After years of grinding through the bureaucratic process and fending off litigation, the US Food and Drug Administration in 2016 declared that it was finally able to regulate electronic cigarettes.
But it would still be years before the agency would require e-cigarette makers to provide information on the health effects of their products, so the FDA could determine whether they should stay on the market. The first deadline for that information was 2018, but the FDA moved it back to 2022.
The lumbering pace of oversight, marked by repeated delays, is emblematic of the many opportunities that medical specialists say the FDA missed to head off what has become an urgent public health crisis around vaping. The inaction, these critics say, allowed two separate but related problems to build: a recent outbreak of vaping-related lung illnesses and an alarming rise in teenagers’ use of nicotine e-cigarettes.
“It’s a national tragedy,” said Eric Lindblom, a former FDA tobacco official now at Georgetown Law’s O’Neill Institute. “They could’ve done all sorts of things on the safety side, or the kid-protection side, or to just generally protect the public health.”
Since the first e-cigarettes hit the market in 2007, the FDA, under presidents Obama and Trump, repeatedly put off regulating them. Among the reasons, according to documents and interviews with former FDA officials and health experts: lack of political will in Washington, D.C., at a time when the industry was lobbying and suing over the possibility; and the hope that vaping would be a less harmful alternative that would compel smokers to give up cigarettes.
Cigarette smoking is the country’s leading cause of premature death. However, research — both recent and dating back to 2012 — suggests that some of the chemicals used in vaping liquids can harm the lungs. The vaping liquid is heated into a gas, typically by battery-operated metal coils, to be inhaled.
In testimony to Congress this past week, Acting FDA Commissioner Ned Sharpless acknowledged the agency delayed its review of e-cigarette products in 2017 after surveys showed that vaping rates among young people had declined. While the agency at the time did not consider vaping to outright be safe, it did view it as likely to be less harmful than cigarettes. And Sharpless said the FDA wanted to give smokers a chance to switch products, or even help them quit nicotine.
“In retrospect, the FDA should’ve acted sooner,” Sharpless said. “We should’ve begun regulating these devices sooner.”
Indeed, Sharpless said, all vaping products are, technically, on the market illegally because the FDA has not approved any for sale. The agency has encouraged companies to apply on their own and provide information on the health effects of their products. But it has also declined to enforce that requirement since 2016, delaying the deadline for companies to apply or have their products taken off the market to 2022 from 2018, and then moving it forward a year to 2021.
Earlier this year, a federal judge called the FDA’s delay “an abdication of its statutory responsibilities,” pushing the agency to move the deadline to May 2020.
“It’s a long and sad story of regulatory failure, both during the Obama and Trump administrations,” said Dennis Henigan, a lead attorney for the Campaign for Tobacco-Free Kids, which sued the FDA over the delays. “There were so many opportunities for FDA to have prevented this epidemic. It failed time and time again.”
But a vaping industry group insisted that companies already are “heavily regulated” — they must disclose their ingredients, for example — and that the products are far safer and less likely to cause cancer than cigarettes.
“Even though we don’t know what the long-term health implications are of e-cigarettes, we do know enough to know that we need to remain focused on ending combustible smoking,” said Tony Abboud, executive director of the Vapor Technology Association. “There is a relative harm issue here that is extremely important.”
The recent wave of vaping-related lung injuries — now linked to 12 deaths and 805 illnesses — appears to be largely associated with additives in black-market marijuana oils, officials said Friday. However, the investigation has been complicated by the disclosure that some patients reported vaping only nicotine.
With little clear information available, Governor Charlie Baker on Tuesday banned sales of marijuana and nicotine vapes in Massachusetts for four months, to give scientists time to determine the cause of the ailments.
The crisis has also brought renewed attention to an epidemic of vaping among young people.
About 27.5 percent of high school students reported using e-cigarettes in the previous month this year, early results of a recent federal survey showed, up from 1.5 percent in 2011. Before the vaping boom, tobacco use had been declining among youths since the 1990s.
E-cigarettes quickly came to be seen as relatively safe and normal, and spawned the rapid spread of vaping of marijuana.
Former FDA commissioner Dr. Scott Gottlieb said in an interview that, while related, the two crises — the lung illnesses and youth vaping — should not be conflated and they require different responses. He said restricting e-cigarettes could drive more people to smoke traditional cigarettes, which would likely be worse for public health.
When he took over the FDA in 2017, Gottlieb said, he pushed to reduce nicotine levels in cigarettes, which he hoped would prompt smokers to quit — or as a last resort, switch to vaping. That proposal is still going through the approval process, which can often take three years, he said.
Gottlieb said the Trump administration inherited a complex challenge of regulating an industry that had grown quickly. E-cigarettes are now a $2.6 billion industry nationwide, with about 20,000 vape shops.
It took the Obama administration seven years, from when the FDA received authority over tobacco from Congress in 2009, to rule that e-cigarettes were also under the agency’s purview. Lindblom, an FDA tobacco official under Obama, said the delay was due to the laborious regulatory process, as well as political concerns about tobacco companies and a lack of support from the White House.
“Whenever you want to do anything major, there’s a ton of industry lobbying against it,” Lindblom said.
At one point during those years, the agency sent the White House Office of Management and Budget a proposed rule restricting flavored e-cigarettes because of their appeal to youths, Henigan said. The office deleted that restriction, records show.
Gottlieb recalled a daunting, time-consuming effort to draw up an e-cig regulatory framework. Without a careful process, Gottlieb said, “we would have been sued, and we probably would have lost. So we needed to get those foundational rules in place.”
His decision to push back the deadline for companies to submit applications, Gottlieb said, came at a time when youth vaping rates were declining.
“Had we known then what we know now about how popular these would become with kids, and how irresponsibly they would be marketed by certain companies, including Juul, we might have made different decisions,” Gottlieb said. “But at the time we made this decision, our hands were tied to some degree,” by the need to move carefully lest the agency’s actions were challenged in court and struck down, he added.
Gottlieb pointed out that the FDA issued warning letters to companies for marketing practices, inspected manufacturing facilities, and established requirements for warning labels.
Bonnie Halpern-Felsher, a professor of pediatrics at Stanford Medicine and a tobacco control expert, said vaping long ago should have operated under regulations that have proved effective for cigarettes: stronger age restrictions for purchase, harsher warning labels, and strict limits on advertising.
She noted that vaping is not nearly as common among youths in Europe, for example; in England, just 1.6 percent of teenagers said they use e-cigarettes at least once a week.
She attributes that to much stronger European Union limits on nicotine levels in e-cigarettes, and on advertising. In the United States, by contrast, Juul Labs had advertised heavily.
Amid the current crisis, Juul Labs said it has suspended all advertising and lobbying. The company added it never marketed to teenagers and has kept its nicotine levels similar to traditional cigarettes to help adult smokers to switch.
But Dr. Jonathan Winickoff, a pediatrician at Massachusetts General Hospital, said e-cigarette companies added fruity flavors, chemicals, and high amounts of nicotine to make their products as enjoyable as possible from someone’s first puff.
“Bingo,” Winickoff said. “They had their magic formula to addict millions of teenagers.”
Marc Maggiore, a 23-year-old Medford resident, recalled how easy it was to start vaping when he was in college — and how difficult it was to quit.
“I took a hit of a friend’s Juul at a party and thought, ‘Wow, this makes me feel great’ — it’s just this buzz of electricity,” Maggiore said. “The issue is how accessible it is to hit it all the time,” he said, unlike cigarettes, which require going outdoors.
Yet some adult smokers say they feel much better vaping.
“I don’t cough at all anymore,” said Tina Dancer, 60, a paralegal from Turners Falls who uses mango-flavored Juuls. “It’s been the most wonderful thing in the world.”
And she took aim at Baker’s ban and other proposed bans on flavored e-cigarettes: “Why are legal abiding people going to be punished because parents don’t supervise kids anymore?”
On Tuesday, as Baker announced his ban, he said government officials should have learned much earlier about any risks associated with vaping.
“I can’t rewrite the past,” he said. “All we can do is play the hand as we see it, going forward.”