FDA WARNING_LETTER - Iwan Ries

The FDA's Center for Tobacco Products reviewed iwanries.com and determined that smokeless tobacco products, including Oliver Twist, General Snus, and Thunder Snus, are offered for sale or distribution in the U.S. without required health warning statements. These products are considered misbranded under sections 903(a)(1) and 903(a)(7)(A) of the FD&C Act because their labeling and/or advertisements fail to include mandatory health warnings.

The Comprehensive Smokeless Tobacco Health Education Act of 1986, as amended, requires specific warnings such as "WARNING: This product can cause mouth cancer" or "WARNING: Smokeless tobacco is addictive." The absence of these warnings renders the products misbranded. Additionally, the company is reminded of the requirement for quarterly rotation of warning label statements on advertising, per a plan approved by the FDA.

The letter demands immediate correction of these violations and similar issues across all promotional materials and sales channels. 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, including discontinuation dates of violative promotions and a compliance plan, is required within 15 working days.