BY PAUL BARTON
Enquirer Washington Bureau
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OLESTRA'S HISTORY
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 1968: P&G researcher Robert Volpenhein and his supervisor, Fred Mattson, were studying fat digestion in Miami Valley Labs when they ran an experiment giving enzymes different kinds of fat. When the resulting fat, called sucrose polyester, was not broken down in the body by enzymes, the two knew they were on to something: a fat that was not digested by the body.
1971: P&G begins talking informally with the Food and Drug Administration (FDA) about use of sucrose polyester, then dubbed olestra.
1975: In what is later viewed as a strategic error, P&G files an investigational new-drug application. The application put olestra in regulatory limbo amid a debate on whether olestra was a drug or a food.
April 1987: P&G applies to the FDA for approval to use sucrose polyester as a fat substitute in snack foods and cooking oils. Analysts estimate olestra could produce more than $1 billion a year in sales for P&G.
September 1987: P&G establishes a separate division to manage the olestra business.
December 1987: The Center for Science in the Public Interest calls for more research into olestra, saying P&G's research showed some rats used in its studies developed leukemia, pituitary tumors and liver abnormalities. The FDA later asks for new tests to be performed on mice.
February 1990: P&G chief Edwin Artzt says olestra's approval is taking longer than the company expected.
December 1993: President Clinton signs a bill allowing two one-year extensions on the olestra patent.
October 1995: P&G chief John Pepper resurrects hope for olestra, predicting the company's Pringles potato chips and other products containing olestra could be on store shelves in 1996 if FDA approval comes soon.
November 1995: An FDA advisory panel deems olestra safe and recommends its approval in a 16-5 vote. FDA Commissioner David Kessler says he will make a decision within two months.
January 1996: FDA approves the use of olestra in certain snack foods and requires labeling on products containing the fat substitute. Frito-Lay is the first non-P&G company to say it will test snacks made with Olean, P&G's brand name for olestra.
March 1996: P&G commits to building its national olestra production plant in its Ivorydale complex in Cincinnati, and pledges to begin operations within three years.
May 1996: Frito-Lay begins selling potato and corn chips made with olestra in three small test markets: Eau Claire, Wis.; Cedar Rapids, Iowa; and Grand Junction, Colo.
Feb. 10, 1998: P&G and Frito-Lay announce plans for the national rollout of salted snacks containing olestra.
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RELATED
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Consumers are voting for olestra chips with their lips
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WASHINGTON -- Procter & Gamble wants the Food and Drug Administration to reconsider the unsavory warning label that accompanies salty snacks made with its fat substitute olestra.
The package wording about possible "abdominal cramping and loose stools" is no longer warranted in light of research done since the food additive was approved in January 1996, company officials said Monday.
"All of the new studies put the label in a new light, so we are asking the FDA to take that into consideration," said Suzette Middleton of P&G's regulatory and clinical development staff. "Consumers can feel very confident about adding this to their diet."
But P&G's longtime opponent on olestra, the Center for Science in the Public Interest (CSPI), a public health watchdog group, argues that the FDA should reconsider the approval it gave to olestra in the first place.
CSPI said the anecdotal evidence continues to mount that potato chips and other snacks with olestra are causing Americans serious gastrointestinal problems.
The two sides laid out their cases as the FDA's Food Advisory Committee began a three-day review of new research on olestra, which is marketed under the name Olean in many fat-free snacks, including the Wow! chips made by Frito-Lay and P&G's fat-free Pringles. The 30-month review was mandated by the 1996 FDA order that approved the ingredient.
P&G scientists contend the period since approval has proved that olestra is not the threat to the gastrointestinal system the warning label suggests.
But they would not comment on whether they wanted the label reworded, or eliminated.
"That is up to the FDA," said P&G spokesman Donald P. Tassone. Meanwhile, P&G spent much of the day laying out recent research it contends proves that olestra snacks are no more severe on the digestive system than snack chips made with regular fat.
"Our data show olestra does not cause diarrhea," said Dr. Nora Zorich, who led P&G's presentation.
One of the studies involved 13-ounce bags of regular and olestra-made potato chips given to moviegoers at a suburban Chicago multiplex. The volunteers were encouraged to eat as many of the chips as possible while watching films. Researchers reclaimed the bags afterward, measured how much was consumed and then monitored participants' gastrointestinal responses over the next 10 days.
Other consumers who had reported abdominal problems to either P&G's or Frito-Lay's toll-free lines went through a "rechallenge" study in which they volunteered for multiple sittings. They were given up to two ounces of olestra chips while they read magazines and drank soft drinks and water.
The rechallenge study, involving a sample of 57 people, again showed that olestra chips were no more likely to cause gastrointestinal problems than regular snack chips, researchers said. But Michael Jacobson, CSPI executive director, said P&G has had too much influence over the studies done so far.
Further, he said, anecdotal evidence continues to pile up from around the country that many consumers are made seriously ill by olestra.
He said there are numerous reports of adults who defecated in their clothes and others who said they had to drive at unsafe speeds to reach a bathroom after eating olestra-containing products. Mr. Jacobson introduced Tracy Blume, who said she was a US Airways flight attendant from North Carolina.
Ms. Blume said she ate olestra chips at a friend's house one weekend and was violently ill for much of the next week.
"I have never experienced anything like this before in my life," she said of the acute abdominal pain and diarrhea.
Mr. Jacobson said, "I think we have to give some significant credence to the anecdotal reports."
He said the FDA made a mistake when it gave approval to sulfites in food in the early 1980s and later had to modify that approval. P&G officials, meanwhile, report that consumers are loving olestra snacks.
More than 80 million bags of olestra chips containing 500 million servings have been sold so far.
"Consumers are voting for it at the grocery store," Ms. Middleton said.
