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

(Bloomberg) -- E-cigarette companies such as Juul Labs Inc. 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.

The Food and Drug Administration began overseeing e-cigarettes in 2016 under the Obama administration. After Donald Trump took office in 2017, the agency pushed back until August 2022 the application deadline for a safety and public health review.

“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.

The anti-tobacco groups had sought a four-month deadline, while the FDA told the judge 10 months was the earliest it would recommend requiring applications to be submitted. The new timing is still “a dramatic improvement,” said Matthew Myers, president of the Campaign for Tobacco-Free Kids, one of the plaintiffs.

“Today’s ruling is an important step forward for public health,” the FDA’s acting commissioner, Ned Sharpless, said in an emailed statement. “The FDA stands ready to accelerate review of these products and will continue its vigorous enforcement and public education efforts to protect kids from e-cigarettes.”

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.

To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net

To contact the editors responsible for this story: Drew Armstrong at darmstrong17@bloomberg.net, Timothy Annett

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