The Vaporatory, LLC – FDA Warning Letter, Feb 26, 2021

The FDA Center for Tobacco Products issued a Warning Letter to Evan Fels regarding e-liquid products manufactured and sold by The Vaporatory, LLC via the website https://thevaporatory.com. The FDA determined these e-liquids are "tobacco products" under section 201(rr) of the FD&C Act and are subject to FDA regulation.

The primary violation identified is the marketing of "new tobacco products" without required premarket authorization. Specifically, "The Vaporatory Blue Razz," "The Vaporatory Black Chapel," and "The Vaporatory Grape Candy" e-liquids were found to be new tobacco products, as they were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization. This renders them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The firm is a registered manufacturer with over 1,700 products listed with FDA. The letter emphasizes the firm's responsibility to ensure all tobacco products and related advertising comply with the FD&C Act and FDA regulations. Failure to address these violations may result in civil money penalties, seizure, and/or injunction. The FDA requires a written response within 15 working days detailing actions taken to address violations, including discontinuing violative sales and a plan for maintaining compliance.