FDA WARNING_LETTER - Stix and Stones, Inc.

The FDA issued a Warning Letter to Mr. Szczepankiewicz regarding the website http://www.cigarhustler.com, which offers cigar products for sale in the U.S. The FDA determined that the Oliva Serie O Cigarillo Sungrown cigar product sold on the website is misbranded under section 903(a)(7)(B) of the FD&C Act because it was sold to a person younger than 18 years of age.

This violates 21 C.F.R. § 1140.14(b), which prohibits retailers from selling covered tobacco products, including cigars, to individuals under 18. The Oliva Serie O Cigarillo Sungrown cigar is classified as a "covered tobacco product" under 21 C.F.R. § 1140.3. Selling this product to a minor also constitutes misbranding under section 903(a)(7)(B) of the FD&C Act, as it violates regulations prescribed under section 906(d), specifically 21 C.F.R. Part 1140.

The FDA requires immediate corrective actions for this and similar violations, ensuring all tobacco products, labeling, and advertising comply with the FD&C Act and FDA regulations across all sales channels. Failure to comply may result in civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction