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. Last Updated: 07/27/2016

U.S. Approves Use of Fat Substitute

WASHINGTON -- The U.S. Food and Drug Administration Wednesday approved the controversial new fat substitute Olestra 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 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 all packages of foods containing Olestra to be labeled with a 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.


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 Pringle potato crisps, would begin appearing on store shelves in test markets within several months.


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


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.


"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.


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.


But diet-conscious Americans are expected to gobble up Olestra products in great quantities. Some industry analysts predict that Olestra could become a $1 billion business for Procter & Gamble.


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.


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


The FDA said it evaluated more than 150,000 pages of data drawn from more than 150 studies. The research showed that Olestra reduces the absorption of some carotenoids -- nutrients found in carrots, sweet potatoes, green leafy vegetables and some animal tissues.


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.





Numerous nutritionists and other experts voiced alarm at the substance's potential long-term health impact.