P&G's OLESTRA "FAT REPLACEMENT" FOOD APPLICATION FOR SUCROSE POLYESTER has been filed with FDA for use in shortenings, oils and salted snacks, the company announced on May 7. Procter & Gamble said that the food additive application is "the result of more than 20 years of detailed testing and analysis of this unique ingredient." The edible oil/sugar ingredient is non-caloric and cholesterol free, P&G maintains. It is calorie-free because it "is not absorbed by the body," P&G said. Although P&G has filed the product as a food additive, it has been studied extensively for treatment use, including the removal of cholesterol from the body. A food additive approval for the ingredient could push the issue of food health claims to a new plane. Exemplary of the type of drug-style trials existing on olestra, one study published in 1986 in the American Journal of Clinical Nutrition suggested that in 10 obese patients tested, the use of olestra caused a decrease in the absorption of cholesterol. Three of the patients had diabetes mellitus only and three had diabetes mellitus and hypertriglyceridemia. In another 16-week outpatient study at the University of Cincinnati, olestra was given to obese subjects in the form of bread spread and salad dressing. The 36 subjects, all of whom had primary hypercholesterolemia, were on a hypocaloric diet, with one third of the group using olestra. The percentage of fat compared to total calories varied between the three groups. The results showed that olestra "induced significant reductions in LDL-C in hypercholesterolemic obese subjects beyond the effects of weight loss alone. The effects of [olestra] were significantly greater than those achieved by the use of a diet which severely limited conventional dietary fat intake."
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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