Tag: JUUL Labs

12/13/22

Juul and the Fight to Regulate Vaping

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On June 23, 2022, the FDA ordered JUUL Labs Inc. to stop selling and distributing its products in the US. After reviewing the company’s PMTAs (premarket tobacco product applications), the FDA concluded the applications did not have sufficient evidence the Juul products would benefit public health, as claimed. Some of the company’s study findings had insufficient and conflicting data—“including regarding genotoxicity and potentially harmful chemicals” leaking from their e-liquid pods. The FDA Commissioner said, “Today’s action is further progress on the FDA’s commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards.”

The FDA thought Juul’s application left regulators with questions about the chemical makeup of its vaping formulations, while Juul thought it submitted enough information and data to address all the concerns. The acting director of the FDA’s Center for Tobacco Products said,

As with all manufacturers, JUUL had the opportunity to provide evidence demonstrating that the marketing of their products meets these standards. However, the company did not provide that evidence and instead left us with significant questions. Without the data needed to determine relevant health risks, the FDA is issuing these marketing denial orders.

The next day the U.S. Court of Appeals placed a temporary hold on the ban, saying Juul’s application warranted “additional review.” Then the FDA announced on Twitter it would allow Juul’s vaping products to remain on the market while it reviewed the application for “scientific issues” unique to the Juul application.

The NYT said the decision to conduct an internal review moved the dispute out of the public eye of the appellate court and returned it to the agency’s private administrative process. The ban in June was celebrated by critics who thought the company should be held accountable for luring teenagers to use its flavored products. Others were critical, saying e-cigarettes are less toxic than traditional cigarettes. Juul argued that it had helped two million adult smokers quit traditional cigarettes. The company also said it had been singled out by members of Congress who influenced the agency to make the ruling.

Juul’s court filing said the agency contended “in more than two dozen places” that Juul did not provide enough data on four chemicals. But Juul said it did provide the data—6,000 pages of data. “Had F.D.A. done a more thorough review (like it did for other applicants), it would have seen data showing that those chemicals are not observable in the aerosol that Juul users inhale.”

Theodore Wagener, the director of the Ohio State University Center for Tobacco Research, said the original ban was surprising, given that independent research teams like his own found that Juul devices were far less toxic than traditional cigarettes. He said Juul aerosol has significantly lower-level and fewer toxicants than cigarettes; and lower chemical levels than other e-cigarettes. It seemed thing were beginning to go Juul’s way, and perhaps was a foreshadowing of the FDA decision.

Then on September 6th Juul agreed to pay $438.5 million to settle a two-year investigation by 33 states into the marketing and sales practices they blamed for starting a national flood in teen vaping. The company did not acknowledge any wrongdoing in the settlement, but said it was trying to resolve past issues while it awaited the FDA decision on whether it would be allowed to continue to sell its products. Connecticut’s attorney general said they were under no illusions that it will stop teen vaping. “But we have essentially taken a big chunk out of what was once a market leader.”

Juul said the settlement aligned with its current business practices. “We remain focused on the future as we work to fulfill our mission to transition adult smokers away from cigarettes — the No. 1 cause of preventable death — while combating underage use.” Under pressure for it marketing practices of targeting youth, Juul revised its business practices and target audience to adult smokers in the fall of 2018. See “Not JUULing Around” and “The Armageddon of Juul.”

The agreement does not resolve all of the company’s legal battles. While Juul had previously reached settlements in lawsuits brought by attorneys general from North Carolina, Washington, Louisiana and Arizona, nine similar cases remain. Major lawsuits filed by New York and California are among those still pending. And about 3,600 lawsuits by individuals, school districts and local governments, have been consolidated in an action that is still wending its way through a California court.

A study done in 2018 and published in the journal Pediatrics looked at 4207 students in ninth-through 12-grades in the Pittsburgh Public Schools. The researchers showed an inverse correlation between protective factors, such as parental monitoring and future orientation and youth vaping. “The differential association of protective factors across tobacco products highlights the unique social and relational features of vaping.”

One of the study’s authors, Kar-Hai Chu, has been studying the evolution of e-cigarettes for the past ten years. He said his research team has done several studies on Juul’s presence on social media, finding at least 25% of Juul’s Twitter followers were under 18. He said their estimate was conservative, as the recent settlement noted above found the number could be as high as 50%.

The immediate and obvious concern was that so many adolescents were being exposed to Juul’s advertisements, but as behavioral scientists, we realized the problems didn’t end there. Not only were kids seeing the ads, but they were sharing them with their friends. In the world of Facebook, Twitter, and Instagram, sharing tobacco content was as easy as a single click.

He described how on Instagram they saw many different flavors of Juul products in colorful cartons. “Decades of research have found that colorful tobacco images are more appealing to younger teens; Instagram was just the latest platform for this strategy.” He then noted a post that made them laugh: “Why do people pee in the Juul room?” But there was truth behind the humor. For teachers and school officials that Twitter post defined the battles they were having.

Kids were using Juul devices in schools, in bathrooms (or Juul rooms), and even in classrooms when teachers’ backs were turned. Schools were desperate for solutions. School administrators had watched adolescent cigarette use decline over the past decade, but this was something new. Yes, it was still a tobacco product, but kids didn’t seem to understand the health impacts. These weren’t teens rebelling by using cigarettes, knowing they were harmful; instead, it was athletes, A-students, and others who believed that e-cigarettes were merely flavored vapor with no impact on their health.

But the golden days for Juul have faded. After Juul gave in to public pressure and stopped selling flavors that appealed to young people, it fell to the fourth favorite among students. Puff Bar, with its candy-and fruit-flavored vapes was first. Altria in December of 2018 bought a 35 percent share of Juul (See “Not JUULing Around”). In a recent filing to its investors, Altria said its share was now valued at $450 million.

Whatever the FDA decision is on Juul, the FDA is purposefully moving to regulate all vaping, all ENDS (electronic nicotine delivery systems). But vaping manufacturers won’t give up without a fight. In an attempt to evade FDA regulation, manufacturers of e-cigarette brands popular with kids have begun to use synthetic nicotine in their products.

However, a new federal law went into effect in April of 2022, clarifying the FDA’s authority to regulate tobacco products containing nicotine from any source. After July 13, 2022, “any new non-tobacco nicotine product that has not received premarket authorization from FDA cannot be legally marketed.” When companies are found to be illegally marketing non-tobacco nicotine products, the FDA will first issue warning letters to achieve voluntary compliance. But the agency will pursue enforcement actions such as civil money penalties, injunction, non-tobacco sales orders, or injunction.

08/17/21

The End of ENDS?

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On Wednesday, June 23, 2021 the Subcommittee on Economic and Consumer Policy held its fourth hearing examining youth vaping in the US. Senator Dick Durbin and the acting FDA Commissioner, Janet Woodcock were witnesses. The FDA is in the process of determining whether e-cigarettes will be legally allowed to stay on the market. “All e-cigarette manufacturers were required to submit Premarket Tobacco Product Applications (PMTAs) to FDA by September 9, 2020, in order to legally stay on the market.” Stat News reported that Senator Durbin and other Democrats accused the FDA of inaction on the issue: “Who is the cop on the beat to whom we entrust our children? It’s the Food and Drug Administration.”

The hearing comes as the FDA begins deciding in earnest which e-cigarette manufacturers can stay on the market, as part of a congressionally mandated process. Manufacturers like Juul, Blu, and Njoy were required to submit marketing applications to the FDA in September but are allowed to stay on the market until at least September 2021, while the agency reviews those applications.

In 2018, the Surgeon General issued an advisory where he declared e-cigarette use among youth an epidemic. “We need to protect our young people from all tobacco products, including e-cigarettes.” Despite this advisory, there has been little concrete action as yet. The chair of the subcommittee said the youth vaping epidemic has continued over the past three years. “More than 20% of high schoolers vape, and 5% of middle schoolers vape.” These are the same levels that led the surgeon general to declare a youth vaping epidemic in 2018. To the FDA, he said:

No matter what your decision on Juul’s PMTA, you know that the problem does not end there. To end the youth vaping epidemic, you’ll have to deny the applications for all products with the same characteristics that made Juul so popular with a generation of children.

Federal officials had singled out Juul for fueling the epidemic because of its intentional advertising aimed at youth and the sleek design of its product, which made Juul far and away the most popular e-cigarette among young people. The company defended its products, saying it took steps to prevent youth from using them. Juul stopped distributing some flavorings to retail stores, but only after the FDA announced plans to restrict the sale of flavored e-cigarettes to young people. The Oversight Committee released internal documents from its investigation of Juul that showed the company knew its products were addictive for teens.

Included in the documents was an internal memo from a Juul-focus group in 2018 that asked the teens why the product was so attractive to kids in Middle School and High School. “Several of the young people responded that the product’s high nicotine content kept kids hooked.” Juul says it chose a high nicotine level for its pods, roughly equivalent to a pack of cigarettes, to entice adults to quit combustible cigarettes. The claim seems somewhat disingenuous, as the company began receiving complaints that its products nicotine levels were too high around one year after Juul launched in 2016.

In an October 2018 CDC press release, “Sales of JUUL e-cigarettes skyrocket, posing danger to youth,” the then director of the CDC Robert Redfield said, “The popularity of JUUL among kids threatens our progress in reducing youth e-cigarette use.” During 2016-2017, Juul Labs’ sales increased 641%, from 2.2 million devices sold in 2016 to 16.2 million devices sold in 2017. Truth Initiative, a nonprofit organization seeking to eliminate nicotine addiction, surveyed 12 to 17-year-olds in April of 2018 to assess how so many young people were getting their hands on Juul products. Seventy-four percent said they obtained Juul in a store. Fifty-two percent said they received Juul from a family member or friend. For more information on Juul, see: “JUUL Is Not a Gem,” “The Armageddon of Juul,” and “Juul’s Empty Harm Reduction Rhetoric.”

While vaping is less harmful than smoking, it still is not safe. As of February 18, 2020, the CDC reported there have been 68 deaths from EVALI—e-cigarette or vaping-associated lung injury. There were 2,807 hospitalized cases or deaths from EVALI. Laboratory data showed that vitamin E acetate, an additive in some THC-containing vaping products was strongly linked to the EVALI outbreak. The CDC recommended that people not use THC-containing e-cigarettes or vaping products. “E-cigarette, or vaping, products (nicotine- or THC-containing) should never be used by youths, young adults, or women who are pregnant.”

Michael Blaha, the director of clinical research at the John Hopkins Ciccarone Center for the Prevention of Heart Disease, shared health information about vaping in “5 Vaping Facts You Need to Know.” While vaping is less harmful than smoking, it still isn’t safe. There are many unknowns about vaping, including what chemicals are included in the vapor inhaled by users and how physical health is affected over the long term. Blaha said people need to understand e-cigarettes are potentially hazardous to their health. “Emerging data suggests links to chronic lung disease and asthma, and associations between dual use of e-cigarettes and smoking with cardiovascular disease. You’re exposing yourself to all kinds of chemicals that we don’t yet understand and that are probably not safe.”

Research suggests nicotine is just as addictive as heroin and cocaine. Many e-cigarette users get more nicotine than smokers because they can buy cartridges that have a higher concentration of nicotine. You can also increase the voltage of an e-cigarette to get a greater hit of the substance. E-cigarettes are not approved by the FDA as smoking cessation tool, even though they have been marketed as such. A study found that most people who intended to use e-cigarettes to stop smoking ended up continuing to smoke both.

According to Blaha, there are several reasons e-cigarettes are enticing to youth. Teens believe vaping is less harmful than smoking. They have a lower cost per-use than traditional cigarettes. They often have added flavorings and there is a lack of smoke from their use. “With no smell, e-cigarettes reduce the stigma of smoking.” Blaha said:

What I find most concerning about the rise of vaping is that people who would’ve never smoked otherwise, especially youth, are taking up the habit . . .  It’s one thing if you convert from cigarette smoking to vaping. It’s quite another thing to start up nicotine use with vaping. And, it often leads to using traditional tobacco products down the road.

When Janet Woodcock testified before the House Subcommittee on Economic and Consumer Policy, she said protecting the youth of the US from the dangers of tobacco products was among the FDA’s most important responsibilities. “We are taking aggressive steps to make sure tobacco products are not being marketed or sold to kids.” After describing the FDA’s efforts to regulate ENDS (electronic nicotine delivery systems), and the agency’s actions to prevent youth access and use of these products, she said: “We still have much to accomplish and will continue to take strong action to protect youth and monitor the effectiveness of our actions.” Given the concerns noted here and in the linked articles, let’s hope that strong action will include the end of some ENDS products that have been clearly soliciting youthful consumers like Juul.

For more information on concerns with vaping and ENDS, see: “The Ticking Time Bomb of Vaping,” “Priming Young Adults with Vaping” and “Not the End of Smoking.”

11/24/20

Juul’s Empty Harm Reduction Rhetoric

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Juul Labs announced on September 3rd that it would be reducing its workforce, allegedly because of the coronavirus pandemic. According to The Wall Street Journal, that will be over half its remaining employees. Earlier this year Juul cut approximately one-third of its workers and stopped sales of its vaporizers in several countries. The September announcement came one day after Washington State filed suit against Juul, alleging the company designed its products to appeal to teens: “Upon the launch of the device, the company flooded social media with colorful ads of young-looking models and pushed fruit and dessert flavored products.”

The Juul Labs announcement of the cutbacks said it was trying “to place the company on a pathway to fulfill its mission by earning trust of key stakeholders while combating underage use.” Throughout 2020 the company said they had continued to carefully evaluate how to allocate its resources, in an evolving category (i.e., vaping devices) lacking in trust. “The global pandemic and ongoing economic crisis have thrown in a level of uncertainty round the world for which we have to prepare.” They plan to prioritize their resources to execute their long-term, focused approach seems to be an attempt to position Juul as a harm reduction product for adult smokers. Juul said these investments will not provide short-term revenue, but they will help the company earn trust and “build a company for the long term to advance the potential for harm reduction for adult smokers and combat underage usage.”

As such, we will be making a significant global reduction in force, and we will be exploring the possibility of exiting a variety of markets in EMEA and APAC that have not provided the kind of return necessary given the cost to continue investing in the market. In any potential new market, we would ensure that we can have science and evidence-based conversations with stakeholders before entering and that vapor products can effectively compete with combustible cigarettes.

Marketing Juul’s e-cigarette as a harm reduction tool for adult smokers may be part of the company’s new marketing strategy, but it also seems this claim was revisionist history of its earlier approach. In January 2019, The New York Times published, “Juul’s Convenient Smoke Screen,” referred to Juul’s TV advertising campaign, “Make the Switch,” as a “new pitch.” It had just taken in a $12.8 billion investment from Altria, the giant tobacco company behind Marlboro. “Now, after making billions of dollars and joining forces with Big Tobacco, Juul is billing itself as a public-health crusader.” There is evidence suggesting Juul Labs did not always have a public health agenda and cannot even enforce no vaping regulations within its own headquarters.

In 2018, Juul Labs told its employees that California-based employees can no longer vape at their desks, enforcing a 2016 California law that banned e-cigarettes in the workplace. But even though the company banned vaping in compliance with state and local laws, employees continued to use their e-cigarettes as their desks. One employee said it was like something straight out of the TV show Mad Men: “Just replace the cigarettes with e-cigarettes.” While some employees hide their Juuls in sweater sleeves, The Wall Street Journal reported the company’s co-founders and others continued to do it openly. “Even the threat of being fired after a fourth vaping offense hasn’t seemed to have done much.” If Juul Labs can’t stop its own employees from vaping at its offices, so how can it credibly pursue a market position as a harm reduction product?

A research and development engineer who helped create the original Juul device said the company didn’t think a lot about addiction because they were not trying to design a cessation product. “Anything about health is not on our mind.” That R&D engineer is still with Juul. In other early interviews, James Monsees, the co-founder and chief-product officer of Juul, played down the idea of a public health mission. In a 2014 interview posted on YouTube, he said the company was not an activist company. “If you don’t like what we’re making better than cigarettes, then have a cigarette, that’s fine.” The impression left is that Juul was presenting its pod as an alternative to cigarettes.

Monsees admitted the company had been forced to be cautious about its marketing. Federal regulations forbid it from promoting its device as a smoking cessation tool, but permits Juul to claim it is a “switching product” for smokers. He said in the January 2019 NYT article that since 2005 he and Adam Bowen, the other co-founder of Juul, have been focused on creating a product to help people switch away from combustible cigarettes. That is a subtle, but different goal than seeing Juul as a harm reduction product. The co-founders’ graduate thesis presentation pitched vaping as a healthier substitute for cigarettes. Interestingly, James Monsees announced his plan to step down as an advisor and board member of Juul Labs in March of 2020; and the YouTube video in which he said Juul Labs was not an activist company has been removed.

Few of the company’s early ads mentioned the risks of cigarettes or advocated for smokers to switch. Instead, they voiced how “Smoking evolved” and how it’s vaping device was “built to satisfy.” There was even a “launch party.” The president of the antismoking advocacy group, Campaign for Tobacco-Free Kids, said Juul’s ad campaign was little more than a P.R. effort aimed at lawmakers and regulators. “Juul has engaged in all the traditional tactics of a company that is trying to fend off meaningful regulation, rather than actually change their behavior . . . That is classic Big Tobacco.”

Juul’s attempt to convince the public it became a teen sensation by accident is disingenuous (See “Not The End Of Smoking”).  Juul products has been facing significant scrutiny for concerns over their health risks and marketed to young people for some time. Drugwatch reported there were currently 758 Juul lawsuits from around the U.S. The cases represent both class action lawsuits and personal injury cases, and the litigation is expected to continue to grow. Many of the lawsuits claim Juul marketed to minors, but the company denies this. “Most of the initial lawsuits in the mass litigation were filed before reports of widespread vaping-related lung injuries and deaths began coming up in mid-2019.”

The first wrongful death lawsuit was filed in October of 2019. A former senior vice president at Juul claimed he was fired after he raised the alarm when 1 million contaminated, mint-flavored Juul pods were shipped to retailers and consumers. He also claimed the company repeatedly sold expired products over his protests. A pair of Alabama college students filed suit in 2019 claiming they developed serious lung problems from vaping Juuls. As of August 2019, the FDA has identified 127 reports of vaping-related seizures or neurological symptoms.

Seizures are a known side effect of nicotine toxicity. “But many teens don’t realize nicotine is an e-cigarette danger.” When Juul e-cigarettes were first on the market, they delivered almost two to five times more nicotine than other e-cigarettes. Maxwell Berger’s lawsuit claimed the massive stroke that left him with a speech impediment, paralysis on his left side and a loss of vision in each eye before he turned 20 was the result of smoking two-Juul-pods-a-day.

Washington State filed suit against Juul Labs on September 2, 2020 alleging the company designed its product to appeal to underage consumers and was deceptive about the addictiveness of its product. Washington State Attorney General Bob Ferguson also claimed Juul misled consumers by not mentioning their cigarette pods contained nicotine. A 2018 survey by Truth Initiative found that 63% of Juul users did not know the product contained nicotine. Robin Koval, CEO and president of Truth initiative, said:

Unfortunately, young people are unaware that JUUL packs a powerful nicotine punch with a single cartridge equal to an entire pack of cigarettes. This escalates the urgency for Food and Drug Administration FDA) regulation and public education regarding the risks for young people.

In 2020, all health-related concerns appear to have some sort of a connection to the COVID pandemic and that is true for e-cigarettes as well. In “Vaping Links to Covid Risk Are Becoming Clear,” The New York Times said experts have warned since the start of the pandemic that the coronavirus, a respiratory pathogen, likely capitalizes on the damaged lungs of smokers and vapers. Doctors and researchers are beginning to pinpoint how smoking and vaping seem to boost the virus’s ability to spread from person to person, infiltrating the lungs and sparking some of COVID-19’s worst symptoms. Doctor Stephanie Lovinsky-Desir, a pediatric pulmonologist at Columbia University, said: “I have no doubt in saying that smoking and vaping could put people at increased risk of poor outcomes from COVID-19.”

While several studies have found smoking can more than double a person’s risk of severe COVID-19 symptoms, the data on vaping and COVID are just beginning to emerge. A team of researchers reported in the Journal of Adolescent Health that a COVID-19 diagnosis was five times more likely among young adults who vape and seven times more likely among dual users—those who vape and smoke cigarettes. “Youth using e-cigarettes and dual-users of e-cigarettes and cigarettes are at greater risk of COVID-19. Given the predominance of e-cigarette use among U.S. youth, our investigation informs public health concerns that the ongoing youth e-cigarette epidemic contributes to the current COVID-19 pandemic.”

Our findings from a national sample of adolescents and young adults show that e-cigarette use and dual use of e-cigarettes and cigarettes are significant underlying risk factors for COVID-19 that has previously not been shown. The findings have direct implications for health care providers to ask all youth and COVID-19–infected youth about cigarette and e-cigarette use history; for parents, schools, and community-based organizations to guide youth to learn more about how e-cigarettes and dual use affect the respiratory and immune systems; for the Food and Drug Administration to effectively regulate e-cigarettes during the COVID-19 pandemic; and for the development and dissemination of youth-focused COVID-19 prevention messaging to include e-cigarette and dual use.

A study published in 2018 did not find switching to ENDS (electronic nicotine delivery systems) helped adult smokers quit. Juul Labs marketing did target youthful users, as one look at the youthful-looking models in the above link “early ads” will show. And Juul’s harm reduction rhetoric is empty, as it can’t even rein in its own employees.

02/18/20

The Armageddon of Juul

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This past year was a terrible one for Juul. In December of 2018 the NIDA-funded Monitoring the Future (MTF) survey revealed that the percentage of students who reported vaping nicotine during the past 30 days doubled among 12th graders (from 11% to 21%) and among 10th graders (from 8% to 16%). The lead author of the study said the policies and procedures in place were not working to prevent youth vaping. “We need new policies and strategies, such as the FDA’s actions announced last month to curb the sales of the JUUL-branded vaping devices.” Two studies published in the Journal of the American Medical Association found that 27.5% of high school students reported current use of e-cigarettes, and more than half who vape used Juul. “‘Juuling’ has become synonymous with vaping for some teens.”

In November of 2018 Juul Labs CEO Kevin Burns announced an action plan that stopped selling some Juul flavor pods at the retail store level (Mango, Fruit, Crème and Cucumber), leaving only Menthol and Mint flavors. They shut down social media accounts with Facebook and Instagram, saying, “By deterring social media promotion of the JUUL system by exiting our accounts, we can better prevent teens and non-smokers from ever becoming interested in the device.” There is an embedded video explaining the lengths Juul Labs planned to go to prevent teen access to their products.

Juul Labs then launched a multimillion-dollar ad campaign attempting to rebrand itself as a stop-smoking aid for adults, spending $11.8 million on TV ads in the first four months of 2019. The ads avoided key word associated with FDA-approved smoking aids, such as “quit,” “addiction” and “health.” Instead, the company’s ads referred to “switching,” to Juul to get a nicotine “fix.” Juuling was said to be an alternative to smoking. The Atlantic noted how Juul seemed to be following a familiar marketing strategy, one used by Big Tobacco.

Throughout the 20th century, as warnings about the health risks of cigarettes arose, tobacco companies repeatedly found new ways to downplay concerns and advertise their products as healthy options. When their claims were refuted by evidence, they traded them out for new claims.

No e-cigarette, including Juul, has been approved by the FDA to help smokers quit, and there is even a disclaimer to that effect on Juul’s website. “I think the Juul ads are very carefully written and lawyered to confuse the public,” said Stan Glantz, a tobacco control researcher at the University of California San Francisco. A letter from the American Heart Association, the American Academy of Pediatrics and four other groups said:

Juul, a product that FDA has found to be largely responsible for the current epidemic of youth usage of highly addictive e-cigarettes, is being advertised and marketed on a massive scale as a smoking cessation product, without the required review and approval by FDA.

In Europe, nicotine levels are capped and advertising is tightly restricted. Britain and other European countries have promoted e-cigarettes as a reduced-risk product to smokers. They also ban most e-cigarette ads on television, newspapers, magazines and websites. By contrast, the FDA permits marketing across all these requiring the ads carry a single warning message: “This product contains nicotine. Nicotine is an addictive chemical.”

There was also a surge of severe lung illnesses linked to vaping. By December 17, 2019, the CDC reported 2,506 hospitalized lung injury cases associated with vaping from all fifty states, and 54 confirmed deaths. Vitamin E acetate was identified as a chemical of concern among people with lung injury (EVALI) cases. The FDA found that THC was present in most samples tested, and most patients reported a history of using THC-containing products. The agency suggested adults who continued to use e-cigarette or vaping products should carefully monitor themselves; and those who do not currently use tobacco products should not start using e-cigarette products: “There is no safe tobacco product.”

Big Tobacco wanted to get a piece of Juul. In December of 2018, the tobacco giant Altria invested $12.8 billion for a 35% nonvoting stake in Juul Labs, with the ability to appoint one director to the board. They appointed K.C. Crosthwaite, Altria’s chief growth officer. The Motley Fool reported that upon regulatory approval, Altria’s nonvoting shares will automatically convert into voting shares and the tobacco company then had the right to appoint a third of Juul’s directors. Among other provisions, Altria would also be able to sell its shares on the market if Juul has an initial public offering. Companies exchanging nonvoting shares for voting shares in an acquired company are required to tell the FTC about it.

Meanwhile, Juul was trying to stay ahead of what was looking like an Armageddon of federal regulation for the industry. In a CNBC documentary, Juul CEO Kevin Burns said he would tell the parents of teens addicted to Juul products, he was sorry: “First of all, I’d tell them that I’m sorry that their child’s using the product.” He went on to say Juul was not intended for them. “I hope there was nothing that we did that made it appealing to them. As a parent of a 16-year-old, I’m sorry for them, and I have empathy for them, in terms of what the challenges they’re going through.” In August of 2019, Burns told Tony Dokoupil on CBS This Morning, not to use their product, telling him, “Don’t use Juul.” Then at the end of September of 2019, Juul Labs announced Kevin Burns would resign as CEO and be replaced by K.C. Crosthwaite.

In a statement announcing that Altria was moving ahead with notifications of its conversion, the company said: “Altria continues to believe that its investment and the services Altria has agreed to provide JUUL will promote competition and have long-term benefits for adult smokers. Altria continues to anticipate that the conversion of its JUUL shares will occur as planned.” When the move is completed, Altria will have much more control over the direction Juul takes. Juul should be in a much better position to meet regulatory requirements because it will have Altria to help it meet the government’s expectations.

The New York Times reported that in changing its leadership, Juul was looking to Big Tobacco for its survival as it faces a federal criminal inquiry, new bans on some of its products, and multiple state and federal investigations into its marketing practices. In announcing its change of leadership, Juul also said it would not fight a proposal to ban most flavored e-cigarettes, which would have a seriously negative effect on its domestic sales. The company also said it would end its marketing campaign, “Make the Switch,” which the FDA said could be construed as an illegal effort “to portray its e-cigarettes as safer than traditional cigarettes.”

Within the last week alone, several television networks decided to stop broadcasting Juul’s ads; Massachusetts announced a four-month ban on the sale of all vaping products; Rhode Island announced a ban on flavors; Walmart said it would stop selling all e-cigarettes; and the F.D.A. announced it had opened a criminal inquiry into the supply chain of vaping products and devices. The Federal Trade Commission also has been investigating Juul’s marketing practices. And the United States attorney for Northern California opened a criminal investigation into the company, a development first reported by The Wall Street Journal.

This anticipates a regulatory face-off at the FDA in May of 2020 when the agency will determine whether e-cigarettes can remain on the domestic market. Juul’s new CEO said this may drive the market for e-cigarettes overseas. At an all-hands meeting at Juul headquarters, Crosthwaite told employees, “International expansion continues to be a huge opportunity given the number of smokers around the world.” But India said it would ban the sale of e-cigarettes, and the attempt to enter the Chinese market fell flat when the country’s tobacco regulator issued a notice asking e-commerce platforms and businesses to shut online stores that sell e-cigarettes.

At the end of October, The Motley Fool said Altria wrote down its Juul investment by $4.5 billion, reflecting how the company sees recent events impacting Juul’s sales and earnings. Altria’s CEO, Howard Willard said in a conference call with analysts, “Certainly in the range of scenarios when we made our investment in Juul, we did not anticipate this dramatic of a change in the e-vapor category.” For the time being, Altria is standing with Juul: “Despite this impairment charge, we remain committed to Juul’s success.”

Nevertheless, former FDA Commissioner Scott Gottlieb said in November of 2019 he thought Juul Labs’ products should be removed from the market, citing the above two studies published in the Journal of the American Medical Association. “It’s very clear that Juul can’t keep their products out of the hands of kids. . . . What’s driving the youth use is primarily Juul.” He said they’ve hooked a lot of kids. Following the study, Juul halted sales of its mint flavor, saying “these results are unacceptable and that is why we must reset the vapor category in the U.S. and earn the trust of society by working cooperatively with regulators, Attorneys General, public health officials, and other stakeholders to combat underage use.” K.C. Crosthwaite said Juul would support any FDA flavor policy and a regulatory process to get its nicotine pods cleared for sale in the US.

But is it too little, too late?

04/30/19

Not the End of Smoking

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America’s teens reported a striking increase in their vaping in the previous 12 months, from 27.8 % in 2017 to 37.3% in 2018. Reported vaping in the 30 days prior to the survey almost doubled among high school seniors, going from 11% in 2017 to 20.9% in 2018. Nora Volkow, the director of the National Institute on Drug Abuse (NIDA), said: “Teens are clearly attracted to the marketable technology and flavorings seen in vaping devices; however, it is urgent that teens understand the possible effects of vaping on overall health; the development of the teen brain; and the potential for addiction.” She went on to say research shows that teens who vape may be at risk of transitioning to smoking cigarettes.

The increase in vaping rates for 2017-2018 was consistent with the findings of the National Youth Tobacco Survey, which said e-cigarettes were the most commonly used tobacco product among U.S. middle school and high school students. The most selected reason for e-cigarette use was they were available in flavors like mint, candy, fruit or chocolate. The lead author for the Monitoring the Future study, which annually surveys 12th, 10th and 8th grade students, said in a letter to The New England Medical Journal the increases in the prevalence of vaping nicotine translated into roughly 1.3 million additional adolescents vaping.

Put in historical context, the absolute increases in the prevalence of nicotine vaping among 12th-graders and 10th-graders are the largest ever recorded by Monitoring the Future in the 44 years that it has continuously tracked dozens of substances. These results indicate that the policies in place as of the 2017–2018 school year were not sufficient to stop the spread of nicotine vaping among adolescents. The rapid entry of new vaping devices on the market, the latest example of which is the Juul, will require continual updates and modification of strategies to keep adolescents from vaping and its associated negative health effects.

Scott Gottlieb, the former commissioner of the FDA, who had been active in efforts to thwart this trend, sent 1,300 warning letters over the summer of 2018 to online and brick-and-mortar stores for selling e-cigarette products to underage consumers. He also sent out warning letters to five manufacturers, asking them to address the popularity of their products with underage consumers or risk the removal of “some or all of their flavored products.”  In the letter sent to Juul Labs, the FDA requested that within 60 days, “you provide a written response to this letter that includes a detailed plan, including specific timeframes, to address and mitigate widespread use by minors.” Giving suggestions for that plan, the letter said Juul Labs could:

  • Discontinue sales to retail establishments that have been subject to an FDA civil monetary penalty for sale of tobacco products to minors within the prior 12 months;
  • Develop or strengthen any internal program you have to check on retailers, and report to FDA the name and address of retailers that have sold products to minors;
  • Eliminate online sales, whether through Internet storefronts controlled by your company or other retailers, or provide evidence to demonstrate that your company’s online sales practices do not contribute to youth use of JUUL products;
  • Revise your current marketing practices to help prevent use by minors;
  • Remove flavored products from the market until those products can be reviewed by FDA.

Then unexpectedly, in the middle of his crusade against teen vaping, Scott Gottlieb resigned as the commissioner of the FDA, effective April of 2019. His stated intention was to spend more time with his wife and three daughters. He said: “There’s perhaps nothing that could pull me away from this role other than the challenge of being apart from my family for these past two years and missing my wife and three young children.” Gottlieb said the policies he initiated will move forward as planned, including the proposed restrictions recently announced on the sale of flavored e-cigarette products. The New York Times said retailers were on Capitol Hill lobbying against the FDA proposals. “Conservative groups and vaping trade associations also have come out in opposition, saying that the agency’s efforts to regulate the e-cigarette industry amount to government overreach.” Yet some public health advocates think the action steps were too late.

A December 2018 investigation reported in JAMA Network Open sought to estimate the concentration of tobacco-related toxins among e-cigarette users. Findings suggested that exclusive e-cigarette use resulted in measurable exposure to tobacco-related toxicants, generally at lower levels than with cigarette smoking. Dual users had higher concentrations of exposure to nearly all biomarkers when compared with cigarette-only smokers. “Several biomarkers measured in this study are metabolites of known carcinogens as well as respiratory, cardiovascular and/or reproductive/developmental toxicants.” The data clearly showed e-cigarette users were exposed to known tobacco-related toxicants.

Another study presented at the American College of Cardiology’s 68ith Annual Scientific Session shoed that adults using e-cigarettes are significantly more likely to have a heart attack, coronary disease and depression when compared to nonusers. The study’s lead author said: “Until now, little has been known about cardiovascular events relative to e-cigarette use. These data are a real wake-up call and should prompt more action and awareness about the dangers of e-cigarettes.”

This study found that compared with nonusers, e-cigarette users were 56 percent more likely to have a heart attack and 30 percent more likely to suffer a stroke. Coronary artery disease and circulatory problems, including blood clots, were also much higher among those who vape — 10 percent and 44 percent higher, respectively. This group was also twice as likely to suffer from depression, anxiety and other emotional problems.

Scott Gottlieb said that if the 2019 National Youth Tobacco Survey shows another spike in teen use of e-cigarettes, “We’re going to be back making new policy in the fall.” One of those possible changes could be taking all pod-based e-cigarettes off the market. “At some point, the youth use of those products becomes so intolerable that they have no redeeming public health value, and we’ll just have to sweep the market of those products. And that includes Juul. Those are the products being abused by the children.”

In a statement released on Wednesday, March 13, 2019, Juul Labs said they are committed to reducing youth usage of their products, while preserving their opportunity to “eliminate combustible cigarettes.” They noted how in November of 2018 they stopped the sale of flavored Juul pods to retail stores, strengthened their retail compliance and secret shopper program, enhanced their online age-verification and exited their Facebook and Instagram accounts.

We support category-wide action including the responsible, restricted sale of flavored products and will review today’s draft guidance as we continue to work with FDA, state Attorneys General, local municipalities, and community organizations as a transparent and responsible partner in combating underage use.

So, what is the bottom line on the risks of e-cigarettes for teens? The CDC has a page of “Quick Facts on the Risks of E-Cigarettes.” It said the use of e-cigarettes in not safe for teens and young adults. They contain nicotine, which is highly addictive “and can harm the adolescent brain development.” Young people who use e-cigarettes may also be more likely to smoke cigarettes in the future, which points to the motive underlying Gottlieb’s crusade.

Finally, what about Juul Labs desire to use its e-cigarette to eliminate combustible cigarettes? One of the strongest arguments for vaping is that it can help people taper off from their addiction to tobacco smoking. A group of researchers sought to generate evidence on the ‘real world’ use of e-cigarettes on the quit rates of adult smokers. They recruited 1284 current, established smokers and then re-contacted them after a year. Although 16% had stopped smoking, they found no evidence that electronic nicotine delivery systems (or ENDS) were helping adults quit “at a higher rate than smokers who did not use these products, despite ENDS users being more likely to make a quit attempt.” In other words, they did not put an END to smoking.

Our study suggests that use of current ENDS products in real world conditions do not seem to improve the chances of quitting for smokers, and, under the current landscape, may not be the disruptive technology that increases the population quit rate and reduces the harm of combustibles. Additional steps may be needed to spur innovation to create low-harm and low-risk products that adequately deliver nicotine, address the misperceptions of relative harm of ENDS compared to cigarettes, and encourage cessation and complete switching from combustibles to low-harm and low-risk products among smokers who do not want to quit smoking.

Changes to their design, to how e-cigarettes are marketed and regulated may be too slow and ineffectual to lead to the above changes on their own, according to the lead author of the ‘real world’ study published in PLoS One. But for now, it seems e-cigarettes are more likely to become an add-on to smokers than an effective tool to stop smoking. “People who use both tobacco and e-cigarettes are actually less likely to quit smoking than people who only stick to tobacco.”