This week a federal judge ruled that the Food and Drug Administration (FDA) must begin reviewing thousands of e-cigarette products currently on the market within 30 days. The ruling was handed down Wednesday in district court by US judge Judge Paul Grimm, who called the FDA’s delay in reviewing vaping products, “so extreme as to amount to an abdication if its statutory responsibilities.” The lawsuit by the American Academy of Pediatrics, the Campaign for Tobacco-Free Kids and other public health groups called for an immediate FDA e-cigarette review, and was filed in Maryland last year in federal court.
The FDA gained oversight of the e-cigarette industry back in 2016, setting a deadline for review of individual vaping products for 2017. The agency then announced an extension of the deadline to 2018, another extension to 2022, and then moved up that deadline earlier this year to 2021. That means thousands of e-cigarette products currently on the market have not been reviewed by the FDA. Both the agency and the vaping industry agree that the companies need more time to prepare for the expensive and cumbersome review process. The FDA claims it does not currently have the resources or manpower to complete the FDA e-cigarette review of products within 30 days. The judge ruled that the FDA has two weeks to submit a specific plan of action to move forward with the reviews. The FDA has the option to appeal the federal court decision.
A spokesperson for the FDA stated that 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.”
Both the FDA and many researchers agree that e-cigarettes are likely less harmful than smoking, and can be an effective nicotine replacement therapy (NRT), and a yearlong study published in the New England Journal of Medicine found that e-cigarette were more effective than other methods to help smokers quit, however there is little long-term research on the health effects of vaping, especially for youth. The popularity of e-cigarettes has grown dramatically over the last several years, and their use has surged to “epidemic” levels among middle and high school students, according to the FDA and the US Surgeon General.
Gregory Conley, President of the American Vaping Association says that the FDA “must appeal this ruling” to “protect adult access to less harmful alternatives to cigarettes.
The public health groups who filed the lawsuit say if the FDA e-cigarette review is allowed to continue, it will put a generation of youth at risk of a lifetime of nicotine addiction.
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