Ragin’ Vapors – FDA Warning Letter, Oct 25, 2022

The FDA issued a Warning Letter to Ragin’ Vapors on October 20, 2022, following a review of submissions and inspection records. The FDA determined that Ragin’ Vapors manufactures and distributes e-liquid products, specifically "Electric Lemon e-liquid products," which are considered tobacco products under section 201(rr) of the FD&C Act due to containing nicotine from any source.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. The "Electric Lemon e-liquid products" were not commercially marketed in the U.S. as of February 15, 2007, and lack an FDA marketing authorization order, a substantial equivalence order, or an exemption. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The failure to provide a required report under section 905(j) is also cited as a prohibited act.

Ragin’ Vapors is required to submit a written response within 15 working days detailing actions taken to address the violations, including discontinuation dates for violative sales and distribution, and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.