FDA WARNING_LETTER - Indonesia Clove Cigarettes - October 14, 2009

The FDA reviewed www.indonesiacigarettes.com on October 14, 2009, finding 65 filtered and 13 unfiltered clove cigarette products offered for sale to U.S. consumers. These products, including "Asam Garam 12" and "Djarum Black Cappuccino," are defined as tobacco products under FFDCA section 201(rr).

The FDA determined these products are adulterated and/or misbranded. Under FFDCA section 907(a)(1)(A), effective September 22, 2009, cigarettes cannot contain artificial or natural flavors (other than tobacco or menthol) that are characterizing flavors. The website represents these products as containing clove, a characterizing flavor. If they contain clove as a characterizing flavor, they are adulterated under FFDCA section 902(5) for failing to comply with section 907(a)(1)(A). If they do not contain clove as a characterizing flavor, they are misbranded under FFDCA section 903(a)(1) due to false and misleading labeling.

The company must immediately cease marketing and selling these products or take other corrective action to achieve compliance. Failure to comply may result in FDA regulatory actions, including seizure and injunction. Adulterated or misbranded tobacco products offered for import into the U.S. are subject to detention and refusal. The