Tobacco Documents Online

AUGUST 10, 1995 CONTACT: (212) 907-5830 FOR IMMEDIATE RELEASE TDBACCQ INDUSTRY FILES SUIT AGAINST FDA. KESSLER PI'aintiffs Describe FDA Action as Trojan Horse; Reab Intent Is Regulation of Industry, Adult Choice NEW YORK -The five U.S. cigarette manufacturers and a North Carolina advertising agency today filed suit against the Food and Drug Administration and Commissioner David Kessler, charging that the agency cannot reach beyond its statutory authority to assert jurisdiction over cigarettes. The suit asks the court to prevent the FDA from taking any action to regulate cigarettes and to order that the proposed regulations be withdrawn because they are illegal_ The FDA actiort defies decades of Congressional and FDA declarations that the agency has rro jurisdiction over tobacco products, said Si:eve Parrish, Philip Morris Companies Inc. senior vice president of Corporate Affairs, speaking on behalf of the industry. Parrish said the action also violates the First and Fifth Am endments to the U.S. Constitution arid the federal Cigarette Labeling and Advertising Act. The suit was filed after Kessler initigted a rule-making procedure to regulate nicotine in cigarettes as a drug and cigarettes themselve:c as devices that deliver nicotine, a position that Parrish characterized as "absurd" and one that defies comrrrorr sense. "David Kessler is trying to sneak through the back door because Congress has repeatedly slammed shut the front door on the issue of regulating cigarettes under the same law the FDA applies to products sold for therapeutic or medicinal purposes," Parrish said. "Kessler's action can only be described as a Trojan Horse, set forward under the guise of preventing youth smoking, a goal everyone :::.ares," Parrish said. "Make no mistake; the real hidden agenda here is prohibition." Parrish said despite Commissioner Kessler's stated intertion to address only youth smoking issues, a letter dated Feb. 25, 1994, indicates more ominous intent.

That letter by Commissioner Kessler states that, "A strict application of these provisions could mean, ultimately, removal from the market of tobacco products containing nicotine at levels that cause or satisfy addiction. Only those tobacco products from which the nicotine had been removed or, possibly, tobacco products approved by FDA for nicotine-replacement therapy would then remain on the market`" Parrish said everyone agrees with President Clinton's position that kids should not smoke, and the President was right when he said Wednesday that government alone could not solve this problem. "But of all the many options available to deal with the issue of youth smoking, the Administration has approved a course of action that opens the door for unelected federal bureaucrats to radically restrict the right of adults to choose to smoke, and the right of cigarette companies to market and sell a product enjoyed by neariy 50 million Americans," Parrish said. "The FDA is simply the wrong government entity with the wrong legal mandate, and years of congressional and court decisions say exactly that. "David Kessler and the anti-smoking cabal would have the American public believe that cigarettes are an unregulated product. Nothing could be further from the truth. "Nine federal government agencies, including the Federal Trade Commission and the Justice Department, oversee various facets of the tobacco industry. But in each of those cases, oversight has been granted by Congress, and Congress has never delegated the authority to regulate cigarettes to the FDA," Parrish said. Parrish also said the FDA's action ignores the affirmative steps tobacco companies have taken and continue to take to prevent youth from smoking. Those steps include educating and assisting retailers in complying with state minimum age laws; providing parents with materials to helc) educate their children; sponsorship of in-school educational programs on resisting peer pressure to smoke; and the adoption of voluntary marketing and advertising codes that prohibit marketing cigarettes to youth. Kessler "has started a process that reaches far beyond his statutory mandate. It usurps both the authority and repeated directions of Congress and the courts. It even contradicts long-held policies of the FDA itself," said Charles A. Blixt, R.J. Reynolds Tobacco Co. senior vice president and general counsel. "We believe the law is clear and we believe the intent of Congress is clear: that the FDA has no jurisdiction over cigarettes," said Blixt said. s "The American public sent very clear instructions to Washington last November: 1. .- as citizens, we want less government and less regulation in our daily lives. And

we want government to start adding some simple common sense into its decision-making process," said Joe Helewicz, Brown and Williamson Tobacco Corp. vice president of Corporate Communications and Administration. The suit was filed by Brown & Williamson Tobacco Corporation, Liggett Group Inc., Lorillard Tobacco Company, Philip Morris Incorporated, R.J. Reynolds Tobacco Company and Coyne-Beahm Incorporated in U.S. District Court for the Middle District of North Carolina. The suit contends that Kessler's action "is an unprecedented and unlawful effort to extend its regulatory reach far beyond its statutory manclate and usurp the authority of Congress." The suit further contends that, since cigarette manufacturers make no claim that their products have any therapeutic value, the FDA cannot lawfully assert jurisdiction. Because no therapeutic health claims have been made by the plaintiffs, "time after time, for more than 80 years, the FDA and its predecessors have informed Congress that cigarettes are beyond the scope of the Fooc, Drug and Cosmetic Act," Parrish said. Parrish also said that, in amending the Act nearly 70 times, Congress has never overruled or nullified FDA's long-standing interpretation that it lacks jurisdiction over cigarettes. Congress has specifically considered 20 bills to give FDA jurisdiction - each time recognizing that FDA does not have that authority and each time failed to pass the legislation that would have given FDA that authority. "This proposal for FDA regulation opens a Pandora's box of legal issues which endangers the ability of the agencyito meet its real legal responsibilities and threatens the legal rights of all Americans," Parrish said. "Our suit is based on the fact that Congress never intended to give any government bureaucrat the options Commissioner Kessler has tried to create for himself," Parrish added.