In a historic shift in public-health policy half a century after the U.S. surgeon general first warned of the lethal dangers of smoking, Congress is poised to give the federal government sweeping new authority to regulate the manufacturing of cigarettes and other tobacco products.
The legislation, long resisted by the tobacco industry, could allow consumers to see for the first time what chemicals and other additives tobacco companies put in their products.
It would empower the Food and Drug Administration to put new limits on harmful ingredients and prohibit tobacco companies from marketing “light” cigarettes.
And it would give the FDA new authority to enlarge warning labels and severely restrict full-color advertising for cigarettes and other tobacco products.
Yet the regulations, which have eluded anti-tobacco advocates for decades, would come with challenges as federal officials are given never-before-used tools to control a product linked to about 400,000 deaths every year in the United States.
Particularly tricky may be keeping up the momentum of the anti-smoking campaign even as regulators try to make cigarettes safer, an effort that could paradoxically make some smokers less inclined to quit.
“We just don’t know what is going to happen,” said Kenneth Warner, dean of the University of Michigan’s School of Public Health, who has studied tobacco use for decades. “This is uncharted territory.”
Nonetheless, the legislation — which has passed the House and is expected to clear the Senate in coming weeks — would effectively end an era in which the tobacco industry was largely exempt from the regulatory scrutiny that has been standard for food, drugs and other consumer products.
The measures also culminate a decades-long campaign by public-health advocates who have chipped away at the industry’s power with taxes, multibillion-dollar lawsuits and state and local limits on where smoking is allowed.
“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 advocate of tougher tobacco regulation. “It would fundamentally change the way tobacco is marketed, advertised and sold in this country.”
In recent years, dozens of states and cities have passed so-called clean-air regulations banning smoking in government buildings, bars, restaurants and other public places.
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This year, Congress passed the largest-ever increase in the federal cigarette tax, boosting it by 62 cents to $1.01 a pack to pay for an expansion of children’s health insurance.
Today an estimated 20 percent of adults in America smoke, down from 42 percent in 1965, a year after the surgeon general’s office issued its first warning about cigarettes.
But the industry has repeatedly 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 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 increase their tobacco intake.
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 in tobacco products and limit addictive nicotine as well as other ingredients and byproducts generated when tobacco products are smoked.
Manufacturers would not be able to introduce new products unless they are reviewed by the FDA and would face new regulations requiring their outdoor advertising and advertising in most retail locations be limited to black and white. Businesses catering only to adults, such as bars, would be exempt.
And the FDA would have the authority to require new warning labels on up to 50 percent of the front and rear panels of tobacco product packaging.
The bills do not permit an all-out ban on nicotine. They also exempt menthol from the flavoring ban.
Lawmakers made additional concessions to the industry by requiring the FDA to consider the economic impact of any new restrictions and giving tobacco companies non-voting representation on a new scientific advisory panel.
Those compromises are not insubstantial, said Stanton Glantz, a longtime 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 end up gaming the regulatory process to enhance the reputation of their products.
Altria — the parent company of industry leader Philip Morris USA, which may have an easier time maintaining its dominance in a more regulated market — has endorsed the bill.
“FDA regulation would provide some clear guidelines for products that could potentially reduce the harm caused by smoking,” said company spokesman William Phelps.
Other manufacturers oppose the legislation.
Several Republican lawmakers have expressed concern that tobacco products will be perceived as safer because they are regulated by the FDA.
There is some risk that could decrease smokers’ motivation to quit, said Dorothy Hatsukami, associate director of cancer prevention and control at the University of Minnesota’s Masonic Cancer Center.
“We have to make sure that we are continuing to educate the public to let them know that even if these products have reduced toxicants, they are still harmful,” Hatsukami said.
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What the bill would do
Under the Family Smoking Prevention and Tobacco Control Act, the FDA would have the authority to:
*Restrict tobacco advertising and promotions, especially to children
*Ban most flavorings in tobacco products
*Require larger, more noticeable health warnings on tobacco products
*Require tobacco companies to disclose the contents of tobacco products and conduct research about the health effects
*Require changes in tobacco products, such as removal or reduction of harmful ingredients
*Prohibit health claims about so-called reduced-risk tobacco products that are not proven or that would discourage tobacco users from quitting
SOURCES: American Lung Association, Congressional Budget Office
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What the FDA regulates
For decades, the tobacco industry has been largely exempt from the federal scrutiny that has been the norm for food, drugs and other consumer products. If the bills become law, that would change, adding the regulation of tobacco to the FDA’s power. Here are some of the agency’s current responsibilities:
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*Food: includes bottled water but excludes meat and poultry
*Drugs: prescription and over-the-counter
*Biologics: products (such as vaccines or blood supplies) used in medicine
*Radiation-emitting electronic products: such as microwave ovens, television receivers, diagnostic X-ray equipment
*Medical devices
*Cosmetics
SOURCE: FDA
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See also related story “Court: Industry made ‘light’ of smoking risks / Long-running case likely headed to Supreme Court” News section, Page 4