FDA Extends PMTA Review Deadline Until June

Agency now expects to take action on 94% of covered applications by March 31
fda sign
Photograph: Shutterstock

The Food and Drug Administration (FDA) said it has extended its review of premarket tobacco product applications (PMTAs) to the end of June.

As of Dec. 31, 2023, the agency had reviewed 72% of covered applications. A covered application is for new tobacco products that were on the market as of Aug. 8, 2016, with a PMTA filed by Sept. 9, 2020, and are sold under the brand names of Juul, Vuse, Njoy, Logic, Blu, Smok, Suorin or Puff Bar, and reach 2% or more of the total retail sales volumes per NielsenIQ reports.

The agency previously said it would be done reviewing applications by the end of last year, but due to challenges in court and amendments made by manufacturers the date has been pushed back to June 30.

“Many of these amendments contain substantial data and scientific explanation,” the FDA said in its report. “The amendments range from a few pages to hundreds of pages and were received on a rolling basis, with the most recent 2023 amendment being filed in December 2023.”

According to the latest status report, provided by the National Association of Tobacco Outlets (NATO), the FDA expects to have acted on 94% of covered applications by March 31.

Since 2020, the FDA has received applications for more than 26 million deemed products and has made determinations on 99% of these applications. It has authorized 23 tobacco-flavored e-cigarette products and devices. The agency is now under a court order to file regular status reports on its review of PMTAs. The agency said it will file its next status report on or before April 22.

This latest report comes as several PMTAs just this week received a marketing denial order (MDO). On Monday, the agency issued a MDO to Bidi Vapor LLC for its Bidi Stick e-cigarette and on Friday the agency denied PMTAs for certain Suorin and Blu Plus e-cigarette products. Prior to those, on Jan. 16 the agency denied 22 Smok e-cigarettes from Shenzhen IVPS Technology Co. Ltd.

Earlier this month a U.S. Fifth Circuit Court of Appeals, New Orleans ruled for the FDA to reconsider the agency’s decision of barring, Triton Distribution and Vapetasia LLC, makers of flavored liquid for e-cigarette from marketing their products. The ruling added that the FDA acted arbitrarily and capriciously in rejecting consideration of marketing plans from the makers.

The court ruled in an opinion by Judge Andrew Oldham that the FDA “sent manufacturers of flavored e-cigarette products on a wild goose chase” regarding the terms necessary for these manufacturers to get approval only to have their applications denied.

A full list of marketing order decisions can be found on the FDA’s website.

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