Vapor Rage LLC – FDA Warning Letter, Nov 17, 2023

The FDA issued a Warning Letter to Vapor Rage LLC on November 16, 2023, following a review of inspection records. The FDA determined that Vapor Rage LLC manufactures and distributes e-liquid products, specifically "Sour Apple," which are considered tobacco products under section 201(rr) of the FD&C Act, as they contain nicotine and are intended for human consumption.

The primary violation identified is that the "Sour Apple" e-liquid product is a "new tobacco product" that was not commercially marketed in the U.S. as of February 15, 2007, and lacks the required premarket marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, this product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as no notice or information was provided as required by section 905(j). The failure to provide such a report is also a prohibited act under section 301(p).

Vapor Rage LLC is required to submit a written response within 15 working days detailing actions taken to address the violations, including discontinuing the sale and distribution of the non-compliant products and outlining a plan for maintaining compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure