Washington, D.C. –It’s a ‘no’ for marketing flavored electronic nicotine dielivery system products (ENDS), according to the FDA.
On Aug. 26, the U.S. Food and Drug Administration issued a batch of more than 50,000 marketing denial orders for ENDS products, including vapes and e-cigarettes.
According to the FDA, the applicants did not provide sufficient evidence that e-cigarettes have any benefit for adult smokers that outweighs the public health threat of children using the products.
“Congress gave the FDA the authority to regulate tobacco products to protect the public from the harmful effects of tobacco use through science-based regulation,” said Acting FDA Commissioner Janet Woodcock, M.D.
“Ensuring new tobacco products undergo an evaluation by the FDA is a critical part of our aim to reduce tobacco-related disease and death. We know that flavored tobacco products are very appealing to young people, therefore assessing the impact or potential or actual youth use is a critical factor in our decision-making about which products may be marketed.”
The FDA has received applications from more than 500 companies covering over 6.5 million tobacco products since the Sept. 9, 2020 court-ordered deadline for submitting premarket applications for new tobacco products.
The agency has stated that it is committed to working to transition the current marketplace so that all vape products available for sale are “appropriate for the protection of public health.”
The products under the marketing denial order may not be introduced or delivered for introduction into interstate commerce. If the product is on the market already, then the law requires it be removed.
The mass rejection does not cover every product from the three companies that applied; remaining vape products remain under consideration.
For example, JD Nova Group LLC had 4.5 million of their products rejected because they did not meet filing requirements for new products.
“Flavored ENDS products are extremely popular among youth, with over 80 percent of e-cigarette users between ages 12 through 17 using one of these products. Companies who want to continue to market their flavored ENDS products must have robust and reliable evidence showing that their products’ potential benefit for adult smokers outweighs the significant known risk to youth,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products.
“The burden is on the applicant to provide evidence to demonstrate that the marketing of their product meets the statutory standard of ‘appropriate for the protection of the public health.’ If this evidence is lacking or not sufficient, the FDA intends to issue a marketing denial order, which requires the product to be taken off or not introduced to market.”
In order for a flavored vape product to be approved, a company must provide acceptable scientific evidence of its benefit to adult smokers. The FDA suggests that evidence be provided via a randomized controlled trial or longitudinal cohort study.
