FDA WARNING_LETTER - shopshefa.com - April 29, 2025

On April 18, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to "To Whom it May Concern" regarding ENDS products sold on shopshefa.com. The FDA determined that products like "EB Create BC5000 Thermal Edition Disposable Vape Device – Sour Grape Chew" and "RAZ DC25000 Disposable Vape Device – Mango Loco" are new tobacco products offered for sale or distribution in the U.S. without the required premarket authorization.

These products are considered "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, they are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as required information was not provided under section 905(j).

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