21 U.S.C. § 387k — Modified risk tobacco products

(a) In general: No one may introduce or deliver a "modified risk tobacco product^*" into interstate commerce^* unless an approval order under subsection (g) is in effect for it.

(b) Definitions: (1) "Modified risk tobacco product" means any tobacco product sold or distributed for use in reducing harm or the risk of tobacco-related disease compared to other commercially marketed tobacco products. (2) Sold or distributed for that use — (A) A product counts as marketed this way if (i) its label^*, labeling^*, or advertising explicitly or implicitly claims it presents lower disease risk or is less harmful than other marketed products, contains a reduced level of, or reduced exposure to, some substance, or doesn't contain or is free of some substance; (ii) its label, labeling, or advertising uses "light," "mild," "low," or similar words; or (iii) after June 22, 2009, the manufacturer takes any other consumer-directed action (through media or otherwise, outside the label itself) that would reasonably lead consumers to believe the product is lower-risk, less harmful, or reduced-exposure. (B) No product is considered marketed this way except through those routes. (C) A smokeless tobacco^* product isn't considered a modified risk product solely because its label uses phrases like "smokeless tobacco," "not consumed by smoking," "does not produce smoke," "smokefree," "smoke-free," "without smoke," "no smoke," or "not smoke." (3) Effective date — The "light/mild/low" rule in (2)(A)(ii) takes effect 12 months after June 22, 2009, for products whose label already used those words on that date, tied to the product's manufacture date; but starting 30 days after that effective date, a manufacturer may not introduce into domestic commerce^* any product — regardless of manufacture date — that doesn't conform to (2)(A)(ii).

(c) Tobacco dependence products: A product meant to treat tobacco dependence, including smoking cessation, is not a modified risk tobacco product under this section if the FDA has approved it as a drug^* or device, subject to the drug/device requirements of subchapter V.

(d) Filing: Anyone may file an application with the Secretary^* for a modified risk tobacco product. It must include (1) a description of the proposed product and any proposed advertising and labeling; (2) the conditions for using the product; (3) the product's formulation; (4) sample labels and labeling; (5) all research documents (including underlying scientific information) about the product's effect on tobacco-related diseases and health conditions, both favorable and unfavorable, and relating to human health; (6) data on how consumers actually use the product; and (7) any other information the Secretary requires.

(e) Public availability: The Secretary must make the application public — except for trade secrets and other confidential commercial information — and must ask interested people to comment on the application and on the proposed label, labeling, and advertising.

(f) Advisory Committee: (1) The Secretary must refer every application under this section to the Tobacco Products Scientific Advisory Committee. (2) The Committee must report its recommendations within 60 days of referral.

(g) Marketing: (1) Modified risk products — Except as paragraph (2) allows, the Secretary may only order that a modified risk product be marketed if the applicant proves that, as actually used by consumers, it will (A) significantly reduce harm and disease risk to individual users, and (B) benefit the health of the population as a whole, counting both users and non-users. (2) Special rule for certain products — The Secretary may instead approve a narrower product if the applicant proves (A) approval would promote public health; the product's modified-risk claim is limited to a reduced or eliminated substance, or reduced exposure to a substance in smoke; long-term epidemiological studies aren't available and can't feasibly be obtained to meet paragraph (1)'s standard; and the short-term scientific evidence available shows a measurable, substantial reduction in illness or death among individual users is reasonably likely in future studies; and (B) additionally, that the exposure reduction is substantial and the substance is genuinely harmful and the product as used delivers the claimed reduced level; the product doesn't meaningfully raise exposure to other harmful substances compared to similar products on the market (or any increase is minimal and outweighed by the overall reduction); consumer-perception testing shows people won't be misled into thinking the product is proven less harmful or lower-risk; and approval would benefit the health of the population as a whole. (C) Conditions of marketing — An order under this special rule lasts at most 5 years, renewable if the Secretary finds the requirements still met based on a new application; it requires the applicant to agree to conduct postmarket surveillance and studies, submitted to the Secretary under an approved protocol, and those results must be submitted annually. (3) Basis — These determinations rest on the applicant's scientific evidence plus any other evidence available to the Secretary. (4) Benefit to health of individuals and of population as a whole — The Secretary must weigh the product's relative health risk to individuals; whether users who'd otherwise quit would instead switch to it; whether non-users would start using it; how it compares to FDA-approved smoking-cessation products; and comments and data submitted by interested people.

(h) Additional conditions for marketing: (1) The Secretary must require that advertising and labeling for a modified risk product let the public understand the modified-risk information and its significance within the context of tobacco's overall health effects. (2) Comparative claims — (A) The Secretary may require that any claim comparing the product to other marketed tobacco products use a representative product of that type (for example, the average of the top 3 brands). (B) The Secretary may also require that the percent or fraction of change, the identity of the reference product, and a quantitative comparison of the reduced substance be stated near the most prominent claim. (3) Label disclosure — (A) The Secretary may require disclosure on the label of other substances in the product, or substances the product's use may create, that could affect disease risk or increase other health risks. (B) If the conditions of use affect the product's risk to health, the Secretary may require labeling of those use conditions. (4) An order under subsection (g)(1) is effective for a specified period of time. (5) Advertising — The Secretary may require an approved product to meet advertising and promotion requirements.

(i) Postmarket surveillance and studies: (1) The Secretary must require an approval holder to conduct postmarket surveillance and studies to track the order's impact on consumer perception, behavior, and health, to let the Secretary check the accuracy of the original findings, and to provide other information the Secretary determines is necessary; results must be submitted annually. (2) Surveillance protocol — Within 30 days of being told to conduct surveillance, the applicant must submit a study protocol for the Secretary's approval. Within 60 days of receiving it, the Secretary must decide whether the proposed lead investigator is sufficiently qualified and whether the protocol will collect the necessary data.

(j) Withdrawal of authorization: After an opportunity for an informal hearing^*, the Secretary must withdraw an order under subsection (g) if the Secretary determines (1) new information means the applicant can no longer make, or the Secretary can no longer support, the required demonstrations; (2) the application omitted material information or included an untrue material statement; (3) the reduced-risk or reduced-exposure representation is no longer valid — including because a product standard was established under section 387g, an action changed the risks of the tobacco products compared against, or postmarket surveillance or studies show the order no longer protects public health; (4) the applicant failed to conduct or submit the required postmarket surveillance or studies; or (5) the applicant failed to meet a condition imposed under subsection (h).

(k) Subchapter IV or V: A product with an order under subsection (g) is not also subject to the tobacco-drug (subchapter IV) or drug/device (subchapter V) requirements.

(l) Implementing regulations or guidance: (1) Scientific evidence — Within 2 years of June 22, 2009, the Secretary must issue regulations or guidance on the scientific evidence needed to assess and continually review modified risk tobacco products. These must, to the extent adequate science exists, (A) set minimum standards for studies needed before an order is issued, showing a substantial reduction in illness or death for paragraph (g)(1) products, or a reasonably likely such reduction for paragraph (g)(2) products; (B) include validated biomarkers, intermediate clinical endpoints, and other feasible outcome measures; (C) set minimum standards for postmarket studies, covering regular and long-term health-outcome and mortality assessments, intermediate clinical endpoints, consumer harm-perception, and impact on quitting and new tobacco use; (D) set minimum standards for required postmarket surveillance, including ongoing consumer-perception assessments; (E) require that study and surveillance data reach the Secretary before any renewal decision; and (F) set a reasonable review timetable. (2) Consultation — These regulations or guidance must be developed with the Institute of Medicine and other appropriate scientific and medical experts. (3) Revision — They must be revised regularly as new science emerges. (4) New tobacco products — Within 2 years of June 22, 2009, the Secretary must also issue a regulation or guidance letting an applicant file a single combined application for a product that is both a "new tobacco product" under section 387j and a modified risk tobacco product under this section.

(m) Distributors: Except as this section allows, no distributor may, after June 22, 2009, take any action that would reasonably lead consumers to believe a tobacco product or its smoke presents lower disease risk, is less harmful, or presents reduced exposure to, or is free of, a substance.