FDA has reviewed about 99% of the PMTAs it received for e-cigarette products.
The US Food and Drug Administration (FDA) issued marketing denial orders (MDO) to 10 companies, which collectively manufacture and market approximately 6,500 flavored e-liquid and e-cigarette products. The companies may not market or distribute these products in the US, and retailers who sell these products risk FDA enforcement action.
FDA said the premarket tobacco product applications (PMTA) for these products did not provide sufficient evidence to show that permitting the marketing of these products would be appropriate for the protection of the public health. Flavors of some of the products denied include citrus, strawberry cheesecake, cool mint, and menthol.
“Science is a cornerstone of FDA’s tobacco product review process,” said Matthew Farrelly, Ph.D., director of the Office of Science within FDA’s Center for Tobacco Products (CTP). “[The] 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.”
Char Owen, president of the American Vapor Manufacturers Association, told The Washington Post, “It doesn’t really matter to the FDA what your scientific evidence is or anything else, they’re pretty much handing anyone out there an MDO (market denial order).”
FDA disclosed the names of eight of the ten businesses it issued MDOs to, declining to disclose the names of the other two in order to preserve potentially sensitive consumer information.
The eight companies are: Imperial Vapors LLC, Savage Enterprises, Big Time Vapes, SWT Global Supply Inc., Great Lakes Vapor, DNA Enterprise LLC dba Mech Sauce, Absolute Vapor Inc., and ECBlend LLC.