Countermanding Kessler


Last week a federal circuit court rejected the Food and Drug Administration's attempt to regulate cigarettes. The decision was a victory not only for the tobacco industry but also for the rule of law.

For eight decades, members of Congress and federal regulators agreed that the FDA and its predecessor agency did not have jurisdiction over tobacco products unless they were explicitly sold for therapeutic purposes. Over the years, tobacco's opponents in Congress sponsored more than a dozen unsuccessful bills aimed at authorizing the FDA to regulate cigarettes.

In 1994, then-FDA Commissioner David Kessler suddenly discovered that his agency already had this power. From the beginning, Kessler's foray into tobacco policy was disingenuous and unprincipled. An ardent opponent of smoking, he first decided to regulate tobacco and then looked for a rationale.

This is what Kessler came up with: "Evidence brought to our attention is accumulating that suggests that cigarette manufacturers may intend that their products contain nicotine to satisfy an addiction on the part of some of their customers. The possible inference that cigarette vendors intend cigarettes to achieve drug effects in some smokers is based on mounting evidence we have received that: (1) the nicotine ingredient in cigarettes is a powerfully addictive agent and (2) cigarette vendors control the levels of nicotine that satisfy this addiction."

If so, Kessler reasoned, a cigarette could be considered a drug under one of the definitions in the Food, Drug, and Cosmetic Act: "articles (other than food) intended to affect the structure or any function of the body of man." Rather than judge manufacturers' intent based on their public statements, as the FDA had always done, he suggested that the agency could infer their intent from indirect evidence.

To hear Kessler talk, such evidence was "accumulating" and "mounting" all over the place. But his essential points–that nicotine is addictive and that tobacco companies control the amount delivered by cigarettes–had been widely acknowledged for quite some time.

People began remarking on the difficulty of breaking the tobacco habit hundreds of years ago, when the drug first became popular in the West. Observers described smokers as "slaves," "thralls," and "tobacco drunkards." Nicotine was isolated in 1828, and its importance as an incentive for smoking was taken for granted by the turn of the century.

Nor was it news that tobacco companies controlled nicotine levels. Several brands of denicotined cigarettes were introduced as early as the 1920s. Claims of reduced tar and nicotine had been conspicuous since the 1950s, and the yields of each brand had been advertised, by agreement with the Federal Trade Commission, since 1971.

Even if you overlooked the fact that Kessler was treating matters of common knowledge as if they were revelations, his focus on addiction was puzzling. "Addictiveness" is not a criterion for regulation under the Food, Drug, and Cosmetic Act.

Then, too, Kessler's new justification for regulating cigarettes as drugs would also apply to beverages containing alcohol or caffeine. Both substances are considered addictive, and there is no question that manufacturers control, say, the amount of alcohol in a can of Budweiser or the amount of caffeine in a bottle of Coke.

Another problem was immediately apparent: The FDA is supposed to ensure that the drugs it regulates are "safe and effective." Cigarettes surely are not safe, and it's not clear what it would mean to call them effective. Effective at satisfying the urge for a cigarette?

Kessler himself acknowledged that a strict reading of the law would require the FDA to remove cigarettes from the market. Consequently, he said, guidance from Congress was "vital."

After the Republicans took control of Congress in November 1994, Kessler changed his mind. The FDA issued proposed regulations for cigarettes in August 1995, classifying them not as drugs but as medical devices. It claimed this implausible maneuver would give it the discretion to regulate tobacco products without banning them.

Calling the FDA's reasoning "obvious sophistry," a three-judge panel of the U.S. Court of Appeals for the 4th Circuit disagreed. "The fact is that Congress did not equip the FDA with tools appropriate for the regulation of tobacco," the majority wrote, "because it had no intention that the Act apply to tobacco products."

In finding that the FDA had exceeded its authority, the court upheld an important principle: Bureaucrats may not exercise powers they have not been granted, no matter how righteous their attitude or unpopular their target.