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08/27/2021

FDA Issues First Denials of Flavored E-Cigarette Marketing Applications

The agency rejects filings for roughly 55,000 products submitted by three companies.
vapor products

SILVER SPRING, Md. — The Food and Drug Administration (FDA) denied the marketing applications for approximately 55,000 flavored electronic cigarette products.

According to the agency, the filings — which were submitted by three applicants — failed to provide evidence the products protect public health. The rejections are the first for electronic nicotine delivery systems (ENDS).

The product applications are from JD Nova Group LLC, Great American Vapes and Vapor Salon, and they include flavors 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 action comes almost a year after the agency's Sept. 9, 2020 deadline for premarket tobacco applications for newly deemed tobacco products.

In all, the FDA 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 marketing denial orders it has issued for applications that have reached the substantive scientific review portion of premarket review.

According to the agency, the products that were rejected cannot be brought to market and need to be removed if they are already on the market. The orders do not include all ENDS products for which the companies submitted applications. Applications for the rest of the products remain under consideration.