FDA WARNING_LETTER - Joanne M. Tovar

The FDA's Center for Tobacco Products reviewed the website http://www.philipmorris-products.net and found that cigarette products offered for sale to U.S. customers are in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Several products are deemed adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)) because they are promoted as "modified risk tobacco products" (e.g., "Lights," "Ultra Lights") without an FDA order, violating section 911(a) (21 U.S.C. § 387k(a)). Examples include "Marlboro Gold" (Lights) and "Marlboro Silver" (Ultra Lights).

Additionally, flavored cigarettes like "Aroma Rich Apple" and "Richmond Cherry" are offered for sale, which is prohibited under section 907(a)(1)(A) of the FD&C Act (21 U.S.C. § 387g(a)(1)(A)) for characterizing flavors other than tobacco or menthol. These products are adulterated under section 902(5) (21 U.S.C. § 387b(5)). If they do not contain characterizing flavors, they are misbranded under section 903(