www.smoko.biz – FDA Warning Letter

The FDA Center for Tobacco Products reviewed the website http://www.smoko.biz and determined that cigarette products offered for sale to U.S. customers are in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The violations include: 1. **Modified Risk Tobacco Product Violations:** Products labeled or advertised with descriptors like "Light" or "Super Light" (e.g., Donskoy Tabak "Donskoy Tabak Lights Cigarettes," Marlboro Silver "Marlboro Silver Super Light Cigarettes") are considered modified risk tobacco products. These are sold without a required FDA order under section 911(a) of the FD&C Act, rendering them adulterated under section 902(8).

2. **Flavored Cigarette Violations:** Several cigarette products (e.g., Aroma Rich Apple, Esse Aura Green Apple, Kiss Strawberry Superslims, Richmond Cherry) are offered for sale purporting to contain artificial or natural characterizing flavors. This violates section 907(a)(1)(A) of the FD&C Act, which prohibits such flavors in cigarettes, making these products adulterated under section 902(5). If these products do not contain characterizing flavors, their labeling or advertising is false or misleading, making them misbranded under section 903(a)(1) or 903(a)(7)(A).