David A. Kessler, former commissioner of the Food and Drug Administration, first suggested that his agency might have jurisdiction over tobacco products in February 1994. At the time, Rep. Henry Waxman (D-Calif.), then chairman of the House Subcommittee on Health and the Environment, told the Los Angeles Times that, without action by Congress, "the FDA is going to have only one option: ban cigarettes." Kessler seemed to agree, saying, "It is vital in this context that Congress provide clear direction to the agency."
But after the Republicans took control of Congress, Kessler decided the FDA could act on its own. By regulating tobacco products as medical devices instead of drugs, he sought to avoid the strict safety and efficacy standards that cigarettes could not possibly meet. Yet last April, after a federal judge ruled that the FDA's claim of jurisdiction was reasonable, the Associated Press reported that Waxman "said the ruling could open the door to an outright ban."
Phil Schiliro, Waxman's press secretary, says his boss, a vocal critic of the tobacco industry, does not favor that outcome, and "Congress won't let it happen. That creates a bigger problem than we have now." But he notes that the medical-device provisions the FDA wants to apply to cigarettes say the agency's regulations are supposed to provide "reasonable assurance of safety and effectiveness." The FDA maintains that there is enough wiggle room to keep cigarettes on the market, but Schiliro concedes that "reasonable people can disagree about whether they have the discretion or not....You could see an argument where they would say, 'We have no choice but to ban this.'" In the end, he says, Congress will have to tell the FDA how to regulate cigarettes. So Kessler had it right the first time.