FDA WARNING_LETTER - Smokers Express

The FDA's Center for Tobacco Products issued a Warning Letter to Smokersexpress.net after reviewing their website and determining that their smokeless tobacco products are offered for sale or distribution in the U.S. The FDA found that several smokeless tobacco products, including Red Man, Grizzly, and Skoal, were misbranded under sections 903(a)(1) and/or 903(a)(7)(A) of the FD&C Act because their website failed to include any required health warning label statements.

The letter specifies that advertisements for smokeless tobacco products must bear one of four mandated health warning statements, as per the Comprehensive Smokeless Tobacco Health Education Act of 1986, as amended. The absence of these warnings renders the products misbranded, as it constitutes a failure to reveal material facts concerning product use consequences. The FDA also noted the requirement for quarterly rotation of warning label statements on advertising for each brand.

Smokersexpress.net is required to immediately correct these violations and ensure all tobacco products, labeling, and advertising comply with the FD&C Act. Failure to comply may result in further FDA action, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. A written response detailing corrective actions and a compliance plan is required within 15 working days.