FDA WARNING_LETTER - Elite Vapes - December 19, 2024

On December 18, 2024, the FDA's Center for Tobacco Products issued a Warning Letter to the entity operating elitevapes.com, identifying the sale and distribution of electronic nicotine delivery system (ENDS) products in the U.S. The FDA determined these products are "tobacco products" under section 201(rr) of the FD&C Act, including those containing nicotine from any source, and are subject to FDA jurisdiction.

The primary violation cited is the marketing of "new tobacco products" without required premarket authorization orders, as mandated by section 910(a) of the FD&C Act. Specific ENDS products listed as lacking authorization include Tyson 2.0 ROUND 2 Vape 7500 – Apple Gummies, Nicky Jam X Fume Vape 10000/Elite Vapes Online Shop – Peach XXX, Death Row Vape DR15000/Elite Vapes Online Shop – Bubble Gum, Funky Republic T17000/Elite Vapes Online Shop – California Cherry, Lost Mary OS5000 Disposable Vape – Oceania Coffee, Geek Bar Vape Pulse 15000 Disposable Vape – Sunny Tart, and Geek Bar Vape Meloso Max 9000 – Coconut Shake. These products are deemed "new" as they were not commercially marketed in the U.S. as of February 15, 2007, and