FDA WARNING_LETTER - Clove Cigarettes Shop - October 06, 2009

The FDA reviewed clovecigaretteshop.com on October 6, 2009, and found the website offering various flavored cigarette products for sale to U.S. consumers. These products, including Absolute Mild, Djarum Black, and Sampoerna A Mild, are considered tobacco products under section 201(rr) of the FFDCA.

The primary violation is that these products are represented as cigarettes containing artificial or natural characterizing flavors (e.g., clove, tea, cappuccino, orange), which is prohibited by section 907(a)(1)(A) of the FFDCA, effective September 22, 2009. If the products contain these characterizing flavors, they are adulterated under section 902(5) for failing to comply with the "special rule for cigarettes." If they do not contain such flavors, but their labeling claims they do, they are misbranded under section 903(a)(1) due to false and misleading labeling.

The FDA requires immediate cessation of marketing and sale of these products or other actions to achieve compliance. Failure to correct this violation may result in regulatory actions, including seizure and injunction. As the company is not U.S.-based, adulterated or misbranded products are subject to detention and refusal of admission. The FDA will notify officials in the company's operating country. A written response detailing the plan for discontinuing sales or rel