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Smokeless yearning for FDA guidance

 
By John Reid Blackwell
Richmond Times-Dispatch
Monday, April 9, 2007
 
 
Smokeless-tobacco manufacturers can't claim that their products are less risky than cigarettes. Making health claims about tobacco products will get them yanked off the market by federal regulators.

But smokeless makers would like to be able to do that, and regulation of the tobacco industry by the Food and Drug Administration could provide the mechanism for it.

Congress is considering legislation that would allow the FDA to regulate tobacco products. The proposal is backed by Philip Morris USA, which could benefit from regulation because of its dominance of the cigarette market. Regulation could limit advertising and create barriers for new competitors to enter the market.

But some smokeless manufacturers don't like the legislation, arguing that it would not distinguish between cigarettes and smokeless products.

"The biggest effect would be to limit and restrict the ability of manufacturers to communicate with adult tobacco users," said Seth Moscowitz, a spokesman for tobacco company Reynolds American Inc. "It would make it much more difficult for various products to compete against one another."

Sara Machir, a spokeswoman for Chester-based tobacco company Star Scientific Inc., said the FDA should be able to set objective standards for what constitutes less risky tobacco products. "The standards that are articulated in this current bill are so high that it will actually discourage companies rather than incentivize them to come up with products that are less harmful," she said.

Lennart Freeman, chief executive officer of Swedish Match North America, wants the FDA to be able to approve some smokeless products as reduced-harm products. He also said there should be fewer restrictions on smokeless products than cigarettes.

Some research does indicate that using smokeless tobacco is far less risky than smoking, although it still carries health risks. The government requires smokeless products to carry three, rotating warning labels that say the products can cause mouth cancer, gum disease and tooth loss and are not a safe alternative to cigarettes.

A study by London's Royal College of Physicians said that smokeless was 10 to 1,000 times less hazardous than cigarettes, depending on the product. Carcinogen levels in various types of smokeless tobacco can vary greatly. Officials with Swedish Match say that research on snus in Sweden has shown that product carries little or no risk of oral cancer, which they say is more often the result of smoking. Sweden does have far lower rates of oral and lung cancer among men than countries where smoking is more prevalent, though it's important to remember that Swedish-style snus is processed and stored differently than other smokeless tobacco, resulting in reduced cancer-causing nitrosamines.

A study by the Swedish National Board of Health in 2005 concluded that "it is impossible to exclude that there are risks associated with snus, although they are very minor in relation to the risks associated with smoking. For every snus user who takes up smoking, there are four smokers who switch to snus when they give up smoking," the board wrote, concluding that the net effects are positive in public health terms.

Freeman said he is frustrated by the tendency to equate all tobacco products as equally risky. "I don't understand why we can't acknowledge that there can be a tobacco product that is less harmful than cigarettes," he said.

While some public-health experts agree that smokeless carries fewer risks, they worry that labeling any tobacco product as less risky could encourage more people to start using it, and ultimately lead more people to cigarettes.

"It is hard to know whether the increased sales [of smokeless] represent a switch," from smoking, said Scott Tomar, a public-health dentist and epidemiologist at the University of Florida. "I would say the available evidence suggests that is a small piece of the market, and it suggests [smokeless] is more of complement to smoking."

There is no precise data on how many cases of oral cancer are caused by smokeless tobacco in the United States, because many smokeless users also have a history of smoking, he said.

"The best estimates that are out there is that there is roughly a four to six-fold elevation in the risk of oral cancer from using smokeless tobacco." That is "probably less" than from smoking, he said.

Gregory N. Connolly, a professor of public health at Harvard University who follows the smokeless industry, said a large-scale switch to regulated smokeless products might provide some public-health benefit.

Consumer acceptance is a problem faced by smokeless-tobacco makers in attempting to offer innovative, potentially reduced-risk products, he said. The products either require spitting, or they have to be altered in such a way that it lowers nicotine levels compared with cigarettes, or they don't deliver nicotine as efficiently as cigarettes.

"Most of these products haven't done well in marketplace, that is the reality," Connolly said.

"If we can get everyone to switch to smokeless tomorrow, it would be a public-health miracle," he said. "But that type of thinking is totally unrealistic. It is a fantasy."

http://www.timesdispatch.com/servlet/Satellite?pagename=RTD/MGArticle/RTD_BasicArticle&c=MGArticle&cid=1173350623348

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