FDA WARNING_LETTER - East West Distributors

The FDA's Center for Tobacco Products reviewed East West Distributors' website, http://www.eastwestdistributors.com, and found that their smokeless tobacco products offered for sale in the U.S. are misbranded. The products, including Beech-Nut, Stokers, Longhorn, RedMan, and Kayak, are considered tobacco products under section 201(rr) of the FD&C Act.

The primary violation is the failure to include required health warning label statements in advertisements for these smokeless tobacco products, which misbrands them under section 903(a)(7)(A) of the FD&C Act. The Comprehensive Smokeless Tobacco Health Education Act of 1986, as amended, mandates specific warnings such as "WARNING: This product can cause mouth cancer." The absence of these warnings makes the advertising misleading under section 201(n) of the FD&C Act.

Additionally, the letter notes the requirement for quarterly rotation of warning label statements on advertising for each brand, in accordance with an FDA-approved plan, as per section 3(b)(3) of the Smokeless Tobacco Act.

East West Distributors must immediately correct these violations and ensure all tobacco products and promotional materials comply with the FD&C Act. 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,