FDA WARNING_LETTER - CoffeeCigarette.com

The FDA's Center for Tobacco Products reviewed coffeecigarette.com and found its cigarette products offered for sale to U.S. customers are tobacco products under the FD&C Act. Several products are adulterated under section 902(8) for being promoted as modified risk tobacco products (MRTPs) without an FDA order. This includes products described as "mild" (e.g., Gudang Garam Surya Slim, Sampoerna A Flava) or having "reduced levels of substances" (e.g., Bentoel Star Mild as "low tar and nicotine"). Under section 911(b)(2)(A), descriptors like "light," "mild," or "low," or claims of reduced substances/harm, classify a product as an MRTP, requiring an FDA order under section 911(g).

Additionally, numerous flavored cigarettes (e.g., Djarum Black, Gudang Garam International, Sampoerna A Mild) are adulterated under section 902(5) because section 907(a)(1)(A) prohibits characterizing flavors (other than tobacco or menthol) in cigarettes. If these products lack a characterizing flavor, they are misbranded under section 903(a)(1) due to false and misleading labeling.

The company must immediately correct these violations and ensure all products comply with the FD&C Act. Failure to comply may result in