Safety evaluation of olestra, a nonabsorbed, fatlike fat replacement.

Olestra is the mixture of the hexa-, hepta-, and octa-esters of sucrose with long-chain fatty acids from any edible oil. Its physical properties are comparable to those of triglycerides, but it is not digested by lipolytic enzymes or absorbed and therefore is noncaloric. Technically, it can replace fat in a wide variety of foods and can be used to make cooked, baked, and fried foods lower in fat and calories. A Food Additive Petition is under review by the FDA, which is comprised of results of extensive testing in animals and humans. The major areas of investigation are metabolism and absorption, chronic toxicity, mutagenicity, carcinogenicity, reproductive and developmental toxicity, safety for gastrointestinal tract, nutrition, and the potential for olestra to affect absorption of drugs. This testing involved studies in five different species of animals and over 30 clinical investigations. The results of this research support the safety of olestra for use in foods.