Scientific Standards for Studies on Modified Risk Tobacco Products (2012) / Chapter Skim
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Appendix A: Section 911 of the Family Smoking Prevention and Tobacco Control Act of 2009
Appendix A: Section 911 of the Family Smoking Prevention and Tobacco Control Act of 2009
Pages 247-256
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From page 247... ...
MODIFIED RISK TOBACCO PRODUCT- The term ‘modified risk tobacco product' means any tobacco product that is sold or dis tributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products.
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From page 248... ...
the label, labeling, or advertising of which uses the descrip tors ‘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 the date of enactment of the Family Smoking Prevention and Tobacco Control Act, 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 com mercially marketed tobacco products, or presents a reduced exposure to, or does not contain or is free of, a substance or substances.
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From page 249... ...
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 deter mines that the applicant has demonstrated that such product, as it is actually used by consumers, will- "(A)
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From page 250... ...
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 mea surable reduction in overall morbidity and mortality among individual tobacco users;
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From page 251... ...
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)
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From page 252... ...
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 under stand 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.
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From page 253... ...
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;
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From page 254... ...
SCIENTIFIC EVIDENCE- Not later than 2 years after the date of enactment of the Family Smoking Prevention and Tobacco Control Act, the Secretary shall issue regulations or guidance (or any com bination thereof) on the scientific evidence required for assessment and ongoing review of modified risk tobacco products.
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From page 255... ...
"(m) Distributors- Except as provided in this section, no distributor may take any action, after the date of enactment of the Family Smoking Prevention and Tobacco Control Act, 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 con tain or is free of, a substance or substances.
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