FDA WARNING_LETTER - Shenzhen Greensound High-Tech Co. Ltd. d/b/a ENVA - September 13, 2024

The FDA's Center for Tobacco Products issued a Warning Letter on September 12, 2024, to the manufacturer of ENDS products sold on myenva.com. The FDA determined that products like "ENVA P8000 Strawberry Kiwi" and "VANE P8000 Pink Lemonade" are being manufactured and offered for sale or distribution in the United States without the required premarket authorization.

Under section 201(rr) of the FD&C Act, these products are classified as tobacco products, subject to FDA jurisdiction. Since March 15, 2022, the definition of "tobacco product" includes products containing nicotine from any source. "New tobacco products," defined as those not commercially marketed in the U.S. as of February 15, 2007, require a premarket authorization order or an exemption.

The identified ENDS products are considered new tobacco products and lack the necessary FDA marketing authorization, making them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The letter states that all new tobacco products on the market without premarket authorization are 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 to address violations, including discontinuation of sales and