FDA WARNING_LETTER - www.555.cigarettes.com

The FDA Center for Tobacco Products reviewed the website http://www.555cigarettes.com and found that smokeless tobacco products offered for sale to U.S. customers are misbranded. The products, including Copenhagen Fine Cut Regular, Copenhagen Pouches, and Marlboro Snus Peppermint, are considered tobacco products under section 201(rr) of the FD&C Act.

The primary violation is the failure to include any health warning label statements on the webpage for these smokeless tobacco products. This violates section 3(b) of the Comprehensive Smokeless Tobacco Health Education Act of 1986 (Smokeless Tobacco Act), which mandates specific health warnings such as "WARNING: This product can cause mouth cancer." Consequently, the products are misbranded under sections 903(a)(1) and/or 903(a)(7)(A) of the FD&C Act, as their advertising is false or misleading due to the omission of material facts concerning product consequences.

The letter also notes the requirement for quarterly rotation of warning label statements on advertising for each brand of smokeless tobacco, as 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 lead to civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/