FDA WARNING_LETTER - E-VAPERZ LLC - July 24, 2025

The FDA issued a Warning Letter to E-VAPERZ LLC, located at 5407 Main Street, Suite 600, Spring Hill, TN, on July 24, 2025, following an inspection by the Center for Tobacco Products. The inspection revealed that E-VAPERZ LLC distributes e-liquid products in the U.S. without the necessary premarket authorization, violating the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, the product "Pinup Vapors Betty-Chill 6MG 60ML" was identified as a new tobacco product lacking FDA marketing authorization, rendering it adulterated and misbranded under sections 902(6)(A) and 903(a)(6) of the FD&C Act.

The regulatory framework requires that all new tobacco products, defined as those not commercially marketed in the U.S. before February 15, 2007, must have a premarket authorization order. The FD&C Act, as amended by the Consolidated Appropriations Act, 2022, extends FDA jurisdiction to products containing nicotine from any source.

E-VAPERZ LLC is required to take immediate corrective actions to comply with the FD&C Act. This includes ceasing the sale and distribution of non-compliant products and submitting a written response within 15 working days detailing the actions taken to address the violations. The response should include the cessation dates of violative sales and a compliance maintenance plan. Failure to comply may result in enforcement actions such as civil penalties, seizure, or injunction. The company is advised to ensure all products and advertising comply with FDA regulations.