Friday, May 7, 2010

FDA Withholding Food Toxicity

The FDA concludes “soybean, genistein and daidzein” on their “Poisonous Plant Database."

CERHR director Dr. Shelby confirms soy as an “estrogenic endocrine disruptor,” well-known as largely poisonous especially during developmental exposure. IACC Dr. Insell agrees that "soy has endocrine disruptor properties" while FDA withheld from the American public.

The NTP describes “Endocrine Disrupting Agents- may turn on, shut off, or modify signals that hormones carry and thus affect the normal functions of tissues and organs.” Endocrine disruptors are overwhelmingly scientifically accepted as POISONOUS to entire body and brain systems particularly during developmental fetal, infant, and child exposure. Soy phyto-estrogenic endocrine disruptors are especially toxic to fetus, infant, and children.

The 2010 NTP Brief on Soy Infant Formula concludes that “Soy infant formula contains soy protein isolate…..Soy protein isolate contains isoflavones with estrogenic activity called ‘phytoestrogens,’ a subset of plant-derived compounds with biological activity similar to the female hormone estrogen. Isoflavones are found in many soy-based food products in addition to soy infant formula…and in some over-the-counter dietary supplements. Soy infant formula was selected for expert panel evaluation because of: (1) the availability of developmental toxicity studies in laboratory animals exposed to soy genistein, (the most abundant isoflavone found in soy infant formula), as well as a number of studies on human infants fed soy infant formula, (2) the availability of information of isoflavone exposures in infants fed soy infant formula, and (3) public concern for effects of soy infants formula on infant or child development.”

The CERHR panel determining the 2010 NTP Brief of Soy Infant Formula did NOT evaluate the intended: (1) Availability of developmental toxicity studies in laboratory animals exposed to soy genistein, as well as a number of studies on human infants fed soy infant formula, (2) Availability of information of isoflavone exposures in infants fed soy infant formula, or (3) Or review or evaluate public concern (or multiple Medwatch reports)for (adverse) effects of soy infant formula on infant or child development.

Soy isoflavones are phytoestrogens to include soy genistein, daidzein, and glycitein of which cause estrogenic endocrine disruptor effects proven as most health-threatening during fetal, infant, and child developmental exposures. Public disclosure is past due!

2010 Draft NTP Brief on Soy Infant Formula asks: “CAN SOY INFANT FORMULA OR ITS ISOFLAVONE CONTENTS ADVERSELY AFFECT HUMAN DEVELOPMENT?

The 2010 Draft NTP Brief answer is .....“POSSIBLY.”
“POSSIBLY” is dictionary defined as “Capable of happening, existing or being true, capable of occurring, capable of developing.” Public disclosure is past due.

2010 NTP Brief on Soy Infant Formula continues with: “Because soy infant formula contains compounds with estrogen-like activity, ‘concern’ has been expressed that feeding soy infant formula might adversely affect development of the reproductive system. However, blood levels of total genistein in infants fed soy infant formula can exceed blood levels in rats administered genistein in the diet or in mice treated by subcutaneous injection at dose levels that induce adverse developmental effects….the possibility that soy infant formula may adversely affect human development cannot be dismissed.”

Where is public disclosure? The CERHR panel review representing this 2010 NTP Brief of Soy Infant Formula were stringently restricted to review minimal studies to determine “reproductive damage within 6 months of age.” The CERHR panel did NOT review Soy Infant Formula causation of: 1. Reproductive damage after 6 months of age, 2. Massive numbers of existing scientific animal and human study evidence proving physiological and neurological adverse effects repeatedly reported as caused by soy isoflavone genistein, daidzein, and glycitein contamination of fetus, infants and children. Again, the multiple scientific studies proving soybean anti-nutrients cause physiological and neurological adverse developmental health effects were also not CERHR panel investigated.

2010 Draft NTP Brief on Soy Infant Formula reports: "CLEAR EVIDENCE OF ADVERSE EFFECTS”....where is public disclosure? Where is soy infant formula withdrawal?

The 2010 Draft NTP Brief on Soy Infant Formula reports: "There is 'CLEAR Evidence' that soy phyto-estrogen genistein cause adverse developmental effects in laboratory animals. Manifested as: decreased age at vaginal opening, accelerated puberty, abnormal estrous cyclicity, cellular changes to the female reproductive tract, and decreased fecundity (i.e. decreased fertility, implants, and litter size).”

2010 Draft NTP Brief on Soy Infant Formula- “Infants fed soy infant formula can have blood levels of total genistein that exceed those measured in neonatal or weanling rodents following treatment with genistein at dose levels that induce adverse effects in the animals."

The NTP confirms that animal testing is a responsible major medical advancement considered relevant to human exposure responses. Particularly where it is medically unethical to deliberately poison fetus, infant and child, animal studies are considered a legitimate tool for study results. Soy phyto-toxic WARNING labels are warranted.

2010 Draft NTP Brief on Soy Forumla continues with, “Breast-Related Measures in Association with use of Soy Infant Formula – premature thelarche before 2 years of age and consumption of soy formula, breast buds more prevalent in 2nd year of life in infants fed soy formula verses milk.”

According to the CERHR panel, the 2010 Draft NTP Brief also reports: "In addition, a limitation of many of the studies that observed adverse effects in rodents is that (soy phyto-toxic) exposure occurred during the period of gestation, lactation and beyond weaning."

“Gestation, lactation and beyond weaning,” ARE in fact the same EXACT time-frames of human developmental soy phyto-toxic exposure! (1) Gestation: Dietary intake of soy phyto-toxic foods/beverages during pregnancy contaminates her fetus during “gestation”. (2) Lactation: Infants fed soy-based formula (most milk formulas in the USA are now contaminated with soy) again contaminate infant with soy phyto-poisoning during “lactation”. Nursing mothers whose dietary intake consists of soy products unknowingly contaminate her infant with soy phyto-toxicity as well. (3) Beyond weaning: This same toddler/child’s dietary intake consists of soy-phyto-toxic contaminated food/beverage products that are mostly unavoidable in the USA marketplace.

2010 Draft NTP Brief concludes, “Observed adverse effects occurred during gestation, lactation, and beyond weaning,” .....remains without public disclosure, without WARNING labels.

Just prior to the CERHR NTP Brief evaluation of soy formula toxicity, several hundred scientific studies detailing extensive evidence of developmental (physiological, reproductive, and neurological) soy phyto-poisoning adverse effects were hand delivered to each CERHR panel member. However, none of these studies were NTP panel reviewed.

Another most important scientific study written by NIEHS scientists; Jefferson, Doerge, Padilla-Banks, Woodling, Kissling and Newbold, titled “Oral Exposure to Genistin, the Glycosylated Form of Genistein, during Neonatal Life Adversely Affects the Female Reproductive System,” again hand delivered to this CERHR panel was also not reviewed.

2010 NTP Brief Table 5 describes: "Summary of Blood Levels of Genistein in Human Infants Fed Soy Infant Formula and Laboratory Animals- Associated effects observed in laboratory animals: Abnormal estrus cyclicity, decrease in litter size, altered ovarian differentiation, delayed vaginal opening, delayed parturition, decreased body weight, accelerated vaginal opening, and mammary gland hyperplasia in males, Increased incidence of multi-oocyte follicles, lower number of live pups per litter, lower number of implantation sites and corpora lutea, higher incidence of histomorphological changes of the reproductive tract (i.e., cystic ovaries, progressive proliferation lesions of the oviduct, cystic endometrial hyperplasia and uterine carcinoma, delayed testicular descent, and mammary gland hyperplasia in males."

With CERHR study review resulting in “reproductive damage within 6 months of age,” (as unreasonably restricted for CERHR panel review), panel did in fact conclude reproductive damaging effects ARE caused by developmental soy formula phyto-poisoning “within 6 months of age.” However, without moral or ethical explanation the majority of the CERHR panel members voted to withhold evidence from public information while at the same time concluding clear evidence of soy phyto-toxic “reproductive damage within 6 months of age” caused to both male and female infants.

One of the 14 CERHR panelist, Dr. Ruth Etzel can confirms shockingly outrageous and unreasonable peer panel decision to hush valid evidence of developmental reproductive soy phyto-toxicity as was their protocal.

For adequate determination of developmental soy phyto-poisoning and legitimate 2010 NTP Brief on Soy Infant Formula information, the CERHR panel did NOT review an overwhelming number of available scientific studies proving soy phyto-toxic-causation of multiple irreversible developmental neurological disorders to include; autism, as well as the soy phyto-poisoning-causation of: Mental Retardation, Downs Syndrome, Cerebral Palsy, Seizures, Behavioral disorders, ADD, ADHD and more.

The CERHR panel determining the 2010 NTP Brief on Soy Infant Formula did NOT review a large number of scientific studies proving soy phyto-poisoning-causation of a multiple severe developmental physiological disorders and life threatening diseases to include: allergies, asthma, gastrointestinal disorders, extensive reproductive disorders (diagnosed after 6 months of age), gender chaos, SIDS, thymus damage, hypothyroidism, kidney, liver, and pancreatic disease, insulin irregularities, diabetes, causation of childhood leukemia, lymphoma, and multiple cancers, as well as cancer metastasis.

2010 Draft NTP Brief on Soy Infant Formula reports: “Additional Sources of Soy Intake by Infants- A number of studies have reported on the use of soy foods in the context of infant feeding and feeding transitions during the first years of life. Data from IFPS II indicated that ~ 6% of infants consume soy foods by 1 year of age. A survey of the isoflavone (estrogen) content of infant cereals in New Zealand led the authors to conclude that supplementation of the diet of a 4-month old infant fed soy infant formula with a ‘single’ serving of cereal can increase isoflavone intake by more than 25% depending on the brand used. Infant may also be exposed to soy flour and soy oil…..in 2002 soy milk was reported as one of the more frequently consumed beverages in children 15 -18 months of age.”

2010 Draft NTP Brief on Soy Infant Formula reports: “Infants fed soy infant formula also have higher blood-based levels of genistein and daidzein compared to other populations such as vegans and Asian populations consuming a traditional diet high in soy foods….and isoflavones can be measured in blood within an hour of soy ingestion.”

In addition to soy's toxic estrogenic endocrine disruptors, this NPT/CERHR expert panel did NOT review the following soy poisons: phytic acid content, multiple heavy metal content, causation of: RET manipulations, Methionine and Tryptophan deficiency, damage to Mitrochondria, inhibition of Tyrosine Kinase, Trypsin, Topoisomerase, Cytokine deficiency, stimulation of P13 Kinase, damage to Interleukins, damage to multiple Essential Minerals, Oxidative Stress, evidence of soybean GMO/RR toxicity, and more.

2010 NTP Brief on Soy Infant Formula continues with: “The primary ingredients in soy infant formula includes corn syrup, soy protein isolate, sugar……” all FDA known developmental toxins.

Where are soy formula/foods WARNING labels?

2010 NTP Brief on Soy Formula: “Aluminum from mineral salts is found in soy infant formula at concentrations of 600-1300 ng/mL, levels that exceed aluminum concentrations in human milk, 4-65 ng/mL.” A 2003 CDC report confirms: “Brain and bone disease caused by high levels of aluminum in the body has been seen in children….Aluminum from the mother can enter her unborn baby through the placenta. Soy based infant formula contains higher concentrations of aluminum, as compared to milk-based infant formula or breast milk. The most important way families can lower exposures to aluminum is to know about the sources of aluminum…… and lessen their exposure to these sources.”

The several other known soy heavy metals were not panel investigated.

The truth is, there are several hundred published studies, as well as NIEHS and FDA reported confirmation of soy phyto-poisoning-causation of severe physiological, reproductive, and neurological disorders and diseases.

Ask FDA Commissioner.....margaret.hamburg@fda.hhs. gov, where are soy product WARNING labels based upon overwhelming scientific evidence, as well as repeat USA health organization confirmation repeatedly proving soy phyto-poisoning of fetus, infant, and child? Where is WITHDRAWAL of soy infant formulas?

The FDA can not promise developmental soy safety. American children are participating in an undocumented experiment, FDA approved. Is this alright by you?