FDA denies marketing of nearly 6,500 flavored e-cigarette products

The FDA has issued marketing denial orders to 10 companies that manufacture and market approximately 6,500 flavored e-liquid and e-cigarette products.

The companies, including Imperial Vapors LLC, Savage Enterprises, Big Time Vapes, SWT Global Supply Inc., Great Lakes Vapor, DNA Enterprise LLC dba Mech Sauce, Absolute Vapor Inc., ECBlend LLC, among others, cannot market or distribute the products in the U.S. and retailers who sell them risk FDA enforcement action, according to a press release from the agency.

The FDA stated in the release that “premarket tobacco product applications (PMTAs) submitted for various flavored e-cigarette products did not provide sufficient evidence to show that permitting the marketing of these products would be appropriate for public health.”

This marketing denial order is among recent efforts the FDA has taken to review and issue decisions on applications for more than 26 million new tobacco products, the majority of which include e-cigarette products.

“Science is a cornerstone of FDA’s tobacco product review process,” Matthew Farrelly, PhD, director of the Office of Science within FDA’s Center for Tobacco Products, said in the release. “Today’s decision to deny approximately 6,500 products was based on the lack of scientific evidence provided in the applications. We will continue to ensure all new tobacco products undergo robust, scientific premarket evaluation to determine whether they meet the appropriate public health standard to be legally marketed.”