FDA Wins Unprecedented Power to Regulate Tobacco

The Senate has voted to give the government extensive new powers to decide how tobacco companies will make and market their products. Supporters say that could spare millions from smoking addiction and premature death.

Photo by: Ellie Van Houtte Tobacco

The legislation would for the first time give the Food and Drug Administration legal authority to regulate and order changes to tobacco products in the interest of public health. Thursday's vote was 79-17.

FDA authority over tobacco has long been a goal of anti-smoking advocates who say it could reduce an annual toll of 400,000 tobacco-related deaths. The House has passed its own similar version, and a resolution of differences would send it to President Barack Obama, who supports it.

"It is a lifesaving act for the millions of children who will be spared a lifetime of addiction and premature death," Sen. Edward Kennedy, D-Mass., said in a statement. Kennedy, now being treated for brain cancer, has long pushed for legislation to give the Food and Drug Administration legal authority to regulate how cigarettes and other tobacco products are made and sold to some 40 million smokers.

Supporters see the bill as a milestone in the anti-smoking effort comparable to the 1964 surgeon general's warning that smoking causes lung cancer, the 1990 banning of smoking on planes and the 1998 settlement in which the tobacco industry pledged the states $206
billion to help fund anti-tobacco campaigns.

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"This moment has been coming for 20 years," said Sen. Dick Durbin of Illinois, the Senate's second-ranking Democrat. "We're going to be able to protect millions of children and Americans from deadly tobacco-related disease."

The House already passed a similar bill, and resolution of relatively minor differences would send it to President Barack Obama. Unlike former President George W. Bush, who fought previous FDA regulation bills, Obama supports it.

Congress has been trying to exert government controls over tobacco, one of the few consumable products not regulated by the FDA, for more than a decade. That effort became more imperative after the Supreme Court, in a 5-4 ruling in 2000, ruled that the FDA did not have the authority to oversee tobacco products under current law.

The bill would allow the FDA to require changes to nicotine yields and other chemicals in cigarettes and other tobacco products, although it could not ban nicotine. It would require tobacco companies to provide detailed lists of ingredients and any changes in those ingredients.

The bill would ban the use of expressions such as "light" and "mild" that might mislead people into thinking there was less health risk in the product.

The FDA also would have the power to restrict tobacco marketing; require pre-market approval of all new tobacco products; ban candied or flavored tobacco products that anti-smoking groups see as a way to entice young people into smoking; limit ads in publications with significant teen readership; and impose stronger warning labels on cigarette packages.

A new FDA office would be financed through a user fee paid by tobacco companies, based on their share of the market. Earlier this year, Congress raised the federal cigarette tax, by 62 cents to $1.01, to help pay for expansion of a federal health program for children.

Opponents, led by Republican Sen. Richard Burr of the tobacco-growing state of North Carolina, argued that the FDA, which is in charge of ensuring the safety of food and drug products, was the wrong place to regulate an item that is injurious to health. Burr also contended that the bill would restrict tobacco companies, including several based in
his state, from developing new products that might be less harmful to users. He unsuccessfully proposed the creation of a new agency that would both regulate tobacco products and encourage efforts to make cigarettes less harmful.

Anti-smoking groups, however, predicted the legislation could have a real effect in cutting into the 3,500 young people who smoke cigarettes for the first time every day, the 40 million Americans who smoke and the $100 billion in annual health care costs related to treatment of
tobacco-related illnesses.

Tobacco use is the single most preventable cause of death in the country, with some 400,000 a year dying from tobacco-related diseases.

Some 87 percent of all lung cancer cases are attributable to smoking, said Dr. Douglas W. Blayney, president of the American Society of Clinical Oncology. "To reverse this trend, the FDA must be able to step in and regulate these deadly products," he said.

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