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09/10/2021

FDA Takes Action on 90% of PMTAs for Newly Deemed Products

The agency denied applications for nearly 1 million flavored electronic nicotine delivery systems.
FDA's newly deemed tobacco products

SILVER SPRING, Md. — One year after the deadline for premarket applications for newly deemed tobacco products, the Food and Drug Administration (FDA) has moved on the lion's share of the submissions.

On Sept. 9, the agency said it has taken action on 93 percent of the premarket tobacco applications (PMTAs) manufacturers submitted for more than 6.5 million tobacco products. Of those submissions, the FDA issued Marketing Denial Orders (MDO) for nearly 1 million flavored electronic nicotine delivery systems (ENDS).

In a joint release, Acting FDA Commissioner Janet Woodcock and Mitch Zeller, director of the FDA's Center for Tobacco Products said the agency issued the MDOs because the product applications "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."

A majority of the PMTAs submitted by the court-ordered deadline of Sept. 9, 2020 were for ENDS products, including electronic cigarettes and e-liquids.

The agency had 12 months to complete the reviews of all the submitted PMTAs — a court-required deadline the agency did not meet.

"… There's more work to be done to complete our remaining reviews and ensure that we continue taking appropriate action to protect our nation's youth from the dangers of all tobacco products, including e-cigarettes, which remain the most commonly used tobacco product by youth in the United States," Woodcock and Zeller said.

In all, the agency has taken action on applications for more than 6 million ENDS products, including refusing to file one company's applications for approximately 4.5 million products because required contents were missing, as well as issuing 132 MDOs for more than 946,000 flavored ENDS products, including flavors such as Apple Crumble, Dr. Cola and Cinnamon Toast Cereal.

"We continue to work expeditiously on the remaining applications that were submitted by the court's Sept. 9, 2020 deadline, many of which are in the final stages of review. For premarket tobacco product applications, our responsibility is to assess whether applicants meet the applicable statutory standard for marketing their new products. As we have said before, the burden is on the applicant to provide evidence to demonstrate that permitting the marketing of their product meets the applicable statutory standard," Woodcock and Zeller said.

The FDA's review also includes a smaller number of pending applications that are being reviewed under the substantial equivalence standard for cigars, pipes and hookah tobacco. Of those, the agency granted marketing orders covering more than 350 products.