New Chief Makes FDA a Regulatory Tiger : Government: He is intent on restoring public confidence in the agency. Businesses are getting the word that deception won't be tolerated.


After years of restraint--some would even say timidity--the federal Food and Drug Administration in recent weeks has become the regulatory tiger of the Bush Administration, aggressively attacking the food industry for deceptive claims on a variety of products.

With a series of sharply worded warnings, court actions and even one warehouse seizure, the agency has jolted food companies long accustomed to deferential treatment by the government. The change has surprised even some FDA officials, who for years had been discouraged from taking action except in cases of life or death.

Most of the impetus for the agency's sudden personality change comes from its new commissioner, Dr. David A. Kessler, a physician and lawyer and an unlikely activist in an Administration that still officially adheres to the theme of getting government off the backs of business.

"He has sent a very powerful message," said Jeffrey Nedelman, a spokesman for the Grocery Manufacturers Assn. "He has our attention."

The agency regulates a broad array of consumers products, including foods, drugs, cosmetics and medical devices.

In recent weeks, the FDA has aimed its enforcement guns at several major food companies, forcing them, for example, to remove the word fresh from their product labels because the foods, in fact, are processed.

And, this week, the agency moved against manufacturers of several vegetable oils and other items for using the words no cholesterol, charging that the designation was misleading because cholesterol is a substance found only in animal products.

"We recommended several times that we take at least some kind of symbolic action, just to show we weren't tolerating this kind of thing--and we were turned down from above time and time again," said Sanford Miller, who was director of the FDA's Center for Food Safety and Applied Nutrition from 1978 to 1987.

"He's going against the big guys in the forest--that's what we wanted to do, take on a big food company or a big drug company and say, 'This is the law and you're compelled to follow the law just like anyone else,' " said Miller, now dean of the graduate school of biomedical sciences at the University of Texas Health Science Center in San Antonio.

"But the philosophy of the (Ronald) Reagan Administration was: the less regulation, the better. They never came to grips with the idea that someone had to make sure that everybody was following the rules, that everyone was playing on a level playing field.

"The interesting thing is that the bulk of the industry suffers when the FDA doesn't enforce the law. Time and time again, companies would come to us and say, 'do something' " about the other companies.

Kessler said that he was not seeking to proliferate regulation or to put his bureaucracy in everyone's business but that he was insistent on enforcing the laws and restoring public confidence in his beleaguered agency.

For years, "people thought they could get away with things," he said in an interview. Now, he said, that will change--and the impact could be broad, because industries that fall under the FDA's authority touch the daily lives of all Americans.

"The issues go well beyond fresh and no cholesterol ," Kessler said. "They go to the willingness of the agency to enforce the statutes. If American consumers can't believe their government is going to protect them from dishonest and unfair dealings, they won't believe their government will protect them against unsafe substances either.

"If you let false and misleading actions happen, that translates into people thinking they can get away with things," he said. "And one day you will end up with unsafe and dangerous things happening."

In recent years, the agency has been laboring under the handicaps of limited resources, a shrinking staff and serious erosion of public respect.

"Enforcement is only a tool," Kessler said. "It's not an end in and of itself. It's the incentive to assure compliance. In the past, the industry would say, 'Let's fix only what we've got to fix.' The incentive to comply wasn't out there."

But now it is, industry executives acknowledged Wednesday. "I can assure you that industry has gotten the message," said Peter Barton Hutt, a Washington food and drug lawyer whose clients include many large food companies. He predicted that companies will now begin to police themselves. "Any intelligent lawyer would advise his clients to do so," he said.

He contended that industry welcomes the changes because the system will now be made fair for everyone.

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