FDA WARNING_LETTER - Janis Larsen

The FDA issued a Warning Letter to Janis Larsen following a review of the website http://www.discount-cigs.net, which offers tobacco products for sale to U.S. customers. The FDA determined that several cigarette products, including “Davidoff Slim Gold 100’s (Lights),” “Davidoff One (Ultra Lights),” “Winston (Lights) Blue,” and “Winston Silver Super Lights,” are adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)). This is because they are promoted as modified risk tobacco products using descriptors like “Light” or “Ultra Light” without an FDA order in effect, as required by section 911(a) and (g) of the FD&C Act. Additionally, “Kiss Superslims Fresh Apple” cigarettes are deemed adulterated under section 902(5) (21 U.S.C. § 387b(5)) due to containing a characterizing flavor other than tobacco or menthol, which is prohibited by section 907(a)(1)(A) of the FD&C Act. Alternatively, if they lack a characterizing flavor, they are misbranded under section 903(a)(1) (21 U.S.C. § 387c(a)(1)) for false and misleading labeling. The firm must immediately correct these violations and ensure all tobacco products comply with the FD&C Act. A written response detailing corrective actions, including dates of discontinuance of violative activities, is required within 15 working days. Failure to comply may result in further FDA action, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction.