RESTON, Va. - Food and Drug Administration staff members on Tuesday backed a Procter & Gamble study showing that people who eat snacks made with its fake fat olestra are not suffering dangerous vitamin shortages.
The company is trying to rebutt charges that olestra's tendency to block absorption of carotenoids and vitamins A, E, D and K could lead to heart disease, cancer or blindness.
Carotenoids are plant pigments found in yellow and red vegetables which are converted into vitamin A in the liver.
An FDA advisory panel that approved the use of olestra more than two years ago is meeting this week to evaluate P&G's latest medical studies.
FDA researchers speaking at the second day of the three-day meeting agreed there were no nutritional deficiencies linked to olestra. There was some decrease in carotenoids in a study of people who were heavy olestra consumers but the decline seemed to be random.
"The carotenoid decrease does not appear to be associated with olestra ingestion," said FDA's Thomas Wilcox.
In the Procter & Gamble study, Indianapolis area consumers were followed for up to a year. They and others at several new sites will continue to be monitored until 2001.
They were asked about what snacks they ate, and whether they were eaten at the same time as fruits and vegetables.
Their blood was then tested for key nutrients and carotenoids.
In another study, Tom Ciulla of the University of Indiana found no change over a year in the density of the eye's macular pigment in Indianapolis residents who ate olestra snacks, suggesting no link to blindness.
When olestra was approved in 1996, the FDA and Procter & Gamble agreed that bolstering it with vitamins A, E, D and K would offset any nutritional deficiency.
The FDA recommended against adding carotenoids, a conclusion backed by the National Cancer Institute (NCI) and the National Eye Institute.
"I do not recommend supplementing olestra with carotenoids," confirmed Peter Greenwald, director of NCI's division of cancer prevention in a June 12 letter to FDA advisers.
In testimony on Monday, FDA staff also sided with Proctor & Gamble research showing limited intestinal problems among people who consume potato chips made with olestra.
FDA staff said they had seen nothing beyond the mild cramping and diarrhea they were aware of when olestra gained approval.
Olestra is a cooking oil made from soybeans or cottonseed which mimics the taste of conventional fatty oils but cannot be absorbed by the body. The product has been touted by P&G as a boon for dieters trying to reduce their fat intake.
All foods made with olestra carry a label required by the FDA saying the product "may cause abdominal cramping and loose stools."
The FDA advisory panel is due to vote on Wednesday on whether the label should be changed, more medical studies conducted or approval reconsidered.
The Center for Science in the Public Interest (CSPI), a nonprofit watchdog group, gained attention last week by publicizing a Harvard study alleging that olestra consumption will lead to thousands of cancer deaths.
On Tuesday, the group attacked the Procter & Gamble studies. "Procter & Gamble cannot show with a reasonable certainty that lowering carotenoids is not harmful," said Michael Jacobsen, executive director of CSPI.
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