Tobacco

FDA Head: 'No' to Tobacco

Cigarettes too "inherently dangerous" for agency to regulate; would "undermine mission"

WASHINGTON -- The head of the federal Food & Drug Administration (FDA) said that his agency should not be required to regulate tobacco, but that it is open to some expanded role in the fight against smoking, reported The Courier-Journal.

Dr. Andrew von Eschenbach, the FDA commissioner, did not attend the hearing Wednesday on legislation to authorize his agency to determine how tobacco products should be made, marketed and sold, said the report.

But in a statement sent to the House Energy & Commerce Committee's Subcommittee [image-nocss] on Health, von Eschenbach said: Associating the agency with the approval of these inherently dangerous products would undermine the agency's mission.

He added that the legislation would not give the FDAwhich is responsible for such things as pharmaceutical safetyadequate money to establish a new regulatory structure for tobacco and that the bill sets unrealistic deadlines to make progress against smoking.

But Representative Henry Waxman (D-Calif.), the bill's sponsor, said the FDA is best suited to regulate tobacco. It has the scientific expertise, is familiar with tobacco issues and would be given enough resources, he said. It's really remarkable that a cigarette is subject to less regulation than a lollipop, he said. We have a moral obligation to do better.

Tobacco-state lawmakers worry about the effect FDA regulation might have on local economies. No tobacco companies or grower groups testified, the report said.

In his statement, Von Eschenbach essentially was reiterating objections to the legislation he first aired in Marchwith a slight twist, the paper said. He added this time that the FDA is open to considering other roles for the agency, if appropriate. Let me assure you that FDA is committed to joining you and other government and private organizations in efforts to minimize the devastating effects caused by tobacco use in a manner consistent with the agency's mission.

Von Eschenbach, an oncologist and three-time cancer survivor, did not elaborate on what role he believes the agency can play. FDA spokesperson Kimberly Rawlings would not expand on the statement for the paper.

Rep. Frank Pallone Jr. (D-N.J.), chairman of the subcommittee, told the Courier-Journal that he did not know why von Eschenbach did not appear.

Several Republican members of the subcommittee voiced objections to the bill. Rep. Michael Burgess (R-Texas), a doctor and former smoker, said FDA regulation of tobacco would be a waste of taxpayer dollars. Smoking is inherently harmful and should be fought in other ways, he said. Why we need the FDA to weigh in on this is a mystery to me, Burgess said.

Rep. Ralph Hall (R-Texas) said the FDA legislation appeared to be an expansion of the federal government and contains user fees that are taxes by another name.

The fees to pay for the FDA regulation would be imposed on the tobacco companies. It would work out to about 2.5 cents per pack, the report said.

The FDA is responsible for ensuring the safety of food products, cosmetics and pharmaceuticals. That's just the problem, said Dr. Alan Blum, director of the University of Alabama Center for the Study of Tobacco & Society. By having to promulgate health and manufacturing standards for cigarettesthe FDA will be communicating the perception that cigarettes are now safer to smoke, Blum told lawmakers.

Despite Blum's and von Eschenbach's concerns, there is no other agency better suited to regulate tobacco, said Richard Bonnie, a University of Virginia professor and chairman of the Institute of Medicine's Committee on Reducing Tobacco Use. Bonnie's committee concluded earlier this year that the death toll from smoking would continue at more than 400,000 annually well into this century. It is time to change course, he said.

According to the report, several witnesses testified that the tobacco companies still are attempting to lure children into smoking, using ads that glamorize cigarettes. Their corporate survival depends on addicting our young people, said Dr. Fred Jacobs, commissioner of the New Jersey Department of Health & Senior Services.

William Corr, executive of the Campaign for Tobacco-Free Kids, said the companies are changing advertising and marketing strategies constantly to improve their product's appeal to youths. That's why it's imperative that the FDA have the authority on an ongoing basis to evaluate and regulate advertising to protect public health, Corr said.

The hearing was the first in the House since the legislation was proposed early this year, the report said. No vote has been scheduled on the bill.

The Senate Health, Education, Labor & Pensions Committee has passed its own version of the bill, but the full Senate has not acted. So far, 200 House members have signed on as co-sponsors of the legislation. The Senate measure has 55 co-sponsors, said the report.

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