The federal agency charged with keeping food and drugs from harming Americans may soon be asked to take a consumer product that kills more than 400,000 people a year and make it safer.
The product is the cigarette - generally acknowledged as anything but safe. Smoking accounts for nearly one in five deaths in the United States.
That toll can be reduced, tobacco foes say, and they point to a bill widely expected to pass a key Senate committee Wednesday as the tool to make it happen.
The legislation would give the Food and Drug Administration the same authority over cigarettes and other tobacco products that the regulatory agency already has over countless other consumer products. It is an authority the Supreme Court ruled in 2000 that the FDA does not have. But neither is it something the agency necessarily wants, according to past comments by FDA commissioner Dr. Andrew von Eschenbach.
The bill would allow the FDA to regulate the levels of tar, nicotine and other harmful components of tobacco products. Cigarette smoke contains more than 4,000 chemicals, more than 40 of which are known to cause cancer.
New products would need FDA approval before they could be sold, according to the legislation. It also would authorize the FDA to set national standards for cigarettes and other tobacco products to control how they are made, as well as force the disclosure of their ingredients, including compounds and additives, and in what quantities. That, supporters claim, should help expose and ultimately limit the ways cigarettes are engineered to the detriment of the public's health.
"If the FDA only prevented tobacco companies from manipulating their products to make it easier to start and harder to quit, it will make a major contribution to reducing the number of people who die," said Matthew Myers, president of the National Center for Tobacco-Free Kids, a supporter of the legislation, which has faltered in previous Congresses.
No one among those for or against the Senate bill, mirrored by matching legislation in the House, believes it could result in a safe cigarette. There is consensus that there is no such thing. But those against the bill maintain it could create that impression.
"It would still be a deadly product. They are not going to make it a safe product by taking out particular smoke constituents. The problem is the public is going to perceive the product is safe because the FDA has assumed jurisdiction," said Dr. Michael Siegel, a Boston University School of Public Health professor.
But advocates say the bill would at a minimum give the FDA the authority to go where the scientific evidence takes it and only then make decisions based on that science to reduce the harm caused by tobacco.
"There is a broad range of actions that the FDA potentially could take, some of which we understand now and some we can only see dimly," said the University of California, San Diego's Dr. David Burns, scientific editor of several surgeon general's reports on tobacco. "To say that there's nothing we can do is nihilistic in thinking and inconsistent with science."
The bill also would keep tobacco companies from tinkering with their products in ways that would make them any more dangerous, supporters add.
"The tobacco industry would not be allowed to manipulate the ingredients - like increase nicotine or decrease nicotine or whatever they do - without disclosing it. The bill would put the burden of proof on industry to demonstrate to the FDA that what they're doing would not be more harmful," said M. Cass Wheeler, chief executive officer of the American Heart Association.
When asked for some likely targets that regulators could tackle, Centers for Disease Control and Prevention chemist David Ashley rattled off more than a half dozen compounds in tobacco and smoke that worry scientists, even though it's unclear just how beneficial removing or reducing their levels would be. They include:
- Nitrosamines, a potent carcinogen. The burley tobacco used in American cigarettes is especially high in nitrosamines.
- Acetaldehyde, a potential carcinogen that may make tobacco more addictive. It's produced when sugars, added to tobacco, are burned.
- Cadmium and lead, two heavy metals that are toxic. Their levels generally depend on the environmental conditions where the tobacco was grown.
The elegance of the bill, Myers said, is it would not dictate to the FDA how to proceed.
"This bill wisely doesn't try to predict what a cigarette will look like once FDA begins to take action. Instead, it says to the scientists at the FDA, 'You have the power to require changes in tobacco products in whatever ways you believe,"' Myers said.
But Ashley, an expert in the constituents of tobacco and tobacco smoke, cautions that cigarettes are a very complex product, and have traditionally changed with time as manufacturers tinker with them.
"One problem from a scientific standpoint is the product changes so often but the health effects are long-term. The cigarettes people are smoking today aren't the cigarettes of 10 years ago," Ashley said, adding: "It's hard to link a change in the products to a particular health end point because there's nothing you can get your hands around."
Another expert called the task of figuring out how to reduce tobacco's harm basic "bread-and-butter stuff" for the FDA.
"This is what they do all the time: develop performance criteria for products," said Jack Henningfield, an addiction expert and former tobacco researcher at the National Institute on Drug Abuse. That in turn would act as an incentive for tobacco companies to create products that are less harmful, he added.
As for the FDA, commissioner von Eschenbach said recently he wouldn't want his agency put in the position where it had to determine a cigarette is safe.
Nor would it appear that the agency could approve any new cigarette, even if it were purportedly safer, under the legislation, said Sen. Richard Burr, who opposes the bill.
"It's an impossible pathway to understand at an agency tasked with a mission that is to prove safety and efficacy," said Burr, adding that could keep any new reduced-harm tobacco product from coming on the market.
Philip Morris USA, maker of Marlboro, America's top-selling cigarette brand, supports the bill. R.J. Reynolds Tobacco Co. and others oppose the legislation, saying its restrictions on advertising would help cement Philip Morris' No. 1 market position.