Nicotine: taming the perils without kicking the habit Companies aim at growing market with 'safer' products

October 15, 1997|By Scott Shane | Scott Shane,SUN STAFF

Joining the growing competition to satisfy the nicotine habits of smokers worried about their health, a tiny Virginia company said yesterday that it has discovered a way to eliminate a key class of cancer-causing chemicals from tobacco.

Star Tobacco and Pharmaceuticals Inc., whose new process for curing tobacco has caused a stir among public health advocates, said it has applied for Food and Drug Administration approval for tobacco chewing gum and lozenges and expects to follow up with a safer cigarette.

Star is negotiating with one of the five big tobacco companies and two major pharmaceutical companies to license its products and curing process, officials said.

If the Petersburg company's claim to have removed cancer-causing nitrosamines from tobacco is confirmed, it will be well positioned to benefit from a burgeoning market for less-hazardous ways to ingest nicotine.

The newest products go well beyond the now-familiar nicotine chewing gum and patches.

R. J. Reynolds Tobacco Co. is test marketing in Tennessee, Nebraska and Georgia a low-smoke cigarette called Eclipse that uses charcoal to heat tobacco rather than burn it. Eclipse releases a nicotine aerosol that can satisfy a smoker's craving while reducing the carcinogens inhaled.

Meanwhile, pharmaceutical companies have introduced a nicotine nasal spray, and a nicotine inhaler is being sold in Europe and will be on the U.S. market soon. One drug company has a nicotine lollipop in development.

All of those products are aimed at the large number of smokers who would like to reduce the risk of cancer, emphysema and heart disease from smoking but who can't or won't give up nicotine.

In surveys, about 70 percent of the 46 million American cigarette smokers say they would like to quit, said Kenneth E. Warner, an expert on smoking and health at the University of Michigan.

"There are all kinds of products that augur a booming market for alternative ways of delivering nicotine," said Warner, co-author of an article in the Journal of the American Medical Association this month that predicts multibillion-dollar demand for "nicotine maintenance" products.

Warner noted that nitrosamines are only one class of carcinogens in cigarette smoke and said removing them would be a substantial but "incremental" step toward a safer cigarette. But he said support is growing among public health officials for nicotine products that, although not completely safe, offer alternatives to smoking ordinary cigarettes or quitting.

In itself, experts say, nicotine is considered relatively safe in moderate doses, although it might increase the risk of heart disease from smoking and complicate pregnancy. The real dangers of cigarettes come from the many toxic substances in smoke that are inhaled with habit-forming nicotine.

Pharmaceutical companies have been required to take their nicotine products through a lengthy, costly FDA approval process. The big tobacco companies have avoided government safety reviews and are appealing a North Carolina judge's ruling that the FDA may regulate nicotine as a drug.

FDA review sought

Star Tobacco is breaking with the rest of the industry by going to the FDA for review of its Gumsmoke tobacco chewing gum, Goldsmoke lozenge and planned CigRX cigarettes.

That decision has won wary praise from some anti-smoking advocates for Star Tobacco, which recently added "Pharmaceuticals" to its name.

"They've taken what to me appears to be an ethical public health approach," said Jack E. Henningfield, a prominent nicotine researcher who worked at the National Institute on Drug Abuse, a federal agency, for many years. With FDA encouragement, Henningfield's Bethesda consulting firm, Pinney Associates, has agreed to provide "guidance" to Star Tobacco without compensation, he said.

John Slade, a New Jersey internist specializing in nicotine and other addictions, said Star Tobacco's move is significant on scientific and regulatory grounds.

"I'm pleased by it," said Slade, who has worked on smoking-related research for 14 years. "It's progress in making tobacco products no more poisonous than they have to be. And it shows the FDA is the appropriate mediator for the complex issues involved."

Products such as Star's might get a boost from the national tobacco settlement pending before Congress. A clause in the settlement would give the FDA the power to require manufacturers of cigarettes and other tobacco products to make them less hazardous if that is technologically feasible.

History has made anti-smoking activists wary of claims about safer cigarettes. Two developments ballyhooed as making smoking safer, filters in the 1950s and low-tar and low-nicotine cigarettes in the 1970s, are now thought to have harmed public health by easing smokers' fears and encouraging them to keep smoking.

In both cases, smokers' tendency to control nicotine dosage by inhaling more deeply or smoking more counteracted any reduction in harm.

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