FDA WARNING_LETTER - [email protected]

The FDA Center for Tobacco Products issued a Warning Letter to http://www.cigarettes-shop.net after reviewing its website, which offers tobacco products for sale to U.S. customers. The letter identifies multiple violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Firstly, several cigarette products, including "Bond Lights" and "Marlboro Lights," are promoted using descriptors like "Lights" or "Super Lights." These are classified as modified risk tobacco products under FD&C Act section 911(b)(2)(A)(ii). Offering these products for sale without an FDA order in effect, as required by section 911(g), renders them adulterated under section 902(8) of the FD&C Act. Secondly, the website offers flavored cigarettes such as "Aroma Rich Apple" and "Kiss Super Slims Clubnichka." Section 907(a)(1)(A) of the FD&C Act prohibits artificial or natural characterizing flavors (other than tobacco or menthol) in cigarettes. Therefore, these flavored cigarettes are adulterated under section 902(5). Alternatively, if these products do not actually contain the advertised characterizing flavors, their labeling and advertising are considered false or misleading, making them misbranded under section 903(a)(1) or 903(a)(7)(A). The FDA requires immediate corrective actions, including discontinuing violative promotion and sales, and a written response within 15 working days detailing these actions and a compliance plan. Failure to comply could lead to civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, injunction, and refusal of admission for imported products.