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IS FDA CHIEF PLANNING OCTOBER SURPRISE?

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Food and Drug Administration Commissioner David Kessler may be planning an October surprise for the tobacco industry and its congressional allies.

Kessler is preparing plans to assert regulatory control over cigarettes under the Food, Drug and Cosmetics Act, according to sources. Anticipating an all-out fight from tobacco-producing states, Kessler is said to favor an announcement timed shortly after Congress adjourns for the year in late September or early October."He (would) regulate advertising, promotion, sales, distribution and manufacturing," a source close to Kessler told us. "By the time (Congress) comes back, you'll have all these tobacco congressmen trying to undo it." With Congress gone, Kessler could seize the element of surprise to blunt congressional opposition and to buy time to implement new regulations.

"There's nothing you can do that's not going to lead to a nuclear war," one FDA source told us. "Everyone knows the companies are going to sue. If we don't assert jurisdiction, everyone knows the (anti-smoking) coalition will come in with a lawsuit on the other side."

Kessler has been edging closer to asserting control over cigarettes since evidence was uncovered this year that American tobacco companies have known for years that cigarettes are addictive. Others have suggested that cigarette makers chemically alter their products to increase the chance of addiction.

In an interview last week, Kessler told us the FDA was "working very hard" on the issue of regulatory jurisdiction. Last February, the FDA announced an investigation into whether nicotine is addictive and should be regulated as a drug. "I'm reluctant to give any timetable whatsoever," said Kessler, who has been methodically laying the groundwork for regulation. "We recognize the enormity, the important social consequences to any decision we would take."

Kessler dismisses the political consequences, even if some Democrats are fretting. Cracking down on cigarette-makers - from a ban on advertising to gradually lowering the levels of nicotine in cigarettes - could alienate Southerners, and could throw toss-up races in the tobacco belt to Republicans. Tobacco already feels burned. On Inauguration Day, first lady Hillary Rodham Clinton banned smoking in the White House. More recently, the White House has been eying tobacco taxes as a way of funding health-care reform.

Although it's Kessler's call, sources say the first lady "signed off" on the decision earlier this year. "I talked to Hillary about this and she said `Go,' " said one House Democratic leader who spoke to Hillary Clinton earlier this year.

A strategist for a Southern House Democrat predicts Kessler's decision could "blow up health-care entirely" and thus backfire on Hillary Clinton's health-care crusade. "It would take good leadership votes and convert them into Republican seats," according to this official. "Why are (they) doing something that is politically harmful to us in our districts. Do they have a death wish?"

For Kessler, the 400,000 people who die every year from tobacco-related illness are the only casualties that count. Having built a case since February during congressional hearings, Kessler is bound to herald the new policy with a clarion call for children's health. The average age of first use is 14. Eliminating cigarette vending machines and outlawing marketing aimed at youth are among the options under consideration. "It is important to come up with an approach that is really directed at reducing the number of kids from becoming hooked," Kessler said.

Kessler has several tools at his disposal. He compares tobacco regulation to the other substances he oversees. "When you regulate prescription drugs or over-the-counter drugs, there are rules with regard to access, rules with regard to advertising, rules with regard to promotion, rules with regard to content, rules with regard to labeling," Kessler says. He clearly leaves the impression that the path for cigarette regulation will follow suit.

Although Kessler rejects the notion of tobacco prohibition, he does a poor job staying poker-faced about his ultimate plans. Look at everything we regulate, he suggests, from saccharin to red dye No. 3 and PCB. "Add up the risks of all those substances and then look at the risks from tobacco," he said. "All the other risks pale in comparison. The fact is, one in five people who are going to be reading your column are going to die from a tobacco-related illness."