Tobacco Documents Online

COMPLAINT SUMMARY The five American cigarette manufacturers and an advertising firm have sued the U.S. Food and Drug Administration and DEivid Kessler, the Commissioner of the Food and Drugs, seeking a judicial declaration that FDA has no authority to regulate cigarettes as drugs, and asking that the court enjoin FDA to withdraw its rulemaking. proceeding to establish such authority. • The plaintiffs are Brown & Williamson Tobacco Corp.; Liggett Group, Inc.; Lorillard Tobacco Co.; Philip Morris Inc.; R. J. Reynolds Tobacco Co. and Coyne-Beahm Inc. The suit was filed in the federal court in the Middle District of North Carolina. In a 32-page complaint, the plaintiffs allege that FDA's action is contrary to Congress's intent to withhold from FDA jurisdiction over cigarettes, is irreconcilable with the existing Federal Cigarette Labeling and Advertising Act and is beyond FDA's authority in the Federal Food, Drug and Cosmetic Act. For 80 years, Congress, the courts and FDA itself have repeatedly affirmed that FDA lacks authority to regulate cigarettes or nicotine in cigarettes, as a drug. The plaintiffs allege that FDA~s initiative has had and will have a significant negative effect on them. While the FDA initiative has no immediate legal effect, FDA's assertion of jurisdiction is its final determination. Accordingly, the plaintiffs are seekinci judicial review at ttria time.