FDA bans Juul from promoting its vaping merchandise within the U.S. – TechCrunch

The axe has fallen for e-cigarette maker Juul.

The FDA ordered the company to cease promoting and distributing its ubiquitous vaping gadgets within the U.S. Thursday, a dramatic finish for a corporation that dominated the e-cigarette market and was valued at $38 billion on the high of its sport.

Juul will now not have the ability to promote its vapes nor its 5% or 3% tobacco and menthol-flavored pods within the U.S. with out “risk[ing] enforcement action” from the U.S. Food and Drug Administration. Retailers may also be prohibited from stocking Juul merchandise within the U.S.

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 manufacturers, JUUL had the opportunity to provide evidence demonstrating that the marketing of their products meets these standards,” Acting Director of the FDA’s Center for Tobacco Products Michele Mital stated. “However, the company did not provide that evidence and instead left us with significant questions.”

In an announcement 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 firm pushed again in opposition to the FDA’s characterization of the knowledge it offered to the regulatory company.

“In our applications, which we submitted over two years ago, we believe that we appropriately characterized the toxicological profile of JUUL products, including comparisons to combustible cigarettes and other vapor products, and believe this data, along with the totality of the evidence, meets the statutory standard of being ‘appropriate for the protection of the public health,’” Murillo stated.

The FDA clarifies that its actions don’t 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 U.S.-based customers.

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