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as a drug. Daughters of women who took DES during pregnancy suffered from infer- tility and cancer when they reached their twenties. inhibitors, phytic acid and genistein. But the FDA literature review dismissed dis- cussion of adverse impacts, with the state- ment that it was important for "adequate processing" to remove them. Genistein could be removed with an alcohol wash, but it was an expensive pro- cedure that processors avoided. Later stud- ies determined that trypsin inhibitor content could be removed only with long periods of heat and pressure, but the FDA has imposed no requirements for manufacturers to do so. The FDA was more concerned with toxins formed during processing, specifically nitrites and lysinoalanine. ”* Even at low levels of consumption—aver- aging one-third of a gram per day at the time—the presence of these carcinogens was considered too great a threat to public health to allow GRAS status. Soy protein did have approval for use as a binder in cardboard boxes, and this approval was allowed to continue, as researchers considered that migration of nitrites from the box into the food contents would be too small to constitute a cancer risk. FDA officials called for safety least somewhat predictive of what occurs in humans. There is no reason to assume that there will be gross malformations of fetuses but there may be subtle changes, such as neurobehavioral attributes, immune function and sex hormone levels." The results, he said, "could be nothing, or could be something of great concern...if mom is eating something that can act like sex hor- mones, it is logical to wonder if that could change the baby's development".” A study of babies born to vegetarian mothers, published in January 2000, indi- cated just what those changes in baby's development might be. Mothers who ate a vegetarian diet during pregnancy had a fivefold greater risk of delivering a boy with hypospadias, a birth defect of the penis.” The authors of the study suggested that the cause was greater exposure to phy- toestrogens in soy foods popular with vege- tarians. Problems with female offspring of vegetarian mothers are more likely to show up later in life. While soy's oestrogenic effect is less than that of diethylstilbestrol (DES), the dose is likely to be higher because it is consumed as a food, not taken QUESTIONS OVER 'GRAS' STATUS Lurking in the background of industry hype for soy is the nagging question of whether it's even legal to add soy protein isolate to food. All food additives not in common use prior to 1958, including casein protein from milk, must have GRAS (Generally Recognized As Safe) status. In 1972, the Nixon administration directed a re-examination of substances believed to be GRAS, in the light of any scientific infor- mation then available. This re-examination included casein protein which became cod- ified as GRAS in 1978. In 1974, the FDA obtained a literature review of soy protein because, as soy protein had not been used in food until 1959 and was not even in common use in the early 1970s, it was not eligible to have its GRAS status grandfa- thered under the provisions of the Food, Drug and Cosmetic Act. The scientific literature up to 1974 recognised many antinutrients in factory- made soy protein, including trypsin APRIL — MAY 2000 NEXUS - 85 Tragedy and Hype: The Third International Soy Symposium Continued from page 24 Continued on page 86