The judge gave the groups 14 days to recommend what remedial action to take and for the FDA to respond.
“It is now the FDA’s responsibility to take immediate action to protect our kids and require manufacturers to apply to the FDA if they want to keep their products on the market, including products like Juul that have fueled the youth e-cigarette epidemic,” the statement said.
The American Vaping Association disagreed with the ruling regarding the FDA’s timeline for e-cigarette reviews.
“We believe that the FDA’s deadline extension was a proper and legal exercise of agency power. Despite promises by the FDA, the agency has still yet to finalize critical documents that the industry needs to file pre‐market applications,” association President Gregory Conley said in an email on Wednesday.
“In order to protect adult access to less harmful alternatives to cigarettes and stop over one hundred thousand Americans from becoming unemployed, FDA and [the Department of Justice] must appeal this ruling,” he said.
A ‘troubling epidemic’
Vaping products, including e-cigarettes, remain on the market and are popular among middle- and high-school-age children.
In March, the FDA released a policy draft aimed at taking action against stores selling flavored e-cig products that are accessible to minors and against websites selling them without verifying buyers’ ages and limiting the maximum quantities they sell.
The FDA also proposed moving up a key timeline: how long these products can stay on shelves without pre-market review. Instead of requiring e-cigarettes to undergo FDA approval before they could be sold, the agency decided in 2017 that it would allow products that were on the market before August 2016 to stay on shelves until 2022 without pre-market review. The new deadline to submit those applications would be August 8, 2021.
Now, the agency is reviewing the judge’s decision, FDA spokesman Michael Felberbaum wrote in an email on Thursday.
“The agency has and will continue to tackle the troubling epidemic of e-cigarette use among kids. This includes preventing youth access to, and appeal of, flavored tobacco products like e-cigarettes and cigars, taking action against manufacturers and retailers who illegally market or sell these products to minors, and educating youth about the dangers of e-cigarettes and other tobacco products,” he wrote.
Health groups aren’t the only voices urging FDA to launch strict regulations on e-cigarettes.
Senator scrutinizes e-cigarette regulations
“It became clear during my meeting with Acting Commissioner Sharpless that he has absolutely no intention of taking legal action he is empowered to take to protect our nation’s children from the addiction of e-cigarettes,” Durbin said. “Dr. Sharpless made it very clear that no action would be taken to ban kid-friendly vaping flavors during this President’s term in office.”
Yet “the intervening year and youth risks they helped ignite makes it more urgent ecigs undergo close scrutiny,” he tweeted.