Tiger Vapes – FDA Warning Letter, Jun 3, 2021

The FDA Center for Tobacco Products issued a Warning Letter to Tiger Vapes, identifying that the company manufactures and distributes e-liquid products, specifically "Tiger vapes Watermelon Jolly 6 mg Nicotine 60 ml e-liquid product," which are deemed tobacco products under the FD&C Act.

The core violation is that this e-liquid product is a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007, and lacks the required FDA marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, the product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required premarket authorization or a substantial equivalence report.

Prohibited acts include the sale of adulterated/misbranded products (section 301(k)) and the failure to provide a required report (section 301(p)). Tiger Vapes, a registered manufacturer with over 100 listed products, is responsible for ensuring compliance. Failure to address these violations may result in regulatory actions such as civil money penalties, seizure, and/or injunction.

Tiger Vapes must submit a written response within 15 working days detailing corrective actions, including discontinuation dates for the violative product