Langit Bali – FDA Warning Letter, Oct 13, 2009

The FDA reviewed the websites www.clovecigarettesoutlet.com, www.clovecigarettesstore.com, www.indoclovecigarettes.com, www.kretek-cigarettes.com, www.theclovecigarettes.com, www.salecheapcigarettes.com, and www.saleclovecigarettes.com on October 13, 2009. These websites offer Djarum, Bentoel, Wismilak, Sampoerna, and Gudang Garam clove cigarettes for sale to U.S. customers.

Under FFDCA section 201(rr), these are tobacco products. The FDA determined these products are adulterated and/or misbranded because they are represented as cigarettes containing a characterizing clove flavor. FFDCA section 907(a)(1)(A) prohibits cigarettes from containing artificial or natural flavors (other than tobacco or menthol) or herbs/spices, including clove, that are characterizing flavors. This "special rule for cigarettes" became effective September 22, 2009.

If the products contain a characterizing clove flavor, they are adulterated under FFDCA section 902(5) for failing to comply with section 907(a)(1)(A). If they do not contain such a flavor, they are misbranded under FFDCA section 903(a)(1) because their labeling falsely represents them