[ad_1]
Sales fell by $500 million. The workforce was reduced by three quarters. Operations in 14 countries were suspended. Many state and local lobbying campaigns have been shut down.
Juul Labs, once a high-flying e-cigarette company that has become a public health villain for many due to its role in the rise of youth vaping, is operating as a shadow of its former self, spending the pandemic largely out of the public eye. in what it calls ‘reset’ mode. Now his survival is at stake as he launches an all-out campaign to persuade the Food and Drug Administration to allow him to continue selling his products in the United States.
The agency is trying to reach September 9 to decide whether Juul’s devices and nicotine pods have enough public health benefits as a safer alternative for smokers to stay on the market, despite their popularity among young people who have never smoked but become addicted to nicotine. After using Juul products.
major healthcare organizations, including the American Heart Association, the American Lung Association, the American Academy of Pediatrics, and the American Cancer Society’s Cancer Action Network, asked the agency to reject Juul’s application.
“The stakes are high,” said Eric Lindblom, a senior scientist at the O’Neill Institute for National and Global Health Law at Georgetown University and a former FDA advisor on tobacco. “If the FDA blows on this, they will face public health lawsuits.”
Juul spares no expense in taking a step back. Last week, the company agreed to pay $40 million just to place one. One of the thousands of lawsuits filed against him (with North Carolina) has avoided an upcoming jury trial. The company had urgently sought the agreement to avoid courtroom testimony from parents and teens as the FDA reviewed its vape products.
Juul did not disclose its 125,000-page application to the agency. However, he paid $51,000 to dedicate the entire May/June issue of the American Journal of Health Behavior to publishing 11 company-funded studies that provided evidence that Juul products help smokers quit. (A spokesperson for Juul said the editors rejected one of the company’s submissions.) That included an extra $6,500 to get the subscription magazine public access.
Three editorial board members of the journal resigned due to the arrangement.
And Juul’s federal lobbying has remained intact. It spent $3.9 million on federal lobbying in 2020, according to the Center for Responsive Policy, which tracks political spending. Altria, the large tobacco company that owns a portion of Juul, spent about $11 million.
According to analysts, Juul’s share of the e-cigarette market has dropped from 75 percent in 2018 to 42 percent last year. But some public health experts say they’re worried that FDA approval will set the stage for the company to rise. and expand its reach again.
Juul has long denied that it knowingly sells its products to young people, and has promised the public over the past few years that it will do everything it can to keep them away from minors. The company denied that it deliberately targeted young people in its deal with North Carolina.
“We have a greater opportunity than ever to transform smokers, but we will only get this opportunity if we continue to fight underage use and continue to behave at a high level,” said Joe Murillo, Juul’s chief regulatory officer, in an interview. We are a regulated company.”
The company is seeking approval for its iconic vaping device, once dubbed the iPhone of e-cigarettes, containing two nicotine strengths of tobacco and menthol flavored pods: five percent and three percent equivalent to the nicotine in an average cigarette pack.
The decision is one of a number of critical issues the FDA is grappling with — including the agency’s approval of a controversial Alzheimer’s drug and decisions on thousands of vaping products made by companies other than Juul — without a permanent commissioner. President Biden has yet to announce a candidate.
Recently, a House panel, deputy commissioner Dr. He questioned Janet Woodcock about the agency’s plans for Juul. He said the agency would base its decision on sound science and could not prejudge the application currently under review.
The decision will largely depend on the answers to two questions: Will smokers use Juul products as exit ramps from traditional cigarettes more than nonsmokers use nicotine exit ramps? And can Juul really keep products away from children?
Much of his research, published in the magazine edition that Juul bought, follows the 12-month experience of 55,000 adults who bought a Juul starter kit. The researchers, all paid for by Juul, concluded that 58 percent of the 17,000 smokers surveyed had quit within 12 months. Twenty-two percent remained dual users of both traditional and e-cigarettes, but reduced their smoking by at least half.
Elbert D. Glover, the journal’s editor and publisher, but retired shortly after the issue came out, said the journal followed its standard protocol for scientists reviewing research before it was published.
The steady decline in Americans who smoke has been a public health success story. This rate dropped from 42 percent in 1965 to 14 percent in 2019. Still, smoking remains the leading cause of preventable death, with about 480,000 people dying from smoking-related diseases each year, according to the Centers for Disease Control and Prevention.
Appearing in the early 2000s, e-cigarettes were designed to give smokers the amount of nicotine they wanted without the carcinogens caused by smoking cigarettes. But no e-cigarette was widely available to the public until Juul launched in 2015.
Juul’s sleek design and new use of nicotine salts in its capsules created a high-nicotine, low-irritant experience in mango, mint, and other flavors that quickly became a trend, especially among high school and middle school students. Instead of helping adults quit smoking, public health officials worried that Juul would be the next generation of nicotine addicts, which has potentially harmful health effects on their developing brains and poses other health risks.
Juul’s rapid growth remained under the FDA’s radar until 2018, when the agency declared a youth vaping epidemic.
“The FDA has left a wide open, Wild West market in place around these vaping products, and unfortunately Juul and others have dived into it and exploited it,” said Clifford E. Douglas, director of the University of Michigan Tobacco Research Network. “What happened next has ruined a truly extraordinary public health opportunity for harm reduction. It is our duty to return to this to serve public health.”
Mr. Douglas believes Juul is now marketing vaping products more responsibly and can play a role in reducing harm to smokers.
Lindblom, the FDA’s former tobacco consultant, is highly critical of Juul, but believes the FDA cannot account for past bad behavior.
“The FDA should consider this going forward and can’t really penalize Juul, but it certainly can take into account how popular Juul is with young people,” he said.
Many of Juul’s critics do not believe the company deserves another chance. They are wary of a ‘reset’ of the company in September 2019, when KC Crosthwaite, the chief executive of Altria, maker of Marlboro cigarettes, was announced as the CEO of Juul.
Mr. Crosthwaite It has unplugged some of Juul’s controversial state and city lobbying campaigns. Although Juul is still sold through distributors in Ukraine, Russia, Italy and the Philippines, it has closed stores in Juul’s foreign markets around the world, excluding the UK and Canada. Under public pressure, it pulled the mint-flavored pods, which accounted for 70 percent of sales, from the market. And suspended all US ads.
“We must put trust at the center of everything we do,” he wrote in an email to company employees last summer.
Critics argue that many of these changes were done at gunpoint—after the FDA threatened to shut the business down if teens continued to have access to Juul.
For these public health advocates, Altria’s $12.8 billion acquisition of shares in Juul in December 2018 makes them even more insecure.
“The Marlboro guy is going to Juul and now he wants us to trust them,” said Matthew L. Myers, head of the Campaign for Tobacco Free Children.
The Federal Trade Commission is now trying to resolve the Altria-Juul deal, alleging that the two companies have entered into a series of deals that eliminate competition by violating antitrust laws.
The Commission alleges that Altria and Juul started out as competitors in the e-cigarette markets, but as Juul became more popular, Altria addressed the competitive threat by ending it. Mark Ten e-cigarettes in exchange for a share of Juul’s profits. Both companies denied the accusations.
Even if the FDA approved Juul products, perhaps with restrictions, the company would face significant trade barriers.
When Juul had to abandon its fruity flavor pods, new competitors sometimes called Juulalikes filled the vacuum with inexpensive, disposable e-cigarettes in flavors like Cherry Frost and Dinner Lady Lemon Tart. Altria now estimates Juul’s value at just under $5 billion, as part of its $38 billion valuation when Altria bought 35 percent of the business in the 2018 deal.
If Juul survives, the company will likely spend the next few years trying to solve thousands of cases.
Fourteen states and the District of Columbia have sued Juul for paying to combat the youth vaping crisis. . The Ministry of Justice’s criminal investigation into the company continues.
There is also multi-regional litigation A federal court in California combined nearly 2,000 cases under the jurisdiction of a single judge, similar to the treatment of opioid cases.
Whether there will be any companies that will be charged if the plaintiffs prevail, according to the FDA.
[ad_2]
Source link