FDA WARNING_LETTER - Seneca Cigarettes

The FDA's Center for Tobacco Products reviewed Two Pine's website, http://www.senecacigarettes.com, and determined that their smokeless tobacco products, including Copenhagen, Grizzly, Kayak, Kodiak, Skoal, and Timber Wolf, offered for sale in the U.S. are misbranded.

The primary violation is the failure to include any required health warning label statements on the website for these smokeless tobacco products. This constitutes misbranding under sections 903(a)(1) and/or 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(1) and § 387c(a)(7)(A)). The letter cites Section 3(b) of the Comprehensive Smokeless Tobacco Health Education Act of 1986 (15 U.S.C. § 4402), as amended by section 204 of the Tobacco Control Act, which mandates specific health warnings for smokeless tobacco advertisements. Additionally, the letter notes the requirement for quarterly rotation of warning label statements on advertising, as per Section 3(b)(3) of the Smokeless Tobacco Act.

Two Pine is required to immediately correct these violations and ensure all tobacco products and related labeling/advertising comply with the FD&C Act and FDA regulations. Failure to comply may result in civil money