NATIONWIDE — The U.S. Food and Drug Administration (FDA) has issued marketing denial orders (MDO) for almost 55,000 flavored electronic nicotine delivery system (ENDS) products after it was determined that applications lacked the evidence that the products would appropriately protect public health.
According to an FDA release from Aug. 26, the denial orders were issued to three different applicants: JD Nova Group, LLC, Great American Vapes, and Vapor Salon. The applicants failed to show enough a benefit for adult smokers, to overcome the spike in underage use of the products. The order is in effect for non-tobacco flavored ENDS products such as Apple Crumble, Dr. Cola and Cinnamon Toast Cereal.
“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 of potential or actual youth use is a critical factor in our decision-making about which products may be marketed.”
According to Mitch Zeller, director of the FDA’s Center for Tobacco Products, a study showed that more than 80 percent of teenage tobacco users are using flavored ENDS.
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,” Zeller said. “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.’”
The FDA received applications from more than 500 companies ahead of court-ordered Sept. 9, 2020 court-ordered deadline for submission of premarket applications to sell new tobacco products. Part of the application requirement was to address underage use of ENDS products. The products saddled with the MDO may not be introduced or delivered for introduction into interstate commerce.