Juul gets temporary reprieve to continue selling e-cigarettes

A federal appeals court on Friday granted Juul Labs a temporary stay that will allow it to keep its e-cigarettes on the market, pending further judicial review of a ruling just a day earlier by the US Food and Drug Administration. ‘prohibit the company’s sales. some products.

The United States Court of Appeals for the District of Columbia issued a temporary stay that had been requested by Juul. The brief order from the appeals court warned that the stay “should in no way be construed as a decision on the merits”.

The suspension involves the FDA’s order on Thursday, when the agency said Juul had to stop selling its products because it provided conflicting and insufficient data that prevented the FDA from assessing the potential health risks of its products. .

It will be up to the appeals court to decide whether Juul should continue to be allowed to sell its products while the company pursues its appeal of the FDA’s decision. The court gave Juul until noon Monday to file an additional motion, and it gave the FDA until July 7 to file a reply motion.

In its emergency filing for a stay, Juul argued that the FDA’s decision to ban sales was driven by political forces that sought to blame the company for the youth vaping crisis. The FDA issued the ruling against Juul “after immense political pressure from Congress,” the filing says, “even though several of its competitors now have larger market shares and significantly higher rates of miner usage. students”.

However, the FDA did not cite underage use in its decision to ban Juul from the market. On the contrary, the agency said Juul failed to provide sufficient evidence that its product prevents chemicals from leaching from the device to the nicotine vapor that users inhale.

While the reprieve is in effect, consumers will be able to purchase Juul cartridges and its tobacco and menthol flavored pods. The FDA had warned that retailers selling Juul products would be subject to enforcement action at some point, but not while a reprieve is in place.

In its court filing, Juul pointed out that the agency’s decision had “already had the intended effect”, indicating that some retailers had stopped selling Juul products.

The FDA is not asking for a blanket ban on all vaping products. Under its new regulatory authority over so-called Electronic Nicotine Delivery Systems, or ENDS, the agency reviewed applications for millions of products. It has already approved 23 of them, including market-leading Vuse Alto, made by RJ Reynolds, and several others produced by NJoy and Logic. (Requests for a million other products have been denied.)

As part of its review, the agency must determine whether a product is a viable alternative to combustible tobacco that can help smokers quit, and whether the public health benefits outweigh the harms.

According to data from Nielsen, the top-selling vape brand in the United States over the past 12 weeks was Vuse Alto, which had sales of $414 million and held 33.4% of the overall e-cigarette market. . Juul was close behind, with a 33% market share. None of the other brands came close to these two companies; the second best-selling brand, NJoy Ace, accounted for only 2.4% of the market.

The cigarette industry in the United States brought in about $99 billion in revenue last year, compared to $7.8 billion for vaping products like Juul, according to Euromonitor, a data research firm. But tobacco sales are down: Euromonitor estimates that cigarette sales will fall by around 13% through 2026, while vaping products are expected to rise by around 22%. Altria, the tobacco giant that took a 35% stake in Juul in 2018, said its sales fell slightly last year, according to regulatory filings.

There are approximately 30 million traditional cigarette smokers in the United States, a number that has been declining for decades.

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