FDA WARNING_LETTER - www.djarumblack-clovecigarettes.com

The FDA's Center for Tobacco Products issued a Warning Letter to djarumblack-clovecigarettes.com after reviewing their website and determining that their cigarette products are offered for sale in the United States. The FDA identified several violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Firstly, several products are deemed adulterated under section 902(8) of the FD&C Act because they are promoted as "modified risk tobacco products" without an FDA order. This includes products described as "mild" (e.g., Djarum Black Menthol, Sampoerna Avolution) or having "reduced levels of substances" like "low tar and low nicotine" (e.g., Bentoel Star Mild, Djarum L.A Lights). Such descriptors classify them as modified risk tobacco products under section 911(b)(2)(A) of the FD&C Act, requiring an FDA order for promotion.

Secondly, numerous flavored cigarettes (e.g., Bentoel Biru, Djarum Black Cappuccino, Gudang Garam International) are adulterated under section 902(5) of the FD&C Act because they contain characterizing flavors other than tobacco or menthol, violating section 907(a)(1)(A). If these products do not contain a characterizing flavor, they are misbranded under section 903(a)(1) or 90