FDA WARNING_LETTER - www.tobaccozoneplacentia.com

The FDA's Center for Tobacco Products reviewed the websites http://www.tobaccozoneplacentia.net and http://www.tobaccozones.com, affiliated with Tobacco Zone, and determined that smokeless tobacco products advertised for sale to U.S. customers are misbranded. The violation stems from the failure to include required health warning label statements in advertisements for products such as Skoal, Kodiak, and Copenhagen chewing tobacco.

This misbranding violates section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)), which states a tobacco product is misbranded if its advertising is false or misleading. The absence of warnings fails to reveal material facts concerning product use consequences, as per section 201(n) of the FD&C Act. Required warnings, mandated by section 3 of the Comprehensive Smokeless Tobacco Health Education Act of 1986, include statements about mouth cancer, gum disease, tooth loss, and addictiveness. Additionally, the letter notes the requirement for quarterly rotation of warning statements on advertising, per section 3(b)(3) of the Smokeless Tobacco Act.

Tobacco Zone must immediately correct these violations and ensure all tobacco products and promotional materials comply with the FD&C Act. Failure to comply may result in civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure,