FDA Needs More Time to Review PMTAs

Agency says it has acted on about 93% of timely submitted applications for new tobacco products so far
FDA building
Photograph: Shutterstock

SILVER SPRING, Md. — The U.S. Food and Drug Administration (FDA) has acted on about 93% of the total timely-submitted premarket tobacco product applications (PMTAs)—but it needs more time to review the rest.

No marketing orders have been issued for tobacco products submitted under the PMTA process since Philip Morris Product S.A.’s IQOS application in December 2020, according to the FDA’s website.

That means the fate of products like San Francisco-based Juul’s Juul Device and Juulpods in Virginia Tobacco and Menthol flavors and Winston-Salem, N.C.-based Reynolds American Inc.’s Vuse Alto and Vuse Solo vapor products remains up in the air.  

As of Thursday, a year after the Sept. 9, 2020, application deadline, all new tobacco products on the market without the required premarket authorization are marketed unlawfully and subject to enforcement action at the FDA’s discretion, the agency said.

“The FDA is committed to completing the review of the remaining products as quickly as possible to provide regulatory certainty and will continue to keep the public informed of our progress. In the meantime, products for which no application is pending, including, for example, those with a Marketing Denial Order (MDO) and those for which no application was submitted, are among our highest enforcement priorities,” the agency said in a press release, attributed to Acting FDA Commissioner Janet Woodcock and the FDA’s Center for Tobacco Products Director Mitch Zeller.

The FDA said it plans on issuing a warning letter before initiating enforcement action, such as civil money penalties, seizure or injunction, and afford the recipient an opportunity to respond.

The agency received applications for more than 6.5 million deemed new tobacco products by Sept. 9, 2020, the majority of which were for electronic nicotine delivery systems (ENDS) products, such as e-cigarettes and e-liquids. Its actions so far include issuing MDOs for more than 946,000 flavored ENDS products because they 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,” Woodcock and Zeller said.

“Flavored ENDS products are extremely popular among youth, with over 80% of e-cigarette users ages 12 through 17 using them,” Woodcock and Zeller said. “However, 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.”

The determination of what is appropriate for the protection of the public health will consider youth use of tobacco products as well as the potential for the products to completely move adult smokers away from combustible cigarettes, Woodcock and Zeller said.

Many of the applications submitted by Sept. 9, 2020, are in the final states of review, the FDA said. For PMTAs, the FDA said its responsibility is to assess whether applications meet the applicable statutory standard for marketing their new products. Its review also includes a smaller number of pending applications being reviewed under the substantial equivalence standard, which includes cigars, pipes and hookah tobacco.

The denials that the FDA has released in the past couple of weeks include the issuance of 132 MDOs for more than 946,000 ENDS products, including flavors like Apple Crumble, Dr. Cola and Cinnamon Toast Cereal. A full list of marketing order decisions can be found on the FDA’s website.

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