§ 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 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—
(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;
(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
(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—
(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—
(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;
(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;
(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.
(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;
(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.
(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—
(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;
(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.