Daytona Cigar Co – FDA Warning Letter

The FDA's Center for Tobacco Products issued a Warning Letter to Daytona Cigar Co. after reviewing their website, daytonacigar.com, and finding that several smokeless tobacco products offered for sale in the U.S. were misbranded. The products, including Oliver Twist Original Chewing Tobacco Bits and various General Snus products, lacked required health warning statements on their webpages.

This violates sections 903(a)(1) and/or 903(a)(7)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which deem tobacco products misbranded if their labeling or advertising is false or misleading. Specifically, the absence of health warnings fails to reveal material facts concerning product use consequences, as mandated by section 3(b) of the Comprehensive Smokeless Tobacco Health Education Act of 1986, as amended by the Tobacco Control Act. This act requires specific warnings like "WARNING: This product can cause mouth cancer." The letter also noted the requirement for quarterly rotation of warning statements on advertising.

Daytona Cigar Co. must immediately correct these violations and ensure all tobacco products, labeling, and advertising comply with the FD&C Act. Failure to comply could result in 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.