum of understanding
(A) In general
(B) Assurances
(c) Crediting and availability of fees
(1) In general
(2) Availability
(A) In general
(B) Prohibition against use of other funds
(i) In general
(ii) Startup costs
(C) Reimbursement of start-up amounts
(i) In general
(ii) Treatment of reimbursed amounts
(D) Fee collected during start-up period
(E) Obligation of start-up costs in anticipation of available fee collections
(3) Authorization of appropriations
(d) Collection of unpaid fees
(e) Applicability to fiscal year 2009
If the date of enactment of the Family Smoking Prevention and Tobacco Control Act occurs during fiscal year 2009, the following applies, subject to subsection (c):
(1) The Secretary shall determine the fees that would apply for a single quarter of such fiscal year according to the application of subsection (b) to the amount specified in paragraph (1)(A) of such subsection (referred to in this subsection as the “quarterly fee amounts”).
(2) For the quarter in which such date of enactment occurs, the amount of fees assessed shall be a pro rata amount, determined according to the number of days remaining in the quarter (including such date of enactment) and according to the daily equivalent of the quarterly fee amounts. Fees assessed under the preceding sentence shall not be collected until the next quarter.
(3) For the quarter following the quarter to which paragraph (2) applies, the full quarterly fee amounts shall be assessed and collected, in addition to collection of the pro rata fees assessed under paragraph (2).
(June 25, 1938, ch. 675, § 919, as added Pub. L. 111–31, div. A, title I, § 101(b)(3), June 22, 2009, 123 Stat. 1826.)

CITE AS: 21 USC 387s

§ 387t. Labeling, recordkeeping, records inspection
(a) Origin labeling
(1) Requirement
(2) Effective date
(b) Regulations concerning recordkeeping for tracking and tracing
(1) In general
(2) Inspection
(3) Codes
(4) Size of business
(5) Recordkeeping by retailers
(c) Records inspection
(d) Knowledge of illegal transaction
(1) Notification
If the manufacturer or distributor of a tobacco product has knowledge which reasonably supports the conclusion that a tobacco product manufactured or distributed by such manufacturer or distributor that has left the control of such person may be or has been—
(A) imported, exported, distributed, or offered for sale in interstate commerce by a person without paying duties or taxes required by law; or
(B) imported, exported, distributed, or diverted for possible illicit marketing,
the manufacturer or distributor shall promptly notify the Attorney General and the Secretary of the Treasury of such knowledge.
(2) Knowledge defined
For purposes of this subsection, the term “knowledge” as applied to a manufacturer or distributor means—
(A) the actual knowledge that the manufacturer or distributor had; or
(B) the knowledge which a reasonable person would have had under like circumstances or which would have been obtained upon the exercise of due care.
(e) Consultation
(June 25, 1938, ch. 675, § 920, as added Pub. L. 111–31, div. A, title III, § 301, June 22, 2009, 123 Stat. 1850.)

CITE AS: 21 USC 387t

§ 387u. Studies of progress and effectiveness
(a) FDA report
Not later than 3 years after June 22, 2009, and not less than every 2 years thereafter, the Secretary of Health and Human Services shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, a report concerning—
(1) the progress of the Food and Drug Administration in implementing this division, including major accomplishments, objective measurements of progress, and the identification of any areas that have not been fully implemented;
(2) impediments identified by the Food and Drug Administration to progress in implementing this division and to meeting statutory timeframes;
(3) data on the number of new product applications received under section 387j of this title and modified risk product applications received under section 387k of this title, and the number of applications acted on under each category; and
(4) data on the number of full time equivalents engaged in implementing this division.
(b) GAO report
Not later than 5 years after June 22, 2009, the Comptroller General of the United States shall conduct a study of, and submit to the Committees described in subsection (a) a report concerning—
(1) the adequacy of the authority and resources provided to the Secretary of Health and Human Services for this division to carry out its goals and purposes; and
(2) any recommendations for strengthening that authority to more effectively protect the public health with respect to the manufacture, marketing, and distribution of tobacco products.
(c) Public availability
(Pub. L. 111–31, div. A, title I, § 106, June 22, 2009, 123 Stat. 1841.)

CITE AS: 21 USC 387u

§ 387v. Reporting on tobacco regulation activities
(a) In general
(b) Required informationEach report submitted under subsection (a) shall contain the following information for the previous fiscal year:
(1) Total annual user fee collections.
(2) Total amount of fees obligated.
(3) The amount of unobligated carryover balance from fees collected.
(4) The amount obligated by the Center for Tobacco Products for each of the following activities:
(A) Compliance and enforcement.
(B) Public education campaigns.
(C) Scientific research and research infrastructure.
(D) Communications.
(E) Leadership, management oversight, and administrative services.
(F) Related overhead activities.
(5) The numbers of applications, categorized by class of tobacco product and review pathway under sections 387e, 387j, and 387k of this title, that were—
(A) submitted;
(B) pending;
(C) accepted;
(D) refused to file;
(E) withdrawn;
(F) denied;
(G) authorized for marketing under an order;
(H) issued a deficiency letter or environmental information request letter; or
(I) referred to the Tobacco Products Scientific Advisory Committee.
(6) The number and titles of draft and final guidance documents and proposed and final regulations issued on topics related to the process for the review of tobacco product applications, whether such regulations and guidance documents were issued as required by statute or by other legal or regulatory requirements, and whether the issuance met the deadlines set forth by the applicable statute or other requirements.
(7) The number and titles of public meetings related to the review of tobacco product applications by the Center for Tobacco Products or other offices or centers within the Food and Drug Administration.
(8) The number of pre-submission meetings relating to applications under section 387j of this title, including the number of meeting requests received, the number of meetings held, and the median amount of time between when such meeting requests were made and when the requests were granted or denied.
(9) The number of full-time equivalent employees funded pursuant to fees collected under section 387s of this title, including identification of the centers and offices within the Food and Drug Administration in which such positions are located.
(10) The number of inspections and investigations conducted at domestic and foreign establishments required to register under section 387e of this title.
(11) The total number of compliance and enforcement actions issued or taken with respect to tobacco products, including warning letters, civil money penalties, no-tobacco-sale orders, and other enforcement actions (including seizures, injunctions, and criminal prosecution).
(c) Public availability
(d) Limitations
(Pub. L. 117–103, div. P, title I, § 112, Mar. 15, 2022, 136 Stat. 790.)

CITE AS: 21 USC 387v