Pubdate: Thu, Dec 2, 1999 Source: International Herald-Tribune Page: 6 Copyright: International Herald Tribune 1999 Contact: http://www.iht.com/ Author: Joan Biskupic, Washington Post Service HIGH COURT FINDS FLAWS IN CASE AGAINST TOBACCO Doubts Cast on U.S. Agency's Effort to Regulate By WASHINGTON - The Supreme Court appeared highly skeptical Wednesday of the Food and Drug Administration's proposal to regulate nicotine in cigarettes as a drug. During one of the most vigorous oral arguments at the court in months, the justices suggested by their questions that they were almost certain to invalid ate the agency's effort, to exert control over a product that medical experts consider a primary cause of preventable disease and death. Justices across the ideological spectrum focused on several flaws in the federal government's argument, notably that the agency had for decades said it lacked authority over tobacco; and that the agency regulates items intended to make people healthier, and cigarettes arguably do the opposite. "It just doesn't fit," Justice Sandra Day O'Connor said of the agency's 1996 assertion of authority and proposed rules to restrict the marketing and sale of tobacco products to young people. The case began three years ago when the agency declared that it could regulate the nicotine, in cigarettes and smokeless tobacco products under the 1938 Food, Drug and Cosmetic Act. That law gives the agency jurisdiction over drugs and devices "intended to affect the structure or any function of the body. " The action marked a decisive moment for the government in its struggle to address tobacco's ills and to stop people from becoming addicted. But after the proposed regulation was challenged by tobacco companies, a federal appeals court in Virginia ruled that the agency lacks authority over tobacco. The appeal Wednesday of that case pitted two leading advocates, Solicitor General Seth Waxman, for the Food and Drug Administration, and Richard Cooper, for Brown and Williamson and the other tobacco companies that sued the agency. Mr. Waxman contended that the agency sought to regulate nicotine as it does other substances that are addictive or act as a stimulant or sedative. He asserted at one point that tobacco is the only ingested product "regulated and inspected by no agency and yet is so dangerous." Many of the justices suggested they thought the agency could only regulate drugs deemed to be safe. Chief Justice William Rehnquist challenged Mr. Waxman's claim that it was only in the 1990s that the agency found the scientific evidence that cigarettes were addictive and seriously affected the body. He referred to the surgeon general's report and other findings in earlier years about cigarettes' harms. For his part, Mr. Cooper contended that Congress never intended to delegate authority over-cigarettes but rather sought to regulate them through a series of tobacco-specific statutes, for example, one governing package labeling. He also emphasized that cigarette makers do not promise certain health effects about their products, as do the manufacturers of other drugs and items that the agency is charged with overseeing. "The FDA comes in when there is a claim of a health benefit," Mr. Cooper said. - --- MAP posted-by: Eric Ernst