A tobacco product with a label, labeling, or advertising that uses the descriptor “light,” “mild,” or “low,” or a similar descriptor, is a “modified risk tobacco product” under section 911(b)(2)(A)(ii) of the FD&C Act (21 U.S.C. 387k(b)(2)(A)(ii)). A tobacco product is also considered a “modified risk tobacco product” under section 911(b)(2)(A)(i) of the FD&C Act (21 U.S.C. 387k(b)(2)(A)(i)) if its label, labeling, or advertising explicitly or implicitly represents that (1) the product presents a lower risk of tobacco related disease or is less harmful than one or more other commercially marketed tobacco products (2) the product or its smoke contains a reduced level of a substance or presents a reduced exposure to a substance or (3) the product or its smoke does not contain or is free of a substance. Under section 911(a) of the FD&C Act (21 U.S.C. 387k(a)), no person may introduce or deliver for introduction into interstate commerce any modified risk tobacco product without an FDA order in effect under section 911(g) of the FD&C Act (21 U.S.C. 387k(g)). A product that is in violation of section 911(a) of the FD&C Act (21 U.S.C. 387k(a)) is adulterated under section 902(8) of the FD&C Act (21 U.S.C. 387b(8)). Because the website uses the descriptor “Light,” or similar descriptors for the above listed products and includes claims that the above products contain a reduced level of a substance, these products are modified risk tobacco products. Because these products are offered for sale to customers in the United States without an appropriate FDA order in effect under section 911(g) of the FD&C Act (21 U.S.C. 387k(g)), these products are adulterated under section 902(8) of the FD&C Act (21 U.S.C. 387b(8)).

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