Desert Vapors LLC – FDA Warning Letter, Nov 30, 2021

The FDA issued a Warning Letter to Desert Vapors LLC on November 30, 2021, following a review of submissions and inspection records. The FDA determined that Desert Vapors LLC manufactures and distributes e-liquid products, which are deemed tobacco products under the FD&C Act and subject to FDA jurisdiction.

The primary violation identified is the marketing of a "new tobacco product," specifically "DESERT VAPORS Custard 0.3% 60ML e-liquid product," without the required premarket authorization. This product was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption. Consequently, this product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The failure to provide a required report under section 905(j) is also a prohibited act.

Desert Vapors LLC is a registered manufacturer with over 19,200 listed products. Their Premarket Tobacco Product Application (PMTA), STN PM0002392, submitted on September 9, 2020, received a Marketing Denial Order on September 13, 2021, covering 418 products. Products with Marketing Denial Orders or no pending applications are high enforcement