FDA WARNING_LETTER - Premium Vapor Technologies LLC - February 12, 2021

On February 12, 2021, the FDA issued a Warning Letter to Travis Pinkerton and Candace Almaguer regarding e-liquid products sold on vapevta.com. The FDA determined that e-liquid products, including "Odin’s Mead" and "Asgard," are tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The primary violation is that these e-liquid products are "new tobacco products" as they were not commercially marketed in the U.S. as of February 15, 2007, and lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because the required notice or information under section 905(j) was not provided.

The letter emphasizes the firm's responsibility as a registered manufacturer with over 140 listed products to ensure compliance with the FD&C Act and FDA regulations. Failure to address these violations may result in regulatory actions such as 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