FDA WARNING_LETTER - N2G2, LLC d/b/a The Hookah - June 22, 2023

The FDA Center for Tobacco Products issued a Warning Letter to Nader Marzok of The Hookah (thehookah.com) on June 16, 2023, for offering for sale or distribution in the U.S. unauthorized electronic nicotine delivery system (ENDS) products. The FDA's review of the website found ENDS products, specifically "Elf Bar Disposable Vape Pod – Lemon Mint" and "Elf Bar Disposable Vape Pod – Grape Energy," being sold.

These products 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 the required premarket authorization order. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The letter emphasizes that all new tobacco products without statutory premarket authorization are marketed unlawfully and are subject to enforcement action, including civil money penalties, seizure, and/or injunction. The firm must submit a written response within 15 working days detailing actions taken to address violations, including discontinuing sales and a plan for future compliance.