FDA misses deadline for decision on e-cigarettes

The FDA announced that it is delaying its decision on whether some e-cigarettes can remain on the market.

The agency has acted on about 93% of 6.5 million applications for “deemed” new tobacco products that were submitted for review, with a court-ordered deadline of Sept. 9, according to a joint statement from Janet Woodcock, MD, acting FDA commissioner, and Mitch Zeller, MD, director of the Center for Tobacco Products. Manufacturers had a court-ordered deadline to submit applications by Sept. 9, 2020. The FDA had 1 year to review the applications.

The FDA said it requires additional time to process the remaining applications.

“We continue to work expeditiously on the remaining applications that were submitted by the court’s Sept. 9, 2020, deadline, many of which are in the final stages of review,” Woodcock and Zeller said in the statement.

Most of the applications were for electronic nicotine delivery systems (ENDS) products like e-cigarettes and e-liquids. These products are popular among adolescents, with more than 80% of users aged 12 to 17 years, according to the FDA.

“As of [Sept. 9, 2021], the agency has taken action on applications for over 6 million ENDS products, including refusing to file one company’s applications for approximately 4.5 million products because required contents were missing, as well as issuing 132 marketing denial orders for more than 946,000 flavored ENDS products,” Woodcock and Zeller said.

Notably missing from the FDA’s rejection of tobacco products are applications from the popular e-cigarette manufacturer JUUL.

Lisa Lacasse, president of the American Cancer Society Cancer Action Network, told CNN that the FDA’s failure to act on JUUL products was “extremely disappointing.”

In addition to ENDS products, the FDA is still reviewing a smaller number of applications for cigars, pipes and hookah tobacco.

Many of the ENDS products recently rejected by the FDA have been marketed “unlawfully” for years, spurring a vaping epidemic. Healio has previously reported on the link between vaping and health issues like lung injury, lung irritation, asthma and other respiratory symptoms. Products such as e-cigarettes, cigars and hookah were not regulated prior to August 2016, according to the FDA.

“More robust tobacco control policies are urgently needed,” Michelle N. Eakin, PhD, an associate professor in the division of pulmonary and critical care medicine at Johns Hopkins University, and colleagues wrote in an American Thoracic Society Tobacco Action Committee policy statement that Healio previously reported on.

Woodcock and Zeller claimed the FDA has made “significant progress” in processing the applications.

“There’s more work to be done to complete our remaining reviews and ensure that we continue taking appropriate action to protect our nation's youth from the dangers of all tobacco products, including e-cigarettes, which remain the most commonly used tobacco product by youth in the U.S.,” they said.

References:

CNN. FDA takes more time to decide on e-cigarettes. https://www.cnn.com/2021/09/09/health/fda-vaping-ecigs-market-decision-deadline/index.html. Accessed September 10, 2021.

Eakin MN, et al. Ann Am Thorac Soc. 2021;doi:10.1513/AnnalsATS.202104-493PS.

FDA. FDA makes significant progress in science-based public health application review, taking action on over 90% of more than 6.5 million ‘deemed’ new tobacco products submitted. https://www.fda.gov/news-events/press-announcements/fda-makes-significant-progress-science-based-public-health-application-review-taking-action-over-90. Accessed September 10, 2021.

FDA. FDA’s deeming regulations for e-cigarettes, cigars, and all other tobacco products. https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/fdas-deeming-regulations-e-cigarettes-cigars-and-all-other-tobacco-products. Accessed September 10, 2021.