The U.S. Food and Drug Administration is set to pull Juul Labs Inc. e-cigarettes from the market, The Wall Street Journal reported, citing people familiar with the matter.
The decision could be announced as early as Wednesday, according to the Journal. Representatives for Juul could not immediately be reached for comment. FDA officials did not respond to a request for comment.
The FDA banned the sale of fruity and sweet flavors for e-cigarettes following criticism that the products were intended for minors, and regulators have reviewed thousands of vaping product applications since they tightened oversight of what had become an unruly market.
Among Juul’s biggest backers is Marlboro maker Altria Group Inc., which has a 35% stake in the company, according to a recent securities filing. Altria values its stake at $1.6 billion, having rated it in a series of moves in recent years. Altria shares fell 10% in New York trading on Wednesday.
A spokesperson for Altria declined to comment.
Earlier this year, the FDA allowed some products made by Juul rival NJOY Inc. to remain on the market, and last year cleared British American Tobacco Plc’s Vuse e-cigarette. Some observers had expected Juul to gain FDA backing after years of back and forth between the company and regulators.
Regulators hoped e-cigarettes could present an alternative for smokers trying to quit using traditional tobacco products, and Juul’s device has remained popular with some adults who say it has helped them quit. stop smoking. Yet public health officials have also documented an epidemic of underage vaping that they say has hooked a new generation of nicotine users. Other health issues, including fear of acute lung disease, have also been linked to e-cigarettes.
Once a much-loved startup with global ambitions, Juul has suffered a series of setbacks in recent years after its sleek USB-like device, flashy ads and fruity flavors raised questions about the health risks associated with the drug. vaping as well as company marketing. tactical. While Juul has said it has never sought to sell e-cigarettes to children, the closed company faces thousands of lawsuits alleging it targets minors. Dozens of states are also investigating Juul advertising.
Being pushed back by US regulators is likely to drastically reduce Juul’s ambitions, at least in the short term. The company could appeal the FDA’s decision through the agency or challenge it in court, or file for revised approval, according to the Journal report. Juul still sells e-cigarettes in some overseas markets.
Juul’s failure to clear would mark a second blow to the tobacco industry in as many days, after the Biden administration said it would order companies to reduce nicotine levels in cigarettes to reduce smoking-related deaths. The FDA is expected to write rules on the switch — a lengthy process that the industry is likely to fight.
Photo: A person smokes a Juul Labs Inc. e-cigarette in this arranged photograph taken in Brooklyn, New York/Bloomberg
Copyright 2022 Bloomberg.
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