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U.S. Department of Health and Human Services

Tobacco Products

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Establishing that a Tobacco Product was Commercially Marketed in the United States as of Feb 15, 2007

 

April 2011

 

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This draft guidance provides information on how a manufacturer (you) may establish that your tobacco product was commercially marketed in the United States as of February 15, 2007. A tobacco product that was commercially marketed in the United States as of February 15, 2007, is not subject to the premarket requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and may serve as the predicate tobacco product in a 905(j) report (demonstrating substantial equivalence) for a new tobacco product (section 905(j)(1)(A)(i) of the FD&C Act, 21 U.S.C. 387e(j)(1)(A)(i); 910(a)(2)(A)(i)(I) of the FD&C Act, 21 U.S.C. 387j(a)(2)(A)(i)(I)). We interpret the phrase “as of February 15, 2007,” as meaning that the tobacco product was commercially marketed in the United States on February 15, 2007.

Section 201(rr) of the FD&C Act defines a tobacco product as “any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product).” (21 U.S.C. 321(rr)). Section 910 of the FD&C Act sets out premarket requirements for new tobacco products (21 U.S.C. 387j). The term “new tobacco product” is defined as “(1) any tobacco product (including those products in test markets) that was not commercially marketed in the United States as of February 15, 2007; or (2) any modification (including a change in design, any component, any part, or any constituent, including a smoke constituent, or in the content, delivery or form of nicotine, or any other additive or ingredient) of a tobacco product where the modified product was commercially marketed in the United States after February 15, 2007” (section 910(a)(1) of the FD&C Act, 21 U.S.C. 387j(a)(1)). 


  

 

 

 

 

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