FDA WARNING_LETTER - Go Vapor LLC - January 25, 2022

The FDA issued a Warning Letter to Go Vapor LLC on January 25, 2022, following a review of submissions and inspection records. The letter states that Go Vapor LLC manufactures and distributes e-liquid products, which are deemed tobacco products under the FD&C Act.

The primary violation identified is the manufacturing, sale, and/or distribution of "Go Vapor Blue Air Head 3mg 10ml e-liquid product" without the required premarket marketing authorization. This product is considered a "new tobacco product" as it was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption. Consequently, the 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 cited as a prohibited act.

Go Vapor LLC is a registered manufacturer with over 271,500 products listed. Their Premarket Tobacco Product Application (PMTA), STN PM0002406, submitted on September 9, 2020, received a Refuse To File determination on August 30, 2021, covering 28,903 products.

The FDA requires Go Vapor LLC to