FDA WARNING_LETTER - Briar Shoppe, The

The FDA's Center for Tobacco Products reviewed the website https://www.briarshoppe.squarespace.com and found that smokeless tobacco products offered for sale to U.S. customers were misbranded. The products, including General Snus, Jakobsson’s Snus, and Thunder Snus, failed to include required health warning label statements on their webpage.

This violates sections 903(a)(1) and/or 903(a)(7)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which deem tobacco products misbranded if their labeling or advertising is false or misleading. Specifically, the absence of warnings fails to reveal material facts about the product's consequences, as per section 201(n) of the FD&C Act.

The Comprehensive Smokeless Tobacco Health Education Act of 1986 (15 U.S.C. § 4402) mandates specific health warnings for smokeless tobacco advertisements, such as "WARNING: This product can cause mouth cancer." The letter also noted the requirement for quarterly rotation of warning statements and compliance with format requirements.

The FDA requires immediate correction of these violations and similar issues across all sales and advertising platforms. 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, including discontinuation dates and