FDA WARNING_LETTER - www.desismokes.com

The FDA issued a Warning Letter to the operators of desismoke.com and wantsmokes.com, citing multiple violations related to the promotion and sale of tobacco products in the U.S. The FDA determined the websites are affiliated due to shared contact information.

The primary violations include: 1. **Modified Risk Tobacco Product Violations:** Products like "Gold Flake Lights" and "Bali-Hai Clove - Canela" (and other "mild" bidis) are promoted using descriptors such as "Lights" or "mild." These are considered modified risk tobacco products under section 911(b)(2)(A)(ii) of the FD&C Act and are adulterated under section 902(8) because they are offered without an FDA order. 2. **Flavored Cigarette Violations:** Products like "Bali-Hai Cherry - Cereja" and "Gold Flake Honeydew Blend" are advertised as flavored cigarettes. This violates section 907(a)(1)(A) of the FD&C Act, making them adulterated under section 902(5). If they lack characterizing flavors, they are misbranded under section 903(a)(1) or 903(a)(7)(A) for false or misleading labeling/advertising. 3. **Health Warning Statement Violations:** Smokeless tobacco products, specifically "BABA 12