GREENBELT, Md.— A U.S. District Court judge imposed a 10-month deadline for manufacturers of electronic cigarettes to turn in applications to the U.S. Food and Drug Administration (FDA) for permission to market their products in the United States, agreeing with the agency’s newly suggested timetable, according to court documents.
In the meantime, manufacturers can still lawfully market and sell e-cigarettes until that deadline and through the review process, if they submit a premarket tobacco application (PMTA) to the FDA in a timely manner.
Over the past couple of years, the FDA has shifted its PMTA deadlines, with the latest being 2021 for combustible products like cigars and hookahs and 2022 for nicotine-delivery devices like e-cigarettes. Then this past May, Judge Paul Grimm of the U.S. District Court for Southern Maryland decided in favor of a lawsuit filed by anti-tobacco groups to nullify that 2022 deadline for e-cigarettes.
The FDA responded with its own court filing, asking Grimm for a timeframe of 10 months following his final ruling and another year after that for it to review the submitted applications. On July 12, Grimm allowed for both the 10-month deadline—making it May 2020—and the yearlong review period after that.
“The FDA stands ready to accelerate the review of e-cigarettes and other new tobacco products … and we remain committed to tackling the epidemic of youth vaping using all available regulatory tools at our disposal,” said Ned Sharpless, acting commissioner for the FDA. “We will continue to take vigorous enforcement actions aimed at ensuring e-cigarettes and other tobacco products aren’t being marketed to, or sold to, kids.”
Plaintiffs in the May 15 ruling, a range of anti-tobacco groups that includes the American Academy of Pediatrics, the American Cancer Society and the American Heart Association, filed the lawsuit in March 2018 and asked for new deadlines of “within four months” of the FDA’s June 12 response, according to an FDA court filing. The four-month deadline would create “massive administrative burdens” on the agency by placing an expected 5,424 to 6,764 applications on its desks for review.
“More importantly, such a precipitous deadline would threaten to abruptly clear the market of e-cigarette products, creating a ‘genuine risk’ that adult former smokers addicted to nicotine would ‘migrate from potentially less harmful [electronic nicotine-delivery systems, or ENDS,] products [such as e-cigarettes] back to combustible tobacco products,’ ” the FDA filing said.
Earlier this year, the FDA authorized IQOS, the “heat not burn” product from New York-based Philip Morris International, for marketing and sale in the United States. The device heats compressed sticks of tobacco to deliver nicotine.