Olestra Approved with Special Labeling

FDA Consumer, April 1996 | Go to article overview

Olestra Approved with Special Labeling


Products containing olestra, a fat-based substitute for conventional fats, are expected to start appearing on store shelves soon. FDA approved olestra last Jan. 24 for use in certain snack foods. The agency is requiring all products containing olestra to be labeled with specific health information.

Procter & Gamble Co. developed olestra, which it is marketing under the trade name Olean.

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 it inhibits the body's absorption of certain fat-soluble vitamins and nutrients. FDA is requiring Procter & Gamble and other manufacturers who use olestra to label all foods made with olestra and 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. FDA will formally review these studies in a public meeting of the Foods Advisory Committee within 30 months from the date of olestra's approval.

The following labeling statement will be 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 bee 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, more frequent bowel movements, and loose stools in some individuals. These gastrointestinal effects do not have medical consequences. …

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