WASHINGTON — While the U.S. Food and Drug Administration (FDA) says it remains focused on curbing the recent rise of e-cigarette use among young people, the agency fears a recent court decision to push up deadlines for new tobacco-product applications could “abruptly clear the market of e-cigarette products,” officials said in court documents.
On May 15, a federal judge in the U.S. District Court in Maryland vacated the FDA’s August 2017 guidance that reset premarket tobacco application (PMTA) deadlines from 2018 to August 2021 for combustibles such as cigars and August 2022 for electronic devices such as e-cigarettes.
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 the FDA’s 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 filing said, “A ‘public health outcome that should be avoided if at all possible, while still achieving the public health benefits of earlier premarket review for … [new tobacco] products, especially with respect to curtailing youth use’.”
The FDA suggested 10 months after any court ruling on the matter, along with a one-year period for the FDA to review the submitted applications. “That would strike a better balance among public health considerations, and allow the agency some time to prepare to absorb a flood of applications significantly sooner than anticipated,” the filing said.
Agreeing to the FDA’s new deadline would also allow the agency to finalize its March 2019 draft guidance, in which it declares its enforcement priorities. That is “one of the most critical public health steps that [the] FDA can take to curb youth vaping,” the document said.