Juul in Jeopardy?

FDA’s decision imminent on taking company’s e-cigarettes off U.S. market: report
Photograph: Shutterstock

SILVER SPRING, Md. — The U.S. Food and Drug Administration (FDA) is preparing to order Juul Labs Inc. to take its electronic cigarettes off the U.S. market, people familiar with the matter told the Wall Street Journal.

The FDA could announce its decision as early as Wednesday, the people said.

Washington, D.C.-based Juul did not respond to a CSP request for comment by posting time.

“We expect the company to appeal, with the products remaining on the market,” Vivien Azer, managing director for cannabis, consumer beverages and tobacco at Cowen Inc., New York, said in a research note.

The marketing denial order would follow a nearly two-year review of data presented by the vaping company, which sought authorization for its tobacco- and menthol-flavored products to stay on the U.S. market.

The FDA has barred the sale of all sweet and fruity e-cigarette cartridges. The agency has cleared the way for Juul’s biggest rivals, Reynolds American Inc., Winston-Salem, N.C., and NJOY Holdings Inc., Scottsdale, Ariz., to keep tobacco-flavored e-cigarettes on the market. Industry observers had expected Juul to receive similar clearance, said the report.

The FDA is reviewing premarket tobacco product applications (PMTAs) for electronic nicotine delivery systems (ENDS)—but for some of the big brands like Juul, Vuse, NJOY, Logic and Blu, decisions may not come until June 2023, according to earlier reports.

The FDA’s court-ordered deadline to complete the review of PMTAs was Sept. 9, 2021, one year after the applications were due; however, it did not meet that deadline. Now the agency is under a Maryland Federal District Court order to file regular status reports on its review of PMTAs.

The FDA has resolved more than 99% of the more than 6.5 million timely applications it received, it said in a May 13 status report filed with the district court, a copy of which was provided by the National Association of Tobacco Outlets (NATO), Minneapolis.

“Given the large influx of concurrent applications, the FDA prioritized review of applications from manufacturers with the greatest market share at the time because decisions on those applications were expected to have the greatest impact on public health,” the FDA said in the status report. “As a result, the FDA allocated significant resources to review applications from the five companies whose brands represented over 95% of the e-cigarette market at that time: Fontem (blu), Juul, Logic, NJOY and R.J. Reynolds (Vuse).”

The agency gave a breakdown of when it expected to be done with decisions on covered applications. Covered applications are limited to applications for new tobacco products on the market by Aug. 8, 2016. They also must have been filed by the Sept. 9, 2020, PMTA deadline. Finally, covered applications are products sold under the brand names Juul, Vuse, NJOY, Logic, Blu, SMOK, Suorin or Puff Bar, or that reach 2% of total retail dollar sales in Chicago-based NielsenIQ’s Total E-Cig Market & Players or Disposable E-Cig Market & Players reports.

To calculate the percentages in its report, the FDA counted each tobacco product for which a marketing order was sought as a separate application, even if the manufacturer made a single submission for multiple products.

Using those definitions, the FDA identified 240 covered applications and provided the following forecast for review completion:

  • 51% by June 30
  • 52% by Sept. 30
  • 56% by Dec. 31
  • 56% by March 31, 2023
  • 100% by June 30, 2023

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