FDA WARNING_LETTER - ZOVOO Technology Co., Ltd. Shenzhen - December 12, 2023

The FDA's Center for Tobacco Products issued a Warning Letter to ZOVOO (Shenzhen) Technology Co Ltd. on December 1, 2023, after reviewing their website, izovoo.com. The review determined that the company manufactures and offers Electronic Nicotine Delivery System (ENDS) products for sale or distribution in the United States. These products are classified as tobacco products under section 201(rr) of the FD&C Act, as they contain nicotine and are intended for human consumption.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization order. Specifically, the products ZOVOO Dragbar F8000 Disposable (Strawberry Orange Mango), ZOVOO Dragbar R6000 Disposable (Watermelon Cherry), and ZOVOO Dragbar 6500 Disposable (Sour Berry) were found to be new tobacco products because they were not commercially marketed in the U.S. as of February 15, 2007, and lack the necessary FDA marketing authorization or exemption.

Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required premarket notification or authorization. The FDA has not received any marketing authorization applications for these products from the firm.

The Warning Letter requires a written response within