Date: Wednesday, Jan. 24, 1996
FOR IMMEDIATE RELEASE
Contact: Food and Drug Administration, Brad Stone (202) 205-4144
Home -- (703) 204-4497



FDA APPROVES FAT SUBSTITUTE, OLESTRA

The Food and Drug Administration today approved olestra -- a fat-based substitute for conventional fats developed by Procter & Gamble Co. -- for use in certain snack foods and required all products containing olestra be labeled.

Because of its unique chemical composition, olestra adds no fat or calories to food. Potato chips, crackers, tortilla chips or other snacks made with olestra will be lower in fat and calories than snacks made with traditional fats.

"Olestra may cause abdominal cramping and loose stools in some individuals, and inhibits the body's absorption of certain fat-soluble vitamins and nutrients," said Commissioner of Food and Drugs David A. Kessler, M.D. "FDA is requiring Procter & Gamble and other manufacturers who use olestra to label all foods made with it, and, to protect the public health, to add essential vitamins -- Vitamins A, D, E and K -- to olestra."

As a condition of approval, Procter & Gamble will conduct studies to monitor consumption as well as studies on olestra's long-term effects. The FDA will formally review these studies in a public meeting of the Foods Advisory Committee within 30 months.

The approval today means that FDA has determined that the available data and information establish that olestra is safe for use in savory snacks.

The following labeling statement will be required on all products made with 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."

Like all food additives, olestra's safety was the primary focus of FDA evaluation. For olestra, the safety evaluation focused not only on its toxicity, but also on the product's effects on the absorption of nutrients and on the gastrointestinal system.

Studies of olestra indicated it may cause intestinal cramps and loose stools in some individuals. These gastrointestinal effects do not have medical consequences. The required labeling will give consumers needed information to discontinue this product if appropriate.

Clinical testing also indicated that olestra absorbs fat-soluble vitamins (Vitamins A, D, E and K) from foods eaten at the same time as olestra-containing products. Studies also demonstrated, however, that this effect could be compensated for by replacing these essential nutrients in olestra-containing snacks. This information will also be provided consumers in the product labeling.

In addition to inhibiting the absorption of essential vitamins, olestra reduces the absorption of some carotenoids -- nutrients found in carrots, sweet potatoes, green leaf vegetables and some animal tissue. The company's post-marketing monitoring of olestra consumption levels and additional studies will provide FDA with further information about olestra's effects on the absorption of carotenoids. The role of carotenoids in human health is not fully understood. FDA will continue to monitor all available scientific research on the role of carotenoids in human health.

In addressing these questions, FDA evaluated more than 150,000 pages of data on olestra, drawn from more than 150 studies. Procter & Gamble submitted these data in its original 1987 food additive petition, and in several amendments filed since then to that petition.

In addition, FDA sought advice from outside experts through its Food Advisory Committee. A special working group of the committee met in public in November 1995 to review and discuss the safety questions regarding olestra. After evaluating data presented by FDA, the company, and organizations and individuals both opposing and supporting olestra's approval, a clear majority of the working group agreed that all the major safety issues had been identified and addressed by the FDA review, and that the data provided reasonable certainty that the proposed use of olestra would be safe. A majority of the full Food Advisory Committee, which later reviewed the data in public, reaffirmed that judgment.

The company, based in Cincinnati, Ohio, plans to market the product soon under the trade name Olean.












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