[FDA Press Release with link to large PDF file Below ]
The Food and Drug Administration said yesterday that products containing olestra, the zero-calorie fat substitute that was supposed to revolutionize the way consumers felt about low-fat snacks, would no longer be required to carry a label indicating that the substance could cause digestive troubles.
Mindfully.org note:
The fact that this product causes diarrhea adds a new dimension to the term
"diet food"
Olestra, which was developed and marketed by Procter & Gamble as Olean, is used in salty snacks like Fat-Free Pringles, Frito-Lay's WOW snacks and Utz's Yes brand of potato chips.
When the F.D.A. approved olestra in 1996, it required companies to place a label on products that contained it, indicating that the ingredient could cause abdominal cramping and loose stools. The label also noted that vitamins A, D, E and K had been added because olestra inhibits the body's ability to absorb them.
But that label, along with changing trends in consumer eating habits, including scant interest in fat-free foods, discouraged many shoppers from buying products that were made with olestra. Food manufacturers opposed the label from the outset.
The F.D.A. said yesterday that it decided to remove the label because most consumers were aware of the risks associated with olestra and new data showed only a minor increase in digestive problems. Regulators also said shoppers found the label confusing and thought that eating the product would not allow them to digest vitamins and minerals that were not affected by olestra.
The new labeling rule, which still requires food manufacturers to add vitamins A, D, E and K to products, is effective immediately.
"We're pleased that the F.D.A. has taken this action and we think their decision is great news for consumers," Greg Allgood, an associate director for Procter & Gamble's Health Sciences Institute, said in a statement. "It will provide additional confidence to the millions of people who are enjoying low and fat-free snacks made with Olean."
But consumer groups opposed the move, contending the F.D.A. had failed in its mission to protect the public from harmful food additives.
"It will condemn many more people to the diarrhea and cramps that olestra too often causes," said Michael F. Jacobson, the executive director of the Center for Science in the Public Interest (CSPI), which has long opposed the use of olestra. "This is part of a pattern of F.D.A. caving in to every food industry desire."
FDA Talk Paper
T03-59
August 1, 2003
Media Inquiries: 301-436-2335
Consumer Inquiries: 888-INFO-FDA
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.
source: http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01245.html 3aug03
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