FDA WARNING_LETTER - www.gotlandssnus.com, www.jakobssonssnus.com

The FDA Center for Tobacco Products issued a Warning Letter to Gotland Snus AB, Sweden, regarding their smokeless tobacco products advertised and sold in the U.S. via websites http://www.gotlandssnus.com and http://www.jakobssonssnus.com.

The FDA determined that several of their smokeless tobacco products are misbranded under section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) because their advertisements fail to include required health warning statements. Section 3 of the Comprehensive Smokeless Tobacco Health Education Act of 1986, as amended, mandates specific warnings such as "WARNING: This product can cause mouth cancer" or "WARNING: Smokeless tobacco is addictive." The absence of these warnings makes the advertising false or misleading.

Products cited for this violation include Gotlandssnus Anis Loose, Jakobsson’s Classic, Jakobsson’s Ice-Fruit, and others. Additionally, the letter notes the requirement for quarterly rotation of warning label statements on advertising for each brand, as per section 3(b)(3) of the Smokeless Tobacco Act, which must be done according to an FDA-approved plan.

Gotland Snus AB is required to immediately correct these violations and ensure all tobacco products and promotional materials comply with the FD&C Act. Failure to comply may result