FDA Eliminates Digestive Warning From Olestra
WASHINGTON -- 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, Reuters reports.
In a ruling, the FDA eliminated that requirement, which has been in warning labels ever since 1996, when the agency allowed Procter & Gamble Co. 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," said George Pauli, associate director for science and policy in the FDA's office of food additive safety. "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, the FDA said.
Before Friday's ruling, packages of products containing Olestra 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.
More companies may now use olestra in their products, one consultant told Reuters. But they are not likely to be able to use it as a major marketing tool like other additives.
"They lost that; they will never get it back," said Ken Harris, a partner at Cannondale Associates. "It cannot be marketed as an ingredient in a positive way."
In a ruling, the FDA eliminated that requirement, which has been in warning labels ever since 1996, when the agency allowed Procter & Gamble Co. 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," said George Pauli, associate director for science and policy in the FDA's office of food additive safety. "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, the FDA said.
Before Friday's ruling, packages of products containing Olestra 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.
More companies may now use olestra in their products, one consultant told Reuters. But they are not likely to be able to use it as a major marketing tool like other additives.
"They lost that; they will never get it back," said Ken Harris, a partner at Cannondale Associates. "It cannot be marketed as an ingredient in a positive way."