Crusading Kessler steers FDA into smoking debate

August 29, 1994|By Susan Baer | Susan Baer,Washington Bureau of The Sun

ROCKVILLE -- To the tobacco industry, Food and Drug Commissioner David A. Kessler has become Public Enemy No. 1 -- a wild-eyed government chief about to unleash his insatiable regulatory appetite on an unsuspecting nation. To the anti-smoking crusaders, he is a knight on a white horse -- the right man at the right time.

But as the intense, bearded and bespectacled bureaucrat nears a decision that could forever change the place of cigarettes in our society, he has left anxious parties on both sides of the issue wondering: Just what does Dr. Kessler really want?

No stranger to controversy, or to the deft political maneuverings needed to win public support for his agenda, Dr. Kessler has signaled to all that, unlike his predecessors who steered clear of the smoking debate, he is entering the fray.

"Add up the risk posed by everything else that we regulate and I would guess that the totality of all that risk doesn't even come close to the risk that cigarettes pose," he said in an interview in his office.

With a fierce streak of independence tempered by keen political instincts, Dr. Kessler, 43, has charted a course from a Republican to a Democratic administration and through a minefield of controversial issues: from breast implants to vitamin labeling and now, to cigarettes.

The smoking debate is likely to be his toughest, most explosive battle yet, and the defining chapter of his activist FDA stewardship.

In June, he told Congress that he finally had proof that tobacco companies manipulate the nicotine in cigarettes to try to hook consumers -- evidence that the industry views nicotine as a drug, he insists. Earlier this month, an FDA advisory panel concluded that nicotine in cigarettes was, in fact, addictive.

Now, as dozens of employees puff away their lunch breaks standing outside the dark glass FDA building in suburban Maryland, administration scientists are closing in on the answer to a question that could lead to further, and possibly profound, restrictions on smoking: Is the nicotine in cigarettes a "drug" and therefore subject to FDA regulation?

Let me assure you we're working very hard to answer that question," Dr. Kessler said, unwilling to reveal how close he is to what would be a landmark pronouncement. "There's been a chipping away over the last 30 years, but there is a momentum now on this issue. We are very much at a turning point."

If Dr. Kessler decides that the FDA should regulate cigarettes, as the tobacco industry both fears and expects, he has the authority to go as far as banning cigarettes outright.

He says he will not do that, recognizing that, aside from igniting a political wildfire, such a ban would create a black market and unfairly punish the millions already addicted.

"Prohibition doesn't work," says Dr. Kessler, a lawyer and doctor who trained for three years at Johns Hopkins Hospital. "We know that."

'Children's disease'

Rather, he intends to concentrate on preventing the next generation from taking up the habit.

"The real important thing for me is, if you don't start smoking by age 21, you don't start smoking," says Dr. Kessler, the father of two young children, who looks at smoking as a "children's disease."

"If we could prevent kids from starting to smoke or become daily users before the age of 21, we're not going to have the next generation smoking."

He says he would favor restricting access of cigarettes to minors by limiting sales to designated stores, much as the sale of alcohol is restricted in some states, and possibly eliminating cigarette machines.

He supports placing further regulations on cigarette advertising to avoid sending the message that smoking is adventuresome and hip.

"The messages we send children through advertising is that there are a lot of benefits that go with smoking," he says. "Take the companies at their word that they don't target children. The impact of their actions is that they're having an effect on children. If I ask my elementary-school child who Joe Camel is, and the answer is that: 'I know not only Joe Camel, I know Josephine,' it has a real effect."

Although they realize some change is inevitable given today's increasingly anti-smoking climate -- when states such as Maryland are trying to ban smoking from all workplaces and even McDonald's has declared itself a smoke-free corporate zone -- tobacco executives take little comfort in Dr. Kessler's stand against prohibition.

"He could issue a set of regulations that would be the functional equivalent of a ban," says Walker Merryman, vice president of the Tobacco Institute. "I think he wants total control over the regulatory aspects of tobacco."

It is hardly the first time the commissioner has thrust himself into a hot seat. The FDA, responsible for monitoring one-fourth of the nation's gross domestic product, seems to face a new controversy at every turn -- AIDS drugs one day, genetically altered tomatoes the next.

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