The FDA’s deadly menthol miscalculation
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The FDA’s deadly menthol miscalculation

If the FDA is truly interested in promoting smoking cessation and saving lives, there are more effective ways to do this than a prohibition.

America is headed in the right direction, if only when it comes to smoking. After decades of decline, cigarette use among adults is lower than ever and practically nonexistent among youth. But that is not good enough for some government officials who are pushing a series of radical policies aimed at forcing the public to hasten its march toward a smoke-free (and now also nicotine-free) society. The closest of these efforts to becoming reality is a proposed rule from the U.S. Food and Drug Administration (FDA) that would outlaw menthol cigarettes nationwide by 2024. 

Based on its own number crunching, the FDA claims the move will save around half a million lives over the next 40 years and reduce health disparities. Supporters of the ban argue that this can be accomplished without triggering the devastating consequences caused by every other drug prohibition in history. The problem, however, is that the FDA’s math is wrong. For millions of adults, communities around the nation, and public health at large, this could prove a deadly miscalculation. 

Like all federal agencies, the FDA is required to provide some justification for major rules, showing why it expects the benefits of that rule to outweigh its costs to society. In the case of banning menthol cigarettes, that justification centers primarily on the lives it is expected to save, which the FDA estimates at between 324,000 to 654,000 by the year 2060. To come up with that number, the agency relied on a series of studies that used predictive modeling to guess how menthol cigarette smokers, now and in the future, might behave in the wake of such a ban.  

These models predict that, while around 56 percent of current and future menthol smokers would respond in ways that do not improve health (such as switching to equally-harmful non-menthol cigarettes or relying on illicit markets), a significant portion—45 percent—would alter their behavior in ways that promote better health. According to these models, however, nearly half of the public health benefits would come from smokers switching to mentholated versions of lower-risk nicotine products, like e-cigarettes. The issue with this in the real world is that smokers may not have that option thanks to the FDA’s own irrational policies. 

Nicotine, though a habit-forming substance, is not what makes smoking dangerous. The danger comes from combustion; the chemicals created by burning tobacco and paper. Despite nearly all evidence indicating that non-combustible sources of nicotine, like e-cigarettes, are safe and effective substitutes for smoking, the FDA continues to do everything in its power (and arguably beyond it) to eliminate the e-cigarette market. Only a handful of options have been approved for sale and the FDA has refused to approve any in menthol flavor (indicating it never will). Smokers already have limited access to any sort of FDA-sanctioned e-cigarette, let alone the type and flavor they might find an acceptable replacement for their cigarettes. As the FDA continues to pull e-cigarettes off the market, including the most popular and effective brands, and as cities and states implement their own e-cigarette bans, issues with limited access will grow. 

If nearly half of the public health benefits the FDA expects from a menthol cigarette ban come from the expectation that many smokers will switch to e-cigarettes, what will happen when the agency’s own policies prevent this from happening? It is possible that more smokers will choose to quit tobacco and nicotine use altogether, making a menthol cigarette ban even more beneficial for public health than the FDA currently predicts. But, evidence suggests smokers will instead choose to switch to non-menthol cigarettes, gaining zero health benefits, or turn to illicit markets, where their risks might actually be increased.

To make matters worse, the FDA’s math also suffers from incorrect assumptions about how illicit markets would respond to a menthol cigarette ban. Though menthol cigarettes make up over a third of all cigarette sales, generate more than $21 billion in revenue, and are used by an estimated 19 million Americans, the FDA claims a ban won’t lead to increases in illicit cigarette sales. But this is yet another miscalculation. 

The already-booming illegal cigarette market in America has traditionally operated via domestic bootlegging, with primarily “mom and pop” enterprises legally purchasing cigarettes in low-tax jurisdictions, such as Virginia, and selling them in high-tax jurisdictions, like New York. Since the scheme involves a product that is legal everywhere in the country, the risks illicit operators face for this sort of smuggling are relatively low. For the same reason, the potential profits smugglers can make are also relatively low, since illicit cigarette dealers must keep the prices they charge for smuggled cigarettes lower than what their customers would pay for legal cigarettes where they live. Because a nationwide ban on menthol cigarettes would prevent would-be menthol cigarette dealers from simply hopping state lines to supply their trade, the FDA assumes they would not even bother. But this is a dangerous underestimation of the resourcefulness of illicit supply chains. 

A national prohibition, whether for menthol cigarettes or anything else, certainly increases the risks for those hoping to profit by selling illicit goods. But, it also vastly increases the rewards for those who do so successfully. Unlike the current market for illicit tobacco which hinges on offering customers cheaper cigarettes, a national prohibition would make illicit sources the only option for menthol smokers. As such, those customers might be willing to pay as much or even more for illicitly supplied menthols as they would have paid when they were legal. By increasing both the demand for and the profitability of illicit menthol cigarettes, a ban may have the unintended effect of attracting international drug cartels into the racket. And given the skill with which these cartels continue to evade authorities, it is not clear why the FDA thinks a cigarette ban would be more successful than any other drug prohibition.

Even if U.S. authorities could stop the flow of illicit cigarettes over our national borders, there is little they could do to stop domestic producers from supplying the market with counterfeit menthols. This task would involve little more than purchasing still-legal non-menthol cigarettes and adding menthol flavoring. The government could do even less about individuals who might make their own supply of menthol cigarettes the same way. 

Far from making menthol cigarettes unavailable, as the FDA assumes, a menthol ban could have the perverse effect of making them far more available, particularly for minors, since illegal dealers aren’t exactly sticklers for age verification. Even more perversely, the ban could harm the very group—people of color—it supposedly seeks to help most. 

While there is no credible evidence that menthol cigarettes are more toxic, harder to quit, or more attractive to youth than non-menthol cigarettes, it is true that they are overwhelmingly preferred by people of color with around 85 percent of black smokers choosing menthols compared to just 30 percent of white smokers. The FDA claims this means that black people would benefit most from a menthol cigarette ban since they will be more motivated to quit smoking. But, it also means that many of the smokers who do not quit and instead turn to illicit markets to get the menthol cigarettes they prefer will be people of color. And, as it is with any drug war, it will be people and communities of color that bear the brunt when local authorities attempt to crack down on illicit activity. 

If the FDA is truly interested in promoting smoking cessation and saving lives, there are more effective and certainly less destructive ways to do this than a prohibition. Another approach would be for the FDA to adopt policies grounded in harm reduction, to encourage smokers who cannot or will not quit using nicotine to switch to less harmful options, such as the already FDA-endorsed (but largely ineffective) nicotine patch, gum, and lozenge, as well as e-cigarettes, snus, and heated tobacco. But, for this to work those products must be at least as accessible, affordable, and palatable to smokers as the cigarettes they are used to. Whether the FDA wants to admit it or not, that means allowing them in flavors smokers want, including menthol. 

In other countries, like the United Kingdom and Japan, tobacco harm reduction has been widely embraced and hugely successful. America has already adopted a similar approach to other substance use issues, such as legalizing cannabis, offering clean needles to people who use intravenous drugs, opioid replacement therapy, and naloxone for overdose prevention. There is no reason that tobacco harm reduction would not be similarly successful if the FDA abandoned its unscientific opposition to nicotine and got out of the way of innovation. Such a harm reduction approach may anger prohibitionists in the anti-tobacco industry and Congress, but unlike the current approach, it might actually save lives.