Napoli Tobacco Trading L.L.C. – FDA Warning Letter

The FDA Center for Tobacco Products reviewed websites http://www.cigarettesguru.com and http://www.dutyfreecigarettes.biz, determining that cigarette products offered for sale to U.S. customers are tobacco products under section 201(rr) of the FD&C Act. The FDA found several products, specifically Oscar Apple Flavor Nano, Oscar Chocolate Flavor Nano, and Oscar Strawberry Flavor Nano, to be adulterated under section 902(5) of the FD&C Act or misbranded under section 903(a)(1) or 903(a)(7)(A) of the FD&C Act.

The violation stems from these products purporting to contain a natural or artificial characterizing flavor, which is prohibited for cigarettes under section 907(a)(1)(A) of the FD&C Act. If these products do not contain a characterizing flavor, their labeling or advertising is considered false or misleading, leading to misbranding.

The letter requires immediate correction of these violations and similar issues, ensuring all tobacco products, labeling, and advertising comply with the FD&C Act. Failure to comply may result in civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. Adulterated and misbranded products offered for import are subject to detention. A written response detailing corrective actions, including discontinuation dates and a compliance plan, is required within 15 working days.