Judge orders FDA to speed up review of e-cigarettes

New push comes amid increasing teenage use

By Maria Hernandez - Associate producer, Associated Press

On Wednesday, a federal judge sided with public health groups suing the Food and Drug Administration and ruled the agency needs to begin reviewing thousands of e-cigarettes on the U.S. market. The district court ruled that the agency evaded its legal duties when it postponed reviewing all U.S. vaping products by several years.

AP News reports several groups, including the American Academy of Pediatrics and Campaign for Tobacco-Free Kids, filed the federal lawsuit in Maryland last year. The groups claim the lack of FDA oversight has led to a rapid increase in underage vaping by teenagers, possibly hooking an entire generation of Americans on nicotine.

“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,” the groups said in a statement.

U.S. Judge Paul Grimm agreed, calling the FDA’s delay “so extreme as to amount to an abdication of its statutory responsibilities.” Grimm calls for the health groups and the FDA to submit plans for moving forward with product reviews within 30 days.

E-cigarettes are nicotine-emitting devices that have evolved into a multibillion-dollar industry in the U.S., despite little research on their long-term health effects. The FDA gained the authority to regulate the products in 2016, but has allowed thousands of products to remain on the market without formal rules or product standards since. The agency claims both their staff and manufacturers need more time to prepare for regulation.

FDA spokesman Michael Felberbaum said in a statement that the agency is reviewing the court decision and “will continue to tackle the troubling epidemic of e-cigarette use among kids.” 

Gregory Conley of the American Vaping Association said the government “must appeal this ruling” to “protect adult access to less harmful alternatives to cigarettes.”

Former FDA commissioner, Scott Gottlieb, said it would not require e-cigarette manufacturers to submit their products for review until 2022, moving the deadline up to 2021 shortly before stepping down.

Wednesday’s ruling follows a similar decision last September, when a federal judge said the FDA must move ahead with adding graphic warning labels to cigarette packs. The FDA was required to take that step under a 2009 law, but the process has been bogged down by legal challenges from tobacco companies.

“The courts are clearly pushing FDA — at the behest of medical and consumer groups — to step up their regulatory pressure on the industry,” said Marc Scheineson, a former FDA official who now advises companies with the law firm Alston & Bird. Scheineson said he expects the FDA to argue that it doesn’t have the resources to process the flood of applications that industry would submit if the ruling is enforced.

The FDA and most health experts agree that e-cigarettes are likely less harmful than traditional cigarettes because they don’t produce the cancer-causing byproducts of burning tobacco. Nonetheless, Nicotine makes both cigarettes and e-cigarettes addictive, and health experts say the chemical is harmful to developing brains.

Also on Wednesday, North Carolina’s attorney general announced the first state lawsuit against e-cigarette giant Juul, which dominates the U.S. vaping market.

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