Juul, once a popular company that was responsible for the teens vaping epidemic, has been ordered to cease sales of e-cigarettes in the United States by the Food and Drug Administration.
The order affects all of Juul’s products on the U.S. market, the overwhelming source of the company’s sales. Juul’s sleek vaping cartridges and sweet-flavored pods helped usher in an era of alternative nicotine products among adults as well, and invited intense scrutiny from antismoking groups and regulators who feared they would do more harm to young people than good to former smokers.
In its ruling, the agency said that Juul had provided insufficient and conflicting data about potentially harmful chemicals that could leach out of Juul’s proprietary e-liquid pods.
“Today’s action is further progress on the F.D.A.’s commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards,”In a statement, Dr. Robert M. Califf stated that he was the agency’s commissioner. “The agency has dedicated significant resources to review products from the companies that account for most of the U.S. market. We recognize these make up a significant part of the available products and many have played a disproportionate role in the rise in youth vaping.”
F.D.A. made the move. This is all part of a wider effort by the F.D.A. to change rules on vaping and smoking, and to decrease deaths from inhalable nicotine products.
The agency revealed plans Tuesday to reduce nicotine in cigarettes to deter the use of illegal consumer products that are most dangerous. F.D.A. In April, the F.D.A. announced that they would ban menthol-flavored cigarettes.
Juul is the latest target of an F.D.A. regulatory action. The agency must now determine whether electronic cigarettes that are currently available for sale (or proposed to be) will be permanently allowed on U.S. shelves. Juul has the power to regulate e-cigarettes.
But it could take years before these proposals take effect — if they can withstand fierce resistance from the powerful tobacco lobby, antiregulatory groups and the vaping industry.
Juul said it would appeal the F.D.A.’s decision.
The ruling was praised by public health organizations.
“The F.D.A.’s decision to remove all Juul products from the marketplace is both most welcomed and long overdue,”Erika Sward is the national vice president for advocacy at American Lung Association. “Juul’s campaign to target and hook kids on tobacco has gone on for far too long.”
An industry trade organization, the American Vapor Manufacturing Association made an announcement that suggested the future fight.
Learn More about Vaping and Smoking
“Measured in lives lost and potential destroyed, F.D.A.’s staggering indifference to ordinary Americans and their right to switch to the vastly safer alternative of vaping will surely rank as one of the greatest episodes of regulatory malpractice in American history,” Amanda Wheeler, the association’s president, said in a statement.
The agency’s ruling capped a nearly two-year review of data that Juul had submitted to try to win authorization to continue selling its tobacco- and menthol-flavored products in the United States. This application asked the company to demonstrate the safety and suitability of the devices for protection of the public’s health.
Juul was the focus of policymakers, regulators and schools for many years. This began in 2018, when F.D.A. became a priority. began an investigation into Juul’s marketing efforts. Juul advertised their product with attractive young models, flavors like cool cucumber and crème brulee. Critics claimed that this attracted minors.
The F.D.A. announced a crackdown on the sale of Juul’s to under-21s in April 2018. announced a crackdown on the sale of such products, including Juul’s, to people under the age of 21.
Use among young people had soared. Monitoring the Future is an annual survey conducted by the National Institute on Drug Abuse. It found that 19 percent, 16 percent, and eight percent of the 12th-graders reported using nicotine during the previous year.
Juul denied it had targeted youth, but the lawsuits were brought by attorneys general and state lawyers general. In some cases, millions of dollars was awarded in damages. Juul paid $40 million in settlements to North Carolina in 2021. This was in addition to the other parties who claimed that Juul had lured underage vapers to the company’s services. Another dozen states are also pursuing lawsuits or investigations.
Scott Gottlieb (ex-F.D.A.) is Dr. Gottlieb. The ex-F.D.A. Commissioner, Dr. Scott Gottlieb, expressed his support for Juul’s action on Wednesday. The Wall Street Journal first reported it.
The news is somewhat less weighty for the industry now than it would have been in Juul’s heyday, given the company’s plummeting market share. Juul is now a significantly smaller player than it was once, with 75 percent market share.
Altria (formerly Philip Morris, the manufacturer of Marlboro) is now facing a major blow. Altria bought 35% of Juul in December 2018, for $12.8 billion. Altria stated that the stake’s value fell to $1.7billion due to regulatory and market headwinds.
Juul was home to more than 4,500 employees at its peak. The company now employs slightly more than 1,000 people, most of them in America, with some others in Canada, Britain, and other places. The company’s revenues have fallen to $1.3billion in 2021 from $2billion in 2019. This is a drop of about 95 percent from its 2019 U.S. sales.
Although nicotine isn’t the main cause of lung cancer or other fatalities from smoking, it is addictive and makes quitting difficult despite its health benefits. Nicotine can have a significant impact on the brain of adolescents, making it vulnerable to its effects. Memory, concentration, learning, and self-control.
Already, e-cigarette firms have stated they intend to challenge the decision.
The U.S. has been selling e-cigarettes for over a decade, without the need to obtain a formal F.D.A. authorization, because they did not fall under the agency’s regulatory purview for several years.
The F.D.A. issued a warning letter to Juul in 2019. Juul received a warning from the F.D.A. stating that Juul violated federal regulations, as it hadn’t been given approval to market and sell products for a healthier alternative to smoking.
Since more than one year ago, the agency has reviewed all kinds of vaping products. Some are still in development. Companies awaiting a decision were allowed to continue selling certain products.
F.D.A. Recently, the F.D.A. stated that it has rejected over a million applications for products it considers more harmful than beneficial. R.J. Reynolds was granted permission to keep marketing Vuse. It was the agency’s first approval of a vaping product manufactured by big cigarette companies.
According to the agency’s review of the devices it found comparable with conventional cigarettes, they had a higher level of nicotine. “significant reduction”However, some harmful chemicals are still present. According to the review, the levels of potential cancer-causing chemicals and toxins in urine and blood of Vuse users were significantly lower than those who smoke.
California law still required R.J. Reynolds warn Vuse customers about exposure to glycidol. “known to the state to cause cancer”Based on research with rats and mice
The agency granted several tobacco-flavored products to Logic Technology Development in March. They said that they could show that their products would help people transition to smoking less traditional cigarettes and also pose a low risk for young new users.
However, some well-known lawmakers and advocates were disappointed when the agency announced it will not complete its review of all the applications for e-cigarette advertising until June 2023. It did so one year after being given a deadline by a judge.
Experts in tobacco control believe that banning Juul from the U.S. Market could prove counterproductive.
Clifford Douglas from the University of Michigan School of Public Health’s Tobacco Research Network stated that Juul was a valuable tool for adult smokers to quit traditional cigarettes.
“They are off-ramps that can provide smokers an alternative to combustibles, which are responsible for virtually every death related to tobacco,”He said. “But now that off-ramp is being narrowed and sort of paved over, which is putting millions of adult lives at stake. One hopes Juul can respond effectively to the request for more scientific analysis, make any product adjustments that may be called for, and again offer their products to adults in need.”
Christina Jewett, Sheila Kaplan and others contributed to reporting.
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