The U.S. Food and Drug Administration issued Marketing Denial Orders (MDOs) to Shenzhen IVPS Technology Co., Ltd. for 22 SMOK e-cigarette hardware products.
Rejected products include devices, pods, nebulizers and cartridges. This is the first time the agency has strictly rejected a large number of hardware products from a company.
The FDA said the products were rejected because they were submitted without specific e-cigarette liquids.
After reviewing the company's tobacco premarket application PMTA, the FDA determined that the application lacked sufficient evidence to demonstrate that allowing marketing of the product is appropriate to protect public health under the Family Smoking Prevention and Tobacco Control Act of 2009. required legal standards. More specifically, the applicant failed to provide sufficient data describing ingredient delivery, product stability, and product abuse liability.
