D & J Vapors, LLC-Horse Cave – FDA Warning Letter, Jan 25, 2022

On January 25, 2022, the FDA issued a Warning Letter to D and J Vapors, identifying violations related to the manufacture and distribution of e-liquid products. The FDA determined that D and J Vapors manufactures and distributes e-liquid products, which are deemed tobacco products under section 201(rr) of the FD&C Act and subject to FDA jurisdiction.

The primary violation cited is the marketing of a "new tobacco product" without the required premarket authorization. Specifically, the "Wizard Blend Candy Cane 3 mg e-liquid product" was found to be a new tobacco product because it was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the failure to provide required notice under section 905(j).

The letter states that marketing new tobacco products without premarket authorization is unlawful and subject to enforcement actions, including civil money penalties, seizure, and/or injunction. D and J Vapors, a registered manufacturer with over 50 listed products, is required to ensure all its tobacco products comply with the FD&C Act and FDA regulations.

The company must submit a written response within 1