FDA WARNING_LETTER - Flavour Warehouse LTD d/b/a Vampire Vape - September 09, 2020

The FDA issued a Warning Letter to Philip Boyle and Nathan Walton of Vampire Vape regarding electronic nicotine delivery system (ENDS) products offered for sale to U.S. customers via their website, https://www.vampirevape.co.uk. The FDA determined these products are tobacco products subject to FDA jurisdiction and the FD&C Act.

The primary violation identified is the sale of "new tobacco products" without required premarket authorization. Specifically, the "Ice Menthol – 10ml Vampire Vape E-Liquid" is cited as a new tobacco product not commercially marketed in the U.S. as of February 15, 2007, and lacking an FDA marketing authorization order or exemption. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The FDA also expressed concern over the product packaging featuring cartoon vampire images, which are commonly marketed to and appeal to children, contributing to rising youth ENDS use.

The letter requires a written response within 15 working days detailing corrective actions, including discontinuation of violative sales and a plan for compliance. Failure to comply may result in regulatory action, including detention and refusal of admission for imported products.