FDA WARNING_LETTER - Shenzhen Fumot Technology Co., Ltd. - November 16, 2022

The FDA issued a Warning Letter to Xiochuan Chen on November 16, 2022, after reviewing the websites https://www.fumot-tech.com and https://randmvape.com. The review determined that Electronic Nicotine Delivery System (ENDS) products, classified as tobacco products under section 201(rr) of the FD&C Act, were being manufactured and offered for sale or distribution in the United States without required premarket authorization.

Specific products cited for lacking marketing authorization include Fumot Original RandM Max Pro, RandM Squid Bar, RandM Squid Box, RandM Switch 2in1, RandM Dazzle 5000, and RandM Dazzle Pro 2600. These are considered "new tobacco products" as they were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization orders or exemptions. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The FDA also expressed concern that the product labeling and advertising for RandM products imitate popular TV shows and movies, potentially promoting youth use. The letter emphasizes that sales of such unauthorized tobacco products are prohibited and contribute to public health concerns.

The FDA has not received marketing authorization applications for these products