FDA orders Juul to stop selling its vaping products in the US – TechCrunch

The ax has fallen for e-cigarette maker Juul.

The FDA ordered the corporate to cease promoting and distributing its ubiquitous vaping gadgets within the US Thursday, a dramatic finish for an organization that dominated the e-cigarette market and was valued at $38 billion on the prime of its recreation.

Juul will now not have the ability to promote its vapes nor its 5% or 3% tobacco and menthol-flavored pods within the US with out “danger[ing] enforcement motion” from the US Meals and Drug Administration. Retailers will even be prohibited from stocking Juul merchandise within the US

The FDA’s ban in opposition to Juul got here after the corporate failed to offer constant proof concerning the security of its vapes and tobacco pods.

“As with all producers, JUUL had the chance to offer proof demonstrating that the advertising and marketing of their merchandise meets these requirements,” Performing Director of the FDA’s Middle for Tobacco Merchandise Michele Mital stated. “Nevertheless, the corporate didn’t present that proof and as a substitute left us with vital questions.”

In a press release to TechCrunch, Juul’s Chief Regulatory Officer Joe Murillo stated that the corporate would pursue a keep and is exploring its different choices to counter the FDA’s ban on its merchandise. The corporate pushed again in opposition to the FDA’s characterization of the data it offered to the regulatory company.

“In our purposes, which we submitted over two years in the past, we consider that we appropriately characterised the toxicological profile of JUUL merchandise, together with comparisons to flamable cigarettes and different vapor merchandise, and consider this knowledge, together with the totality of the proof, meets the statutory normal of being ‘acceptable for the safety of the general public well being,'” Murillo stated.

The FDA clarifies that its actions do not instantly prohibit particular person possession or use of Juul merchandise, although acquiring the corporate’s vapes and pods is about to be way more tough for US-based customers.

Regulatory woes had already minimize deeply into the corporate’s valuation, however the FDA’s actions spell outright doom for its US operations. Juul rivals Reynolds American and NJOY Holdings beforehand acquired authorization and shall be allowed to proceed promoting their very own merchandise, although the FDA maintains that tobacco is dangerous and addictive even when vaped.

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