FDA WARNING_LETTER - reBreathe Vapor Products - August 31, 2021

The FDA Center for Tobacco Products issued a Warning Letter to Debbra Warren regarding e-liquid products manufactured and sold via rebreathevapor.com. The FDA determined that products like reBreathe Vapor MBL and reBreathe Vapor MBL Menthol are "new tobacco products" under section 201(rr) of the FD&C Act, as they are derived from tobacco and intended for human consumption, and were not commercially marketed in the U.S. as of February 15, 2007.

These products are in violation because they lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act, making them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) due to the absence of required notice or information under section 905(j).

The letter emphasizes the firm's responsibility, as a registered manufacturer with over 800 listed products, to ensure compliance with the FD&C Act and FDA regulations. Failure to correct these violations may result in regulatory actions including civil money penalties, no-tobacco-sale orders, seizure, and/or injunction. The firm must submit a written response within 15 working days detailing corrective actions, including discontinuation of violative sales and a plan for ongoing compliance.