FDA WARNING_LETTER - www.AdilacCoffee.com

The FDA Center for Tobacco Products issued a Warning Letter to Adila Coffee regarding cigarette products sold on their website, www.adilacoffee.com, offered to U.S. customers. The FDA determined these products are tobacco products under the FD&C Act.

The primary violations include: 1. **Modified Risk Tobacco Product Violations:** Products like "Gudang Garam Surya Slim Merah" ("Mild") and "Clas Mild" ("Low Tar and Nicotine") are promoted with descriptors such as "mild" or "low," or represent reduced substance levels. This classifies them as modified risk tobacco products under section 911(b)(2)(A) of the FD&C Act. Introducing these products into interstate commerce without an FDA order under section 911(g) renders them adulterated per section 902(8).

2. **Flavored Cigarette Violations:** Numerous clove-flavored cigarettes, including "Dji Sam Soe," "Djarum 76," and "Sampoerna," are offered for sale. Section 907(a)(1)(A) of the FD&C Act prohibits cigarettes from containing characterizing flavors other than tobacco or menthol. These flavored cigarettes are adulterated under section 902(5). If they do not contain a characterizing flavor, their labeling/advertising is false or misleading, making them misbranded under section 903