Gatlinburlier, INC – FDA Warning Letter

The FDA Center for Tobacco Products reviewed www.gatlinburlier.com and www.gbtobacco.com, determining that smokeless tobacco products were promoted for sale in the U.S. These websites are affiliated, sharing contact information and referencing "The Gatlinburlier" in Gatlinburg, TN. The advertised products are tobacco products under section 201(rr) of the FD&C Act.

The FDA found that the smokeless tobacco products are misbranded under section 903(a)(7)(A) of the FD&C Act because advertisements failed to include required warning label statements from section 3 of the Comprehensive Smokeless Tobacco Health Education Act of 1986, as amended. Specifically, products like Big Orange Chew, Oliver Twist Golden Mild Sunberry, and others were promoted without warnings such as "WARNING: This product can cause mouth cancer" or "WARNING: Smokeless tobacco is addictive."

The letter also noted the requirement for quarterly rotation of warning label statements on advertising for each brand, per section 3(b)(3) of the Smokeless Tobacco Act, which must follow an FDA-approved plan.

The FDA requires immediate correction of these violations and similar issues to ensure compliance with the FD&C Act. Failure to comply may result in civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. A written response detailing corrective actions, including discontinuation