New section

New section

Should the federal government regulate vaping?

Robert M Califf, MD
October 28, 2019

In this two-part series exclusive to AAMCNews, former FDA Commissioner Robert M. Califf, MD, examines the history of tobacco regulation and suggests how we might curb the current epidemic of vaping-related lung illness.

New section

New section

Editor’s note: The opinions expressed by the author do not necessarily reflect the opinions of the AAMC or its members.

Recent statistics on electronic nicotine delivery systems (ENDS), popularly known as “vaping devices” or “e-cigarettes,” are frightening. The most recent data from the U.S. Centers for Disease Control and Prevention (CDC) indicate that a quarter of U.S. high school seniors report having vaped in the previous month. The health consequences of a generation of teenagers addicted to nicotine could be devastating, and if that’s not bad enough, more than a thousand recent cases of severe acute lung injury and at least 26 deaths have now been associated with the use of vaping products.

According to the CDC, as of October 15, 2019, among the 849 patients for whom data are available (out of a total of 1,479 reported U.S. cases of vaping-related lung injury), 78% reported using vape products that contained THC and just under one-third reported using THC vape products exclusively. Meanwhile, 58% reported using vapes that contained nicotine and 10% reported using nicotine vapes exclusively. Because of the overlap between the groups using THC and nicotine vape products, it is unclear whether these cases involved only commercially available products, as opposed to “black market” components. The situation has already become severe enough to merit its own name: E-cigarette or Vaping Associated Lung Injury (EVALI).

Many people have asked me about my views on vaping. My thoughts on this topic, gathered below, encompass a history of interaction with tobacco products both as an academic clinician and during an intense stint as Commissioner of the U.S. Food and Drug Administration (FDA). I hope these reflections will be useful to the many concerned people who are now considering what should be done in the face of an emerging public health problem.

The link between tobacco and disease

Lately, I’ve been thinking about these issues every time I walk by the statue of James Buchanan “Buck” Duke in front of the Duke Chapel on the grounds of the university where — barring a handful of years devoted to completing a residency and to serving at the FDA — I’ve spent the last half century. J.B. Duke, the benefactor of Duke University, made his initial fortune by developing a scalable approach to manufacturing and distributing cigarettes. When he took over the family business at age 28, the industry was transitioning from producing tobacco for hand-rolled cigarettes to the industrial manufacture (and aggressive marketing) of mass-produced tobacco products. Within 5 years, the American Tobacco Company was producing and distributing half of all American-made cigarettes and had established a global conglomerate of multiple kinds of tobacco products. It became such a dominant enterprise that the Supreme Court dissolved it in a 1911 antitrust action, and the Dukes went on to more constructive enterprises, developing extensive textile companies and investing in hydroelectric power generation to create what would become Duke Power. The rest of the devastating tobacco epidemic is history — a history inextricably entwined with the founding of Duke University.

Fast-forwarding to 2004, I find myself at Oxford University, sitting at the head table at a celebration for the renowned epidemiologist Sir Richard Doll. Sir Richard, then over 90 years old and still working, had led what is arguably the most important study of the lethal effects of tobacco, the British Doctors Study. He and his colleagues followed an entire cohort of British doctors until all of them died — truly a study with 100% follow-up. In the end, there was a 10-year difference in life expectancy between doctors who smoked and those who didn’t. This was literally the “smoking gun” for the fact that smoking causes premature death, heart disease, and cancer in addition to a host of other health problems. It would, however, take decades to translate this epidemiological breakthrough into partially effective public policy.

When I assumed the post of FDA Deputy Commissioner in 2015 … I had no knowledge of the complexity of regulating a product that harms people’s health but is liked by a large proportion of the population, supported by a tradition of lethally effective lawyering, and heavily subsidized by an industry with deep pockets and a significant political constituency.

As a cardiac intensivist and clinical cardiologist, for decades I witnessed firsthand the ravages of tobacco products in the patients cared for by our cardiac team. In the early 1980s cardiac care units were packed with middle-aged men with acute myocardial infarction, and sudden death was depressingly common. I didn’t think much about nicotine addiction, other than noticing how difficult it was to stop smoking despite various aids and medications. When I assumed the post of FDA Deputy Commissioner in 2015, I thought the agency was poised to continue contributing to the noticeable decline in the use of tobacco products that had taken place in recent decades. I had no knowledge of the complexity of regulating a product that harms people’s health but is liked by a large proportion of the population (many of whom are addicted to it), supported by a tradition of lethally effective lawyering, and heavily subsidized by an industry with deep pockets and a significant political constituency.

How the FDA came to regulate tobacco

There is a widespread misconception that the FDA has been regulating tobacco products since the time that a young FDA commissioner, David Kessler, MD, confronted the tobacco industry in the 1990s. Kessler and his colleagues used their authority to uncover documents revealing the tobacco industry’s efforts to obfuscate evidence of harm from their products and to optimize the addictive activity of nicotine on the brain in secret human and animal studies. They also found that tobacco companies were using an old-fashioned method of gene editing — breeding plants from seeds that were irradiated to create mutations that would increase nicotine content.

Kessler’s argument in 1996 hinged on the assertion that nicotine was a drug and therefore should fall under the FDA’s jurisdiction. After a long journey through the lower courts, the case went to the Supreme Court, which ruled against the FDA by a 5-4 vote. The court’s majority held that the control of products that were neither safe nor effective for health did not fall under the federal Food, Drug, and Cosmetic Act from which the FDA derives its regulatory authority. At the same time, the FDA was pushing for better regulation of dietary supplements to empower the agency to evaluate the safety and efficacy of food supplements prior to marketing. The public health lost on both counts, as we now have a supplement industry worth almost $200 billion that promotes health claims with no evidentiary standard, and the tobacco industry successfully used the courts to block the FDA from regulating tobacco.

Although Kessler’s leadership exposed the egregious misdeeds of the tobacco industry, it was not until the election of President Barack Obama in 2008 that Congress passed the Family Smoking Prevention and Tobacco Control Act (TCA), which specifically assigned authority for the regulation of tobacco products to the FDA on the premise that adults had the freedom to choose to use tobacco products but minors should not be exposed to an addictive substance.

The FDA then started a new center, the Center for Tobacco Products (CTP), whose current director, Mitch Zeller, JD, cut his teeth as part of Kessler’s team. In addition to specifying how tobacco products would be regulated, the CTP — which was essentially a startup within a decades-old organization — developed an enforcement approach and undertook a major research effort supported by hundreds of millions of dollars in funding derived from user fees assessed to the regulated industry. Among the many interesting elements of the TCA was a provision that prohibited the FDA from outlawing tobacco altogether, and a stipulation that the nicotine concentration of the leaf could not be reduced to zero, although it could be lowered based on scientific evidence. One particularly positive outcome of this regulation was the allocation of substantial funding to support desperately needed research on tobacco product toxicity and the epidemiology of the use of tobacco products in conjunction with the National Institutes of Health.

It was not until the election of President Barack Obama in 2008 that Congress passed the Family Smoking Prevention and Tobacco Control Act (TCA), which specifically assigned authority for the regulation of tobacco products to the FDA on the premise that adults had the freedom to choose to use tobacco products but minors should not be exposed to an addictive substance.

A recurring societal theme that has shaped the regulation of tobacco is the ambiguous view that our society holds about addictive substances. For example, alcohol, marijuana, opioids, amphetamines, and tobacco have major differences, but they share a risk of either addiction or extraordinary dependence with repetitive use. Alcohol is legal, but prohibited for youth in state regulation. Marijuana until recently was uniformly illegal, but is now legal in many states for medical use and in a moderate number of states for recreational use, although it remains illegal under federal law. Amphetamine derivatives are contained in many over-the-counter and prescription medications, but methamphetamine is illegal and its use is growing rapidly again as opioids become more difficult to obtain. Opioids are prescribed legally, but they are illegal for consumer use. The result of this mix of legal and illegal use of addictive substances is that our jails are full of drug users who have committed nonviolent crimes, significant premature death and disability is tolerated, and there are enormous disparities in enforcement as functions of wealth, race, and power. The compromise embodied in the TCA, in which the FDA is enjoined to regulate tobacco without eliminating its use, reflects this ambiguous American view of individual freedom versus the risk posed by addictive and dangerous substances.

A path to enforcement

However, to fully understand the history of tobacco regulation since the passage of the TCA, one also needs a basic understanding of how federal laws are interpreted and implemented. In essence, once Congress enacts a law, that law must then be interpreted, and federal rules provide binding instructions on how a law is interpreted by the relevant federal agencies. Guidances are nonbinding recommendations that describe tactical approaches to implementing a law as interpreted within the context of the rules. Before a rule can be enacted, a proposed rule must be posted for a period of public comment and written responses made to each comment. Rules with significant economic impact require evaluation of the potential societal economic impact on the United States, a task performed by a little-known cadre of health economists employed by the relevant agency (the FDA has several dozen health economists) and checked and revised by the Office of Management and Budget. Before a rule is finalized, it goes up and down the chain of the executive branch of government and a formal “notice-and-comment” process requires public posting of the proposed rule and a formal response to every comment.

In order to regulate a tobacco product, the FDA had to write a rule that would specify which products it deemed to be subject to the TCA. The law immediately deemed cigarettes, cigarette tobacco, smokeless tobacco, and hand-rolled tobacco as subject to the TCA, and required the FDA to stipulate what other tobacco products it would regulate. Thus, in order to regulate cigars, e-cigarettes, and hookah and vaping products, the FDA had to write a rule that was processed through the formal “notice-and-comment” rule-making process. The shorthand for this effort is “deeming regulation.”

At every step of the way, attempts to regulate tobacco and related products have been contested and undermined by the tobacco industry, whose relationship with regulators stands in stark contrast to that of medical product industries and the FDA. The FDA’s mission statement identifies ensuring public safety as its primary mission, but also encompasses the promotion of innovation under the premise that approved or cleared products will improve longevity, function, or quality of life. The question at the heart of the agency’s relation with the tobacco industry is, essentially, “what can be done with regulation to limit the number of people killed or disabled by tobacco products?”

An important facet of this story concerns the FDA’s battle with the tobacco industry over advertising. Because of the modern interpretation of the First Amendment, companies essentially have the same rights of free speech as those enjoyed by individuals, and any government interference with that speech requires definitive evidence of an overriding societal interest. Prior to my tenure at the FDA, the agency suffered a legal defeat when a panel of judges on the U.S. Court of Appeals for the District of Columbia ruled that the graphic warnings (essentially, pictures of people experiencing the dire health consequences of tobacco use) that the FDA sought to mandate on tobacco product packaging infringed on the First Amendment rights of tobacco companies. This ruling came despite definitive research demonstrating that the use of such warnings was associated with significant reductions in smoking behavior in controlled studies that almost certainly would have led to a reduction in death and disability. Since that defeat, the agency has continued to gather evidence about the effectiveness of this approach and once again is poised to issue a rule requiring the placement of graphic warnings on tobacco packaging.

The question at the heart of the agency’s relation with the tobacco industry is, essentially, “what can be done with regulation to limit the number of people killed or disabled by tobacco products?”

The economic impact of tobacco use

An additional key background issue concerns the economics of tobacco and tobacco products. My own introduction to these issues occurred during a clandestine breakfast meeting with a famous demographer and epidemiologist who had conducted a 1990s version of a “big data” analysis. This person’s conclusions: tobacco produced economic benefit not only because it created jobs, but also because it reduced longevity after retirement. In other words, people who die from tobacco-related diseases often die from sudden cardiac death, myocardial infarction, stroke, or lung cancer — all of which are associated with relatively short intervals of disability.

At the time, this rather cold-blooded argument seemed solid from a purely economic perspective. Nevertheless, I couldn’t help feeling that like most people, when I reached retirement age, I would like to enjoy those extra years after my normal working life. At the time I had not heard of the concept of “lost consumer surplus,” a term used in economics to measure the difference between what consumers are willing to pay for a good or service and the “market equilibrium” price.

When I arrived at the FDA, I was fascinated to learn that this concept had become a hot-button issue in the economic evaluation of tobacco policy, with a group of economists arguing that the loss of consumer surplus offsets a very high proportion of the economic benefit of reducing the use of tobacco products. Notably, the argument’s rationale assumes an individual consumer making a free and informed choice, but that is a big assumption when the individual in question is addicted to a substance (in this case, nicotine) and has been subjected to a protracted and sophisticated campaign of misleading messaging. I raise this issue not to debate a complicated economic concept but to point out that what appears obvious to a medical or public health professional can look different to people from other vantage points.

Discussing policies related to vaping products would be difficult without this background. In Part 2 of this piece, I will give my personal perspective on the complex issue of regulating vaping products.

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).

New section