FDA WARNING_LETTER - MyCloveCigarettes.com - October 13, 2009

The FDA issued a Warning Letter to http://www.myclovecigarettes.com following an October 13, 2009, website review, identifying the sale of various filtered and unfiltered clove cigarettes to U.S. consumers. These products, including brands like Bentoel Biru and Djarum Black, are classified as tobacco products under FFDCA section 201(rr). The core issue is that these cigarettes are represented as containing clove, a characterizing flavor. Under the Family Smoking Prevention and Tobacco Control Act (FSPTCA), cigarettes cannot contain artificial or natural characterizing flavors (other than tobacco or menthol) after September 22, 2009. Consequently, if the products indeed contain clove as a characterizing flavor, they are adulterated under FFDCA section 902(5) for violating section 907(a)(1)(A). Conversely, if they do not contain such a flavor, they are misbranded under FFDCA section 903(a)(1) due to false and misleading labeling. The firm must immediately cease marketing and selling these products or take corrective action to achieve compliance. A written response detailing the plan for discontinuing sales or relabeling is required within 15 working days. Non-compliance could lead to regulatory actions like seizure or injunction, and import refusal for foreign firms.