26 Jul 2007

FDA to rule on tobacco

The US Congress is poised to pass a bill that would give the US Food and Drug Administration the authority to regulate tobacco.

But experts are divided on whether the bill, which is expected to be passed, will have significant impact on tobacco use.

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.

The bills would also strengthen bans against tobacco advertising and not allow tobacco manufactures to make false claims or use terms such as "light" and "low tar." They would also ban cigarette sales to minors and strengthen warning labels.

In an amendment added Wednesday, the Senate bill would also require that cigarette packs carry graphic warnings that illustrate the health risks of smoking. The warnings would be similar to those already used in Canada and elsewhere, the Associated Press reported.

Only new products will need approval
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 not have the authority to increase the legal age for buying cigarettes or restrict where cigarettes are sold.

As a result, the proposed legislation has supporters as well as detractors.

"I think the bill is strong, it has the potential to bring about the most fundamental changes in how tobacco products are manufactured and marketed that we have ever seen," said Matthew L. Myers, president of the Campaign for Tobacco-Free Kids. "The bill could provide the FDA authority that could save millions of lives."

No real teeth
But Dr Michael Siegel, a professor at Boston University's School of Public Health, believes the proposed law has no real teeth. "The bill is widely misperceived by the public," he said. "The perception is that this is a bill that's going to save lives by putting the tobacco companies under strict FDA regulation. The reality is that this bill was largely crafted by Philip Morris, who made sure that although the FDA would regulate cigarettes, they wouldn't have a free hand in doing so."

Philip Morris USA, the nation's largest tobacco producer, has about 50 percent of the US cigarette market, including Marlboro, the best-selling brand. The company said it supports the legislation as a way of meeting the goal of FDA regulation called for in a recent Institute of Medicine 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."

We are going to tie your hands
Still, Boston University's Siegel believes the bills have serious shortcomings. "Essentially what the bill does is, it says to the FDA, go ahead and regulate cigarettes, but we are going to tie your hands. And we are going to tie your hands in a way that protects Phillip Morris at the expense of the public's health," he said.

Siegel also thinks the bill could be misinterpreted as conferring FDA approval of cigarettes. "The very idea of putting a deadly product like this under the FDA creates a perceived seal of approval," he said.

Another tobacco company executive agrees with Siegel but for a different reason. John W. Singleton Jr., director of communications at Reynolds American Inc., whose brands include Camel cigarettes, said 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."

To be funded by tobacco companies
Another potential problem with the bill, some critics contend, is that funding for the FDA to oversee tobacco would come from so-called "user fees" paid by tobacco companies, amounting to about $450 million a year. This is the same type of programme that provides FDA funding to offset the costs of approving drugs under the controversial Prescription Drug User Fee Act (PDUFA).

PDUFA has been criticized by public health advocates as creating a cozy relationship between the FDA and the drug industry it regulates.

"This [tobacco] bill will probably have the effect of giving the tobacco companies undue influence over the rule-making process, just as a similar situation has done with drug companies," said Stanton A. Glantz, director of the Centre for Tobacco Control Research and Education at the University of California, San Francisco.

Despite these conflicting views, the American Lung Associations is one of the groups supporting the proposed legislation. "This is something we have been trying to get done for the last decade," said Erika Sward, the association's director of national advocacy. "This is a win for public health."

Sward said the bill alone won't solve the tobacco problem, and that the lung association will have to begin a program to pressure the FDA to act in the public's best interests.

"Our major work will begin once the President signs this legislation," she said. "It is the responsibility of the public health community to make sure that FDA is taking every aggressive step it needs to in reducing the toll tobacco takes." – (HealthDayNews)