FDA WARNING_LETTER - http://www.diebelsg.com

The FDA Center for Tobacco Products issued a Warning Letter to Mr. Diebel regarding smokeless tobacco products offered for sale on http://www.diebelsg.com. The FDA determined these products are misbranded under sections 903(a)(1) and/or 903(a)(7)(A) of the FD&C Act because the website fails to include required health warning label statements.

Specific products cited for lacking health warnings include AG Snus Jagarpris Original, General Snus Trial Pack Asst Flavors, General Snus Classic Blend, General Snus Dry Mini Mint, General Snus Original, General Snus White, General Snus Wintergreen, Oliver Twist Original, Oliver Twist Sunberry, Oliver Twist Tropical, and Oliver Twist Wintergreen.

The letter states that advertisements for smokeless tobacco products must bear one of four specific health warning statements as per Section 3(b) of the Comprehensive Smokeless Tobacco Health Education Act of 1986, as amended. Failure to include these warnings makes the products misbranded. The letter also notes the requirement for quarterly rotation of warning label statements on advertising, in accordance with an FDA-approved plan.

Mr. Diebel is required to immediately correct these violations and ensure all tobacco products, labeling, and advertising comply with the FD&C Act and FDA regulations. Failure to comply may result in further FDA action, including civil money penalties, no-tobacco-sale orders, criminal prosecution