FDA WARNING_LETTER - AZCigs.com

The FDA issued a Warning Letter to the operator of http://www.azcigs.biz, http://www.azcigs.com, and http://www.azcigs.net after reviewing their websites and determining that cigarette products were offered for sale to U.S. customers. The FDA found that several cigarette products, including those labeled "Lights," "Ultra Lights," "Super Lights," "Premium Lights," or "Extra Lights," are promoted as modified risk tobacco products. Under section 911(b)(2) of the FD&C Act, such descriptors classify them as modified risk tobacco products. The firm is in violation of section 911(a) of the FD&C Act because these products are introduced into interstate commerce without an FDA order in effect under section 911(g). Consequently, these products are deemed adulterated under section 902(8) of the FD&C Act. The FDA requires immediate corrective actions to bring all tobacco products into compliance, including discontinuing the violative promotion, advertising, sale, and distribution. A written response detailing corrective actions and dates of discontinuation must be submitted within 15 working days. Failure to comply may result in further FDA actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and injunction, with imported adulterated products subject to detention.