FDA WARNING_LETTER - Hiland's Cigars

The FDA Center for Tobacco Products reviewed Hiland's Cigars' website, http://www.hilandscigars.com, and found violations related to the distribution and sale of smokeless tobacco products in the U.S.

The first violation is the sale of "Stoker's Black Wild Cherry Chewing Tobacco" to a person under 18 years of age, which misbrands the product under section 903(a)(7)(B) of the FD&C Act and violates 21 C.F.R. § 1140.14(a).

The second violation concerns the absence of required health warning label statements on the website for several smokeless tobacco products, including various General Swedish Snus and Stoker's Chewing Tobacco products. This misbrands these products under sections 903(a)(1) and/or 903(a)(7)(A) of the FD&C Act, as it constitutes false or misleading advertising and labeling by failing to reveal material facts, violating the Comprehensive Smokeless Tobacco Health Education Act of 1986. The letter also notes the requirement for quarterly rotation of warning labels.

Hiland's Cigars must 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 civil money penalties, no-tobacco-sale orders, criminal prosecution