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FDA temporarily lifts order banning Juul e-cigarettes

The Food and Drug Administration on Tuesday temporarily lifted a ban it imposed last week on the sale of Juul products. Photo by sarahjohnson1/Pixabay
The Food and Drug Administration on Tuesday temporarily lifted a ban it imposed last week on the sale of Juul products. Photo by sarahjohnson1/Pixabay

July 6 (UPI) -- The U.S. Food and Drug Administration has temporarily lifted the ban it imposed last month on the sale of Juul Labs Inc. products, stating it needs to conduct further review of the e-cigarette maker's application that says its wares protect public health.

The federal regulator announced the temporary suspension of its marketing denial order Tuesday on Twitter and via an update to its original press release dated June 23 that states the company must immediately stop selling and distributing its products while those currently on store shelves must be removed.

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"This administrative stay temporarily suspends the marketing denial order during the additional review but does not rescind it," the FDA said in the update.

"All electronic nicotine delivery systems, or ENDS products, including those made by Juul, are required by law to have FDA authorization to be legally marketed. The stay and the agency's review does not constitute authorization to market, sell or ship Juul products," it said.

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Joe Murillo, Juul's chief regulatory officer, told UPI in a statement that they will continue to sell its products amid the regulator's review process.

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"We remain confident in the quality and substance of our applications and believe that ultimately we will be able to demonstrate that our products do in fact meet statutory standard of being appropriate for the protection of public health," Murillo said. "We now look forward to re-engaging with the FDA on a science- and evidence-based process to pursue a marketing authorization for Juul products."

To sell tobacco products in the United States, companies are required to submit a Premarket Tobacco Product Application that must provide scientific data demonstrating its product is "appropriate for the protection of public health."

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Nearly two weeks ago, the FDA issued a marketing denial order for Juul's e-cigarette device and four types of Juulpods, stating the company's applications "lacked sufficient evidence regarding the toxicological profile of its products to demonstrate that marketing its products" would benefit the health of the public.

The next day, the U.S. Court of Appeals for the D.C. Circuit approved Juul's request for a temporary stay to allow it to continue selling its products as it considers the case.

On Tuesday, the FDA said it has "determined that there are scientific issues unique to the Juul application that warrant additional review."

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