For Immediate Release: Thursday, February 13, 1997
Contact: Penelope Miller 202/332-9110, ext. 358
or Michael F. Jacobson, ext. 328
In documents marked "Confidential and Proprietary," Frito-Lay admits that olestra caused "anal
oil leakage" in a study commissioned by the company. Olestra is the controversial non-caloric fat
substitute marketed by Procter & Gamble.
Contact: Penelope Miller 202/332-9110, ext. 358
Last April, Frito-Lay became the first company to market olestra-containing chips. It sold a line of "Max" potato chips and corn chips in three test markets. It is expected to begin a new test market in Indianapolis in several days.
The Frito-Lay report states: "The anal oil leakage symptoms were observed in this study (3 to 9% incidence range above background), as well as other changes in elimination. . . . Underwear spotting was statistically significant in one of two low level consumer groups at a 5% incidence above background." Despite those problems, the authors of the report concluded that olestra-containing snacks "should have a high potential for acceptance in the marketplace."
The Frito-Lay documents were obtained by the Center for Science in the Public Interest (CSPI), a nonprofit organization that has opposed the approval and use of olestra.
In addition to the "elimination changes," Frito-Lay reported that people who consume 12 ounces or more of olestra chips a week "may experience a greater variety of gastrointestinal changes (up to a 7% incidence)." Twelve ounces is equivalent to six average 2-ounce servings of chips, according to U.S. Department of Agriculture data. Those higher-level consumers experienced diarrhea, cramps, loose stools, nausea, underwear spotting, and other symptoms. All of those symptoms have been reported by numerous consumers in the four test markets for Frito-Lay's and Procter & Gamble's olestra snacks. People who ate less olestra experienced certain symptoms, but at lower rates.
A confidential Frito-Lay memo dated August 4, 1995, expressed concern that people would be particularly aware of digestive problems the first few times they ate olestra snacks. "There is a potential for this phenomena to affect general product acceptance." An August 12,
1995, confidential memo reported that the company had developed a "risk management plan. . . . to manage public perception of [olestra-]related digestion issues, and to effectively handle any real issues that might emerge through the [olestra] market introduction."
The Frito-Lay report is significant because Procter & Gamble has argued strenuously that the additive does not cause "anal leakage." The Food and Drug Administration agreed even though CSPI had provided statistical analyses indicating that anal leakage occurred in Procter & Gamble's own controlled studies.
In a letter to CSPI executive director Michael F. Jacobson earlier this year, Frito-Lay vice president Philip J. Pifer said that his company had not submitted the results of its study to the FDA because major shortcomings in it "made it impossible to reach any valid conclusions or judgments." Pifer refused to provide CSPI with any details about the research, including additional data. The Frito-Lay report does not acknowledge that the study had any shortcomings. Jacobson wrote yesterday to FDA commissioner David Kessler that, "We suspect that if the shortcomings were so serious the company would not have devoted more than a year to preparing a report and would have described the shortcomings in the report."
The Frito-Lay study was conducted in 1993 and the report written in August 1995, three months before the FDA's Food Advisory Committee debated olestra's safety. In the report, olestra was called by the code name "Broadway Oil," or BWO. The study involved 306 subjects who ate olestra chips for four weeks and conventional chips for four weeks.
CSPI urged the FDA to obtain full information about Frito-Lay's research and decide for itself whether the data shed new light on olestra's gastrointestinal effects. Jacobson said that Procter & Gamble may have violated FDA regulations by not providing the FDA with Frito-Lay's study when the agency was considering approving olestra. Jacobson added, "It's important that the FDA examine the original data, because we've been told that Frito-Lay may have used only selected data to hide the extent of gastrointestinal problems."
Aside from problems like diarrhea, olestra inhibits the body's absorption of carotenoids, such as lycopene and alpha-carotene, which appear to protect against heart disease, cancer, and macular degeneration (the major cause of blindness in the elderly). Academic experts who have opposed olestra because of that problem include Walter Willett and Meir Stampfer of the Harvard School of Public Health; Mark Hegsted, the former chief of human nutrition at the U.S. Department of Agriculture; and Johanna Seddon, co-author of a paper linking low carotenoids to macular degeneration.
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