FDA WARNING_LETTER - Mysnus AB - May 21, 2012

The FDA issued a Warning Letter to Mysnus AB after reviewing their website, http://www.mysnus.com, which offers smokeless tobacco products for sale to U.S. customers. The FDA determined that Mysnus AB's smokeless tobacco products are adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)). This adulteration stems from the promotion of these products as "modified risk tobacco products" (MRTPs) without an FDA order in effect, as required by section 911(a) of the FD&C Act (21 U.S.C. § 387k(a)). Specifically, the website displays promotional statements such as "All products are pasteurized, with low levels of Nitrosamines" for several snus products, and refers to others as "mild snus." These claims classify the products as MRTPs under section 911(b)(2)(A)(i) and (ii) of the FD&C Act. Mysnus AB is required to immediately correct these violations and submit a written response within 15 working days detailing corrective actions, including dates of discontinuing violative promotion, advertising, sale, and/or distribution. Failure to comply may lead to further FDA actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction, and refusal of admission for imported products.