Ruling turns up pressure for FDA to strictly regulate e-cigarettes

Some politicians and pediatricians have urged the US Food and Drug Administration to take strong, swift action on the growing use of e-cigarettes among America’s youth, but the latest move comes from a federal judge who ordered the agency to speed up its review of thousands of vaping products now on the market.

Wednesday’s ruling by District Judge Paul W. Grimm of US District Court for the District of Maryland was part of a lawsuit that the American Academy of Pediatrics and other health groups filed against the FDA last year for initially delaying a review of the safety and health impact of e-cigarettes and cigars.

Grimm ruled that, in 2017, the agency acted illegally by allowing e-cigarettes to remain on the market until 2022 before companies applied for FDA authorization and by permitting products to remain on the market indefinitely during review, according to a joint statement from the Campaign for Tobacco-Free Kids, the American Academy of Pediatrics, the American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association and the Truth Initiative.

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.

Last year, more than 3.6 million middle and high school students reported using e-cigarettes within the previous 30 days, according to data from the National Youth Tobacco Survey. The data showed that vaping increased nearly 80% among high schoolers and 50% among middle schoolers between 2017 and 2018.

Effective in 2016, the FDA finalized a rule that extended its regulatory authority to all tobacco products, including e-cigarettes, and has yet to introduce sweeping rules or standards.

Experts worry that e-cigarettes could put kids’ developing brains at risk, get them hooked on nicotine early in life and be a gateway to smoking and other drugs. The FDA previously has argued that it needs more time to introduce formal regulations.

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

Also Wednesday, Acting FDA Commissioner Dr. Ned Sharpless met with Illinois Sen. Dick Durbin to discuss agency regulation of e-cigarette and cigar flavorings. Durbin said in a news release that he urged Sharpless to “immediately removing kid-friendly flavors from the market,” among other actions.

“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.”

In response, the FDA directed CNN to comments Sharpless made Wednesday at a public workshop on youth tobacco cessation: “I intend to focus on keeping tobacco products out of the hands of America’s youth,” he said and noted that under his leadership, the agency would maintain its “energy and focus” against the threat of vaping among youth

Sharpless and Durbin met about six weeks after the resignation of FDA Commissioner Dr. Scott Gottlieb, which prompted a swirl of questions about whether the agency would continue to pursue vaping among youth as aggressively as he did.

In a post on Twitter on Thursday, Gottlieb said that the e-cigarette industry was given time in 2017 to prove that products could help with traditional cigarette cessation and “could bend death and disease from tobacco.”

Yet “the intervening year and youth risks they helped ignite makes it more urgent ecigs undergo close scrutiny,” he tweeted.

“If 2019 data shows trends continue it should call into question marketability of the pod based ecigs kids abuse,” he wrote in a subsequent post.