Mr. Kessler Goes to Washington : Regulation: After seven months on the job, the FDA’s chief has revitalized a moribund agency.

When friends and colleagues talk about Food and Drug Administration Commissioner David A. Kessler, one word keeps coming up: Focus.

“He has one characteristic overall, and that is focus, “ says Wayne Pines, a friend who worked at the FDA himself for many years. “He’s very focused,” Pines repeats. “He’s in control.”

Kessler came to Washington in November to turn the FDA around, and ever since then he’s been focused on that goal--and firmly in control.

Over the past seven months, he has revitalized what had been a moribund--and much-criticized--agency and turned it into a fearsome watchdog that has become a symbol for tough public regulation.

What’s more, he has done so in the face of an Administration that by and large has decried tough federal regulation. Although President Bush hasn’t been as anti-regulation as his predecessor Ronald Reagan was, he and his top advisers have been decidedly cool to efforts to reverse the deregulation process that the Reagan camp fostered.

Kessler’s moves have been dramatic by any measure. His first was to crack down on the major food companies for what he charged was engaging in deceptive package-labeling. In April, the FDA seized Procter & Gamble’s Citrus Hill Fresh Choice orange juice from a Minnesota warehouse after the company ignored demands to remove the term “fresh” from its label because the orange juice actually had been processed. A few days later, the agency formally warned three food firms against making “no cholesterol” claims on vegetable oil products--which, Kessler points out, are still 100% fat, and hardly “health” foods.

But the new commissioner hasn’t stopped there. He has begun to streamline significantly the FDA’s procedures for approving drugs used to treat life-threatening diseases, such as cancer. And he has served notice that the agency will not tolerate the use, marketing, and promotion of illegal substances, such as silicone injections.

Not surprisingly, perhaps, Kessler has become a much-talked-about commodity, both in Washington and across the country. In a takeoff on Kessler’s hard-line approach to truth-in-product-labeling, late-night comedian Jay Leno wryly complained during a monologue that his Bumblebee brand tuna did not contain any bumblebees. And a Far Side cartoon recently featured an anteater asking a waitress: “Hmmmm, are the red ants fresh off the hill?”

But the new commissioner insists there is no conflict between him and the White House. Kessler says he warned Bush Administration officials when he was interviewed for his current job that he had every intention of enforcing the law.

“I think the Administration is fully behind us,” he says. “If the statute is on the books, there’s no question it has to be enforced.”

And, he predicts, now that corporations know that the FDA means business, they will begin to police themselves. “There is no doubt in industry’s minds now that the agency is watching,” he says.

There is every indication that they are. All the firms that Kessler has targeted so far have moved quickly to meet the FDA’s demands once their realized the agency was serious, and industry lawyers say they are advising their clients to act on their own before the government forces them to.

Kessler’s new “focus” has been important because the FDA, which regulates thousands of foods, drugs, cosmetics and medical devices, touches the lives of all Americans every day. Put another way, it regulates products that amount to 25 cents of every consumer dollar spent.

To be sure, not everyone has been happy with Kessler’s actions. His bluntly worded warning about silicone injections drew ire from dermotolagists, who complained that his criticism of silicone injections unfairly implied that they were widely used.

And some food industry officials, while pleased with the FDA’s new enforcement approach, say Kessler should have waited for the agency to draft new regulations before clamping down on the “no cholesterol” claims.

The turnabout in the FDA has been conspicuous. For years, the FDA had been a beleaguered and slumbering agency, reacting only to urgent public health crises--cyanide-poisoned Tylenol or Chilean grapes, for example. FDA officials said they didn’t have enough staffers or enough money to do their jobs effectively.

Industry, accustomed to hands-off treatment from the federal government, got away with virtually anything that wasn’t life-threatening. And to make matters worse, the agency was further scandalized by revelations that officials in its generic drugs division had accepted bribes from drug companies to speed up the approval of their products.

“There was a crisis of confidence in whether the agency was up to the task,” Kessler concedes. “I think we’ve turned the agency on. We’ve said to the rank-and-file at the FDA: ‘We want you to do your jobs.’ ”

Indeed, one FDA insider says--almost gleefully--of Kessler’s first strike against Procter & Gamble: “P&G; didn’t think we were going to do what we did. Never in their wildest dreams did they think we would send in the U.S. marshals. And, historically, they had every reason to feel that way.”

Kessler came to the FDA from the Albert Einstein College of Medicine in the Bronx, where he had been medical director since 1984. The work involved managing four hospitals and the medical school. Despite his schedule as medical director, Kessler also made it his business to treat sick children in one of New York’s municipal emergency rooms every week. For five years, he also taught food and drug law and Columbia University School of Law.

He jokes now that this is the “first time I’ve held only one job.”

He’d worked in Washington before, from 1981 to 1984 as a consultant to the Senate Labor and Human Resources Committee on food and drug law issues. Sen. Orrin G. Hatch (R-Utah), then the chairman of the committee, recalls Kessler as “just the same as he is today--sure of himself.”

Hatch says Kessler would “do anything that had to be done. If he had to sweep the floor, he would. He was willing to get in there and fight to get things done. The only thing he wouldn’t do was get coffee for anybody, not even himself. He thought coffee was bad for your health.”

Kessler also served--until his nomination as FDA commissioner--on a blue-ribbon commission charged with examining says to strengthen and reform the agency. As a result, he was no stranger to the relevant issues.

There is a certain irony to Kessler’s making food labels his first big target: He and his family eat out or bring carryout home most of the time. They rarely shop for food. “We’re busy,” he says. “I’m not a cooker and (wife) Paulette’s not a cooker.” But Americans want “honest information, not half-truths” about food, he says.

Kessler, a “fat kid” who weighed 205 pounds last fall, decided that a public health official should not be overweight. He dropped nearly 60 pounds by devoting scrupulous attention to what he ate--even if he didn’t cook it himself. He also started running.

“I used to eat everything,” he says. “I used to be very sedentary. I started the diet last November. I just cut back. I changed dramatically the kinds of food I was eating. I was very, very careful.”

A native of Brooklyn, Kessler was reared in Freeport, a village on the south shore of Long Island. His father was an engineer, his mother a school psychologist.

Growing up, he always thought of himself as a scientist--especially “when I was sitting in school, reading poetry that was beyond me”--and says he was profoundly influenced by teachers who were scientists and by scientific educational experiences. “I had some great mentors,” he says. He participated in a National Science Foundation program, and spent time studying in the world-famous Woods Hole marine biology laboratory.

During the turbulent ‘60s, he shied away from the political extremism of his peers, choosing instead to delve deeper into his beloved science. In 1968, when a student strike at Amherst forced the cancellation of classes, he left the campus and headed for Memorial Sloan-Kettering Hospital in New York City.

“It gave me an extra month to go into the lab and do research,” he says. “It’s not that I was apolitical. I was training to be a scientist, training to be a doc.”

One legacy of Kessler’s having come of age in the 1960s was a deep belief in public service. “It’s very important to serve,” he says. “We’re finding that people of my generation are willing to come here and give up a lot.” But he also feels that an individual “is useful only for a limited period of time. You stay as long as your effectiveness is on the rise, and the key is knowing when to leave.” He is not in awe of Washington, friends say, nor did he come here to impress or please people--but to do a job.

Hatch says he anticipates big things from his former staffer. “Cracking fingers over orange juice labeling is one thing--it did set a tone--but there are many many more important things that have to be done besides that. I expect them to really excel, and I expect he’ll get them there.”

Kessler’s pace--working long days into the evenings--is likely to change now that his family has arrived from New York. He has been married for 17 years to Paulette Steinberg Kessler, a corporate litigator--he calls her “the real lawyer in the family”--and they have two children, Elise, 8, and Benjamin, 6. The family stayed in Scarsdale so that children could finish their school year. Kessler, who commuted to New York every weekend, calls that seven-month period the “hardest” part of taking the job.

Indeed, Wayne Pines, now a public relations executive who declined an offer from Kessler to return to the FDA, recalls telephoning him in New York several times, only to be told Kessler couldn’t talk because he was playing with his children.

“I knew after that to call him only after his kids were in bed,” Pines says. “Before that, he wasn’t focused on anything but them.”