FDA WARNING_LETTER - Vaporescence LLC d/b/a Vape King USA - February 12, 2021

The FDA issued a Warning Letter to Carla Castner on February 12, 2021, regarding e-liquid products manufactured and sold via vapekingusa.com. The FDA determined that products like Vaporescence Select Blueberry and Vaporescence Select Coconut are "new tobacco products" under the FD&C Act because they were not commercially marketed in the U.S. as of February 15, 2007.

These products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because they lack the required premarket authorization order or exemption. The letter emphasizes that it is the firm's responsibility, as a registered manufacturer with over 1,000 listed products, to ensure compliance with all applicable provisions of the FD&C Act and FDA regulations.

Failure to address these violations may result in regulatory actions, including civil money penalties, seizure, and/or injunction. The firm must submit a written response within 15 working days detailing corrective actions, including discontinuing violative sales and a plan for future compliance.