FDA WARNING_LETTER - CloveCigarettesMart.com - October 13, 2009

The FDA issued a Warning Letter to clovecigarettesmart.com after a website review on October 13, 2009, identified the sale of various filtered and unfiltered clove cigarettes to U.S. consumers. These products are classified as tobacco products under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (FFDCA). The FDA determined that the products are either adulterated or misbranded due to their characterizing clove flavor, which violates the Family Smoking Prevention and Tobacco Control Act (FSPTCA).

Specifically, if the products contain clove as a characterizing flavor, they are adulterated under FFDCA section 902(5) for failing to comply with the special rule for cigarettes in section 907(a)(1)(A), which prohibits artificial or natural flavors (other than tobacco or menthol) that characterize the product, effective September 22, 2009. Alternatively, if the products do not contain a characterizing clove flavor, they are misbranded under FFDCA section 903(a)(1) because their website labeling is false and misleading by representing them as having such a flavor.

The firm must immediately cease marketing and selling these products to the United States or take other actions to achieve compliance. A written response detailing the plan for discontinuing sales or relabeling is required within 15 working days. Failure to comply may lead to regulatory actions like seizure and injunction, and products offered for import will be detained.