Federal court issues temporary block of FDA decision to ban all Juul e-cig products

President Joe Biden’s Food and Drug Administration announced Thursday that it had, in effect, banned the marketing and sale of the popular e-cigarettes produced by Juul Labs, a devastating blow that would almost certainly result in that company going bankrupt and out of business.

That ban was short-lived, however, as a federal court on Friday blocked the FDA’s ban from going into effect while the court system considers an emergency appeal from Juul in regard to that FDA order, the Daily Caller reported.

Juul, which produces and sells nicotine vaporizing devices that are generally regarded as safer healthwise than regular tobacco cigarettes, had already voluntarily withdrawn its popular flavored cartridges from the market in 2019 under the threat of an impending FDA ban on flavored nicotine products that was ultimately imposed in 2020.

FDA effectively bans all Juul e-cig products

The FDA announced Thursday that it had issued “marketing denial orders” against all four of Juul’s products that are marketed in the U.S., which served as an effective and immediate ban on the company continuing to do business.

The federal agency claimed that Juul’s applications for full approval of its products “lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health.”

Yet, despite the effective ban, the FDA acknowledged that “To date, the FDA has not received clinical information to suggest an immediate hazard associated with the use of the JUUL device or JUUL pods.”

Nevertheless, it went ahead with the decision to immediately ban the company’s products due to the unknown possibility of “potential toxicological risks.”

Emergency motion wins temporary reprieve

According to the Associated Press, however, Juul can continue to market its products as usual for the time being thanks to a three-judge panel of the D.C. Circuit Court of Appeals that acted immediately on a Friday morning emergency motion from Juul and issued a temporary block against the FDA order.

In its motion requesting emergency action from the court in regard to the “extraordinary and unlawful action” of the FDA, Juul asserted that it had provided sufficient evidence in support of its product in a 125,000-page application for approval that had been filed two years ago.

Given that time frame, in which the products have been for sale the entire time, the company argued that the FDA couldn’t suddenly assert a “critical and urgent public interest” in immediately banning its products now. Further, Juul noted that it had inexplicably been banned while the FDA had granted authorization to a number of other similar products marketed by its competitors.

Business as usual for now, but potential bankruptcy looms

For now, thanks to the court’s ruling, Juul will be able to continue to conduct business as usual while the merits of the case are fully considered by the courts.

That said, should it ultimately lose its challenge against the FDA’s decision to ban its products, the Daily Caller noted that Juul has acknowledged that it could potentially have to file for bankruptcy and go out of business.

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