Olestra Approved With Special Labeling

Olestra Approved with Special Labeling

Snack products containing olestra, a fat-based substitute for conventional fats, now appear on store shelves. FDA approved olestra for use in certain snack foods in January 1996. The agency requires 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 the essential vitamins vitamins A, D, E, and K to olestra.

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 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, more frequent bowel movements, and loose stools in some individuals. These gastrointestinal effects do not have medical consequences. The required labeling will give consumers needed information to discontinue the 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 that replacing these essential nutrients in olestra-containing snacks compensates for this effect. This information will also be included in the product labeling.

In addition to inhibiting the absorption of essential vitamins, olestra reduces the absorption of carotenoids--nutrients found in carrots, sweet potatoes, green leaf vegetables, and some animal tissue. The company's postmarketing 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, and FDA is continuing to monitor all available scientific research on it.

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 subsequent amendments.

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 about olestra. The working group evaluated 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 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 reaffirmed that judgment.

FDA Consumer magazine (April 1996)

Please bookmark The Center For Weight Loss and Healthy Living
Make us your healthy living and weight loss center.

The information and product descriptions appearing on this website are for
information purposes only, and are not intended to provide medical advice to individuals.

Consult your doctor before starting a weight loss program or exercise program.