| 3/22/00
11:10 a.m. Kessler Control It's surprising this lawless gambit went as far as it did. By Jacob Sullum Mr. Sullum is a syndicated columnist and senior editor at Reason magazine. |
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Probably no one was more surprised by this than Kessler himself, who stepped down as the FDA’s commissioner in 1997 and is now the dean of Yale Medical School. In 1994, when he first suggested that the FDA might have jurisdiction over cigarettes, he worried that the Food, Drug, and Cosmetic Act would force the agency to ban them. "It is vital in this context that Congress provide clear direction to the agency," he said in a letter to Scott Ballin, then chairman of the Coalition on Smoking or Health. "We intend therefore to work with Congress to resolve, once and for all, the regulatory status of cigarettes under the Food, Drug, and Cosmetic Act." After the Republicans took control of Congress that fall, however, Kessler decided that congressional guidance wasn’t so important after all. In 1995 the FDA proposed regulations that classified cigarettes as medical devices and imposed sweeping restrictions on tobacco advertising, promotion, and sales. By implausibly lumping cigarettes with pacemakers and hearing aids, the FDA hoped to gain some regulatory leeway. But the law still required the FDA to provide "reasonable assurance of safety and effectiveness" — something it obviously could not do for cigarettes. The fact that cigarettes did not fit into the regulatory framework established by the Food, Drug, and Cosmetic Act was strong evidence that Congress never wanted the agency to regulate them. "If tobacco products were within the FDA’s jurisdiction," the Supreme Court observed, "the Act would require the FDA to remove them from the market entirely. But a ban would contradict Congress’ clear intent as expressed in its...tobacco-specific legislation," which has always been based on the assumption that cigarettes would remain legal. Then, too, over the years Congress has repeatedly rejected legislation that would have granted the FDA authority over cigarettes, and until 1994 the agency itself consistently said it did not have such authority in the absence of explicit health claims by cigarette manufacturers. Kessler tried to justify his reversal by citing "mounting evidence" of nicotine’s addictiveness. To anyone familiar with the history of smoking, Kessler’s sudden discovery of tobacco’s habit-forming potential was puzzling. "It struck me that Kessler should get an Emmy," Alan Blum, founder of the anti-smoking group Doctors Ought to Care, told me. "It’s either extremely dishonest, or it’s more than extremely naive." Given Kessler’s willingness to twist the law in the service of his anti-smoking crusade, the former explanation seems closer to the mark. |