Editor’s note: The opinions expressed by the author do not necessarily reflect the opinions of the AAMC or its members.
As an epidemic of acute lung injury and death associated with the use of vaping products continues to sweep the nation, public health advocates have called on the federal government to restrict the sale of these products until the cause of the outbreak is discovered.
If vaping products were considered a drug, this would almost certainly have occurred by now. But as we discussed in the first part of this series, the federal government’s ability to regulate a substance that is neither safe nor effective for health is complicated by the laws that protect the public’s right to consume legal but potentially addictive or dangerous substances.
As with other tobacco products, understanding the history of vaping products in this context is instructive. In the early 2000s, Chinese medical researcher Hon Lik patented the e-cigarette as a way to help cigarette smokers quit the habit. Without the toxic and carcinogenic combustion substances produced in cigarettes, e-cigarettes were deemed healthier, and could be used by cigarette smokers as a way to wean themselves from their nicotine addiction. But the use of such products threatened to produce an epidemic of nicotine addicts, particularly if the concentration of profoundly addictive nicotine reaching the lungs, and therefore the brain, could be optimized.
Unfortunately, the technology also enabled the addition of ingredients with attractive smells and tastes, making the vaping experience that much more appealing. Iniquitous marketers devised a system of targeted digital advertising combined with the establishment of local “vape shops” that could mix the ingredients and sell them in a social environment resembling a coffee shop, thus becoming one of the fastest growing small businesses in the United States.
How young people became addicted to vaping
In 2015, during my tenure as Commissioner, the U.S. Food and Drug Administration (FDA) proposed a rule that would have eliminated flavors from tobacco products. The evidence was overwhelming that the primary purpose of the flavors (and the accompanying packaging and branding) was to attract young people to the products. It was not entirely clear whether addicted teenagers would eventually gravitate from vaping to tobacco use, but the FDA had preliminary evidence that this risk was substantial. The primary public health goal, from my perspective, was to reduce the number of tobacco-related deaths, cancers, strokes, heart attacks, and instances of heart and renal failure. I hoped that we would be able to strike a favorable balance, one that limited the growth of vaping while evidence could be gathered to determine whether vaping is a truly effective approach to weaning people from tobacco products.
The United Kingdom’s National Health Service had already decided to encourage vaping by tobacco users as a means to reduce tobacco usage, but the evidence we saw was inconclusive as to whether tobacco users were more likely to reduce tobacco use or convert to “dual use,” given that vapers could use their devices in public places where combustible tobacco products were outlawed. In addition, any benefit to current smokers had to be weighed against the risks of nicotine addiction in people who otherwise would not be using tobacco products. As the proposed rule made its way through the U.S. Office of Management and Budget, the flavor ban was stricken for reasons that were not specified.
The mix of marketing and confusion about who was assuring the safety of vaping products has apparently led to a common belief in young people that these products are safe — so much so that “juuling” is a common event in university libraries as students try to concentrate on their studies.
At the time, our best evidence indicated that in controlled short-term trials, vaping could be used much like nicotine gum or medication to enable a person to discontinue tobacco products, especially when this was combined with behavioral support. However, in the real world, there was competing evidence that tobacco users would become dual users because of the ability to intersperse vaping and tobacco use to achieve even greater levels of nicotine, and a modeling study conducted by researchers at Dartmouth concluded that the capacity for harm from vaping outweighed the likely benefit, even given “optimistic” assumptions. At the time, there was no direct evidence of harm from vaping and the limited biological studies of nicotine gave a mixed picture — clear potential for addiction, and activation of the cardiovascular system, but fewer of the toxic effects of the carcinogens and inflammation-producing components of tobacco tar. However, the FDA had no authority to require clear delineation of the chemical components in the vaping mix, and there was reason for concern that unbeknownst to the user, toxic ingredients might be present.
In the midst of all this activity, Juul arrived on the market. Enterprising former Stanford students combined elegant engineering with sleek Silicon Valley design and marketing to create a product with unprecedented appeal, especially among younger consumers. In addition, the impact of extensive and sophisticated social media campaigns has not been fully appreciated. I was personally amazed by the degree of seemingly coordinated (and possibly automated) online activity visible in my Twitter feed whenever tobacco and vaping were mentioned. While this activity was not specific to Juul, it fits the pattern of highly effective use of social media to spread misinformation on this topic. In addition, good old American ingenuity yielded a plethora of home-grown approaches to vaping illegal drugs to achieve a concentrated high. The mix of marketing and confusion about who was assuring the safety of vaping products has apparently led to a common belief in young people that these products are safe — so much so that “juuling” is a common event in university libraries as students try to concentrate on their studies. Much like the American Tobacco Company in the days of J.B. Duke, Juul quickly established a commanding market position, and now Altria, one of the largest U.S. tobacco companies, has bought a dominant position in the company. The ultimate result: millions of addicted teenagers, hundreds to thousands of people with acute lung injuries, dozens of deaths, and still no ban on flavors.
What should be done now?
Having left the FDA in 2017, I have no inside knowledge regarding the information available to the FDA and U.S. Centers for Disease Control and Prevention. Nevertheless, these are the steps I would personally recommend:
- Flavors in vaping products should be banned immediately and the campaign about the dangers of unregulated vaping should be dramatically increased. The latter step is particularly urgent, given the scale and sophistication of online messaging aimed at advertising and spreading misinformation about vaping. We have an epidemic of serious lung injury and death that must be quelled, especially in teenagers and children.
- The timeline for enforcement discretion must be brought back to “as soon as possible.” Those who want to promote and sell products that have the potential to cause this degree of harm with no health benefit should be required to perform rigorous premarket clinical studies. The exact constituents of vaping products should be revealed and penalties for adulteration should be enforced.
- Surveillance should be increased to identify individuals and groups selling vaping products to minors; those who violate the law should be vigorously punished.
Beyond these immediate measures, we need a national discussion on what to do about vaping and adults. As long as cigarettes and cigars are legal for adults, my assumption is that public appetite for prohibition of these products will be lacking. If improving longevity and functional status were our only goals, banning over-the-counter vaping products and instead assigning prescription-only status would be the most sensible approach. However, there is a widespread view in the United States that adults have the right to choose harmful and addictive lifestyles — at least, up to a point. It may be possible to distinguish between the “vape tank”-style products more commonly used by adults and the disposable e-cigarettes and sleek rechargeable vaping devices whose appeal to teenagers and children may deserve particular attention. The admixture of the current lethal epidemic with cannabis and cannabis extracts, as well as vitamin E acetate and street drugs, makes the issue even more complex.
The regulatory trifecta would be to: 1) require the tobacco industry to lower the amount of nicotine in its products to subaddictive levels (if nicotine can be dialed up using irradiation and selective breeding, it can also be dialed down, even if the law forbids regulation that reduces the level to zero); 2) ban over-the-counter vaping products; and 3) support prescription vaping so that the 30 million current tobacco users do not go through acute withdrawal all at the same time. Such a regulatory regime could eliminate over 400,000 tobacco-related premature deaths per year.
We should move to enact strict regulation to limit the harm done by vaping products, augmented by an aggressive public education program that is particularly aimed at vulnerable young people, but not excluding adults.
Outright prohibition of vaping products seems impracticable on several grounds. First, the belief in personal freedom is a dominant feature of American culture: we allow people to eat unhealthy food, ski in dangerous places, and use guns, despite the obvious risks. Additionally, addictive substances with psychoactive properties, when proscribed by law, become economic and social substrates for illegal markets, stimulating dangerous business deals with associated violent and nonviolent crime and filling our prisons with people who would otherwise be contributing to society. A regime of legal prohibition also dissuades people from seeking help with addiction for fear of stigma that might negatively affect future employment and social mobility.
While I would personally prefer the trifecta described above, given these factors, I believe that we should move to enact strict regulation to limit the harm done by vaping products, augmented by an aggressive public education program that is particularly aimed at vulnerable young people, but not excluding adults.
Robert M. Califf, MD, MACC, is Vice Chancellor for Health Data Science, Director of Duke Forge, and the Donald F. Fortin Professor of Cardiology at Duke University School of Medicine. He sits on the corporate board for Cytokinetics and is board chair for the People-Centered Research Foundation. He is also employed as an advisor by Verily Life Sciences (Alphabet).
