FDA approves fake fat for use in snack foods despite its side effects Substitute Olestra has taste, adds no calories

January 25, 1996|By LOS ANGELES TIMES

WASHINGTON -- The U.S. Food and Drug Administration approved the new fat substitute Olestra yesterday for use in such salty-type snack foods as potato chips and crackers, a decision that is likely to open the door to future uses in a wide range of foods.

While Olestra has the taste and texture of fat, it adds no fat or calories. However, it also has been associated with some unpleasant side effects, including abdominal cramping, diarrhea-like symptoms and the depletion of important nutrients from the body.

For this reason, the FDA will require that all packages of foods containing Olestra be labeled with an explicit warning of its possible side effects. Once a package is opened and its contents put into a bowl, however, consumers will probably not be able to tell whether the snacks contain Olestra.

Manufacturers of foods made with Olestra also will be required to add vitamins A, D, E and K, which would otherwise be swept out of the body by the fake fat.

To appear in months

The product, which will be known as Olean, was developed and will be marketed by Procter & Gamble Co. P&G said snacks with Olestra, including its own Pringles potato crisps, would begin appearing on store shelves in test markets in a few months.

"Americans can get ready to taste history because snacks made with Olean eliminate the taste trade-off with many fat-free or reduced-fat snacks," said P&G Chairman and Chief Executive John Pepper.

FDA Commissioner David A. Kessler said Olestra met the safety standard required by law for all new food additives.

The side effects "are real effects in some people, but we do not believe those effects are medically significant," he said. Otherwise, "we would not have approved it."

Support, opposition

Many nutritionists and public health groups supported the FDA's decision. But the Center for Science in the Public Interest said it was "bitterly disappointed" and would appeal the decision, in the courts if necessary.

"We will urge consumers not to eat Olestra products and urge food manufacturers not to market them," said Michael Jacobson, the food group's executive director.

But diet-conscious Americans are expected to gobble up Olestra products with great enthusiasm and in great quantities.

Some industry analysts predict that Olestra could become a $1 billion business for Procter & Gamble.

Expanded uses for Olestra beyond snack foods would require an additional FDA review and a separate approval.

"Obviously, we're very pleased with the FDA's decision," said Dr. Chris Hassall, associate director of regulatory and clinical development for Procter & Gamble. "Consumers have let us know they are interested in fat-free snacks that taste as good as the originals. The FDA decision shows that Olestra can be safely used. Consumers can now make their own choice."

As a condition of approval, Procter & Gamble also has agreed to study the consumption and long-term effects of the substance, which consists of a molecule so big that it cannot be digested or absorbed by the body.

The FDA will formally review the results at a public meeting within 30 months.

Olestra, which was first studied as a possible cholesterol-reducing drug, has been in development for 25 years and is the first fake fat that is heat-stable and can be used in baking and frying.

A typical serving of regular potato chips contains 10 grams of fat and 150 calories.

The same serving of potato chips made with Olestra has no fat and 60 calories.

The FDA said it evaluated more than 150,000 pages of data drawn from more than 150 studies.

The research showed that Olestra could cause intestinal cramps and loose stools in some individuals, which posed no medical danger.

Clinical tests also showed that the substance absorbed fat-soluble vitamins A, D, E and K from foods eaten at the same time. That effect could be offset by replacing these nutrients in the Olestra-containing snacks.

Olestra also reduces the absorption of some carotenoids -- nutrients found in carrots, sweet potatoes, green leafy vegetables and some animal tissues. The FDA said it would study the impact of carotenoid depletion.

The role of carotenoids in human health is not fully understood, although many researchers believe they protect against lung and prostate cancer, heart disease and macular degeneration, a condition that can cause blindness in the elderly. For this reason, numerous nutritionists and other experts voiced alarm at the substance's potential long-term health impact.

Dr. John S. Bertram of the University of Hawaii's cancer research center called Olestra "a public health time bomb."

Other experts, as well as the American Public Health Association, had urged that the product be denied approval.

The FDA consulted experts at the National Cancer Institute and the National Eye Institute, who said the health benefits of DTC carotenoids were still unproved. They did not recommend that Olestra products be supplemented with carotenoids.

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