FDA WARNING_LETTER - FUNCOOL Technology Co., Limited d/b/a RAZ Vape - September 13, 2024

On September 12, 2024, the FDA's Center for Tobacco Products issued a Warning Letter to Junhui Pan regarding electronic nicotine delivery system (ENDS) products sold on https://www.raz-vape.com. The FDA determined these products are tobacco products under section 201(rr) of the FD&C Act, subject to FDA jurisdiction and compliance requirements, including those for products containing nicotine from any source as amended on March 15, 2022.

The primary violation is the marketing of "new tobacco products" without required premarket authorization. Specifically, the RAZ Vape DC25000 Disposable Vape Razzle Dazzle, RAZ Vape TN9000 Disposable Vape Sour Mango Pineapple, and RAZ Vape TN9000 Disposable Vape Tropical Storm were identified as new tobacco products not commercially marketed before February 15, 2007, and lacking FDA marketing authorization orders under section 910(c)(1)(A)(i) of the FD&C Act. 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 notices or information under section 905(j).

The FDA requires a written response within 15 working days detailing actions taken to address violations, including discontinuation