A Perfect Vape, LLC – FDA Warning Letter, Jun 22, 2023

The FDA issued a Warning Letter to A Perfect Vape, Inc. on June 22, 2023, for manufacturing and distributing e-liquid products without required marketing authorization. The FDA determined that A Perfect Vape, Inc. manufactures and distributes e-liquid products, which are considered tobacco products under section 201(rr) of the FD&C Act, as they are made or derived from tobacco or contain nicotine from any source and are intended for human consumption.

The specific violation identified is the marketing of "A Perfect Vape Dragon Fruit 6mg 60ml" without a premarket authorization order. This product is deemed a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007, and lacks the necessary FDA marketing authorization or exemption. Consequently, the product is adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required notice or information.

The FDA noted that while the firm submitted a Premarket Tobacco Product Application (STN PM0005390) on May 13, 2022, covering 4,140 products, it did not include the violative product. The letter emphasizes that all new tobacco products on the market without statutory premarket authorization are unlawful and subject to enforcement