The U.S. Food and Drug Administration has issued marketing denial orders (MDOs) for about 55,000 flavored electronic nicotine-delivery system (ENDS) products from JD Nova Group, Great American Vapes and Vapor Salon. In a news release published on its website, the agency explained that the applications from the three applicants lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health threat posed by the levels of youth use of such products.
The products subject to this action include flavors with names 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. “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.”
The FDA has received applications from more than 500 companies covering more than 6.5 million tobacco products. Although the agency has issued other negative actions for some applications, this is the first set of MDOs the FDA has issued for applications that have reached the substantive scientific review portion of premarket review.
The products subject to an MDO for a premarket application may not be introduced or delivered for introduction into interstate commerce. If the product is already on the market, the product must be removed from the market or risk enforcement. The MDOs announced today do not include all ENDS products for which the companies submitted applications. Applications for the rest of the products remain under consideration.
Recently, the agency refused to file more than 4.5 million applications from JD Nova Group on the basis that they did not meet the filing requirements for a new tobacco product seeking a marketing authorization.
“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, 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.”
The FDA has until Sept. 9, 2021, to decide on the remaining estimated 2.5 million PMTAs.