Breathing easy
Should the government regulate the safety of tobacco products? Who would benefit most?
In 1994, Philip Morris President William Campbell testified before Congress that he "strenuously" objected to the idea that nicotine is an addictive drug. That was not even 10 years ago. Today, the same company willingly concedes that tobacco is both addictive and harmful.
At a congressional hearing earlier this month, Mike Szymanczyk--the current CEO of Philip Morris--actually requested federal oversight of tobacco by the Food and Drug Administration, once considered the industry's nemesis. "Regulation needs to focus on how we can reduce harm to society," he said.
The turnaround comes with a new crop of products from the tobacco industry, which claim to reduce the health risks of smoking. These products include cigarettes that may have lesser amounts of cancer-causing compounds as well as gadgets that electrically heat tobacco instead of burning it, cutting down on the harmful chemicals released in cigarette smoke. Antismoking advocates have long argued for FDA oversight of tobacco, and Congress is considering legislation that would grant the FDA that authority. But health officials are concerned that products meant to lessen the risks of tobacco could have untoward consequences for public health. "Here are products that theoretically have less toxins," says Jack Henningfield, an addiction expert at Johns Hopkins University. "But if it is used by someone who otherwise wouldn't have used tobacco or if it keeps a smoker from quitting, then the harm to the public could increase."
Wariness. History has taught public-health experts to be wary of so-called safer tobacco products. The most glaring example has been "light" or low-tar cigarettes, which were introduced to smokers in the 1960s. Close to 90 percent of smokers eventually switched from their traditional brand of smokes to the lighter products, which many thought would pose fewer dangers to their health. But a report released two years ago by the National Cancer Institute showed that smokers tend to compensate for the modifications, either by inhaling more deeply to get more nicotine or by covering holes placed in filters that are meant to allow more clean air into the lungs. As a result, disease rates have not declined as expected. "It took more than 20 years to conclude that smokers who switched to light cigarettes did not reduce their lung cancer risk," says Scott Leischow, chief of the Tobacco Control Research Branch at NCI. "The light cigarette experience taught us valuable lessons that we should not repeat in the future."
One of those lessons is that tobacco companies cannot be trusted to make truthful statements to the public about their products, says William Corr, executive director of the Campaign for Tobacco-Free Kids in Washington. "The people who switched to light or low-tar cigarettes were the ones who were most concerned about their health," he says. "In fact, the tobacco companies knew all along that their products weren't safer." Last March, a judge in Illinois fined Philip Morris $10 billion for misleading consumers in its ads for light and low-tar cigarettes. The judge found that Philip Morris knew that smokers would alter their smoking behavior to achieve higher levels of nicotine and that some brands, including Marlboro Lights, contained more hazardous components than regular Marlboro cigarettes. The company is removing the words "lowered tar and nicotine" from the packaging of its light cigarettes, says Brendan McCormick, senior manager of media affairs for Philip Morris.
The newer "reduced risk" products purport to have fewer amounts of various toxins. Smoke from tobacco contains a complex array of about 4,000 chemicals, including heavy metals, arsenic, lead, cyanide, and other contaminants. Brown & Williamson Tobacco is currently test-marketing Advance Lights, which are cigarettes with a special filter that the company says lowers the amount of toxins that reach the smoker. The brand also contains "flue-cured" tobacco, from a process that uses "a combination of high-temperature and high-speed airflow that inhibits the formation of tobacco-specific nitrosamines, some of which are categorized as carcinogens," according to a written statement from the company.
Healthy innovations? Philip Morris and R. J. Reynolds Tobacco have products that heat rather than burn tobacco in order to create a minimal amount of smoke. Philip Morris is test-marketing Accord, a product that is "about the size of a tape recorder, maybe a little smaller," says Jack Nelson, the company's president of operations and technology. A special cigarette is inserted into the battery-operated gadget and a computer chip detects when the smoker is taking a puff. It then heats a portion of the tobacco. "The cigarette doesn't continue to burn," he says. Accord "controls the temperature so it . . . reduces virtually everything in the smoke chemistry that is considered to be harmful, at least that we can measure."
But questions have been raised about R. J. Reynolds's version, which is called Eclipse. The product is smoked like a cigarette, although the tobacco is heated rather than burned. In an April 2000 news release, the company said Eclipse "may present smokers with less risk of cancer, chronic bronchitis, and possibly emphysema, when compared to other cigarettes." But a study commissioned by the Massachusetts Department of Public Health found that Eclipse produced as much, if not more, of cancer-causing toxins as two comparative ultralight brands of cigarettes. The study also found that Eclipse released higher levels of carbon monoxide, a leading cause of cardiovascular disease in smokers. RJRT spokesperson Carole Crosslin says the company does not believe that valid scientific conclusions can be drawn from the study.
Disputes like this highlight the need for government regulation of this new generation of tobacco products, experts say. "It is not that these products are inherently bad," says Johns Hopkins's Henningfield. "But right now we're in the worst days of the snake-oil salesmen," where even public-health officials don't know what to believe, let alone the average consumer. Corr of Tobacco Free-Kids says that smokers who are addicted to nicotine are especially vulnerable to marketing messages that claim to reduce the health risks of smoking. "There is enormous potential on the part of smokers to change their behavior if they think it will be better for their health," he says.
It is up to Congress to pass legislation that will grant the FDA the authority to regulate reduced-risk and conventional tobacco products. In 2000, the Supreme Court turned down the FDA's bid to regulate cigarettes as medical devices, asserting that Congress would have to extend the FDA's jurisdiction before the agency could intervene. There are currently two competing proposals to broaden the FDA's authority. One, which is supported by the public health community, was introduced by Sens. Ted Kennedy, a Massachusetts Democrat, and Mike DeWine, an Ohio Republican, last year. The other, crafted by Rep. Tom Davis, a Republican from Virginia, gives the tobacco companies more leverage to resist the FDA's attempts to rein in their manufacturing and promotional activities. It is this version that Philip Morris favors.
Both proposals follow the counsel of the Institute of Medicine, which two years ago supported federal regulation of safer tobacco products. "With appropriate and comprehensive research, surveillance, education, and regulation, these products could possibly reduce the risk of tobacco-related disease," says Robert Wallace, vice chairman of the committee charged with writing the report. He says regulation should focus on disclosure of product ingredients, toxicity testing, oversight of marketing and promotional health claims, and surveillance of the products' use once they are on the market.
Consumers could benefit from FDA regulation of reduced-risk tobacco products, if only because they will no longer have to rely solely on the tobacco companies for information. But the companies themselves stand to gain enormously from federal oversight, says Richard Daynard, chairman of the Tobacco Products Liability Project at Northeastern University School of Law. The courts could view FDA regulation as grounds for pre-emption: That is, if a product meets the standards set by the government, the company can't be sued for selling something dangerous. Moreover, if smokers choose to smoke conventional cigarettes, the companies would be able to argue they had offered a choice. "Before, juries were sympathetic because people were addicted," says Daynard. "Now, they can say, `You should have switched so it's your own fault.' "
This story appears in the June 23, 2003 print edition of U.S. News & World Report.