Full story from FDA:
On January 16, FDA issued marketing denial orders (MDOs) to Shenzhen IVPS Technology Co., Ltd for 22 SMOK brand e-cigarette products. The denied products include devices, pods, atomizers, and cartridges, which are part of an e-cigarette system marketed without an e-liquid. The company must not market or distribute these products in the United States or they risk FDA enforcement action. However, the company may submit new applications for the products that are subject to these MDOs.
“Science is a cornerstone of FDA’s tobacco product review process, and CTP remains committed to evaluating applications based on a public health standard that considers the risks and benefits of the tobacco product to the population as a whole,” said Brian King Ph.D., M.P.H., Director of FDA’s Center for Tobacco Products. “It is the applicant’s responsibility to provide sufficient scientific evidence to demonstrate that marketing a new tobacco product is appropriate for the protection of the public health. In this case, the applicant failed to provide this evidence.”