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New ‘Cigarette’ Really a Drug, Koop Claims

From Reuters

U.S. Surgeon General C. Everett Koop said today that RJR Nabisco Inc.'s new “smokeless” cigarette is a “drug-delivery system” that should be regulated by the federal government.

A decision by the Food and Drug Administration to regulate the new product as a drug device could severely hamper and even cripple RJR Nabisco’s efforts to market the cigarette, already being sold in two regions of the country.

“I don’t see how you can fail to regulate that cigarette,” Koop said in an interview with Reuters and the international television agency Visnews.

Only Called ‘Cigarette’

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“They (manufacturers) call it a cigarette, and they want to call it a cigarette because cigarettes are not regulated, but it really is a drug-delivery system,” he said.

Koop also said he was disturbed by the efforts of the U.S. trade representative’s office to open up overseas markets to U.S. cigarette exports. The Reagan Administration has supported manufacturers in attempts to sell cigarettes to Japan and South Korea, among other countries.

“It does bother me as a health officer that this country is involved in exporting disease, disability and death to countries that can ill afford that price down the road,” he said.

If the FDA decides to regulate the new product as a drug or drug-delivery device, RJR Nabisco could be required to withdraw the product from the market and would have to provide detailed proof of its safety before it could be allowed back on the market, an FDA spokesman said.

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Not Much Chance

“I don’t think it would be given much chance to be shown safe,” the spokesman said. “It’s been pretty widely established that cigarettes are hazardous. It would be assumed it would not be able to be marketed.”

Koop said he thought the FDA should ask RJR Nabisco to postpone marketing its “smokeless cigarette,” called Premier, which has a carbon tip that heats air drawn through a tobacco jacket and a “flavor pouch” containing tobacco extract. The firm has already reportedly spent $1 billion on Premier.

“It seems to me that one of the definitions of a cigarette would be that you burn tobacco, and you don’t burn tobacco in this cigarette,” Koop said. “But you do have a little cylinder containing nicotine and the hot air going over that delivers a jolt of nicotine to the smoker, the so-called smoker,” he said.


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