Twenty-one years ago, a Chinese pharmacist named Hon Lik patented the first electronic cigarette. Lik smoked heavily, and hoped to help people quit smoking by giving them the nicotine they crave in a safer way.
His invention succeeded wildly. It spawned a $28-billion industry that is disrupting the global tobacco business. Leading tobacco control experts say that vapes have begun to reduce the disease and deaths caused by smoking, which kills about 480,000 people a year in the United States. Vaping is much less harmful than smoking, and more effective for smoking cessation than nicotine patches or gum.
Yet US regulators have made a dismal mess of the vapes market.
Instead of promoting safe and effective vaping, the federal government, led by the Center for Tobacco Products, a unit of the Food and Drug Administration, has gone to great lengths to keep vapes and other reduced-risk nicotine products out of the hands of consumers who want them.
FDA authorization processes set a higher bar for vapes than for new cigarettes, as Lindsey Stroud, a senior fellow at the Taxpayers Protection Alliance, has argued. Of millions of applications, just a short list of products have been authorized—few of them popular, all owned by tobacco companies that can afford to clear the hurdles, and barely any in the non-tobacco flavors that appeal most to adults who smoke.
“The response of the US government has been to try to stymie rather than facilitate a transition.”
Safer nicotine products around the world “are driving down cigarette sales at unprecedented rates,” David Sweanor, a Canadian lawyer, longtime anti-tobacco activist and market analyst, told Filter. “But the response of the US government has been to try to stymie rather than facilitate a transition.”
Worse, the FDA and anti-tobacco advocacy groups have exaggerated the risks and downplayed the benefits of vaping. Most people who smoke, as a result, don’t understand that switching to vapes can help them live longer, healthier lives.
Even doctors misperceive the risks: Most believe nicotine is the direct cause of the harmful effects of cigarette smoke.
It’s not. Nicotine, a dependence-forming chemical, keeps people smoking. What makes people sick are thousands of other chemicals, produced by combustion, which collect in a substance known as tobacco tar that lodges in the lungs.
Outside of the US, some governments promote what’s called tobacco harm reduction. They encourage people who smoke but who cannot or will not quit nicotine to switch to safer alternatives.
Consider Sweden, where people obtain nicotine by sucking on smoke-free products called snus. Smoking there has almost disappeared and rates of tobacco-related diseases are the lowest in Europe.
In Japan, cigarette sales have fallen by more than half as people switch to smoke-free devices that heat but do not burn tobacco. In the United Kingdom, nearly 3 million people have quit smoking in the last five years by using vapes; some hospitals hand them out to people who smoke.
Thankfully, those who want vapes in the US can get them despite the FDA’s efforts to keep most of them off the market.
“The FDA has created a gigantic, chaotic mess.”
An estimated 18 to 20 million people here use vapes, the vast majority of which are unregulated and technically illegal. Some await FDA authorization, others are tied up in FDA-related court cases and still others have simply ignored and bypassed the regulators.
“The FDA has created a gigantic, chaotic mess,” Clive Bates, a British tobacco control expert, told Filter. Many of these “products could be anything, made anywhere, under any conditions.”
Change could soon come to the FDA. The Supreme Court heard oral arguments on December 2 in a case challenging the Center for Tobacco Products’ decision to deny two manufacturers of flavored vapes permission to market their products.
More importantly, the incoming Trump administration will revisit the issue. Following a meeting with vaping industry executives before the election, Trump wrote on social media: “I saved Flavored Vaping in 2019, and it greatly helped people get off smoking … I’ll save Vaping again!”
Like electric cars, vapes are a clean 21st-century innovation made possible by advances in battery technology. Lithium-ion batteries heat a liquid containing nicotine, flavorings and other chemicals, creating an aerosol mist that users inhale. There is no combustion.
Even the FDA concedes that vapes “can generally be a lower-risk alternative for adults who smoke cigarettes.”
So what’s the problem?
It’s all about the kids. The phenomenal success of the vape brand Juul, which was marketed to young people, set off a moral panic over teenage vaping, driven by Democratic politicians and anti-tobacco advocacy groups. The interests of adults who smoke have been cast aside.
“When it comes to kids, FDA feels very strongly that a precautionary, prevention lens is critical. That is the driving force for the actions that we take.”
Flavored vapes are at the heart of the debate. The FDA says that flavors deemed to entice kids, like banana split and gummy bear, pose an unacceptable risk to young people. No matter that it’s illegal for anyone under 21 to buy nicotine products.
“When it comes to kids, FDA feels very strongly that a precautionary, prevention lens is critical,” said Brian King, director of the Center for Tobacco Products. “That is the driving force for the actions that we take.”
Of 34 FDA-authorized vaping products, 30 are tobacco-flavored, with little appeal for adults who don’t want to be reminded of the combustible cigarettes they are trying to leave behind. The other four are outmoded menthol-flavored vapes made by NJoy, a unit of tobacco giant Altria.
Consequently, renegade products dominate the market. Elf Bar, Breeze and Mr. Fog are now the leading brands, according to King and industry analysts. All are illegally imported from China and widely available.
It’s a classic example of “massive government malfunction” when regulators pursue an approach that creates a thriving illicit or gray market, Ethan Nadelmann, the founder of the Drug Policy Alliance, told Filter.
To understand how FDA lost control of the market, a bit of history is required.
Zeller had high hopes for the plan. “Then things started to fall apart,” he told Filter.
As it happens, tobacco harm reduction has been endorsed by public health experts for decades. Among them is Mitch Zeller, a longtime FDA official who ran the Center for Tobacco Products from 2013 to 2022. In 2001, Zeller commissioned what turned out to be a 657-page report from the Institute of Medicine embracing harm reduction; the report urged tobacco and drug companies “to develop and introduce new products that will reduce the burden of tobacco-related disease.”
In the landmark Tobacco Control Act of 2009, which gave FDA the authority to regulate tobacco products, as vapes are termed, Congress told the agency to support reduced-risk products so long as they are “appropriate for the protection of public health,” a phrase that has taken on outsized importance in the vaping debate.
In 2017, then-FDA Commissioner Scott Gottlieb and Zeller unveiled a comprehensive blueprint to regulate tobacco products. Among other things, it set forth a regulatory framework that would give the FDA until 2022 to carefully authorize safer nicotine products.
Zeller had high hopes for the plan. “Then things started to fall apart,” he told Filter, through a succession of events that no one could have anticipated.
One problem was obvious: By the time FDA got around to regulating vapes, sales were already surging. They were driven largely by the popularity of Juul.
What was invariably described as an epidemic of youth vaping peaked in 2019: Some 27.5 percent of high school students reported vaping at least once in the past 30 days and nearly 10 percent were frequent users, the FDA said. Gottlieb and Zeller grew alarmed.
Advocacy groups sued the FDA, arguing that vapes were flooding the market. They won, forcing the agency to hurry its regulatory process.
Meantime, a lung disease that killed 68 people and hospitalized thousands more was mislabeled EVALI—E-cigarette or Vaping Use-Associated Lung Injury—and wrongly attributed to nicotine vapes by the CDC and anti-tobacco groups. The disease was caused by adulterated THC cartridges.
“E-cigarette companies and the tobacco companies that back them are preying on America’s youth.”
Billionaire philanthropist Michael Bloomberg entered the fray, launching a $160-million initiative to end youth vaping in 2019. “E-cigarette companies and the tobacco companies that back them are preying on America’s youth,” he said.
By then, Altria had agreed to buy 35 percent of Juul for $12.8 billion. The Bloomberg-funded Campaign for Tobacco-Free Kids ran newspaper ads headlined: “Big Tobacco is back, thanks to JUUL—with a whole new way to get kids hooked on nicotine.”
Democrats in Congress demanded that the FDA clear the market of all flavored vapes. Anti-smoking groups that had previously supported harm reduction did an about-face. The American Cancer Society said flatly: “E-cigarettes should not be used to quit smoking.”
The Gottlieb-Zeller comprehensive plan was dead. Or, as Zeller put it, the plan has been “cryogenically frozen and it has yet to be unfrozen.”
The anti-vaping frenzy got results. Seven states and the District of Columbia have banned or severely restricted sales of flavored vapes. The Post Office won’t deliver vapes, and you can’t buy them on a military base.
Teen vaping petered out. The latest annual National Youth Tobacco Survey found that vaping by high school and middle school students has declined by 70 percent from its peak, with about 600,000 teens—one out of every 45—saying they vaped on at least 20 of the last 30 days.
While teasing out cause and effect is hard, it certainly looks as if vaping is helping to make teen smoking a thing of the past.
Yet at the height of teen vaping, something else happened. “Youth smoking was already declining before e-cigarettes became available, but smoking rates declined faster after e-cigarettes appeared,” said researcher Arielle Selya.
Teen smoking has now fallen to the lowest level ever recorded by the survey. That should bury the canard that vaping is a gateway to smoking. To the contrary, while teasing out cause and effect is hard, it certainly looks as if vaping is helping to make teen smoking a thing of the past.
Ken Warner, the former dean of the school of public health at the University of Michigan and a leading tobacco control expert, has called the decline in youth smoking “one of the great public health triumphs of the present century.”
But what about adults who smoke? There are about 28 million of them in the US. Like young people, they’re likely to prefer flavored vapes. They’ve largely been neglected by the FDA and ignored by anti-tobacco groups.
That’s a social justice issue, critics like Warner say.
Smoking rates are higher among people with low incomes, as well as people with mental health conditions, Indigenous people and LGBTQ+ people. These marginalized groups are largely invisible to Washington policymakers and lack political clout.
By contrast, the anti-vaping movement took root in the tonier precincts of Manhattan and Silicon Valley. Its campaigns have been generously funded by Bloomberg, who is also a major donor to the Democratic Party.
“FDA has been under unrelenting, powerful political pressure” to protect kids at the expense of adults who smoke, Jeff Weiss, a former NJoy executive who continues to advocate for reduced-risk products, told Filter.
In a 2024 paper published in the Food Drug and Law Journal, Weiss argues that advocacy groups, led by the Campaign for Tobacco-Free Kids, have “successfully driven the Center’s priorities, its policies, its major product review decisions and even its communications strategy.”
“The clear reality is that the FDA has been captured.”
Often, powerful industries dominate regulators, a phenomenon known as regulatory capture. Here, Weiss and others say, the regulators have come under the sway of the advocacy groups and their political allies.
“The clear reality is that the FDA has been captured,” Cliff Douglas, a lifelong anti-smoking activist who is now president of the nonprofit Global Action to End Smoking, told Filter. He sees flavored vapes as exactly the sort of innovation Congress envisioned when it told the FDA to identify and encourage the use of safer nicotine products.
Matthew Holman, the former director of science at the Center for Tobacco Products, similarly believes that the FDA pays insufficient attention to adults who smoke. Leadership failed to listen to the agency’s scientists, he has said.
For example, when the FDA scientists recommended that the agency authorize menthol-flavored vapes from a company called Logic, they were overruled by higher-ups, internal memos show. Holman left the FDA to join Philip Morris International (PMI), which makes safer nicotine products as well as cigarettes.
Zeller and King deny being influenced by anti-tobacco groups. The law, they say, puts the burden on companies to prove that their products are “appropriate for the protection of public health.”
“The standards that Congress set—not FDA, Congress—were high,” Zeller said. The question before the Supreme Court, in essence, is whether the FDA applied those standards fairly.
Win or lose in court, about the best thing that can be said about the FDA for now is that the agency has failed to keep countless flavored vaping products away from consumers.
The agency has tried everything—sending out hundreds of warning letters about unregulated sales, imposing modest civil penalties on manufacturers and retailers, forming a joint task force with other federal agencies to seize illegal vapes at the border—but the vapes market continues to grow briskly.
This shouldn’t be surprising. Banning a product that consumers want rarely works. People have used nicotine for thousands of years, long before Big Tobacco arrived on the scene. Nicotine, it would seem, delivers benefits—it can improve memory and focus, and reduce anxiety—while posing health risks that are uncertain but well short of life-threatening. Caffeine is comparable.
The good news is that nicotine vaping is reducing cigarette sales, according to the tobacco companies and Wall Street analysts. By just how much, it’s impossible to know, but some surveys suggest that about a third of the 18 to 20 million people who vape have given up cigarettes entirely. They’ve made what could be a lifesaving choice.
What we’ll never know is how many more people would have made that same choice had they been encouraged to do so by the FDA and others in the government who are responsible for improving the public’s health.
Photograph by Vaping360 via Flickr/Creative Commons 2.0
Correction, January 9: A previous version of this article stated that the FDA wrongly attributed “EVALI” to nicotine vapes. While the FDA supported this idea to a degree, it was principally promoted by the CDC.
The Influnence Foundation, which operates Filter, has received grants from Global Action to End Smoking, and unrestricted donations from Altria, PMI and (previously) Juul. It also received a one-off donation from the Taxpayers Protection Alliance to support travel to a harm reduction event, and previously received a restricted grant from the Drug Policy Alliance to support a journalism fellowship. Filter‘s Editorial Independence Policy applies.