From Our 2007 Archives

Congress Starts Hearings on FDA's Control of Tobacco

By Steven Reinberg
HealthDay Reporter

WEDNESDAY, Oct. 3 (HealthDay News) -- As Congressional hearings on the issue got underway Wednesday, the chief of the U.S. Food and Drug Administration reiterated his opposition to a proposed bill granting the agency oversight over tobacco products.

The Family Smoking Prevention and Tobacco Act may be well-intentioned, said Dr. Andrew C. von Eschenbach in a statement released to meeting attendees, but "the bill could undermine the public health role of FDA."

The agency is charged with regulating goods that promote the public health, he noted, but the new bill "would ask us to apply this framework to tobacco products that, when used as intended, produce disease rather than promote health," von Eschenbach said. "FDA cannot 'approve' a tobacco product in this context, because there is no scientific context to determine benefit to outweigh the numerous risks."

In fact, "we are concerned that the public will believe that products 'approved' by the Agency are safe and that this will actually encourage individuals to smoke more rather than less," the former oncologist said.

Von Eschenbach also voiced concerns that the agency simply does not have the resources, either in money or skilled workers, to take on a new "tobacco center."

Wednesday's hearings on Capitol Hill on whether the U.S. Food and Drug Administration should regulate tobacco have certainly relit a long-smoldering debate.

Those on both sides of the issue remain divided on whether the bill will impact tobacco use, blamed for killing some 436,000 Americans a year, or almost one in every five deaths.

Overall, 200 sponsors have lined up to support legislation pending in the House, including Rep. John Dingell, (D-Mich.), chairman of the House Energy & Commerce Committee's Subcommittee on Health, which is hosting this week's hearing.

The bill also has the support of 55 senators and more than 500 public advocacy groups, according to Mathew L. Myers, president of the nonprofit Campaign for Tobacco Free-Kids.

"The hearings are the next step for a bill that is gaining momentum and bipartisan support," said Myers.

One of the bill's more surprising backers: Philip Morris USA, the nation's largest tobacco producer, which controls about half of the U.S. cigarette market, including Marlboro, the nation's bestselling brand.

The company has said it supports legislation as a way of meeting the goal of FDA regulation that was called for in a recent U.S. Institute of Medicine (IOM) report.

"These bills provide the framework for comprehensive FDA regulation of tobacco products and provide important policy solutions to many of the complex issues involving tobacco products," Howard Willard, Philip Morris USA's executive vice president of corporate responsibility, said in a prepared statement. "FDA regulation, as introduced in Congress, would be the most effective way to address the Institute of Medicine's concerns."

Philip Morris's support is the prime reason longtime antismoking crusader Stanton A. Glantz -- the director of the Center for Tobacco Control Research and Education at the University of California, San Francisco -- said he is not supporting the new bill.

"I remain skeptical of the bill, because it's basically going to benefit Philip Morris," Glantz said. "I think that the FDA should have control over tobacco, but not on terms that Philip Morris wrote. I think that the people who are supporting this bill will live to regret it."

Other tobacco companies have lined up against the bill.

John W. Singleton Jr., director of communications at Reynolds American, Inc., whose brands include Camel cigarettes, said that the bill would protect Phillip Morris's market share, in part, by limiting advertising.

"If you make it more difficult to communicate with smokers, and you have half the market, it results in the market share getting locked in," Singleton said. "If you get locked in at 50 percent [like Philip Morris], that's pretty good. The bill gives Phillip Morris a competitive advantage."

Singleton is also concerned about how the FDA would actually regulate tobacco products and the chemicals they contain should the bill become law. "These details aren't clear, and they would need to be worked out," he said.

Identical bills in the House of Representatives and the Senate would grant the FDA the same authority over tobacco that it has over drugs, medical devices and many foods. The bill would allow the agency, which has come under fire in recent years for its monitoring of the drug industry, to regulate the levels of tar, nicotine and other harmful ingredients in cigarettes and smoke. That smoke contains some 4,000 chemicals, more than 40 of which are known to cause cancer.

The bills would also strengthen bans against tobacco advertising and bar tobacco manufacturers from making false claims or use terms such as "light" and "low tar" to describe products. They would also ban cigarette sales to minors and strengthen package warning labels.

The Senate version of the bill would also require that cigarette packs carry graphic warnings illustrating the health risks of smoking.

However, the bills would not require FDA approval of tobacco products already on the market -- only new products would need FDA approval before they could be sold to consumers. In addition, the FDA would have no authority to increase the legal age for buying cigarettes or restrict where cigarettes might be sold.

Still, the hearings themselves are good news, said M. Cass Wheeler, CEO of the American Heart Association.

"We cannot continue to allow the tobacco industry to oversee its own products. That makes as much sense as the three little pigs giving the big bad wolf the keys to their homes," Wheeler said in a statement released Wednesday. "With more than 400 Americans dying each day from cardiovascular diseases caused by smoking, we cannot waste another minute in giving the Food and Drug Administration the authority to regulate the tobacco industry."

SOURCES: Stanton A. Glantz, Ph.D., director, Center for Tobacco Control Research and Education, University of California, San Francisco; Mathew L. Myers, president, Campaign for Tobacco-Free Kids, Washington, D.C.; John W. Singleton Jr., director, communications, Reynolds American Inc.; Oct. 3, 2007, statement, American Heart Association; Oct. 3, 2007, statement, Andrew C. Von schenbach, Commissioner, U.S. Food and DRug Administration

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