FDA WARNING_LETTER - Revolution Vapor LLC - March 12, 2021

The FDA's Center for Tobacco Products reviewed Revolution Vapor's website, revolutionvapor.com, and determined that e-liquid products, specifically "Revolution Vapor Fruit Bomb" and "Revolution Vapor Arctic Ice," are manufactured and offered for sale or distribution 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 identified violations stem from these e-liquid products being "new tobacco products" that 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 because the required notice or information under section 905(j) was not provided.

Revolution Vapor, a registered manufacturer with over 19,400 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 actions taken to address the violations, including discontinuing the sale and distribution of the non-compliant products and a