FDA WARNING_LETTER - ejuice-online.com - May 20, 2025

On May 9, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to "To Whom It May Concern" regarding the website https://ejuice-online.com. The FDA determined that the website offers for sale or distribution in the U.S. electronic nicotine delivery system (ENDS) products that are considered "tobacco products" under section 201(rr) of the FD&C Act, as amended to include nicotine from any source.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the EB Designs BC5000 Disposable Vape 5000 Puffs - Strawberry Pear Orange Ice and Funky Republic Ti7000 Disposable Vape by Elf Bar 7000 Puffs – California Cherry were cited. These products are deemed "new tobacco products" 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 adulterated under section 902(6)(A) of the FD&C Act and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required premarket notification. The letter emphasizes that all new tobacco products on the market without statutory premarket authorization are unlawfully marketed and subject to enforcement.

The FDA requires a