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Is a cigarette still a cigarette if it isn’t just tobacco rolled in paper? The tobacco industry said yes and is beginning to carve out a new market niche for “reduced risk” products. By advertising the potential benefits of the new smokes, cigarette makers are hoping to appeal to smokers worried about their health. And last week’s $145 billion judgment in a Florida class action over the dangers of traditional cigarettes only adds to the industry’s urgency to produce a less risky product. Public health advocates are clamoring for federal regulation of the new products. They argue that the new, “safer” tobacco products such as Eclipse, made by the R.J. Reynolds Tobacco Co., are just as hazardous as the cigarettes that have prompted government and courtroom scrutiny in recent years. For now, all eyes are on the Food and Drug Administration: The American Lung Association and other anti-smoking groups are calling on the agency to crack down, but many observers feel this fight will likely be settled in Congress. “I think the FDA will be very reluctant to get into this issue,” said a government attorney, who doubts the FDA will want to risk losing another tobacco battle in the wake of the U.S. Supreme Court decision earlier this year foreclosing the agency from regulating tobacco. “I think, given the happenings of the past few years, Congress is going to have to decide this issue,” adds Phil Schiliro, press secretary for Rep. Henry Waxman (D-Calif.), who’s been a leader in the fight against Big Tobacco. “I don’t think Congress can do anything this year.” CARBON AND GLASS The Eclipse cigarette is the clearest example of the new territory that tobacco companies are conquering. R.J. Reynolds released Eclipse nationally this spring, claiming that using it instead of traditional cigarettes may reduce a smoker’s chances of getting cancer or emphysema. Eclipse is a slim white stick that looks similar to a Camel or any other cigarette a smoker would pull from a pack. But it’s made of glass and carbon, as well as paper and tobacco, and it produces less smoke than traditional cigarettes. Instead of directly torching shredded and dried tobacco leaves, smokers of Eclipse light a carbon heat source at the tip, which then passes hot air through tobacco and glycerin and into a filter. A small amount of tobacco, about 3 percent of what a normal cigarette uses, is burned in the process. Reynolds estimates it has spent more than $1 billion since the 1980s developing the product. The first efforts to create a reduced-risk cigarette, unveiled in 1988, resulted in a product called Premier. It was a bomb. Customers said it tasted bad, smelled worse, and was too difficult to light or smoke. Reynolds pulled it off the market after just a few months. The FDA never ruled on whether to regulate the product. Eclipse was introduced in 1996 in several small test markets. Reynolds rolled it out nationally in April, a month after the Supreme Court’s ruling in FDA v. Brown & Williamson Tobacco Corp. The public health community has always sounded the alarm about Eclipse. Several scientists published a 1998 study in the Journal of Cancer Epidemiology, Biomarkers and Prevention, saying the glass in Eclipse often breaks, putting smokers at risk of inhaling glass particles. Reynolds insists the conclusions of the study are 100 percent wrong, and that there is no danger. But it is the Eclipse marketing campaign, which started in April, that has incensed the public health community. Eclipse is sold directly to consumers, through a toll-free phone number and a Web site. The company touts Eclipse as a “reduced risk” product, and said it has scientific data to back up the claim. Reynolds’ own studies, reviewed by a scientific panel at the company’s request, say its smoke has 80 percent lower levels of many of the carcinogens in traditional smoke, and produces 46 percent less bronchial inflammation and 36 percent less inflammation of the lower lungs. The American Lung Association sent a letter to the FDA in May, asking it to crack down. The agency said it is reviewing the marketing campaign and “the regulatory status of Eclipse.” Action on Smoking and Health, a long-time tobacco foe, plans to file a formal petition within a month, asking the FDA to assert its authority. “The Eclipse is a bad product,” said Paul Billings, chief lobbyist for the American Lung Association. “If it’s going to be sold, it should have to go through a rigorous approval process like any other drug-delivery device.” What bothers the public health community is that the only information they have on whether a product like Eclipse is safer is from the tobacco companies themselves and they don’t trust the industry to tell the truth. “This product may or may not be better,” said Judy Wilkenfeld, an attorney who specialized in tobacco issues at the Federal Trade Commission and the FDA, who now works for the Campaign for Tobacco-Free Kids. “There is no way we will ever know.” The other fear is that if Reynolds is able to make an unregulated “reduced risk” product, other companies, with more grandiose plans, will follow. Star Scientific Inc. has developed StarCure, a tobacco the company said has significantly lower levels of nitrosamines, a carcinogenic in tobacco. Brown & Williamson has ordered the crop. And Philip Morris is working on Accord, another modified cigarette. Accord is a special tobacco and paper cigarette, which is inserted into a lighter device. The lighter heats sections of the cigarette, but burns little of it. The company said Accord produces less ash and smoke, but it has not made any promises about a safer product. “We have no current plans to make any risk claims related to the Accord because the government has determined there is no such thing as a safe cigarette,” said Philip Morris Cos. spokesman Brendan McCormick. “It may be possible to reduce the risks on certain products. That should be the major effort of any tobacco legislation in Congress.” ECLIPSED BY THE SUPREME COURT But Reynolds said it’s on safe ground. The company argues the feds have no authority over tobacco products, including Eclipse. Though the FTC has undisputed authority to review ads for misleading or deceptive claims, the company believes it is free to make and sell Eclipse as it sees fit unless Congress said otherwise. “The fact of the matter is, the Eclipse is a cigarette,” said Seth Moskowitz, a Reynolds spokesman. “They tried to assert authority over the tobacco companies. The courts have upheld that the FDA has no regulatory authority over the tobacco industry.” Anti-tobacco activists sketch out two strategies for the FDA to use to regulate Eclipse. One is to categorize it as a drug- delivery device, and the other is to contend the ads are actually health claims, which would bring Eclipse under the agency’s jurisdiction. The agency already failed with the drug-delivery-device argument in the Brown & Williamson case. But public health groups say Eclipse is different from traditional cigarettes. They argue that it is a nicotine-delivery device, like the patch or the Nicotrol inhaler, which are regulated by the FDA. Reynolds vehemently disputes that argument. The health-claim line of attack will be just as fiercely contested. Reynolds said it has been careful not to make any health claims. “We are saying that the Eclipse may present smokers with less risk compared to other cigarettes, so we are not saying the Eclipse is a safe cigarette,” Moskowitz said. “These are nontherapeutic claims.” Even attorneys who have long battled the tobacco companies doubt that Eclipse could be regulated under current law. “The Supreme Court said tobacco is tobacco,” said G. Robert Blakely, a professor at University of Notre Dame Law School. “I can’t see how the public health community is right. I think the FDA should have won that decision, but the Court said, ‘No, this is a legislative question.’ “ STAKING A CLAIM TO REGULATION In years past, the FDA has successfully cracked down on certain tobacco products. In 1952, it seized cartons of Fairfax cigarettes. The manufacturer claimed its cigarettes, which contained chlorophyll, prevented diseases such as scarlet fever, whooping cough, and tuberculosis. The FDA also forced Trim cigarettes off the market in the 1950s because they were touted as a cure for obesity. In the 1980s, the FDA shut down the Favor cigarette, a plastic tube out of which smokers sucked nicotine vapor. The FDA never released a pronouncement on Reynolds’ Premier, but those close to the agency say it was seriously considering regulation. Anti-tobacco activists are hoping that the agency will follow this regulatory tradition and take on Eclipse. “I disagree with any statement of Reynolds that this is definitely beyond regulation,” said Mitch Zeller, who recently left his post as head of the FDA’s Office of Tobacco Programs to take a job at the American Legacy Foundation, a tobacco education group. “I am not saying it’s black and white. But there is a credible, colorable legal argument that the claims [about reduced risk] make this product a regulated product.” Nonetheless, many are doubtful the FDA will take on Eclipse. The agency refused to comment. But the fact that Reynolds has been selling the product without interference is seen as a sign. “My suspicion is that if the FDA were going to exert authority, they would have already done so or given indications to that effect,” said Edward Sweda, an attorney with the Tobacco Products Liability Project. In the end, Congress will most likely end up facing the question of whether to police “reduced risk” products. Some of the previous failed tobacco bills attempted to regulate reduced-risk products. In the next Congress, when the public health community hopes a tobacco bill will pass, the question of how to handle products like Eclipse may be an even more important part of the debate. “The Eclipse is a prime example of why FDA regulation is necessary,” said Myers of the Campaign for Tobacco-Free Kids. “It serves as a litmus test as to whether a particular bill is going to do any good.”

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