Tiger Vapor, LLC – FDA Warning Letter, Jul 25, 2022

On July 25, 2022, the FDA issued a Warning Letter to Tiger Vapor, LLC, following a review of submissions and inspection records. The FDA determined that Tiger Vapor manufactures and distributes e-liquid products, which are classified as tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the TIGER VAPOR Below Zero e-liquid products were found to be new tobacco products because they were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization orders or exemptions. This renders the products adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the failure to provide required information under section 905(j).

The letter states that manufacturing or selling adulterated/misbranded products is a prohibited act under section 301(k), and failure to provide required reports is a prohibited act under section 301(p). Tiger Vapor, a registered manufacturer with over 6,100 listed products, is responsible for ensuring compliance. Failure to address these violations may result in regulatory actions, including civil money penalties, seizure, and/or injunction.

Tiger Vapor