The U.S. Food and Drug Administration issued its first marketing denial orders (MDOs) for electronic nicotine delivery system (ENDS) products. The FDA made the determination that these applications–representing about 55,000 flavored ENDS products from three different applicants–lacked the sufficient evidence demonstrating how they would benefit adult smokers and aid in the growing numbers of youth using these products.
The companies that received the MDOs include JD Nova Group LLC which received a refuse to file letter weeks ago [read more here], Great American Vapes, and Vapor Salon. The products involved in these denial orders are non-tobacco flavored ENDS products that include flavors such as Dr. Cola, Cinnamon Toast Cereal and Apple Crumble.
“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. in a press release. “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.”
Since these companies had submitted a PMTA that was then issued a MDO in response, the products that were submitted to the FDA for review must now be removed from the market. These companies all have other applications that are still being reviewed by the FDA.