Hold your fire

In debating the relative health risks of various nicotine products, one consideration trumps all others.

By Clive Bates

What is the best alternative to smoking cigarettes? Unless we are allowed the answer “not smoking cigarettes,” then sadly this is the wrong question. We are already seeing commentators and companies declaring they have the best product or being champions of vapor products, heated tobacco or snus—as though preferred product choice was like supporting a football team.

So, let’s be clear. There best alternative product to cigarettes is the one that works for a particular individual, at a particular time, in a certain setting, in a given jurisdiction. That will differ between people, and the same person will have different preferences at different times. There just isn’t a single best product.

The most important distinction from a health and public policy point of view is whether or not the nicotine product is combustible—i.e., whether the product is designed so that dried and cured tobacco is set on fire and the resulting smoke is inhaled. Almost everything else is incidental, a second- or third-order issue.

Choice and risk in the nicotine market

We are now seeing a spectacular expansion of choice in reduced-risk alternatives to smoking. Within the broad category of smoke-free products we can identify four subcategories (see figure). Within each of these four, there is rapidly advancing diversification driven by innovators, consumer demands and regulators.

These products represent a disruption in the tobacco and consumer nicotine marketplace. Even long-established products like snus are taking on a new role as awareness of the “Swedish experience” grows and the products are repackaged as “modified-risk.” These products are quite different from each other but, in my view, we should treat these smoke-free products in more or less the same way for policy, fiscal and communications purposes—as a broad noncombustible category of consumer alternatives to smoking.

There is nothing inherently superior in health terms about nontobacco products such as e-cigarettes compared with tobacco products such smokeless tobacco. Some appraisals, for example, Nutt et al, 2014, have suggested that e-cigarette use would be safer than smokeless tobacco use. But why? Smokeless tobacco does not involve lung exposure, but vaping does—couldn’t that create different risks than those posed by smokeless products? I’ll guess it is because the authors instinctively ranked any tobacco product as being inherently more dangerous than any nontobacco product because of some hunch about the “dirtiness” of tobacco itself. But there is no scientific basis for that.

The aerosol generated by heated-tobacco products may be more chemically complex than typical e-cigarettes—and potentially more hazardous. But is this difference a material concern for policymakers? I think it should make little difference. Heating hardly matters as long as there is no burning—that is, as long as the temperature of the tobacco stays safely below 350 degrees Celsius, the temperature at which combustion occurs. What matters is that the products are all much safer than smoking—the differences between the various smoke-free products matter much less than the difference between smoked and smoke-free products. Imagine there was a scale of harm ranging from 1 to 100, with combustible cigarettes being 100. Suppose noncombustible products are in the range of harms from 1 to 5. The relative difference between smoke-free products could be a factor of five—a large range—but in practice this is in a tiny absolute range at the extreme end of a spectrum of risks that includes smoking.

Some may object that, for public health reasons, we should concentrate on whatever noncombustible products is the least harmful and propose that as the preferred alternative to smoking. Why have any additional risk if it is unnecessary? While that logic is superficially attractive, it would not in practice reflect the public health optimum. To put it bluntly, the perfectly safe product that no one wants to use is of little value from a public health point of view. This is the reason why pharmaceutical nicotine products have not been a conspicuous consumer success, even though some are licensed for continued use for nicotine maintenance. For an alternative to smoking to succeed in public health terms, there has to be both substantially lower risk and people have to want to use it instead of smoking. For minor absolute differences in risk, then it will be worth making trade-off to widen the appeal.

Appeal and product diversity

This brings us to the fundamental point about tobacco harm reduction: appeal matters. And consumer appeal is what the consumer decides is appealing. For some, a product that is as close as possible to their smoking experience could be their ideal choice—and so they may choose a heated-tobacco product. Others may be trying to distance themselves from their life as a tobacco consumer and will welcome a fruit-flavored vapor product. For some nicotine users, the discreet use of a nontobacco oral product might be useful when smoking or vaping is inappropriate. In some jurisdictions, high taxes or regulations may shape consumer preferences, for example by making e-cigarettes more affordable than heated-tobacco products. For some, trying new flavors, products and techniques may be part of the experience, and industry innovators, if permitted, will find endless ways to cater to curiosity.

These consumer preferences may also change in response to marketing, to new studies and media stories, or through advice from other users or vape shops. Preferences are shaped by the environment as well as the consumer. What users find appealing may also change with the time of day or with the progress of a journey from smoking to being smoke-free lasting months or years. Nothing is fixed; product and brand loyalty is fluid.

How should all these diverse preferences be met? From a public health perspective, what each company does is less important than how the market as a whole presents diverse product choices to the consumer. We need a market that provides a wide range of attractive products, with a rapid pace of innovation and responsiveness to evolving consumer tastes. The shape of that market will depend in large part on regulation.

Regulation to support a diverse marketplace

The main threat to consumer choice in the smoke-free market is excessive and disproportionate regulation. The system defined under the U.S. Tobacco Control Act and administered by the U.S. Food and Drug Administration is a case in point. The premarket tobacco product application (PMTA) process is extremely burdensome, very slow and highly opaque. There are few firms that have the resources and capabilities to clamber over these extraordinarily high regulatory barriers to entry. The likely result will be extreme market concentration, dominated by large companies with the means to cross-subsidize their reduced-risk products from ongoing cigarette sales. There will be relatively few products, and these will be simple designs that can be more easily evaluated. The market will shift toward products that appeal to regulators rather than to consumers.

The challenge is to create a smoke-free marketplace that is shaped more like the beer market. That means a few super-brewers like Anheuser-Busch InBev with global brands, but with a range of medium-sized national and regional breweries, and a long tail of microbreweries making exotic beers catering for every imaginable taste. To shape the reduced-risk consumer nicotine market this way demands “risk-proportionate” regulation (see “The Principle of Proportionality,” Tobacco Reporter, December 2018) in which the regulatory burdens, controls, and taxation reflect the risk to the consumer. This would create the conditions for a flourishing smoke-free industry: low barriers to entry, a high degree of competition and a rapid pace of innovation.

Quantifying risk in a diverse market

If consumers have more choice but less risk, we have new challenges in understanding and measuring the overall health impact of the tobacco market. For a thought experiment, imagine you have a choice between two patterns of consumption for a community: 20 percent smoking and no one vaping or 10 percent smoking and 30 percent vaping. In the latter case, there is twice the nicotine prevalence but half the smoking prevalence. Which would be the better outcome for public health? In my view, the option with lower smoking prevalence is by far the better public health outcome, even though there are twice as many users.

We need a more nuanced approach to characterizing the overall impact of the tobacco market—something better than smoking or tobacco-use prevalence. In its response to a consultation on “healthy people” indicators in the United States, the National Tobacco Reform Initiative advocates use of “harm weighting” in characterizing tobacco use, creating an index of tobacco use that takes account of the differences in risk between different products. This would help to focus minds on the real public health problem: that problem is combustion and smoke.

“More Choice, Less Risk” is the theme for the 2019 Global Tobacco & Nicotine Forum (GTNF), to be held Sept. 24-26 in Washington, D.C. Visit www.gtnf.org for details.