New Tools Help FDA Get Tougher in Tracking Threats to Product Safety : Public health: The decision to turn a small Cincinnati field lab into a state-of-the-art National Forensic Chemistry Center was made after several embarrassing incidents.

More than four years ago, a scare over the possible cyanide poisoning of grapes imported from Chile stumped the Food and Drug Administration. Were the grapes really tainted? If so, by whom, and when? Would they be dangerous if consumed?

The answers never came.

Though agency investigators found cyanide in two grapes plucked from among tens of thousands sitting on a Philadelphia dock, they could never say whether the contamination took place in Chile, on a boat en route to the United States, on the docks or perhaps at the FDA’s own lab. There was controversy over how much cyanide was in the two grapes. There was confusion over the threat to public health.

Grocery shelves were cleared. Tons of fruit spoiled as the FDA imposed an embargo, then lifted it five days later. Chilean growers lost an estimated $240 million.

In the end, there was little evidence that the threat was real, but substantial evidence that the agency charged with policing thousands of consumer goods and much of the nation’s food supply was not equipped to do the job.

Fast forward to June, 1993, when consumers began complaining of syringes found in Pepsi products.

Detecting a syringe was not a daunting task, but determining whether the soda itself had been tainted called for sophisticated analysis. Forensic scientists at an FDA lab here--opened after the grape fiasco--analyzed samples of the soda, syringes and cans with electron microscopes and other equipment. They concluded the soda was not contaminated. No product recall would be necessary.

As the FDA advised consumers that they could protect themselves by shaking the container or emptying the drink into a glass, members of a newly formed FDA criminal investigative team began “flying polygraphers across the country” interviewing those who had complained, said FDA Commissioner David A. Kessler.

They went to Winfield, Ill., where hospital employee Keith Willis said he had found a syringe in a Pepsi bought from the hospital vending machine. Under questioning by a polygraph operator, he admitted he had put the syringe in the can, according to an affidavit prepared by FDA agent Gregory Simpson.

They went to Milwaukee, where Katherine Wuerl, an employee of a local newspaper, also admitted to the syringe hoax after an FDA agent and an FBI polygraph expert quizzed her about discrepancies in her story, according to Assistant U.S. Atty. Steven M. Biskupic. Why, they asked, had she shifted from Diet Pepsi to Pepsi? Why had she bought the soda at a suburban store, but waited until three hours later to open it when she was with a group of people in the newspaper’s employee lounge? One day, Wuerl’s first-person account of finding the syringe was front-page news in the Milwaukee Sentinel; now she faces up to a year in prison for allegedly violating the Food, Drug and Cosmetic Act by making false product-tampering claims.

In all, 37 people have been charged. Guilty pleas or convictions have been obtained in 13 cases; charges are pending in the 24 other cases.

In contrast to the grape case, the investigative work on the Pepsi incident was swift and definitive. It allowed Kessler to reveal the hoax quickly, announce arrests and end an incident that otherwise might have continued to worry consumers and the company.

Just as significant, the response marked a turning point in the agency’s evolution as the nation’s chief commodity cop.

The criminal unit “has already proven its value,” said Rep. John D. Dingell (D-Mich.), who spearheaded several investigations into the FDA.

And the manufacturer of Pepsi, understandably, is pleased. “Our product was on trial, and the fact that they moved so quickly helped,” said Pepsi spokesman Andrew Giangola. “It would have been potentially catastrophic had the situation continued to play itself out.”

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Three years ago there was more disdain than regard for the FDA. “Clueless” is how one congressional staff aide who researched the agency for an oversight committee described the FDA then. “The whole agency by the end of the 1980s was just in hideous shape. They were defenseless,” the staff member said.

As Chile and the fruit industry pressed to recover damages from the cyanide scare, the FDA suffered further when outside criminal and congressional investigators found that some of the country’s largest makers of generic drugs had submitted fraudulent test data to the agency and bribed FDA officials to allow products onto the market.

Kessler said the agency’s weakness was clear: There were plenty of regulators on staff who understood how the food and drug industry should work, but few with the investigative ability to ferret out fraud, track down counterfeit pill makers or draw a confession from someone calling in a fake product complaint.

Shortly after taking office in 1990, Kessler announced plans to establish the new 100-member Office of Criminal Investigations, for the first time putting a fully trained federal police force behind the Food, Drug and Cosmetic Act.

The force, which has been operating since January, was assembled by Terrell Vermillion, a 23-year veteran of the Secret Service. The agents have an average of 12 years of experience in other federal law enforcement agencies. The unit has helped develop an attempted murder case against a Florida woman who put lye in cough syrup she gave to her twins. It also is helping in the prosecution of a company charged with selling “look-alike” amphetamines in Iowa.

The number of people charged in the Pepsi case already is more than were cited under product tampering laws in the decade since those provisions were enacted in 1983, according to the FDA.

The decision to turn a small Cincinnati field lab into a state-of-the-art National Forensic Chemistry Center was made shortly after the grape incident. Besides working on cases sent by Vermillion’s investigators, researchers also are creating an encyclopedia that outlines what happens when poisons or other contaminants are put in common consumer products.

That vital information was missing in the grape crisis, said lab director Fred Fricke. No one was sure, for example, what cyanide would do to a grape, how much poison the fruit could absorb or what a poisoned grape would look like at different stages.

“We just did not know all of the reactions to cyanide in fruit at that time--would it turn an apple purple, or whatever,” said Fricke, a 30-year FDA veteran. “We had none of those answers.”

In an effort to get answers, Fricke’s small lab of four researchers was expanded to 29, including 11 people with doctorates.

The bulk of the staff’s time is spent on specific cases, but otherwise researchers are free to hypothesize about questions such as this: What would happen if a vengeful drug lord tried to taint bananas with cocaine? (The answer: Not much. Cocaine ingested orally would be harmful only in amounts so large that the contamination would be obvious.)

Meanwhile, the lab continues its work on Pepsi--partly to bolster pending criminal prosecutions and partly to add to its general understanding of soft drinks.