FDA panel probes safety of fat substitute - C&EN Global Enterprise

Nov 20, 1995 - Eng. News , 1995, 73 (47), p 11 ... A working group of FDA's Food Advisory Committee began hearings on P&G's safety review of olestra u...
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Beaver (Hght) greets SRI winners (from left) Smith, Bhown, and Schneider.

technology/7 Beaver notes. In the first contest, Monsanto received 182 formal proposals and about 200 other submis­ sions. Independent judges named by the Center for Waste Reduction Technolo­ gies (CWRT) in Washington, D.C., which is affililated with AIChE, nar­ rowed the field to 54 finalists. The final­ ists were reviewed by six experts from government and industry. CWRT mem­ ber firms have the option of jointly fund­ ing runner-up proposals and have al­

ready decided to fund two projects based on four similar ideas. SRI received an initial $500,000 when the award was announced last spring (C&EN, April 10, page 9) and will get the remaining $500,000 if development work indicates the technology can be ap­ plied to Monsanto's manufacturing op­ erations. SRI has a year to demonstrate the process's feasibility on a bench scale with a flow rate of at least 1 lb per hour. Joseph Haggin

FDA panel probes safety of fat substitute Procter & Gamble's (P&G) eight-year effort to win Food & Drug Administra­ tion approval to market olestra, its noncaloric synthetic fat substitute, en­ tered a new stage last week. A working group of FDA's Food Advisory Com­ mittee began hearings on P&G's safety review of olestra use as a fat replace­ ment in some snacks.

The panel will determine if all criti­ cal safety issues have been addressed and if there is a "reasonable certainty of no harm" from olestra consump­ tion. FDA will base its decision, in part, on the panel's work. If FDA gives a green light, olestra could be used to replace 100% of the fat used in snacks such as cheese puffs and pota­ to chips. However, there is op­ position to approval of OR olestra. Opponents say it causes, among other things, depletion of im­ RO OR portant nutrients and a variety of gastrointestinal Triglyceride ROdisturbances. Olestra Olestra is a sucrose polyester. It looks like fat, R= 6-, 7-, or 8-carbon fatty acid group cooks like fat, and gives food the rich taste and Olestra has all the qualities of ordinary triglyceride mouth feel of ordinary fats, but its size and shape make it indigestible. fat. It is heat stable, so it can be used in frying,

cooking, and baking. But it differs from ordinary triglyceride fats because the sucrose polyester molecule is too big for fat-digesting enzymes to attack, thus contributing neither calories nor fat to the diet. For example, a serving of ordinary potato chips contains 10 g of fat and 160 calories. The same serving of chips cooked in olestra contains zero fat and only 70 calories. 'Olestra is the most thoroughly test­ ed new food ingredient ever consid­ ered by FDA," says Keith C. Triebwasser, P&G's director of regulatory and clinical development. Over the past 25 years, P&G has conducted more than 100 animal and 98 human studies, and it submitted 150,000 pages of test data to FDA. P&G is reported to have spent about $200 million researching and testing olestra. On the other hand, the Center for Science in the Public Interest (CSPI)—a Washington, D.C.-based health advoca­ cy group—is urging FDA to deny ap­ proval to olestra. "Olestra sounds too good to be true, and it is," says CSPI Executive Director Michael F. Jacobson. "Olestra is the first food additive with negative nutritional value." Indeed, Jacobson adds, "In recent weeks, Procter & Gamble has been run­ ning away from its own best studies." These studies, he says, indicate that olestra significantly depletes serum carotenoids and other fat-soluble nutri­ ents, which many believe are essential to protect people against heart disease, cancer, and blindness. In fact, P&G in­ tends to compensate for any potential drop in lipophilic nutrients by adding vitamins A, D, E, and Κ to products made with olestra. But CSPI says that won't work. CSPI also says that P&G data dem­ onstrate that even small amounts of olestra can cause gastrointestinal symptoms—ranging from loose stools to nausea, cramps, and fecal urgency, to passive anal leakage of olestra. P&G contends that people eating normal amounts of olestra-containing snacks do not experience such problems. But Jacobson cites studies of subjects who experienced gastrointestinal symptoms after eating 8, 20, and 32 g of olestra per day divided over three meals. Those levels would be found in 0.8, 2, and 3 oz of olestra-fried potato chips, respectively, he notes. Linda Ruber NOVEMBER 20,1995 C&EN

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