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FDA bans sale of JUUL vape devices in the US

The United States’ Food and Drug Administration (FDA) has weighed in on vape maker JUUL, ruling that the manufacturer is banned from selling its products in the US. It has also instructed JUUL to remove its current devices in the market or face further action.

This decision comes after a two-year long review by the FDA into the selling of tobacco and menthol flavoured e-cigarettes, vape pens and flavour pods.

“Today, the U.S. Food and Drug Administration issued marketing denial orders (MDOs) to JUUL Labs Inc. for all of their products currently marketed in the United States. As a result, the company must stop selling and distributing these products,” a press statement confirmed.

“In addition, those currently on the U.S. market must be removed, or risk enforcement action. The products include the JUUL device and four types of JUULpods: Virginia tobacco flavored pods at nicotine concentrations of 5.0% and 3.0% and menthol flavored pods at nicotine concentrations of 5.0% and 3.0%. Retailers should contact JUUL with any questions about products in their inventory,” it added.

The ban does not extend to devices that have already been purchased in the US or in possession of customers, but as there will be no supporting products on the market over the coming months, the company’s operations in the US have been dealt a decisive blow.

That said, JUUL has told Engadget that it is exploring all possible options in fighting the decision, so this may not be the last chapter in this saga.

“We respectfully disagree with the FDA’s findings and decision and continue to believe we have provided sufficient information and data based on high-quality research to address all issues raised by the agency,” chief regulatory officer, Joe Murillo, told the publication in an official statement.

“We remain committed to doing all in our power to continue serving the millions of American adult smokers who have successfully used our products to transition away from combustible cigarettes, which remain available on market shelves nationwide,” he added

As for how it plans to continue fighting remains unclear, particularly as the FDA has determined that the evidence provided by JUUL so far has not been good enough to convince the regulator.

“After reviewing the company’s premarket tobacco product applications (PMTAs), the FDA determined that the applications 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,” it explained.

Either way, this is a significant development as regards vaping and the e-cigarette market in the US. Should the decision stand, other regions and regulators may come to similar decisions over JUUL.

[Image – Photo by Jordan Whitfield on Unsplash]

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