FDA WARNING_LETTER - Vape Lizard E-Juice LLC - May 21, 2021

The FDA issued a Warning Letter to Vape Lizard E-Juice, LLC, following a review of submissions and inspection records, determining the company manufactures and distributes e-liquid products, which are deemed tobacco products under the FD&C Act. The letter specifically identifies VAPE LIZARD Juice Co 3mg 70%VG/30%PG Strawmelon e-liquid product as a "new tobacco product" that was not commercially marketed in the U.S. as of February 15, 2007.

The primary violation is the distribution of this new tobacco product without the required premarket authorization, specifically an FDA marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act, or an exemption. Consequently, the product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as no notice or information was provided as required by section 905(j). These actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act.

Vape Lizard E-Juice, LLC, a registered manufacturer with over 400 listed products, is responsible for ensuring compliance. The FDA requires a written response within 15 working days detailing corrective actions, including discontinuation dates for violative sales/