Article 616B3 FDA backpedals on Juul ban, says it’s re-reviewing company’s “unique” issues

FDA backpedals on Juul ban, says it’s re-reviewing company’s “unique” issues

by
Beth Mole
from Ars Technica - All content on (#616B3)
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Enlarge (credit: Getty | Mario Tama)

The US Food and Drug Administration on Tuesday paused a decision that would effectively force Juul off the US market. On Wednesday, the two sides agreed to put their court battle on hold as the regulator conducted an additional review of Juul's products.

For people who use Juul products, the new development doesn't change much for now: A panel of federal appeals court judges had already issued an administrative stay on June 24, which meant Juul products could remain on the market while the company fought the FDA's denial of its marketing authorization request in court. But, in the longer term, it represents an embarrassing backpedal by the FDA and signals that Juul may have a good chance of permanently reversing the denial.

On June 23, the FDA announced that it denied US marketing authorization for all Juul products, effectively forcing the company off the e-cigarette market it previously dominated. Though the FDA's decision had been leaked to the press the day before, it still jolted industry watchers, consumers, and Juul, which said in court documents it first got wind of the decision through the press leak.

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