123STA T . 1 8 13 PUBLIC LA W 111 – 31 —J U NE 22 , 2 0 0 9tha t wouldber ea s o n abl y e xp e c ted to result i n con - su m ers belie v in g that the tobacco product or its smo k e may present a lower risk o f disease or is less harmful than one or more commercially marketed tobacco prod- ucts , or presents a reduced exposure to, or does not contain or is free of, a substance or substances .‘ ‘ (B)LIM I TA TI ON . —N o tobacco product shall be consid- ered 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 ) S MO KEL E S STO B A C CO PR O DU CT.—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 con- sumed by smoking’, ‘does not produce smoke’, ‘smokefree’, ‘smoke-free’, ‘without smoke’, ‘no smoke’, or ‘not smoke’. ‘‘( 3 ) EF FECTI V E DATE.— T he provisions of paragraph ( 2 )(A)(ii) shall take effect 1 2 months after the date of enactment of the F amily Smoking P revention and Tobacco Control Act for those products whose label, labeling, or advertising contains the terms described in such paragraph on such date of enact- ment. The effective date shall be with respect to the date of manufacture, provided that, in any case, beginning 3 0 days after such effective date, a manufacturer shall not introduce into the domestic commerce of the U nited States any product, irrespective of the date of manufacture, that is not in conform- ance with paragraph (2)(A)(ii). ‘‘(c) TOBACCO D EPENDENCE 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 sub j ect to the re q uire- ments of chapter V . ‘‘(d) FILIN G .—Any person may file with the Secretary an applica- tion 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 informa- tion) 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 AVAILABILIT Y .—The Secretary shall make the application described in subsection (d) publicly available (except Com m entp e ri o d.
