FDA Chief: Tobacco Rules Could Backfire

The Associated Press
Tuesday, March 6, 2007; 10:08 PM

WASHINGTON -- Government regulation of tobacco could backfire by leading smokers to light up more often and inhale more deeply, the Food and Drug Administration chief said Tuesday.

In an interview with The Associated Press, Dr. Andrew von Eschenbach said that if the FDA reduced nicotine levels in cigarettes, people would change their smoking habits to maintain current levels of the addictive drug. Bipartisan legislation introduced last month would give the FDA broad regulatory authority over tobacco and its ingredients, including nicotine.

"We could find ourselves in the conundrum of having made a decision about nicotine only to have made the public health radically worse. And that is not the position FDA is in; we approve products that enhance health, not destroy it," said von Eschenbach, a urologic surgeon and oncologist who was confirmed as FDA commissioner in December.

A nicotine expert said von Eschenbach's fears may be unfounded. Dr. Neal Benowitz of the University of California, San Francisco, said a small study sponsored by the National Cancer Institute _ which von Eschenbach once led _ suggested gradually reducing nicotine levels doesn't force smokers to compensate by smoking more or inhaling more deeply. In fact, Benowitz said, a gradual reduction can wean smokers from the habit.

And a backer of the legislation said von Eschenbach misunderstood its thrust: "The bill gives the FDA the authority to adjust nicotine levels _ if doing so is demonstrated to save lives," said Matthew Myers, president of the Campaign for Tobacco-Free Kids. "The status quo is the tobacco industry decides how much nicotine and other toxic substances are in tobacco products."

In 1996, the FDA moved to regulate tobacco. The Supreme Court ruled in 2000 that Congress had not authorized the agency to do so. Von Eschenbach said repeatedly that the issue of regulating tobacco is a complex one.

"What I don't want to see happen is that we are in a position where we are determining that a cigarette is safe," he said, while acknowledging smoking kills more than 400,000 Americans a year. He later suggested regulation wasn't the solution.

"We have the opportunity to take a very important comprehensive, public health approach to this problem. And it's not a matter of giving FDA regulation or authority. It's a matter of addressing the public health problem that's before us," von Eschenbach said.

The newly introduced bill would let the FDA act to discourage children from starting smoking and to encourage adults to quit, in part by reining in advertising, bolstering existing sales restrictions and strengthening warning labels. It also would let the FDA order the elimination or reduction of harmful and addictive ingredients in tobacco. The agency couldn't ban nicotine outright, but the bill would give the FDA the power to reduce nicotine levels.

"The Bush administration has consistently undercut public health efforts to effectively regulate tobacco products and reduce youth smoking. In that context, this latest statement by an administration official is no surprise," said Sen. Edward Kennedy, D-Mass., a co-author of the Family Smoking Prevention and Tobacco Control Act.

In an hourlong interview with AP reporters and editors, von Eschenbach repeatedly said the FDA doesn't need more regulatory authority. When asked if the FDA needed more money, he suggested the agency needs to look at "enhancing our efficiencies, maximizing our outputs for the dollar invested on part of the American people."

Von Eschenbach used a racing metaphor to describe his vision of the FDA's role as a regulatory agency: Its guidelines, regulations and policy are like guardrails that rigidly hem in a speedway that the agency has worked to clear of speedbumps, he said.

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© 2007 The Associated Press