FDA WARNING_LETTER - Campbell Tartan, Inc. d/b/a Smokes on Burdick

The FDA Center for Tobacco Products issued a Warning Letter to Mr. Milne regarding violations found on his websites: http://www.kalamazoocigars.com, http://www.kalamazoosmokes.com, and http://www.smokesonburdick.com. The FDA determined that smokeless tobacco products, specifically General Snus and Levi Garrett, offered for sale or distribution on these sites are misbranded.

The primary violation is the failure to include required health warning label statements on webpages for these smokeless tobacco products. This constitutes misbranding under sections 903(a)(1) and/or 903(a)(7)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as the labeling and/or advertising is false or misleading due to the omission of material facts. The Comprehensive Smokeless Tobacco Health Education Act of 1986, as amended, mandates specific health warnings such as "WARNING: This product can cause mouth cancer" or "WARNING: Smokeless tobacco is addictive."

The letter also notes the requirement for quarterly rotation of warning label statements on advertising for each brand of smokeless tobacco, in accordance with an FDA-approved plan.

Mr. Milne is required to 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