The U.S. Food and Drug Administration has rejected the marketing approval application for about 55,000 flavored electronic nicotine delivery system (ENDS) products from three applicants. This is the FDA’s first marketing denial orders (MDOs) for ENDS products, though it has issued other negative actions for some applications earlier.

“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.

The FDA’s review of new tobacco products before they can be legally marketed ensures that they meet the standard Congress set in the law to protect the public health.

The FDA denied the applications from JD Nova Group LLC, Great American Vapes, and Vapor Salon for lack of sufficient evidence that the products have a benefit to adult smokers sufficient to overcome the public health threat posed by youth use of such 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.

The products subject to this action are non-tobacco-flavored ENDS and they include flavors such as Apple Crumble, Dr. Cola and Cinnamon Toast Cereal.

The action ensures that new tobacco products undergo an evaluation by the FDA as it is critical for them to reduce tobacco-related disease and death. These products were the first set of MDOs issued by the FDA after completing the substantive scientific review part of the premarket review.

The FDA has received applications from more than 500 companies covering more than 6.5 million tobacco products ahead of the September 9, 2020 court-ordered deadline for submission of premarket applications for deemed new tobacco products.

The FDA said it is focused on transitioning the current marketplace to one in which all ENDS products available for sale have demonstrated that they are “appropriate for the protection of the public health.”

The FDA has advised that none of the products that are subject to an MDO for a premarket application should be marketed. If so, the product must be removed from the market or risk enforcement.

The federal agency had previously notified one of the companies, JD Nova Group LLC, that their premarket tobacco product applications associated with approximately 4.5 million of their products did not meet the filing requirements for a new tobacco product seeking a marketing authorization.

Data from the 2020 National Youth Tobacco Survey (NYTS) shows that 1.8 million fewer U.S. youth are currently using e-cigarettes compared to 2019, after two years of disturbing increases in youth e-cigarette use. However, the FDA remains very concerned about the 3.6 million U.S. youth who currently use e-cigarettes.

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