FDA WARNING_LETTER - SwedLex / Swedsnus

The FDA's Center for Tobacco Products reviewed http://www.swedsnus.com and determined that smokeless tobacco products offered for sale or distribution in the U.S. are misbranded. These products, including numerous listed brands like Catch Original Licorice mini and Ettan Snus Loose, are considered tobacco products under the FD&C Act.

The primary violation is the failure to include any health warning label statements on the website, as required by Section 3(b) of the Comprehensive Smokeless Tobacco Health Education Act of 1986 (Smokeless Tobacco Act), as amended by the Tobacco Control Act. This renders the products misbranded under sections 903(a)(1) and 903(a)(7)(A) of the FD&C Act, which address false or misleading labeling and advertising. The FDA also noted the requirement for quarterly rotation of warning label statements on advertisements, in accordance with an FDA-approved plan.

The company must immediately correct these violations and ensure all tobacco products, labeling, and advertising across all platforms comply with the FD&C Act and FDA regulations. Failure to comply may result in civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. Adulterated and misbranded products imported into the U.S. are subject to detention and refusal. A written response detailing corrective actions, including discontinuation dates for violative activities and a compliance plan, is required