FDA WARNING_LETTER - The Zen Vaper E-Liquids, LLC - November 30, 2021

The FDA Center for Tobacco Products issued a Warning Letter to Donald Thompson regarding e-liquid products sold on thezenvaper.com. The FDA determined these e-liquids are tobacco products under the FD&C Act and require premarket authorization.

The inspection revealed that products like Apple Fritter, French Toast, and Loopy Milk - Fruity Cereal & Milk are "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007. These products lack the required FDA marketing authorization order, rendering them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

Although the firm is a registered manufacturer with over 800 listed products and submitted a Premarket Tobacco Product Application (PMTA) (STN PM0003686) on September 9, 2020, FDA issued a Marketing Denial Order for this PMTA on September 15, 2021, covering 125 products.

The letter emphasizes that all new tobacco products marketed without premarket authorization are unlawful and subject to enforcement actions, including civil money penalties, seizure, and/or injunction. The firm must submit a written response within 15 working days detailing actions taken to address violations, including discontinuing sales and a plan for future compliance.