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FDA Talk Paper

T03-59
August 1, 2003

Media Inquiries: 301-436-2335
Consumer Inquiries: 888-INFO-FDA

FDA Changes Labeling Requirement for Olestra

The Food and Drug Administration (FDA) today announced a change in the labeling requirement for olestra -- the zero calorie fat substitute developed by Procter & Gamble Co. (P&G;) for use in certain snack foods -- because FDA has concluded the label statement is no longer warranted.

As a result of this decision, manufacturers will not be required to display the 1996 label statement on products containing olestra. However, FDA will require manufacturers to continue adding Vitamins A, D, E, and K to such products. 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."

FDA approved olestra in 1996 for use in savory snacks like potato chips, cheese puffs, and crackers. As part of that approval, FDA required manufacturers to add vitamins A, D, E, and K to olestra-containing foods to compensate for olestra’s effects on these fat-soluble vitamins.

Also, as part of that approval, FDA required manufacturers to place a label statement on all products made with olestra informing consumers that olestra may cause abdominal cramping and loose stools in some individuals, that it inhibits the body’s absorption of vitamins A, D, E, and K and other nutrients, and that these vitamins have been added to compensate for olestra’s effects on these nutrients.

FDA conducted a scientific review of several post-market studies submitted by P&G;, as well as adverse event reports submitted by P&G; and the Center for Science in the Public Interest. FDA concluded that the label statement was no longer warranted because:

"Real-life" consumption studies of products containing olestra showed olestra caused only infrequent, mild gastrointestinal (GI) effects. In fact, a 6-week study with more than 3,000 people showed that the group consuming olestra-containing chips experienced only a minor increase in bowel movement frequency compared to those people who consumed only full-fat chips.

Post-market studies showed consumers are aware of olestra and its potential GI effects.
Post-market consumer studies showed that consumers were confused by the required label because they did not understand that the label meant there would be no loss of vitamins. These post-market studies also indicated that consumers erroneously believed that vitamins and minerals not affected by olestra would be lost.
At a 1998 FDA Foods Advisory Committee meeting there was agreement that an asterisk-linked statement on the ingredient panel about added vitamins A, D, E, and K would be more useful to consumers.

While the current labeling requirements are effective immediately, FDA realizes and consumers can expect that there may be a period of time before companies introduce the new product label. For additional information, please visit http://www.fda.gov/OHRMS/DOCKETS/98fr/00F-0792-NFR00001.pdf.

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