Swisher International, Inc. – FDA Warning Letter, Jun 25, 2015

The FDA issued a Warning Letter to Swisher International, Inc. after reviewing their Facebook page (https://www.facebook.com/SwisherXtreme) and observing two "free sample" events. The FDA determined that Swisher's Kayak smokeless tobacco products were offered for sale or distribution in the U.S. and are subject to FDA jurisdiction.

The primary violation identified was that Kayak smokeless tobacco products are misbranded under sections 903(a)(1) and/or 903(a)(7)(A) of the FD&C Act. This is because the company's Facebook page and branded t-shirts worn by employees at events failed to include any required health warning label statements. Specifically, the Facebook page displayed photos of employees wearing Kayak logo t-shirts without warnings. FDA investigators also witnessed employees wearing Kayak-branded t-shirts without health warnings at free sample events on June 11, 2015, in Weatherford, TX, and on June 25, 2015, in Luling, TX.

The letter cites Section 3(b) of the Comprehensive Smokeless Tobacco Health Education Act of 1986, as amended by Section 204 of the Tobacco Control Act, which mandates specific health warning statements for smokeless tobacco advertisements. The FDA considers the absence of these warnings to make the labeling and/or advertising false or misleading.