FDA WARNING_LETTER - CloveDealer Imports Co Ltd.

The FDA Center for Tobacco Products issued a Warning Letter to Mr. Januar regarding the website http://www.clovedealer.com, which offers cigarette products for sale in the United States. The FDA determined these products are tobacco products under section 201(rr) of the FD&C Act.

Several cigarette products are deemed adulterated under section 902(8) of the FD&C Act because they are modified risk tobacco products sold without an FDA order. This includes products described as "light" or "mild" (e.g., Sampoerna Avolution Menthol, Sampoerna Avolution, Marlboro Black Menthol) or those claiming reduced levels of substances like "low tar low nicotine" (e.g., LA Lights, Sampoerna A Mild 12). Such descriptors classify them as modified risk tobacco products under section 911(b)(2)(A)(ii) or 911(b)(2)(A)(i) of the FD&C Act, requiring an FDA order for sale under section 911(a).

Additionally, numerous cigarette products are adulterated under section 902(5) or misbranded under section 903(a)(1) or 903(a)(7)(A) of the FD&C Act due to purporting to contain a natural or artificial characterizing flavor. Examples include Apache Clove, Djarum Black Capp