title: Olestra: a new food additive.
abstract: In 1987, Procter and Gamble Company (Cincinnati, Ohio) petitioned the US Food and Drug Administration (FDA) to amend the food additive regulations to allow sucrose esterified with fatty acids (olestra) to be used as a replacement for conventional fats. The petitioner later restricted its request for use in savory snacks. FDA considered evidence submitted by the petitioner, the opinions of experts, proceedings from the FDA Food Advisory Committee, and public discussion and concluded on January 25, 1996, that olestra was safe for use in savory snacks (eg, salty snacks such as potato chips, corn chips). Olestra is not toxic, carcinogenic, genotoxic, or teratogenic and is neither absorbed nor metabolized by the body, but may be associated with gastrointestinal tract symptoms such as cramping or loose stools. In addition, olestra affects the absorption of fat-soluble vitamins but does not affect the absorption of water-soluble nutrients. The petitioner's studies concluded that when olestra was consumed with foods containing vitamins A, D, E, or K, the fat substitute could have an effect on the absorption of these nutrients. Therefore, FDA is requiring that fat-soluble vitamins lost through absorption be added back to olestra as follows: 170 IU vitamin A per gram olestra, 12 IU vitamin D per gram olestra, 2.8 IU vitamin E per gram olestra, and 8 micrograms vitamin K per gram olestra. As part of the conditions of approval FDA is requiring that the food labels of products containing olestra disclose the vitamin compensation and the potential gastrointestinal effects. FDA is also requiring that further studies examining consumption patterns and the effects of olestra on human beings be conducted.
authors.affiliation: Office of Special Investigations, US Food and Drug Administration, Rockville, MD 20857, USA.
authors.forename: D M
authors.initials: DM
authors.lastname: Prince
authors.forename: M A
authors.initials: MA
authors.lastname: Welschenbach
mesh_terms: D004064:Digestive System / Q000503:physiopathology; D017277:Drug Approval; D019358:Fat Substitutes / Q000009:adverse effects; D005227:Fatty Acids / Q000009:adverse effects; D006801:Humans; D013395:Sucrose / Q000009:adverse effects / Q000031:analogs & derivatives*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D019358:Fat Substitutes; D005227:Fatty Acids; D013395:Sucrose; C013692:sucrose polyester