FDA WARNING_LETTER - vaping.com - June 17, 2025

The U.S. Food and Drug Administration (FDA) issued a warning letter to SV3, LLC, operating as Vaping.com, concerning violations related to the sale of electronic nicotine delivery system (ENDS) products. The inspection identified that products such as Mixed Fruit Funky Republic Ti7000 and Tropical Delight Funky Republic Fi3000 were being marketed without the necessary premarket authorization, as required under the Federal Food, Drug, and Cosmetic Act (FD&C Act). These products are classified as new tobacco products since they were not commercially available in the U.S. before February 15, 2007, and lack FDA marketing authorization, rendering them adulterated and misbranded.

The regulatory framework mandates that all tobacco products containing nicotine, regardless of its source, comply with the FD&C Act. The FDA"s jurisdiction was expanded by the Consolidated Appropriations Act, 2022, to include products with nicotine from any source. The letter emphasizes that failure to comply with these regulations could result in enforcement actions, including penalties, seizure, or injunction.

SV3, LLC is required to respond within 15 working days, detailing corrective actions taken to address the violations and ensure compliance. The response should include cessation dates for the sale of non-compliant products and plans to maintain adherence to the FD&C Act. The company is advised to submit their response to the FDA"s Office of Compliance and Enforcement via email and mail.