FDA WARNING_LETTER - SV3, LLC - June 06, 2025

On June 6, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to SV3, LLC (Phoenix, AZ), operating via vaping.com. The FDA determined that SV3, LLC offers Electronic Nicotine Delivery System (ENDS) products for sale or distribution in the United States, which are classified as tobacco products under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The primary violation cited is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the products "Mixed Fruit Funky Republic Ti7000" and "Tropical Delight Funky Republic Fi3000" were identified as new tobacco products not commercially marketed before February 15, 2007, and lacking FDA marketing authorization orders. This renders them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as required information was not provided per section 905(j).

The FDA emphasized that all new tobacco products on the market without statutory premarket authorization are unlawful and subject to enforcement actions, including civil money penalties, seizure, and/or injunction. SV3, LLC is required to respond within 15 working days, detailing actions taken to address violations, including discontinuing sales and a plan for compliance.