Anti-tobacco groups urge FDA to act on outstanding applications for e-cigarettes

WASHINGTON — It’s been more than four months since the Food and Drug Administration (FDA) was supposed to decide which e-cigarette products can remain on the market, but the agency still hasn’t completed some of the reviews.

In response, several anti-tobacco groups sent a letter to the FDA urging it to take action on the outstanding premarket tobacco product applications (PMTAs) and pushed for the FDA to deny applications for flavored e-cigarette products.

“We write to urge the U.S. Food and Drug Administration (FDA) to expedite decisions on the premarket tobacco product applications (PMTAs) still pending before the agency involving the flavored e-cigarette products, including those with menthol flavoring and, based on the best available scientific evidence, deny the pending applications for all non-tobacco flavored e-cigarettes in order to protect the nation’s young people from the health harms of these products,” the letter said.

The letter was signed by the American Academy of Pediatrics, the American Heart Association, and the Campaign for Tobacco-Free Kids among others.

“Every day that FDA delays action, more of our kids remain at risk,” said Matthew Myers, President of the Campaign for Tobacco-Free Kids. “While the FDA has ruled on applications from a lot of small companies, it hasn’t ruled on the applications from the large companies whose products are being used by a majority of kids.”

In response to the push by the groups, Gregory Conley, President of the American Vaping Association, pointed to data showing that youth vaping has been declining and blasted anti-tobacco groups who “continue to push for a new drug war by amping up the moral panic around safer nicotine products.”

According to the Centers for Disease Control and Prevention (CDC), the use of e-cigarettes went down among middle and high school students from 2019 to 2020.

But even with the drop, the CDC said it “estimated that more than 2 million U.S. middle and high school students reported currently using e-cigarettes in 2021.”

In a statement, the FDA said:

“The FDA has and continues to make significant progress on our comprehensive actions to protect the public, especially youth, from the harms of tobacco products and looks forward to continuing to work with the Administration to further these goals. When it comes to premarket review of tobacco products, an unprecedented number of products were the subject of applications submitted by the court-ordered September 9, 2020 deadline. Over the past year, the agency has taken final action on 99% of the nearly 6.7 million products that were the subject of timely submitted e-cigarette applications. FDA has been devoting tremendous resources to the applications for the millions of products it has received. FDA continues 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. The agency has around 55,000 products pending that are the subject of timely submitted PMTAs.”