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Health

FDA panel generally endorses safety of olestra

P&G graphic

But product warning labels to remain

In this story:

June 17, 1998
Web posted at: 7:02 p.m. EDT (2302 GMT)

WASHINGTON (CNN) -- An advisory panel to the U.S. Food and Drug Administration decided Wednesday after 2 1/2 days of hearings that the lastest studies of the fat substitute olestra, made by Procter & Gamble, raise no new public health concerns.

Olestra "has now received its 30-month checkup, and it has passed with flying colors," P&G Chairman John Pepper said. "After this latest incredibly thorough review, everyone can feel doubly confident about the safety."

However, the panel recommended that products containing olestra should still carry a label warning that it may cause abdominal cramping and diarrhea. The label might be removed in a few years if ongoing studies show favorable results, the panelists said.

The panel, which approved olestra two years ago, met to evaluate Proctor & Gamble's latest medical studies. Most of the panelists agreed there was "a reasonable certainly of no harm" from olestra.

The panel was told that scientific studies showed such problems were minor and prevented no great risk to health.

Consumer group still claims olestra is 'unsafe'

The consumer-advocacy group Center for Science in the Public Interest and the head of Harvard University's nutrition department had urged the FDA panel to pull olestra off the market or require stricter warning labels.

Critics say olestra tends to block absorption of vitamins and nutrients called carotenoids, and that that deficiency could lead to heart disease, cancer or blindness.

But the FDA panel said it was too early to tell whether carotenoids were essential in protecting people from chronic disease.

Olestra is used by P&G, Nabisco and PepsiCo's Frito-Lay as a fat substitute in chips and snacks. It is made from soybean or cottonseed oil, and is not absorbed by the body.

"In general for consumers, the advice from the advisory committee should be reassuring," said Joe Levitt, director of the FDA's Center for Food Safety and Applied Nutrition.

"There was general agreement among advisory committee members that there were no new data that raised significant new public health concerns."

Olestra review to be ongoing

The panel, comprised mostly of doctors from various medical colleges, said P&G's medical studies showed that the rate of diarrhea or cramps was the same among consumers who ate conventional potato chips and those who ate those containing olestra.

Most panelists said they wanted to review more data in the future, which they expected to get from ongoing P&G studies.

"This is a dynamic situation that should be revisited as more information is collected," said Owen Fennema, a panel member from the University of Wisconsin.

The FDA panel also accepted the company's findings that those who eat snacks made with olestra are not suffering dangerous vitamin shortages, as claimed by some consumer groups.

Digestive symptoms from olestra were moderate, no worse than had been previously reported and potentially just an annoyance, the panel said.

Reuters contributed to this report.

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