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.
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."
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”!
http://www.niehs.nih.gov/health/topics/agents/index.cfm
http://www.niehs.nih.gov/health/topics/agents/index.cfm
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.
Gail Elbek
Research Scientist
@soysorry
