Tiger Vapor, LLC – FDA Warning Letter, May 5, 2022

The FDA issued a Warning Letter to Tiger Vapor, LLC on May 5, 2022, following a review of submissions and inspection records. The FDA determined that Tiger Vapor, LLC manufactures and distributes e-liquid products, specifically "Tiger Vapor Watermelon e-liquid products," which are deemed tobacco products under section 201(rr) of the FD&C Act.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. These products were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization orders under section 910(c)(1)(A)(i) of the FD&C Act, nor are they exempt. Consequently, these products are considered adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the lack of required notice or information under section 905(j).

The letter states that the failure to provide the required report under section 905(j) is a prohibited act under section 301(p). Tiger Vapor, LLC is a registered manufacturer with over 6,100 products listed. The FDA emphasizes that all new tobacco products on the market without premarket authorization are unlawful and subject to enforcement actions, including civil money penalties, seizure, and/