FDA could get new control over tobacco
In a historic shift in public health policy, 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 victory, which eluded anti-tobacco advocates for decades, comes with challenges as well as promise, as federal officials are given never-before-used tools to control a product that is still linked to approximately 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 E. Warner, dean of the University of Michigan’s School of Public Health who has studied tobacco use for decades. “This is uncharted territory.”
Altria Group Inc. -- the parent company of industry leader Philip Morris, 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,” company spokesman William Phelps said.
Other manufacturers oppose the legislation.
The bill, 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 bill also culminates 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 L. Myers, president of Campaign for Tobacco-Free Kids, a leading national 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. Earlier this year, Congress passed the largest ever increase in the federal cigarette tax, boosting it 62 cents to $1.01 a pack, to pay for expanding children’s health insurance.
Today, an estimated 20% of adults in America smoke, down from 42% in 1965, a year after the U.S. surgeon general’s office issued its first warning about the dangers of 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 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 A. Waxman (D-Beverly Hills) and Sen. Edward M. Kennedy (D-Mass.) -- the FDA would have the power to prohibit such claims.
The agency also would be able to ban most flavorings -- menthol would still be allowed -- in tobacco products and place limits on 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 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.
And the FDA would have the authority to require new warning labels on as much as 50% of the front and rear panels of tobacco product packaging.
The bills do not permit an all-out ban on nicotine. Lawmakers made additional concessions to the industry by requiring the FDA to consider the economic impact of any new restrictions and giving tobacco companies nonvoting representation on a new scientific advisory panel.
Those compromises are not insubstantial, said Stanton A. Glantz, a longtime tobacco control advocate who heads the Center for Tobacco Control Research and Education at UC 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.
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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Tobacco regulation
1964: The surgeon general issues a landmark report linking smoking to lung cancer.
1965: Warning labels are mandated on cigarette packs stating, “Caution: Cigarette smoking may be hazardous to your health.”
1969: Cigarette advertising is banned on TV and radio.
1979: Smoking is restricted in all federal buildings in the United States.
1990: Smoking is banned on all U.S. commercial airline flights.
1994: Mississippi becomes the first state to sue the tobacco industry to recover costs for tobacco-related illnesses.
1998: The tobacco industry agrees to pay $206 billion, which will help fund anti-tobacco programs, as part of a settlement agreement with 46 states.
2000: U.S. Supreme Court rejects a Clinton administration effort to give the Food and Drug Administration authority to regulate tobacco.
2009: Congress approves the largest-ever increase in the federal cigarette tax, boosting it 62 cents, to $1.01 a pack.
Source: Office of the Surgeon General
