FDA WARNING_LETTER - Relevant Vapes - February 28, 2024

The FDA Center for Tobacco Products issued a Warning Letter to Relevant Vapes on February 27, 2024, after reviewing their website, relevantvapes.com. The FDA determined that the company offers electronic nicotine delivery system (ENDS) products for sale in the U.S. that are considered "tobacco products" under section 201(rr) of the FD&C Act, as they contain nicotine from any source and are intended for human consumption.

The primary violation is the marketing of "new tobacco products" without the required premarket authorization order, as mandated by section 910(a) of the FD&C Act. The FDA identified specific ENDS products lacking authorization: EB Design BC5000 Malibu, Breeze Plus 800 Tiramisu, Funky Republic TI7000 Pink Bomb, Hyde Curve Max – Pina Colada, and Lost Mary MO5000 – Pineapple Apple Pear. These products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because they were not commercially marketed before February 15, 2007, and lack the necessary marketing authorization or exemption.

Relevant Vapes must submit a written response within 15 working days detailing actions taken to address the violations, including discontinuing sales and a plan for future compliance. Failure to comply may