FDA WARNING_LETTER - Make Webo AB - March 12, 2019

The FDA issued a Warning Letter to MaKe WeBo AB, specifically Marcus Nilsson, on February 22, 2019, following a review of their website, https://snus.us. The FDA determined that smokeless tobacco products offered for sale to U.S. customers on this website are misbranded under sections 903(a)(1) and/or 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(1) and § 387c(a)(7)(A)).

The primary violation identified is the failure to include any required health warning label statements for numerous smokeless tobacco products advertised on the website. Examples include XRANGE Goteborgs Rape Slim White Strong Portion, Epok Mint White Slim, and General – Classic Loose Extra Strong. Section 3(b) of the Comprehensive Smokeless Tobacco Health Education Act of 1986 (15 U.S.C. § 4402), as amended, mandates specific health warnings for smokeless tobacco advertisements. The absence of these warnings renders the products misbranded, as their labeling and/or advertising are considered false or misleading due to the failure to reveal material facts about product consequences.

The letter also notes the requirement for quarterly rotation of warning label statements on advertising for each brand of smokeless tobacco, in accordance with an FDA