Justices to weigh nicotine control

Ruling on FDA's role could decide future of tobacco industry

November 29, 1999|By Lyle Denniston | Lyle Denniston,SUN NATIONAL STAFF

WASHINGTON -- Days of reckoning seem to arrive so regularly for the nation's tobacco companies that potential legal catastrophe is almost routine.

As the tobacco companies face an ominous government lawsuit while paying out millions of dollars in state tobacco settlements, a confrontation this week at the Supreme Court could decide the beleaguered industry's future.

In a hearing set for Wednesday, the justices will examine a legal question that on the surface seems simple: Does the Food and Drug Administration have the authority to regulate nicotine as a drug, and cigarettes as a device for delivering nicotine into the human body?

The stakes in the case could be especially high, according to the industry and its adversaries in the public health community: The industry sees the potential that, if it loses the case, cigarettes might be banned altogether or made free of nicotine -- a cigarette, it believes, the nation's 50 million smokers would not buy.

Public health advocates see the chance to bring the industry under an ever-tightening regime of federal controls that could change the culture of tobacco in America. The government could superintend virtually everything the companies do -- from research to production, to marketing and advertising, to sales.

"The issue at this point is not what is the best way to regulate tobacco, but whether the FDA has any authority to regulate at all," says Allison M. Zieve, a staff attorney for Public Citizen Litigation Group, which supports the FDA in the case.

But much could flow from the court's focus on the FDA's basic powers.

Scott D. Ballin, a tobacco and health policy consultant, argues: "FDA authority is the cornerstone to effective controls over what has been and remains this nation's single most preventable cause of disease and death."

Industry spokesman Scott Williams counters: "This is about whether an unelected agency can single-handedly ban a legal product." Congress, he insists, has control over tobacco policy and has never delegated such power to the FDA, and the agency is forbidden to grasp that authority on its own.

Both sides appear to be looking beyond the specific question about the FDA and are anticipating a future that is foreseen only in dim outline. But that future could begin to take definite shape after the justices rule, probably by early next summer.

If the FDA wins, the toughest restrictions it wrote three years ago, mainly to deny minors access to cigarettes and chewing tobacco, would begin to take effect. But the industry would get another round in the lower courts -- to challenge the specifics of those controls and, in the case of advertising restrictions, to contest their constitutionality.

The industry would promptly ask Congress to take away all FDA power over tobacco products. The tobacco companies don't believe the agency would confine its regulatory power to protecting youths but would move to a more coercive approach affecting adult smokers, too. The industry would try to get Congress to blunt any such effort.

But if the industry wins in the Supreme Court, that would take the FDA out of the tobacco regulation field, removing -- for years to come -- any significant prospect of strong federal regulation of the companies.

In that event, tobacco foes would turn to Congress for help, but an effort to restore FDA authority would probably be doomed on Capitol Hill. Congress refused last year to pass major legislation to control the industry, and tobacco lobbyists remain influential with many lawmakers.

Some limits

Without congressional action, the industry would then have only its labeling controlled by the federal government. Some other limits would exist -- including the ban on billboards and some forms of advertising imposed under the deal the companies made in November 1998 to settle lawsuits by 46 states.

While the industry argues that those limits go far toward protecting children from tobacco and that individual companies are doing more on their own, public health advocates say the industry is not nearly as restricted as it should be -- and would be under the FDA's existing proposals.

If the FDA is out of the picture, the industry might face some limits as a result of pending and future lawsuits against the companies. But those cases tend to be about money alone and probably would not lead to direct controls on industry conduct.

Regulatory reach

The FDA has been enforcing the nation's food and drug law for 61 years. But, for most of that time, it thought it had no power to regulate tobacco products.

In 1991, a small group within the FDA began asking why the agency had left tobacco beyond its reach. As Dr. David A. Kessler, then the FDA's commissioner, recalled recently, the discussion focused on the fact that the FDA "regulates everything else that comes in contact with the body; why not tobacco?"

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