The FDA ordered Juul to stop selling its products in the U.S.
The majority of the company's sales are in the U.S. Antismoking groups and regulators feared that the products would do more harm to young people than good to former smokers, so they put intense scrutiny on them.
The F.D.A. is committed to ensuring that all electronic nicotine delivery system products currently being marketed to consumers meet our public health standards. Products from companies that account for most of the US market are reviewed by the agency. Many of these products have played a disproportionate role in the rise of youth Vaping.
The move by the F.D.A. is part of a wide-ranging effort to remake the rules for smoking and vaping products.
Nicotine levels in traditional cigarettes will be slashed in order to discourage use of legal consumer products. The F.D.A. said in April that it would ban the sale of cigarettes with flavors other than tobacco products.
Now that the F.D.A. has authority over e-cigarettes, it is necessary for the agency to determine which electronic cigarettes currently for sale, or proposed for sale, will be allowed onto U.S. shelves.
It could take years before these proposals take effect, if they can resist the tobacco lobby and antiregulatory groups.
The F.D.A. made a decision.
The ruling was welcomed by public health groups.
The American Lung Association welcomed the decision of the F.D.A. to remove all Juul products from the market. It has gone on for far too long.
The American Vapor Manufacturing Association said in a statement that the fight would go on.
One of the greatest episodes of regulatory malpractice in American history will be F.D.A.'s indifference to ordinary Americans and their right to switch to the vastly safer alternative of Vaping.
The agency ruling capped a nearly two-year review of data that Juul had submitted to try to win authorization to continue selling its tobacco products in the US. The company had to prove that its devices were appropriate for the protection of public health.
The F.D.A. began an investigation into Juul's marketing efforts. Before that time, Juul advertised its product using attractive young models and flavors that were popular with children.
The F.D.A. will be cracking down on the sale of such products to people under the age of 21.
Young people's use had gone up. According to Monitoring the Future, in the past year, 19 percent of 12th graders, 16 percent of 10th graders and 8 percent of eighth graders reported using e-liquid.
Some cases resulted in millions of dollars in damages against the company, despite the company denying that it targeted young people. The company agreed to pay 40 million dollars to the state of North Carolina in a settlement in the year 2021. There are more than a dozen pending lawsuits in other states.
According to The Wall Street Journal, the former F.D.A. commissioner explained his approval of the move against Juul.
The news is not as important for the industry as it would have been in the past. Juul has a much smaller share of the market than it used to.
The news is a blow to the company, formerly known as Philip Morris and now known as Marlboro. The value of that stake fell by the end of the year because of smaller market share.
The company had more than 4,000 employees. Most of it is in the US, but there are also some in Canada, Britain and other countries. The company's revenue has fallen from $2 billion to $1.3 billion in the next four years.
Nicotine isn't the cause of lung cancer and other deadly illnesses from smoking, but the drug is extremely addictive, making it hard for smokers to quit. Nicotine can affect the brain in a number of ways.
The decision will be challenged in court.
For more than a decade, e-cigarettes have been sold in the US without formal F.D.A. authorization.
The company was warned by the F.D.A. because it didn't get approval to sell its products as a healthier alternative to smoking.
For more than a year, the agency has been reviewing all types of vaping products, some in development, and companies waiting for a decision have been allowed to sell some products.
More than a million applications have been rejected by the F.D.A. because of their health risks. R.J. Reynolds was authorized to market Vuse. This is the first time the agency has approved a product made by a tobacco company.
The agency found that the devices it compared with traditional cigarettes contained a significant reduction in harmful chemicals. The blood and urine of people who use the Vuse device are less polluted than those who smoke.
California law requires R.J. Reynolds to warn Vuse buyers about the risks of exposure to glycidol, which is known to cause cancer.
In March, the agency authorized several tobacco-flavor products from Logic Technology Development, saying the company was able to show that its products were likely to help adults make the transition from traditional cigarettes while posing a low risk of attracting new users.
The agency disappointed some prominent lawmakers and advocacy groups when it announced recently that it would not be able to finish reviewing all of the e-cigarette marketing applications until June 2023.
The decision to ban Juul from the U.S. market was misguided, according to some tobacco control experts.
According to the director of the Tobacco Research Network at the University of Michigan, the F.D.A. seemed to punish Juul for its past marketing to teenagers, and that many experts had come to see Juul and other e-cigarettes as valuable tools for helping.
He said that they are off ramps that can provide smokers an alternative to tobacco products. Millions of adult lives are at risk because the off ramp is being narrowed andpaved over.
Christina Jewett reported.
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