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Senate bill gives FDA power over tobacco

The tobacco-control movement celebrated another milestone yesterday as the U.S. Senate easily passed a bill giving the government unprecedented power over the making and marketing of tobacco products.

The tobacco-control movement celebrated another milestone yesterday as the U.S. Senate easily passed a bill giving the government unprecedented power over the making and marketing of tobacco products.

Supporters say the law will enable the Food and Drug Administration to protect children from the addictive lure of cigarettes, make tobacco products safer, and, ultimately, save some of the 400,000 lives lost annually to tobacco-related illness.

"For four or five decades, tobacco companies have preyed on our children . . . knowing they'd get addicted at a young age," said Richard J. Durbin of Illinois, the Senate's second-ranking Democrat. Now "Joe Camel will be given a life sentence and put away forever."

But like every victory in the decades-long battle to curb the tobacco industry, the latest one comes with limitations, compromises, and inherent conflicts. Even many antismoking activists doubt the law will have the intended public-health impact.

"I don't think the bill, in and of itself, will reduce the health burden of tobacco," said Phillip Gardiner, research administrator for the Tobacco-Related Disease Research Program at the University of California. "I see it as another tool in our tool chest."

Others worry that the FDA, already stumbling under its vast responsibility for ensuring the safety of food and drugs, is making an unholy alliance.

"It's sort of like asking the police commissioner to regulate prostitution," said John Cohn, a lung-disease specialist at Thomas Jefferson University Hospital in Philadelphia. "And I don't know whether it's worth distracting the FDA from its fundamental role."

Under the law, the FDA will establish a tobacco-control center funded by fees on the industry that are expected to reach $500 million annually by 2013.

'Low tar,' etc.

Tobacco companies will have to disclose their product research and ingredients - secrets previously revealed only in court cases - and seek approval for new products. The FDA will publish an annual list of harmful ingredients by brand and can ban the most dangerous of the estimated 6,000 chemicals in cigarettes, except nicotine, the key to addiction. Nicotine, the bill says, can only be reduced.

"Light," "low tar," and other labeling that implies reduced health risks will be prohibited unless studies prove the claims. And package warning labels will be enlarged, possibly including graphic photos of tobacco-related organ damage.

Among safeguards aimed at youngsters, cigarette flavoring will be banned, except for menthol. Many African American smokers choose menthol cigarettes, which studies have shown intensify inhalation and addiction.

"Menthol cigarettes were included in previous versions of the bill," said Jennifer Ibrahim, a tobacco-control researcher at Temple University. "Banning mentholated cigarettes was not politically feasible because the tobacco companies did not want that."

Still, the bill had huge support, passing 79-17, and drawing yes votes from all six area senators.

'Miracles still happen'

The House has passed a similar bill. President Obama, a smoker who quit and has struggled not to backslide, has vowed to sign the bill, unlike former President George W. Bush, who opposed FDA regulation.

Among the measure's die-hard champions was Sen. Edward M. Kennedy (D., Mass.), who was not on Capitol Hill because he is being treated for brain cancer. "Miracles still happen," he declared in a statement. "The United States Senate has finally said no to Big Tobacco."

Senate opponents, led by Republican Richard Burr of North Carolina, a prime tobacco-growing state, said that the FDA was not the appropriate watchdog and that its oversight would deter the development of less-harmful products.

The FDA first tried to regulate tobacco as a drug in the early 1990s, but the industry sued. It fought all the way to the Supreme Court, which ruled 5-4 in 2000 that the FDA had no authority to control tobacco products unless Congress changed the law.

A turning point came in 2001 when Philip Morris U.S.A., the nation's largest tobacco company, broke industry ranks and said it saw the wisdom of "reasonable" government oversight. Rivals R.J. Reynolds Tobacco and Lorillard Tobacco have long opposed FDA regulation.

Yesterday, the Altria Group, parent company of Philip Morris, said the legislation, though not perfect, was an important step.

It "would establish a regulatory structure and standards for the manufacturing and marketing of tobacco products that should provide important benefits to adult consumers for many years to come," the company said in a statement.

Although the bill is a watershed, it will not have an immediate effect. The FDA has one to five years to issue rules, depending on the provision. Rules for reporting product ingredients, for example, could take two years and won't immediately be imposed on small manufacturers.

Gardiner of the Tobacco-Related Disease Research Program speculated that tobacco companies may wage another legal battle over some of the provisions.

"They love to go to court," he said of the $89 billion industry. "They have all the money in the world."

But the courts - of law and of public opinion - have been turning against tobacco.

In 1998, in the biggest civil settlement in U.S. history, the tobacco industry agreed to pay $206 billion to settle Medicaid lawsuits brought by the states. Across the country, municipalities and states including Philadelphia and Pennsylvania have banned smoking in public places. About 20 percent of Americans smoke, half the rate of the 1970s.

And last month, in a novel Racketeer Influenced and Corrupt Organizations case, a federal appeals court found the industry guilty of a conspiracy to defraud consumers about the dangers of smoking.

The RICO conviction underscored the quandaries the FDA will face as it tries to work with and against Big Tobacco, activists say. For example, the FDA must create a Tobacco Products Advisory Committee to review scientific evidence and make recommendations. Three of the panel's 12 members will be from the industry, although they won't have voting rights.

"How can the FDA expect convicted racketeers to be on an advisory committee?" asked Bronson Frick, associate director of Americans for Nonsmokers' Rights. "It would be like having mob bosses on a Justice Department task force on organized crime."

Matthew Myers, president of the Campaign for Smoke-Free Kids, which has lobbied hard for the new law, took the long view.

"You can stay with the status quo, with industry controlling the level of nicotine in products - no one knows how much - and companies deciding what health claims to make. Or you can give control to an agency with a history of scientific expertise in regulating products. This fills an important gap."