FDA WARNING_LETTER - DENTON VAPE SHOPPE - October 19, 2021

The FDA issued a Warning Letter to Denton Vape Shoppe, identifying their e-liquid products as tobacco products subject to FDA jurisdiction. The letter states that the DENTON VAPE SHOPPE BLACK CHERRY 3MG e-liquid product is a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007.

The primary violation is the manufacturing, sale, and/or distribution of this product without the required premarket marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, the product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as no required notice or information was provided. Prohibited acts include holding for sale after interstate shipment resulting in adulteration/misbranding (section 301(k)) and failure to provide a required report (section 301(p)).

Denton Vape Shoppe, a registered manufacturer with over 1,000 listed products, is informed that all new tobacco products marketed without premarket authorization are unlawful and subject to enforcement, including civil money penalties, seizure, and/or injunction. The firm must submit a written response within 15 working days detailing actions to address violations, including discontinuation dates of violative sales/distribution, and