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Former FDA head says agency cannot handle tobacco
July 24, 2007 / 5:22 PM / 10 years ago

Former FDA head says agency cannot handle tobacco

WASHINGTON (Reuters) - The U.S. Food and Drug Administration is not prepared to take on tobacco regulation, although a Senate committee is pushing to give the agency that power, former commissioner Dr. Mark McClellan said on Tuesday.

“I think there is some potential for regulation of tobacco. I‘m a little bit nervous about putting it in FDA,” said McClellan, who now co-chairs the Coalition for a Stronger FDA.

The FDA itself, as well as groups such as the Campaign for Tobacco-Free Kids and the American Heart Association, have lobbied for the agency to take on regulation of cigarettes and other tobacco products.

Currently, the tobacco industry is very lightly regulated, with the Department of Agriculture, Federal Trade Commission and Department of Health and Human Services having some input but no overall control over what goes into cigarettes.

Sen. Edward Kennedy, a Massachusetts Democrat, has introduced a bill that would allow the FDA to restrict tobacco advertising, prevent cigarette sales to minors, mandate stronger warning labels, bar misrepresentation of tobacco’s dangers, and order removal of dangerous ingredients from cigarettes.

The Senate Health, Education, Labor and Pensions committee will consider the legislation on Wednesday.

The Supreme Court ruled in 2000 that the FDA had overstepped its authority when it issued unprecedented, sweeping curbs on cigarettes and smokeless tobacco in 1996.

In response, anti-smoking activists and their congressional allies proposed legislation that would give the FDA the power it needed to enforce the regulations. But the legislation has never made it through Congress.

McClellan, appointed by President George W. Bush, said he did not think the FDA was the right agency to regulate tobacco. “Having been at FDA, the agency doesn’t have any staff that’s used to thinking about how do you make an unsafe product relatively more safe,” he told reporters.

McClellan also said the FDA was already stretched too thin. “It has way more to do than it has manpower or resources to do,” he said.

McClellan said tobacco should be better regulated, however.

“Hopefully this discussion in the Senate health committee will help trigger some ideas about a new regulatory structure that could actually work to do it,” McClellan said.

“Hopefully that discussion in committee will be a start of really identifying how, if we’re going to go towards more tobacco regulation, how we can make sure we do it in a way that will lead to improvement in health outcomes, not to more smoking, not to more people thinking this is a safe enough cigarette and things like that,” he added.

“There’s a lot of nervousness at the FDA about being caught in that kind of problem.”

Smoking is the number one preventable cause of death in the United States, leading to 440,000 annual deaths according to the Centers for Disease Control and Prevention.

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