The FDA’s Unconscionable Campaign to Destroy Juul 

    Shock and disbelief. That’s what ripped through the tobacco harm reduction community when the US Food and Drug Administration (FDA) ordered Juul e-cigarettes off the market on June 23. The reason? After examining $100 million worth of scientific submissions, and with certain knowledge that millions of people have used Juul vapes for years—mostly to replace deadly cigarettes—with no significant demonstrated adverse health effects, the agency claimed, “there is insufficient evidence to assess the potential toxicological risks of using JUUL products” and that they are not “appropriate for the protection of public health.”

    Straight-up lying.

    On July 5, after reviewing Juul’s legal filings, the FDA issued an administrative stay on its own decision. That decision had been preceded by two years of review. Yet suddenly, the agency decided that there were “scientific issues unique to this application that warrant additional review.” Juul got a stay of execution.

    Comparing harm reduction products to the cigarettes they replace is what counts—not some arbitrary, rigged bureaucratic standard.

    The FDA’s lies are shocking when overwhelming evidence to the contrary exists in plain sight. Like right at the FDA! The agency recently authorized several e-cigarettes for sale under its Premarket Tobacco Product Applications (PMTA) process: Logic, NJOY Ace and Vuse Solo. In 2019, under a different process, it authorized IQOS, a heat-not-burn product, to be marketed as “modified risk,” and in 2020 green-lit an updated version. How can anyone credibly believe that those brands protect public health, but Juul and thousands of other denied products do not?

    This is what so enrages people who vape and supporters of tobacco harm reduction: the rampant science-denial and arrogant dismissal of the experience of millions who use Juul or other vapes to quit smoking. Comparing harm reduction products to the cigarettes they replace is what counts—not some arbitrary, rigged bureaucratic standard.

    The FDA is either so clueless it doesn’t realize, or else just doesn’t care, that its clearly political decision to punish Juul for supposed transgressions years ago only appeases anti-vaping fanatics, damages public trust and invites yet more contempt for the agency.

    Banning Juul, if it happens, is criminal, and will go down in infamy as a death sentence for smokers.

    The harm reduction movement has long had a terrible reality to confront. The US government doesn’t really care about preventing premature death or suffering, from drug overdose to HIV/AIDS to COVID-19 to mass shootings. The FDA’s actions, when cigarettes continue to kill over 480,000 people every year in the US—and when there is a proven tool to reduce or even eliminate that toll—are the latest evidence.

    In the midst of all the misinformation, hatred and fear-mongering, we should never forget the revolution that James Monsees and Adam Bowen started when they created Juul. It was the first e-cigarette to take off on that scale, and it has helped millions of people around the world stop smoking. Juul has saved lives. Former smokers themselves, Monsees and Bowen said their goal was to “erase combustible cigarettes from the face of the earth.”

    To that end, they worked for years to build an e-cigarette that was safe, attractive, simple to use and delivered the right hit of nicotine. They created a sleek, Apple-inspired device that was deliberately designed not to look like a cigarette and to be discreet. Someday it should be on display at the San Francisco Museum of Modern Art. And people preferred it to cigarettes!

    The goal of eliminating cigarettes is in grave danger—and not because of mistakes Juul made early on when they launched and marketed the product. Rather, the goal is being thwarted by US tobacco control groups dead set on destroying vape companies, putting small vape shops out of business and passing more vape restrictions and flavor bans. This deranged, multi-pronged strategy morphed over the years from ending smoking to total nicotine prohibition. Now, it’s as if the FDA has become a branch of the Drug Enforcement Administration (DEA), an agency that lives to ban drugs.

    The cruelty is astonishing, especially when you consider who smokes at the highest rates and most needs harm reduction alternatives: people who are unhoused, Indigenous people, LGBTQ people, people with mental health diagnoses.

    They manufactured a classic drug panic, accusing Juul of creating a teen vaping “epidemic.”

    The Truth Initiative, Campaign for Tobacco-Free Kids (CTFK) and Parents Against Vaping E-cigarettes (PAVE), with Bloomberg money and powerful allies in Congress, went bat-shit on Juul. In a way, it’s a proxy war against the tobacco companies that they were never able to destroy. Their trump card is to continuously cite the tobacco industry’s nefarious past to smear and, they hope, wipe out the future of vaping. For Big Tobacco, read “Big Vape.”

    They manufactured a classic drug panic, accusing Juul of creating a teen vaping “epidemic.” For a couple of years the number of teens experimenting with Juul increased; it was cool to use a mango Juul at a party, and rebellious to sneak a cucumber vape in school bathrooms. But there was never an epidemic. Daily vaping rates among youth who had never smoked remained very low.

    The corporate media played a disgraceful role in sustaining this fiction. Week after week, they published utterly biased, hyperbolic and evidence-free stories about Juul. Articles excoriating the company accused them of “hooking a new generation on nicotine” and “planting the seeds of a public health crisis,” and asked, “Did Juul lure teenagers and get customers for life?”

    Tobacco harm reductionists knew all along it was a fad, that eventually Juuling would not be cool and teens would quit or switch to the next hip brand.

    And we were right. The 2021 National Youth Tobacco Survey showed that teen vaping declined by a whopping 60 percent. In 2019, high school e-cigarette use (past 30 days) peaked at 27.5 percent; last year it was 11.2 percent. And guess what? The disposable e-cigarette Puff Bar is now far more popular among teenagers than Juul, according to data from the US Centers for Disease Control and Prevention (CDC) and the FDA. Less than 6 percent of high school vapers said Juul was their preferred brand, compared to 26 percent who used Puff Bar.

    So Juul didn’t hook a new generation on nicotine or get customers for life after all.

    But the attacks continued. The company has been inundated with lawsuits. In 2021, it agreed to pay $40 million to settle one in North Carolina. Thirteen other states, including California, Massachusetts and New York have piled on and sued. Nearly 2,000 other cases have been filed by cities, counties and school districts. The central claim in each case is that Juul intentionally addicted teenagers to its product with “high”-level nicotine pods. Never mind that there is more nicotine in a pack of cigarettes than a Juul pod, or that youth smoking rates—the real issue—have fallen to all-time lows.

    How many more smokers would have made the switch if the war to destroy Juul hadn’t been waged? That is the real tragedy.

    The attempt to bankrupt Juul with a tsunami of lawsuits and an FDA ban on sales was the endgame for the extremists in tobacco control organizations. The prospect of millions of adults no longer having access to their safe alternative to cigarettes didn’t bother them.

    How many more smokers would have made the switch if the war to destroy Juul hadn’t been waged? That is the real tragedy.

    Juul made mistakes, but what corporation hasn’t? It tried to correct them, but tobacco control zealots and some in the tobacco harm reduction community weren’t having it. The problem is that Juul has tried to placate opponents of vaping, and that has proven to be futile.

    The company didn’t vigorously challenge the vicious lies continuously circulated by tobacco control groups, medical societies and junk scientists. It didn’t explicitly reject the false narrative that its product created a teen vaping epidemic. It offered public apologies to parents whose teens vape. It promised to combat underage use—something it could never fully deliver on and that set it up for even more criticism.

    It voluntarily removed its popular flavored pods from the market before the law required this—angering Juul users and tacitly lending credibility to the idea that flavors are used to attract minors. It reached legal settlements in lawsuits, and issued statements saying the company was in “reset” mode and wanted to earn trust from key stakeholders.

    This strategy of pleading for redemption merely emboldened Juul’s haters. Instead of focusing on vulnerable groups with the highest rates of smoking, the company was forced on the defensive and into survival mode.

    Juul disappeared into the secret and über-expensive netherworld of the FDA’s PMTA process. The deck was always stacked against getting authorization because of cozy, decades-long relationships between the FDA and men like Matt Myers. For 26 years, Myers has been the leading carnival barker at the CTFK. He’s been close with the former FDA commissioner, the ineffective and bloviating Mitch Zeller, and the current one, Robert Califf, a cardiologist who is hopelessly misinformed about vaping.

    PAVE was also able to muscle its way into influencing the FDA’s decision about Juul’s PMTAs. Powerful politicians aligned with the antivaping agenda exerted enormous pressure through back channels and public shaming to shut Juul down.

    On a Zoom webinar in June, with two of the founders of PAVE, Rep. Raja Krishnamoorthi (D-IL) demonstrated this cozy relationship. “I’m so heartened that the FDA, after I and my office actually had a long conversation with the FDA commissioner about this … finally decided to stop Juul from issuing this rather murky set of marketing materials in regards to their product and issued marketing denial orders,” he said. “I’m so glad that we have an ally in the FDA Commissioner who is willing to look at this with the objectivity necessary to decide what needs to be done in protecting the health of the United States.”

    Objectivity? Protecting health? That would be laughable if the lives of so many people were not in jeopardy.

    The climate that tobacco control created for Juul admittedly made it hazardous for the company to do anything. But how much better it would have been to see Juul go all-out against the enemies of harm reduction, mobilizing a “Juul Nation” of consumers to fight for their right to vape. It had the money to fund advocacy groups to pack public hearings to testify against vaping and flavor bans and to pressure politicians. It could have hosted conferences and used social media platforms to debunk myths about vaping and expose the junk science they were based on.

    The forces aligned against Juul and vaping have demonstrated that they don’t care if smokers continue to die.

    And crucially, Juul needed to hit back hard on the outright lies that wrongly linked nicotine vapes to the 2019 outbreak of lung disease—the name of which, EVALI, or “e-cigarette or vaping use-associated lung injury,” was itself yet another lie.

    Juul could have sued tobacco control groups, the FDA, and media outlets for defamation or libel and threatened to shut them down. There is no question that these groups, and the media, made numerous false statements and allegations that damaged the company. Instead of apologizing and paying out millions in bogus lawsuits, Juul should have exposed the true motives of all the litigation.

    In its petition to an appeals court for a temporary stay on the FDA’s Marketing Denial Order, it finally did. Juul argued that the FDA issued its decision “after immense political pressure from Congress once it became politically convenient to blame [Juul Labs, Inc.] for youth vaping, even though several of its competitors now have a larger market share and much higher under-age use.”

    The forces aligned against Juul and vaping have demonstrated that they don’t care if smokers continue to die. But at least Juul and its allies can fight with all they have for the rights of smokers to access products that can save their lives. That’s a hill worth dying on.

     


     

    Photograph of Juul advertising in New York in 2019 by Helen Redmond 

    The Influence Foundation, which operates Filter, has received grants from Juul Labs, Inc. Filter‘s Editorial Independence Policy applies.

    • Helen is the senior editor of Filter. She has written about nicotine, mental health and drug policy for publications including Al Jazeera, AlterNet, Harper’s and The Influence. As an LCSW, she works with drug users in medical and community mental health settings. An expert on tobacco harm reduction, she provides training and consultation on mental health, nicotine use and THR, and in 2016 organized the first Tobacco Harm Reduction Conference in the US. Helen is also a documentary filmmaker.

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