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FDA COULD SPARK NEW KIND OF CIG AD JOE CAMEL MIGHT BE REPLACED BY LAUNDRY LIST OF TOXIC SUBSTANCES

By Published on .

WASHINGTON-In his push to curb tobacco use, Food & Drug Administration chief David Kessler might be building a case for tobacco advertising.

It wouldn't be advertising with cartoon animals, smiling twentysomethings or on-the-edge racers, but rather copy-laden advertising aimed at providing smokers with a detailed analysis of what they're putting in their lungs.

Such advertising would probably supplement package inserts, similar to those small-type, multipage mini-brochures that fill out the boxes of over-the-counter and prescription drugs. And it might be accompanied by a major overhaul of the cigarette pack, analogous to the way the 1990 Nutrition Labeling & Education Act changed food labeling.

Instead of only the current side-panel warnings, the label would be changed to reflect a variety of health related-information for smokers.

Those were among the possibilities that arose last week in the backwash of a two-day meeting of a scientific FDA advisory panel that convened to consider nicotine as an addictive substance. The eight-member committee unanimously decided that, yes, nicotine is addictive, just as Surgeon General C. Everett Koop declared in his 1988 report to Congress.

But still to be resolved to the satisfaction of Commissioner Kessler is whether there exists a threshold level of nicotine that would be safe for consumption. Resolving that question and one other issue are about all that stand between the status quo and Dr. Kessler asserting FDA regulatory authority over tobacco, its sale and marketing.

"We are continuing our inquiry into the basis for [the FDA] asserting jurisdiction," said Associate Commissioner Jim O'Hara. "The advisory committee spoke pretty clearly to the question of nicotine being addictive, but still to be addressed is whether a [tobacco marketer] intends to affect the structure of a body."

The FDA declined to speculate on where Dr. Kessler turns next to answer the remaining, yet critical, questions, or even when a determination might occur.

"There is no artificial timetable for what is a very important public health and regulatory issue," Mr. O'Hara said. "And we've never speculated on the regulatory options."

Still, the FDA repeatedly pointed to testimony before the panel by a Penn State Ph.D. who proposed a new means of rating and labeling cigarettes, and doing away with such terms as "light" or "ultralight" as used by some tobacco marketers for reduced tar and nicotine brands.

"Terms such as `light' provide connotations that may be interpreted as beneficial when, in fact, even exposure to the smoke of a few cigarettes per day has well documented adverse health effects," said Lynn Kozlowski.

After developing an improved method of measuring nicotine and other tobacco components, he said, the data should be conveyed on the label.

Dr. Kessler had previously mentioned prescription drug advertising when asked about the implications for advertising should his agency assume regulatory control for tobacco.

Walker Merryman, Tobacco Institute VP, said the hearings' failure to answer all of Dr. Kessler's outstanding concerns represented a "setback."

"The FDA still lacks any regulatory authority because they cannot show that tobacco marketers intend to affect the structure of the human body, and they are not advertising their products as being therapeutic," Mr. Merryman said. "He's still looking to be able to convince Congress to grant FDA enhanced authority, but he's not there yet and may never be.

"I'm sure he's going to press ahead, but is FDA regulation imminent? No. And if he keeps pressing, he's will wind up in court under a legal challenge by the tobacco companies."

Scott Ballin, chairman of the Coalition on Smoking OR Health, speculated the FDA might be headed in a direction that would wind up treating cigarettes and cigarette ads much like it currently handles nicotine patches that are obtained by prescription only.

"It was clear from the panel that tobacco products and regulated tobacco patches should not be treated differently," said Mr. Ballin, a leading anti-tobacco activist. "I'm not sure David Kessler is going to wait for Congress ... even though he said he wanted their guidance. He's doing what he's obligated to do-enforce the law."

Ira Teinowitz in Chicago contributed to this story.

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