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deBriefings DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Food and Drug Administration National Center For Toxicological Research Jefferson, Ark. 72079-9502 Fallon and Mary Enig on the politics and health implica- tions of soy products (see NEXUS 7/03, April-May 2000), had quite an impact on readers, particularly those who had been consuming soy for many years without realising that it was related to their inexplicable health problems. The article mentioned the work of Daniel Sheehan, PhD, and Daniel Doerge, PhD, from the US Food and Drug Administration's National Center for Toxicological Research, who wrote a protest letter ahead of a new FDA ruling "authorizing the use, on food labels and in food labeling, of health claims on the association between soy protein and reduced risk of coronary heart disease (CHD)". The FDA had come to the conclusion that "soy protein included in a diet low in saturated fat and cholesterol may reduce the risk of CHD by lowering blood cholesterol lev- els". However, the FDA disregarded contradictory evidence, and the new ruling came into effect on 26 October 1999. Drs Sheehan and Doerge were interviewed for the ABC's 20/20 program in the US, broadcast on 9 June and since screened widely around the world. The program looked at the controversy over the safety of soy products as a healthy source of protein, focusing on the relationship between soy and breast cancer in women, accelerated brain ageing in men and developmental disorders in infants. The two researchers told 20/20 that they had tried in vain to stop the FDA's recommendation because it could be misinter- preted as a broader general endorsement beyond solely having benefits for the heart. (For program summary, see http://abc- news.go.com/onair/2020/2020_000609_soy_feature.html.) The following is the text of their letter dated 18 February 1999. (Please note that while it does refer to a number of studies involv- ing animals, we would like to make it clear that NEXUS in no way condones or supports the efficacy, validity or morality of ani- mal experimentation or vivisection.) QO: publication of "Tragedy and Hype", an article by Sally Daniel M. Sheehan, PhD Director, Estrogen Base Program Division of Genetic and Reproductive Toxicology and Daniel R. Doerge, PhD Division of Biochemical Toxicology February 18, 1999 Dockets Management Branch (HFA-305) Food and Drug Administration Rockville, MD 20852 Drs Sheehan and Doerge were interviewed for the ABC's 20/20 To whom it may concern, program in the US, broadcast on 9 June and since screened widely We are writing in reference to Docket #98P-0683; "Food around the world. The program looked at the controversy over _—_ Labeling: Health Claims; Soy Protein and Coronary Heart the safety of soy products as a healthy source of protein, focusing Disease". We oppose this health claim because there is abun- on the relationship between soy and breast cancer in women, dant evidence that some of the isoflavones found in soy, accelerated brain ageing in men and developmental disorders in including genistein and equol, a metabolize of daidzein, infants. The two researchers told 20/20 that they had tried in vain demonstrate toxicity in estrogen-sensitive tissues and in the to stop the FDA's recommendation because it could be misinter- thyroid. This is true for a number of species, including preted as a broader general endorsement beyond solely having humans. Additionally, the adverse effects in humans occur in benefits for the heart. (For program summary, see http://abc- several tissues and, apparently, by several distinct mechanisms. news.go.com/onair/2020/2020_000609_soy_feature.html.) Genistein is clearly estrogenic; it possesses the chemical The following is the text of their letter dated 18 February 1999. _ structural features necessary for estrogenic activity (Sheehan (Please note that while it does refer to a number of studies involv- and Medlock, 1995; Tong et al., 1997; Miksicek, 1998) and ing animals, we would like to make it clear that NEXUS in no induces estrogenic responses in developing and adult animals way condones or supports the efficacy, validity or morality of ani- and in adult humans. In rodents, equol is estrogenic and acts mal experimentation or vivisection.) as an estrogenic endocrine disrupter during development (Medlock et al., 1995a,b). Faber and Hughes (1993) showed alterations in LH regulation following developmental treatment - # 1 with genistein. Thus, during pregnancy in humans, isoflavones per se could be a risk factor for abnormal brain and reproduc- UNTA PRED AD 5 PA C E tive tract development. Furthermore, pregnant rhesus mon- keys fed genistein had serum estradiol levels 50-100 per cent higher than the controls in three different areas of the maternal Tr circulation (Harrison et al., 1998). Given that the rhesus mon- =<. _ key is the best experimental model for humans, and that a “~ woman's own estrogens are a very significant risk factor for breast cancer, it is unreasonable to approve the health claim until complete safety studies of soy protein are conducted. Of equally grave concern is the finding that the fetuses of genistein-fed monkeys had a 70 per cent higher serum estradiol level than did the controls (Harrison et al., 1998). Development is recognized as the most sensitive life-stage for estrogen toxicity because of the indisputable evidence of a very wide variety of frank malformations and serious functional deficits in experimental animals and humans. In the human population, DES exposure stands as a prime example of adverse estrogenic effects during development. About 50 per cent of the female offspring and a smaller fraction of male offspring displayed one or more malformations in the — =