FDA WARNING_LETTER - Vapor Rage LLC - October 26, 2021

The FDA issued a Warning Letter to Alexander Assa and Nick Mullen of Vapor Rage on October 15, 2021, following a review of their website, vapor-rage.com. The FDA determined that e-liquid products, specifically "Nancy’s Blend" and "Wicked Brew," were being manufactured and sold 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 core violation is that these e-liquid products are "new tobacco products" as they were not commercially marketed in the U.S. as of February 15, 2007, and lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

Vapor Rage is a registered manufacturer with over 1,800 products listed with the FDA. A Premarket Tobacco Product Application (PMTA) (STN PM0001115) submitted on September 5, 2020, resulted in a Refuse to Accept determination for 29 products on July 6, 2021, and a Marketing Denial Order