FDA Asks Court for PMTA Extension

120-day reprieve gives nicotine manufacturers more time during coronavirus crisis
Photograph: Shutterstock

WASHINGTON — The U.S. Food and Drug Administration (FDA) has taken a critical step toward pushing back the May 12 deadline for tobacco and nicotine manufacturers to apply to keep e-cigarettes and other new products on the market, the agency has announced.

On March 30, the FDA filed a motion with the U.S. District Court for the District of Maryland requesting a 120-day extension of the premarket application deadline for many e-cigarettes, cigars and other tobacco products.

In the motion, the agency said the extension was needed solely because of the coronavirus outbreak, and that it would not do so “but for these highly unusual circumstances.”

If granted, the 120-day extension would move the deadline to Sept. 9, 2020.

“FDA remains aware of the recent surge in youth use of e-cigarettes and the public health imperative that these and other deemed new tobacco products undergo premarket review,” the FDA said. “The agency is committed to implementing and enforcing the premarket requirements in the law.”

Lakeville, Minn.-based NATO submitted a letter March 24 to the FDA’s Center for Tobacco Products (CTP) asking for an extension of the deadline. Tom Briant, executive director for the tobacco retailing association, asked Mitch Zeller, director of the CTP, to petition the court because “retail employees would need to determine whether hundreds of deemed tobacco products can remain on store shelves if [PMTAs] are submitted to the FDA by May 12, 2020, or need to be removed from stores if such applications are not submitted to the agency by that deadline.”

The extra burden would take away from the task of providing essential products such as food and fuel to the public, Briant said.

FDA officials strongly encouraged applicants who are able to submit applications to do so as soon as possible, asking companies with a large number of submissions to contact the agency to discuss their plans and method of submission.

On July 12, 2019, the U.S. District court ordered the FDA to require submission of applications for premarket review by May 12, 2020, for deemed new tobacco products on the market as of Aug. 8, 2016.

If the court grants this extension, the FDA intends to revise its January 2020 enforcement priorities guidance to be consistent with the new deadline, the agency said. Consistent with the original court order, the agency would also intend to provide companies that submit timely applications with continued enforcement discretion for a period of up to one year from the date an application was submitted—up to Sept. 9, 2021, if the 120-day extension is granted—or unless a negative action is taken by FDA during that time.

Until a court decision is made, the May 12, 2020, deadline is in effect. The FDA encouraged manufacturers who have concerns about meeting that deadline for any reason to contact the agency directly.

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