Originally published in Regulation
The U.S. Food and Drug Administration has recently proposed expanding its regulatory authority over tobacco products to include the regulation of cigars, pipe tobacco, hookah tobacco, electronic cigarettes (e-cigarettes), and other novel tobacco products such as dissolvable products and gels. Cigars are the most commonly used among this group, though e-cigarette use is rapidly expanding.
The U.S. Food and Drug Administration has recently proposed expanding its regulatory authority over tobacco products to include the regulation of cigars, pipe tobacco, hookah tobacco, electronic cigarettes (e-cigarettes), and other novel tobacco products such as dissolvable products and gels. Cigars are the most commonly used among this group, though e-cigarette use is rapidly expanding. If Federal Food, Drug, and Cosmetic Act requirements were to be applied to those products, they would mandate establishment registration and product listing, ingredient listing, submissions prior to the introduction of new products, labeling requirements, and prohibition of free samples. Additional provisions would include minimum age and identification requirements, vending machine restrictions, and required warning statements for packages and advertisements.
This article argues that the FDA jeopardizes public health by not developing an appropriate benefit-cost analysis of the proposed rule. The FDA “anticipates,” without quantifying, substantial benefits from reducing harm by regulating e-cigarettes and non-cigarette tobacco products. The FDA also does not adequately assess costs that appear likely from its suppression of the e-cigarette market. The evolving literature on e-cigarettes strongly suggests they help smokers to quit smoking. The proposed rule endangers public health by pushing e-cigarette manufacturers to focus efforts toward developing attributes unrelated to improved public health, thereby promoting combustible tobacco use and reducing the number of smokers who would use e-cigarettes to quit or reduce cigarette consumption. Public health would worsen because e-cigarettes are a safer alternative to tobacco cigarettes.
Harm Reduction Theory
The FDA implicitly assumes that consumption of all tobacco products should be reduced to zero. While tobacco use is known to be risky, economic theory demonstrates that few to no activities are optimally provided at zero quantity. This applies to consumption of risky products as well as efforts aimed at decreasing their use. There are costs and benefits to improving public health, and “perfection”—the elimination of all risks—is not an optimal public health strategy in a world with scarce resources. The FDA simply states that current tobacco policies are suboptimal and does not consider the possibilities that tobacco products are not equally risky or that all tobacco products are equally controllable through regulation. In claiming this, the FDA dismisses the essence of what is known as “harm reduction theory.” Harm reduction theory asserts that minimizing damage from some risky behavior may promote public health more effectively than simply attempting to eliminate the behavior. Applied to tobacco use, placing highest priority on reducing risks from combustible tobacco products is a reasonable strategy that the FDA should at least discuss.
Such a model is in line with estimates that up to 98 percent of tobacco-related deaths are attributable to combustible products such as cigarettes, pipes, and cigars. The FDA downplays the possibility that noncombustible products (e.g., nicotine-replacement therapies, smokeless tobacco, e-cigarettes) are substantially less dangerous than combustible tobacco products by claiming there is too little information available to make such judgments.