The U.S. Food and Drug Administration announced late last month it will start a dialogue about using its rulemaking powers to reduce nicotine levels in cigarettes to nonaddictive levels. The goal would be to “decrease the likelihood that future generations become addicted to cigarettes and allow more currently addicted smokers to quit.”
The idea has had a warm reception from tobacco-control advocates in the United States, with several heralding it as the beginning of an “endgame” for smoking. But is it really?
People smoke cigarettes for the nicotine. A cigarette with subaddictive levels of nicotine is no longer a cigarette, just as whiskey with 1 percent alcohol is not whiskey. Almost no one will use very low nicotine cigarettes because, by design, they do not provide the most essential feature of a cigarette – a nicotine hit. This would be a de facto prohibition of a product used by 38 million Americans, with retail sales of $94 billion, including more than $40 billion in tax and settlement revenue. Many users are dependent and habituated to the product’s use and either don’t want to or cannot just quit or switch to other products.
The FDA has funded a multimillion dollar program of research into reducing nicotine, but it does not support this proposed prohibition. What the research program has accomplished largely is to gather an impressive base of knowledge about products that, in reality, will rarely be used. Most of the research involves trials using volunteers who are paid to participate and given free products. This cannot tell us anything about how the real-world market will respond to a de facto prohibition of conventional cigarettes.
Outlawing a product doesn’t make it disappear. We know this from the war on drugs. Many options are open to both consumers and the supply chain. People could use the internet to buy conventional cigarettes internationally or they could switch to cigars, hand-rolled tobacco or new products designed to test the boundaries of the regulation. A major question is what the response of criminal enterprise will be. No one knows how big the inevitable black market will be, no one even knows how to guess and there is no consensus on how much of a black market would be too much.
A major issue is complication that inevitably would accompany a forced behavior change imposed on tens of millions of smokers over a short period of time. The degree of coercion and likely backlash involved would be major vulnerabilities. Proponents of very low-nicotine cigarettes suggest the rise of e-cigarettes and other vapor products could reduce the degree of coercion required by providing an easy transition to much lower-risk products. But this only works if the alternatives are good substitutes for smoking for nearly all users. That’s something that might be achievable within the next 10 to 20 years, given a pro-innovation regulatory regime. But therein lies the paradox: if the products are sufficiently good substitutes for smoking, then the coercive approach is unnecessary. Markets and consumer preferences will generate the necessary transition.
The legal basis and political mandate for reducing nicotine is extremely weak. The FDA believes it has power to take this action under 2009’s Tobacco Control Act. Certain provisions of the law prohibit the FDA from banning cigarettes or reducing nicotine levels to zero, as Congress determined these decisions too important to leave solely to rulemaking by a federal bureaucracy. It is an open question whether the reduced nicotine proposal would or would not be covered by those prohibitions. What shouldn’t be in question is that it would have the same practical effect as the measures placed off-limits by Congress. For this reason, the measure could be challenged successfully in the courts.
The FDA also would have to account for wider consequences and show that the regulation complies with President Donald Trump’s executive orders 13,563 and 12,886 governing regulatory practice. Taking a sample of just four of many questions that would need to be addressed in a full policy assessment, the FDA would need to show what impact the rule would have on American tobacco farmers and whether they would be expected to grow genetically modified nicotine-free tobacco; what effects law enforcement and customs agencies would see from this new category of mass crime and new opportunities for criminal enterprise and corruption; what effects states would see from the impact on tax and related revenues; and whether the creation of an illegal supply chain for cigarettes would create new risks to teenagers, for example, through a more readily available supply of opioids.
Since it was given jurisdiction in 2009, the FDA has managed to do almost nothing new or consequential to regulate cigarettes. It has not even succeeded in its aim to ban menthol-flavored cigarettes, a trivial measure compared to eliminating nicotine. The agency’s decision to start a dialogue on reducing nicotine is good and timely, as it will surface the serious practical, political, legal and ethical objections to the idea.
But even for supporters of reducing nicotine, the more pressing priority must be the availability and acceptability of low-risk alternatives to smoking such as vapor products. That requires a pro-innovation regulatory framework, a favorable fiscal regime and raising public awareness about how much less risky smoke-free products are compared to smoking. Perhaps we can all agree on that?
Clive Bates is editor of Counterfactual and is based London, England. Carrie Wade is harm reduction policy director of the R Street Institute in Washington, D.C.