FDA Approves Fat Substitute for Salty Snacks
The Food and Drug Administration on Wednesday approved Olestra, the controversial new fat substitute, 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 has been associated with some unpleasant side effects, including abdominal cramping, diarrhea-like symptoms and the depletion of important nutrients from the body.
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 will also be required to add vitamins A, D, E and K, which otherwise would be swept out of the body by the so-called fake fat.
The product, which will be known as Olean, was developed and will be marketed by Procter & Gamble Co. P&G; said that snacks with Olestra, including its own Pringles potato crisps, would begin appearing on store shelves in test markets within several 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.
After the FDA announcement, P&G; shares jumped $2.125 to $88.25 on the New York Stock Exchange.
FDA Commissioner David A. Kessler said that Olestra meets 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.”
But the Center for Science in the Public Interest, with the support of many nutritionists and public health groups, led the fight against the FDA’s approval. The center 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 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 review the results formally at a public meeting within 30 months.
“This is the first of a novel group of ‘macro’ ingredients” in the food supply, Kessler said. “It’s the responsible thing to do. We have an obligation to monitor this product.”
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 zero fat and 60 calories.
The long and contentious battle over Olestra has pitted expert against expert, with each side accusing the other of distorting the facts. In November, an FDA advisory panel concluded that the substance posed “a reasonable certainty of no harm,” which is the standard required by law for food additives.
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 pose no medical danger, the agency said.
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 that it would continue to study the impact of carotenoid depletion.
The role of carotenoids in human health is not fully understood, although many researchers believe that 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 Assn., had urged that it be denied approval.
The FDA consulted experts at the National Cancer Institute and the National Eye Institute, who said that the health benefits of carotenoids still are unproved. They did not recommend that Olestra products be supplemented with carotenoids.
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How It Works
Olestra is a synthetic chemical that looks like regular far, but its molecules are too large and tightly packed to digest. So it passes through the body without stopping to fatten hips.
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The Proposed Label
This is the label proposed by the Food and Drug Administration to appear on products containing Olestra.
“This Product Contains Olestra. Olestra may cause abdominal cramping and loose stools. Olestra inhibits the absorption of some vitamins and other nutrients. Vitamins A, D, E, and K have been added.”
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Regular Fat
The body’s digestive enzymes break off the spokes of fatty acid from their core, and the body absorbs them.
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Olestra
With Olestra, so many fatty acid spokes are crowded around the core that the digestive enzymes can’t find a breaking. So Olestra doesn’t release any fat or calories.
Source: Procter & Gamble, Times staff
