FDA WARNING_LETTER - CLS Trading, LLC d/b/a Vape Dudes HQ - January 15, 2021

On January 15, 2021, the FDA issued a Warning Letter to Chris Snuffer of Vape Dudes, following a review of their website, vapedudes.com. The FDA determined that e-liquid products, specifically "Ice ICE," were 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 regulation.

The primary violation identified is the marketing of a "new tobacco product" without the required premarket authorization order, as mandated by section 910(a) of the FD&C Act. "Ice ICE" was deemed a new tobacco product because it was not commercially marketed in the U.S. as of February 15, 2007, and lacked an FDA marketing authorization order or exemption. Consequently, the product is considered adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required information under section 905(j).

Vape Dudes, a registered manufacturer with over 25,800 products listed with FDA, is responsible for ensuring compliance across all its tobacco products, labeling, and advertising. Failure to address these violations may result in regulatory actions, including civil money penalties, seizure, and/or injunction. The company