FDA Chief: Please Don't Make Us Regulate Tobacco


Last week FDA chief Andrew von Eschenbach, who earlier this year expressed concern about legislation that would give his agency regulatory authority over tobacco products, testified against the bill, known as the Family Smoking Prevention and Tobacco Control Act. Von Eschenbach said tobacco regulation does not fit well with the FDA's mission to approve products based on a determination that their benefits outweigh their risks:

FDA cannot "approve" a tobacco product in this context, because there is no scientific context to determine benefit to outweigh the numerous risks. It will be very challenging to transform existing science into a logical regulatory structure. There is little science available to the FDA on which to base decisions on tobacco product standards (such as reducing or eliminating harmful constituents, reducing the amount of nicotine in products, or requiring changes to tobacco product components) or premarket approval.

Von Eschenbach also worried that "associating any agency whose mission is to promote public health with the approval of inherently dangerous products would undermine its mission and likely have perverse incentive effects." For example, "We are concerned that the public will believe that products 'approved' by the Agency are safe and that this will actually encourage individuals to smoke more rather than less." Richard Bonnie, the University of Virginia law professor who chaired the Institute of Medicine's Committee on Reducing Tobacco Use, questioned the basis for this concern, saying, "It seems highly unlikely that such a gross distortion of public understanding could occur when public and private agencies, including FDA itself, are taking aggressive steps to discourage people from using tobacco products and to help people quit."

While I doubt that FDA regulation would lead many people to view cigarettes and other tobacco products as completely safe, it does seem plausible that consumers will tend to view them as less hazardous than they are now. After all, reducing the dangers posed by tobacco products is one of the main rationales for FDA regulation; the FDA is supposed to vet tobacco companies' health claims (one reason Philip Morris, which has been experimenting with safer cigarettes for years, supports the bill). Moreover, the concern that reduced-risk claims, even completely truthful ones, might encourage people to continue smoking is reflected in the bill, which instructs the FDA to take such effects into account when weighing the likely impact of a new product on "the public health." That charge could perversely lead the FDA to keep safer products off the market, depending on its predictions about how current and potential smokers would respond and its assessment of how they otherwise would have behaved. The difficulty of making that call, even leaving aside the ethical problem with substituting a collectivist calculation for the individual judgments of consumers, only reinforces Von Eschenbach's point that the FDA is ill-suited for such a task.