FDA WARNING_LETTER - www.cheapindonesiacigarettes.com - November 07, 2012

The FDA Center for Tobacco Products reviewed the website http://www.cheapindonesiacigarettes.com, determining that cigarette products offered for sale to U.S. customers are tobacco products under section 201(rr) of the FD&C Act and subject to FDA jurisdiction. The review revealed that several products, including Ardath, Bentoel, and Gudang Garam, are either adulterated or misbranded. Specifically, products purported to contain artificial or natural characterizing flavors (other than tobacco or menthol) violate section 907(a)(1)(A) and are thus adulterated under section 902(5) of the FD&C Act. Alternatively, if these cigarettes lack a characterizing flavor, their labeling is false and misleading by representing clove as a characterizing flavor, rendering them misbranded under section 903(a)(1). The firm is required to immediately correct these violations and ensure all tobacco products comply with the FD&C Act. A written response detailing corrective actions, including dates of discontinuing violative sales and promotion, must be submitted within 15 working days. Failure to comply may lead to further FDA actions such as civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, injunction, and detention or refusal of admission for imported products.