21 U.S.C. § 387k (FOOD AND DRUGS)
§ 387k. Modified risk tobacco products
(a) In general
No person may introduce or deliver for introduction into interstate commerce any modified risk tobacco product unless an order issued pursuant to subsection (g) is effective with respect to such product.
(b) Definitions
In this section:
(1) Modified risk tobacco product
The term “modified risk tobacco product” means any tobacco product that is sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products.
(2) Sold or distributed
(A) In general
With 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
No tobacco product 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”, except as described in subparagraph (A).
(C) Smokeless tobacco product
No smokeless tobacco product 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” solely because its label, labeling, or advertising uses the following phrases to describe such product and its use: “smokeless tobacco”, “smokeless tobacco product”, “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) shall take effect 12 months after June 22, 2009, for those products whose label, labeling, 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 shall not introduce into the domestic commerce of the United States any product, irrespective of the date of manufacture, that is not in conformance with paragraph (2)(A)(ii).
(c) Tobacco dependence products
A product that is intended to be used for the treatment of tobacco dependence, including smoking cessation, is not a modified risk tobacco product under this section if it has been approved as a drug or device by the Food and Drug Administration and is subject to the requirements of subchapter V.
(d) Filing
Any 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
The Secretary shall make the application described in subsection (d) publicly available (except matters in the application which are trade secrets or otherwise confidential, commercial information) and shall request comments by interested persons on the information contained in the application and on the label, labeling, and advertising accompanying such application.
(f) Advisory Committee
(1) In general
The Secretary shall refer to the Tobacco Products Scientific Advisory Committee any application submitted under this section.
(2) Recommendations
Not later than 60 days after the date an application is referred to the Tobacco Products Scientific Advisory Committee under paragraph (1), the Advisory Committee shall report its recommendations on the application to the Secretary.
(g) Marketing
(1) Modified risk products
Except 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 general
The 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 required
To 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
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 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 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 to review the accuracy of the determinations upon which the order was based in accordance with a protocol approved by the Secretary.
(iii) Annual submission
The results of such postmarket surveillance and studies described in clause (ii) shall be submitted annually.
(3) Basis
The 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 whole
In 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
The Secretary shall require for the marketing of a product under this section that any advertising or labeling concerning modified risk products 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.
(2) Comparative claims
(A) In general
The Secretary may require for the marketing of a product under this subsection that a claim comparing a tobacco product to 1 or more other commercially marketed tobacco products shall compare the tobacco product to a commercially marketed tobacco product that is representative of that type of tobacco product on the market (for example the average value of the top 3 brands of an established regular tobacco product).
(B) Quantitative comparisons
The Secretary may also require, for purposes of subparagraph (A), that the percent (or fraction) of change and identity of the reference tobacco product 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 may require the disclosure on the label of other substances in the tobacco product, or substances that may be produced by the consumption of that tobacco product, 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.
(B) Conditions of use
If the conditions of use of the tobacco product may affect the risk of the product to human health, the Secretary may require the labeling of conditions of use.
(4) Time
An order issued under subsection (g)(1) shall be effective for a specified period of time.
(5) Advertising
The Secretary may require, with respect to a product for which an applicant obtained an order under subsection (g)(1), that the product comply with requirements relating to advertising and promotion of the tobacco product.
(i) Postmarket surveillance and studies
(1) In general
The Secretary shall require, with respect to a product for which an applicant obtained an order under subsection (g)(1), that the applicant conduct postmarket surveillance and studies for such a tobacco product to determine the impact of the order issuance on consumer perception, behavior, and health, to enable the Secretary to review the accuracy of the determinations upon which the order was based, and to provide information that the Secretary determines is otherwise necessary regarding the use or health risks involving the tobacco product. The results of postmarket surveillance and studies shall be submitted to the Secretary on an annual basis.
(2) Surveillance protocol
Each applicant required to conduct a surveillance of a tobacco product under paragraph (1) shall, within 30 days after receiving notice that the applicant is required to conduct such surveillance, submit, for the approval of the Secretary, a protocol for the required surveillance. The Secretary, 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 as necessary to protect the public health.
(j) Withdrawal of authorization
The 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
A product for which the Secretary has issued an order pursuant to subsection (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 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
The regulations or guidance issued under paragraph (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) 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 shall issue a regulation or guidance that permits the filing of a single application for any tobacco product that is a new tobacco product under section 387j of this title and which the applicant seeks to commercially market under this section.
(m) Distributors
Except as provided in this section, no distributor may take any action, after June 22, 2009, with respect to a tobacco product that would reasonably be 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.
(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.)
heading: Statutory Notes and Related Subsidiaries
heading: Modification of Deadlines for Secretarial Action
text: 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.