US to consider regulating `smokeless cigarette' as a drug

The future of the ``smokeless cigarette'' will be debated today in Congress, where health organizations say they will brand the product as a thinly disguised drug delivery system. In a hearing before a United States House of Representatives subcommittee, R.J. Reynolds Tobacco Company, the nation's second-largest cigarette manufacturer, is expected to counter the assertion that its product is not a cigarette.

``People are making uninformed accusations on the basis of something they know very little about,'' says Maura Payne, a Reynolds spokeswoman. ``They have jumped to conclusions, which we feel is very irresponsible.''

The battle over defining the ``smokeless cigarette'' is important because it will determine whether or not the Food and Drug Administration regulates the product. The FDA is required to review and regulate drug devices - but not cigarettes.

A number of groups, including the American Medical Association, petitioned the FDA in April to regulate the product, claiming it is nothing more than a ``nicotine delivery system.''

Gregory Connolly, a representative of the American Public Health Association, says the product, if regulated, might be used to help people quit smoking by limiting dosages of nicotine. But unregulated use would be dangerous, he says.

``The question is whether we are going to allow a company to market an addictive chemical in this country with no regulation,'' Mr. Connolly says. He worries that children, people trying to quit, and those who have already stopped smoking will be lured to try a product they think is less harmful.

Ms. Payne, the Reynolds spokeswoman, says those ideas are fanciful at best. ``We're marketing to smokers who we think would be interested in an alternative to cigarettes that burn tobacco,'' she says.

An FDA decision to regulate the smokeless cigarette might cost Reynolds the $125 million it has invested, but could potentially hurt the $35 billion tobacco industry even more by limiting its options for dealing with the smoking and health controversy. The battle has been widened since health groups petitioned the FDA this spring to regulate ``low tar'' and ``low nicotine'' cigarettes, which make up 55 percent of industry sales.

The FDA appears to be caught in a political vise between the powerful tobacco lobby and health advocates. The FDA budget is controlled by agriculture subcommittees, which include a number of senators and congressmen who support the tobacco industry. On the other side, the American Medical Association, American Heart Association, American Cancer Society, American Lung Association, and American Public Health Association are pushing to regulate the product.

The ``smokeless cigarette'' looks like, and is about the same size as, a regular cigarette. It has about one-third of the tobacco, and none of that is burned. It has a hot burning carbon tip to heat air that passes over a ``flavor'' capsule containing the nicotine and other additives.

Some believe the innovative Reynolds product signals a new, albeit subtle, change in direction for the industry and society.

``For the past 30 years the debate has been: Is there a safe tobacco product,'' Connolly says. ``The debate has dramatically changed to: Is there a safe source of nicotine?''

Regulating products whose main or only function is to deliver nicotine is not new to the FDA. Early last year, it took action to regulate a cigarette look-alike called Favor. The product, which the FDA says was a drug, consisted of a hollow tube with a nicotine-soaked plug at the other end. The customer did not light the product, but only inhaled nicotine vapors.

The company ceased production and distribution shortly after it got a letter from the FDA saying the product was subject to review. A Reynolds spokesman told federal officials last fall that Reynolds would drop the idea and take a loss rather than submit it to the FDA for review.

``I expect the tobacco industry to continue its decline,'' says Joseph Frazano, a tobacco industry analyst with Oppenheimer Securities in New York. ``Maybe the smokeless cigarette would make the decline occur at a slower pace, and maybe it would truly be a safer cigarette.''

Reynolds has been walking a fine line on the health claim issue, Connolly says. Last fall, Edward Horrigan, Reynolds' president, introduced the product as the ``world's cleanest cigarette,'' which was later dubbed the ``smokeless'' cigarette. At the press conference, he said the product ``eliminates or greatly reduces most of the compounds often associated with the smoking and health controversy.''

Reynolds has never explicitly claimed that the ``smokeless cigarette'' was safer or healthier than other cigarettes. The company is not making ``implicit health claims, explicit or otherwise,'' says Ms. Payne.

``We have Reynolds saying this product is great and wonderful,'' says Scott Balin, an American Heart Association spokesman. ``That's fine, but no one's checking it. No one knows what's inside.''