FDA WARNING_LETTER - Amsterdam Tobacco Co - September 24, 2009

The FDA issued a Warning Letter to Amsterdam Tobacco Co. following a September 24, 2009, website review, which revealed the sale of flavored cigarette products to U.S. consumers. These products, including various vanilla, cherry, mint, grape, chocolate, strawberry, and clove flavored cigarettes, are classified as tobacco products under FFDCA section 201(rr). The primary concern is the marketing of cigarettes containing artificial or natural characterizing flavors, which violates the "special rule for cigarettes" under FFDCA section 907(a)(1)(A), effective September 22, 2009. Specifically, if the products contain these characterizing flavors, they are adulterated under FFDCA section 902(5). Conversely, if the products lack these flavors but are labeled as having them, they are misbranded under FFDCA section 903(a)(1) due to false and misleading labeling. The FDA mandates immediate corrective action, requiring the company to cease marketing and selling these products or relabel them for compliance. A written response detailing the compliance plan is required within 15 working days. Non-compliance may lead to regulatory actions such as seizure, injunction, or refusal of admission for imported products.