Puffing Smoke in the Eye of Judicial Restraint

Last week, the U.S. Supreme Court took up the issue of tobacco regulation. In 1996, the Food and Drug Administration, after a half-century of declining jurisdiction, asserted authority over tobacco products. The industry balked, arguing that it was too late in the day for the agency to act. In any event, said Big Tobacco, the FDA is only given authority over “drugs” that are “intended to affect the structure or function of the body,” and we only “intend” our products for “smoking pleasure.” A divided federal appellate court in Virginia, not far from the Marlboro Man’s home, sided with cigarette makers, and the justices’ questioning last week appears inclined to snuff out the government’s authority as well.

A decision adverse to the FDA would be most unwise, but not just because the health of a good part of the nation rests in the balance. Also under considerable pressure is the integrity of the court’s commitment to judicial restraint. The FDA’s statutory authority is broad. As such, judges are expected to defer to reasonable agency interpretation, even when an agency has a change of heart. As Justice Antonin Scalia, the court’s conservative voice for restrained judicial behavior, has observed, where a federal agency has been given discretion, “there is no apparent justification for holding the agency to its first answer, or penalizing it for a change of mind.” But adhering to this judicial canon takes extraordinary temperance, especially when it will sustain as plausible an agency interpretation with which one strongly disagrees.

The tobacco companies insist that they are immune to FDA regulation since the industry never utters a word about tobacco’s addictive qualities. So as far as the companies are concerned, unless they actually admit that their products have bodily effects, regulatory agencies can’t touch them.

On appeal, the FDA relies on the venerable legal principle that the law presumes that every person intends the foreseeable consequences of his or her actions. What’s more, the FDA bases long-standing regulations that define the intended effect of a product not just by what the manufacturer claims, but by all relevant facts and circumstances, including that the product may be employed for purposes other than those for which it is sold. And while the FDA ignored some of these facts and circumstances for a long time, there is much new information. In 1980, when the FDA declined to regulate cigarettes, no major health organization had determined tobacco to be addictive. Today, they all have. Before, argues the FDA, consumers used tobacco products for pleasure in spite of their bodily effects; now, an overwhelming percentage of consumers use these products to sustain addiction or for stimulation or sedation.

This is all blowing smoke, claims the industry. The “pharmacological effects of nicotine have been well-known for decades.” That’s kind of surprising, given that the industry’s chief executives in 1994 stated just the opposite under oath before Congress. The truth is that the industry has gone out of its way to hide what a recently disclosed Brown & Williamson internal memo so succinctly disclosed: Since “smoking is a habit of addiction . . . we are, then, in the business of selling nicotine, an addictive drug.”

Tobacco’s last refuge is to insist that the logical end point of the FDA’s claim of authority is a complete ban of tobacco products, something the industry insists its friends in Congress would never endorse. The FDA denies a ban is in the offing. The agency sees its primary responsibility as prohibiting the sale of tobacco to children, while leaving it available to adults to mitigate the harmful effects of nicotine withdrawal.

Does FDA have authority or not? Congress, of course, could have readily cleared the air. It chose not to. Instead, disregarding Dante’s admonition against unwarranted neutrality, a Senate Appropriations Committee noted some time back that its continued funding of the agency was “in no way to be construed as concurring or disagreeing with any court ruling regarding FDA’s authority.”

And so the ultimate question must be: Who is to make tobacco policy? An administrative agency given the task by elected representatives of protecting the public health, or the Supreme Court? The answer seems to hinge on whether past paeans to judicial restraint are more than wisps of smoke.