FDA WARNING_LETTER - BJ's II, Inc.

The FDA's Center for Tobacco Products reviewed bjstobacco.com and found that smokeless tobacco products offered for sale in the U.S. were misbranded. The website failed to include required health warning label statements for products like Copenhagen, Kodiak, and Skoal. This violates Section 903(a)(1) and/or 903(a)(7)(A) of the FD&C Act, which deem products misbranded if their labeling or advertising is false or misleading. The Comprehensive Smokeless Tobacco Health Education Act of 1986 mandates specific health warnings for smokeless tobacco advertisements, which were absent. Additionally, the letter notes the requirement for quarterly rotation of warning statements on advertising, per Section 3(b)(3) of the Smokeless Tobacco Act. The company must immediately correct these violations and ensure all tobacco products, labeling, and advertising 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 and a compliance plan is required within 15 working days.