The Cigarette Smokescreen: The FDA is passing up a historic opportunity to reduce the harmful effects of tobacco
Cigarette smoking is one of the major preventable scourges of human health. Public health experts and regulators—and yes, even smokers—know it. But by being politically correct and focusing on unproven or misguided approaches, the FDA is passing up a historic opportunity to mitigate the health effects of cigarette smoking. Specifically, FDA officials are struggling to reconcile science and politics in applying their new powers to regulate tobacco. They aren’t succeeding.
As a result of the landmark 2009 Family Smoking Prevention and Tobacco Control Act, the FDA was tasked with regulating not just cigarettes, but a range of tobacco products. The agency’s oversight of tobacco is fundamentally different from any other product it regulates simply because tobacco is an inherently, irredeemably dangerous product. Unlike drugs, it isn’t beneficial in any way; and unlike food, it isn’t a necessity.
The legislation gives the FDA the authority to review and ban proposed new products unless they are proven to significantly improve public health. This has already led to unanticipated legal and scientific arguments over so-called “reduced harm” products.
The director of the FDA’s Center for Tobacco Products, Dr. Lawrence Deyton, seemed to be on the right track, at least in principle, when he told the Society for Research on Nicotine and Tobacco last year that “complex problems require multi-faceted, comprehensive approaches based on the best available science.”
However, the agency’s approach to several regulatory issues belies Deyton’s homage to science (a traditional trapping of many a regulator assuming a new office).
All tobacco products are not created equal. Cigarettes are by far the deadliest of them all, but other forms of tobacco, particularly smokeless products such as Swedish-style snus or newer dissolvable products, although not entirely safe, are far less harmful. Studies in Sweden have shown that such products can be used by smokers to reduce their tobacco-related risk.
It may seem counter-intuitive but nicotine, although highly addictive, is not particularly bad for you in the amounts delivered by cigarettes or smokeless products. The vast majority of the health risks from tobacco come from the burning and inhalation of smoke. Quitting tobacco altogether remains the ideal outcome, but switching to lower-risk products would be a boon to the health of smokers. This sort of “harm reduction” via substitution of a lesser evil is philosophically similar to the administration of methadone to wean addicts off heroin and to the rationale for treating cancer with highly toxic chemotherapeutic drugs.
Tobacco is an inherently, irredeemably dangerous product.
Yet smoking tobacco is so reviled among public health activists that many are reluctant to acknowledge that some tobacco products are far less dangerous than others, and that harm reduction is a valid, if imperfect, solution.
Will the FDA endorse tobacco harm reduction and thereby help smokers who have failed to quit by traditional means—and whose success rates are poor—or will it buy into the “quit or die” approach endorsed by many tobacco control activists?
While the jury is still out, some of the questions posed by the FDA at a workshop last year suggested a sweeping anti-tobacco, rather than anti-smoking, approach. The scientists, appointed by the FDA, focused on whether the introduction of modified-risk tobacco products, and the reduced-risk claims manufacturers would like to make for them, would reduce overall tobacco use. But that is the wrong question. Instead, they ought to be asking how they can set up a regulatory environment that would lead to fewer and less severe tobacco-related diseases. The distinction is critical, underscoring the difference between an anti-tobacco agenda and a policy that embraces life-saving harm reduction.
A previous example of the FDA’s resistance to harm reduction came in July 2009, when the agency issued a warning about a product called e-cigarettes, which many smokers were (and are) using to give up real cigarettes. They look like cigarettes and many versions supply users with vaporized nicotine, some even boasting an LED light at the tip for verisimilitude. They contain no tobacco and are non-combustible, and thus do not expose users to the risks of smoking. For the vast majority of smokers unable to quit even with the help of drugs and counseling, e-cigarettes could be a life-saver; but after performing a cursory laboratory analysis of the products, regulators warned smokers to avoid them, essentially telling them to stay with deadly cigarettes.