Deal to Stop FDA Cigarette Regulation May Be Impossible

Two Antismoking Groups Threaten Suit to Upset Key Condition Demanded by Industry

Court Likely to Establish FDA Jurisdiction Even if Agency and White House Object

A tentative congressionally-brokered deal to avoid regulation of cigarettes by the Food and Drug Administration (FDA) may be impossible because the President cannot provide the key condition demanded by the tobacco industry, says the attorney whose law suit paved the way for the FDA's current proposal.

"The industry's demand for a guarantee that the FDA will never regulate tobacco cannot be provided by the agency or the President," said law professor John Banzhaf, "because antismoking groups can always go to court ¾ as we have before ¾ to require the agency to act."

"The evidence from the secret documents revealed so far, together with information already in the FDA's files, makes such a ruling very likely," says Banzhaf, Executive Director of Action on Smoking and Health (ASH).

In 1980 ASH sued the FDA to require it to regulate nicotine in cigarettes, the same way it regulates nicotine in patches and chewing gum.

Although the court declined to order the agency to act because the evidence available at the time was weak, it did hold for the first time that so-called extrinsic evidence ¾ including internal tobacco industry documents, patents and patent applications, and even a tendency by many users to become addicted ¾ could be used to support the finding that nicotine in cigarettes was a "drug."

Now ASH, as well as the Coalition on Smoking OR Health, a group made up of the major national health organizations, is seriously considering another law suit based upon the much stronger evidence of manufacturer intent now available to establish the agency's jurisdiction.

"In court the tobacco industry can't use its vast monetary resources and political clout as it can when the decision lies before Congress or in the White House," says Banzhaf. "Courts follow the law, not political pressures."

Moreover, he says, if the court establishes that the FDA has jurisdiction over cigarettes, the public simply will not stand for a congressional abrogation of that decision.

FOR IMMEDIATE RELEASE: Sunday, July 30, 1995

FOR MORE INFORMATION, CALL: John Banzhaf (202) 659-4310

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