FDA WARNING_LETTER - Wicks & Wires Vape Shoppe - April 07, 2020

The FDA issued a Warning Letter to Joseph Pirrota regarding the sale of Electronic Nicotine Delivery System (ENDS) products on the website https://www.wicksandwires.com. The FDA determined these products are tobacco products under section 201(rr) of the FD&C Act and are subject to FDA regulation.

The core violation is the sale of "new tobacco products" without required premarket authorization, as mandated by section 910(a) of the FD&C Act. Specific products cited include VapeShot DISC Starter Pack, Kilo E-Liquid 1K Starter Kit, and STLTH Starter Kit. These ENDS products were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization orders or exemptions. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The letter requires a written response within 15 working days detailing corrective actions, including discontinuation of violative sales and a plan for future compliance. Failure to comply may result in civil money penalties, seizure, and/or injunction. Adulterated and misbranded products are also subject to import detention and refusal.