---
kind: "section"
citation: "21 U.S.C. § 387k"
title: "21"
title_heading: "Food and Drugs"
number: "387k"
heading: "Modified risk tobacco products"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/387k"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter IX — Tobacco Products"
---

# §387k. Modified risk tobacco products

- (a) **In general—** No [person](/usc/21/321.md?p=e) may introduce or deliver for introduction into [interstate commerce](/usc/21/321.md?p=b) any modified risk [tobacco product](/usc/21/321.md?p=rr-1) unless an order issued pursuant to [subsection (g)](#g) is effective with respect to such [product](/usc/21/360eee.md?p=13).
- (b) **Definitions—** In this section:
  - (1) **Modified risk tobacco product—** The term “modified risk [tobacco product](/usc/21/321.md?p=rr-1)” means any [tobacco product](/usc/21/321.md?p=rr-1) that is sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed [tobacco products](/usc/21/321.md?p=rr-1).
  - (2) **Sold or distributed—**
    - (A) **In general—** With respect to a [tobacco product](/usc/21/321.md?p=rr-1), the term “sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed [tobacco products](/usc/21/321.md?p=rr-1)” means a [tobacco product](/usc/21/321.md?p=rr-1)—
      - (i) the [label](/usc/21/321.md?p=k), [labeling](/usc/21/321.md?p=m), or advertising of which represents explicitly or implicitly that—
        - (I) the [tobacco product](/usc/21/321.md?p=rr-1) presents a lower risk of tobacco-related disease or is less harmful than one or more other commercially marketed [tobacco products](/usc/21/321.md?p=rr-1);
        - (II) the [tobacco product](/usc/21/321.md?p=rr-1) or its smoke contains a reduced level of a substance or presents a reduced exposure to a substance; or
        - (III) the [tobacco product](/usc/21/321.md?p=rr-1) or its smoke does not contain or is free of a substance;
      - (ii) the [label](/usc/21/321.md?p=k), [labeling](/usc/21/321.md?p=m), or advertising of which uses the descriptors “light”, “mild”, or “low” or similar descriptors; or
      - (iii) the [tobacco product manufacturer](/usc/21/387.md?p=20) of which has taken any action directed to consumers through the media or otherwise, other than by means of the [tobacco product](/usc/21/321.md?p=rr-1)’s [label](/usc/21/321.md?p=k), [labeling](/usc/21/321.md?p=m), or advertising, after June 22, 2009, respecting the [product](/usc/21/360eee.md?p=13) that would be reasonably expected to result in consumers believing that the [tobacco product](/usc/21/321.md?p=rr-1) or its smoke may present a lower risk of disease or is less harmful than one or more commercially marketed [tobacco products](/usc/21/321.md?p=rr-1), or presents a reduced exposure to, or does not contain or is free of, a substance or substances.
    - (B) **Limitation—** No [tobacco product](/usc/21/321.md?p=rr-1) shall be considered to be “sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed [tobacco products](/usc/21/321.md?p=rr-1)”, except as described in [subparagraph (A)](#b-2-A).
    - (C) **Smokeless tobacco product—** No [smokeless tobacco](/usc/21/387.md?p=18) [product](/usc/21/360eee.md?p=13) shall be considered to be “sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed [tobacco products](/usc/21/321.md?p=rr-1)” solely because its [label](/usc/21/321.md?p=k), [labeling](/usc/21/321.md?p=m), or advertising uses the following phrases to describe such [product](/usc/21/360eee.md?p=13) and its use: “[smokeless tobacco](/usc/21/387.md?p=18)”, “[smokeless tobacco](/usc/21/387.md?p=18) [product](/usc/21/360eee.md?p=13)”, “not consumed by smoking”, “does not produce smoke”, “smokefree”, “smoke-free”, “without smoke”, “no smoke”, or “not smoke”.
  - (3) **Effective date—** The provisions of [paragraph (2)(A)(ii)](#b-2-A-ii) shall take effect 12 months after June 22, 2009, for those [products](/usc/21/360eee.md?p=13) whose [label](/usc/21/321.md?p=k), [labeling](/usc/21/321.md?p=m), or advertising contains the terms described in such paragraph on June 22, 2009. The effective date shall be with respect to the date of manufacture, provided that, in any case, beginning 30 days after such effective date, a [manufacturer](/usc/21/360hh.md?p=3) shall not introduce into the domestic [commerce](/usc/21/387.md?p=5) of the [United States](/usc/21/387.md?p=22) any [product](/usc/21/360eee.md?p=13), irrespective of the date of manufacture, that is not in conformance with [paragraph (2)(A)(ii)](#b-2-A-ii).
- (c) **Tobacco dependence products—** A [product](/usc/21/360eee.md?p=13) that is intended to be used for the treatment of tobacco dependence, including smoking cessation, is not a modified risk [tobacco product](/usc/21/321.md?p=rr-1) under this section if it has been approved as a [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1) by the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration and is subject to the requirements of subchapter V.
- (d) **Filing—** Any [person](/usc/21/321.md?p=e) may file with the [Secretary](/usc/21/321.md?p=d) an application for a modified risk [tobacco product](/usc/21/321.md?p=rr-1). Such application shall include—
  - (1) a description of the proposed [product](/usc/21/360eee.md?p=13) and any proposed advertising and [labeling](/usc/21/321.md?p=m);
  - (2) the conditions for using the [product](/usc/21/360eee.md?p=13);
  - (3) the formulation of the [product](/usc/21/360eee.md?p=13);
  - (4) sample [product](/usc/21/360eee.md?p=13) [labels](/usc/21/321.md?p=k) and [labeling](/usc/21/321.md?p=m);
  - (5) all documents (including underlying scientific information) relating to research findings conducted, supported, or possessed by the [tobacco product manufacturer](/usc/21/387.md?p=20) relating to the effect of the [product](/usc/21/360eee.md?p=13) on tobacco-related diseases and health-related conditions, including information both favorable and unfavorable to the ability of the [product](/usc/21/360eee.md?p=13) to reduce risk or exposure and relating to human health;
  - (6) data and information on how consumers actually use the [tobacco product](/usc/21/321.md?p=rr-1); and
  - (7) such other information as the [Secretary](/usc/21/321.md?p=d) may require.
- (e) **Public availability—** The [Secretary](/usc/21/321.md?p=d) shall make the application described in [subsection (d)](#d) publicly available (except matters in the application which are trade secrets or otherwise confidential, commercial information) and shall request comments by interested [persons](/usc/21/321.md?p=e) on the information contained in the application and on the [label](/usc/21/321.md?p=k), [labeling](/usc/21/321.md?p=m), and advertising accompanying such application.
- (f) **Advisory Committee—**
  - (1) **In general—** The [Secretary](/usc/21/321.md?p=d) shall refer to the [Tobacco Products](/usc/21/321.md?p=rr-1) Scientific [Advisory Committee](/usc/21/360fff.md?p=1) any application submitted under this section.
  - (2) **Recommendations—** Not later than 60 days after the date an application is referred to the [Tobacco Products](/usc/21/321.md?p=rr-1) Scientific [Advisory Committee](/usc/21/360fff.md?p=1) under [paragraph (1)](#f-1), the [Advisory Committee](/usc/21/360fff.md?p=1) shall report its recommendations on the application to the [Secretary](/usc/21/321.md?p=d).
- (g) **Marketing—**
  - (1) **Modified risk products—** Except as provided in [paragraph (2)](#g-2), the [Secretary](/usc/21/321.md?p=d) shall, with respect to an application submitted under this section, issue an order that a modified risk [product](/usc/21/360eee.md?p=13) may be commercially marketed only if the [Secretary](/usc/21/321.md?p=d) determines that the applicant has demonstrated that such [product](/usc/21/360eee.md?p=13), 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](/usc/21/321.md?p=rr-1) and [persons](/usc/21/321.md?p=e) who do not currently use [tobacco products](/usc/21/321.md?p=rr-1).
  - (2) **Special rule for certain products—**
    - (A) **In general—** The [Secretary](/usc/21/321.md?p=d) may issue an order that a [tobacco product](/usc/21/321.md?p=rr-1) may be introduced or delivered for introduction into [interstate commerce](/usc/21/321.md?p=b), pursuant to an application under this section, with respect to a [tobacco product](/usc/21/321.md?p=rr-1) that may not be commercially marketed under [paragraph (1)](#g-1) if the [Secretary](/usc/21/321.md?p=d) 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](/usc/21/321.md?p=k), [labeling](/usc/21/321.md?p=m), and advertising for such [product](/usc/21/360eee.md?p=13) that would cause the [tobacco product](/usc/21/321.md?p=rr-1) to be a modified risk [tobacco product](/usc/21/321.md?p=rr-1) under [subsection (b)](#b) is limited to an explicit or implicit representation that such [tobacco product](/usc/21/321.md?p=rr-1) 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)](#g-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 required—** To issue an order under [subparagraph (A)](#g-2-A) the [Secretary](/usc/21/321.md?p=d) 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](/usc/21/360eee.md?p=13) as actually used exposes consumers to the specified reduced level of the substance or substances;
      - (ii) the [product](/usc/21/360eee.md?p=13) as actually used by consumers will not expose them to higher levels of other harmful substances compared to the similar types of [tobacco products](/usc/21/321.md?p=rr-1) then on the market unless such increases are minimal and the reasonably likely overall impact of use of the [product](/usc/21/360eee.md?p=13) 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](/usc/21/321.md?p=k) and market the [product](/usc/21/360eee.md?p=13), consumers will not be misled into believing that the [product](/usc/21/360eee.md?p=13)—
        - (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](/usc/21/321.md?p=rr-1); 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](/usc/21/321.md?p=rr-1) and [persons](/usc/21/321.md?p=e) who do not currently use [tobacco products](/usc/21/321.md?p=rr-1).
    - (C) **Conditions of marketing—**
      - (i) **In general—** Applications subject to an order under this paragraph shall be limited to a term of not more than 5 years, but may be renewed upon a finding by the [Secretary](/usc/21/321.md?p=d) that the requirements of this paragraph continue to be satisfied based on the filing of a new application.
      - (ii) **Agreements by applicant—** An order under this paragraph shall be conditioned on the applicant’s agreement to conduct postmarket surveillance and studies and to submit to the [Secretary](/usc/21/321.md?p=d) the results of such surveillance and studies to determine the impact of the order on consumer perception, behavior, and health and to enable the [Secretary](/usc/21/321.md?p=d) to review the accuracy of the determinations upon which the order was based in accordance with a protocol approved by the [Secretary](/usc/21/321.md?p=d).
      - (iii) **Annual submission—** The results of such postmarket surveillance and studies described in [clause (ii)](#g-2-C-ii) shall be submitted annually.
  - (3) **Basis—** The determinations under paragraphs [(1)](#g-1) and [(2)](#g-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](/usc/21/321.md?p=d).
  - (4) **Benefit to health of individuals and of population as a whole—** In making the determinations under paragraphs [(1)](#g-1) and [(2)](#g-2), the [Secretary](/usc/21/321.md?p=d) shall take into account—
    - (A) the relative health risks to individuals of the [tobacco product](/usc/21/321.md?p=rr-1) that is the subject of the application;
    - (B) the increased or decreased likelihood that existing users of [tobacco products](/usc/21/321.md?p=rr-1) who would otherwise stop using such [products](/usc/21/360eee.md?p=13) will switch to the [tobacco product](/usc/21/321.md?p=rr-1) that is the subject of the application;
    - (C) the increased or decreased likelihood that [persons](/usc/21/321.md?p=e) who do not use [tobacco products](/usc/21/321.md?p=rr-1) will start using the [tobacco product](/usc/21/321.md?p=rr-1) that is the subject of the application;
    - (D) the risks and benefits to [persons](/usc/21/321.md?p=e) from the use of the [tobacco product](/usc/21/321.md?p=rr-1) that is the subject of the application as compared to the use of [products](/usc/21/360eee.md?p=13) for smoking cessation approved under subchapter V to treat [nicotine](/usc/21/387.md?p=12) dependence; and
    - (E) comments, data, and information submitted by interested [persons](/usc/21/321.md?p=e).
- (h) **Additional conditions for marketing—**
  - (1) **Modified risk products—** The [Secretary](/usc/21/321.md?p=d) shall require for the marketing of a [product](/usc/21/360eee.md?p=13) under this section that any advertising or [labeling](/usc/21/321.md?p=m) concerning modified risk [products](/usc/21/360eee.md?p=13) enable the public to comprehend the information concerning modified risk and to understand the relative significance of such information in the context of total health and in relation to all of the diseases and health-related conditions associated with the use of [tobacco products](/usc/21/321.md?p=rr-1).
  - (2) **Comparative claims—**
    - (A) **In general—** The [Secretary](/usc/21/321.md?p=d) may require for the marketing of a [product](/usc/21/360eee.md?p=13) under this subsection that a claim comparing a [tobacco product](/usc/21/321.md?p=rr-1) to 1 or more other commercially marketed [tobacco products](/usc/21/321.md?p=rr-1) shall compare the [tobacco product](/usc/21/321.md?p=rr-1) to a commercially marketed [tobacco product](/usc/21/321.md?p=rr-1) that is representative of that type of [tobacco product](/usc/21/321.md?p=rr-1) on the market (for example the average value of the top 3 [brands](/usc/21/387.md?p=2) of an established regular [tobacco product](/usc/21/321.md?p=rr-1)).
    - (B) **Quantitative comparisons—** The [Secretary](/usc/21/321.md?p=d) may also require, for purposes of [subparagraph (A)](#h-2-A), that the percent (or fraction) of change and identity of the reference [tobacco product](/usc/21/321.md?p=rr-1) and a quantitative comparison of the amount of the substance claimed to be reduced shall be stated in immediate proximity to the most prominent claim.
  - (3) **Label disclosure—**
    - (A) **In general—** The [Secretary](/usc/21/321.md?p=d) may require the disclosure on the [label](/usc/21/321.md?p=k) of other substances in the [tobacco product](/usc/21/321.md?p=rr-1), or substances that may be produced by the consumption of that [tobacco product](/usc/21/321.md?p=rr-1), that may affect a disease or health-related condition or may increase the risk of other diseases or health-related conditions associated with the use of [tobacco products](/usc/21/321.md?p=rr-1).
    - (B) **Conditions of use—** If the conditions of use of the [tobacco product](/usc/21/321.md?p=rr-1) may affect the risk of the [product](/usc/21/360eee.md?p=13) to human health, the [Secretary](/usc/21/321.md?p=d) may require the [labeling](/usc/21/321.md?p=m) of conditions of use.
  - (4) **Time—** An order issued under [subsection (g)(1)](#g-1) shall be effective for a specified period of time.
  - (5) **Advertising—** The [Secretary](/usc/21/321.md?p=d) may require, with respect to a [product](/usc/21/360eee.md?p=13) for which an applicant obtained an order under [subsection (g)(1)](#g-1), that the [product](/usc/21/360eee.md?p=13) comply with requirements relating to advertising and promotion of the [tobacco product](/usc/21/321.md?p=rr-1).
- (i) **Postmarket surveillance and studies—**
  - (1) **In general—** The [Secretary](/usc/21/321.md?p=d) shall require, with respect to a [product](/usc/21/360eee.md?p=13) for which an applicant obtained an order under [subsection (g)(1)](#g-1), that the applicant conduct postmarket surveillance and studies for such a [tobacco product](/usc/21/321.md?p=rr-1) to determine the impact of the order issuance on consumer perception, behavior, and health, to enable the [Secretary](/usc/21/321.md?p=d) to review the accuracy of the determinations upon which the order was based, and to provide information that the [Secretary](/usc/21/321.md?p=d) determines is otherwise necessary regarding the use or health risks involving the [tobacco product](/usc/21/321.md?p=rr-1). The results of postmarket surveillance and studies shall be submitted to the [Secretary](/usc/21/321.md?p=d) on an annual basis.
  - (2) **Surveillance protocol—** Each applicant required to conduct a surveillance of a [tobacco product](/usc/21/321.md?p=rr-1) under [paragraph (1)](#i-1) shall, within 30 days after receiving notice that the applicant is required to conduct such surveillance, submit, for the approval of the [Secretary](/usc/21/321.md?p=d), a protocol for the required surveillance. The [Secretary](/usc/21/321.md?p=d), within 60 days of the receipt of such protocol, shall determine if the principal investigator proposed to be used in the surveillance has sufficient qualifications and experience to conduct such surveillance and if such protocol will result in collection of the data or other information designated by the [Secretary](/usc/21/321.md?p=d) as necessary to protect the public health.
- (j) **Withdrawal of authorization—** The [Secretary](/usc/21/321.md?p=d), after an opportunity for an [informal hearing](/usc/21/321.md?p=x), shall withdraw an order under [subsection (g)](#g) if the [Secretary](/usc/21/321.md?p=d) determines that—
  - (1) the applicant, based on new information, can no longer make the demonstrations required under [subsection (g)](#g), or the [Secretary](/usc/21/321.md?p=d) can no longer make the determinations required under [subsection (g)](#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](/usc/21/360eee.md?p=13) reduces risk or exposure is no longer valid, including if—
    - (A) a [tobacco product](/usc/21/321.md?p=rr-1) standard is established pursuant to [section 387g of this title](/usc/21/387g.md);
    - (B) an action is taken that affects the risks presented by other commercially marketed [tobacco products](/usc/21/321.md?p=rr-1) that were compared to the [product](/usc/21/360eee.md?p=13) 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)](#g-2-C-ii) or [subsection (i)](#i); or
  - (5) the applicant failed to meet a condition imposed under [subsection (h)](#h).
- (k) **Subchapter IV or V—** A [product](/usc/21/360eee.md?p=13) for which the [Secretary](/usc/21/321.md?p=d) has issued an order pursuant to [subsection (g)](#g) shall not be subject to subchapter IV or V.
- (l) **Implementing regulations or guidance—**
  - (1) **Scientific evidence—** Not later than 2 years after June 22, 2009, the [Secretary](/usc/21/321.md?p=d) shall issue regulations or guidance (or any combination thereof) on the scientific evidence required for assessment and ongoing review of modified risk [tobacco products](/usc/21/321.md?p=rr-1). 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)](#g) to show that a substantial reduction in morbidity or mortality among individual tobacco users occurs for [products](/usc/21/360eee.md?p=13) described in [subsection (g)(1)](#g-1) or is reasonably likely for [products](/usc/21/360eee.md?p=13) described in [subsection (g)(2)](#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](/usc/21/321.md?p=rr-1), 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](/usc/21/321.md?p=d) prior to the decision on renewal of a modified risk [tobacco product](/usc/21/321.md?p=rr-1); and
    - (F) establish a reasonable timetable for the [Secretary](/usc/21/321.md?p=d) to review an application under this section.
  - (2) **Consultation—** The regulations or guidance issued under [paragraph (1)](#l-1) shall be developed in consultation with the Institute of Medicine, and with the input of other appropriate scientific and medical experts, on the design and conduct of such studies and surveillance.
  - (3) **Revision—** The regulations or guidance under [paragraph (1)](#l-1) shall be revised on a regular basis as new scientific information becomes available.
  - (4) **New tobacco products—** Not later than 2 years after June 22, 2009, the [Secretary](/usc/21/321.md?p=d) shall issue a regulation or guidance that permits the filing of a single application for any [tobacco product](/usc/21/321.md?p=rr-1) that is a new [tobacco product](/usc/21/321.md?p=rr-1) under [section 387j of this title](/usc/21/387j.md) and which the applicant seeks to commercially market under this section.
- (m) **Distributors—** Except as provided in this section, no [distributor](/usc/21/387.md?p=7) may take any action, after June 22, 2009, with respect to a [tobacco product](/usc/21/321.md?p=rr-1) that would reasonably be expected to result in consumers believing that the [tobacco product](/usc/21/321.md?p=rr-1) or its smoke may present a lower risk of disease or is less harmful than one or more commercially marketed [tobacco products](/usc/21/321.md?p=rr-1), or presents a reduced exposure to, or does not contain or is free of, a substance or substances.

## Source credit

(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.)

## Notes

### Statutory Notes and Related Subsidiaries

### Modification of Deadlines for Secretarial Action

With respect to any time periods specified in an amendment by div. A of Pub. L. 111–31 that begin on June 22, 2009, within which the Secretary of Health and Human Services is required to carry out and complete specified activities, with certain limitations, the calculation of such time periods shall commence on the first day of the first fiscal quarter following the initial 2 consecutive fiscal quarters of fiscal year 2010 for which the Secretary has collected fees under section 387s of this title, and the Secretary may extend or reduce the duration of one or more such time periods, except that no such period shall be extended for more than 90 days, see section 6 of Pub. L. 111–31, set out as a note under section 387 of this title.