Federal Judge Responds to Health Groups Lawsuit, Gives FDA 30-Day Notice
The Food and Drug Administration has agreed to give the vaping industry more time in terms of deeming regulations dates, however a federal judge doesn’t agree.
Public health groups — the American Academy of Pediatrics, Campaign for Tobacco-Free Kids and more — took a lawsuit to the Maryland federal court last year, and now a federal judge says that the FDA has “shirked its legal duty when it postponed reviewing all U.S. vaping products by several years,” according to a report by the Associated Press. The groups’ lawsuit stated that the FDA’s extension has been the reason that underage vaping has resulted in an “explosion” and went so far to say that an entire generation could be addicted to nicotine.
The groups’ statement said, “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.”
Since 2016, deeming regulations have been on the forefront of everyone’s minds in the vaping industry, and while the FDA gained power to regulate with more formal rules and product standards, members of the governing body have taken their time to decide which route they would like to go. The new regulatory date was 2022 for manufacturers to submit products for review, but former FDA Commissioner Scott Gottlieb moved that up to 2021 before he left in April.
And now, U.S. Judge Paul Grimm has ruled. He says the FDA’s delay of regulations are “so extreme as to amount to an abdication of its statutory responsibilities.” Grimm has ruled for health groups and the FDA to submit their plans for product reviews within a lighting fast 30 days.
Now that Gottlieb has resigned his post, we are yet to see how the FDA will formally respond, however spokesman Michael Felberbaum provided an emailed statement in which he said that the agency “is reviewing the court decision and ‘will continue to tackle the troubling epidemic of e-cigarette use among kids.’”
Appeal is an option that Gregory Conley, president of the American Vaping Association agrees with. He says that the FDA must appeal to “protect adult access to less harmful alternatives to cigarettes.”Marc Scheineson, former FDA official and current adviser with law firm Alston & Bird, told the Associated Press that if appealed, 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.”