WASHINGTON — The head of the Food and Drug Administration has cautioned R. J. Reynolds Tobacco Co. not to introduce its new "smokeless" cigarette pending a federal review of whether it is a cigarette or a drug.
The company announced Tuesday that it would begin limited sales of its revolutionary Premier cigarettes in October in some test markets.
In a letter to R. J. Reynolds' Chairman and President Edward Horrigan Jr. dated Thursday, Food and Drug Commissioner Frank Young said FDA review of the product "could very well take several months to complete." Young's letter was made available by the FDA on Friday.
RJR spokesman Maura Payne said R. J. Reynolds, a subsidiary of RJR Nabisco Inc. of Winston-Salem, N.C., would have no immediate comment on the FDA commissioner's letter.
But RJR Nabisco has said previously that it would not introduce the product if it were found to fall under the FDA's regulatory authority.
The agency, the federal government's drug safety regulator, has been asked by the Coalition on Smoking or Health and the American Medical Assn. to regulate the product, which is actually a reduced-smoke cigarette rather than a smokeless one, as if it were a drug.
If the FDA concluded that the product were under its jurisdiction and a drug, it would be required under federal law to find that the product was safe and effective for treatment of a medical condition before it could allow the cigarette to be marketed.
RJR had planned on test marketing Premier in Arizona and northern Missouri starting Oct. 1. Phoenix and St. Louis were to be the two largest cities for the test, analysts said.
If the product were found to be a cigarette, it would come under the jurisdiction of the Treasury Department's Bureau of Alcohol, Tobacco and Firearms, which has no such safety and effectiveness requirements.
"If it were clear that we have jurisdiction over this product, we would request that you not market prior to our evaluation of the product," Young wrote to Horrigan.
"Since, however, the jurisdiction issue is unclear at this point, I must emphasize . . . that if R. J. Reynolds decides to market this product in interstate commerce prior to our determination, the firm does so at its own risk," Young said.
If the FDA were to conclude the cigarette is a drug, "any product on the market would be considered an unapproved drug or device subject to FDA regulatory actions including, but not limited to, seizure or injunction," he said.
The cigarette emits much less smoke than traditional cigarettes, and the company expects it will be allowed in the growing number of places that have banned smoking.
According to R. J. Reynolds, the Premier heats, rather than burns, tobacco and produces a "cleaner" smoke that is composed of 90% water and glycerol.
The smoker lights a carbon heat source in the end of the cigarette. Air warmed by the heat source passes through a tobacco roll, a capsule containing spray-dried tobacco extract, glycerol and flavoring agents, and a filter made of tobacco and a traditional cigarette filter, according to the tobacco company.