FDA WARNING_LETTER - Perfect Vape LLC - October 07, 2021

The FDA Center for Tobacco Products issued a Warning Letter to Myloc Lam, Perfect Vape, regarding e-liquid products offered for sale on perfectvape.com. The FDA determined these e-liquid products, including "Perfect Vape E-Liquid – Malibu Sunrise 50/50" and "Perfect Vape E-Liquid – Chewy Watermelon 90/10," are "new tobacco products" under section 201(rr) of the FD&C Act.

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 (section 910(c)(1)(A)(i)) and were not commercially marketed in the U.S. as of February 15, 2007. Perfect Vape's Premarket Tobacco Product Application (PMTA) STN PM0001260, covering 140,198 products, received a Refuse to File determination on July 15, 2021.

The FDA requires a written response within 15 working days detailing actions taken to address violations, including discontinuing violative sales and a plan for compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.