FDA WARNING_LETTER - www.snuscentral.com

The FDA Center for Tobacco Products reviewed snuscentral.com and determined that its smokeless tobacco products promoted for sale in the U.S. are adulterated. The products are considered "modified risk tobacco products" under the FD&C Act because they are described as "milder" or having reduced levels of substances (e.g., "Milder than other General Snus Products," "very low 0.85 nitrosamines (TSNA) level" for "Thunder Extra Strong Original Loose Snus").

Under section 911(a) of the FD&C Act, modified risk tobacco products cannot be introduced into interstate commerce without an FDA order. Since no such order is in effect, these products are adulterated per section 902(8) of the FD&C Act.

Additionally, the letter notes that the company must comply with the Comprehensive Smokeless Tobacco Health Education Act, which requires specific warning label statements on advertisements for smokeless tobacco products and quarterly rotation of these warnings.

The FDA requires immediate correction of these violations and a written response within 15 working days detailing corrective actions, including dates of discontinued violative promotion, advertising, sale, and distribution, and a plan for future compliance. Failure to comply may result in civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction.