When it comes to the public’s health, it always seems to take a crisis before protections are put in place. The Food, Drug, and Cosmetic Act of 1938 — the bedrock law that first required companies to conduct safety studies of medications before they could be sold — was passed only after a tainted drug killed scores of children.
In 1962, a scare over birth defects caused by thalidomide led to groundbreaking standards for clinical trials. Medical device controls? Enacted in 1976 after the Dalkon Shield caused infertility and infections in thousands of women. Food safety legislation? It received bipartisan support only after the recall of 500 million eggs tainted by salmonella.
My public health students often ask an obvious question: Why is it so challenging for regulatory agencies to prevent calamities in the first place? In years past, I have struggled with a concise answer to this question — until now.
Now, I tell them to examine why the Food and Drug Administration was unable to keep millions of youths from becoming addicted to electronic cigarettes, how the agency wound up taking much of the blame for hundreds of people with severe lung injuries, and why long-overdue action to protect the public still remains out of reach.
Lesson 1: Imminent economic harm beats the threat of injury to the public
The story starts in September 2008, during the administration of President George W. Bush. The FDA detained early batches of e-cigarettes on the grounds that they appeared to be unapproved medical devices designed to deliver the drug nicotine.
The manufacturers quickly took the agency to court, arguing that their products were neither devices nor drugs. Instead, they claimed that e-cigarettes were most akin to traditional cigarettes, which the Supreme Court had recently said the FDA could not regulate without new legislation from Congress. The companies sought an injunction against the FDA on the grounds that the agency was causing them immediate and irreversible economic harm.
The FDA’s response was, in essence, that e-cigarettes barely resemble cigarettes and look a lot more like nicotine inhalers, which are regulated devices that contain drugs. As the case was pending, FDA released early data revealing the presence of harmful chemicals in e-cigarettes. The agency also held a press conference and warned the public of the risks of addiction and lung injury.
I remember this moment well because at the time I served as principal deputy commissioner of the FDA. “We’re concerned about them because of what we know is in them and what we don’t know about how they affect the human body,” I told The New York Times.
The FDA’s efforts didn’t help. District Court Judge Richard Leon issued a restraining order against the FDA to prevent “irreparable” harm to the e-cigarette industry. Criticizing the agency for “its tenacious drive to maximize its regulatory power,” Leon wrote, “I am not convinced that the threat to the public interest in general or to third parties in particular is as great as FDA suggests.”
Lesson 2: Courts show little deference to public health agencies
The FDA appealed the district court decision, arguing that Leon had given “extraordinarily little weight to public health concerns.” Supporting the agency’s position, the American Lung Association, the American Academy of Pediatrics, the American Cancer Society, and other health authorities wrote a friend of the court brief.
These organizations argued that the district court decision could “result in increases in tobacco use, especially among children, by introducing non-smokers to smoking behaviors and nicotine through use of unregulated products like electronic cigarettes.” Their brief also noted that without quick FDA action, e-cigarettes could be “manufactured and marketed in ways that appeal to children — e.g. by using flavors that appeal to children.” These fears would later be proven true.
But the industry stuck to its position that economic damage outweighed those “conjectural and speculative” health benefits of regulation.
At the appeals court, the FDA made a special effort to point out that regulation did not mean the end of the e-cigarette industry. The agency would not be forced to remove all products from the market. Rather, the agency could leave e-cigarettes on the market “while the new … applications were prepared, provided certain time frames and other specific conditions were met.”
In other words, the FDA could allow companies to sell e-cigarettes as the agency phased in manufacturing standards, restrictions on flavors, and other standards. The agency’s view was then, as it is now, that regulation should balance the potential benefits of these products to smokers looking to quit against the risks of new nicotine addiction among youth.
But its efforts failed. In December 2010, the D.C. Circuit Court of Appeals again sided with the tobacco industry, refusing to grant deference to the agency’s position that its authority to regulate drugs and medical devices was the most appropriate path for regulating these products.
By this time, a new law give the FDA authority over tobacco products had passed Congress. The court required the agency to use the new Tobacco Control Act to oversee e-cigarettes and related devices that allow the user to “vape.” But this law required years of rulemaking before the FDA could impose any restrictions. And during this period, the industry was able to grow rapidly.
Lesson 3: Growing industries wield political power
In 2011, the year I left the FDA, the agency began the arduous process of addressing vaping under the Tobacco Control Act. This process required calls for public comment, economic and regulatory analyses, and reviews by a multiple offices in the Department of Health and Human Services and the White House.
It would be three more years before the FDA was ready to start regulating e-cigarettes. The first proposal was published in April 2014. Among other topics, the agency sought public comment about the “availability of flavored e-cigarette liquids” and “the possibility that these flavors could appeal to youth.”
Within about a year, as the Los Angeles Times reported, the FDA had determined that 4 in 5 youths who vaped cited flavors as a reason, and that the actual flavors used “largely overlapped” with those used in Kool-Aid, Jolly Ranchers, and Life Savers. Inside the Obama administration, health officials proposed removing such favors from these products, with an effective date of November 2016.
The industry fought back. This time, instead of the courts, the playing field was the White House’s Office of Management and Budget, which approves major rules from agencies like the FDA. During dozens of meetings in the White House, small business owners and their lobbyists brought industry scientists to contest the FDA’s findings. Lobbyists showed signs of picketers holding signs saying, “I vape. I vote.” Store owners predicted an economic “vapocalypse.”
I should note that one of the lobbyists for e-cigarette manufacturers was a former White House staffer who had reviewed the FDA’s proposed rule the prior year.
Industry won again. The final regulation took effect in 2016 without the flavor provisions. The regulation gave manufacturers two years to submit key health data or face their products’ removal from the market. Early in the Trump administration, though, with a looming threat of White House or congressional action to protect the vaping industry, the FDA extended this deadline.
As two administrations were trying to find a kinder and gentler path with the industry, a new company called Juul entered the market. With its teen-friendly marketing, intense flavors, and ability to deliver high levels of nicotine, Juul quickly became the dominant device in the country. As reports of rapid increases in youth vaping became public, the FDA imposed modest restrictions on sales, and the surgeon general issued a warning to parents.
But enormous damage to public health has already been done. By 2018, 3.6 million kids were vaping, representing a 78% increase in just one year, with more than two-thirds choosing flavored products. In 2019, the FDA found that “more than 5 million youth … used e-cigarettes in the past 30 days and nearly one million reporting daily use.” The agency determined “that while cigarette smoking is at an all-time low among high school students, increases in e-cigarette use have reversed progress made in the decline of overall youth tobacco use.”
Lesson 4: When crisis strikes, the press and public draw the wrong lessons
In the summer of 2019, the vaping crisis became a full-blown catastrophe. Alert physicians at the Children’s Hospital of Wisconsin noticed a pattern of adolescents coming to the hospital struggling to breathe; their X-rays revealed severe lung injuries. The common factor: vaping. At a press conference on July 25, the doctors joined state health officials to sound the alarm.
Almost immediately, the medical community across the country began to report new cases. The precise cause of the outbreak remains unclear, with the Centers for Disease Control and Prevention focused on the potential role of vitamin E acetate as an additive in products that may also contain THC, the active chemical in marijuana. As I write this, CDC has counted 2,172 cases of severe lung disease across the country, with 42 deaths.
Vaping injuries became front-page news, with the imminent risk of injury sharing space with a new appreciation for the explosion of its use among youths. Seizing the moment of crisis, several state health officials took action, with some banning flavors in e-cigarettes and others temporarily banning their sale altogether. A major part of the news, however, became how the FDA had failed.
An Oct. 14 New York Times headline read “E-Cigarettes Went Unchecked in 10 Years of FDA Inaction.” While the headline was later changed to the more accurate phrase “Federal Inaction,” it’s not hard to see why the first draft said “FDA.”
For several years, many advocates had trained their criticism on the FDA for not doing more about electronic cigarettes. A few months earlier, the American Lung Association had given the agency an F for “lack of action” on vaping, even though the lung association knew, or should have known, that there was a lot more to the story.
During the previous decade, the FDA had tried to protect the public, and especially youths, from the potential harms of e-cigarettes. Yet the agency had been stopped by the courts, impeded by the White House, and repeatedly warned to back off by members of Congress. The fundamental problem was not that the FDA had been sitting on its hands. The problem was that its hands were tied.
Shouldering the lion’s share of the blame has undermined the FDA’s credibility at a critical point in time. In September, President Trump announced a ban on flavors for vaping products, although he didn’t have a plan for implementing it. Notably, FDA officials had no role in announcing the news to the public, nor have they been able to propose and defend a more comprehensive approach to maximizing the benefits of e-cigarettes for adults who smoke while minimizing the risks to youth.
As the ensuing days turned into weeks, the industry regrouped and argued — yet again — that the economic damage to industry outweighs the risks to public health. The news media covered the tribulations of e-cigarette retailers (“it has been a rough few months”) around the country. Economic arguments have apparently convinced the president not to proceed with a ban on flavored e-cigarettes.
At least until the next crisis strikes.
Final exam: What will it take for next time to be different?
The easy answer is: greater respect for scientific agencies. Individuals without scientific expertise — including judges and politicians — should not be so quick to dismiss the role of those who best understand serious risks to health and what can be done to stop them.
Short of this shift, greater transparency would be a step forward. When judges restrict agency action, they should refrain from claiming that the risks are not real or could easily be prevented through alternative approaches. Instead, they should acknowledge in their decisions that harms predicted by experts may well come to pass. White House staffers should sign their names to decisions that stop the actions of FDA and other agencies that are intended to save lives. And the media should investigate the decision-making behind the scenes, just as the Washington Post has done in reporting that it was Trump’s campaign manager who influenced his recent reversal on vaping.
Advocates, for their part, should orient themselves to the entire government, not just to a regulatory agency. It’s not enough to press the FDA or another agency to take a specific action. Efforts should also be directed to political appointees and courts with the power to stop the agency.
As for the scientific agencies themselves? Career regulators should keep doing their jobs, using the best available evidence to put forward reasonable, effective standards to save lives. They should beware the siren call of self-censorship and point out to elected leaders that preventable crises often have serious consequences for political popularity as well as for the health of their constituents.
Why does it always seem to take a crisis? The beginning of wisdom is to look beyond the regulatory agency alone for the answer.
Joshua M. Sharfstein, M.D., is professor of the practice in the Department of Health Policy and Management at the Johns Hopkins Bloomberg School of Public Health and the author of the “Public Health Crisis Survival Guide: Leadership and Management in Trying Times” (Oxford University Press, 2018).