FDA WARNING_LETTER - Vape Juice Depot - May 01, 2024

On April 30, 2024, the FDA's Center for Tobacco Products issued a Warning Letter to VapeJuiceDepot.com after reviewing their website and determining they offer electronic nicotine delivery system (ENDS) products for sale in the U.S. These products are classified as tobacco products under section 201(rr) of the FD&C Act, including those with nicotine from any source, as per the Consolidated Appropriations Act, 2022.

The FDA identified three specific ENDS products lacking required premarket authorization: Elf Bar Vape/EB Design TE 6000 Disposable - Strawberry Ice, Funky Republic Vape/Funky Republic Ti7000 Disposable – Mango Kiss, and Lost Mary Vape/Lost Mary OS5000 Disposable – Cherry Peach Lemonade. These are considered "new tobacco products" under section 910(a) of the FD&C Act because they were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization orders or exemptions.

Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required premarket authorization and failure to provide necessary information under section 905(j). The letter mandates a written response within 15