FDA WARNING_LETTER - ACF, Inc.

The FDA Center for Tobacco Products reviewed bodacigars.com and determined that smokeless tobacco products offered for sale in the U.S. are misbranded. The products, including various General Snus types (Classic Blend, Loose, Mini Mint, Mint, Nordic Mint, Original, White, Wintergreen), lack required health warning statements on their webpage. This violates 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)), which deem products misbranded if labeling or advertising is false or misleading, including failure to reveal material facts.

The Comprehensive Smokeless Tobacco Health Education Act of 1986, as amended, mandates specific health warnings for smokeless tobacco advertisements (e.g., "WARNING: This product can cause mouth cancer."). Additionally, quarterly rotation of warning labels on advertising is required per 15 U.S.C. § 4402.

The FDA requires immediate correction of these violations and any similar issues across all advertising platforms. Failure to comply may result in civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, or injunction. A written response detailing corrective actions, including discontinuation dates and a compliance plan, is required within 15 working days, referencing RW