In Shift, FDA Says It Could Classify Nicotine as a Drug
In a major policy reversal, the Food and Drug Administration Friday asserted its authority to classify nicotine as a drug--a move that could lead to regulating or even banning virtually all cigarettes. But the agency urged Congress to provide clear direction on what it should do.
In a letter to anti-smoking advocates, FDA Commissioner David A. Kessler all but accused the tobacco industry of stoking a public addiction, citing “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, Kessler noted, “it could have dramatic effects on our society.”
“A 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?”
Kessler’s comments came in a letter to 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 Assn., the American Lung Assn. 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,” Ballin said.
The tobacco industry disagreed. “Cigarettes are not addictive,” said Brennan Dawson, a spokeswoman for the Tobacco Institute. “And if Congress were to consider this, it would be a very hotly debated topic.”
Rep. Henry A. Waxman (D-Los Angeles), chairman of a House Energy and Commerce subcommittee on health, said 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, Waxman said, “the FDA is going to have only one option: ban cigarettes,” since the FDA cannot approve a drug that is known to be unsafe.
A less drastic approach, he said, may be for the government to regulate the level of nicotine in cigarettes and other tobacco products.
Waxman said he plans to hold hearings on the question.
Rep. Mike Synar (D-Okla.), who has been pushing the FDA for years to regulate cigarettes, said Kessler’s position should add new impetus to a bill that he, 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.”
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. 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 proved 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, 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.”
Kessler also cited research showing that “77% of smokers desire to quit but cannot primarily because of nicotine addiction.”
“Although technology was developed years ago to remove nicotine from cigarettes and to control with precision the amount of nicotine in cigarettes,” Kessler said, “cigarettes are still marketed with levels of nicotine that are sufficient to produce and sustain addiction.”
Kessler’s letter came just days before the scheduled airing of an investigation by ABC-TV’s “Day One” program alleging that the tobacco industry has “for years” added extra nicotine to cigarettes to enhance their addictive qualities.
But an FDA official said the timing of Kessler’s letter was a coincidence. “We did it when the letter was finally in shape,” the official said, adding that he has been aware of the developing legal strategy for nearly a year.
Despite his tough words, Kessler said the agency would defer to Congress on whether to regulate cigarettes, noting: “Given the widespread use of cigarettes and the prevalence of nicotine addiction, such a regulatory action could have dramatic effects on society,” including, he said, the potential emergence of a black market.
“We recognize that the regulation of cigarettes raises societal issues of great complexity and magnitude,” Kessler said. “It is vital in this context that Congress provide clear direction to the agency.”
