www.rockbottom-wholesale.com – FDA Warning Letter

The FDA Center for Tobacco Products reviewed rockbottom-wholesale.com and determined that smokeless tobacco products promoted for sale to U.S. customers are misbranded. The products, including "KODIAK WINTERGREEN," "GRIZZY WINTERGREEN," "BEECH-NUT," "CANNON BALL CHEWING TOBACCO," and "DAYS WORK CHEWING TOBACCO," are tobacco products under the FD&C Act.

The primary violation is the failure to include required health warning label statements in advertisements for these smokeless tobacco products, as mandated by section 903(a)(7)(A) of the FD&C Act and section 3 of the Comprehensive Smokeless Tobacco Health Education Act of 1986, as amended. This omission renders the advertising false or misleading, as it fails to reveal material facts about product consequences.

The FDA requires immediate corrective action, including discontinuing violative promotion, advertising, sale, and distribution. The company must also ensure compliance with all applicable federal laws and regulations, including the quarterly rotation of warning label statements on advertising for each brand. Failure to comply may 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.