Tuesday, August 30, 2016

TO CFSAN, who repeatedly fail to lawfully report massive existing published study evidence concluding adverse soy phyto-poisonous physiological, reproductive, and neurological effects are caused to most vulnerable exposed fetus, infants, and children.

Relative to my telephone conversation with CFSAN Dr. Patricia Hansen, it is clear that the CFSAN is without valid evidence of soy infant formula safety, while soy formulas, soy contaminated infant "milk" formulas and foods are marketed under the false public impression of not only soy safety but good health.  Neither are true, and neither are FDA established.  The CFSAN withholding of existing mass evidence that repeatedly and increasingly concludes fetal contamination is caused by maternal soy phyto-poison consumption is additional evidence of illegal U.S. marketing of misbranded and adulterated soy products.  An in-depth collection of FDA, NIH, and worldly renowned soy researcher published studies, as well as multiple health official testimonials, all conclude a long history of highest level health-threats due to the soy phyto-poisonous-causation of a host of deleterious developmental effects.  It remains fair to wonder not only why this long history of CFSAN failure to protect fetal, infant, and child health, but also why the CFSAN tends to protect billion dollar American soybean industries and Monsanto's GMO soy, rather than supporting an extensive history of overwhelming study evidence concluding a host of causal physiological, reproductive, and neurological adverse developmental effects.  Most vulnerable developmental exposure to multiple soy phyto-poisons are not FDA established as safe, while withheld from legitimate public disclosure.

According to multiple U.S. Food, Health, and Child Laws, Codes, and Acts, it is illegal to market unknown "fluctuating dosage levels" of this cornucopia of soybean phyto-poisons which include, and are not limited to: soy phytoestrogenic hormone disruptors, phytic acid, enzyme inhibitors, heavy metals, and additional developmental poisons as FDA listed below.  Only in the U.S. are soy infant formulas, soy contaminated infant "milk" formulas and foods so popularly marketed on grocer shelves.  Other countries around the world, listen to the scientific studies, practice child-safety first and prohibit baby-soy products on their shelves.  As healthiest brands of dog and cat foods promote, "No soy," or "Never soy," the CFSAN pollutes the fetal, infant, and child body and brain with inescapable soy phyto-poisons as an undisclosed, undocumented, child-health experiment, while illegally withholding public disclosure.

In the United States, as more than any other country in the world, there is unquestionably enormous power behind multi-billion dollar American soybean industries, as well as Monsanto GMO soybeans, while there are more soy formulas, soy contaminated infant "milk" formulas and foods marketed here in the U.S. than anywhere else in the world.  Worldwide countries refuse the marketing of soy formulas and foods to their babies due to overwhelming evidence of adverse health effects, while soy phyto-poisons are NOT proven as developmentally health-safe.  How much longer will the CFSAN illegally conceal a LONG, LONG, LONG history, an in-depth history that exposes deleterious soy phyto-poisonous adverse developmental fetal, infant, and child soy phyto-poisonous effects from lawful public disclosure?

As healthy brands of dog and cat foods fairly label "no soy" or "never soy" for best pet health, the CFSAN continues to allow the U.S. marketing of soy phyto-poisonous formulas to American babies, as well as contaminating infant/child soy foods, while massive numbers of published studies all report the high risk of adverse physiological, reproductive, and neurological effects, which remain publicly concealed. 

There is NO CFSAN established fetal, infant, or child phyto-poisonous soy safety, and a trusting American public, loving parents deserve this right to know the truth. 

Without benefit to market soy infant formulas for lactose intolerance, now there are lactose-free formulas.  Without reason to market soy formulas due to milk allergy, soy is a leading toxic allergen.  There is in fact NO known reason to market soy phyto-poisonous infant formulas, NO benefit, while containing fluctuating levels of a large variety of soybean phyto-poisons as illegally marketed, while NEVER established or CFSAN proven as developmentally safe, or to promote developmental growth.  Other than industry profits, there remains NO reason to market soy phyto-poisons to American babies and children, and NO reason for maternal soy phyto-poisonous contamination of fetus.

We are talking about NOT just one, two, or three published studies concluding adverse developmental soy phyto-poisonous effects, but in fact, decades-worth of nearly a thousand (and more) published study reports published by your own renowned FDA and NIH researchers, worldly researchers, ALL concluding a large variety of severe and irreversible adverse developmental body and brain risks caused to once healthy fetus, infants, and children due to this most vulnerable state of exposure to soy phyto-poisons. 

Why are these massive adverse developmental health soy phyto-poisonous studies, as well as FDA and NIH and CFSAN testimonials CFSAN ignored?  Instead of responsibly focusing upon a long history of valid study evidence as well as researcher testimonials, the CFSAN continues to use a scandalous NTP Brief on Soy Infant Formula, of which multiple "Guidelines" are broken, of which insignificant funded panel members conclude "Clear Evidence of Adverse (soy formula) Effects," but then the majority (of few total panelists) will vote, "minimal concern," to the delight of attending soybean lobbyists.  Clearly this deliberate scapegoat is CFSAN abused in order to rationalize their cover-up of existing massive and overwhelming evidence concluding severe and permanent adverse developmental soy phyto-poisonous effects as a matter of fact.   As CFSAN known, several decades worth of valid study soy phyto-poisonous adverse developmental health evidence, published from legitimately dedicated FDA, NIH, and worldwide soy phyto-toxic researchers conclude a large assortment of horrific and irreversible adverse physiological, reproductive, and neurological fetal, infant, and child effects, which remain CFSAN underappreciated, in fact illegally ignored and withheld.

FDA- 1999 Federal Register Notice in regards to GRAS status confirms, “No data were submitted to document the current levels of nitrites or nitrosamines in soy protein isolates.  GRAS status of soy did not include a thorough evaluation of the safety of potentially harmful components, e.g. lysioalanine, nitrites, and nitrosamines, trypsin inhibitors, phytates or phytic acid, and isoflavones."

Soy baby formulas also contain highest levels of not only several soy phyto-poisons, but also highest levels of developmentally toxic: corn syrup and sugar!  A certain combination for a host of severe childhood disorders, including obesity and those related diseases obesity can cause. 

FDA 1999 Federal Register Notice also states- Trypsin inhibitors- potential effects on pancreatic function...  trypsin inhibitors are responsible for [pancreatic] hyperplasia and formation of nodules seen in animal studies.  Further... high levels of trypsin inhibitors in humans can evoke this mechanism."  

Under section 409 and 201(s) of the Act each ingredient added to food including infant formula MUST have GRAS status for intended use.  “Safe or safety means there is reasonable certainty in the minds of competent scientists that the substances are not harmful under the intended condition of use." 

Competent scientists have not found developmental exposure to the many soybean phyto-poisons to be fetal, infant, or child safe.  The FDA has never confirmed soy phyto-poisonous ingredients with GRAS status as was demanded by soy profiteers, such as Archer Daniels Midland.

The Select Committee on GRAS Substances report on soy protein isolate- “Feeding soy protein isolates as the sole or major source of protein has impaired the utilization of fat-soluble vitamins or of minerals, especially calcium, phosphorus, magnesium, zinc, and copper.  The presence of up to 50 parts per million nitrite in soy protein isolates raises other possibilities of concern...

FDA Poisonous Plant Database includes soybean "genistein" and "daidzein" on their list of plant poisons. 

CFSAN Director Michael Shelby is one of countless who confirm soy phyto-estrogens are endocrine disruptors.  As well known established proven fact,  soybeans contain multiple phyto-estrogen endocrine disruptors, as the same endocrine or hormone disruptors that are CFSAN known, well-known as highest level developmental (as all animal and human) poisons.  Humans of all ages metabolize genistein, and daidzein differently, while some are capable of metabolizing daidzein into another soy endocrine disruptor, equol.  Frightfully, fetal, infant, and child exposure to soy phyto-estrogenic endocrine disruptors are NOT metabolized as a same one level endocrine disruptor poison for all.  No one knows the soy endocrine disruptor level that each fetus, infant, and child is exposed to, or able to metaboliize, or in combination with exposure to additional hormone disruptors, thus defining adulterated and misbranded soy phyto-estrogens. 

1999 NIEHS renowned soy experts, Daniel Doerge and Sheehan- began reporting on soy exposure to fetus, infants, and children concluding, “NO dose is without risk, the extent of risk is simply a function of dose."
Your own CFSAN Janice Oliver confirms, “FDA acknowledges 'concerns' have been voiced about possible effects of isoflavones in soy infant formula on sexual development, neurobehavioral development, immune function, and thyroid disease.” 

There remains NO lawful CFSAN public disclosure of your own CFSAN "concerns" as lawfully required by U.S. Food, Health, and Child Laws.

“NIEHS News" reports, (Soy) "Phytoestrogens are something to worry about.”

Terrible, terrible, and again without lawful public disclosure, the NIEHS includes, “Soy Infant Formula" on their list of “Environmental Agents" while confirming their list:  "Air pollution, Allergens, Arsenic, Dioxins, Endocrine disruptors, Formaldehyde, Lead, Mercury, Pesticides, Radon, Styrene, Water pollution, Soy Infant Formula”! 

Picture this: loving parents are feeding their baby a bottle of soy phyto-poisons, repeatedly, day and night over 24 hours, for up to a year or more, while CFSAN is placing their children at risk for innumerable severe and irreversible adverse health effects without public disclosure.  I can promise you that no FDA, CFSAN, or NIH Official will feed their baby soy-polluted formulas or foods.

NIEHS “[Soy] Isoflavones in soy products including soy formula are referred to as phytoestrogens because of their ability to act like the hormone estrogen in the body."

Ongoing since the 1970's and to this day, multiple NIEHS scientists: Doerge, Sheehan, Change, Newbold, Patisaul, Jefferson, and countless more consistently conclude extreme and outrageous soy phyto-poisonsous fetal, infant, and child adverse body and brain effects.  CFSAN allows soy phyto-poisons to be marketed as adulterated and misbranded across the U.S..

Soy phyto-poisonous experts NIEHS Drs. Sheehan and Doerge sent this letter to the FDA In 1999...screaming out their evidence of developmental soy phyto-poisoning decades ago and forever more!   (Look it up in your FDA files). 

"There is abundant evidence that some of the isoflavones found in soy, including genistein and equol, a metabolize of daidzen, demonstrate toxicity in estrogen sensitive tissues and in the thyroid.  This is true for a number of species, including humans.  Genistein is clearly estrogenic... In rodents, equol is estrogenic and acts as an estrogenic endocrine disruptor during development.  Faber and Hughes showed alterations in the LH regulation following developmental treatment with genistein.  Thus, during pregnancy in humans, isoflavones per se could be a risk factor for abnormal brain and reproductive tract development.  Of equally grave concern is the finding that the fetuses of genistein fed monkeys had a 70 percent higher serum estradiol level than did the controls.  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 human population DES exposure stands as a prime example of adverse estrogenic effects during development.  ...potency and dose differences between DES and the soy isoflavones do not provide any assurance that  the soy protein isoflavones per se will be without adverse effects.  Our conclusions are that no dose is without risk: the extent of risk is simply a function of dose.  Additionally, isoflavones are inhibitors of they thyroid peroxidase which makes T3 and T4.  Inhibition can be expected to generate thyroid abnormalities...  There exists a significant body of animal data that demonstrates goitrogenic and even carcinogenic effects of soy products.    The serum levels of isoflavone in infants receiving soy formula that are about five times  higher than in women receiving soy supplements who show menstrual cycle disturbances, including an increased estradiol level....  Furthermore, we need to be concerned about transplacental passage of isoflavones as the DES cause has shown us that estrogens can pass the placenta.  The animal data is also consistent with adverse effects in humans.  Subsequently, this same group showed a significant dose-dependent risk for development of vascular dementia and brain atrophy from consumption of tofu, a soy product risk in isoflavones.  I am unconvinced that the long history of apparent safe use of soy products can provide confidence that they are indeed without risk.  It should also be noted that... soy protein foods are GRAS  is in conflict with recent return by CFSAN to Archer Daniels Midland of a petition for GRAS status for soy protein because of deficiencies in reporting adverse effects in the petition.  Thus GRAS status has not been granted.  Linda Kahl can provide you with details.  Taken together, the findings presented here are self-consistent and demonstrate that genistein and other isoflavones can have adverse effects in a variety of species, including humans.  Isoflavones are like other estrogens in that they are two-edged swords....  The health labeling of soy protein isolate for foods needs to be considered just as would the addition of any estrogen or goitrogen to foods, which are bad ideas.  Estrogens... drugs are regulated by FDA and are taken under a physicians]'s care.  Patients are informed of risks, and are monitored by their physicians for evidence of toxicity.  There are no similar safeguards in place for foods, so the public will be put at potential risks from soy isoflavones in soy protein isolate without adequate warning and information."    

2015, NIEHS officer of Communications, Ian Thomas confirms, "...our scientists study things in the environment that could potentially make people sick.  This might include chemical agents like formaldehyde and pesticides or natural agents like mold and arsenic.  This also includes the study of soy."

And NIEHS NTP Senior Scientist John Bucher reports, "The larger issue of just how significant exposures to potential [soy] endocrine disruptors are to public health is still a subject of intensive research.  To date it appears that exposure to the developing fetus are more potentially harmful that those after birth."

Is there any way possible that CFSAN is NOT familiar with the long, long history of multiple NIEHS soy phyto-poisonous expert researcher testimonies, of whom for decades past, and present, continue to warn of developmental deleterious body and brain effects cause by developmental exposure to soybean phyto-poisons?  Or why does the CFSAN remain content with unlawful denial, while adulterating and misbranding the labeling of the assortment of soy phyto-poisons that saturate the American market, and contaminate fetus, infants, and children, as nowhere else in the world. 

Soy expert Dr. Setchell, “To deny that soy isoflavones have biological effects would be absurd given a wealth of evidence from in vitro, in vivo, cellular and molecular studies.”

NTP and NIEHS Director Linda Birnbaum also confirms, “… public health 'concern' about soy formula effects on infants and young children….  Soy fed infants... have highest exposure to any environmental estrogens… effects can be observed long after the actual exposure has ceased.”

2010, NIEHS researchers Patisaul and Jefferson conclude an in-depth horrific list of soy developmental adverse effects: stating- "increasing 'concern' is that phytoestrogens may interfere with the organizational role of estrogen in the developing brain and reproductive system.  Manipulation of estrogen during specific critical windows of development throughout gestation and early infancy leads to a myriad of adverse health outcomes including malformations in the ovary, uterus, mammary gland and prostate, reduced fertility, disrupted brain organization and reproductive tract cancers.” 

READ the "Cons," as reported by NIEHS Patisual and Jefferson!  Patisual and Jefferson state, "In general, the severity of the health effects correspond with timing and level of exposure, an observation which was the first, clear demonstration of how important it is to consider 'critical windows of exposure' when attempting to predict potential consequences of human exposure to endocrine disruptors, such as the phytoestrogens."  READ THE LONG LIST OF TRAGIC SOY- "CONS" - http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3074428/.

Also Look At: Medwatch reports, and your own CFSAN Adverse event reporting system (CAERS), post market surveillance system that includes several hundred adverse health reports from desperate parents regarding soy infant formula as the cause of their child(rens) adverse health effects. 

Soy phyto-poisons are so very relevant to massive numbers of study evidence, that even common sense dictates the cause of adverse fetal, infant, and child effects, due to most vulnerable developmental exposure to fluctuating dosage levels of multiple soy phyto-poisons!   "NO DOSE IS WITHOUT RISK."  At least until can be proven as safe.  Instead, it looks as though the CFSAN uses developmental soy phyto-poisonous unproven safety to protect billons in soy industry profits as priority, and least of all, fetal, infant, and child health.

There remains no lawful public disclosure to the fact that there is NO found FDA established- acceptable dosage level, for fetal, infant, and child exposure to the innumerable soy phyto-poisons.  This is NOT new information, but in fact decades old, and continually ongoing as current. 

In addition to the illegal marketing of fluctuating dosage levels of several soy phytoestrogenic endocrine disruptors, there are also fluctuating dosage levels of additional soybean phyto-poisons: phytic acid, essential enzyme inhibitors, heavy metals, and a variety of additional soy plant-poisons that are particularly capable of stealing the once healthy brain, and/or the once healthy body from developing child. 

As fact the CFSAN has NO factual evidence that fetal, infant, and child developmental exposure to the many soybean phyto-poisons will NOT cause a lifetime of developmental agony that coincides with medical financial hardships.  Without public disclosure of massive soy phyto-poisonous facts, the CFSAN targeted prey are once healthy children. 

Until proven as otherwise safe, at this time there is NO evidence that developmental exposure to the many soy phyto-poisons will NOT cause any variety of life-changing adverse physiological, reproductive, and/or neurological effects, and it is past due that the CFSAN tell this toxic-truth to a large population of innocent American people, and loving parents. 

And ask renowned endocrine disruptor expert, Dr. Leonardo Trasande.  His expertise confirms that exposure to soy phyto-poisonous endocrine disruptors as a cause of adverse health, forces extensive financial burdens upon families due to a lifetime of required medical treatments caused by exposure to soybean phyto-toxic hormone disruptors.

Why does the CFSAN remain deceptively mute towards a large population of trusting American people?  It is difficult to understand why CFSAN, Patricia Hansen reiterates that the CFSAN is (somehow) not familiar with near a thousand NIH Pubmed severe and irreversible adverse developmental soy phyto-poisonous study conclusions, and your own U.S. Health Official testimonials as included above, and throughout the below links.   

Soy phyto-poisons are repeatedly and increasingly study reported to CAUSE innumerable adverse developmental effects: Cancers, (largely leukemia and pancreatic cancers), thyroid disorders/diseases, immunodeficiency disorders, obesity, diabetes, asthma, allergies, gastrointestinal disorders, kidney and liver damage, gender chaos, homosexuality, brain and behavioral disorders to include autism, seizures, ADHD. 

As fact there is not a fetal, infant, or child disorder or disease that can be eliminated from the causal list of developmental exposure to any one (and worst in the combination) of innumerable soy phyto-poisons... as can be expected.

Also, care to review the Attachment which is again loaded with adverse health soy phyto-poisonous concluding studies, published up until Mid- 2009.  There are in fact many more FDA, NIH, and worldly renowned researcher studies published since 2009, also concurring a wide variety of severe and irreversible adverse developmental soy effects to this current date. 

Tell me, how many hundreds of soy phyto-poisonous published studies will it take for the CFSAN to cooperate with lawful public warning labels?

Fetal, infant, and child exposure to fluctuating levels of soy phyto-poisons are not FDA proven as developmentally safe, and an innocent and trusting U.S. public deserves this essential and immediate right-to-know critical adverse health truth. 

Your time is important, but your truth is life-saving!  When can a trusting American public expect the FDA CFSAN to faithfully disclose the fetal, infant, and child soy phyto-poisonous truth?  

Gail Elbek
Research Scientist 

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