FDA WARNING_LETTER - Square Vape Labs Inc. - February 26, 2021

The FDA Center for Tobacco Products issued a Warning Letter to Anthony Napolitano regarding e-liquid products manufactured and sold by Square Vape Labs via squarevapelabs.com. The FDA determined that e-liquid products, including "Pound," "Teddy Roos," and "Fruit Stripe Gum," are tobacco products under section 201(rr) of the FD&C Act and are subject to FDA regulation.

The primary violation is the marketing of "new tobacco products" without required premarket authorization orders, as mandated by section 910(a) of the FD&C Act. These products were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization, rendering them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The letter emphasizes the firm's responsibility, as a registered manufacturer with over 38,800 listed products, to ensure compliance with the FD&C Act and FDA regulations (21 C.F.R. Parts 1140, 1141, and 1143). Failure to comply may result in civil money penalties, seizure, and/or injunction. The firm must submit a written response within 15 working days detailing corrective actions, including discontinuation of violative sales and a plan for