Scientists Warn Against Rapid Reduction of Nicotine Levels

A high-powered group of independent scientists urged the Clinton administration Wednesday to take a cautious approach in regulating nicotine, warning that dramatic reductions in its levels in cigarettes could have adverse, unintended public health consequences.

The scientists, who were called in to help the administration review a pending $368.5-million settlement with tobacco companies, stressed that if the government lowered nicotine levels precipitously, it might increase cigarette consumption and prompt smokers to inhale more deeply. That, in turn, would increase the risk of heart disease, cancer and other illnesses attributable to smoking.

A provision of the pending settlement that would make it difficult for the Food and Drug Administration to reduce nicotine levels has been heavily criticized by President Clinton, numerous legislators and public health advocates.

On Wednesday, the scientists said that although they believe the FDA needs full authority to regulate the cigarette industry, there are no easy answers in the effort to reduce smoking and that it is more complicated than simply reducing nicotine levels.

“The industry is positioning nicotine as the poster child of product regulation so they can avoid talking about other issues . . . “ said Dr. John Slade, chairman of the American Society of Addictive Medicine’s nicotine committee.

Slade said considerably more attention must be paid to reducing carcinogens in cigarettes, a goal he said Japanese cigarette makers have shown is clearly possible.

Lynn T. Kozlowski, a professor of Bio-Behavioral Health at Penn State University, said some smokers are operating on the mistaken assumption that several types of cigarettes described as “light” are safer than other brands. He said that the FDA needs more power to assess and regulate the claims made by the industry about such cigarettes.

All six researchers who participated in the 90-minute meeting have written scholarly papers about various aspects of smoking. Some pressed administration officials to make it easier for smokers to obtain nicotine in ways other than smoking.

“Cigarettes are the most deadly form of nicotine delivery ever developed,” said Kenneth E. Warner, a professor at the University of Michigan School of Public Health. But, Warner said, it’s easier now for people to obtain cigarettes than alternative products, such as Nicorette.

In effect, the government currently favors the “distribution and marketing of the dirty forms” of nicotine, Warner said. The FDA should look into ways to permit smokers “at least some options whereby they might be able to get nicotine without inflicting such severe damage on themselves” with cigarettes, he added.

After the session, Bruce Reed, Clinton’s domestic policy advisor, estimated it would take the administration about a month to complete its review of the proposed tobacco settlement. In addition to reiterating Clinton’s objections to the settlement’s restrictions on the FDA, Reed indicated that the administration may push for stiffening provisions in the pact that now would impose penalties of up to $2 billion a year on the industry if smoking by minors is not reduced within five years.

Among other things, the settlement would fund a $500-million-a-year anti-smoking campaign and provide $25 billion in research funds. The industry also would accept severe marketing and advertising restrictions. In return, 40 state lawsuits and 17 private class-action suits against the industry would be settled. In addition, class-action suits or Medicaid recoupment suits of the type filed by the 40 states against the industry would be barred in the future.

Secretary of Health and Human Services Donna Shalala scoffed when a reporter suggested that administration officials already have decided to embrace the broad outlines of the agreement and would suggest only minor changes.

“It’s absolutely incorrect to say we generally agree with it. . . . We haven’t made our final decision yet,” Shalala said.

She added it has become clear that the government needs a “much more sophisticated strategy” toward tobacco regulation.

In order to formulate such a strategy, the scientists said it was essential for the government to obtain all of the tobacco companies’ internal research documents on nicotine and smoking’s impact on health.

“Hardly a month goes by that we’re not surprised” by some new revelation about what the industry knows, said Jack E. Henningfield, a former leading researcher at the National Institute of Drug Abuse who is now a professor at Johns Hopkins. He said the industry had “buried and was trying to keep buried” considerable research it conducted abroad, including studies of nicotine dose levels, filters and reduction of toxins in cigarettes.

In a related development, a group of Democratic senators and congressmen introduced legislation aimed at limiting tobacco use abroad, particularly by children.

The measures would require U.S. cigarette makers to place warning labels in the language of the country to which they are exporting their products. The bills also would prevent U.S. trade representatives from threatening to impose sanctions on countries that have advertising bans on tobacco products, so long as the bans are applied to both domestic and foreign producers.

“It is particularly important that we move on this issue now because of the proposed settlement,” said Sen. Ron Wyden (D-Ore). “Under that agreement, tobacco companies would be forbidden from sponsoring an auto race here in the U.S., but could sponsor a contest--as one already has--to see which kid could smoke the most cigarettes simultaneously in Africa.”

He added: “The only thing ‘global’ about this settlement is that it gives the tobacco companies the rest of the globe.”