FDA WARNING_LETTER - www.nefsak.com

The FDA Center for Tobacco Products issued a Warning Letter to Mr. Nassar after reviewing the website nefsak.com, which offers cigarette tobacco and roll-your-own tobacco products for sale to U.S. customers. These products, including "A Plus Rolling Tobacco" in flavors like Cherry, Vanilla, Honey Dew, Toffee Vanilla, and Apple, fall under FDA jurisdiction. The primary violation identified is that these flavored products are adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)) because they contain artificial or natural characterizing flavors, which are prohibited in cigarette tobacco and roll-your-own tobacco by section 907(a)(1)(A) of the FD&C Act. Additionally, the FDA stated that if these products do not actually contain a characterizing flavor, they are misbranded under sections 903(a)(1) or 903(a)(7)(A) of the FD&C Act due to false or misleading labeling and advertising. The letter mandates immediate correction of these violations, cessation of all violative promotion, advertising, sale, and distribution, and submission of a written response within 15 working days detailing corrective actions and a compliance plan. Failure to comply could result in severe enforcement actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, injunction, and refusal of admission for imported products.