An eighteen-year-old waitress was admitted to a Pittsburgh intensive care unit with difficulty breathing, sudden stabbing pains in her chest and a worsening cough. Her condition continued to deteriorate even after the hospital put her on antibiotics. A doctor said: “She was unable to get enough oxygen into her blood from her lungs and required a mechanical ventilator (respirator) to breathe for her until her lungs recovered.” She needed to have fluid drained from her lungs and was diagnosed with hypersensitivity pneumontis, or “wet lung.” Her medical problem was attributed to a two or three week habit of vaping.
Her case study appeared in the medical journal Pediatrics and received local and national media attention. KDKA-TV, which was quoted above, and CNN are just two of the media outlets covering the story. The treating physician and lead author of the case study said chemicals in e-cigarettes led to lung damage and inflammation. “As electronic cigarette use increases, we will be seeing more case reports and side effects.” CNN reported that the 2016 National Youth Tobacco Survey reported that 1.7 million high school students said they had used e-cigarettes in the previous 30 days.
The specific e-cigarette product used by the teen was not mentioned in any of the articles. However, Time and CNBC noted that a product known as “JUUL” accounted for about 33% of the e-cigarette market as of late 2017. The JUUL Labs product has become so popular, that using it is now known as “juuling.” Like tobacco products, JUUL is legally available only for adults 18 and over. But JUUL devices are reported to be wildly popular with teens.
Ironically, the chief administrative officer for JUUL Labs said: “We really don’t want kids using our product.” He said two former smokers created JUUL to help adults quit smoking. However, each JUUL cartridge contains as much nicotine as a pack of cigarettes. The JUUL device fits in the palm of your hand, as illustrated in the above photo. A JUUL starter kit contains the device, four cartridges and a USB charger in order to charge it in a USB port. Time said:
Because of their sleek design and resemblance to USB drives, JUUL products are easy for students to conceal and use in school — sometimes even in the middle of class. (JUULs also produce less smoke than many similar devices, making them even more discreet.) The problem has grown widespread enough that school districts in states including Kentucky, Wisconsin, California and Massachusetts have voiced their concerns and, in some cases, begun amending school policy to address the issue. Some college publications, including those at New York University and the University of Illinois, have also reported on the trend.
In “What is Juul?” Truth Initiative noted that while JUUL Labs says JUUL is just for adults, it comes in flavors that have a proven appeal to young people. And many young people do not realize they are inhaling nicotine with e-cigarettes. A study published in the American Journal of Public Health found that 99% of all the e-cigarettes sold in 2015 contained nicotine. “Youth are more likely to try flavored e-cigarettes, and believe that they are less harmful than tobacco-flavored e-cigarettes.”
In 2015, 16 percent of high school students and 5.3 percent of middle school students used e-cigarettes, the most commonly used tobacco product among U.S. youth. This research provides further evidence that restrictions and warning labels for products containing nicotine are necessary to protect and inform youth.
Truth Initiative did a survey in April of 2018 to assess where teens are getting their hands on JUUL. The most common way was through a store or retail outlet. Another common source was from friends or family members; 52% received JUUL from a social source. Only 6% bought it online, yet “nearly all youth who tried to buy the product online were successful.” Truth Initiative and five other public health and medical groups filed suit in federal court in March of 2018 for the FDA to take action against JUUL.
On April 24, 2018, the FDA issued a statement from Commissioner Scott Gottlieb, who said the FDA “will not tolerate the sale of any tobacco products to youth.” They issued 40 warning letters to retailers known to have sold JUUL products to youth. They also sent an official request to JUUL Labs requiring the company to submit documents related to product marketing and whether certain product features, ingredients or specifications appeal to different age groups. “We don’t yet fully understand why these products are so popular among youth. But it’s imperative that we figure it out, and fast.”
Commissioner Gottlieb said the FDA was planning additional enforcement actions against companies they believed were marketing products in ways that were misleading to kids. These were just the first in a series of efforts within the FDA’s newly formed Youth Tobacco Prevention Plan. He hoped this sent a clear message to all tobacco product manufacturers and retailers. “If kids are flocking to your product or you’re illegally selling these products to kids, you’re on the agency’s radar.”
The youth-focused steps we’re taking are consistent with our responsibility to protect kids and significantly reduce tobacco-related disease and death, and I intend to do everything within my power to fulfill that duty.
Then on May 17, 2018 and again on June 21, 2018 the FDA sent out official requests to a total of six additional e-cigarette manufacturers requiring them to submit information like that requested of JUUL Labs to help the agency better understand the youth appeal to these products. The companies had until July 12, 2018 to respond to the FDA. The companies were selected based on product attributes that overlapped with those of JUUL. These attributes included the use of e-liquids with high nicotine concentration; a small size, making them easily concealable; and intuitive product design features for ease of use. Commissioner Gottlieb said:
Too many kids continue to experiment with e-cigarette and vaping products, putting them at risk for developing a lifelong nicotine addiction. These products should never be marketed to, sold to, or used by kids and it’s critical that we take aggressive steps to address the youth use of these products. This includes taking a hard look at whether certain design features and product marketing practices are fueling the youth use of such products.
A study published in PLOS One by Weaver et al. said ENDS (electronic nicotine delivery systems) were not helping adult smokers quit. The study randomly sampled 1,284 adult smokers in August/September of 2015 and re-contacted them one-year later. Adults who didn’t use ENDS were more likely to have quit smoking at the end of the study than those who has used ENDS at some point during the study. The researchers, Weaver et al., said:
We found no evidence that ENDS use, within context of the 2015–2016 US regulatory and tobacco/vaping market landscape, helped adult smokers quit at rates higher than smokers who did not use these products. Absent any meaningful changes, ENDS use among adult smokers is unlikely to be a sufficient solution to obtaining a meaningful increase in population quit rates.
The Wall Street Journal quoted the lead author of the study as saying, “These products have not been fulfilling the public health promise of helping people in the U.S. quit smoking.” He added that changes in design, marketing and regulation may help them become more effective as smoking cessation tools. The researchers speculated that older ENDS might be ineffective because they fall short of the “real world” of smoking. It other words, they don’t have a high enough nicotine content to tempt smokers to switch from cigarettes completely. Disturbingly, while this speculation is not yet supported by research, it could be used to present higher nicotine ENDS like JUUL as harm reduction tools, subtly changing the public health dialogue away from smoking cessation. “Any amount of smoking is harmful, and it’s really not benefiting them if they don’t quit entirely.”
The senior author of the study was alarmed with the large percentage of dual users noted at the end of the study. More than half of those who also vaped at the beginning of the study were still smoking a year later. And over half of those smokers were also vaping. The study also found that none of the flavors used in ENDS other than menthol or mint were associated with lower odds of quitting when compared to non-ENDS users. “We need to be much more consistent in our guidance to smokers about how to use these products and that they need to quit smoking and avoid dual use.”
NPR noted how San Francisco banned the sale candy-flavored e-cigarettes, “but a tobacco industry-funded campaign” forced a voter referendum on the ban. The measure, known as Prop E, was opposed by “No on Prop E,” which received its funding from R.J. Reynolds—“to the tune of nearly $12 million.” Some of their slogans included “bans don’t work” and “voting no preserves adult choice.” The referendum took place on June 5, 2018, wheere Prop E was soundly supported, with 68% voting “yes” on Prop E to ban candy-flavored e-cigarettes.
Surprisingly, on January 5, 2018, Philip Morris International announced its plan to stop selling cigarettes in Britain at an unspecified future date. The managing director of PML said: “We believe we have an important role to play in helping the U.K. become smoke-free.” Yet like other tobacco companies, Philip Morris has been developing alternatives to conventional cigarettes. The company currently sells a technology called iQOS in about 24 countries. “It heats tobacco without burning it, reducing levels of harmful chemicals found in cigarette smoke.”
Former Philip Morris employees and contractors told Reuters about “a number of irregularities” in the clinical trial studies submitted by the company in its application to the FDA for approval of its iQOS device. One principal investigator failed to get informed consent from participants, a basic procedure during clinical trials, and the experiment had to be excluded. A review of hundreds of pages of publically available study reports also uncovered “shortcomings in the training and professionalism of some of the lead investigators, as well as their knowledge of the study results.”
A group of tobacco research and policy experts reviewed detailed summaries of Reuters’ reporting and Philip Morris’ response. The experts, including a former head of the FDA and two former scientific advisers for the agency, said those findings raise concerns about Philip Morris’ clinical trial program.
The New York Times reported on January 25, 2018 that an advisory committee recommended the FDA reject the Philip Morris International application to market the iQOS as safer than traditional cigarettes by an eight-to-one vote. The committee rejected the company’s claim that “scientific studies have shown that switching completely from cigarettes to the IQOS system can reduce the risks of tobacco-related diseases.” Although the committee did agree the device would limit exposure to the harmful chemicals in conventional cigarettes, it expressed doubt smokers would completely switch to use only iQOS. Rather, many on the committee thought smokers could become long-term dual users of the device and cigarettes.
An FDA decision on IQOS had not been made public by the beginning of July. But Reuters noted that ten U.S. Senators sent a letter to FDA Commissioner Gottlieb in February of 2018 calling on the agency to reject the Philip Morris application to market the iQOS device as less risky than cigarettes. They encouraged the FDA to avoid rushing through new products like the iQOS “without requiring strong evidence that any such product will reduce the risk of disease, result in a large number of smokers quitting, and not increase youth tobacco use.” A thorough review of the application was “especially critical given the tobacco industry’s deceitful history of marketing products under the guise of lower risk.” So far, the company has spent more than $3 billion developing new smoking technologies like iQOS.
JUUL Labs just announced it will sell cartridges with 40% less nicotine beginning in August of 2018. Initially only mint and Virginia tobacco flavored JuulPods will be available in the lower nicotine cartridges. In October there will be a wider release. I wonder if they will offer their top selling fruity flavored cartridges in a lower nicotine option?
The Verge noted JUUL Labs carefully avoided saying whether the lower nicotine cartridge will eventually lead to no nicotine at all. The company describes its product as a “switching tool” to help adults stop smoking cigarettes. And a 40% reduction isn’t enough to make JUUL less addictive. An expert said nicotine levels would have to be cut by 85 to 95 percent to make cigarettes (and by implication JUULs) significantly less addictive. If the company goal is to get smokers to switch from cigarettes to JUUL, cartridges with low enough concentrations of nicotine to be less addictive and a real harm reduction technology are unlikely.
Public health efforts have drastically curtailed the use of tobacco and cigarettes over the past several decades. Cigarette use has become stigmatized. So companies like Philip Morris International and JUUL Labs are trying to position their new nicotine delivery systems as harm reduction devices. But they may be as bad for you as the tobacco products they seek to replace. JUUL and iQOS are not really public health gems.