FDA close to gaining oversight of tobacco

WASHINGTON — In a historic shift in public-health policy, Congress is poised to give the federal government sweeping new authority to regulate the manufacture of cigarettes and other tobacco products.

The legislation, long resisted by the tobacco industry, could allow consumers to see what chemicals and other additives tobacco companies put in their products. It would empower the Food and Drug Administration (FDA) to put new limits on harmful ingredients and prohibit tobacco companies from marketing "light" cigarettes.

It also would give the FDA new authority to enlarge warning labels and severely restrict full-color advertising for cigarettes and other tobacco products.

The change would bring challenges along with the promise of federal control over a product linked to approximately 400,000 deaths every year in the United States.

Particularly tricky might be keeping up the momentum of the anti-smoking campaign even as regulators try to make cigarettes safer, an effort that paradoxically could make some smokers less inclined to quit.

The bill effectively would end an era in which the tobacco industry was largely exempt from the regulatory scrutiny standard for food, drugs and some other consumer products.

The Senate on Tuesday voted 84-11 to consider the bill, a month after the House overwhelmingly passed a similar measure giving the FDA authority to regulate cigarettes and other tobacco products.

Sixty votes were needed to open debate, and the success in reaching that threshold increase the likelihood that the Senate will move to a final vote by the end of the week or early next week. If the House concurs with the Senate measure, it would go to President Obama, who is ready to sign it into law.

"This would be the most significant change in the federal government's approach to tobacco in history," said Matthew Myers, president of Campaign for Tobacco-Free Kids, a leading national advocate for tougher tobacco regulation. "It would fundamentally change the way tobacco is marketed, advertised and sold in this country."

Dozens of states and cities have passed so-called "clean-air" regulations banning smoking in government buildings, bars, restaurants and other public places. Earlier this year, Congress passed the largest increase ever in the federal cigarette tax, boosting it by 62 cents, to $1.01 a pack, to pay for expanding children's health insurance.

Today, an estimated 20 percent of U.S. adults smoke, down from 42 percent in 1965, a year after the U.S. Surgeon General's office issued its first warning about the dangers of cigarettes.

But the industry repeatedly has dodged more stringent limits, including basic regulation of what is in tobacco products. Tobacco companies went to court in the late 1990s to block a Clinton-administration initiative to give the FDA regulatory authority over tobacco.

"If you look at a box of macaroni and cheese, you can see what kind of dye has been used. All the ingredients are scrutinized to determine whether they are dangerous to consumers' health," said Gregg Haifley, a senior lobbyist for the American Cancer Society Cancer Action Network. "Not so tobacco. It has remained virtually the only unregulated consumable product in America."

Public-health advocates say that has allowed companies to advertise "light" and "mild" cigarettes as safer alternatives when, in fact, the products still contain harmful additives and induce many users to intensify their smoking.

Under the legislation moving through Congress — sponsored by Rep. Henry Waxman, D-Calif., and Sen. Edward Kennedy, D-Mass. — the FDA would have the power to prohibit such claims.

The agency also would be able to ban most flavorings — menthol still would be allowed — in tobacco products and place limits on nicotine and other ingredients and byproducts generated when tobacco products are smoked.

Manufacturers would not be allowed to introduce new products without having them reviewed by the agency and would face new regulations on outdoor and retail advertising, limiting it to black and white. Businesses catering only to adults, such as bars, would be exempted.

The FDA would have the authority to require new warning labels covering as much as 50 percent of the front and rear panels of tobacco-product packaging.

The bills do not permit an all-out ban on nicotine. Lawmakers made concessions to the industry by requiring the FDA to consider the economic effect of any new restrictions and giving tobacco companies nonvoting representation on a new scientific-advisory panel.

Those compromises are not insubstantial, said Stanton Glantz, a tobacco-control advocate who heads the Center for Tobacco Control Research and Education, at the University of California, San Francisco. "One thing one learns from dealing with tobacco companies is that the devil is in the details."

Glantz is among a handful of public-health advocates who fear that tobacco companies will use the regulatory process to enhance the reputation of their products.

Several Republican lawmakers have expressed concerns that tobacco products will be perceived as safer because they are regulated by the FDA.