FDA WARNING_LETTER - Vapors Gold LLC - April 01, 2021

The FDA issued a Warning Letter to Mark West of Vapor's Gold on March 26, 2021, following a review of their website, https://vaporsgold.com. The FDA determined that e-liquid products, specifically "Blu Sour Gummy" and "Netella," are manufactured and offered for sale in the U.S. These products are classified as tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The primary violation is the marketing of "new tobacco products" without the required premarket authorization order, as mandated by section 910(a) of the FD&C Act. Since these e-liquids were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization or exemption, they are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

Vapor's Gold, a registered manufacturer with over 500 products listed with FDA, is responsible for ensuring compliance. Failure to address these violations may result in regulatory actions, including civil money penalties, seizure, and/or injunction. The company must submit a written response within 15 working days, detailing corrective actions, including discontinuing the sale and distribution of the violative products, and a plan