www.deweyavesmokeshop.com – FDA Warning Letter

The FDA issued a Warning Letter to Mr. Stebbins of deweyavesmokeshop.com after reviewing their website and determining that their smokeless tobacco products, offered for sale in the U.S., are misbranded. The products 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 smokeless tobacco products, as mandated by section 3 of the Comprehensive Smokeless Tobacco Health Education Act of 1986, as amended. This renders the products misbranded under section 903(a)(7)(A) of the FD&C Act, which states that advertising is misleading if it fails to reveal material facts about product consequences.

Numerous products, including various brands of snuff, chewing tobacco, and other smokeless tobacco, were advertised without any of the four required warning labels (e.g., "This product can cause mouth cancer," "Smokeless tobacco is addictive"). Additionally, the letter noted the requirement for quarterly rotation of warning label statements on advertising for each brand, in accordance with an FDA-approved plan.

The FDA requires immediate correction of these violations and similar issues across all advertising platforms and retail establishments. Failure to comply may result in further actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. A written response detailing corrective actions, including discontinuation dates