FDA Removes Requirement for Warning on Olestra Products
The FDA on Friday removed a requirement that labels on foods with olestra must include a warning that the products might cause cramps and diarrhea, the AP/St. Paul Pioneer Press reports. The FDA said that the side effects from olestra -- a synthetic chemical compound comprised of sugar and soybeans that tastes similar to fat but passes undigested through the body -- are mild and rare. The FDA approved sales of products with olestra in 1996, provided that the labels detailed potential gastrointestinal side effects. The FDA based the decision to allow the removal of the warning on a study of the effects that potato chips with Olestra had on individuals who ate them over a six-week period. Half of the 3,000 study participants ate potato chips with olestra, and half ate chips that they believed contained olestra but did not. Participants who ate potato chips with Olestra experienced "only slightly" more frequent bowel movements than those who ate the chips without olestra, according to FDA food additive chief George Pauli, the AP/Pioneer Press reports. In addition, Pauli said that some participants who attributed abdominal pain to olestra had either appendicitis or weeks of diarrhea from intestinal viruses (Neergaard, AP/St. Paul Pioneer Press, 8/3).
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