FDA asks for help from Congress to regulate cigarettes as drugs.

A recent statement by U.S. Food and Drug Administration (FDA) Commissioner David Kessler citing evidence that tobacco companies deliberately keep addictive levels of nicotine in cigarettes has sparked new interest in Congress in regulating cigarettes as drugs. In a letter sent to an antismoking group in February, Kessler said that although the FDA already has the authority to regulate tobacco products, the agency wants "clear direction" from Capitol Hill on how to go about doing it.

The letter, sent to the Washington, D.C.-based Coalition on Smoking OR Health, prompted a series of congressional hearings and staff briefings on the issue. Lawmakers are considering a bill sponsored by Rep. Mike Synar (D-Okla.) that would regulate the manufacture, labeling, sale, distribution, and advertising of tobacco products (H.R.2147).

In his letter, Kessler expressed concern that under the current drug-regulation law, which requires manufacturers to prove that their products are safe, the FDA could be forced to ban cigarettes that contain nicotine. "Given the widespread use of cigarettes and the prevalence of nicotine addiction, such a regulatory action could have dramatic effects on our society," he wrote. A representative from Synar's office told congressional

staffers at a March briefing that his bill would provide a way to regulate cigarettes without requiring their removal from the market.

The FDA in the past has declined to regulate cigarettes. The Food, Drug, and Cosmetic Act authorizes the agency to regulate products that manufacturers intend to be used as drugs--those meant "for therapeutic or diagnostic use or to affect the structure or function of the body," Kessler wrote.

"[C]igarette vendors have in the past been given the benefit of the doubt as to whether they intend cigarettes to be used for this purpose, because some people smoke for reasons other than the drug effect," he added.

But he said the agency has been accumulating evidence that tobacco companies deliberately produce cigarettes with addictive levels of nicotine. "This evidence . . . suggests that cigarette vendors intend the obvious--that many people buy cigarettes to satisfy their nicotine addiction," Kessler w rote. If confirmed, this finding would give the FDA a legal basis for regulating cigarettes as drugs, he said.

Thomas Lauria, a representative of the Tobacco Institute, an industry group, disputed Kessler's statements. "We utterly disagree" that cigarette makers manipulate nicotine content to keep smokers hooked, he said. He also rejected the conclusion that nicotine is addictive. "We have no idea what their evidence is," Lauria said.

At the briefing, Dr. John Slade of the St. Peter's Medical Center in New Brunswick, New Jersey, pointed to a 1988 Surgeon General's report that identified nicotine as the addictive agent contained in cigarettes. l he report concluded that nicotine addiction is much like ad diction to heroin or cocaine. Slade also cited polls showing that most smokers want to quit, adding that few succeed on the first try.

"The tobacco industry obviously has been skirting the law for some time to the detriment of the public health," said Scott Ballin, chair of the Coalition on Smoking OR Health and vice president of the American Heart Association. The coalition--which comprises the heart association, the American Cancer Society, and the American Lung Association--has been urging the FDA to regulate cigarettes as drugs since 19X8.

Ballin agreed with Kessler that regulation designed to wean people from their nicotine addiction is preferable to an outright ban on cigarettes. "There are 45 million addicted people out there," he said. "Saying that tomorrow there will be no nicotille in cigarettes is not the way to go."

The Senate is considering its own version of the tobacco-regulation bill (S. 672), sponsored by Jeff Bingaman (D. -N.M.).