FDA WARNING_LETTER - Wholesale Depot Corp

The FDA's Center for Tobacco Products reviewed Wholesale Depot Corporation's website, wholesaledepotcorp.com, and determined that their smokeless tobacco products are promoted for sale in the United States. These products, including "Copenhagen Long Cut 5ct" and "Grizzly Fine Cut Natural 5ct," are subject to FDA jurisdiction.

The primary violation identified is that the smokeless tobacco products are misbranded under section 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(A)). This is because the advertisements for these products fail to include any of the required warning label statements mandated by section 3 of the Comprehensive Smokeless Tobacco Health Education Act of 1986 (15 U.S.C. § 4402), as amended. Examples of required warnings include "WARNING: This product can cause mouth cancer" and "WARNING: Smokeless tobacco is addictive." The letter also notes the requirement for quarterly rotation of warning label statements on advertising, in accordance with an FDA-approved plan.

Wholesale Depot Corporation is required to immediately correct these violations and ensure all tobacco products and promotional materials 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, seizure, and/or injunction. The