Asserting that nicotine is a drug, FDA says it could ban cigarettes

February 26, 1994|By Los Angeles Times

WASHINGTON -- In a major policy reversal, the Food and Drug Administration asserted yesterday its authority under existing law to regulate and even ban virtually all cigarettes, but it urged Congress to provide clear direction on what the agency should do.

All but accusing the tobacco industry of stoking a public addiction, FDA Commissioner David A. Kessler cited % 5/8 accumulating evidence that nicotine content in cigarettes is being manipulated for that very end -- thus making cigarettes, in effect, a drug that falls under FDA jurisdiction.

If the agency eventually reached such a formal finding, Dr. Kessler noted, "it could have dramatic effects on our society."

strict application of these provisions could mean, ultimately, removal from the market of tobacco products containing nicotine at levels that cause or satisfy addiction," he said.

An FDA spokesman added: "The real bottom line is: We and the Congress need to address this issue and determine whether or not we are to regulate cigarettes. Is this in fact what the public will is?"

Dr. Kessler's comments came in a letter to an anti-smoking group, the Coalition on Smoking OR Health, which for years has urged the FDA to regulate cigarettes as a drug.

"We are surprised, but very pleased," said Scott D. Ballin, chairman of the coalition, which is composed of the American Heart Association, the American Lung Association and the American Cancer Society.

"The tobacco industry is in the drug business. We know it. People who are desperately fighting their addiction to nicotine know it. And now the FDA knows it," he said.

The tobacco industry disagreed.

"Cigarettes are not addictive," said Brennan Dawson of thTobacco Institute. "And if Congress were to consider this, it would be a very hotly debated topic."

Rep. Henry A. Waxman, D-Calif., chairman of a House Energand Commerce Committee's subcommittee on health, said Dr. Kessler's position will "require us to do a lot of thinking and force Congress to figure out a more rational scheme for handling tobacco."

Unless Congress acts, "the FDA is going to have only one option: ban cigarettes," since the FDA cannot approve a drug that is known to be unsafe, Mr. Waxman said.

A less drastic approach, he said, may be for the government to regulate the level of nicotine in cigarettes and other tobacco products.

Mr. Waxman said he plans to hold hearings on the question.

Rep. Mike Synar, D-Okla., has been pushing the FDA for years to regulate cigarettes. He said Dr. Kessler's position should add new impetus to a bill that he, Mr. Waxman and more than 40 other members of Congress have sponsored to give the FDA "explicit jurisdiction to regulate the advertising, promotion, labeling and content of tobacco without banning it from our society."

Dr. Kessler's letter capped a week in which the tobacco industry took some major hits.

On Wednesday, McDonald's Corp. announced that, effective immediately, its 1,400 corporate-owned fast-food outlets will ban smoking and encourage its franchisees to do the same.

On Thursday, Dr. M. Joycelyn Elders, in the surgeon general's annual report on smoking, sternly warned young people that "tobacco addicts and it kills."

The industry is further under siege because President Clinton's health care reform agenda proposes to raise the federal cigarette tax by 75 cents per pack, up from the current 24 cents.

Cigarette smoking has been proven to contribute to heart disease, strokes and a variety of cancers and respiratory ailments. Health officials blame smoking for an estimated 434,000 deaths annually.

In recent years, as anti-smoking measures have proliferated at local levels, public interest groups have stepped up their pressure on the federal government to take aggressive action.

But until now, Washington has done little to heed those calls, with previous FDA commissioners adamantly refusing to assume jurisdiction over tobacco.

In his letter, which seeks to navigate a potential legal minefield, Dr. Kessler said cigarettes can be regulated as a drug because )) of "accumulating [evidence] that suggests that cigarette manufacturers may intend that their products contain nicotine to satisfy an addiction on the part of some of their customers."

Dr. Kessler also cited research showing that "77 percent of smokers desire to quit but cannot primarily because of nicotine addiction."

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