Blog - Tobacco Reporter

Study: Malaysians Vape to Cut Smoking

Nearly half (49 percent) of Malaysian smokers choose to vape to cut down on cigarette consumption or quit smoking completely, reports The New Straits Times, citing a 2021 survey of 500 people carried out by Kantar Group

“This appears consistent with mounting scientific evidence that smokers prefer vaping and is effective to help them kick the habit,” said Delon Human, president and CEO of Health Diplomats, a health, nutrition, and wellness consulting group.

“Available evidence so far shows that most smokers want to quit the habit. For example, in the United Kingdom, around two-thirds of smokers, regardless of their social group, want to stop smoking, and vaping has become the method of choice to quit smoking in that country,” Human said.

The survey also found that 52 percent of Malaysian smokers perceive vaping to be less harmful than smoking cigarettes. Eighty-six percent said that vaping should be made available to smokers as a less harmful product, and 90 percent believed that vaping should be actively promoted as a less harmful alternative to smoking cigarettes.

This study shows vaping in Malaysia has great potential to help the government reduce smoking prevalence as it is a popular tool used by smokers to cut down and quit smoking.

Delon Human, president and CEO, Health Diplomats

“Studies on the use of e-cigarettes have pointed to the fact that vaping is not risk-free but significantly less harmful than smoking cigarettes,” said Human. “Interestingly, the rate of Malaysian smokers understanding this fact is high compared to other countries,” he said.

In the U.K., by contrast, only 29 percent of smokers believe vaping was less harmful than smoking, despite the country’s adopting a harm reduction approach in encouraging cigarette smokers to switch to vaping, according to Human.

Malaysia is currently contemplating new rules for e-cigarettes.

Most of the Malaysians surveyed support regulations for e-cigarettes and believe they should be regulated as consumer products instead of medicinal products.

At the same time, 81 percent believe regulations must be put in place to ensure the products are not defective and meet product and quality standards and are not sold to minors or underage children.

“This study shows vaping in Malaysia has great potential to help the government reduce smoking prevalence as it is a popular tool used by smokers to cut down and quit smoking,” said Human.

June 6, 2022

Singapore: Smoking Prevalence Drops to 10 Percent

The smoking prevalence in Singapore dropped to 10.1 percent in 2020 from 13.9 percent in 2010, reports The Straits Times, citing the city’s Ministry of Health (MOH).

The MOH attributes the decline to its multi-year, multi-pronged approach to reduce and discourage the use of tobacco products among Singaporeans. The ministry says it works with multiple partners to deliver public education to increase awareness of the harms of tobacco use, smoking cessation programs, legislative measures, taxation and enforcement.

Among other measures, the MOH raised the minimum legal age for smoking to 21, and banned emerging tobacco products, on the premise that these can be gateways to smoking.

The MOH is also studying the examples of New Zealand, Malaysia and Denmark, which recently announced plans to implement tobacco-free generation policies. The department says it will examine how these countries develop and enforce the bans, to determine if this can be similarly applied in Singapore.

June 6, 2022

Global THR Proponents Unite Ahead of COP10

A global audience, via multiple platforms, tuned into watch sCOPe’s two-day broadcast during the recent World Vape Day (WVD) and World No Tobacco day (WNTD).

“sCOPe22’s success was critical given delegates will be discussing and debating harm reduced products at next year’s COP10 [the 10th session of the Conference of the Parties to the World Health Organization’s Framework Convention on Tobacco Control]. sCOPe22 showed that consumer advocates worldwide are united and highly motivated to fight for millions of smokers’ lives,” said Nancy Loucas of the Coalition of Asia Pacific Tobacco Harm Reduction Advocates (CAPHRA).

Tobacco harm reduction (THR) consumer advocates livestreamed for eight hours on May 30 and May 31. The panel discussions and presentations included representatives from Asia Pacific, Africa, Europe, North America and Latin America.

sCOPe’s return on #WVD22 and #WNTD22 followed its five-day livestream last year during COP9—the ninth Conference of Parties to the World Health Organization (WHO) Framework Convention on Tobacco Control (FCTC).

“Countries represented at COP10 need to fully understand that millions of lives depend on delegates’ substantive discussions and subsequent recommendations on safer nicotine products next year. The red light must turn green—It’s long overdue.

“Last year the FCTC kicked the subject for touch, but next year it’s all on. All eyes will be on COP10 to see if delegates start following the evidence not the emotion. THR works. Vaping bans don’t, and THR advocates are keener than ever to expose and change WHO’s fraught position,” said Loucas.

Countries represented at COP10 need to fully understand that millions of lives depend on delegates’ substantive discussions and subsequent recommendations on safer nicotine products next year.

Nancy Loucas, CAPHRA

sCOPe22 participants included the European Tobacco Harm Reduction Advocates, Vaping Saved My Life South Africa, Association of Vapers India and CAPHRA.

The Americas were also well represented with Latin American-based ARDT Iberoamerica, Rights For Vapers Canada, the Tobacco Harm Reduction Association of Canada, and the U.S. Consumer Advocates for Smoke-free Alternatives Association.

“sCOPe22 uncovered many powerful personal stories of ex-smokers whose lives have been saved by switching to 95 percent-less harmful vaping. Instead of demonizing safer nicotine products, WHO needs to embrace them. Outrageously, WHO’s misguided advice and bullying sees hundreds of millions of smokers still blocked from accessing these life-saving products,” said Loucas.

According to Loucas, THR advocates are buoyed by the fact that every year more and more countries are ignoring WHO’s anti-vaping campaign. Instead, they’re legalizing and regulating safer nicotine products.

“In the Asia Pacific region alone, The Philippines, Malaysia and Thailand are set to join nearly 70 countries worldwide which have wisely regulated vaping with dramatic declines in their overall smoking rates. If WHO wants to improve global health and save smokers’ lives, they’d promote a THR approach next year—at the latest,” she said.

June 6, 2022

Los Angeles Bans Sale of Flavored Tobacco

The Los Angeles City Council voted unanimously to end the sale of nontobacco-flavored tobacco products—including flavored e-cigarettes, menthol cigarettes and flavored cigars.

The council’s action will make Los Angeles the largest city in the country to end the sale of flavored tobacco products, according to the Campaign for Tobacco-Free Kids (CTFK). Los Angeles joins over 120 California communities that have taken similar action.

The legislation will now move to Mayor Eric Garcetti, who is expected to sign it, according to Filter. If passed, the ban would go into effect in January 2023.

Mitch O’Farrell, the councilmember who introduced the legislation, tweeted after the vote went through, “We just took a huge step forward against Big Tobacco’s deadly agenda in Los Angeles. This morning, I led the City Council’s unanimous approval of a prohibition on the sale of flavored tobacco to everyone 21 and younger in LA, making us the largest city in California and the nation to take this kind of action against these products.”

The ban applies to people of any age, however, not just those 21 and younger.

The ordinance also applies to zero-nicotine vapor products, but it does not, however, apply to hookah. “Normally, proponents and supporters of flavor bans will object heavily to … exemptions for hookah tobacco and lounges,” said Stefan Didak, a California-based vape advocate. “More often than not, an attempt at passing a ban fails because they withdraw their support.”

“However, several of the major groups—including Annie Tegen, the vice president of state advocacy for CTFK—praised the council ahead of their vote on the amendments and congratulated them on doing the right thing,” Didak said. “Not a single word of dismay about the exemption for hookah lounges. I thought that was very much out of character.”

Hookah lounge owners and retailers protested the ban, stating that it would eliminate a cultural tradition. It’s also speculated that the CTFK may have overlooked the exception of hookah in order to gain what they see as a big win with the LA ban, especially after years of back and forth trying to pass said ban.

June 3, 2022

U.S. Health Groups Call off Menthol Lawsuit

Action on Smoking and Health (ASH), the African American Tobacco Control Leadership Council (AATCLC), the American Medical Association (AMA) and the National Medical Association (NMA) are dismissing their joint lawsuit against the United States Food and Drug Administration. A rulemaking process to ban menthol as a characterizing flavor is in progress, and “we are grateful to be able to declare victory in this case,” the plaintiffs wrote in a joint statement.

The lawsuit followed the 2013 Citizen’s Petition, which called on the FDA to prohibit menthol in cigarettes.

“As African American physicians, we are thrilled with the FDA’s proposed rule to ban menthol in cigarettes and flavored cigars as a remedy to settle our lawsuit,” said Rachel Villanueva, president of the NMA. “This proposed rule will save lives and improve health within Black communities. This would not have been possible without the leadership and assistance of our co-plaintiffs and attorneys, whom we wish to sincerely thank.”

“We are encouraged by the FDA’s recent action to propose a ban on menthol-flavored cigarettes. We look forward to participating in the rulemaking process as we continue our collective push to ensure these harmful products are removed from the market once and for all,” said AMA President Gerald E. Harmon.

“The FDA has finally taken a major step forward to protect the health of Black Americans, but the work is far from done. We will not stop until no more Black lives are lost due to the predatory marketing of menthol cigarettes and flavored little cigars,” promised Phillip Gardiner, co-chair of the AATCLC.

“ASH’s goal is to use litigation as a tool to protect the right to health of all citizens against the harms of the tobacco industry,” said Kelsey Romeo-Stuppy, managing attorney at ASH. “We are proud to have been a co-plaintiff in this extraordinary demonstration of the power of proactive litigation.”

June 3, 2022

Singapore Cracks Down on Illegal Vape Products

Singapore authorities destroyed an some 6,500 seized vape products with an estimated value of more than SGD1 million ($726,639) on May 31, reports Channel News Asia. Among the seized items incinerated on World No Tobacco Day were 6,500 e-vaporizers, 83,500 pods and 8,000 e-liquids. Together, they weighed more than a ton.

In Singapore, it is an offence to sell, possess for sale, import or distribute e-vaporizers and related components. Violators risk fines of up to SGD10,000 and jail up to six months.

The penalty for possessing and using a vape is a fine of up to SGC2,000.

Between 2017 and 2021, the Health Sciences Authority (HSA) caught 383 illegal e-vaporizer sellers. HSA, which works with the Immigration and Checkpoints Authority to enforce against vaping, noted that some illegal importers have started to change tactics to avoid detection, by concealing products in lighting fixtures, for example.

The agency says it has stepped up vigilance and enforcement actions.

Last year, authorities destroyed almost 12,300 e-vaporizers, about 4,500 e-liquids and nearly 175,000 pods and components, with an estimated street value of almost SGD2 million.

June 2, 2022

Dutch Mull ‘Australian’ Cigarette Prices

The Dutch government is considering increasing the price of cigarettes to between €30 ($31.96) and €47 per pack in 2040, reports the NL Times.

Inspired by the example of Australia, where a pack of cigarettes costs the equivalent of €24, Public Health Secretary Maarten van Ooijen hopes the high prices will deter people from smoking.

Currently a pack of cigarettes currently cost about €8 in the Netherlands. The government’s coalition agreement calls for an increase to €10 per pack.

Scientific research reveals that financial disincentives to smokers work only when prices are raised substantially. A recent study by Maastricht University showed, for example, that half of smokers will quit only once a pack costs €60 or more.

The proposed price hike is one step in the government’s plan to achieve a “smoke-free generation” by 2040, as set down in the National Prevention Agreement of 2018. The government wants only 5 percent of Dutch residents to smoke by 2040. Currently about 20 percent are smokers.

June 2, 2022

Mexico Outlaws E-Cigarettes

Mexican President Andrés Manuel López Obrador signed a decree on May 31 outlawing the sale of e-cigarettes, reports AP.

Assistant Health Secretary Hugo López Gatell lashed out at industry claims that vaping is safer than smoking, calling it “a big lie.”

Mexico has aggressively legislated against vapor products. Imports of vaping devices have been prohibited since at least October. Before that, legislators used consumer protection and other laws to discourage sales.

Despite the most recent decree, many Mexicans import or buy vaping cartridges or fluid illicitly.

At least 5 million Mexicans have tried vaping at least once, according to government figures.

June 1, 2022

A New Sheriff in Town

China’s tobacco monopoly asserts its authority over vapor products.

By George Gay

It is wise to take seriously the warning that you should be careful what you wish for.

At the Global Tobacco and Nicotine Forum (GTNF) in London in September, which was held about six months after new vaping industry regulations had been publicly mooted in China, one speaker told those listening how vaping industry regulations were overdue, necessary and to be welcomed. At the time, I assumed this welcome was predicated on the belief that the regulations would be beneficial—that they would allow the industry to grow in a stable way and, in doing so, serve the interests of the businesses involved, smokers wanting to quit their habit, and society at large while, at the same time, helping to remove from the industry cowboy operators and substandard products.

Things have moved on since then. The regulations, formulated by the State Tobacco Monopoly Administration, were foreshadowed at the end of 2021, published in March 2022, became effective from May and are due to come fully into force in October.

The question is: Are the regulations beneficial? I would say they are far from ideal, but then ideal would probably have been an ambition too far. Looking on the bright side, they are better than a ban, as has been introduced in Hong Kong and elsewhere, and, furthermore, given the considerable investment in these regulations and the systems necessary to operate them, unless some unforeseen catastrophe occurs, they seem to rule out a ban being introduced, at least in the short term to medium term. But they will undoubtedly rein in the country’s vaping industry—severely in some areas.

The rise of China’s vaping industry has been hugely impressive, and the future had held out the offer of phenomenal growth, but now, predictions must surely be revised downward, particularly in respect of the domestic market, probably much less so in respect of exports. But in taking stock of this situation, it is necessary to bear in mind the relative importance of the huge and so far largely untapped domestic market.

Domestic Sales Versus Exports

One of the provisions of the regulations that will likely have upset those businesses and consumers looking for beneficial outcomes, assuming consumers in China tend to prefer the sorts of vaping products most popular in other countries, is the ban on flavored products other than those with tobacco flavors. They are unlikely, too, to have been overjoyed by a ban on nicotine-free products.

On the other hand, the industry can take heart from the fact that products with flavors other than tobacco and those that are nicotine-free may be manufactured for export where such products do not conflict with the laws of the country of destination. Basically, export products must comply with the laws, regulations and standards of the destination country, though, where the country of destination does not have vaping regulations in place, export products will have to comply with China’s regulations.

This difference between the requirements for local and export products raises an interesting question. The ban on the sale of nontobacco flavored and nicotine-free vaping products in China seems to be based, at least in part, on the idea that products with these properties are the ones favored by young people, who should be discouraged or, where minors are concerned, banned from vaping. This seems to be an ethical stance, but it is difficult to see how, given such an ethical stance, exports of such products could be allowed, even to countries that do not ban them.

The regulation’s authors say, in translation, the “Measures for the Administration of Electronic Cigarettes” are being put in place in order “to further strengthen the supervision of new tobacco products such as e-cigarettes, regulate the market order, ensure the health and safety of the people, and promote the legalization and standardization of industrial governance in accordance with the Tobacco Monopoly Law of the People’s Republic of China, the Law of the People’s Republic of China on the Protection of Minors [and] the Regulations on the Implementation of the Tobacco Monopoly Law of the People’s Republic of China.” The regulations are said to cover the production, sale, transport, import and export, supervision and management of vaping products.

Market Order

There seem to be some curiosities in the regulations. From my reading, the regulators have gone down the U.S. route in deeming electronic cigarettes to be tobacco products, at least for the purposes of incorporating them under expanded tobacco laws. And while they refer to “vaping products,” they tend to refer to the use of these products as involving “smoking” rather than “vaping.” Having said that, I should point out that these are issues picked up by Western eyes from a translation of the regulations, which, unsurprisingly, have gone through a number of revisions.

One of the things that jumps out at a Westerner from the stated aims of the regulations is the idea of regulating “the order of the market.” China’s economic system is such that, in part, the regulations are concerned with supply-side matters whereas in much of the rest of the world, such considerations would not come into the picture. Elsewhere, the market is controlled, if that is the right word, by demand, so if it becomes oversupplied, prices fall and, eventually, companies go bust. Or that’s the basic theory. In reality, some companies are considered to be too “important” to fail and have to be bailed out by taxpayers.

The regulations aim to balance supply with demand through such mechanisms as setting production and sales targets, overseeing imports, controlling the expansion of companies, concentrating production sites, restricting product transport and overseeing wholesale and retail trading.

Some of these controls are to be exercised through the licensing and registration of existing and new manufacturers, wholesalers and retailers, and even the expansion of their operations, or other changes, including moves into the trading of imported products. One of the requirements for obtaining a license will be that the applicant has access to sufficient funds to carry out whatever enterprise it wants to engage in, which, along with certain other restraints, some observers believe will tend to favor the bigger companies and weed out smaller ones. Again, this weeding out of the smaller players seems to be following the U.S. route, though by using a registration requirement applied to the company rather than the product.

Big Versus Small

Whether you view such provisions as good or bad will probably depend on whether you are a small vaping industry operator in China likely to be driven out of business or a big one that will benefit from fewer competitors. Of course, if China is successful in using such a system to stabilize the market and ensure underfunded companies don’t go bust with all the social fallout such failures can cause, it will probably be seen to have done a good job. But there are clearly dangers in disadvantaging smaller businesses working within an industry that, because of its youth, is dependent on innovation for its success, commercially and socially.

In addition, the market will be closely controlled by “a unified national e-cigarette transaction management platform” through which manufacturers, wholesalers and retailers will have to process and record all their trading and transactions. Wholesalers wishing to trade in imported vaping products will have to obtain permission to do so, and the imported goods will have to comply with all local technical requirements and regulations and be sold, appropriately labeled, through the transaction management platform.

There are provisions in the regulations for dealing with counterfeit and inferior products and the infringement of intellectual property rights, including through the encouragement by rewards of people reporting cases of the illegal production and sale of vaping products.

The regulations will govern registered trademarks along with warnings and other messages applied to tobacco packaging, and they hold that e-cigarette advertising will be in line with tobacco advertising, which is consistent with their being regarded as tobacco products. E-cigarette exhibitions aimed at promoting such products are banned.

Sales of vaping products through “information networks” other than the transaction management platform are banned, as are sales through vending machines and sales to minors, with the onus being on retailers to check identity documents where the age of the would-be purchaser is in doubt.

The regulations will see the introduction of a product traceability system, and they will control the sites of retail outlets, including in respect of banning such outlets “around” schools. And they will provide for quality control through the inspection, testing, monitoring and evaluation of products under institutions set up to conduct technical reviews based on the submission of application materials, such as inspection and testing reports. Those engaged in production will be required to establish product quality assurance systems and be responsible for the quality of their products.

Meanwhile, in April, the State Administration for Market Regulation, the standards committee, published the national standards for electronic cigarettes (GB 41700-2022), which provides, among other things, details about the technical requirements for vaping products and relevant test methods, safety standards, permitted ingredients and nicotine levels and concentrations.

Encouragingly, some reports indicate that the newly regulated industry players will be encouraged to carry out vaping industry R&D in respect of raw materials, finished products and risk assessments, and that they will be encouraged to promote the application of green technology and other environmentally friendly practices.

George Gay is Tobacco Reporter’s European editor, but his territory spans the globe. Based in London, George has covered the tobacco industry since 1982, initially for a U.K.-based publication and since 2004 for Tobacco Reporter. George’s understanding of industry issues, combined with his keen sense of observation and dry wit, have earned him a loyal following among Tobacco Reporter’s readers.

June 1, 2022

The Takeaways

What lessons should regulators learn from the United States?

By Clive Bates

The U.S. Food and Drug Administration has had jurisdiction over tobacco products since Congress passed the Tobacco Control Act and it entered into force in 2009. Through its Center for Tobacco Products (CTP), the FDA regulates tobacco products, which include nicotine products such as e-cigarettes and e-liquids in the United States. With the recent retirement of Mitchell Zeller, the CTP’s director since 2013, it is an excellent time to take stock. Here we look at six lessons from the experience that might help guide regulation in other jurisdictions.

First lesson: Understand how well-intentioned but poorly designed regulation can harm public health. The regulation of newer, safer products should reflect the political reality that the most hazardous products, cigarettes, will remain pervasively available. In the United States, variants of just under 3,000 cigarette products have been on the market since 2009, largely untouched by onerous regulation. The Royal College of Physicians signaled the risks that flow from excessive regulation of safer alternatives in its 2016 report Nicotine without smoke: “… if [a risk-averse and precautionary] approach also makes e-cigarettes less easily accessible, less palatable or acceptable, more expensive, less consumer-friendly or pharmacologically less effective, or inhibits innovation and development of new and improved products, then it causes harm by perpetuating smoking.”

Regulatory regimes that are tougher on the alternatives to cigarettes function as anti-competitive barriers to entry. Sound regulatory practice requires efficiency, transparency and predictability with burdens proportionate to risk. Unfortunately, the premarket tobacco product application process by which safer products must enter the market to compete with cigarettes is astonishingly expensive and opaque and fails any test of proportionate regulation. It functions to protect the cigarette trade and concentrate the vape market into a monoculture of uninspiring products. This is partly the law itself, but much is down to how the FDA has interpreted its responsibilities under the law.

Second lesson: Use standards and a notification regime rather than a product-by-product regime. The problem with an authorization regime is that it requires a public health agency to say “yes” to allowing a nicotine product onto the market. For institutional cultural reasons, many will find this challenging to do. Asymmetries in risk aversion mean regulators tend to be far more reluctant to accept the risk of saying “yes” and something bad happening than saying “no” and something good not happening. Both outcomes are harmful, but the former is what energizes regulators while the latter is hidden. A further issue with authorization systems is that they are easily politicized, providing a focus for campaign organizations to press for the decisions they want from regulatory agencies. For example, the FDA has been pushed hard by well-funded campaigns to ban flavored e-cigarette products. In contrast, the European Union has used a notification system with standards codified into the EU’s Tobacco Products Directive and, as a result, has a diverse and competitive market without a huge problem of youth uptake and far less political tension.

Third lesson: The regulator should accept the same disciplines it imposes on the regulated entities. The Tobacco Control Act, which is the FDA’s regulatory foundation, repeatedly refers to “appropriate for the protection of public health” as a guiding principle. For example, this test is applied to new nicotine products as part of the premarket review process. But does the FDA ensure that its own approach is appropriate for the protection of public health? By setting the burden of proof so high, the FDA has implemented a de facto ban on flavors other than tobacco and (possibly) menthol in vaping products. This is probably a response to intense and well-funded activism. But it will have the effect (if not the intent) of closing all the vape shops and radically collapsing the diversity of products on the U.S. market. Imagine if the FDA had to prove that its approach to flavors is “appropriate for the protection of public health.” That is precisely what it would have to do if it introduced a product standard to ban flavored products. The agency would not be able to do it, and it should not be doing it by default.

Fourth lesson: Risk perceptions matter, and regulators can help. One of the important purposes of public health regulation is to promote consumer behaviors that improve health. That should include, for example, making it easier and more desirable to vape than to smoke. But that cannot work if consumers do not understand which options are safer. In the United States, despite federal communications budgets of hundreds of millions of dollars, the public risk perceptions about nicotine are in a terrible state and, in many cases, deteriorating. In 2020, less than 3 percent of adults held the correct belief that e-cigarettes are much less harmful than cigarettes, but 62 percent wrongly believed that e-cigarettes are as harmful or more harmful than cigarettes—a view for which there is no evidence. Seventy-two percent wrongly believe that smokeless tobacco is no less harmful than cigarettes. A majority (56 percent) wrongly believe that nicotine is the primary cause of smoking-related cancer. The statements and communications campaigns of regulators and public health agencies like the Centers for Disease Control and Prevention in the United States can improve these perceptions or make them worse. Either through risk aversion or by design, the leading federal agencies have contributed to the landscape of poor risk perceptions and have hence undermined their own effectiveness. This has especially been the case through agency efforts to deter youth use. These have strayed into the exaggeration of the harms of nicotine vaping and inappropriately capitalized on the scare over the outbreak of lung injuries in 2019 that was widely but falsely attributed to nicotine vaping.

Fifth lesson: Apply some skepticism and science to the claims of activists. A regulator should be objective and cautious about activists’ claims and draw on the best possible science to guide its actions. Between 2017 and 2019, the rate of vaping among U.S. high school students shot up from 11.7 percent to 27.5 percent, an alarming rise by any standard. This generated a climate of moral panic in the public, media and politics—with flavored vapes and the marketing practices of e-cigarette companies blamed for the rise. Cooler heads advised caution and to look more carefully at the underlying patterns. That was good advice. It turned out that most teen vaping was infrequent, most frequent use was concentrated in young people who might otherwise be smoking, and very few tobacco-naive users showed any sign of dependence. We know that the causes of youth vaping are similar to the causes of youth smoking: characteristics of the individual and their circumstances rather than the products being the primary driver. For many young people, their frequent vaping may have been a beneficial displacement from smoking or diversion from cigarette uptake. From 2019 to 2021, teenage vaping fell sharply, especially among the infrequent users, suggesting that the dramatic rise had been a frothy and transient fad. Yet, by basing a response on the headline numbers rather than the underlying usage patterns, the FDA may have done more harm than good to both adolescents and adult smokers by overreacting to a moral panic based on a false premise. The science and data were there to navigate this crisis with a steady hand, but the FDA chose the path of least resistance and accepted activists’ claims at face value and acted accordingly.

Sixth lesson: Adopt a realistic economic and behavioral model. How can a regulator use its powers wisely and make proper determinations if it has a poor grasp of the products and behaviors it is regulating? One way of looking at vaping products is that they are a form of smoking cessation device, a kind of pimped-up nicotine-replacement therapy. In that case, a regulator might demand clinical trials to show efficacy in smoking cessation and intervene to reduce “abuse liability”—the risk that the product will attract users for reasons other than its therapeutic indication. The other way of looking at vaping products is that they are competitive alternatives to cigarettes for people who wish to use nicotine for whatever reason. They work by presenting a rival value proposition to smokers. To do this successfully, they must be appealing and pleasurable and meet the needs of people who do not even want to quit smoking (those most at risk from smoking-related harm). Few medical or public health regulators have the conceptual tools to deal with ideas like pleasure or appeal without seeing them as an abuse liability. In reality, vaping and heated-tobacco products are best understood as part of a major technology transition from combustible to noncombustible technologies in the consumer nicotine market. The regulatory regime for such products needs to encourage and not suppress innovation, allowing innovators to do the heavy lifting in securing the eventual obsolescence of cigarettes. That is a far more ambitious aim than placing smoking cessation products on the market. Alas, few regulators, including the FDA, appear equipped for the challenge.

Clive Bates is the director of Counterfactual Consulting and the former director of Action on Smoking and Health (U.K.).

June 1, 2022