Judge Orders FDA to Speed Up Review of E-cigarettes

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Judge Orders FDA to Speed Up Review of E-cigarettes

A federal budget has ordered the U.S. Food and Drug Administration (FDA) speed up the review of e-cigarettes currently being sold on the U.S. market. This ruling coincides with claims made by several public health groups that accused the FDA of neglecting its public duty of reviewing all U.S. vaping products by several years.

Last year, several groups including the Campaign for Tobacco-Free Kids and the American Academy of Pediatrics filed a federal lawsuit in Maryland, questioning the lack of FDA oversight of the e-cigarettes being sold in the U.S. According to these groups, the lack of oversight has led to an increase in underage vaping by teenagers and puts an entire generation at risk of becoming addicted to nicotine.

U.S. Judge Paul Grimm agreed, going so far as to call the FDA delay in oversight “so extreme as to amount to an abdication of its statutory responsibilities.” To this, FDA spokesman Michael Felderbaum responded that the agency would continue to tackle the troubling epidemic of e-cigarette use among kids. The agency also has the option of appealing the decision.

The FDA gained the power to regulate e-cigarette and other tobacco products in 2016. Due to the number of products already on the market, and the number of products entering the marketplace since the 2016 Deeming Rule, thousands of e-cigarette and other tobacco products remain on the market without a formal review. Departing FDA commissioner Scott Gottlieb led the effort to crackdown on the rising number of minors using vapor and e-cigarette products but also showed some leniency, stating that the FDA would not require e-cigarette manufacturers to submit their products for review until 2022 before moving that deadline up to 2021 before he left the agency.

Judge Grimm, however, feels 2021 is not soon enough. He has called for the FDA and health groups to submit plans for product reviews within 30 days of May 15, 2018. While the FDA and most health groups appear to agree that e-cigarettes are slightly less harmful than traditional cigarettes, there is little research completed on the long-term health effects of e-cigarette use, especially on young users who appear to be attracted to e-cigarette devices.

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