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Fat substitute gets FDA approval

BMJ 1996; 312 doi: https://doi.org/10.1136/bmj.312.7026.270a (Published 03 February 1996) Cite this as: BMJ 1996;312:270
  1. Terri L Rutter

    The US Food and Drug Administration last week approved the controversial fat substitute Olestra. The move follows fears voiced by two professors from the Harvard School of Public Health that the product will cause long term detrimental health effects. Their fears in turn led a group of 30 public health specialists to write to the administration's commissioner, David Kessler, appealing to him to refuse approval.

    Olestra, a mixture of sugar and vegetable oil, is a sucrose polyester made by attaching six or seven fatty acids on to a sucrose molecule. Other fat substitutes have three molecules attached to a glycerol molecule and so resemble real fat more closely. Olestra's bulkier shape is too large to be absorbed by the intestine, so it passes through the digestive tract, leaving behind no fat or calories.

    Proctor and Gamble, the company that spent 25 years making Olestra, filed an application in 1987 to use the product—which has the feel, taste, and cooking properties of real fat—as a replacement for shortening and cooking oils in the preparation of salty and savoury snacks, such as potato crisps.

    Since 1987 the company has presented 150 scientific studies in an attempt to prove Olestra's safety as a food additive and particularly to discredit claims that Olestra causes gastrointestinal problems. In the largest of these studies over 3000 participants of all ages ate as many snacks made with Olestra as they chose for five months. In some people, the product caused soft stools, and flatulence. The company argued that many foods cause similar symptoms.

    Walter Willet and Meir Stampfer, two professors from the Harvard School of Public Health, argue that eating Olestra can lead to long term health problems because as it passes out of the digestive system the fat soluble vitamins A, D, E, and K and carotenoids attach to the Olestra molecule and are swept away along with it.

    Professors Willet and Stampfer included with their letter to Kessler a bibliography of 26 references to studies that link low carotenoid concentrations and increased risk of macular degeneration, prostate and breast cancer, and heart disease. Proctor and Gamble says that there is only weak evidence that low carotenoids cause disease and that people do not tend to eat foods containing vitamins and snacks at the same time.

    As a condition of Olestra's approval, Proctor and Gamble must fortify its product with the vitamins A, D, E, and K, and carry out studies into its long term health effects.—TERRI L RUTTER, medical writer, Boston

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