FDA WARNING_LETTER - Gasoline Stations Unlimited #10, Inc. d/b/a University 76

The FDA Center for Tobacco Products issued a Warning Letter to Kanwar Bagga after reviewing the website http://www.university76.com, which offered cigarette products for sale in the United States. The FDA determined that several cigarette products, including Natural American Spirit, Marlboro, and Parliament, are adulterated under section 902(8) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). These products are classified as "modified risk tobacco products" (MRTPs) under section 911(b)(2)(A)(ii) of the FD&C Act because their labeling or advertising uses the descriptor "Light." Under section 911(a) of the FD&C Act, MRTPs cannot be introduced into interstate commerce without an FDA order in effect under section 911(g). The firm's sale and distribution of these "Light" branded cigarettes without the required FDA order constitutes a violation, rendering the products adulterated. The FDA demands immediate corrective actions, including discontinuing the violative labeling, advertising, sale, and distribution of these tobacco products. A written response detailing corrective actions and a compliance plan must be submitted within 15 working days. Failure to comply may result in severe enforcement actions, such as civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, injunction, and refusal of admission for imported products.