Health Group Urges FDA Not to Approve New Fat Substitute

Just as Olestra, the revolutionary new experimental fat substitute, appeared closer than ever before to reaching the marketplace, an influential consumer group charged Wednesday that the substance is unsafe and asked the Food and Drug Administration not to approve it.

The Center for Science in the Public Interest said that Olestra depletes the body of critical carotenoids, such as beta carotene, which are protective against numerous disorders, and causes serious gastrointestinal problems, including diarrhea.

But officials from Procter & Gamble Co., its manufacturer, insisted that the substance is safe, saying that it had been studied for 25 years in at least 60 clinical trials and in more than 8,000 adults and children.

Procter & Gamble is seeking government approval only for its use in snack foods, such as potato or tortilla chips. But the company ultimately hopes to expand its use to numerous other products, including salad dressings, baked goods, ice cream, fried foods, such as french fries, and processed and restaurant foods.

An FDA advisory panel is scheduled to examine the data in two weeks and decide whether to recommend that the agency approve the substance for use in snacks. To expand its uses, the company would need further FDA review and approval.

Olestra, which was first studied as a possible cholesterol-reducing drug, is the first so-called “fake fat” that is heat-stable and can be used in baking and frying. Simplesse, a fat substitute made from milk and egg white protein, was approved by the FDA in 1990 for use in frozen desserts but cannot be used in cooking.

Olestra is a sucrose “polyester”--a technical term for the chemical binding process--made from sugar and vegetable oil. But the extra fatty acids in it cannot be digested or absorbed by the body--which is why it adds no fat or calories.

However the Center for Science in the Public Interest, after studying existing research--much of it conducted by the company itself--said that Olestra can produce unpleasant--and possibly dangerous--side effects and urged that approval be denied.

“Let me be clear: CSPI heartily endorses lower-fat foods and safe fat substitutes, such as Simplesse and various vegetable gums,” said Michael Jacobson, the center’s executive director. “But Olestra does not fit the bill.”

The center has long advocated foods low in fat and in recent years has studied--and criticized--Chinese, Italian and Mexican restaurant food and movie theater popcorn for their high-fat content.

Olestra can eliminate carotenoids from the blood, as well as vitamins A, D, E and K, which are believed to be protective against certain cancers, stroke, heart disease and blindness in the elderly, the center said.

The nutrients attach themselves to Olestra and are vacuumed out of the body before they can be absorbed.

And even small servings can cause gastrointestinal problems, such as nausea, bloating and diarrhea, in both children and adults, the center said.

Procter & Gamble accused the center of distorting study results, and emphasizing isolated examples, rather than the body of research. While not denying the side effects, company officials said they are not applicable to “the real world,” i.e., consumer eating patterns.