FDA WARNING_LETTER - www.snusory.com

The FDA Center for Tobacco Products issued a Warning Letter to Mr. Lewerenz after reviewing his website, http://www.snusory.com, which offers smokeless tobacco products for sale in the United States. The FDA determined that several products, including Bernard Wiesn Snuff and Oliver Twist Original, are misbranded under section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)). This misbranding is due to the failure to include required health warning label statements in advertisements, as mandated by section 3 of the Comprehensive Smokeless Tobacco Health Education Act of 1986, as amended. The letter also reminds the firm of the requirement for quarterly rotation of warning labels under section 3(b)(3) of the Smokeless Tobacco Act. The FDA requires immediate correction of these violations and similar deficiencies across all advertising platforms. A written response detailing corrective actions, dates of discontinued violative activities, and a compliance plan must be submitted within 15 working days. Non-compliance may result in severe enforcement actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, injunction, and refusal of admission for imported products.