Federal Judge Orders FDA to regulate e-cigs

This past Wednesday a federal judge ordered the US Food and Drug Administration (FDA) to speed up their reviews of thousands of electronic cigarettes on the market, in accordance with public health groups that sued the FDA over their stance on e-cigs.

The lawsuit against the agency was filed in Maryland federal court last year by the American Academy of Pediatrics and other public health groups, including the Campaign for Tobacco-Free Kids. The groups argued that the way the FDA was delaying their regulation of e-cigarettes had contributed to an increase in underage vaping.

The judge says that the FDA's delay regarding the review of e-cigs for as long as several years was a serious dereliction of their duty to the public.

Judge Paul Grimm ruled that the decision by the FDA amounted to “an abdication of its statutory responsibilities”. Grimm added that as the FDA was figuring out how to properly implement laws around e-cigs, they had afforded the manufacturers of the devices the chance to harm the public without any legal ramifications.

The ruling states the FDA now has two weeks to put together – and submit – an official plan of action for moving forward with their reviews. It was noted the FDA would still need to go through all of the standard rulemaking procedures.

Manufacturers of electronic cigarettes have been on notice for some time now that the time would come when they would need to submit their products for review and approval by the FDA. Grimm wrote that if any manufacturers had chosen to not prepare properly for this time, then any hardship that they encountered over the ruling was of their own making.

An FDA spokesman said of the ruling;

"[FDA] 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.”

The agency was granted the authority to regulate any tobacco products back in 2016. When the current administration changed in 2017, however, the FDA decided that they would delay enforcing laws surrounding vaping products until 2022.

During that time, manufacturers of these products were able to bring products out on to the market without adhering to any standards or rules, even though the FDA understood the health risks to the public.

Former FDA Commissioner Scott Gottlieb changed the deadline from 2022 to 2021 before he stepped down from his position last month, but the decision from Judge Grimm means that the FDA needs to start acting even sooner. The FDA has the chance to appeal the ruling, and they have argued that manufacturers and the staff reviewing these products require more time to prepare for potential regulation.

E-cigarettes are becoming more popular with middle-and-high-school students, which prompted federal health officials to refer to the increase in youth usage as an “epidemic”. The public health groups who sued the FDA argued that if the delay continued, it would put an entire generation of youth at risk of becoming nicotine addicts.  

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