FDA WARNING_LETTER - Smoke Shop Plus

The FDA's Center for Tobacco Products reviewed magnoliasmokeshop.com and found that smokeless tobacco products, specifically Copenhagen and Skoal, were offered for sale to U.S. customers. These products are subject to FDA jurisdiction under the FD&C Act.

The primary violation identified is that the advertised smokeless tobacco products are misbranded under section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)) because their advertisements fail to include any required health warning label statements. The Comprehensive Smokeless Tobacco Health Education Act of 1986, as amended, mandates specific warnings such as "WARNING: This product can cause mouth cancer" or "WARNING: Smokeless tobacco is addictive." The absence of these warnings makes the advertising false or misleading.

Additionally, the letter notes the requirement for quarterly rotation of warning label statements on advertising for each brand of smokeless tobacco, in accordance with an FDA-approved plan, as per section 3(b)(3) of the Smokeless Tobacco Act (15 U.S.C. § 4402).

The FDA requires immediate correction of these violations and similar issues across all advertising platforms, including other websites and retail establishments. Failure to comply may result in further FDA action, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and