Last July marked the first anniversary of the Food and Drug Administration’s Comprehensive Tobacco Plan, intended to weaken the desire for nicotine’s most dangerous delivery device: the cigarette. Described as a “multi-year roadmap to better protect youth and help addicted adult smokers quit,” the FDA’s actions to date indicate, paradoxically, they are moving in the opposite direction of that goal, and instead strengthening the relationship smokers have with cigarettes.

It is no surprise that cigarette companies’ stock sharply rose following the FDA’s shocking announcement Wednesday to consider a complete ban of all flavored vapor products. This translates to a maddening $20 billion infusion for the major cigarette companies. Although the FDA’s plan claims to be science-based, its major tenets conflict with the best available science and are fully consistent with the prohibitionist approach of the tobacco control community, including Bloomberg-funded public health advocates Campaign for Tobacco Free Kids and the Truth Initiative. From alcohol to abstinence-only sex education, history has given us several examples of why this might not be the best approach.

In July 2017, FDA Commissioner Scott Gottlieb announced that “a key piece of the FDA’s approach is demonstrating a greater awareness that nicotine — while highly addictive — is delivered through products that represent a continuum of risk and is most harmful when delivered through smoke particles in combustible cigarettes.”

Based on the idea that “the overwhelming amount of death and disease attributable to tobacco is caused by addiction to cigarettes – the only legal consumer product that, when used as intended, will kill half of all long-term users,” the FDA unveiled a two-pronged approach to regulation. First, regulate, enforce, and educate people on the dangers of tobacco, and second, research and promote the development of innovative products that are less dangerous than combustible cigarettes. Unfortunately, however, the only actions they’ve taken so far are aimed at regulation of both combustible and noncombustible products.

In the year since its announcement, the FDA has rapidly progressed in its goal to regulate, enforce, and educate people on the dangers of tobacco and e-cigarettes. The FDA has solicited comments on two regulatory proposals surrounding nicotine concentration limits and the role flavors play in the use and cessation of all tobacco products. Five public health campaigns have been launched aimed at protecting adolescents from cigarettes and nicotine — all while the FDA has failed to act on the second goal of the road map, which is encouraging the development of innovative products to help current smokers switch to less risky products.

While these goals may seem antithetical, it is necessary for the second goal to be fully realized. Regulating low-nicotine cigarettes will only work if there is easy access to alternative, reduced-risk nicotine delivery products that can satisfy the urge to smoke for many, if not most, smokers — a fact the FDA acknowledged in the commissioning of an advisory paper titled, “ Illicit Trade in Tobacco Products after Implementation of an FDA Product Standard.”

The broadest category of these reduced-risk products, e-cigarettes, have proven popular among adult smokers and more effective for long-term smoking cessation than traditional quit products, such as nicotine gum and the patch. While it is true many nonsmoking teens have experimented with e-cigs, very few have gone on to daily use or moved onto cigarettes. As teen smoking rates have declined in the last several years, it would be difficult to conclude that e-cigarettes serve as a gateway to the combustible kind. In fact, among adult users, it’s been consistently shown that less than 1 percent of nonsmokers use e-cigarettes regularly, but over 95 percent of e-cigarette users are former smokers or are in the process of quitting.

Moreover, e-cigarettes are vastly less harmful than their combustible counterparts. One recently published paper estimates the risk of cancer from e-cigarettes is less than 0.6 percent the risk posed by cigarettes. Another estimates the cancer risk posed by exhaled e-cig vapor is less than 0.01 percent the risk posed by environmental tobacco smoke. Several comprehensive reviews by international research organizations reinforce the idea that while e-cigs are not totally risk free, the difference in risk between the two products is substantial enough to recommend that smokers who are unable or unwilling to quit, should switch.

Actions taken by the FDA to date raise the question of what can be done in the best interests of public health. One of the main principles of harm reduction, when applied to other drugs of abuse, is to focus on attainable solutions versus impossible ideals. Perhaps the best alternative to this less-than-optimal tobacco control plan is to redefine the goal of “a tobacco-free society” to “a smoke-free society” and add a tobacco harm reduction component to current tobacco control programming.

To secure more substantial and rapid reductions in the numbers of smokers, and smoking-related illness and death, there are multiple opportunities for improvement on the FDA’s current actions. And, more likely than not, if they’re implemented we will see even more reductions in the numbers of teens recruited to a lifetime of tobacco-related addiction.

We should continue to restrict sales of all tobacco-related products to minors, and more heavily tax the highest risk products. The FDA should amend its regulatory scheme from one designed to eliminate entry of any fundamentally new product into the marketplace to one that places the greatest regulatory burden on the most hazardous products, while assuring the quality and responsible marketing of lower risk products.

We predict when the first approach to the FDA’s road map is emphasized over the second (which is seemingly forgotten), the clear winner will be the products that are legally protected and ubiquitou: combustible cigarettes.

 

Image credit: Lumen Photos