OTT Enterprises, LLC d/b/a Tobacco Barn – FDA Warning Letter, Oct 22, 2019

The FDA issued a Warning Letter to Tobacco Barn (tobacco-barn.com) on September 30, 2019, following a review of their website. The FDA determined that Al Capone Sweets Cognac Dipped cigars, offered for sale, are tobacco products subject to FDA jurisdiction.

The primary violation identified was the sale of Al Capone Sweets Cognac Dipped cigars to a person younger than 18 years of age, which constitutes misbranding under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)). This violates 21 C.F.R. § 1140.14(b), which prohibits the sale of covered tobacco products to minors.

Tobacco Barn is required to immediately correct this violation and any similar issues across all sales platforms, including other websites and retail establishments. Failure to comply may result in further FDA actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. The company must submit a written response within 15 working days detailing corrective actions, including dates of discontinued violative sales and a plan for maintaining compliance.