FDA WARNING_LETTER - Vixen Vapors LLC d/b/a Vixen Vapors Pantego - February 15, 2024

The FDA issued a Warning Letter to Vixen Vapors LLC d/b/a Vixen Vapors Pantego on February 15, 2024, based on a review of inspection records. The company manufactures and distributes e-liquid products, which are classified as tobacco products under the FD&C Act, including those containing nicotine from any source, and are subject to FDA jurisdiction.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the product "Vixen Vapors Pompeii 14mg 120ml" was found to be 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. This renders the product 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 notice or information under section 905(j).

The FDA considers the sale and distribution of such products prohibited acts under sections 301(k) and 301(p) of the FD&C Act. The company is required to submit a written response within 15 working days, detailing actions taken to address violations, including discontinuing sales/distribution of violative products, and a plan