April 1, 1996
Contact: Penelope Miller (202) 332-9110, ext. 358
Michael F. Jacobson, ext. 328
Last January, the FDA approved the fat substitute olestra on the condition that products bear the proposed notice: "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."
The FDA, though, said that the actual wording might change, depending upon consumer research conducted by Procter & Gamble and any other information the agency received. Procter & Gamble is expected to lobby the FDA for bland, reassuring language.
Today, the nonprofit Center for Science in the Public Interest, which opposed the FDA's approval of olestra, submitted a 25-page comment to the FDA urging clearer labeling. CSPI urged that the label alert consumers to all the gastrointestinal symptoms caused by olestra, including diarrhea, loose stools, anal leakage, gas, and fecal urgency. "Inclusion of all symptoms is necessary," CSPI executive director Michael Jacobson said, "to ensure that consumers are able to identify the cause of problems induced by olestra."
CSPI also urged that consumers be alerted to the loss of carotenoids that olestra causes. According to the Department of Health and Human Services (the FDA's parent agency) and the Department of Agriculture, carotenoids are important because of their likely role in preventing cancer and other chronic diseases.
Jacobson said, "Many leading academic experts and current and former government scientists opposed the approval of olestra, because small amounts can greatly reduce carotenoid absorption. Nevertheless, the FDA, when it approved olestra, dismissed concerns about carotenoids. Consumers must be told about olestra's effect on these nutrients."
The FDA is allowing companies to print the required notice on the front or the back of the package. CSPI said that the notice is so important that it should be required on the front of the package. CSPI also urged that the size of the notice increase along with the size of the package so that a small notice won't get lost on a big package.
CSPI has filed a formal appeal of the FDA's decision to approve olestra. CSPI has also filed complaints with the Federal Trade Commission concerning Procter & Gamble's advertising for olestra and urged that the FDA-required label notice be included in ads for olestra and olestra-containing foods. Neither agency has responded.
CSPI is a nonprofit health-advocacy organization that was founded in 1971. CSPI is supported largely by the 750,000 subscribers to its Nutrition Action Healthletter. CSPI is well-known for its studies of theater popcorn, Chinese restaurants, and other foods eaten outside of the home.
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CSPI's Proposed Olestra Label Notice
(Front of package)
NOTICE. This product contains olestra. Olestra can cause diarrhea, loose stools, fecal urgency, nausea, gas, and bloating. Olestra can cause underwear staining, anal leakage, greasy bowel movements, and oil in toilet. Symptoms should go away within 48 hours after you stop eating olestra foods. If symptoms persist, call your doctor.
Olestra reduces the absorption of some nutrients, and vitamins A, D, E, and K have been added to compensate. However, other nutrients, including carotenoids have not been replaced. Loss of carotenoids may increase the risk of cancer, heart disease and blindness.
** See back label for further information.**
(Back label, in highlighted box)
NOTICE. IF YOU TAKE COUMADIN, HAVE A BOWEL OR MALABSORPTION DISORDER, SUCH AS ULCERATIVE COLITIS OR IRRITABLE BOWEL, CONSULT YOUR PHYSICIAN BEFORE EATING THIS OR OTHER OLESTRA FOODS.
Children and older people should limit their intake of olestra foods. If you experience a problem after eating this product, AVOID ALL OLESTRA FOODS and call this toll-free number: 1-800-xxx-xxxx.