Shenzhen IVPS Technology Co., Ltd., a Chinese manufacturer of electronic nicotine delivery system (ENDS) products, has filed an appeal against the U.S. Food and Drug Administration's (FDA) marketing denial order for six of its SMOK-branded open-system electronic cigarette kits. The appeal, joined by a Dallas-based distributor of the products, has been filed with the U.S. Court of Appeals for the Fifth Circuit.

The FDA issued the marketing denial order on January 16, stating that the applications for the SMOK products failed to provide sufficient data to characterize constituent delivery, product stability, and product abuse liability. However, Shenzhen IVPS strongly challenges these assertions, emphasizing that it invested over $30 million in the applications, collaborated with leading laboratories for extensive testing, and conducted clinical studies to evaluate the products' safety profiles.

The company's CEO, Welfer Ouyang, expressed concern that the FDA's denial is based on isolated data from testing the devices with e-liquids that are not compatible with them. Shenzhen IVPS also disputed the FDA's characterization of youth use of SMOK products, stating that the agency's claims were misleading.

The FDA's marketing denial orders for the SMOK products were issued because the applications lacked sufficient evidence to demonstrate that marketing the products would be appropriate for public health protection. The products include a range of devices, pods, atomizers, and cartridges that are marketed without a specific e-liquid.