Sales fell by $500 million. The workforce has been cut by three-quarters. Operations in 14 countries have been abandoned. Many state and local lobbying campaigns have been shut down.
Juul Labs, the once illustrious e-cigarette company that has become a public health villain for many because of its role in the teen vaping wave, has acted as a shadow of its former self, leaving the pandemic largely unnoticed by the public. in what it calls “reset” mode. Now, its survival is at stake as it mounts an all-out campaign to convince the Food and Drug Administration to allow it to continue selling its products in the United States.
The agency is trying to meet a September 9 deadline to decide whether Juul’s nicotine devices and pods have sufficient public health benefit as a safer alternative for smokers to continue to market or not after using Juul products.
Major medical organizations, including the American Heart Association, the American Lung Association, the American Academy of Pediatrics, and the American Cancer Society Cancer Action Network, asked the agency to deny Juul’s application.
“The stakes are high,” said Eric Lindblom, a senior scholar at the O’Neill Institute for National and Global Health Law at Georgetown University and a former FDA adviser on tobacco. “If the FDA attacks this, they will face public health lawsuits.”
Juul spared no expense to push back. Last week, the company agreed to pay $40 million to settle a lawsuit (with North Carolina) among thousands against it, avoiding a jury trial. The company urgently sought an agreement to avoid courtroom testimony from parents and teens while the FDA was reviewing its vaping products.
Juul did not make its 125,000-page application public to the public company. But it paid $51,000 for the entire May/June issue of the American Journal of Health Behavior devoted to publishing 11 company-sponsored studies that provide evidence that Juul products help. smokers quit. (A Juul spokesperson said editors rejected one of the company’s submissions.) That fee includes an additional $6,500 for open access to the journal subscription to all.
Three members of the magazine’s editorial board resigned over the arrangement.
And Juul’s federal lobbying activity remains strong. It spent $3.9 million on federal lobbying in 2020, according to the Center for Responsive Politics, which tracks political spending. Altria, the major tobacco company that owns Juul, spent nearly $11 million.
Juul’s share of the vaping market fell dramatically, to 42 percent last year, according to analysts, from a high of 75 percent in 2018. But some public health experts The council said it was concerned that FDA approval would provide a basis for the company to move forward. and expand its reach again.
Juul has long denied that it knowingly sells its products to teenagers and has publicly pledged in recent years to do all it can to keep them away from minors. In its agreement with North Carolina, the company did not admit to intentionally targeting young people.
In an interview, Joe Murillo, Juul’s managing director, said, “We have a greater opportunity to convert smokers than ever before, but we will have that opportunity if and only if we continue to fight the use of minors and continue to act like the management company we are. “
The company is seeking approval for its iconic vaping device, once dubbed the iPhone of e-cigarettes, with tobacco and menthol flavored pods in two nicotine levels: 5 %, which is equivalent to the nicotine in an average pack of cigarettes, and 3 percent.
The decision is one of the key issues the FDA has grappled with – including the agency’s recent approval of a controversial Alzheimer’s drug and decisions on thousands of vaping products made by the FDA. companies other than Juul produce – without a permanent commissioner in place. President Biden has yet to announce a nominee.
Recently, a panel of the House of Commons questioned the commissioner, Dr Janet Woodcock, about the agency’s plans for Juul. She said the agency would make a decision based on sound science and that she could not influence the application, which is still under review.
The decision will largely be based on answers to two questions: Will more smokers use Juul products as a method of switching from traditional cigarettes than non-smokers will use it as a transition method to switch to nicotine? And can Juul really keep products away from children?
Much of Juul’s published research in the journal edition it purchased followed the 12-month experience of 55,000 adults who purchased a Juul starter kit. The researchers, all paid for by Juul, concluded that 58% of the 17,000 smokers who stayed in the study had stopped smoking after 12 months. Twenty-two percent are still dual users of both traditional cigarettes and e-cigarettes but have cut their smoking intake by at least half.
Elbert D. Glover, the journal’s editor and publisher, but who retired shortly after its publication, said the journal follows standard procedures for scientists to check research before publication. .
The steady decline in American smokers has been a public health success story. This rate has fallen from 42 percent in 1965 to 14 percent in 2019. However, smoking remains the leading cause of preventable death, with around 480,000 people dying from related diseases. to smoke each year, according to the Centers for Disease Control and Prevention.
E-cigarettes, which appeared in the early 2000s, were designed to provide smokers with the nicotine fixation they crave without the carcinogens arising from cigarette burning. But until Juul launched in 2015, no e-cigarettes had come to the attention of the public.
Juul’s sleek design and novel use of nicotine salts in its pods created a low-irritant, high-nicotine experience in mango, mint, and other flavors, quickly becoming fashionable. , especially in middle and high school students. Public health officials are concerned that instead of helping adults quit, Juul is creating a new generation of nicotine, with potentially harmful health effects on their developing brains and suffocation. other health risks.
Juul’s rapid growth remained on the FDA’s radar until 2018, when the agency announced an epidemic of vaping among young people.
“The FDA has left a wide, Wild West market around these vaping products and unfortunately Juul and others have,” said Clifford E. Douglas, director of the University of Michigan Tobacco Research Network. jump in and exploit it.” “What happened next ruined a truly exceptional public health opportunity for harm reduction. It’s our duty to return to that work in the service of public health. “
Mr. Douglas believes that Juul is marketing its vaping products more responsibly and that they can play some role in reducing harm to smokers.
Lindblom, a former FDA tobacco adviser, has been critical of Juul, but believes the FDA cannot account for past bad behavior.
“The FDA has to evaluate this going forward and can’t really punish Juul, but can certainly look at how popular Juul is among young people,” he said.
Many critics of Juul do not believe the company deserves another chance. They are wary of the company’s “reset,” announced in September 2019 when KC Crosthwaite, a top executive of Altria, the maker of Marlboro cigarettes, became chief executive. by Juul.
Mr. Crosthwaite pulled the plug on some of Juul’s controversial city and state lobbying campaigns. He has closed stores in Juul’s overseas markets around the world, excluding the UK and Canada, although Juul is still sold through distributors in Ukraine, Russia, Italy and the Philippines. Under public pressure, he took the mint-flavored fruit, which accounts for 70% of market sales. And he has suspended all US advertising.
“We must place faith in making money at the heart of everything we do,” he wrote in an email to company employees last summer.
Critics argue that most of these changes have been made with guns — made after the FDA threatened to close the business if teens continued to have access to Juul.
For these public health advocates, Altria’s December 2018 purchase of a $12.8 billion stake in Juul adds to their distrust.
“The Marlboro man has come to Juul and now wants us to trust them,” said Matthew L. Myers, president of the Campaign for Tobacco-Free Children.
The Federal Trade Commission is currently trying to unravel the Altria-Juul deal, alleging that the two companies entered into a series of anti-competitive agreements that violate antitrust laws.
The Commission argued that Altria and Juul started out as competitors in the e-cigarette market, but as Juul became more popular, Altria responded to the competitive threat by discontinuing production of e-cigarettes. Mark Ten in exchange for a share of Juul’s profits. Both companies deny the allegations.
Even if the FDA approves Juul products, perhaps with restrictions, the company will face significant business obstacles.
When Juul was forced to stop offering fruit-flavored pods, new competitors, sometimes nicknamed Juulalikes, flooded the vacuum with cheap, disposable e-cigarettes in flavors like Cherry Frost and Dinner Lady Lemon Tart. Altria currently estimates Juul’s value at less than $5 billion, a fraction of its $38 billion valuation when Altria bought 35% of the business in a 2018 deal.
If Juul survives, the company will most likely spend the next few years settling thousands of lawsuits.
Fourteen states and the District of Columbia, sued Juul, seeking money to pay for combating the youth vaping crisis. A criminal investigation into the company by the Department of Justice is still underway.
There are also multi-district litigation in a federal court in California, which has combined nearly 2,000 cases under one judge, similar to the handling of opioid cases.
Whether there are any companies left to collect from if the plaintiffs win the case is up to FDA