EBS Trading Group LLC – FDA Warning Letter, Jul 16, 2024

The FDA issued a Warning Letter to Sagi Isaschar regarding the website https://thevapersworld.com, which offers electronic nicotine delivery system (ENDS) products for sale in the United States. These products are considered tobacco products under section 201(rr) of the FD&C Act, as amended by the Consolidated Appropriations Act, 2022, to include nicotine from any source.

The FDA determined that two specific ENDS products, "Elf Bar Vape Disposable BC5000 – Crazi Berry" and "Lost Mary BM5000 Disposable Vape Device 3% Nic – Cranberry Soda," are "new tobacco products" that lack the required premarket authorization order. These products were not commercially marketed in the U.S. as of February 15, 2007, and do not have FDA marketing authorization or exemptions.

Consequently, these products are deemed adulterated under section 902(6)(A) of the FD&C Act and misbranded under section 903(a)(6) of the FD&C Act because required information was not provided under section 905(j). The letter emphasizes that marketing new tobacco products without premarket authorization is unlawful and subject to enforcement actions, including civil money penalties, seizure, and injunction.

The recipient must submit a written response within 15 working days detailing actions taken to address the violations, including discontinuing sales and a