WASHINGTON -- One of the leading researchers in the field of nutrition and degenerative diseases said Wednesday that long-term use of a new fat substitute, already available nationwide in potato chips, may cause thousands of additional cases of cancer and heart disease.
Dr. Walter Willett, the chairman of the nutrition department at the Harvard School of Public Health, said it would be better if there were none of the fat substitute, olestra, in the food supply but if it is permitted it should carry a warning about potential long-term hazards. He made his comments at a news conference held by the Center for Science in the Public Interest, a nutrition advocacy group that has campaigned against olestra, and conducts regular studies on food and nutrition.
Procter & Gamble, which sells olestra under the brand name Olean, and the Food and Drug Administration, which approved the fat substitute 2 1/2 years ago, disagree with Willett's conclusions and say that olestra is safe, though they acknowledge the possibility of short-term problems for some people. That is why all products containing olestra must carry a label warning that "olestra may cause abdominal cramping and loose stools." There have been thousands of reported complaints about these short-term effects.
WOW potato chips, made by Frito-Lay, the first product in nationwide distribution to contain olestra, have been on the market since March.
Next week an FDA advisory committee will decide whether to permit olestra to stay on the market, and it appears that there will be no change in its status.
Willett said that the approval of olestra is forcing the public to "participate in a massive and uncontrolled experiment without their informed consent." He based his claim on olestra's interference with the absorption of fat-soluble nutrients, both vitamins and carotenoids. Carotenoids are what make fruits and vegetables red, yellow or orange.
When the FDA approved the use of the olestra in 1995 it required that the fat-soluble vitamins A, D, E and K be added to foods containing olestra, but it did not require the addition of the carotenoids, because there was insufficient proof that they were protective against any diseases.
Since then, the Department of Health and Human Services, the National Cancer Institute and the World Cancer Research Fund have recognized carotenoids' likely benefits. "Dietary Guidelines for Americans," published by the Department of Health and Human Services, cites their "potentially beneficial role in reducing the risk for cancer and certain other chronic diseases."
Most of the evidence comes from large human studies that associate low intakes or blood levels of these nutrients with higher risk of certain cancers -- including lung, prostate, breast and colon -- as well as higher risk of heart disease and stroke and macular degeneration, the most common cause of blindness in the elderly.
Willett and 13 colleagues from other research institutions have sent a letter to the FDA acknowledging that "carotenoids have not been proven with certainty to provide human health benefits, but numerous biochemical, clinical and epidemiologic studies indicate that carotenoids are likely to protect against several cancers."
One of the signers, Dr. William Connor, professor of medicine and clinical nutrition at Oregon Health Sciences University in Portland said, "Before putting olestra into food it must be proven completely safe because we clearly don't need it."
But Procter & Gamble says olestra is helpful in reducing caloric and fat intake.
Concerning carotenoids, Procter & Gamble's own studies found that a 1-ounce package of potato chips made with olestra will reduce their level in the blood by 50 percent.
If olestra sells as well as Procter & Gamble hopes, Willett and his Harvard colleague, Dr. Meir Stampfer, believe that the average carotenoid levels in the population would be reduced by about 10 percent. Based on these assumptions Willett said they estimate an additional 2,000 to 9,800 cases of prostate cancer, 32,000 additional cases of coronary heart disease, 1,400 to 7,400 excess cases of lung cancer and 80 to 390 more cases of macular degeneration.
Willett stressed that "there is no proof that these excess cases will occur." But, he added, "These estimates indicate the size of the gamble that Procter & Gamble is willing to take with your health and mine."
It appears that the Food and Drug Administration does not agree with Willett's conclusions. Dr. Alan Rulis, director of the office of premarket approval in the Center for Food Safety and Applied Nutrition, said, "I don't want to prejudge the issue. It is far from settled, but we have not seen real documented consensus agreement about the benefits of carotenoids. The regulatory status of olestra will be status quo."
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