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FDA removes Olestra warning

The Food and Drug Administration removed the warning on Olestra after it concluded that side effects are mild and rare.
/ Source: The Associated Press

Snacks made with the fake fat olestra no longer will have to bear the unappetizing label that warned they might cause cramps and diarrhea. The Food and Drug Administration lifted the warning Friday, concluding that if the zero-calorie fat substitute has any stomach-troubling effect, it’s mild and rare.

The FDA approved olestra’s sale in 1996, as long as packages bore labels spelling out possible gastrointestinal side effects. The synthetic chemical made of sugar and vegetable oil tastes like fat, but passes through the body undigested.

The warning caused something of an uproar and helped limit olestra’s slower-than-anticipated sales.

The consumer advocacy group Center for Science in the Public Interest repeatedly urged the FDA to remove olestra from the market, noting embarrassing episodes it had caused some consumers. Ultimately, the FDA received about 20,000 reports of gastrointestinal complaints among olestra eaters.

But olestra maker Procter & Gamble argued that the fake fat was safe and the complaints coincidence — after all, the company said, stomach upset and diarrhea are very common.

Friday, the FDA said it was convinced by a study that tracked how 3,000 people felt after eating chips during a six-week period. Half ate chips with olestra, and half ate chips they thought contained olestra but really didn’t, said FDA food additive chief George Pauli.

The olestra eaters had only slightly more frequent bowel movements than the people who ate full-fat chips, he said.

Of more concern to FDA were that people had falsely attributed serious health problems to olestra because of the warning label. Pauli cited people who blamed olestra for abdominal pain that turned out to be appendicitis and others who had weeks of diarrhea from intestinal viruses.

Some people might experience mild abdominal discomfort after eating olestra, just as some people do after eating high-fiber fruit, Pauli said. Fruit doesn’t bear a warning label, however, and now olestra won’t either.

Consumers should see the warning gradually disappear from labels as snack makers use up already-produced packaging, said Greg Allgood of Procter & Gamble, which makes olestra.

The fake fat is used in P&G’s Fat-Free Pringles, Frito-Lay’s WOW! snacks and Utz’s Yes! brand of potato chips. P&G said Americans have eaten more than 3 billion servings of snacks that contained olestra since 1996.

The anti-olestra group CSPI didn’t immediately respond to FDA’s decision.

Because olestra is undigested, it inhibits absorption of a few fat-clinging vitamins. FDA requires manufacturers to add vitamins A, D, E and K to products made with olestra to counter that effect. That requirement will continue, but packages no longer will have to disclose why the vitamins are being added.