FDA WARNING_LETTER - Vaper Generation LLC - August 17, 2023

The FDA issued a Warning Letter to Vaper Generation LLC after reviewing inspection records, determining the firm manufactures and distributes e-liquid products, including REMIX Too Witches 6mg/ml 100ml. These products are classified as "tobacco products" under section 201(rr) of the FD&C Act, especially after the March 2022 amendment extending jurisdiction to nicotine from any source. The primary violation is the marketing of "new tobacco products" without the required premarket authorization, as the products were not commercially marketed before February 15, 2007, and lack an FDA marketing order or exemption. Consequently, the product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required notice or information under section 905(j). These actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act. The FDA requires Vaper Generation LLC to submit a written response within 15 working days, detailing actions taken to cease violative sales and distribution, and outlining a plan for future compliance. Failure to address these violations may lead to regulatory actions such as civil money penalties, seizure, or injunction, and imported products may be refused admission. The firm is responsible for ensuring all its tobacco products comply with the FD&C Act and implementing regulations.