http://www.leinsterclinic.ie/maynooth_doctor/Articles/78-soy-_base_d-in... *SOY _base_D INFANT FORMULAS – ARE THEY SAFE ?* Dr NEVILLE  WILSON. Soy _base_d infant formulas (SBIF) have been in use in the West for nearly 100 years, providing a non-milk _base_d alternative to human or dairy milk in cases of perceived infant allergy or intolerance to dairy milk protein or lactose. (1). In the last 45 years the original soy flour product has been replaced by the Soy Protein Isolate (SPI) reported to be free of cow’s milk protein and lactose, and necessarily fortified with iron, vitamins and minerals, and the amino-acids L-methionine, L-carnitine, and taurine. (2).  Docosahexanoic and arachidonic acids have also been added to provide essential fatty acids. The protein content derives from a soy isolate, the fat content from vegetable oils, which may vary between manufacturers, and carbohydrate sources are a variety of corn syrup products. The popularity of soy-_base_d products, for children and adults, derives from consumer confidence inspired by aggressive marketing strategies initiated by the multi-billion dollar Soy Industry. *CLAIMS OF SOY SAFETY*. The successful promotion of Soy products has been driven by vociferous claims of safety against a background of dissenting voices raising concerns about developmental abnormalities in adolescents who used SBIF during their early formative years. Outcomes from several animal studies and retrospective human studies have prompted concerns about nutritional adequacy, sexual development, thyroid disease, immune function and neurodevelopment in subjects exposed to soy products. These concerns are considered by Merritt and Jenks to be groundless in their documented argument for the safety of SBIF. Their paper, “Safety of Soy-_base_d  Infant  Formula containing Isoflavones: the Clinical Evidence”  (3) challenges the conclusions imbedded in international policy on SBIF which discourages the routine use of SBIF and recommends only their considered use under medical supervision in extreme cases of clinical need. The UK, NZ, Ireland, Australia, Canada and Switzerland have issued policy statements challenging the routine use of SBIF. Merritt and Jenks provide a comprehensive list of supportive references in defence of their soy-safety argument. They conclude that SBIF are a healthy alternative to human and cow’s milk and that no conclusive evidence supports concerns about safety for infants who consume soy-_base_d products. Their professional ties to the pharmaceutical companies that produce SBIF are noted. Claims of Soy safety have also been lodged by the International Formula Council, (4) representing the Infant Formula industry, which  disputes  the perception of harm arising from soy isoflavones.  Further safety claims have been made  by the Soyfoods Association of North America, who, in 2007, appealed to statements of soy safety, issued by “health experts” such as the US Food and Drug Administration (FDA) (5), the American Cancer Society (6), the National Cancer Institute (7), and the American Institute of Cancer Research (8).  Soyfoods Association of North America issued a soy-safety statement _base_d on the conclusions of these organisations that soy products are heart-healthy, contain health-beneficial isoflavones, have no adverse hormonal effects, are safe in pregnancy, reduce the risk of breast cancer, and have no adverse effects on thyroid function. *SOY SAFETY CLAIMS DISPUTED*: A fact sheet contradicting earlier claims of soy safety emerged from Cornell University suggestive of mounting evidence that high soy diets increase the risk of breast cancer,  and in October, 2005  SOLAE, A Soy Industry company, withdrew it’s FDA petition for soy safety in the face of growing evidence that soy can cause, contribute or accelerate the growth of cancer. In July 2005 the Israeli Health Ministry warned of potential harm to soy fed infants, echoing the warnings of those issued by the British Committee on Toxicity and the Swiss Federal Health Service. These warnings related to emerging evidence _link_ing soy to digestive, immunological and neuroendocrine problems, as well as to a rising incidence of infertility, hypothyroidism and pancreatic cancer. The UK Committee on Toxicity and Chemicals in Food (COT) had already, in 1996, raised concerns about phytoesrogens in infant soy formulas. (10). Subsequently, the British Dietetic Association (BDA) issued similar warnings (2003) and discouraged the use of soy protein in children’s feeds during the first 6 months of life, at which time developing organs are vulnerable to phytoestrogen exposure. These several warnings and _expression_s of concern call for a cautious approach to the use of SBIF in children during their periods of critical development. *TOXICITY OF SOY PRODUCTS*: Kaayla Daniel  (11) reviews the anti-nutrient and toxic components of soy products and exposes several fraudulent health claims made by persons allied to the Soy Industry. Her counter arguments to claims of safety relate to hidden dangers of soy protein allergies (chap.25) and the toxic and harmful elements of soy protein isolate (SPI), the main ingredient of SBIF (chap. 8). Not only does SPI exhibit a wide range of mineral deficiencies and sulphur-containing amino-acids (chap. 8)  but  increasing levels of carcinogen  are generated during the modern production process. SPI was originally used as a sealer and binder for cardboard boxes, and  the Federation of American Society for Experimental Biology (FASE had approved its safe use only for that purpose. *MODERN PROCESSING METHODS*: The distinctly contrasting rapid processing methods of current soy products to the slow traditional fermentation methods employed by Asian producers have permitted the unwelcome retention of “anti-nutrients” and toxic contaminants in modern commercially produced soy products Potent trypsin enzyme inhibitors and haemaglutinin (clot promoters) are not eliminated by the modern processing of soy products, and harmful phytates are retained, which prevent the absorption of essential minerals like calcium, magnesium, iron and zinc.  Acid washing in aluminium and exposure to high temperatures and pressures to produce the textured vegetable protein further denatures the protein content of the PSI and introduces the added potential for aluminium toxicity. Despite the fact that SPI has never received GRAS (Generally Recognised as Safe) status, the FDA, in it’s 1999 health claim ruling, dismissed questions of harm arising from carcinogenic nitrites, nitrosamines and lysinoalinines, with the recommendation that “good manufacturing practices are and should be employed”. (12). There is no guarantee that such recommendations are being adopted. *FORMULA FOR DISASTER*: Contrary to statements by Mark Messina, a Soy industry spokesperson, SBIF are not used by Asian babies. The first experimental “soybean milk” was produced in 1928, but was used by adults and not children. (13). Asian babies do not use soy _base_d formulas. They are generally breast –fed and then switched to dairy _base_ infant formulas. The inherent lack of vitamins A, K, B12, and the minerals zinc, iron and calcium in early soy products necessitated their later fortification, with added vitamin C to enhance iron uptake. Iodine was added in 1961 to reduce the incidence of thyroid dysfunction and amino-acids methionine, carnitine and taurine added. The emergence of SPI in the early 1960s was not without concern for mineral deficiency and manganese toxicity. Manganese is present in soybeans, and, while it’s absorption is partially limited by the presence of phytates, significant amounts are nevertheless absorbed , thereby presenting the potential for manganese toxicity to the infant brain. This may result in neurotransmitter impairment and the potential for a range of behaviour problems, learning disabilities and violent tendencies. The allergenic nature of soy creates an added risk for infants who are allergic to cow’s milk, since they may demonstrate similar allergic reactions when exposed to soy products. (14). *HORMONAL CONCERNS*: A primary concern for consumers of SBIF is their exposure to high levels of phytoestrogens (plant estrogens) known as isoflavones, of which genistein, diadzein and glycitein constitute the highest levels. (15). The affinity of these phytoestrogens for oestrogen receptor sites throughout the human body create the potential for harmful interference with normal developmental and reproductive processes. (16), (17). A former Toxicologist at the FDA Centre for Toxicological Research states that infants being fed soy products “are at risk in a large uncontrolled and basically unmonitered human infant experiment”(18). This assessment was dismissed in 1995 by the UK  Infant and Dietetic Food Association (IDFA), who declared in a later statement (1999) that SBIF are “safe and infants thrive on them “. IDFA statements that “levels of phytoestrogens in SBIF are low, and that most of the effects of phytoestrogens are positive” are dismissed by Kaayla Daniels as “plainly incorrect”. (P331). The high levels of phytoestrogen present in SBIF have been estimated to be 13000 – 22000 more times the level of oestrogen found in milk-_base_d formulas. A Swiss Health Service Bulletin warns that 100g of Soy protein provides as much oestrogen as 1 oral contraceptive pill. (OCP).  Infants drinking SBIF thus ingest the equivalent  of  3 to 5 OCPs, or more, per day. (19). Male sex hormones exposed to genistein at a critical developmental stage during infancy may lead to physical, mental and behavioural defects at puberty, with  _expression_ of delayed puberty in boys and early sexual maturation in girls. The rising trend of precocious puberty may be explained by this phenomenon. (20). The 1986 Puerto Rico Study, largely ignored by promoters of the Soy industry, suggests a _link_ between premature breast development and soy formula ingestion. (21). A 2002 report from the Dept. of Food Science and Nutrition at the University of Illinois aroused added concerns for genistein effects on the thymus gland, thereby producing possible immune abnormalities. Levels of genistein in mice, compared to those in soy-fed human infants, caused significant atrophy of the thymus, and also suppressed humoral immunity, suggestive of similar immune impairment in soy-fed human infants. (22). An additional concern is that Bisphenol A (BPA) is a potentially toxic additive which is widely used in plastic packages and also the resin lining the food cans used in SBIF. The US Environmental Working Group (EWG) states that BPA is a toxin that may leach from containers into food products and induce cancer cell growth and neuronal desturbances in infants using these products. *CONCLUSION:* Until phytoestrogens can be shown to be safe for infants they should be removed from soy-_base_d infant formulas. SBIF are not a safe alternative for breast or dairy milk and should only be used in limited medical conditions under strict supervision and for a limited period only. Dr. Neville Wilson. 31 July, 2008.                                               *REFERENCES:**  *    1. Journal Nutrition. 2004; 134 (5); 12205-12245.    2. Paediatrics 1976; 57(2); 278-285.    3. Journal Nutrition. 2004 May; 134(5): 12205-12245.    4. www.fdw <http://www.fda/.gov/FDAC/departs/2000/400_ltrs.html    5. www.fda.gov (8January, 2007).    6. www.cancer.org/Dec 28, 2006.    7. Nutrition in Cancer Care ( www.cancer.gov/ 28 Dec 2006.    8. www.aicr.org/ 28 Dec, 2006.    9. www.foodstandards.gov.uk/news/newsarchive/working_group    10. Journal Fam.Health Care 2003,13,4,93.    11. The Whole Soy Story – Kaayla T. Daniel, PhD, CCN.    12. Life Sciences Research Office 1979 contract # FDA 223-75-2004    13. Chinese Journal Physiol. 1928, 2, 409.    14. www.racp.edu.au    15. Journal Agric Food Chem. 1994, 42, 1674-1677.    16. Proc Soc Exp Biol. Med 1998, 217,247-253.    17. NZ Med Journal 2000, 113, 1103,24-26.    18. D.Sheehan – clinical chem.1997, 43,850.    19. The Whole Soy Story – Kaayla T. Daniel, p 331.    20. Fenton – www.emedicine.com    21. The Whole Soy Story – Kaayla T. Daniel, pp 341-343.    22. www.pnas.org/content/99/11/7616.abstract ? ck=nck.