FDA WARNING_LETTER - Amarico SA

This FDA Warning Letter addresses multiple violations concerning the sale and distribution of tobacco products to U.S. customers via several websites, including www.cigarettes-enligne.biz and www.cigarettes.all-cigs.com. The products, including cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco, fall under FDA jurisdiction.

Key violations include: 1. **Modified Risk Tobacco Products (MRTP) Violations:** Cigarettes labeled with descriptors like "Lights," "low tar," or "lower tar" (e.g., Ardath Lights, Cigaronne Exclusive Slims Lights, Lambert & Butler Gold, Silk Cut) are considered MRTPs. These were sold without the required FDA order under section 911(a) of the FD&C Act, rendering them adulterated under section 902(8). 2. **Flavored Cigarette and Tobacco Violations:** Numerous cigarette and cigarette tobacco/roll-your-own tobacco products (e.g., Bentoel clove, Kiss strawberry, Domingo Mango, Mac Baren Cherry Choice) are offered with characterizing flavors (other than tobacco or menthol). This violates section 907(a)(1)(A) of the FD&C Act, making them adulterated under section 902(5). If they do not contain a characterizing flavor, their labeling/advertising is false or misleading, misbranding them under section 90