Health Officials Urge FDA to Ban ‘Smokeless’ Cigarette

Top federal health officials have joined a growing campaign to persuade the Food and Drug Administration to ban a new cigarette-like product, the so-called “smokeless” cigarette, which delivers nicotine by heating, rather than burning, tobacco.

“I do not believe that marketing this product is in the best interest of the public health,” Surgeon General C. Everett Koop said in a recent letter to FDA Commissioner Frank E. Young.

Young has been trying to decide for months whether his agency has jurisdiction over the cigarette, developed by the R. J. Reynolds Tobacco Co.

Health Issues Unregulated

Tobacco is regulated by the Treasury Department’s Bureau of Alcohol, Tobacco and Firearms for tax purposes and the Federal Trade Commission for advertising claims, but it remains unregulated under federal statutes related to health issues.

But Koop and officials from the National Institutes of Health, the National Cancer Institute, the Centers for Disease Control, the National Heart, Lung and Blood Institute, the Alcohol, Drug Abuse and Mental Health Administration and Congress insisted in separate letters to Young that the new device is a “nicotine-delivery system” that does not require tobacco, and that nicotine is an addictive drug that clearly comes under the FDA’s authority.

Their letters joined formal petitions already filed with the FDA by the American Medical Assn., the American Heart Assn., the American Lung Assn. and the American Cancer Society, all asking that the agency regulate the product.

R. J. Reynolds has maintained that the company has not made therapeutic claims, would not make such claims in labeling or advertising the cigarette and would not imply that it is safe or safer than any other cigarettes on the market. Thus, the company has argued, the FDA does not have jurisdiction over the product.

The cigarette, known as “Premier,” is not being sold on a national basis, but it is being test-marketed in Arizona and Missouri, where it reportedly is not doing well.

William Grigg, a spokesman for the FDA, said that he could not predict when Young would act, explaining that the petitions are “still under consideration.”

“Traditionally--and because the Food, Drug and Cosmetic Act doesn’t mention tobacco--cigarettes and other tobacco products haven’t been regulated by the FDA unless they made a health claim,” Grigg added.

But Koop and others insisted that health claims are implicit in statements that the firm has made previously.

“RJR states regarding the product: ‘A majority of the compounds produced by burning tobacco are eliminated or greatly reduced, including most compounds that are often associated with the smoking and health controversy,’ ” Koop wrote. “To me, this suggests a health claim that the product is ‘safe’ or ‘safer’ than conventional products, which could result in reduced quitting by smokers, increased relapse by ex-smokers and increased initiation by adolescents.”

Rep. Henry A. Waxman (D-Los Angeles), chairman of the House Energy and Commerce subcommittee on health, who sponsored hearings last summer on the addictive properties of nicotine, also wrote to Young. Waxman said that he was “increasingly disturbed” by Young’s failure to act and that he was “persuaded” by a review of the legislative history of the Food, Drug and Cosmetic Act that the regulation of “Premier” is within the agency’s jurisdiction.

“To exempt Premier from the health and safety provisions . . . would represent a misreading of the act and an abrogation of your agency’s statutory authority,” he wrote.

Others who wrote to Young recommending that the FDA regulate the product included Dr. James O. Mason, director of the federal Centers for Disease Control; Dr. Claude Lenfant, director of the National Heart, Lung and Blood Institute; Charles R. Schuster, director of the National Institute on Drug Abuse; Dr. William T. Friedewald, associate director for disease prevention at the National Institutes of Health, and Dr. Alan S. Rabson, acting director of the National Cancer Institute.