Tag: ENDS

12/19/23

Health Effects of Vaping

Photo by Itay Kabalo on Unsplash

The American Heart Association recently published a scientific statement on the use of e-cigarettes, “Cardiopulmonary Impact of Electronic Cigarettes and Vaping Products.” It describes the latest usage trends, the current scientific evidence about e-cigarettes and identifies current health impacts. It noted that vaping and e-cigarette use has grown exponentially over the past ten years, particularly among youth and young adults. They have been touted as safer alternatives to tobacco cigarettes, and even as potential tobacco-cessation products. However, e-cigarettes in 2019 led to more than 2,800 hospitalizations.

The CDC reported that as of February 18, 2020, a total of 2,807 hospitalized EVALI (e-cigarette or vaping product use-associated lung injury) cases or deaths were reported. Laboratory data showed that vitamin E acetate, an additive in some THC-containing products, was strongly linked to the EVALI outbreak. The CDC and FDA recommended that people not use THC-containing ENDS—electronic nicotine delivery system. After the identification of the primary cause of EVALI, and a significant decline in EVALI cases, the CDC stopped collecting data from states as of February 2020, the beginning of the COVID pandemic.

By 2019 in the U.S., 27.5% of high school students said they used e-cigarettes or ENDS. These products are the most commonly used tobacco products among youth, a growing number of whom reported never smoking combustible cigarettes. Data from the National Youth Tobacco Survey (NYTS) indicated current use in the past 30 days of ENDS increased from 1.5% in 2011 to 20.8% in 2018, an estimated 3.1 million students. Among middle school students, current e-cigarette use increased from .6% in 2011 to 4.9% in 2018, an estimated 570,000 students. See the following figure from “Cardiopulmonary Impact of Electronic Cigarettes and Vaping Products.”

Data from the 2019 NYTS indicated 25.5% of 12th graders reported current e-cigarette use compared to 11% in 2017. Current THC (cannabis) vaping increased in 12th graders from 4.9% in 2017 to 14.0% in 2019, 4.3% to 12.6% with 10th graders, and 1.6% to 3.9% with 8th graders. The prevalence of ENDS use among youth remained stable despite the pandemic. Data from 2020 showed ENDS use declined to 19.6% among high school students and to 4.7% among middle school students. “Whether this is an artifact of the great societal disruptions from the global pandemic or represents a decreased trend remains to be seen.”

Because of the rapid evolution of ENDS, it is important to examine prevalence rates with other vaping products besides e-cigarettes such as e-hookahs (e-waterpipes). E-hookahs are a new category of vaping devices, introduced in 2014 and recently patented by Philip Morris [the tobacco company], that are marketed as healthier alternatives to traditional hookah fruit-flavored tobacco smoking. Findings from the nationally represented PATH study (Population Assessment of Tobacco and Health; 2014–2015) in children 12 to 17 years of age indicated that 7.7% were identified as ever-users of e-hookahs compared with 14.26% who were ever-users of ENDS products.

Studies in the U.S. indicate a rapid increase in ever and current ENDS use among adults since 2010, “with the vast majority of users being current or former cigarette smokers.” Recent analysis of NHIS (National Health Interview Survey) data from 2014 to 2018 showed young adults 18 to 24 years of age are using ENDS at high rates. Current use increased from 5.1% to 7.6%. There were large increases among never-smokers (1.5% to 4.6%) and former smokers (10.4% to 36.5%).

See “Cardiopulmonary Impact of Electronic Cigarettes and Vaping Products” for a detailed discussion of the acute health effects and toxicity of e-cigarettes and vaping products.

Chronic Health Effects and Toxicity of E-Cigarettes and Vaping Products

E-cigarettes were created in China in the early 2000s and introduced to the US market in 2007. The basic mechanism heats or atomizes a liquid solution or e-liquid that generally contains a humectant (a substance used to keep things moist), nicotine and flavoring agents. The e-liquid formulations can contain other drugs beside nicotine, including THC, methamphetamine and methadone. The FDA attempted to stop the importation of these products, recognizing they could be used as drug-delivery devices. But a 2010 court ruling, Smoking Everywhere, Inc. vs US Food and Drug Administration deemed e-cigarettes should be considered tobacco products, and fall under the 2009 Family Smoking Prevention and Tobacco Control Act.

E-cigarettes and vaping were introduced in the US 16 years ago, and only saw widespread adoption in the past ten years. “We do not yet know the long-term health effects of these products.” Tobacco use was not recognized as a major preventable cause of death until many years after cigarette smoking became widespread. An increasing incidence of lung cancer was not noted until 1930. Definite scientific evidence associating cigarette smoking and lung cancer was not reported until the 1950s.

In 1964, the US Surgeon General report on tobacco and health attributed the increase in lung cancer to cigarette smoking. Only then did cigarette smoking per capita begin to decline. With the delayed development of chronic disease from smoking, lung cancer deaths did not begin to fall accordingly until decades after the 1964 report.

See the following figure taken from “Cardiopulmonary Impact of Electronic Cigarettes and Vaping Products.”

In 2018 an evidence-based summary of the health concerns with ENDS found no available evidence that ENDS use was associated with coronary heart disease, stroke, and peripheral artery disease. There was insufficient evidence that ENDS use was associated with long-term effects on heart rate, blood pressure and cardiac function. There was also no available evidence on whether ENDS use causes respiratory diseases in humans. There was only moderate evidence ENDS use is associated with increased asthma problems, and limited evidence of adverse effects of ENDS exposure on the respiratory system.

There have been few studies of the chronic cardiovascular effects of ENDS because they have only been available for the past 16 years! Assuming similar time delays for the appearance of chronic disease from cigarettes and for ENDS, “epidemiological increases in disease prevalence would not be expected to be observed for years.”

Vaping devices have not been shown to be safe for long-term use. The short- and long-term toxicities of inhaling aerosols generated from liquids containing vegetable glycerin, propylene glycol, nicotine, or flavors are unknown. Inhaling aerosols generated from THC- or CBD-containing liquids, which often contain additional chemical components, also have unknown health effects. Thus, elucidating their long-term respiratory, cardiac, and cancer health effects is a public health priority.

E-Cigarette and Vaping Products as Cigarette-Cessation Products

The Cochrane Review found that nicotine e-cigarettes can be effective in helping people stop smoking for at least six months. They were found to be more effective than nicotine replacement therapy and cessation with e-cigarettes without nicotine. And yet, they strongly discouraged those who have never smoked from using e-cigarettes, especially young people. “This is because they are a relatively new product and we don’t yet know the long-term health effects.”

“Cardiopulmonary Impact of Electronic Cigarettes and Vaping Products” said in the Cochrane Review adverse events were higher at 12 weeks to 6 months in ENDS users when compared to no support or behavioral support only. One study compared e-cigarettes with varenicline (Chantix), finding e-cigarettes were less effective than varenicline. Four of 27 e-cigarette users versus 13 of 27 varenicline users stopped smoking. The main study results assessed smoking cessation and not complete product cessation. “This could mean that participants who quit smoking continued ENDS use.”

Another study compared nicotine ENDS plus a nicotine patch (NRT) with NRT alone and NRT plus nicotine-free ENDS. The patch alone has a 2% abstinence rate. The patch and nicotine-free ENDS had a 4% abstinence rate and the nicotine patch and nicotine ENDS had a 7% abstinence rate. “No current ENDS products have FDA approval as a tobacco-cessation aid. There is only low to moderate confidence of improved cessation with nicotine-containing ENDS products compared with NRT or behavioral interventions.”

There are few empirically tested prevention and cessation programs for youth ENDS use. Using novel technology—text messages, social media—that have been used extensively to advertise ENDS products to youth, as wells as educational efforts targeting parents and health educators, and other methods have been shown to promote smoking cessation among youth. But further work is needed to develop and test effective interventions.

Conclusion

ENDS products have undeniably been increasing in popularity, particularly among young adults and teens, in the past decade. The constituents of these products often include nicotine, which is well established to have negative health effects and strong addictive properties. Other ingredients, particularly in flavored products, have known health risks. Because ENDS products are not regulated as classic therapeutic drugs or devices, there are no dedicated long-term safety studies. Critical questions remain unanswered about the short-term and, in particular, long-term health effects of ENDS products. Because the products have only recently gained widespread use, decades of prospective or retrospective data are not yet available to examine the long-term health effects of cigarettes. Early analysis suggests some utility of ENDS as a smoking cessation product; however, any benefit needs to be juxtaposed with a clear understanding of the health risks of the ENDS products themselves and the risks of product availability leading to nonsmokers initiating ENDS use.

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.