FDA WARNING_LETTER - Briar Patch Loehmann's

The FDA Center for Tobacco Products reviewed the website http://www.briarpatch.biz and found that smokeless tobacco products offered for sale in the U.S. were misbranded. The products, including various General, Oliver Twist, and Stoker's brands, failed to include any required health warning label statements on the website. This violates sections 903(a)(1) and/or 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(1) and § 387c(a)(7)(A)), which deem products misbranded if their labeling or advertising is false or misleading.

The Comprehensive Smokeless Tobacco Health Education Act of 1986, as amended, mandates specific health warnings for smokeless tobacco advertisements (15 U.S.C. § 4402). The absence of these warnings on the website constitutes a failure to reveal material facts about product consequences, making the products misbranded. Additionally, the company is reminded of the requirement for quarterly rotation of warning label statements on advertising, per 15 U.S.C. § 4402(b)(3).

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