FDA WARNING_LETTER - Free Range Vapor LLC - July 19, 2022

The FDA Center for Tobacco Products issued a Warning Letter to Monica Vondruska of Free Range Vapors after reviewing the website https://www.freerangevapors.com. The review determined that e-liquid products, specifically Party Fowl, Pig in Mud, and Hot Llama, are manufactured and offered for sale or distribution in the U.S. These e-liquids are considered "new tobacco products" under section 201(rr) of the FD&C Act, subject to FDA jurisdiction and requiring premarket authorization as they were not commercially marketed before February 15, 2007. The firm failed to obtain the necessary marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the lack of required notice or information under section 905(j). The FDA emphasized that all new tobacco products marketed without premarket authorization are unlawful and subject to enforcement actions, including civil money penalties, seizure, and injunction. The firm, a registered manufacturer with over 70 products, was instructed to submit a written response within 15 working days detailing actions taken to address these violations, including discontinuing violative activities and outlining a compliance plan.