FDA WARNING_LETTER - Vapemarkdown.com - February 28, 2024

The FDA Center for Tobacco Products issued a Warning Letter on February 27, 2024, to Vape Mark Down (vapemarkdown.com) after reviewing their website and determining they offer electronic nicotine delivery system (ENDS) products for sale in the U.S. These products are considered tobacco products under the FD&C Act, specifically section 201(rr), which includes products containing nicotine from any source.

The primary violation identified 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 specific products cited are: Elf Bar BC5000 13ML Rechargeable Disposable Pod Device – Rainbow Cloudz, Lost Mary by Elf Bar MO5000 13.5ML Rechargeable Disposable Vape – Berry Rose Duo Ice, Elf Bar Funky Republic TI7000 17ML Rechargeable Disposable Vape – Pomelo Pearl Grape, Cali Bars 12ML Disposable Pod Device – Fresh Berries, and Hyde Edge Recharge 10ML Disposable Pod Device – Mango Peaches & Cream. These products are deemed "new" because they were not commercially marketed in the U.S. as of February 15, 2007, and lack the necessary FDA marketing authorization or exemption.

Consequently, these products are adulterated under section 902(6)(A) and mis