21 USC 387k - Modified risk tobacco products

U.S Code last checked for updates: Oct 16, 2024

§ 387k.

Modified risk tobacco products

(a)

In general

(b)

Definitions

In this section:

(1)

Modified risk tobacco product

(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

(C)

Smokeless tobacco product

(3)

Effective date

(c)

Tobacco dependence products

(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

(f)

Advisory Committee

(1)

In general

(2)

Recommendations

(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

(ii)

Agreements by applicant

(iii)

Annual submission

(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

(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 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

(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

(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