FDA WARNING_LETTER - First Class Distribution, LLC d/b/a EJuice Store - May 01, 2024

On April 30, 2024, the FDA's Center for Tobacco Products issued a Warning Letter to Royce Pearson regarding the sale of electronic nicotine delivery system (ENDS) products on ejuicestore.com. The FDA determined that certain ENDS products offered for sale are "tobacco products" under section 201(rr) of the FD&C Act, including those containing nicotine from any source, following a legislative amendment on March 15, 2022.

The letter states that "new tobacco products" require premarket authorization. The FDA identified three specific ENDS products lacking this authorization: Elf Bar BC5000 Vape – Strawberry Watermelon, Pineapple Mango Disposable Vape (5000 Puffs) by Lost Mary OS5000, and Pink Bomb Disposable Vape (7000 Puffs) by Funky Republic TI7000. These products are considered "new tobacco products" as they were not commercially marketed in the U.S. as of February 15, 2007, and lack the required FDA marketing authorization or 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 FDA requires a written response within 15 working days detailing actions taken to address the violations, including discontinuing sales and a