In a major showdown over the power wielded by federal agencies, the US Supreme Court this week is being asked to decide whether Congress granted the Food and Drug Administration the authority to regulate tobacco.
The dispute, set for oral argument here tomorrow, is being called the most important public health and safety issue considered by the high court over the past half century.
If the court sides with the FDA and allows proposed regulations aimed at curbing teen smoking, the new rules could help hundreds of thousands of American children avoid addiction to nicotine.
If a majority of justices agree with the position of the tobacco industry - that the FDA lacks the power to enact such antismoking rules - it will be left to Congress to decide how, or even if, the tobacco industry should be further regulated.
Either way, reverberations from the case will extent far beyond US borders.
"What happens at the FDA will have global implications for how tobacco products are viewed and regulated," says Jack Henningfield, a professor at Johns Hopkins School of Medicine in Baltimore and a leading authority on nicotine addiction. "Globally, you are talking about 1.2 billion cigarette smokers of which the World Health Organization predicts a half billion will prematurely die."
Currently, the tobacco industry is regulated primarily through congressionally mandated warning labels, a prohibition on television advertising, a ban on sales to minors, and rules that protect nonsmokers from secondhand smoke in confined places like airplanes and elevators.
Limits on advertising
In 1996 the FDA entered the tobacco-regulation arena by writing an additional set of regulations aimed at curbing teen smoking. The new rules restrict sales methods like vending machines and ban billboard and magazine advertising aimed at young viewers.
The industry challenged the regulations, arguing that the FDA, throughout most of its history, rejected jurisdiction over tobacco and that Congress never granted the agency the authority to impose such restrictions. A federal appeals court in Richmond, Va., agreed with the industry and struck down the regulations.
"We do not dispute in this case that Congress has charged the FDA with protecting the public health and that tobacco products present serious health risks for the public," writes Judge H. Emory Widener Jr. in the 2-to-1 appeals court decision. But he adds, "Based on our examination of the regulatory scheme created by Congress, we are of the opinion that the FDA is attempting to stretch the act beyond the scope intended by Congress."
Judge Widener adds: "At its core, this case is about who has the power to make this type of major policy decision ... [and] neither federal agencies nor the courts can substitute their policy judgments for those of Congress."
After an extensive investigation of smoking and the addictive effects of nicotine, the FDA decided that under the Food, Drug and Cosmetic Act it had the necessary authority to regulate tobacco.
Relying in part on internal tobacco-industry documents uncovered during state lawsuits against the industry, the agency decided that nicotine is a drug and that cigarettes are basically drug-delivery systems.
Under the law, the FDA may regulate drugs and drug-delivery systems. But the tobacco industry insists that drug and delivery system regulations apply only to health-care products.
"We don't claim that tobacco products have health benefits. Our products are sold with a warning that says the opposite," says Bert Rein, a Washington lawyer representing Brown & Williamson Tobacco Corp., one of the parties in the case.
If the tobacco industry's position prevails, it will illustrate what some analysts see as a telling irony. There is no debate over the FDA's ongoing regulation of nicotine gum and patch products, which are designed to wean addicted smokers off tobacco.
"The gum and the patch are very subdued forms of nicotine delivery and they are designed to be safe and without addiction potential," says Mr. Henningfield. "The real irony is that the most addictive, toxic, and potent form of nicotine is cigarettes - and they are not regulated."
An additional irony is that the FDA has the authority to regulate nicotine-free cigarettes, but not the real thing, says John Banzhaf of the Washington advocacy group Action on Smoking and Health.
Whether such examples will sway the Supreme Court justices is doubtful, according to some analysts. "Unfortunately, consistency and logic are not generally the kinds of things the Supreme Court looks at in cases like this," says Mr. Banzhaf.
From the tobacco industry's perspective, the case is all about regulatory power and whether the kinds of decisions the FDA was making are better made by members of Congress.
"At the end of the day it is Congress's call. This is a critical matter of public policy, it involves hundreds of millions of people," Mr. Rein says. "Tobacco is ultimately a political issue, people's freedom to indulge themselves versus the health consequences that may result from those decisions." It isn't a question for FDA experts in medicine and science, he says, but rather it is an issue to be resolved through the political process in Congress.
Henningfield disagrees. He says in matters of public health and safety science should prevail over politics. "I think the tobacco companies are scared to death that the industry will be regulated by an agency that understands concepts such as drug delivery, addiction, and control over drug dosing," he says.
(c) Copyright 1999. The Christian Science Publishing Society