On Thursday, U.S. health officials ordered Juul to remove its e-cigarettes from the market. This is the latest setback for the beleaguered firm, which is generally held responsible for a rise in teen smoking throughout the country.
Following years of regulatory delays, the Food and Drug Administration is taking this move as part of a broad initiative to provide scientific scrutiny to the multibillion-dollar vaping sector.
The FDA ordered Juul to cease distributing its vaping kit and cartridges with tobacco and menthol flavors. Existing products must be taken off the market. According to the government, customers are not prohibited from owning or using Juul’s products.
Companies must demonstrate the public health benefits of their e-cigarettes for them to remain on the market. In actuality, it means demonstrating that adult smokers who take them are probably going to cut back on their smoking, while minors are probably not going to become addicted to them.
According to the FDA, several of the top sellers, like Juul, may have contributed “disproportionately” to the spike in teen vaping. The organization stated on Thursday that there was insufficient information in Juul’s application to support the claim that promoting its products “would be appropriate for the preservation of the public health.”
Juul stated that it disagrees with the FDA’s conclusions and would work to have the ban delayed while it weighs its options, which may include filing an appeal and speaking with regulators.
The FDA said in a statement that Juul’s application raised serious concerns for authorities and lacked sufficient details to assess any possible dangers. The government cited “insufficient and inconsistent facts” in the company’s studies into topics such as possibly dangerous substances leaking from Juul’s cartridges.
“The FDA is issuing these marketing denial orders without the evidence required to identify relevant health hazards.” The FDA’s tobacco center’s acting director, Michele Mital, was quoted in the statement.
Juul presented sufficient data and information, according to the company’s statement from Joe Murillo, chief regulatory officer, to answer all concerns highlighted by regulators. He pointed out that the company’s application, which was submitted more than two years ago, included comparisons to other products including combustible cigarettes.
He said that it also contained details on any possible negative impacts of the business’s products.
Since last autumn, R.J. Reynolds, Logic, and other businesses’ tobacco-flavored e-cigarettes have received FDA approval. However, industry participants and anti-tobacco activists have argued that those products only make up a minuscule portion of the $6 billion American vaping business.
The organization said on Thursday that users of Juul products or smokers who wish to stop using cigarettes and cigars might transition to e-cigarettes that have been approved by the FDA.
Regulators frequently put off making decisions about products from market leaders, such as Juul, which continues to be the most popular vaping brand despite declining sales.
More than a million additional e-cigarette and associated product applications were turned down by the government last year, mostly because of their potential appeal to young people.
The FDA’s action was praised by anti-tobacco organizations, with the American Lung Association describing it as “far overdue and very welcome.” It was a “shameful decision,” according to the American Vapor Manufacturers Association.
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More than ten years ago, e-cigarettes made their debut in the United States, promising smokers a safer substitute. Bypassing many of the harmful chemicals created by burning tobacco, the devices heat a nicotine solution into a vapor that is breathed.
However, research on whether they actually assist smokers in quitting smoking has produced mixed findings. Additionally, business pressure and conflicting political interests frequently held down FDA efforts to rule on vaping devices and their claims.
The number of businesses providing various vaping products and nicotine solutions in different flavors and intensities increased to hundreds.
When Juul’s high-nicotine, fruity-flavored cartridges swiftly spread throughout the country among middle and high school children in 2018, the issue of vaping assumed a new urgency. Numerous federal and state investigations into the company’s early marketing techniques, which included giving out free Juul devices at events sponsored by teenage influencers, are ongoing.
The business came under pressure in 2019 to stop all advertising and do rid of its fruit and dessert tastes. The FDA only allowed tobacco and menthol as flavors in tiny vaping devices the following year. Separately, Congress increased the legal smoking and vaping purchasing age to 21.
However, the debate over whether e-cigarettes should even be allowed to stay on the market persisted.
Anti-tobacco organizations successfully sued the FDA to force it to expedite its review, therefore the FDA has been operating under a court order to deliver its judgments.
Those groups may have exerted political pressure on the FDA, according to Kenneth Warner, a tobacco expert at the University of Michigan’s department of public health.
Warner, who had not read Juul’s application, said, “I think they would have had a hard time arriving at any other conclusion.” Moreover, he said he doesn’t accept payments for cigarettes.
In response, an FDA spokeswoman said that the firm hadn’t provided sufficient details for a thorough evaluation of the risks associated with its products and that by itself the organization wouldn’t rule in favor of Juul.
Although Juul continues to be a top seller, a recent government poll reveals that teenagers are moving away from the brand.
As many children were compelled to learn at home during the epidemic, the poll overall revealed a decline in the rate of teen vaping by close to 40%. However, considering that the data was first gathered online rather than in classrooms, federal officials issued a warning regarding how to interpret the findings.
Juul, which was created by two Stanford University students, debuted in 2015 and quickly rose to the top of the vaping industry. The U.S. e-cigarette industry is still dominated by Juul to the tune of close to 50%. It formerly had more than 75% of the power.
Altria, the world’s largest tobacco company and the maker of Marlboro cigarettes, invested approximately $13 billion in Juul in 2018.
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The FDA also unveiled proposals on Tuesday to set a maximum nicotine level for specific tobacco products to lessen their addictiveness. The organization also mentioned in that release that it had engaged in a multimedia public education campaign to inform kids about the possible dangers of using e-cigarettes.