FDA WARNING_LETTER - www.smoke-cash.com

The FDA's Center for Tobacco Products issued a Warning Letter to smoke-cash.com after reviewing their website and determining that their cigarette products are offered for sale to U.S. customers. The FDA found that several products are 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., using "Lights" and "Ultra Lights" descriptors) without an FDA order in effect, violating section 911(a). Additionally, specific flavored cigarettes, including "Aroma Rich Apple," "Aroma Rich Rum Cherry," and "Kiss Super Slims Fresh Apple 100s," are adulterated under section 902(5) (21 U.S.C. § 387b(5)) for containing characterizing flavors other than tobacco or menthol, which is prohibited by section 907(a)(1)(A). If these products do not contain characterizing flavors, they are misbranded under sections 903(a)(1) or 903(a)(7)(A) for false and misleading labeling. The firm must immediately correct these violations and submit a written response within 15 working days detailing corrective actions, dates of discontinuance, and a compliance plan. Failure to comply may result in civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, injunction, and detention of imported products.