Go Vapor LLC – FDA Warning Letter, Jan 20, 2022

The FDA issued a Warning Letter to Go Vapor LLC on January 20, 2022, following a review of submissions and inspection records. The company manufactures and distributes e-liquid products, specifically Go Vapor E-Juice Dragonfruit 10mL 3mg/mL and Go Vapor E-Juice Straw Kiwi 10mL 3mg/mL, which are deemed tobacco products under the FD&C Act.

The primary violation is the marketing of "new tobacco products" without the required premarket authorization. These e-liquids were not commercially marketed in the U.S. as of February 15, 2007, and lack an FDA marketing authorization order or exemption. Consequently, these products are adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as required information under section 905(j) was not provided. The failure to provide such reports is a prohibited act under section 301(p).

Go Vapor LLC is a registered manufacturer with over 271,400 listed products. Their Premarket Tobacco Product Applications (PMTAs), STN PM0002406, submitted on September 9, 2020, received a Refuse To File determination on August 30, 2021, covering 28