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July 13, 2019 01:00 pm

Judge Gives E-Cigarette Makers 10 Months To Seek FDA Review

An anonymous reader quotes a report from Bloomberg: E-cigarette companies such as Juul must submit applications to U.S. regulators by May 2020 to keep their vaping products on the market, a federal judge ruled Friday. The ruling was the result of a court case brought by anti-tobacco and public-health groups after the FDA had delayed an earlier application deadline. The groups argued that the agency had abdicated its duty to regulate the products, which have been blamed for a rise of youth use of vaping products. A company's e-cigarettes will be able to stay on the market for up to one year while the FDA considers its application, according to the order. In anticipation of having to move more quickly, the FDA issued a guideline last month to help e-cigarette makers craft their applications. "Given the uncertainty in the efficacy of e-cigarettes as smoking cessation devices, the overstated effects that a shorter deadline may have on manufacturers, the industry's recalcitrance, the continued availability of e-cigarettes and their acknowledged appeal to youth, and the clear public health emergency, I find that a deadline is necessary," U.S. District Judge Paul Grimm wrote in his order. Juul said it was supportive of the application process and had been preparing research on its products and how they're used by smokers. "We're confident in the content and quality of the materials we will submit with our application," said spokeswoman Lindsay Andrews.

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Original Link: http://rss.slashdot.org/~r/Slashdot/slashdot/~3/8DDQLlK8-XI/judge-gives-e-cigarette-makers-10-months-to-seek-fda-review

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