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Fine Print Will Get Close FDA Inspection

Regulations: The agency is not likely to cede any of its recently won control over cigarettes. Nicotine levels could be a sticking point.


WASHINGTON — The Food and Drug Administration, which recently won a stunning legal victory for regulatory control over cigarettes, is not likely to willingly yield any of that power as a condition for a settlement with the tobacco industry.

"Any limitations on the FDA's ability to regulate nicotine would be giving back what already has been won," former FDA Commissioner David A. Kessler said Friday in an interview.

"We need to look carefully at the fine print and the loopholes," added Kessler, who headed the agency until February and who three years ago initiated its aggressive investigation into nicotine and tobacco.

"There may be enough limitations [in the proposed settlement] to effectively prevent the FDA from regulating nicotine in any meaningful way--and that's not acceptable," Kessler said. "The White House will need to evaluate this very carefully."

FDA officials refused to comment Friday on terms of the settlement.


But if the FDA wasn't talking, at least one of its defenders was. In a statement condemning the settlement, the American Lung Assn. said "the FDA's authority to regulate tobacco is sacrosanct" and "no changes to the FDA's current authority or limits on future authority are acceptable." However, while the full implications of the settlement were unclear Friday, it appeared that the deal would circumscribe some of the FDA's regulatory authority.

The lowering of the amount of nicotine in cigarettes to nonaddictive levels has long been one of the tobacco industry's greatest fears. As a result, while the settlement appears to give the FDA the authority to regulate nicotine levels, it imposes a standard of proof that could make that extremely difficult legally.

Under the terms of the settlement, the FDA could regulate nicotine as a drug but could not ban it until after 2009. It would also allow the agency to ban nicotine only if it could ensure that such a ban would not create an underground market in cigarettes containing the substance.

Under other parts of the agreement, the FDA would establish standards to control other unhealthful ingredients already in tobacco products and would have to certify that any new ingredients are safe.

The settlement also would make current FDA rules designed to protect children from tobacco advertising the law of the land.

Last summer, President Clinton proposed stringent new rules--the first of which became effective in February--to curb teenagers' access to cigarettes and restrict tobacco advertising targeted toward young people.

Clinton supported the FDA's conclusion that it had jurisdiction over tobacco because nicotine is a drug--as defined by agency drug statutes--and that cigarettes, as drug-delivery devices, fall under the FDA's authority to regulate medical devices.


In April, in a staggering defeat for the tobacco industry, a federal judge in North Carolina agreed with the FDA that nicotine is a drug and that cigarettes are drug-delivery systems under agency jurisdiction. However, he did strike down the agency's proposals to curb advertising.

While FDA officials refused to discuss how the settlement might affect the agency, it would be surprising if they did not share Kessler's views.

FDA officials repeatedly have said they have no intention of banning cigarettes or nicotine. They have left open the possibility of regulating the level of nicotine in cigarettes, but the agency is not considering such action--especially because researchers do not know the threshold of nicotine addiction.

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