Vaping Zone – FDA Warning Letter, Jan 20, 2022

The FDA issued a Warning Letter to Vaping Zone on January 20, 2022, following a review of submissions and inspection records. The FDA determined that Vaping Zone manufactures and distributes e-liquid products, specifically citing "Vaping Zone Red Cig 30ml 6mg e-liquid product," which are deemed tobacco products under section 201(rr) of the FD&C Act and subject to FDA jurisdiction.

The primary violation identified is the marketing of a "new tobacco product" without the required premarket authorization. The "Vaping Zone Red Cig 30ml 6mg e-liquid product" was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as required notice or information was not provided.

The letter states that Vaping Zone is a registered manufacturer with over 11,500 products listed with FDA. All new tobacco products on the market without premarket authorization are considered unlawfully marketed and subject to enforcement actions, including civil money penalties, seizure, and/or injunction.

Vaping Zone is required to submit a written response within 15 working days detailing actions taken to address the violations, including dates of