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Companies Putting Olestra in Chips Can Remove Diarrhea Warnings

FDA drops digestive warning from olestra
August 1, 2003
By Brad Dorfman

CHICAGO, Aug 1 (Reuters) - The Food & Drug Administration will no longer require companies that sell snacks and other foods containing the controversial fat substitute olestra to warn that it can cause cramping and other digestive problems.

In a ruling, the FDA eliminated that requirement, which has been in warning labels ever since 1996, when the agency allowed Procter & Gamble Co. PG.N to market the fat substitute, which is sold under the brand name Olean.

The decision comes after an FDA review of new scientific data, including clinical studies of people eating olestra, a substance made from soybeans and sugar, under "real-life" conditions, P&G said on Friday.

"We found that most studies couldn't even detect a difference from regular chips," George Pauli, associate director for science and policy in the FDA's office of food additive safety, said. "The effects that were reported were mild and really didn't have any effect on people's lives."

Studies using normal consumption of products with olestra showed the additive caused only infrequent, mild gastrointestinal effects, FDA said.

P&G uses Olestra in its fat-free Pringles chips and PepsiCo Inc.'s PEP.N Frito-Lay unit uses olestra in Wow! chips. Before Friday's ruling, packages of those products have had to contain a label that read: "This Product Contains Olestra. Olestra may cause abdominal cramping and loose stools. Olestra inhibits the absorption of some vitamins and other nutrients. Vitamins A, D, E, and K have been added."

Consumers will now see an asterisk after each of these added fat-soluble vitamins listed in the ingredient statement of products containing olestra. The asterisk will reference the statement, "Dietarily insignificant," the FDA said.

According to the U.S. Surgeon General, more than 60 percent of American adults are obese or overweight.

But despite concerns about cutting fat from diets, olestra has never reached the potential Cincinnati-based P&G had hoped for, in part because consumers were turned off by the potential painful digestive consequences of eating chips with Olean.

Last year P&G sold the plant that makes olestra to Twin Rivers Technology L.P., a P&G supplier and contracted to buy the olestra it needs from that plant.

Manufacturers attempting to sell products with olestra usually faced the problem of getting past the question of digestive problems associated with the product, Greg Allgood, associate director of P&G's health sciences institute, said.

"All of them have been in a Catch-22 because with this label, any time we tried to build consumer awareness, that came up and it was self-defeating," he said last month.

More companies may now use olestra in their products, one consultant said. But they are not likely to be able to use it as a major marketing tool like other additives, including sweetener Nutrasweet.

They lost that, they will never get it back," Ken Harris, partner at Cannondale Associates, said. "It cannot be marketed as an ingredient in a possitive way." (Additional reporting by Lisa

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