FDA Memo Concluded Olestra Causes Diarrhea
1995 FDA Review of Unpublished P&G Study Posted On Internet
WASHINGTON - A 1995 Food and Drug Administration (FDA) review of an important study sponsored by Procter and Gamble (P&G) demonstrated that olestra can cause severe diarrhea. The FDA review of the “Fecal Parameters” study, obtained by the Center for Science in the Public Interest (CSPI) through the Freedom of Information Act (FOIA), is now posted on the Internet at www.cspinet.org/olestra/fda_memo.html.
The “Fecal Parameters” study was conducted in 1989. However, P&G did not submit the study to the Food and Drug Administration (FDA) until December 6, 1995, three weeks after an FDA advisory committee completed its review of what it believed were all the "key" studies of olestra. P&G maintains more than 150 studies demonstrate olestra’s safety, but rarely acknowledges the “Fecal Parameters” study.
"CSPI is posting the FDA review on the Internet to assist physicians and consumers," said Michael F. Jacobson, Ph.D, CSPI’s executive director “Physicians who diagnose patients with gastrointestinal symptoms should be aware that olestra might be the culprit.”
The “Fecal Parameters” study was reviewed by FDA medical officer Karl Klontz, M.D., and described in a memorandum dated December 26, 1995. According to Dr. Klontz, olestra caused a statistically significant increase in diarrhea. The key phase of the study involved 16 people who believed they previously had reacted to olestra. Dr. Klontz said that six of the 11 subjects who experienced diarrhea while eating 20 grams of olestra per day reported the diarrhea as "severe." Dr. Klontz concluded that “the increased water loss in the stools of subjects reporting olestra-associated diarrhea or loose stools is of concern. The concern is not so much for young, healthy persons, but for the elderly and young children. . . .These conclusions reinforce the need to have a clear, informative label on all olestra-containing products.”
In 1996, the FDA approved the use of olestra in salty snack foods. Currently, the FDA is considering whether to drop or retain the olestra warning notice (“may cause abdominal cramping or loose stools”) from packages. In addition, the Federal Trade Commission is considering CSPI’s complaints about the deceptive advertising of olestra and products made with it.
P&G and CSPI have submitted to the FDA more than 16,000 reports of adverse reactions to olestra. That is more reports than the FDA has received for all other food additives combined. Many of those reports describe cases of severe diarrhea similar to that reported in the “Fecal Parameters” study.
CSPI urges people who believe they suffered adverse effects as a result of eating olestra to call 1-888-OLESTRA or send an e-mail via www.cspinet.org/olestraform/