FDA WARNING_LETTER - http://www.eu-cigs.com

The FDA's Center for Tobacco Products issued a Warning Letter to the operator of http://www.eu-cigs.com after determining that cigarette products, including "Davidoff Ultra Lights," "Marlboro Lights Menthol," "Parliament Lights/Aqua Blue," and "Parliament Extra Lights/Silver Blue," were offered for sale or distribution to U.S. customers. These products are classified as tobacco products under section 201(rr) of the FD&C Act. The primary violation identified is that these cigarettes are modified risk tobacco products, as their labeling and advertising use descriptors such as "Ultra Lights" or "Lights," which fall under section 911(b)(2)(A)(ii) of the FD&C Act. Under section 911(a), no modified risk tobacco product may be introduced into interstate commerce without an FDA order in effect under section 911(g). Consequently, the sale or distribution of these products without such an order renders them adulterated under section 902(8) of the FD&C Act. The firm is required to immediately correct these violations, discontinue all violative labeling, advertising, sale, and distribution, and submit a written response within 15 working days detailing corrective actions and a compliance plan. Failure to comply may result in severe enforcement actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, injunction, and refusal of admission for imported products.