Nevertheless, Vietnam’s National Assembly voted in November 2024 to ban nicotine vapes, which help drive down smoking rates in those countries where they are available. For people who smoke and cannot or will not quit nicotine, vaping is a far safer way to get it.

Smoking kills; vaping, as best as we can tell, does not.

So why did Vietnam ban vapes? A cynic might say that lawmakers were trying to protect Vinataba, the government-owned tobacco company, from a competitive threat. Vinataba controls about two-thirds of the cigarette market.

Disinformation from the Bloomberg network and from the WHO played a role. The WHO is a key cog in the Bloomberg machine.

But some credit—or blame—for the vaping ban surely belongs to Michael Bloomberg, the billionaire American philanthropist whose foundation supports an influential global network of anti-tobacco groups, including the World Health Organization. These groups oppose vaping as well as smoking, not just in Vietnam but in more than 50 low- and middle-income countries, from Argentina to Zambia.

The Bloomberg-funded crusade against vaping has scored big wins in some of these countries over the years. Brazil became one of the world’s first countries to ban vape sales in 2009. A decade later, India did so by executive order. At about the same time as Vietnam acted, Mexico enshrined a complete ban on nicotine vapes in its constitution.

Unsurprisingly, illicit vape markets have flourished in all those countries.

Vapes are advertised on Instagram and WhatsApp in Brazil, sold by brick-and-mortar retailers in India and available on street corners in Mexico, where experts say drug trafficking organizations are trying to capture the market.

Vapes, like drugs in general, will remain available where there is demand. But problems with illicit markets include that consumers don’t know what they are buying. Unregulated manufacturers and retailers have little incentive to adhere to quality controls or to age restrictions, when youth use was cited as a justification for Vietnam’s ban. Misinformation about vapes, which dissuades people from switching, remains widespread, and those messages are only reinforced when governments impose prohibition.

All of this was known—or should have been—as Vietnam debated its vape ban.

It’s difficult from afar to understand how and why lawmakers ignored or glossed over the evidence that vaping bans don’t work. But disinformation from the Bloomberg network and from the WHO played a role. The WHO is a key cog in the Bloomberg machine, as I’ve reported.

According to Vietnamnet Global, a popular news site, an official from Vietnam’s ministry of health said at an October 2024 seminar that “no scientific evidence supports the claim that e-cigarettes or heated tobacco products reduce harm or aid in quitting smoking.” This is patently false.

The ministry official is also quoted as saying that “the notion that e-cigarettes are 95 percent less harmful than traditional cigarettes, often quoted by a small group of experts, stems from a study funded by the tobacco industry and lacks scientific credibility.” This, too, is false: The 95 percent figure, which is admittedly a rough estimate, came from the United Kingdom’s leading public health agency.

The Bloomberg team has enjoyed a “deep collaboration with the government … in Vietnam,” Dr. Kelly Henning of Bloomberg Philanthropies wrote in a blog post, since deleted.

Why did the ministry get things so wrong?

Clive Bates, an advocate for tobacco harm reduction, wrote on a nicotine Listserv:

It is inconceivable to me that the Ministry would have a tobacco control seminar and WHO and its Bloomberg funded “partners” would not be present. So it is difficult not to conclude that they have promoted, passively or actively, these blatant falsehoods. 

Vietnam is one of 10 priority countries identified by the Bloomberg Initiative to Reduce Tobacco Use. And the Bloomberg team has enjoyed a “deep collaboration with the government and local organizations in Vietnam,” Dr. Kelly Henning, who leads Bloomberg Philanthropies’ public health work, wrote in a blog post, since deleted, after a visit to Vietnam in 2018.

Bloomberg and its allies cheered Vietnam’s vape ban.

Under the headline “Vietnam Acts Decisively to Protect Youth From Heated Tobacco Products and E-Cigarettes,” Vital Strategies—a nonprofit focused on global health, which supports harm reduction with other drugs—characterized the ban as a victory over the tobacco industry. Sandra Mullin, a senior vice president at Vital Strategies, is quoted as saying: “The government of Vietnam is to be commended for this life-saving measure.”

Vital Strategies received more than $43m for its tobacco work from Bloomberg Philanthropies in 2021 and 2022, according to the foundation’s income tax return. Bloomberg is Vital Strategies’ biggest funder, by far.

Angela Pratt, the WHO’s representative in Vietnam, wrote on social media: “This is a vote for health, especially the health of Vietnam’s young people.” Dr Tedros Adhanom Ghebreyesus, the WHO’s director-general, chimed in to say: “Congratulations, #Vietnam, on making this bold decision to protect your citizens, especially the young ones, from vaping and heated tobacco products.”

When people are given the option to switch to vapes, millions do. The Bloomberg network wants to eliminate that option.

Bloomberg Philanthropies gave the WHO more than $18m for its anti-tobacco work in 2021 and 2022, tax filings show. WHO officials have said that Bloomberg’s money helps them implement their programs but does not affect policy making.

Not to be outdone, the Campaign for Tobacco-Free Kids published a statement “commending the Vietnamese government for prioritizing the health and well-being of youth.” The campaign had nothing to say about the 16 million adults who smoke in Vietnam and could benefit from access to safer nicotine alternatives.

Bloomberg Philanthropies gave more than $40 million to the Campaign for Tobacco Free Kids in 2021 and 2022 for its tobacco work, and tens of millions more for other projects. It is the campaign’s biggest donor.

All of this would be laughable if the life-and-death stakes were not so high.

Jonathan Foulds, a professor of public health at Penn State and smoking cessation expert, wrote on social media that Vietnam’s decision, “to leave cigarettes as the monopoly legal source of nicotine is to negligently cause excess deaths. This is public health ignorance at its worst.”

He’s got good reason to be concerned: Peer-reviewed studies in the United States, funded by the National Institutes of Health, have found that bans or restrictions on vape sales are associated with increases in smoking. When people are given the option to switch to vapes, millions do. The Bloomberg network wants to eliminate that option.

The most powerful evidence that bans on safer nicotine products do more harm than good comes from countries that have taken the opposite approach. They have permitted and, in some cases, promoted safer nicotine products, including vapes, oral tobacco and devices that deliver nicotine by heating tobacco, as opposed to burning it.

In Sweden, where people get their nicotine from smoke-free pouches called snus, smoking has nearly disappeared. In Japan, cigarette sales have fallen by more than half, as people switch to heat-not-burn devices. New Zealand, where vapes are legal—and the government encourages people who smoke to switch—is on track to reduce its smoking rate to below 5 percent.

None of this evidence seems to matter to Bloomberg Philanthropies and its allies. The foundation is accountable to no one and has been unwilling to listen to critics.

Bloomberg Philanthropies, Vital Strategies and the Campaign for Tobacco-Free Kids did not respond to Filter’s interview requests for this story.

Incredibly, Angela Pratt, the WHO’s representative in Vietnam, told Filter that “there is no evidence that these products help people to give up smoking tobacco.”

The WHO office in Vietnam responded via email to several questions.

Angela Pratt, the WHO’s representative in Vietnam, said that “new nicotine and tobacco products are not safe, and they are not healthy.” But this ignores the critical comparison with the deadly combustible tobacco they can replace.

She also said, correctly enough, that “regulating or restricting these products is extremely difficult.” 

Pratt spouted some nonsense, too. Incredibly, she said that “there is no evidence that these products help people to give up smoking tobacco.”

No evidence? The UK’s National Health Service says that “you are roughly twice as likely to quit smoking if you use a nicotine vape compared with other nicotine replacement products, like patches or gum.” Consider, too, this summary of numerous studies from the trusted Cochrane group of health researchers, as well as the testimony of countless people who say vaping helped them to quit smoking.

Facts and evidence, it’s clear, are again being cast aside in the debate about smoking and vaping. People who smoke—an estimated 1.3 billion of them, most living in low- and middle-income countries—pay the price.

Photograph of a man smoking in Hanoi, Vietnam, by Clemence B. via Flickr/Creative Commons 2.0

The post Michael Bloomberg Won His Vietnam War on Vaping appeared first on Filter.

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!”

Protecting the Kids

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.

“Big Tobacco Is Back”

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 Influence 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.

The post How the FDA Made a “Gigantic, Chaotic Mess” of the US Vapes Market appeared first on Filter.

Many harm reduction advocates have viewed the Triton case, as it’s known, as central to their hopes of keeping a wide range of vaping products available to aid smoking cessation.

For nearly 90 minutes, the Supreme Court justices peppered lawyers for the FDA and vaping companies Triton Distribution and Vapetasia with pointed questions, seeking to determine whether the agency had acted fairly and legally in 2021 when it denied the two companies permission to make e-liquids.

For the most part, the justices focused on narrow, procedural issues and not on the larger, life-and-death question of whether risks that flavored vapes pose to young people are outweighed by the benefits they deliver to adults who use them to quit smoking.

This case, as a result, is unlikely to resolve that debate or bring major changes to the FDA. It is significant, nevertheless, because a decision to either uphold or rebuke the FDA will send a message to new leadership. President-elect Donald Trump has nominated Dr. Martin Makary, a Johns Hopkins surgeon and critic of the agency, to lead the FDA.

“This case was never going to be the game-changer that would cause a million flavored vape products to be authorized,” Greg Conley, director of legislative affairs for the American Vapor Manufacturers Association, told Filter. “Regardless of the outcome, we have a new administration coming in.”

Indeed, during the hearing, Eric Heyer, a lawyer for the vaping companies, noted pointedly: “The president-elect is on the record as saying, I’m going to save flavored vapes.” He was referring to a September 20 comment by Trump on Truth Social.

Cliff Douglas, chief executive of the nonprofit Global Action to End Smoking, noted that the justices had sharply challenged Heyer’s claims that FDA had improperly changed the rules facing vaping companies between 2018 and 2021.

“One hopes for the justices to find that the system is broken, but that doesn’t seem likely.”

Nor did the justices seem to be interested in the broader critique of FDA, which has largely failed to create a regulated, functioning market for safer nicotine products. The vast majority of vapes sold in the US today have not been authorized by the agency.

Braving sub-freezing temperatures on the windswept marble steps of the Supreme Court building, Douglas told Filter, “One hopes for the justices to find that the system is broken, but that doesn’t seem likely.”

Instead, the case turns on the more limited question of whether the FDA’s guidance to vaping companies remained legal, even as it shifted following what the FDA invariably described as an “epidemic” of youth vaping in the late 2010s.

In January, the conservative Fifth Circuit Court of Appeals issued a stinging rebuke of the FDA, saying it had sent vaping companies trying to comply with its rules “on a wild goose chase.”

Heyer called the shifts in FDA guidelines “a massive sea change,” made without proper notice, as the agency came to the conclusion that flavored vaping products needed to show not just that they help adults quit smoking, but also that they are more effective than tobacco-flavored vapes at doing so.

This standard has had the effect of denying authorization to all flavored products except for a couple of outmoded menthol vapes made by NJoy, a unit of tobacco giant Altria.

“The agency absolutely flip-flopped,” Heyer said in court. “They certainly misled.”

But Curtis Gannon, deputy solicitor general, argued for the FDA that it was up to companies to prove that their products are “appropriate for the benefit of public health,” the standard set by the landmark Tobacco Control Act of 2009. Flavored vapes create heightened risks to kids, he said, so companies need to demonstrate that they provide heightened benefits to adults who want to give up cigarettes.

“Common sense tells us that a flavor like ‘Mother’s Milk and Cookies’ is going to be disproportionately attractive to children,” Gannon said. Triton and Vapetasia also make such flavors as “Killer Kustard Blueberry” and “Jimmy the Juice Man Peachy Strawberry.”

“They have the burden of proof,” Gannon said. “They need to supply the evidence. The data just wasn’t there.”

Heyer countered that two-thirds of adults who use vapes prefer flavors.

All nine justices participated in the oral arguments. Some showed a sophisticated understanding of the issues. Others, not so much.

“We know nicotine is addictive. You put it in to addict people. Presumably, you put it in to addict adults and children.”

Justices Neil Gorsuch and Samuel Alito, who are conservatives, delved deeply into the FDA’s procedures, seeking to understand whether the agency had acted arbitrarily.

By contrast, Justices Elena Kagan, Kentanji Brown Jackson and Sonia Sotomayor appeared to be disposed towards supporting the regulators.

Justice Kagan said: “There’s just not a lot of mystery here about what FDA is doing … FDA has been completely upfront about the role of flavors.”

“Everybody basically knows that flavors are particularly dangerous in terms of kids starting the use of smoking products,” she added.

For her part, Sotomayor seemed a bit confused about the role of vapes in the fast-changing marketplace for products that deliver nicotine. She asked: “Could you make a smoking product that didn’t have nicotine?”

Gannon seemed surprised by the question but allowed that, yes, you could make a vaping product without nicotine.

Sotomayor then asked: “Other than addiction, why would someone put nicotine into a product and then try to hide the flavor of tobacco? Meaning, I, I’m a little bit at a loss.”

Gannon again stumbled a bit, but Sotomayor persisted, saying: “We know nicotine is addictive. You put it in to addict people. Presumably, you put it in to addict adults and children.”

She didn’t appear to understand that vapes are designed, in part, to deliver nicotine to people who are already dependent on it—or for people who simply want to enjoy its benefits while avoiding the health harms of combustible products. Compared to combustible cigarettes, which kill about half of longtime users, vapes are relatively benign.

The justices are not expected to issue a ruling in the case for months. By then, vape companies may be looking at a very different FDA.

Photograph by Joe Ravi via Wikimedia Commons/CC-BY-SA 3.0

The Influence Foundation, which operates Filter, has received grants from both Global Action to End Smoking and Altria. Filter‘s Editorial Independence Policy applies.

The post Supreme Court Justices Grill FDA, Vape Companies in Triton Case appeared first on Filter.

You read that right.

Truth Initiative, according to its July 12 report, ultimately wants governments to ban not just combustible cigarettes but all commercial nicotine products.

Gone would be nicotine vapes, which have helped millions of people in the United States quit smoking.

Gone would be snus, oral tobacco pouches that have helped to drive the smoking rate in Sweden to the lowest in Europe.

Gone would be devices known, inelegantly, as “heat not burn” products. These heat tobacco to produce vapor, and have reduced cigarette sales at an unprecedented rate in Japan.

Not just kids, but adults would eventually be prohibited from using nicotine.

Critics fear Truth’s focus on nicotine prevention could keep deadly cigarettes around longer by exaggerating the dangers of lower-risk substitutes.

“A tobacco-free future is possible,” declared Robin Koval, the president and CEO of Truth Initiative, during an online panel discussion about the plan.

But is it desirable?

Experts who favor tobacco harm reduction—the idea that people who are unable or unwilling to quit nicotine should be encouraged to switch from cigarettes to far safer products—say it is neither.

“The end game should be reducing premature deaths from tobacco, not the eradication of nicotine, which is not going to happen and is misguided policy,” K. Michael Cummings, a veteran tobacco-control expert and professor at the Medical University of South Carolina, told Filter. 

 “Changing the objective from reducing smoking-related deaths and disease to destroying the tobacco industry and eliminating nicotine use is completely misguided,” said Alex Wodak, a physician and the director of the Australian Tobacco Harm Reduction Association.  

Critics fear that Truth Initiative’s new focus on nicotine prevention could keep deadly cigarettes around longer by exaggerating the dangers of lower-risk substitutes. Combustible cigarettes are estimated to cause 480,000 deaths annually in the United States. If people who can’t otherwise quit are discouraged from seeking safer ways to obtain nicotine, more deaths and disease will result.

Truth Initiative’s 18-page report, “Gamechanger: Shifting from tobacco control to ending the industry’s influence for good,” is, in fact, a game-changer. It outlines an  ambitious set of policies intended to decrease “the access, appeal and addictiveness” of nicotine products and to “denormalize all tobacco use, ultimately relegating it to a behavior of the past.” The only exception to the ban would be medications approved by the US FDA.

In the near term, Truth wants to see a national ban on menthol cigarettes and cigars; a ban on the flavored vaping products that people who switch find most helpful; sales of nicotine products restricted to adults-only stores; a dramatic reduction in the number of outlets selling tobacco; reduced nicotine levels in cigarettes; and improved access to pharmaceutical smoking-cessation drugs.

In the medium and longer term, Truth wants to develop new quitting options; cap nicotine levels in all nicotine products; and, eventually, prohibit the sales of tobacco and nicotine products, as two California cities, Beverly Hills and Manhattan Beach, have done.

“Today it’s disposable e-cigarettes. Tomorrow, it’ll be oral nicotine pouches. We don’t need these products. We don’t want to use these products.”

To move towards a nicotine-free world, Truth endorses laws that are designed to create either a “Tobacco-Free Generation” or a “Nicotine-Free Generation.” Under these laws, no one born after a specified date can legally be sold tobacco or nicotine.

New Zealand has enacted legislation that prevents those born after 2008 from ever being able to buy cigarettes, while the city of Brookline, Massachusetts, passed a local ordinance saying that no one born after January 1, 2000, can ever buy cigarettes or vaping products.

State and local tobacco control programs are the incubators that lead to federal action in the US, said Stacy Gogosian of Truth Initiative during the panel discussion. She made clear that Truth is targeting next-generation nicotine products as well as cigarettes.

“The industry’s going to fight all of these policies tooth and nail and they’re just going to keep introducing the next thing,” Gogosian said. “Today it’s disposable e-cigarettes. Tomorrow, it’ll be oral nicotine pouches. The next day, it’ll be something we don’t even know yet.”

“We don’t need these products,” she said. “We don’t want to use these products.”

Who Gogosian is referring to when she says “we” is unclear, but it’s surely not the estimated 17 million or so Americans who use nicotine vapes, most of whom previously smoked.

Truth Initiative and its allies say that curbs on the sales of tobacco and nicotine  are politically popular, citing a CDC-sponsored survey that found that 57 percent of adults support prohibiting the sales of all “tobacco products.”

“We have to convince decision makers that this is not just the right thing for them to do, it’s the popular thing to do,” said Chris Bostic, policy director of anti-smoking group Action on Smoking and Health. “Nobody wants their kids to smoke.”

“Can anyone name any psychoactive substance enjoyed by many which has been more-or-less eradicated from planet earth in the last few thousand years?”

In the report, Truth Initiative takes pains to differentiate its approach from prohibition.

“Endgame policies are not prohibition policies, as they do not call for immediate or near-term prohibition of all commercial tobacco product sales,” the report says.

It’s wrong to describe Truth’s approach as prohibition, Koval said during the panel discussion. “It’s another scare tactic of the industry,” she alleged, adding: “Not all these policies will go into effect on the same date at the same time.”

The argument from Truth appears to be that phasing in anti-smoking and anti-nicotine laws, along with improved smoking-cessation programs, will over time reduce or even eliminate demand.

“Done properly, a comprehensive collection of endgame policies will instead make tobacco something that people simply do not want,” the report says.

This is magical thinking, critics say.

About 1.3 billion people in the world use tobacco, according to the World Health Organization. Global prohibition of other drugs has failed to end their availability while creating many harms.

“Can anyone name any psychoactive substance enjoyed by many which has been more-or-less eradicated from planet earth in the last few thousand years?” Wodak asked.

“No group has pushed harder or yelled louder for FDA and DOJ to outlaw vaping and kick in the doors of anyone perceived as disobedient.”

Truth, which did not respond to Filter’s request for comment by publication time, also says that its endgame policies are not aimed at consumers, but at manufacturers and retailers.

That claim, too, is disputed.

Alli Boughner, vice president of American Vapor Manufacturers, an industry group, says it’s absurd for Truth Initiative to claim that its proposals don’t target or criminalize users.

“No group has pushed harder or yelled louder for FDA and DOJ to outlaw vaping and kick in the doors of anyone perceived as disobedient,” Boughner told Filter, describing the endgame plan as “totally dislocated from the real world or even basic human decency.”

Harm reduction advocates especially object to the way that Truth fails to distinguish between the harms caused by smoking and those attributed to nicotine. The Truth report says nicotine can damage adolescent brain development and “increase risk of cardiovascular, respiratory, and gastrointestinal disorders.” Some of these claims are disputed. But nowhere does Truth reckon with the fact that people derive benefits from nicotine.

Some people report that nicotine lifts their mood, eases stress and helps them to focus.  Decoupling nicotine from cigarettes should change the way we think about nicotine, says Clive Bates, a British harm reduction advocate.

“Nicotine should join the list of socially acceptable psychoactive substances like caffeine, like the moderate consumption of alcohol and, increasingly, like cannabinoids,” he said. We don’t lose our minds when young people have a drink or take coffee.”

Founded in 2000 and formerly known as the American Legacy Foundation, Truth Initiative remains the largest anti-tobacco nonprofit in the US. It reported net assets of $726 million and spending of $118 million in its 2021 fiscal year, according to its most recent federal tax return. As president and CEO, Koval was paid about $932,000 in salary and benefits. 

Photograph by Tony Webster via Wikimedia Commons/Creative Commons 2.0

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The cause to which they have devoted themselves has saved millions of lives. As recently as 1980, more than one in three Americans smoked. Today, about one in eight currently smoke. That’s a monumental victory for public health.

Lately, though, Warner and Douglas have taken on a new and vexing challenge. They want to bring the tobacco control community together around the deeply divisive topic of e-cigarettes. In a paper in the journal Health Affairs, they put forth a policy agenda that is designed to prevent kids from vaping while making e-cigarettes available to adults who want to use them to quit smoking.

Their quest for common ground has generated both interest and criticism from tobacco harm reduction proponents and groups representing the e-cigarette industry. Douglas hopes to promote more dialogue by creating a new organization, based at the University of Michigan. So far, though, they do not appear to be making headway with the advocacy groups that have taken a hard line against e-cigarettes.

Staunch opponents of vaping include veteran tobacco warrior Matt Myers, the president of the Campaign for Tobacco-Free Kids (CTFK); the aggressive startup PAVE, which stands for Parents Against Vaping E-Cigarettes; Vital Strategies, a Washington, DC-based public health group; and the Truth Initiative, a nonprofit that wants to rid the world of nicotine dependence as well as tobacco use.

Warner and Douglas worked with Myers for years, and they’re well acquainted with Robin Koval, the chief executive of the Truth Initiative. So you might think that establishing a constructive dialogue around vaping would be easy.

It has been close to impossible.

“There’s been much less reaction to the paper than we’d hoped,” Warner told Filter.

“We’re really troubled by the polarized nature of the discussion,” Douglas said. “It’s really difficult.”

The difficulty is, at least in part, because the two sides can’t agree on what they are trying to accomplish.

They are not alone in seeking to bridge the divide over vaping. In a talk at the University of Michigan, Mitch Zeller, the former director of the FDA’s Center for Tobacco Products (CTP), lamented the fact that opponents in the vaping debate are talking past one another, especially on social media.

“Can we get a commitment to seek common ground?” Zeller asked. “So far, that common ground has completely eluded the field of public health and tobacco control.”

“Especially when it comes to the loudest mouths in the field, I don’t see any interest whatsoever in seeking common ground, even on matters of principle,” he said.

His successor at CTP, Brian King, also called for a “constructive dialogue” in a recent interview with Koval.

The question is, why is it so difficult to find common ground, or even to have a productive conversation about vaping?

It is, at least in part, because the two sides can’t agree on what they are trying to accomplish.

The vaping debate revolves around tobacco harm reduction, which in this context means encouraging people who can’t or won’t quit smoking to switch to much less harmful products like e-cigarettes to get their nicotine, even if those products aren’t entirely benign.

Advocates for harm reduction, including Warner, Douglas and other veterans of the anti-smoking campaigns, are clear about their purpose: They want to reduce death and disease caused by tobacco products. Period.

Advocacy groups funded by Bloomberg Philanthropies, which has spent well over $160 million to campaign against e-cigarettes, have laid out different goals.

The name of the Campaign for Tobacco-Free Kids speaks to its purpose. (Though maybe they would be better off changing the name to “nicotine-free kids.”) Still, Myers focuses on young people, as does PAVE’s Meredith Berkman. They have little to offer adults who smoke.

Truth Initiative says that it aims to “achieve a culture where young people reject smoking, vaping, and nicotine.” All things nicotine have become a target.

Others like Margaret Chan, the former head of the World Health Organization (WHO), have declared that their goal is to “make sure that the tobacco industry goes out of business.”

Without agreement on a destination, it’s hard to agree on a path to get there.

The Battle Over Harm Reduction

Consider, for starters, the core issue in tobacco control: whether to embrace harm reduction.

Warner, Douglas and their co-authors, Karalyn Kiessling and Alex Liber, regard e-cigarettes as both a potential problem and an important solution. Their proposals in the Health Affairs paper are designed to strike a balance between their desires to keep vapes away from kids but make them available to adults.

“The goal should be a policy mix that can address both objectives constructively,” they write.

Their recommendations include selling e-cigarettes just in adult-only stores like tobacco shops (and not in gas stations or convenience stores), limiting but not eliminating flavors, curbing advertising and taxing combustible cigarettes higher than e-cigarettes to encourage adults who smoke to switch.

For a time, the FDA, Truth Initiative, Tobacco-Free Kids and Vital Strategies were all seemingly open to tobacco harm reduction.

The FDA’s comprehensive plan for tobacco and nicotine regulation, which was put forth by former FDA Commissioner Scott Gottlieb and Zeller in 2017, recognized that vaping could be a safer alternative to smoking. Its decision last year to permit the marketing and sale of a handful of tobacco-flavored vaping products also reflected harm reduction principles.

The Michael Bloomberg-funded coalition slammed the door to harm reduction when teen vaping grew to what the FDA called “epidemic” levels in 2018 and 2019.

Back in 2016, Truth Initiative invited academics and activists, including harm reduction advocates, to a two-day conference called “Rethinking Nicotine” in Washington.

Meanwhile, Vital Strategies wholeheartedly campaigns for harm reduction policies to help people who use illegal drugs protect themselves from overdoses, HIV or Hepatitis C.

Even Matt Myers has expressed support for alternative delivery mechanisms for nicotine. Long before vaping came to the US, Myers said:

The challenge to me is not to eliminate smoking, but the death and disease from smoking. That should be the end goal. If you had a product that addicted 45 million people and killed none of them, I would take that deal. Then you’d have coffee! I have to believe that if the marketplace incentives were such that over time someone could devise a product that would give the same satisfaction as tobacco but didn’t kill them, people would flock to it.

Of course, we now have that product: the e-cigarette.

The Michael Bloomberg-funded coalition slammed the door to harm reduction when teen vaping grew to what the FDA called “epidemic” levels in 2018 and 2019. Since then, even though youth use of e-cigarettes has fallen, Myers and his allies have fought vaping at every turn, taking what is close to a prohibitionist stance.

Tobacco-Free Kids calls for sweeping bans on flavored vaping products, citing the risks to young people.

Truth Initiative warns that e-cigarettes threaten to “undo all the progress that the public health community and government have made over decades to reduce cigarette smoking.”

Vital Strategies urges the FDA and legislators to prohibit flavors and restrict marketing, access and sales of e-cigarettes.

King emphasized that “when it comes to enforcement and compliance, nothing is off the table.” The FDA has since shown that it was no idle threat.

Most importantly, the FDA’s Center for Tobacco Products has not authorized the sale or marketing of any flavored vapes, aside from tobacco flavors, which are unappealing to many adults who want to quit cigarettes.

In his recent conversation with Robin Koval, the FDA’s Brian King stressed the agency’s commitment to young people. “Anything we can do to continue to reduce use among youth is a good thing,” King said, “and I’m committed to making that happen with the full arsenal of resources that FDA has.”

Anything we can do? At a conference in September, King emphasized that “when it comes to enforcement and compliance, nothing is off the table.” The FDA has since shown that it was no idle threat. That does not signal a balanced approach.

Meantime, the FDA’s The Real Cost anti-vaping campaign has demonized e-cigarettes with commercials like this one (“vaping can deliver toxic metals like nickel and lead into your lungs”) and this one, showing a school girl writhing in agony (“are you possessed by nicotine?”).

Rarely, if ever, do anti-vaping crusaders acknowledge the benefits of safer nicotine products to adults who smoke. Unless they do, finding common ground will be next to impossible.

The Role of Industry

The longtime tobacco warrior and researcher Stanton Glantz put it plainly, once saying he’d “like to just destroy the tobacco industry… It has no business existing.”

While Glantz’s influence has waned amid scandals, Big Tobacco continues to be cast as the villain by the Bloomberg-funded coalition. Antipathy toward the industry excludes informed, influential voices from dialogue about tobacco control.

Journals and academic societies, including the esteemed Society for Research on Nicotine and Tobacco (SRNT), will not publish research by scientists at tobacco companies, including e-cigarette companies. Those employed by the industry cannot attend SRNT meetings, and independent scientists who take industry funding are denounced as shills.

At a recent Food and Drug Law Institute (FDLI) event, Myers described e-cigarette companies as “an industry that, based on its behavior, appears willing to go after kids any time regulation and enforcement allows it to do so.” Certainly some bad actors in the industry fit that description.

“People who have given much of their careers to public health are being criticized, ostracized and branded as traitors because they embrace the idea of stakeholder engagement.”

But Scott Ballin, a former vice president of the American Heart Association who has worked collaboratively on tobacco issues for decades, argues that industry is not a monolith.

“Industry is all kinds of different people,” Ballin told Filter. “Big Companies. Little companies. The vaping industry. Growers. Distributors.”

Academics with even the slimmest ties to e-cigarette makers risk reputational damage, Ballin said: “People who have given much of their careers to public health are being criticized, ostracized and branded as traitors because they embrace the idea of stakeholder engagement.”

Matthew Holman, a tobacco scientist who spent 20 years at the FDA, most recently as chief scientist at CTP, was sharply criticized when he left in July to join Philip Morris International (PMI). PMI says that it is building its future “on smoke-free products that are a much better choice than cigarette smoking.”

Several months after beginning work at PMI, Holman says he takes the company at its word. “These people are just as committed to public health as I am,” he told Filter. “They’re just as dedicated as I am. That has been a wonderful realization.”

PMI and other tobacco companies have begun to shift their product mix away from combustible cigarettes and toward reduced-harm alternatives.

Given the right incentives, Bates told Filter, tobacco companies can be persuaded to see vaping “as a good corporate strategy that gets them out of the merchant of death business.”

Clive Bates, the former director of UK anti-smoking charity Action on Smoking and Health, says they can help end death and disease from smoking. Given the right incentives, Bates told Filter, tobacco companies can be persuaded to see vaping “as a good corporate strategy that gets them out of the merchant of death business.”

Some industry leaders are willing to accept regulation. Tony Abboud, the executive director of the Vapor Technology Association, which represents vape shops, says his group would accept reasonable restrictions on where e-cigarettes can be sold and how they can be marketed.

Abboud also said: “We’ll sit down with anybody.”

But Amanda Wheeler, the president of the American Vapor Manufacturers Association (AVM), says the point-of-sale restrictions put forth by Warner and Douglas go too far. Wheeler owns a vape shop in Arizona, but she believes that e-cigarettes should be available in gas stations and convenience stores so that they remain easily accessible to adults who smoke.

The trouble is, gas stations and convenience stores have low rates of compliance when it comes to selling to underage individuals, according to a study of retailer compliance in the state of New Jersey.

Christine Delnevo, the director of the Center for Tobacco Studies at Rutgers and an author of the research, says underage consumers were able to buy tobacco products more than 40 percent of the time.

“I’m strongly in favor of [the] proposal that all tobacco products, including e-cigarettes, be sold in adult-only outlets,” she told Filter.

Nothing About Us Without Us

With the occasional exception, dialogues about tobacco are dominated by elites—the leaders of advocacy groups, government regulators and academics. Adults who smoke or vape are not often heard, except on Twitter, where they are very active.

Imagine, instead, if an FDA chief or CDC scientist or Matt Myers sat down with, say, Kim “Skip” Murray, who smoked for decades before switching to e-cigarettes and formerly owned a vape shop in rural Minnesota.

Murray says she’d begin by thanking them for their efforts over the years to end death and disease from smoking. She would then voice her concern that “we have forgotten that too many people die from smoking.” Then she’d probably talk about her son. “About his smoking, about his being a dad and having a heart attack at age 29. And how vaping helped him quit smoking,” she told Filter.

Warner and his co-authors write in Health Affairs that the neglect of adults who smoke “is a matter of social justice.”

They note: “African Americans suffer disproportionately from smoking-related mortality, and Americans with lower educations and incomes, members of the LGBTQ community, and people with mental health conditions constitute a disproportionate share of the smoking population.” These people, they say, stand to gain from harm reduction.

You may wonder what the anti-vaping groups have to say about all this. I did, too, so I reached out by email to the Campaign for Tobacco-Free Kids, Truth Initiative, PAVE and Vital Strategies. None responded. (The editor of this article also separately reached out to all four organizations, and received no response either.)

As for Bloomberg, the billionaire whose money is funding anti-vaping campaigns, he, too, has been unwilling to engage with critics. Some of the world’s leading experts on tobacco and public health—including Warner, Douglas and Steven Schroeder, the former president of the Robert Wood Johnson Foundation—tried for months to arrange a meeting with him and share evidence showing that his foundation’s opposition to flavored e-cigarettes is doing more harm than good.

They were rebuffed.

They’re a little like a political candidate with a comfortable lead in the polls who feels no pressure to debate an opponent.

It’s hard to know why the groups that oppose vaping are reluctant to engage with critics. Perhaps it’s because they are mostly winning the debate. They have support in Congress, at the regulatory agencies and at the state and local level. Residents in California voted to ban the sale of most flavored nicotine products on election day this year.

They’re a little like a political candidate with a comfortable lead in the polls who feels no pressure to debate an opponent.

In the court of public opinion, the anti-vaping groups, for now, have won. Most Americans now believe, wrongly, that e-cigarettes are just as dangerous or more dangerous than combustible cigarettes. The relentless anti-vaping messaging from the CDC, FDA and the Bloomberg-funded coalition government has been effective.

But to what end? Misperceptions about the dangers of e-cigarettes surely will discourage adults who smoke from switching to vapes, which reputable scientists agree are much safer. That’s tragic.

It’s for this reason that Douglas has decided to create a new platform that will bring together independent experts to engage in what he calls “respectful and collaborative conversation” about smoking and alternative ways to deliver nicotine. The new organization, which does not yet have a name, will be based at the University of Michigan and aim to provide trusted information and analysis to policy makers and the media. Douglas and colleagues are seeking foundation funds to get the project off the ground.

Some anti-smoking advocates will root for him to succeed. No one expects it to be easy.

Photograph by Marl Clevenger on Unsplash

R Street Institute supported the production of this article through a restricted grant to The Influence Foundation, which operates Filter. The Influence Foundation has also received grants from PMI. Filter’s Editorial Independence Policy applies.

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