FDA issued the first marketing denial orders (MDOs) for electronic nicotine delivery system (ENDS) products after determining the applications for about 55,000 flavored ENDS products from three applicants lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health threat posed by the well-documented, alarming levels of youth use of such products. The products from JD Nova Group LLC, Great American Vapes, and Vapor Salon subject to this action are non-tobacco-flavored ENDS and they include flavors such as Apple Crumble, Dr. Cola and Cinnamon Toast Cereal. This action represents a significant step toward making progress on the unprecedented number of applications received by the Sept. 9, 2020 court-ordered deadline for submission of premarket applications for deemed new tobacco products, and addressing youth use of flavored ENDS products. FDA has received applications from over 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 FDA has issued for applications that have reached the substantive scientific review portion of premarket review. The agency is committed to working to transition 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 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. |
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