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Chances Bright for Legislation Seeking FDA Regulation of Tobacco

By Lyndsey Layton
Washington Post Staff Writer
Monday, May 11, 2009

After 15 years of debate, tens of millions spent on lobbying and a roller-coaster legislative history, public health advocates say they believe Congress is finally ready to regulate tobacco -- and their opponents privately agree.

This week, a Senate committee will take up its version of a bill that passed the House by a comfortable margin last month. Supporters say they have more than the 60 votes needed to make the legislation filibuster-proof when it reaches the Senate floor sometime after Memorial Day.

The sponsors, Rep. Henry A. Waxman (D-Calif.) and Sen. Edward M. Kennedy (D-Mass.), with help from party leaders, have pushed the legislation onto a fast track. And President Obama, himself a smoker who has struggled to quit, has said he intends to sign the bill -- a reversal from President George W. Bush, who sought to kill it.

The legislation would give the Food and Drug Administration broad powers over the manufacturing and marketing of tobacco, a product used by 20 percent of Americans yet largely unregulated.

The very idea of tobacco regulation strikes some as nonsensical: Take a product that, if used as directed, will kill a third of those who use it and place it under the control of an agency charged with protecting public health. But advocates say FDA oversight is the best hope for reducing the 400,000 deaths each year from tobacco use.

"If this happens, and if the FDA uses its powers, it will be an enormous public health achievement," said Matthew L. Meyers, president of the Campaign for Tobacco-Free Kids, who has been pushing the legislation for 15 years.

For the first time, the $89 billion tobacco industry would have to disclose the ingredients in its products. Under the measure, the FDA could ban the most harmful of the estimated 6,000 chemicals used in cigarettes, cigars and other tobacco products. And it could reduce the amount of nicotine, perhaps to a point where tobacco is no longer addictive and smokers who want to quit can break free more easily. The bill stops short of allowing the FDA to ban tobacco or reduce the amount of nicotine to zero.

The legislation would require tobacco companies to expand the size of warning labels from 30 percent to 50 percent of the package. The Senate bill mandates that graphic images of the health effects of tobacco consumption be included.

Advertising and promotion would be restricted. Tobacco manufacturers would be unable to use the terms "light," "mild" and "low" unless they can scientifically prove that the product so labeled is less harmful than standard tobacco. The bill would also create a tobacco center within the FDA funded by fees from the industry that are estimated to reach more than $500 million annually by 2013, according to the Congressional Budget Office.

The FDA first tried to regulate tobacco in the 1990s, but the industry battled it to the Supreme Court, which ruled 5 to 4 in 2000 that the agency had exceeded its statutory authority. It called on Congress to amend the law.

But during that legal battle, the political climate surrounding the issue shifted rapidly enough that by the time the Supreme Court rendered its decision, a curious thing had happened: Philip Morris, the maker of Marlboro and the largest tobacco company in the country, said it would accept some government oversight.

At the time, Philip Morris executives were charting a strategy to improve the company's image and regain the social acceptance it had lost in the 1990s as congressional hearings, court cases and suits by state attorneys general unearthed evidence that tobacco companies lied to the public about the addictive nature of nicotine. In late 2001, Philip Morris changed its name to the Altria Group; executives said they wanted to craft a new image untainted by cigarettes. They also embraced federal oversight as a way to convince the public that Altria was socially responsible, according to internal company documents.

William Phelps, a spokesman for Altria, said the company thinks FDA approval will help Altria market new products that are less dangerous to the health. Altria recently acquired U.S. Smokeless Tobacco; is testing "snus," a new line of "spit-free" smokeless tobacco products; and recently opened a $350 million research facility in Richmond to develop products that pose lower health risks.

Sen. Mike Enzi of Wyoming, the top Republican on the committee that will discuss the bill, said he wants to see some kind of legislation on tobacco but is opposed to the Kennedy measure. "It makes me leery when a tobacco company is backing this," he said. "Nothing changes in it without Philip Morris's approval."

Some public health professionals are also skeptical.

"I'm a little suspicious of anything that Philip Morris supports," said Richard Hurt, a doctor who directs the nicotine-dependence program at the Mayo Clinic. "I haven't known Philip Morris to do anything in the interest of public health."

Altria's competitors also oppose the bill. They say Altria is backing it because restrictions on marketing tend to freeze market shares, which would lock Philip Morris into the top spot.

Sen. Richard Burr (R-N.C.), whose state is home to R.J. Reynolds Tobacco and Lorillard Tobacco, has threatened to filibuster the Kennedy bill. He and Sen. Kay Hagan (D-N.C.) have proposed an alternative bill that would promote "reduced risk" tobacco products instead of restricting cigarettes.

David J. Adelman, a tobacco analyst for Morgan Stanley, said FDA regulation was not likely to hurt the industry's overall profits, unless the agency demands so many changes in tobacco products that consumers no longer want to smoke them. He said the bill could squeeze out small companies because they are less able to afford the process involved to get a new product approved for the market.

Lobbying activity surrounding the bill is intense. In the first quarter of 2009, Altria spent $4.29 million to make its case regarding this bill and a couple of other pieces of tobacco legislation, according to federal lobbying records. Its chief rival, Reynolds American, owner of R.J. Reynolds, spent $1.59 million in that period. Lorillard, the third-largest tobacco maker, paid lobbyists $850,000 in the first three months, records show. The Campaign for Tobacco-Free Kids, meanwhile, spent $157,000 during that period.

"I think a lot of people want to get something on the books to begin the process of regulation," said Hurt of the Mayo Clinic. "The tobacco companies are still wildly successful. They still have 43 million smokers, and they're not going to give them up easily. Only time will tell whether this is a mistake or the beginning of reducing the tobacco toll in this country."

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