Mrs. Deanna-(Deonaa) and Mr. Gerald Hernesmaa

#102 - 2151 West 39^th^ Ave.

Vancouver, BC, Canada

Canada V6M-1T6

\(604\) - 264 - 0714

[[healthwise933@shaw.ca]{.underline}](mailto:healthwise933@shaw.ca) .

**[Volunteer - Researcher]{.underline}**

Health Action Network Society,

#202 - 5262 Rumble Street

Burnaby, BC (Vancouver, BC)

Canada , V5J - 2B6

. [[www.hans.org]{.underline}](http://www.hans.org/) , (604) - 435-0512

10

**Ms Shellee Anderson;** **[June 4, 2004]{.underline}**

**Team Leader; Nutrition Policy,**

**Division of Dockets Management,** By E-MAIL [and]{.underline} By FedEx

**Food and Drug Administration,** June 6, 2004 June 4^th^

5630 Fishers Lane, Room 1061 (HFA-305)

Rockville, MD 20852,

USA

[[fdadockets@oc.fda.gov]{.underline}](mailto:fdadockets@oc.fda.gov)

**Dear Ms Anderson**,

In submitting this petition for filing our **[objection]{.underline}**
to Solae Corporation's application for a Qualified Health Claim for Soy
Protein and Cancer, (see Docket Number above), we would like you and
your staff in the FDA to seriously consider this submission with the
following collection of 61 scientific research abstracts, **(the
evidence)**, out of a continually growing list of hundreds available,
that represents a fast growing body of scientifically creditable medical
and dietary research on the many serious health hazards, including
cancer, from putting soy in our food supply. (Personally, we have
collected over 200 abstracts documenting the harmful side-effects of
eating soy, and thi collection of ours represents only some of those
available in the scientific community, world wide.). All abstracts
presented here are [also]{.underline} published in the NIH Medline data
base and are representative of current and past research from around the
world, in 2004 and going back to 1953, even as far back as 1925. The
full research is also available via these abstracts. Notice that some of
the research studies included with this petition are from the US
Department of Energy and NCTR which are Federally operated and funded,
and other very reputable research institutions from around the world.

You will be able to see from the scientific research, the evidence,
which includes but is not limited to the evidence in this petition of
objection to Solae Corporation's request for a "Qualified Health Claim,"
that the research is from well-designed studies, from around the world,
conducted in a manner which is consistent with generally recognized
scientific procedures and principles which show that **[there does
exist]{.underline}** significant scientific agreement among experts
qualified by scientific training and experience, from around the world,
a very strong statistically significant association of harm to human and
animal health from the consumption of soy and soy protein ingredients in
our food supply and **an [INCREASED RISK]{.underline} of a variety of
cancers and other major and life threatening health problems, referred
to in this submission as "Hidden Harm,"** which includes but is not
limited to breast cancer, prostate cancer, increased cancer cell
proliferation, tumor growth, DNA and chromosome damage, immune system
damage-(including T-cell production, activity), DNA double strand
breaks, thyroid damage and thyroid cancer, and damage to the myelin
sheath surrounding the nerves. .

In this, our petition of objection, we will [also]{.underline} point
out, what are in our opinion, based on publically known facts, several
serious errors, flaws, misrepresentations, in Solae Corporation's
application requesting a Qualified Health Claim for Soy Protein and
Cancer. Since the Solae Corporation is newly formed in around April of
2003, less than a year before they made their application to the FDA
this year, 2004, I would expect that their lack experience and knowledge
would mostly, but not completely, accounts for these errors,
misrepresentation(s) of the facts in their application to the FDA, as
well as, their narrow focus on their selection of research, (from that
which is easily and widely available world wide), used in trying to
justify and prove their flawed argument for a Qualified Health Claim for
Soy and Cancer.

. **\... / 2**

**- 2 -**

**Petition of Objection To**

**[( Docket \# 2004Q-0151 ) - Solae Corporation requests FDA Health
Claim]{.underline}**

**re: Qualified Health Claim: Soy Protein May Reduce Risk Of Cancer**

This long known and ignored and now denied **"[evidence]{.underline}"**
of the **"[Hidden Harm]{.underline}"** from the many serious and
sometimes deadly health hazards to human and animal health from the
naturally occurring toxic ingredients in soy, **genistein**,
**daidzein**, and **beta-Sitosterol,** is research done in both vivo and
in vitro. **Beta-Sitosterol is a compound [common]{.underline} in soy
oil, [and]{.underline} also present in soy protein.** We feel that this
**"[evidence]{.underline}"** documenting the many serious health hazards
from eating soy in important news to everyone, information that the
average person needs to know, but has not been told, information even
withheld from the general public, we feel as censored through denial by
the soy industry, FDA, Health Canada, the news media in general, and
most governments around the world. Yet this information has been long
known and ignored for all these years by the soy industry, new media,
authors of many well know books on nutrition, the food industry, the
health food industry, the FDA, American and Canadian Cancer Societies,
the mainstream medical system, the alternative health system,
Naturopaths, and many government departments in most countries around
the world, in a manner similar to they way the \...

**1.)** knowledge of the health hazards of smoking was kept from people
30 - 50 years ago, and

**2.)** knowledge of the health hazards of HRT, estrogens, was kept from
people for over 30 years prior to 2002,

> **3.)** and the present way Monsanto keeps the \"Hidden Danger in Your
> Milk from BGH growth hormone,", still is secret and censored in the
> news media today, see \...
> [[http://www.foxBGHsuit.com]{.underline}](http://www.foxBGHsuit.com/)
> and
> [[http://www.thecorporation.tv/about/]{.underline}](http://www.thecorporation.tv/about/)
> .

We all know that the goal of the soy industry, like all businesses, is
to move product, to sell more and more product, but it shouldn't be at
the expense of the health of people and animals, as it is today. When it
is, then making money is all about the profit motivation, making money
at the expense of the public good, peoples health, rather than along
with the health, safety and well being of the customer. Why should any
one be forced to take risks to their personal health from soy
ingredients in the food they eat, like Soy Protein Isolate, SPI, when
the individual has not been made aware of the dangers, in order for them
to exercise their choice to eat soy or not ??. Those who manfacture and
sell soy products, ingredients have not received "[informed
consent]{.underline}" from the general population, from anyone exposed
to these hazards from eating soy. Informed consent from issuing a
**Health Protection Advisory, or a Public Health Warning** about these
**"[Hidden Dangers]{.underline}."** We all have the "[Right to
Know]{.underline}," first, to make an "Informed Choice" if they are
willing to be exposed to the health hazards of eating soy ingredients in
their food. Everyone has the right not be experimented on, used as
"Guinea Pigs" according to the **"[Declaration of
Helsinki]{.underline}"** and the **"[Nuremberg Code]{.underline} "**.
According to international agreement and law, this kind of choice should
have been, and should be, made available to everyone all these past
years, especially cancer patients, women, pregnant women, children and
the elderly. Is there any accountability in government and the food
industry??. Since we all have the "[Right to Know]{.underline}," this is
where you, the FDA, can start to put a stop to this harm to our health
from soy ingredients in our food supply. Isn't it the roll of the FDA to
protect the citizens it represents ??, or is it to protect and further
the financial interest of the business world, the corporations, at the
expense of the safety and well-being of the citizens the FDA represents
and is supposed to protect ??. You know the old saying, "Safety starts
at the top, Safety is no accident."

Soy has always been a serious health hazard and nothing has changed that
over the past several thousand years, even the westernized processing of
soy does not remove these health hazards, but also adds more, adds to
the toxic, poisonous, cancer causing ingredients to soy, along with
their harmful side-effects. These harmful side-effects are pointed out
on the next page and are supported with current and past scientific
research. We also feel that the FDA should not allow the soy industry to
self-regulate itself by allowing them GRAS Self Determination.

Because of the strong evidence coming from the research scientists own
studies, many researchs feel it necessary, feel that it is "The Right
Thing To Do" \... The Humanitarian Thing To Do" \... "The Ethical Thing
To Do" \... to inform people, to give people a chance and a choice to
protect themselves and the ones they love from danger by giving cautions
and warning in their abstracts about eating soy and soy ingredients and
soy supplements.

\* Note - When pharmaceutical companies advertise their drugs in TV
commercials, these TV commercials are required to notify, warn, the
general public watching of the negative side-effects, of the adverse
medical health hazards they may experience from taking the drug being
advertised. There is no such warning to consumers about the many serious
and sometimes deadly health hazards from soy and ingredients in our
foods supply. This is in contravention of the laws in many countries
requiring **[informed consent]{.underline}** from the consumer, as in
Canada and the USA. See the list of the many health hazards below

**\... / 3**

**- 3 -**

**Petition of Objection To**

**[( Docket \# 2004Q-0151 ) - Solae Corporation requests FDA Health
Claim]{.underline}**

**re: Qualified Health Claim: Soy Protein May Reduce Risk Of Cancer**

Here are some examples of the cautions and warning you will find in this
collection of abstracts in this submission, alerting people to the fact
that soy and soy ingredients like soy protein isolate, SPI, genistein
and diadzein and beta-sitosterol most definitely do cause cancer cells
and tumors to grow, in vivo and in vitro \...

Page 29

> --- "Therefore, **[caution is warranted]{.underline}** for
> postmenopausal women consuming dietary genistein while on TAM therapy
> for E-responsive breast cancer."

Page 32

> --- Women with current or past breast cancer "[should be aware of the
> "risks" of potential tumor growth]{.underline}" when taking soy
> products.

Page 33

> --- women with estrogen-dependent brest cancer or predisposition to it
> may want to [reduce]{.underline} their consumption of soy products
> with a high isoflavone content.
>
> --- In the paper in Carcinogenesis, the researchers compared the
> isoflavone in its two forms, as a glycoside (genistin, as it appears
> in plants) and aglucone (genistein). They found that both forms
> produced similar tumor growth rates, and that the conversion of
> genistin in the body [begins with contact with saliva]{.underline} in
> the mouth.
>
> --- In Cancer Research, Helferich compared soy protein isolates
> containing varying levels of isoflavones.
>
> --- researchers found that estrogen-dependent tumor growth increases
> as the isoflavone content increased in the soy-containing diet.

Page 38

> --- Breast cancer is one of the most common forms of cancer observed
> in women, and endogenous estrogen is thought to play a major role in
> its development.
>
> --- Because of this, any conditions or exposures which enhance
> estrogenic responses would result in an increased risk for breast
> cancer.

page 39

> --- The [proliferation]{.underline} rate of breast lobular epithelium
> \... significantly increased \... after just 14 days \... of soy
> supplementation \... when both the day of menstrual cycle & age of
> patient were accounted for. Thus short-term use of dietary soy
> containing isoflavone levels found in modern soy foods
> [stimulates]{.underline} breast proliferation.
>
> --- Genistein causes Proliferation of cultured human breast cancer
> cells \... Dees concluded that \' women [should not]{.underline}
> consume particular foods, (eg. soy-derived products), to prevent
> breast cancer\'.

Page 42

> --- A study with (24) normal pre- and post- menopausal white women,
> ages 30 - 58 were studied for one year.
>
> --- The authors noted that "the findings [did not]{.underline} support
> our a priori hypothesis" that soy protected Asian women against breast
> cancer.
>
> --- "Instead, this pilot study indicates that "[prolonged
> consumption]{.underline}" of soy protein isolate has a "[stimulatory
> effect]{.underline}" on the premenopausal female breast \...
> [genistein]{.underline} and [daidzein]{.underline} in Soy protein
> isolate (SPI).

So to try and bend the scientific evidence to try to make it fit what
the soy industry and the pharmaceutical companies want it to look like,
that soy supposedly prevents cancer, is doing the same thing the
pharmaceutical companies did for over 20 years before June 2002, when
the studies on Hormone Replacement Therapy, HRT, were stopped because
these studies were proving that HRT was causing the very illness in
women, including cancer, that the pharmaceutical companies were claiming
and saying that HRT prevented.

What are some of these growing number of serious side-effects from
eating soy and Soy Protein Isolate, SPI ??. They are listed on the next
page under the heading **"[Hidden Harm.]{.underline}"** The abstracts,
scientific evidence, proving this is at the end of this submission,
showing how soy damages human and animal health , while clearly
documenting these known and ignored cancer risks to consumers from the
Solae (and other) soy products. These health hazards are well known to
much of the general scientific community, but ignored and suppressed,
even denied by the soy industry, their scientists, the news media, the
mainstream medical system, the natural health industry, the alternative
health system, American and Canadian Cancer Societies, and many
government departments from around the world like the FDA and Health
Canada, and from those making their living from producing, promoting and
selling soy and soy ingredients like soy protein isolate, SPI.

**\... / 4**

**- 4 -**

**Petition of Objection To**

**[( Docket \# 2004Q-0151 ) - Solae Corporation requests FDA Health
Claim]{.underline}**

**re: Qualified Health Claim: Soy Protein May Reduce Risk Of Cancer**

**"The Hidden Harm"** that is done to people from putting soy and soy
ingredients into our food supply without notifying and informing people
of these many harmful side-effects to health is listed below. While
reading this list of just some of the harmful side-effects from eating
soy and soy ingredients in our food, keep in mind that
[Genistein]{.underline} in soy is a dietary topoisomerase II-poison, it
accumulates in the body over time, building up a toxic load over time
and is one of the cause of the medical problems listed below. Also keep
in mind that because of this, genistein causes **DNA [double strand
breaks]{.underline}** leading to, among other things, **chromosomal
aberrations and leukemia's, like acute infant leukemia, AIL, otherwise
known as Cancers of different types.**

The negative health risks of soy in our food supply clearly far out
weighs any imagined benefits to health.

**"[Hidden Harm]{.underline}"**

**No Health Protection Advisory, No Public Health Warnings**

The many harmful side-effects to human and animal

health from putting soy in our food supply.

**Known, Ignored, Denied**

Although this petition of objection to Solae's application for
"Qualified Health Claim for Soy and Cancer Prevention" is primarily
focusing on [cancer, breast cancer and damage to the immune system and
DNA damage]{.underline}, many other scientifically documented, yet
ignored, health hazards from eating soy also include but [are not
limited to]{.underline} those in the list below\...

\... Asthma \... Heart disease , arrhythmia

\... Brain [and]{.underline} Nervous System damage - \... Irritable Bowl
Syndrome

(genistein destroys myelin sheath protecting nerves, \... Liver disease

as in "Alzheimer's and Parkinson's disease", \... Leukemia, infantile
acute leukemia, (IAL)

and learning disabilities as in ADD/ADHD) \... Infertility and
reproductive problems

\... Cancer(s) / Breast / liver / uterine / colon / thyroid / pancreas /
thyroid \... Osteoporosis

\... Causing the Reoccurrence of cancer(s). \... Premature, delayed
puberty, Pseudo-Puberty

\... Cell *DEATH* , animal *DEATHs*, [and]{.underline} human *DEATHs*
\... Pancreatic disorders

\... Chronic fatigue \... Thyroid suppression, Goiter,

\... Chromosome fragmentation, and errors in its orientation Hyper and
Hypo-thyroidism

\... DNA damage Graves' or Hashimoto's Disease

\... Diabetes \... Immune system suppression - including

\... Depression , Dementia (suppression of T-cell production, activity)

\... Endocrine disruption \... Subtle changes in sexually dimorphic
behaviors

\... Growth problems \... Weight gain

\... Genistein in soy is a dietary topoisomerase II-poison, it
accumulates in the body over time, building up a toxic load and causes
**DNA [double strand breaks]{.underline}** leading to **chromosomal
aberrations and leukemia's, like AIL.**

Pregnant women and their unborn child are at great risk of harm from soy
ingredients in our food supply. The toxic ingredient in soy genistein
crosses the placenta and blood-brain barrier, "teratogenic," causing
birth defects, as test have shown. The placenta does not represent a
barrier to these poisons. Children, especially children -- who in some
instances may be affected by soy products consumed either by themselves
(for instance, in baby formula) or by their mothers prior to giving
birth need to be protected from these health hazards. Infants are the
most vulnerable and defenseless individuals of our society. Also, see
abstracts in reference section below and at the end.

**The negative health risks of soy in our food supply clearly far out
weighs any imagined benefits to health.**

**\... / 5**

**- 5 -**

**Petition of Objection To**

**[( Docket \# 2004Q-0151 ) - Solae Corporation requests FDA Health
Claim]{.underline}**

**re: Qualified Health Claim: Soy Protein May Reduce Risk Of Cancer**

The metabolism, physiology and biochemistry of a \... fetus \... infant
\... or child \... is fundamentally different from that of an adult. A
host of vital organ systems continue to grow and mature from conception
throughout childhood. At critical periods of developmental change, these
systems are susceptible to the toxic effects of pesticides and toxic
chemicals, both individually and \"in mixtures.\" Many organ systems,
for example the nervous system and brain, can be permanently,
[and]{.underline} subtly damaged by exposures to toxic substances
in-utero or throughout early childhood that, at the same level, cause no
measurable harm to adults **( Jacobson 1996, CDC 1997, NRC 2000 ).**

The endocrine (hormone) system , (immune system), is perhaps even
[more]{.underline} sensitive to toxic exposure than the nervous system,
and over the past decade, enormous effort has been put into the study of
how pesticides and toxic chemicals [interfere]{.underline} with normal
endocrine signaling and function.

A significant body of research in animals now shows that \...
\"[ultra-low doses]{.underline}\" \... toxic chemicals on critical days
of development can cause changes in hormone function [and]{.underline}
effects on organ development and function that often only appear
[later]{.underline} in life. A growing number of these studies show that
low doses at a susceptible moment of development can cause
**[more]{.underline}** of an effect than high doses **(vom Saal 1997,
Alworth 2002, Hayes 2003.** This is particularly relevant to childhood
[and]{.underline} fetal exposures via food & water where the timing of
the exposure is at least as important as dose.

The use of the Precautionary Principle at \...
[[http://www.biotech-info.net/rachels_586.html]{.underline}](http://www.biotech-info.net/rachels_586.html)
says that people have a duty to take anticipatory action to prevent
harm, have an obligation to try to stop it. This includes those in the
FDA at the decision making level to not allow Solae Company's
application. The FDA has more than a reasonable suspicion from
scientific proof, (including but not limited to what is presented here),
that something bad [might be and will be going to happen]{.underline},
when soy and soy ingredients like Soy Protein Isolate, SPI, is added to
our food supply and the FDA has an obligation to try to stop it. Not at
sometime in the future, but now. Why ??. Because FDA knows of the
**"[Hidden Harm]{.underline}"** people are currently experiencing from
soy ingredients in our food supply. If they claim they do not, then they
sure do after reading this submission. The Precautionary Principle is
not really New. It is captured in common-sense aphorisms down throughout
history, such as "[An ounce of prevention is worth a pound of
cure]{.underline}" \... "[Better safe than sorry]{.underline}" \...
"[Look before you leap]{.underline}" \... "[Error on the side of
caution]{.underline}" \... etc., etc.

[When talking about Social Justice]{.underline}, Socrates said about
"[Courage]{.underline}," \... "Examine your thoughts, statements and
actions by pursuing their implications, on the assumption that if they
are true, they would not lead to false consequences,\" and about \...
"[Humanitarian Action]{.underline}" \... "Choose wisdom so that society
is incapable of doing wrong."

[The American College Dictionary, 1964]{.underline} , definition of
"[Ethics]{.underline}" \... n. pl. 1.) The principles of morality,
[including]{.underline} both the science of the good [and]{.underline}
the science of right.

U.S. food safety law has mandated the precautionary approach since 1958.
In that year, Congress passed the Food Additive Amendment to the Food,
Drug and Cosmetic Act requiring that new additives to food be
demonstrated safe through standard scientific testing before they are
marketed. (21 U.S.C. Sec. 321). Those in the FDA in positions of
authority and in the decision making process to approve or reject
Solae's application know that US laws requires that soy and soy
ingredients must be proven safe. ***US Law Mandates Rigorous Application
of the Precautionary Principle.***

An official Senate report described the intent of the amendment (21
U.S.C. Sec. 321) as follows: \"While Congress did not want to
unnecessarily stifle technological advances, it nevertheless intended
that additives created through new technologies be proven safe before
they go to market. S. Rep. 2422, 1958 U.S.C.C.A.N. 5301-2. (emphasis
added) This clearly shows that the precautionary principle is the
cornerstone of food safety law in the United States.

As both the FDA\'s regulations and the federal courts have decreed,
general recognition of safety can only be imputed if there is an
overwhelming consensus in the community of qualified experts. While
unanimity is not required, any significant and sound disagreement
prevents a determination that consensus exists.

To approve a Qualified Health Claim for soy as Solae requests the FDA to
do would be breaking the law and misrepresenting the dangerous facts.

**\... / 6**

**- 6 -**

**Petition of Objection To**

**[( Docket \# 2004Q-0151 ) - Solae Corporation requests FDA Health
Claim]{.underline}**

**re: Qualified Health Claim: Soy Protein May Reduce Risk Of Cancer**

The requisite consensus for Soy has never existed, and the FDA is well
aware of it because the predominant consensus among its own experts was
that these soy ingredients entail unique risks and cannot be presumed
safe. The pervasiveness of concern within the FDA\'s scientific staff is
attested by the 2 FDA whistle blower stated : \... Researchers and
"[Whistle-blowers]{.underline}" Daniel Doerge Ph.D and Daniel Sheehan
Ph.D are two of the U.S.A.'s Food and Drug Administration's, FDA, expert
scientists on soy who signed a Feb. 18, 1999 letter of protest to the
FDA when the FDA granted soy a "health claim" in 1999. This letter
expresses serious concerns regarding the perceived safe use of soy, if
soy was to be granted a "health claim," and includes 26 documented
scientific referenced studies, (Abstracts), that show a link between
eating soy and serious health problems.

[In their letter of protest they said]{.underline},

"... it is inappropriate to allow a health claim for Soy [Protein
Isolate]{.underline}, SPI, ... it could be misinterpreted, ... the
health labeling of SPI for foods needs to be considered just as would
the addition of any "[Estrogen]{.underline}" or
"[Goitrogen]{.underline}" to foods, which are bad ideas.
[Estrogenic]{.underline} and [goitrogenic]{.underline} drugs are
regulated by the FDA, and are taken under a physician's care. Patients
are informed of risks, and are monitored by their physicians for
evidence of toxicity. No similar safeguards are in place for foods, so
the public will be put at potential risk from soy isoflavones in SPI
without adequate warning and information\..."

See letter \...
[[http://abcnews.go.com/onair/2020/2020_000609_soyfdaletter_feature.html]{.underline}](http://abcnews.go.com/onair/2020/2020_000609_soyfdaletter_feature.html),
**article withdrawn**,

and at \...
[[http://health.groups.yahoo.com/group/hypothyroidism/message/7065]{.underline}](http://health.groups.yahoo.com/group/hypothyroidism/message/7065)
, **Use Google Search for more.**

But even in the case of unanimity, U.S. law additionally prescribes that
consensus cannot rest on hypotheses but must be based on scientific
evidence that clearly establishes safety. Both the FDA\'s regulations
and the federal courts have consistently held that such evidence should
include studies published in the peer-reviewed scientific literature.
(21 CFR Sec. 170.3(h)). Moreover, FDA regulations emphasize that the
tests supporting a general recognition of safety \"\...require the same
quantity and quality of scientific evidence as is required to obtain
approval of the substance as a food additive.\" (21 CFR Sec. 170.30(b))
This means, in the FDA\'s words, that the tests must demonstrate \"a
reasonable certainty \... that the substance is not harmful under its
intended conditions of use.\" (21 CFR Sec. 170.3(I)). Therefore, even if
expert consensus about the safety of soy and soy ingredients actually
existed, which it doesn't, the law requires that their safety still must
be established through standard scientific tests.

The short list of abstracts in the reference section, shows that it is
very well documented scientifically that soy causes a variety of very
serious adverse medical and developmental conditions in susceptible
persons, like various types of cancers.

The science very clearly establishes that soy [is not]{.underline}
medically necessary, but [there is]{.underline} a medical necessary to
warn people of these serious health hazards so people can then choose to
[avoid]{.underline} soy and soy ingredients in our food supply for
disease prevention and for maintaining good health.

In fact, in the next **1998** abstract below, being the **[1^st^
abstract]{.underline}** presented for your consideration, it is stated
in a meta-analysis done then by ***[Strauss L., Santti R., Saarinen N.,
Streng T., Joshi S., and Makela S.,]{.underline}*** at the **Institute
of Biomedicine and Medicity Research Laboratory, University of Turku,
Finland**, found that

> "\... there is no [direct]{.underline} evidence for the beneficial
> effects of phytoestrogens in humans. \... All information is based on
> consumption of phytoestrogen-rich diets, and the causal relationship
> and the mechanisms of phytoestrogen action in humans still remain to
> be demonstrated \... In addition, the possible adverse effects of
> phytoestrogens have not been evaluated \... It is plausible that
> phytoestrogens, as any exogenous hormonally active agent, might also
> cause adverse effects in the endocrine system, i.e. act as endocrine
> disrupters \...".

**\... / 7**

**- 7 -**

**Petition of Objection To**

**[( Docket \# 2004Q-0151 ) - Solae Corporation requests FDA Health
Claim]{.underline}**

**re: Qualified Health Claim: Soy Protein May Reduce Risk Of Cancer**

**Since 1998,** there is still no [direct]{.underline} medical evidence
proving the need for soy in our food supply, nothing has changed and
this is still exactly the case today as it was back in 1998. This fact
is part of the reason why Solae says twice on pages 115 and 116 in their
application for a Qualified Health Claim, which is discussed in the
3^rd^ point of this submission, that "\...However, this, Solae's,
evidence is not conclusive\..." for their request for a Qualified Health
Claim of Soy and Cancer Prevention.. To attempt to knowing endanger the
public's health to scientifically known health hazards by submitting
evidence that is not conclusive, is, I suggest, a criminal act of global
proportions, as is explained in quite legal detail further on in this
submission.

\-
[[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10022277&dopt=Abstract]{.underline}](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10022277&dopt=Abstract&itool=iconabstr)
.

**Toxicol Lett. 1998 Dec 28;102-103:349-54.**

**1998 "Dietary phytoestrogens and their role in hormonally dependent
disease," --- *[Strauss L., Santti R., Saarinen N., Streng T., Joshi S.,
Makela S.,]{.underline}* Institute of Biomedicine and Medicity Research
Laboratory, University of Turku, Finland.**

> -- Although epidemiological studies suggest that diets rich in
> phytoestrogens may be associated with low risk of breast and prostate
> cancer, **there is no direct evidence for the beneficial effects of
> phytoestrogens in humans.** It is plausible that phytoestrogens, as
> any exogenous hormonally active agent, might also cause adverse
> effects in the endocrine system.
>
> **-- Epidemiological studies suggest that diets rich in phytoestrogens
> (plant estrogens), particularly soy and unrefined grain products, may
> be associated with low risk of breast and prostate cancer.** It has
> also been proposed that dietary phytoestrogens could play a role in
> the prevention of other estrogen-related conditions, namely
> cardiovascular disease, menopausal symptoms and post-menopausal
> osteoporosis.
>
> -- However, there is no direct evidence for the beneficial effects of
> phytoestrogens in humans.
>
> -- All information is based on consumption of phytoestrogen-rich
> diets, and the causal relationship and the mechanisms of phytoestrogen
> action in humans still remain to be demonstrated.
>
> -- In addition, the possible adverse effects of phytoestrogens have
> not been evaluated.
>
> -- It is plausible that phytoestrogens, as any exogenous hormonally
> active agent, might also cause adverse effects in the endocrine
> system, i.e. act as endocrine disrupters.

**Again, in 2003,** The United Kingdom Chief Medical Officer, the
highest medical officer in the UK has issued a "Health Protection
Advisory" about the long term reproductive harm to children from soy
protein. He has drawn on the findings of at least four expert
committees, going back to July 1996. In his Health Protection Advisory,"
he has warned all doctors that \...

> \... soy - based infant formulas should be used only in exceptional
> circumstances, because of "\... a risk to long term reproductive
> health \...".

Further information on the UK Expert Committee's findings in a report in
March **2003** called "Committee on Toxicity of Chemicals in Food,
Consumer Products and The Environment, Report on Phtoestrogens and
Health," is at \...
[[http://www.food.gov.uk/multimedia/pdfs/2003-03.pdf]{.underline}](http://www.food.gov.uk/multimedia/pdfs/2003-03.pdf)
, and also says \...

> "\... After reviewing the data and conclusions in the report relating
> to soy-based infant formula, SACN considered that there is cause for
> concern about the use of soy-based infant formula. Additionally, there
> is neither substantive medical need for, nor health benefit arising
> from, the use soy-based infant formulae \..."

So, one can see that Solae's meta-analysis of studies of various cancer
studies in their submission is flawed, right from the start. Why ??.
Solae admits in their application for a Qualified Health Claim for Soy
and Cancer that "\... the evidence in their application is not
conclusive \...". Further comment on this is covered in my **3^rd^
point** below. Therefore the conclusions Solae use to request a
Qualified Health Claim from the FDA should not be accepted, and is
reason enough in itself for the FDA to reject Solae's application
outright. If the FDA allows Solae's application, it will be giving false
hope to hundreds of millions of people around the world, and subjecting
them to unnecessary and unimaginable pain and suffering and agony for
the very same illness of cancer, which everyone is desperately trying to
avoid.

**\... / 8**

**- 8 -**

**Petition of Objection To**

**[( Docket \# 2004Q-0151 ) - Solae Corporation requests FDA Health
Claim]{.underline}**

**re: Qualified Health Claim: Soy Protein May Reduce Risk Of Cancer**

As you can see in the [2^nd^ abstract]{.underline} presented below for
our consideration, this 2002 abstract on proving that soy damages the
immune system is research done and payed for by the soy industry. The
soy industry released the results of their own study in May **2002**. In
the collection of abstracts presented in this submission of objection,
and else where, there is reference and scientific research showing how
important a strong immune system is for a healthy body. Actually, it is
quite amazing that this **study** was even released for publication, and
yet this study was [funded]{.underline} by the United Soybean Board
[and]{.underline} the Illinois Council on Food and Agricultural
Research.

\-
[[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12032332]{.underline}](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12032332)
.

***Proc Natl Acad Sci USA* 2002 *May 28;99(11):7616-21.***

**2002 "The phytoestrogen genistein induces thymic and immune changes: a
human health concern ?," -- *[Yellayka S. and others]{.underline},***
**Department of Veterinary Biosciences, University of Illinois, Urbana,
IL 61802, USA.**

> -- Use of soy-based infant formulas and soy/isoflavone supplements has
> aroused concern because of potential estrogenic effects of the soy
> isoflavones genistein and daidzein. Here we show that s.c. genistein
> injections in ovariectomized adult mice produced dose-responsive
> decreases in thymic weight of up to 80%. Genistein\'s thymic effects
> occurred through both estrogen receptor (ER) and non-ER-mediated
> mechanisms, as the genistein effects on thymus were only partially
> blocked by the ER antagonist ICI 182,780.
>
> -- Genistein decreased thymocyte numbers up to 86% and doubled
> apoptosis, indicating that the mechanism of the genistein effect on
> loss of thymocytes is caused in part by increased apoptosis. Genistein
> injection caused decreases in relative percentages of thymic
> CD4(+)CD8(-) and double-positive CD4(+)CD8(+) thymocytes, providing
> evidence that genistein may affect early thymocyte maturation and the
> maturation of the CD4(+)CD8(-) helper T cell lineage. Decreases in the
> relative percentages of CD4(+)CD8(-) thymocytes were accompanied by
> decreases in relative percentages of splenic CD4(+)CD8(-) cells and a
> systemic lymphocytopenia.
>
> -- In addition, genistein produced suppression of humoral immunity.
>
> -- Genistein injected at 8 mg/kg per day produced serum genistein
> levels comparable to those reported in soy-fed human infants, and this
> dose caused significant thymic and immune changes in mice. Critically,
> dietary genistein at concentrations that produced serum genistein
> levels substantially less than those in soy-fed infants produced
> marked thymic atrophy.
>
> -- [These results raise the possibility]{.underline} that serum
> genistein concentrations found in soy-fed infants may be capable of
> producing thymic and immune abnormalities, as suggested by previous
> reports of immune impairments in soy-fed human infants.

More and more people are coming to realize that it is quite common for
industry and corporations in general to hide and suppress findings that
are quite (-)negative for their products and services. Many times,
people have to use the "Freedom of Information laws" to get information
that should otherwise be easily and readily available to them. A good
example of this is, is in the article "Doctors Without Borders, Why You
Can't Trust Doctors," or Drug Companies at \...
[[http://www.washingtonmonthly.com/features/2004/0404.brownlee.html]{.underline}](http://www.washingtonmonthly.com/features/2004/0404.brownlee.html)
For examples, also, see the new 2003 movie called "The Corporation" and
the book by the same name at \...
[[http://www.thecorporation.tv/synopsis.php]{.underline}](http://www.thecorporation.tv/synopsis.php),
and at \...
[[http://www.thecorporation.com/]{.underline}](http://www.thecorporation.com/),
and at \...
[[http://www.thecorporation.tv/usa/]{.underline}](http://www.thecorporation.tv/usa/),
and at \...
[[http://www.thecorporation.tv/trailer/]{.underline}](http://www.thecorporation.tv/trailer/)
.

As you read through this large and continually growing volume of well
established and creditable scientific research, the evidence, showing
harm to both human and animal health from consuming soy in our food
supply, it is necessary to also consider a short list of internationally
accepted Legal Definitions. One such Legal Term to be given serious
consideration from \... **Blacks Law Dictionary, 6^th^ Edition, 1990**,
is the definition of **"[The Preponderance Of Evidence]{.underline}"**
at \...
[[http://www.trufax.org/reports/legal.html]{.underline}](http://www.trufax.org/reports/legal.html)
. Think of this definition when considering the hundreds of abstracts
available, the scientific evidence, on the many serious harmful
side-effects from putting soy in our food supply,

> ***[Preponderance of evidence]{.underline}*:** Evidence which is of
> greater weight or more convincing that the evidence which is offered
> in opposition to it; it may not be determined by the number of
> witnesses, but by the greater weight of all evidence, the opportunity
> for knowledge, information possessed.

The **"[Hidden Harm]{.underline}"** caused from eating soy is considered
by the soy industry as mere externalities. "An externality occurs in
economics when the actions of one consumer or firm affect the well being
or production of another consumer or firm with whom there is no direct
business relationship." Click on this website \...
[[http://encyclopedia.thefreedictionary.com/externality]{.underline}](http://encyclopedia.thefreedictionary.com/externality)
.

**\... / 9**

**- 9 -**

**Petition of Objection To**

**[( Docket \# 2004Q-0151 ) - Solae Corporation requests FDA Health
Claim]{.underline}**

**re: Qualified Health Claim: Soy Protein May Reduce Risk Of Cancer**

**[The concerns about the carcinogenesis of modern soy is not
new]{.underline}.** In fact , the US government, especially the
Department of Agriculture scientists, also knew soy meal caused
infertility. It was no secret as it was published by Chang et al in
**1953.**

The scientific research in this petition of objection will show much of
the scientific research on the toxic and poisonous side-effects of
eating soy, and this will show that soy hasn't change in this way for
over 2 thousand years, even with the modern westernized processing
techniques of high heat and high pressure cooking, as the isoflavones
genistein, daidzein, and **beta-Sitosterol,** will greatly reduce these
natural occurring toxins, but will not eliminate. Even the soy industry
admits to this and referrers to these toxins as anti-nutrients.

Here, below, is a short introductory list of 11 abstracts, a preview,
just a example, of the 61 abstracts summarys in the reference section at
the end of this petition, out of hundreds available from around the
world. They are just some of the examples of current and past research
in both vivo and vitro from hundreds available in NCBI, PubMed, that
documents these many serious health hazards.

**[Short Introductory List]{.underline}**

**See reference section at end for 61**

\-
[[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15113961]{.underline}](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15113961)
.

***J Nutr.* 2004 *May;134(5):1145-1151.***

**2004 "beta-Sitosterol, beta-Sitosterol Glucoside, and a Mixture of
beta-Sitosterol and beta-Sitosterol Glucoside Modulate the Growth of
Estrogen-Responsive Breast Cancer Cells In Vitro and in Ovariectomized
Athymic Mice," --- *[Ju YH, Clausen LM, Allred KF, and
others]{.underline}, Department of Food Science and Human Nutrition and
Department of Animal Sciences, University of Illinois at
Urbana-Champaign, Urbana, IL 61801 USA, [and]{.underline} Department of
Physiology, University of Kentucky, Lexington, KY 40536; IMAGINutrition,
[and]{.underline} MetaResponse Science, Laguna Niguel, CA 92677, USA.***

> **-- Further evidence from [current]{.underline} research that
> beta-Sitosterol, a compound [common]{.underline} in soy oil,
> [and]{.underline} also present in soy protein, can
> [stimulate]{.underline} the growth of MCF-7 [breast
> cancer]{.underline} cells\"**
>
> **-- [In summary]{.underline}, BSS and MC [stimulated MCF-7 cell
> growth]{.underline} in vitro. Although BSSG comprises only 1% of MC,
> BSSG made MC less estrogenic than BSS alone in vitro. However, dietary
> BSS and MC protected against E(2) - [stimulated MCF-7 tumor
> growth]{.underline} and lowered circulating E(2) levels.**

\-
[[http://www.eurekalert.org/pub_releases/2001-05/NIoE-Iucs-3005101.php]{.underline}](http://www.eurekalert.org/pub_releases/2001-05/NIoE-Iucs-3005101.php)
.

***Cancer Research* 2002 *June, EurekAlert 31 May* 2001*.***

**2002 "Increased uterine cancer seen in mice injected with genistein, a
soy estrogen, as newborns," -- *[Newbold R. Jefferson W., Padilla E.,
Bullock B.C.,]{.underline}* Wake Forest University School of Medicine,
Winston-Salem, N.C., USA,**

> **-- Genistein is carcinogenic**
>
> **-- Infant mice given genistein developed cancer of the uterus later
> in life. "The data suggest that genistein is carcinogenic if exposure
> occurs during critical periods in a young animal's development."**

**\... / 10**

**- 10 -**

**Petition of Objection To**

**[( Docket \# 2004Q-0151 ) - Solae Corporation requests FDA Health
Claim]{.underline}**

**re: Qualified Health Claim: Soy Protein May Reduce Risk Of Cancer**

\-
[[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11250801&dopt=Abstract]{.underline}](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11250801&dopt=Abstract)
.

**Environ Health Perspect 2001 Mar;109 Suppl 1:5-20.**

**2001 "Cross-species and interassay comparisons of phytoestrogen
action," -- *[Whitten P.L., Patisaul H.B.]{.underline}*, *Department of
Anthropology, Emory University, Atlanta, Georgia 03022*, USA.**

**Humans are affected at [lower doses]{.underline} than rodents.**

> **-- [This paper compiles]{.underline} animal [and]{.underline} human
> data on the biologic effects and exposure levels of phytoestrogens in
> order to identify areas of research in which direct species
> comparisons can be made. \"In vivo data show** that phytoestrogens
> have a wide range of biologic effects at doses and plasma
> concentrations seen with **[normal]{.underline}** human diets.
>
> **-- [Significant in vivo-responses]{.underline} have been observed in
> animal [and]{.underline} human tests for \... bone \... breast \...
> ovary \... pituitary\... vasculature \... prostate \... and serum
> lipids.\"**
>
> -- The doses reported to be biologically active in humans (0.4\--10
> mg/kg body weight/day) [are lower than]{.underline} the doses
> generally reported to be active in rodents (10\--100 mg/kg body
> weight/day), although some studies have reported rodent responses at
> lower doses.
>
> **-- [The similarity of reported proliferative and antiproliferative
> doses]{.underline}** illustrates the need for fuller examination of
> dose-response relationships and multiple end points in assessing
> phytoestrogen actions.

\-
[[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10762754&dopt=Abstract]{.underline}](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10762754&dopt=Abstract)
.

***Eur J Cancer* 2000 Apr;36(6):796-802.**

**2000 "Genistein induces apoptosis and topoisomerase II-mediated DNA
breakage in colon cancer cells," -- *[Salti G.I., Grewal S., Mehta R.R.,
Das Gupta T.K., and others]{.underline}*,** **University of Illinois at
Chicago, College of Medicine, Department of Surgical Oncology, Chicago,
USA**

> **-- DNA breakage** in colon cancer cells occurred **-
> [within]{.underline} 1 hour -** of treatment with genistein.

\-
[[http://www.soyonlineservice.co.nz/Refs/Helf.htm]{.underline}](http://www.soyonlineservice.co.nz/Refs/Helf.htm)
.

\-
[[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=9848512]{.underline}](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=9848512)
.

***Cancer Res* 1998 *Sep 1;58(17):3833-8., [and]{.underline} Cancer Res*
1999 *Mar 15;59(6):1388*.**

**1998 "Estrogenic effects of genistein on the growth of estrogen
receptor-positive human breast cancer (MCF-7) cells in vitro and in
vivo," -- *[Hsieh C.Y., Santell R.C., Haslam S.Z., Helferich
W.G.]{.underline}*, Department of Food Science and Human Nutrition,
Michigan State University, East Lansing 48824, USA.**

> -- Proliferation of cultured human breast cancer cells \... Dees
> concluded that \' women [should not]{.underline} consume particular
> foods, (eg. soy-derived products), to prevent breast cancer\'.
>
> -- [IN SUMMARY]{.underline}, genistein can act as an estrogen agonist
> in [vivo]{.underline} and in [vitro]{.underline}, resulting in the
> proliferation of cultured human breast cancer cells (MCF-7) and the
> induction of pS2 gene expression. Here we present new information that
> dietary genistein stimulates mammary gland growth and enhances the
> growth of MCF-7 cell tumors in ovariectomized athymic mice.
>
> -- [Dr Craig Dees]{.underline} of Oak Ridge National Laboratory has
> also found that soy isoflavones cause breast cancer cells to grow. He
> reported that \'low concentrations of genistein may stimulate MC-7
> cells to enter the cell cycle\'. **Dees concluded that \' women
> "[should not]{.underline}" consume particular foods, (eg. soy-derived
> products), to prevent breast cancer\'.**

**\... / 11**

**- 11 -**

**Petition of Objection To**

**[( Docket \# 2004Q-0151 ) - Solae Corporation requests FDA Health
Claim]{.underline}**

**re: Qualified Health Claim: Soy Protein May Reduce Risk Of Cancer**

\-
[[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=9848512&dopt=Abstract]{.underline}](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=9848512&dopt=Abstract&itool=iconfft)
.

***Am J Clin Nutr* 1998 Dec;68(6 Suppl):1431S-1435S.**

**1998 "Effects of soy-protein supplementation on epithelial
proliferation in the histologically normal human breast," --
*[McMichael-Phillips D.F. and others]{.underline}*, Depart. of
Epithelial Biology, Paterson Institute for Cancer Research, Christie
Hospital NHS Trust, Manchester, United Kindgom**

> -- Soy foods [stimulates]{.underline} breast proliferation \... after
> just 14 days
>
> -- Forty-eight women with benign or malignant breast disease were
> randomly assigned a normal diet either alone or with a 60 gram soy
> supplement containing 45 mg isoflavones, taken for 14 days. The
> [proliferation]{.underline} rate of breast lobular epithelium \...
> significantly increased \... after just 14 days \... of soy
> supplementation \... when both the day of menstrual cycle & age of
> patient were accounted for. Thus short-term use of dietary soy
> containing isoflavone levels found in modern soy foods
> **[stimulates]{.underline}** breast proliferation.

\-
[[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10022277&dopt=Abstract]{.underline}](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10022277&dopt=Abstract&itool=iconabstr)
.

**Toxicol Lett. 1998 Dec 28;102-103:349-54.**

**1998 "Dietary phytoestrogens and their role in hormonally dependent
disease," --- *[Strauss L., Santti R., Saarinen N., Streng T., Joshi S.,
Makela S.,]{.underline}* Institute of Biomedicine and Medicity Research
Laboratory, University of Turku, Finland.**

> -- Although epidemiological studies suggest that diets rich in
> phytoestrogens may be associated with low risk of breast and prostate
> cancer, **there is no direct evidence for the beneficial effects of
> phytoestrogens in humans.** It is plausible that phytoestrogens, as
> any exogenous hormonally active agent, might also cause adverse
> effects in the endocrine system.
>
> **-- Epidemiological studies suggest that diets rich in phytoestrogens
> (plant estrogens), particularly soy and unrefined grain products, may
> be associated with low risk of breast and prostate cancer.** It has
> also been proposed that dietary phytoestrogens could play a role in
> the prevention of other estrogen-related conditions, namely
> cardiovascular disease, menopausal symptoms and post-menopausal
> osteoporosis.
>
> -- However, there is no direct evidence for the beneficial effects of
> phytoestrogens in humans.
>
> -- All information is based on consumption of phytoestrogen-rich
> diets, and the causal relationship and the mechanisms of phytoestrogen
> action in humans still remain to be demonstrated.
>
> -- In addition, the possible adverse effects of phytoestrogens have
> not been evaluated.
>
> -- It is plausible that phytoestrogens, as any exogenous hormonally
> active agent, might also cause adverse effects in the endocrine
> system, i.e. act as endocrine disrupters.

\-
[[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=9168007&dopt=Abstract]{.underline}](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=9168007&dopt=Abstract&itool=iconabstr)
.

***Environ Health Perspect* 1997 Apr;105(Suppl 3):633-636.**

**1997 "Dietary estrogens stimulate human breast cells to enter the cell
cycle," -- *[Dees C., Foster J.S., Ahamed S., Wimalasena
J.]{.underline}*,** **Health Sciences Research Division, Oak Ridge
National Laboratory, Tennessee, USA**

> -- [Stimulates]{.underline} human [breast cancer cells]{.underline} to
> enter the cell cycle
>
> -- Dietary estrogens were found to increase enzymatic activity
> [leading to]{.underline} breast cancer. "Our findings are consistent
> with a conclusion that dietary estrogens at low concentrations do not
> act as antiestrogens, but act like DDT and estradiol to
> [stimulate]{.underline} human [breast cancer cells]{.underline} to
> enter the cell cycle.

\-
[[http://www.mercola.com/article/soy/avoid_soy.htm]{.underline}](http://www.mercola.com/article/soy/avoid_soy.htm)
, **Foot Note #53.**

**1992 *"Bulletin de L'Office Federal de la Santé Publique*," No 28,
July 20, 1992.**

> -- The Swiss Health Service estimates that **100 grams of soy
> protein** provides the estrogenic equivalent of the **contraceptive
> pill.**

**\... / 12**

**- 12 -**

**Petition of Objection To**

**[( Docket \# 2004Q-0151 ) - Solae Corporation requests FDA Health
Claim]{.underline}**

**re: Qualified Health Claim: Soy Protein May Reduce Risk Of Cancer**

\-
[[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=2548712&dopt=Abstract]{.underline}](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=2548712&dopt=Abstract&itool=iconabstr)
.

***Cancer Res* 1989 Sep 15;49(18):5111-7.**

**1989 "Inhibitory effects of the tyrosine kinase inhibitor genistein on
mammalian DNA topoisomerase II," -- *[Markovits J., Linassier C., Fosse
P., Pierre J., and others]{.underline}*,** **Laboratorie de
Pharmacologie Moleculair, URA 158 du CNRS, U 140 de I'NSERM, Institute
Gustave Roussy, Villejuif, France.**

> **-- Genistein [stimulates]{.underline} double strand DNA breaks.**
>
> -- Finally, genistein treatment of DC-3F cells results in the
> occurrence of protein-linked **[DNA strand breaks]{.underline}** as
> shown by DNA filter elution. Viscometric (lengthening) studies
> demonstrate that genistein isn't a DNA intercalator. Genistein is
> therefore an interesting compound because it induces cleavable
> complexes without intercalation. Taken together, our results show that
> genistein is an inhibitor of both protein tyrosine kinases and
> mammalian DNA topoisomerase II. This could be accounted for by the
> sharing of a common structure sequence between the two proteins at the
> ATP binding site.

In the reference section at the end of this submission, there are more
examples of current and past abstract summaries of research in both vivo
and vitro our to hundreds available world wide, that documents these and
many other long known and ignored serious health hazards from putting
soy in our food.

We feel that there are three errors, flaws, in Solae Corporation's
application request for a Qualified Health Claim for Soy Protein and
Cancer. We feel that we can demonstrate that their statements are false,
distorted, slanted and misleading. Since the Solae Corporation is newly
formed in around April of 2003, less than a year before they made this
application, I would expect that their lack of knowledge and experience
would partly, but not completely, accounts for these errors and
misrepresentation(s) of the facts. We also feel that Solae knowingly
used an extremely narrow selection of past research to try to bend the
truth in order to try to justify and prove their flawed argument for a
Qualified Health Claim for Soy and Cancer.

**[1 st. Point of Error By The Solae Corporation]{.underline}**

**[On page 115 of the Solae's Application, in Section C: Analytical
Data]{.underline}**

I feel, as supported by the evidence here and similar facts elsewhere,
there is a very inaccurate and misleading statement by Solae Corporation
as to how much soy has been eaten in past centuries, and an error in the
way they phrased their sentence in the application, which we feel is
from either their inexperience and lack of knowledge from being a newly
formed Corporation early in 2003 and / or an attempt to fool the FDA
with misinformation in order to get their claim accepted.

In their inaccurate statement in their application they say that **"\...
Soybeans \... have been consumed as a dietary protein staple by
population for centuries (Messina et al, 1994a) \...".** Without Solae
including more accurate information form current and past research in
order to reflect a more truthful historical statement, their sentence
with its reference we feel, and as the evidence shows to knowledgeable
people, is highly inaccurate and misleading as it is presently left to
the understanding of both the FDA staff evaluating their application and
readers from the general public at large. Without Solae writing a more
complete and accurate presentation and understanding of the facts in
history and the historical use of soy in Solae's application, it easily
appears to an [informed]{.underline} reader, that those who wrote this
application use the words "[a dietary protein staple by populations for
centuries]{.underline}" as a smokescreen, a vague reference to how much
soy they, the Solae Corporation, wants you, the FDA and the readers of
their Application to believe Asians and Japanese ate in the past. What
Solae wrote is a not true. Their vague reference in their sentence
illustrates the great lack of historical knowledge Solae Corporation has
on this topic, (or pretends to have). We feel their sentence in question
here is intentionally and deliberately and purposely written to confuse
and then used in order to hide from both the ill-informed general public
and the FDA staff the real historical truth and real understanding of
the issue(s) in order to get Solae's application in question approved by
the FDA under what we feel is misinformation.

Below are fact that a company like Solae, with their limited knowledge
and experience, who professes to be knowledgeable about the history
should know. I feel that it is very negligent of them to have not
presented these facts correctly, when the opposite of what they claim is
really the true. A similar situation to that experienced from
information coming from the pharmaceutical companies on their claim that
Hormone Replacement Therapy, HRT, was safe and beneficial. Let me
illustrate with some historical facts that should be known by the
representatives of the Solae Corporation. The following facts are
hopefully known by the staff in the FDA who have the authority to accept
and/or reject this application. We will just mention a few of many
studies on this topic.

**\... / 13**

**- 13 -**

**Petition of Objection To**

**[( Docket \# 2004Q-0151 ) - Solae Corporation requests FDA Health
Claim]{.underline}**

**re: Qualified Health Claim: Soy Protein May Reduce Risk Of Cancer**

It has been argued that high levels of soy isoflavones such as genistein
and daidzein in Asian diets protect the inhabitants of Japan and China
from certain degenerative diseases, especially breast and prostate
cancer. Actually, consumption of soy in traditional Asian diets is low.
A **1975** report lists safeties as minor sources of protein in Japan
and China.**(1.)** Major sources of protein listed were meat including
organ meats, poultry, fish and eggs. Average isoflavone consumption in
Asian diets ranges from 10-28 mg/day, as shown in the table below.
Studies indicate that isoflavone consumption at levels slightly
exceeding those found in tradition diets results in thyroid suppression
and endocrine disruption. The AdvantaSoyTMClearTM supplement would add
30-50 mg of isoflavones to a 100-gram serving of various common foods,
levels that exceed the amounts found in traditional diets and that are
in the range of levels shown to cause problems, especially for sensitive
individuals. It is not only possible but likely that many individuals
will consume two or more servings of foods to which the Cargill
isoflavones have been added, especially as these foods will be promoted
with much advertising touting their health benefits. Two or more
servings of such foods would provide 60-100 mg isoflavones per day, an
amount that clearly poses dangers after only a brief period of daily
intake.

**[Isoflavones]{.underline}**

Japan (1996 survey),**(2.)** 10 mg/day

Japan (1998 survey),**(3.)** 25 mg/day

Japan (2000 survey),**(4.)** 28 mg/day

China (1990 survey),**(5.)** 10 mg/day

In Japanese subjects receiving adequate iodine, Soy still
**[causes]{.underline}** thyroid suppression after 3 months use,**(6.)**
38 mg/day

In American women, **[causing]{.underline}** hormonal changes, after 1
month,**(7.)** 45 mg/day

AdvantaSoyTMClearTM. 30-50 mg/ 100 g serving

**[References]{.underline}:.**

**1.** *Nutrition during Pregnancy and Lactation*. California Department
of Health, **1975.**

**2.** Fukutake M, Takahashi M, Ishida K, Kawamura H, Sugimura T,
Wakabayashi K. Quantification of genistein and genistin in

soybeans and soybean products. *Food Chem Toxicol* **1996**;34:457-461.

**3.** Nagata C, Takatsuka N, Kurisu Y, Shimizu H. Decreased serum total
cholesterol concentration is associated with high intake of soy

products in Japanese men and women. *J Nutr* **1998** Feb;128(2):209-13.

**4.** Nakamura Y, Tsuji S, Tonogai Y. Determination of the levels of
isoflavonoids in soybeans and soy-derived foods and estimation

of isoflavonoids in the Japanese daily intake. *J AOAC Int*
**2000**;83:635-650.

**5.** This exhaustive study of Chinese diets found that legume
consumption ranged from 0 to 58 grams per day, with an average of 13

gams. Assuming that 2/3\'s of this is from soy beans, then consumption
averages about 9 grams of soy products per day. Isoflavone

content would be about 10 mg/day. Chen J, Campbell TC, Li J, Peto R.
*Diet, Lifestyle and Mortality in China. A study of*

*the characteristics of 65 counties*. Monograph, joint publication of
Oxford University Press, Cornell University Press, China

People's Medical Publishing House. **1990.**

**6.** Y Ishizuki, et al, "The effects on the thyroid gland of soybeans
administered experimentally in healthy subjects," *Nippon*

*Naibunpi Gakkai Zasshi* **1991**, 767: 622-629

**7.** Cassidy A, Bingham S, Setchell KD. Biological effects of a diet
of soy protein rich in isoflavones on the menstrual cycle of

premenopausal women. *Am J Clin Nutr* **1994**;60(3):333-340.

**8.** *Washington Post Health Section,* January 30, **2001.**

**9.** Burros M. Doubts Cloud Rosy News on Soy. *New York Times*,
January 26, **2000.**

There is also the **1998** survey which found that the average daily
amount of soy protein consumed in Japan was about eight grams for men
and seven for women - less than two teaspoons. (**40.** Nagata, C. et
al., Journal of Nutrition (1998) 128:209-213.)

Then there is also the famous Cornell China Study, conducted by Colin T.
Campbell, found that legume consumption in China varied from 0 to 58
grams per day, with a mean of about twelve. (**41.** Campbell, Colin T.
et al., The Cornell Project in China.) And I could go on and on, as
there are other studies.

**\... / 14**

**- 14 -**

**Petition of Objection To**

**[( Docket \# 2004Q-0151 ) - Solae Corporation requests FDA Health
Claim]{.underline}**

**re: Qualified Health Claim: Soy Protein May Reduce Risk Of Cancer**

Now with this evidence, lets assume that two-thirds, ( 2/3\'s ), of
legume consumption is soy, then the maximum consumption is about 40
grams, or less than three tablespoons per day, with an average
consumption of about nine grams, or less than two teaspoons. A survey
conducted in the 1930\'s found that soy foods accounted for only 1.5 per
cent of calories in the Chinese diet, compared with 65 per cent of
calories from pork. (**42.** Chang, K.C. (ed.), Food in Chinese Culture:
Anthropological and Historical Perspectives, New Haven, 1977.) Also
Asians traditionally cooked with lard, not vegetable oil, which is
recently being comprised of soy or mostly soy, or soy and canola.

**In reality, except I times of famine, Japanese and Asians ate soy, and
still do eat soy in [very small amounts]{.underline}, as a
[condiment]{.underline} (a seasoning),** **not** as a protein
substitute, **not** as a replacement for animal foods, even fermented
soy, with one exception !. Celibate monks living in monasteries and
leading a vegetarian lifestyle find soy foods quite helpful because they
dampen libido. Asians have been aware of the toxic, poisonous nature of
soy as far back as during the **Chou Dynasty (1134-246 BC).** The
Chinese did not eat unfermented soybeans as they did other legumes such
as lentils, because the soybean contains large quantities of natural
toxins or **\"anti-nutrients\"**, as the soy industry calls them.
Fermentation and the western methods of processing soy only lowers the
toxic levels and the toxic effects of these "anti-nutrients" in soy, but
it dies not eliminate them. When precipitated soy products like tofu are
consumed with meat, the mineral-blocking effects of the phytates are
reduced. **(18.** Sandstrom, B. et al., **\"[Effect of protein level and
protein source on zinc absorption in humans]{.underline}\"**, Journal of
Nutrition 119(1):48-53, January 1989; Tait, Susan et al., **\"[The
availability of minerals in food, with particular reference to
iron]{.underline}\"**, Journal of Research in Society and Health
103(2):74-77, April 1983.) The Japanese traditionally eat a small amount
of tofu or miso as part of a mineral-rich fish broth, followed by a
serving of meat or fish.

Also, soy advertisers and soy manufactures, like the Solae Corporation,
selectively claim lower rates of reproductive cancers for Japanese and
Asians eating soy, while knowing and ignoring the fact that the Japanese
and Asians also have much higher rates of cancer of the esophagus,
stomach, liver, pancreas, and thyroid, particularly as soy also causes
these came types of cancers in a variety of laboratory test animals.
(**38.** Harras, Angela (ed.), Cancer Rates and Risks, National
Institutes of Health, National Cancer Institute, 1996, 4th edition, and
**39.** Searle, Charles E. (ed.), Chemical Carcinogens, ACS Monograph
173, American Chemical Society, Washington, DC, **1976.**) (and in farm
animals). This also includes cancer of the pancreas (**14.** Rackis,
Joseph J. et al., \"The USDA trypsin inhibitor study. I. Background,
objectives and procedural details\", Qualification of Plant Foods in
Human Nutrition, vol. 35, 1985).

**[2 nd. Point Of Error By The Solae Corporation]{.underline}**

[One page 13 of Solae's application]{.underline} is a statement for one
of Solae Corporation's justifications for accepting its application on
for a Health Claim for Soy Protein as it relates to Cancer, they say,
**"\... the FDA has recognized soy protein products as having GRAS
status at various times throughout the past three decades \...".** We
feel that this statement on the history of soy in our food supply is not
true.

Unaware by the general public, the historical knowledge of the naturally
carcinogenic properties of soy have a long, known, ignored and denied
publically by the soy industry and the US FDA for over 40 years. We feel
that the statement by the Solae Company in its application to the FDA is
definitely and deliberately false, distorted, slanted and misleading
because of these next points . So, Why doesn't soy protein does not have
GRAS determination.

**1.)** Soy protein was slipped into the food chain about **1959** even
though the developmental research (funded by ADM and Mead Johnson)
demonstrated that it caused serious infertility problems in laboratory
rats and their offspring. This is recorded in a series of papers in the
**"[Journal of Nutrition" by Schultze, Liener et al]{.underline}** in
the **1950\'s**

**2.)** In **1966**, "The Committee for Food Safety" was worried about
soy's carcinogenic properties.

**3.)** In **1972**, the Nixon administration directed a re-examination
of substances believed to be GRAS (Generally Recognized As Safe), in the
light of any scientific information then available. In **1974**, the FDA
obtained a literature review of soy protein because, as soy protein had
not been used in food until **1959** and was not even in common use in
the early 1970s, it was not eligible to have its GRAS status
[grand-fathered]{.underline} under the provisions of the Food, Drug and
Cosmetic Act. The scientific literature up to **1974** recognized many
antinutrients in factory-made soy protein, including trypsin inhibitors,
phytic acid and genistein. The FDA was more concerned with toxins formed
during processing, specifically nitrites and lysinoalanine. Even at low
levels of consumption - averaging one-third of a gram per day at that
time - the presence of these carcinogens was considered too great a
threat to public health to allow GRAS status.

**\... / 15**

**- 15 -**

**Petition of Objection To**

**[( Docket \# 2004Q-0151 ) - Solae Corporation requests FDA Health
Claim]{.underline}**

**re: Qualified Health Claim: Soy Protein May Reduce Risk Of Cancer**

**[History of soy]{.underline} \...** continued.

**4.)** The definitive textbook **"Chemical Carcinogens"** published by
the American Chemical Society in **1976** had a chapter titled **"Plant
Carcinogens"** that identified soy isoflavones as known carcinogens.

**5.)** The only evaluation was done by The Life Sciences Committee of
FASEB in its **1978** **"Evaluation of Soy Products for Human
Consumption"** for the Food and Drug Administration (SCOGS-101 under
contract to the FDA \# 223-75-2004) declined GRAS determination because
of the risks of carcinogenic nitrosamines, lysinoalanines, and nitrite
occurring during the modern processing, heat treatment. FASEB assumed
the heat treatment was removing the natural poisons, and did not
evaluate their safety at all. In a **1980** study, McGuinness E.E., it
was found that long periods of heat and pressure, requiring 130 degrees
Celsius, could deactivate the trypsin inhibitors, genistein, in soy, but
that denatured the soy protein to the point that the protein became
virtually useless. So, one was faced with either choosing less heating,
resulting in more surviving poisonous trypsin inhibitors, or more
heating, resulting in useless protein. Consequently, here is no
standardization as to who soy protein is processes. Toxin levels can
vary widely. **[William Jarvis, Ph.D.]{.underline},** Department of
Health Promotion and Education, [Loma Linda University]{.underline},
Loma Linda, California, USA. The FDA has imposed no requirements for
manufactures to use heat treatment, or any guidelines as to how long or
how high the temperature needs to be. **"The effects of long-term
feeding of soya flour on the rat pancreas," --- *[McGuinness E.E, Morgan
R.G., Levison D.A. and others]{.underline}*** ***Scandinavian Journal of
Gastroenterology,* 1980*; 15(4):497-502.*** FDA officials called for
safety specifications and monitoring procedures before granting of GRAS
status for food. These were never performed. To this day, the use of soy
protein is codified as GRAS only for the limited industrial use as a
cardboard binder. This means that soy protein must be subject to
premarket approval procedures each time manufacturers intend to use it
as a food or add it to a food.

**6.)** In **1999**, an application by Archer Daniels Midland Corp for
GRAS determination of GRAS (GRN 00001) for isoflavones was declined due
to the failure of the applicant to reveal health risks. (Not to mention
the more current scientific research documented natural occurring
carcinogenic chemicals is soy called **[genistein]{.underline}** and
**[daidzein]{.underline}** and **[beta-Sitosterol]{.underline}** in May
2004 ).

You will find a fuller discussion of **GRAS** in the Home Page of
[[www.soyonlineservice.co.nz]{.underline}](http://www.soyonlineservice.co.nz/)
**\"Trouble for Soy Protein\"**, including Dr Fitzpatrick\'s opposition
to the grant of health claim labeling by the FDA. The material in
[[www.soyonlineservice.co.nz]{.underline}](http://www.soyonlineservice.co.nz/)
**\"Doses Simplified\"** gives an idea of how toxic the levels of
isoflavones are in the products.

[In addition]{.underline}, Soy is in breach of, in violation of -
"[WHO/CODEX]{.underline} - Food Safety Standards," WHO/Codex General
Standards for [Soy]{.underline} Protein Products. World Health
Organization, WHO/Codex Standard 175-1989 **[and]{.underline}**
WHO/Codex General Guidelines for the Utilization of Vegetable Protein
Products (VPP) in Foods CAC/GL 4-1989. These standards do not allow
approval of food ingredients that has been shown to have \... Subacute
toxicity \... Chronic toxicity \... Reproductive toxicity \... or have
\... Teralogenic effects \... mutagenic effects \... and fail to have
scientific studies last at least 3 month in length. It is well
documented that soy produces those health hazards banned by the WHO.
When the scientific studies go into the 2^nd^, 3^rd^ and 4^th^ month and
longer, this is when the serious health hazards start to show up in a
variety of laboratory test animals, as is reflective of scientific
research in this submission and as reported in real life experience
situations. See \...
[[http://www.soyonlineservice.co.nz/Refs/Codex.htm]{.underline}](http://www.soyonlineservice.co.nz/Refs/Codex.htm)
.

[To add insult to injury]{.underline}, soy protein fails to meet,
fulfill, and satisfy the [1958 "Delaney Amendment]{.underline}" to the
USA's FDA Reg.'s which prohibits the use of any food additive if it is
found to cause cancer in any animal species or in man, at any dose
level.

Add up all this and more to "Hidden Harm" soy is doing to our health as
seen in the growing list of known and ignored side-effects, and you have
100\'s of millions of crime scenes taking place around the world every
day.

The negative health risks of soy in our food supply clearly far out
weigh any claimed benefits to health.

The weed of crime bears bitter fruit. Does the soy industry and all its
supporters really think they'll all get away with it ??. Do they really
think I, we, wouldn't know ??.

**\"\... Money, not truth, drives science -- even at the expense of the
health and lives of the nation\'s citizens \...\"**, by Dr. Phyllis
Mullenix, Ph.D., formerly of Harvard University, Dept. of Neuropathology
and Psychiatry, See \...

**Did Government Approve Citizens as Toxic Waste Sites ?, Are We Being
Poisoned ?, and it is no mistake !!,** at \...
[[http://www.lef.org/fda-museum/8_water/intarticles/fluoride-01-98.html]{.underline}](http://www.lef.org/fda-museum/8_water/intarticles/fluoride-01-98.html)
and
[[http://www.whale.to/b/fl2.html]{.underline}](http://www.whale.to/b/fl2.html)

and
[[http://www.fannz.org.nz/text/mullinex.html]{.underline}](http://www.fannz.org.nz/text/mullinex.html)
.

**\... / 16**

**- 16 -**

**Petition of Objection To**

**[( Docket \# 2004Q-0151 ) - Solae Corporation requests FDA Health
Claim]{.underline}**

**re: Qualified Health Claim: Soy Protein May Reduce Risk Of Cancer**

**[3 rd. Point Of Error By The Solae Corporation]{.underline}**

**[Also on page 115 and 116, Section D]{.underline}**, Model Health
Claim, of the Solae Corporations Application, there are claims in two
troubling request in Subsection D.1. Proposed Claims.

**[Solae's 1^st^ request in Subsection D.1. Proposed
Claims]{.underline}**. "The following statement is proposed for foods
that meet the qualifying criteria for the soy protein and reduced risk
of certain cancers health claim:

> **A.)** "Soy protein may reduce the risk of certain cancers.
> Scientific evidence suggests that consumption of soy protein may
> reduce the risk of certain forms of cancer. However, this evidence is
> not conclusive."

Here, Solae freely admit that their evidence is not conclusive. Also,
the research, the evidence, presented here in our submission of
objection further supports Solae's statement that "\... their evidence
is not conclusive \...". Also, the evidence presented here
**[contradicts their claim of reduced cancer risk from eating
soy]{.underline}.** In fact, the scientific research presented here,
from experts in their own fields from around the world, disproves
Solae's claim of cancer prevention, and proves the opposite, that is,
the consumption of soy protein like soy protein isolate, SPI, does
**[very greatly increases the risk]{.underline}** of certain cancers,
including breast cancer. **The negative health risks of soy in our food
supply clearly out weigh any claimed or imagined benefits to health.**

**[Solae's 2^nd^ request in Subsection D.1. Proposed
Claims]{.underline}**. "The following statement is proposed for foods
that meet the qualifying criteria for the soy protein and reduced risk
of certain cancers health claim:

> **B.)** "Soy protein may produce anti-carcinogenic effect in the body.
> Scientific evidence suggests that consumption of soy protein may
> produce anti-carcinogenic effects in the body. However, this evidence
> is not conclusive.

Here again, they freely admit that their evidence is not conclusive on
this point as well. The research, the evidence, presented in this
submission further supports their claim that "\... their evidence is not
conclusive \...". In fact, the scientific research presented here in our
submission from around the world, again does prove the exact opposite of
Solae's claim. That is, the consumption of soy protein **[does
not]{.underline}** in any way produce anti-carcinogenic effects in the
body, but, the consumption of soy protein like soy protein isolate, SPI,
does **[very greatly increases the risk]{.underline}** of certain
cancers, including breast cancer. **The negative health risks of soy in
our food supply clearly out weigh any benefits to health.**

The evidence is Solae's application is not conclusive by their own
admission. This is further evidence, extremely important evidence for
the FDA to use as reason to deny, to turn down and to decline Solea
Corporation's application for a Qualified Health Claim for soy and
cancer. I repeat again from what I have said earlier toward the
beginning of this submission \...

> In fact, in the 1998 abstract above and in the reference section
> below, it is stated in a meta-analysis done by ***[Strauss L., Santti
> R., Saarinen N., Streng T., Joshi S., and Makela S.,]{.underline}***
> at the **Institute of Biomedicine and Medicity Research Laboratory,
> University of Turku, Finland**, that "\... there is no direct evidence
> for the beneficial effects of phytoestrogens in humans. \... All
> information is based on consumption of phytoestrogen-rich diets, and
> the causal relationship and the mechanisms of phytoestrogen action in
> humans still remain to be demonstrated \... In addition, the possible
> adverse effects of phytoestrogens have not been evaluated \... It is
> plausible that phytoestrogens, as any exogenous hormonally active
> agent, might also cause adverse effects in the endocrine system, i.e.
> act as endocrine disrupters \...".

There is still no direct evidence, nothing has changed and this is still
exactly the case today as it was in 1998, and before. This is part of
the reason why Solae says in their application in the 3^rd^ point I make
above that "\... However, this evidence is not conclusive \...". To
knowingly endanger peoples health to known and ignored health hazards,
"Hidden Harm," by submitting evidence that is not conclusive, is, I
suggest, a criminal act of global proportions, as is explained in quite
legal detail further on in this submission.

**\... / 17**

**- 17 -**

**Petition of Objection To**

**[( Docket \# 2004Q-0151 ) - Solae Corporation requests FDA Health
Claim]{.underline}**

**re: Qualified Health Claim: Soy Protein May Reduce Risk Of Cancer**

It is deeply disturbing to Deanna, me and other dedicated and caring
people who are aware of the many serious health hazards of soy in our
food supply that Solae Corporations says that their request for a
**[Qualified Health Claim: Soy Protein and Cancer]{.underline}** "\...
is consistent with the model claims of other authorized cancer related
health claims of the FDA (Dietary Fat and Cancer -& 101.73;
Fiber-Containing Grain Products - & 101.76; and Fruits and Vegetable and
Cancer - & 101.78 \...". It appears from Solae's request that the other
claims they are referring to will also give people false hope and
mislead people to an inaccurate and unsafe conclusion about soy and
other soy ingredients as being safe; where as, the conclusive evidence
presented by us does justify the Solae's claims about soy as "not
conclusive." We feel that Solae's inconclusive claims are in effect
worthless, and proof that their application should not be approved by
the FDA.

But, in reality, as you read through this continually growing body of
scientific research from credible medical and dietary research, **[the
evidence]{.underline},** which includes **[but is not limited
to]{.underline}** what is presented here in this petition of objection
to Solae's application for a Health Claim is conclusive in proving soy
and soy protein isolate, SPI as be unsafe, and pose a clear danger to
the public and should not be allowed in our food supply.

The FDA should deny Solae Corporations application and be looking for
"[conclusive evidence]{.underline}." The FDA will find "[conclusive
evidence]{.underline}" in the scientific research presented there in our
submission. Evidence that shows "\... soy does [very greatly increases
the risk]{.underline} of certain cancers, including breast cancer \...".
Soy protein products create an **"[INCREASED RISK]{.underline}"** of
various cancers, including breast cancer.

The evidence presented here demonstrates that nothing has changed
regarding the unsafe use of soy and soy protein ingredients like SPI
being put in our food supply since the **Chou Dynasty (1134-246 BC).**
So, this is still exactly the present situation today, as it has always
been for the last couple of thousand years.

As pointed out in a very interesting article on cancer a couple of weeks
ago, this month, in May **2004**, in the Vancouver Sun News paper, here
in Vancouver, BC, \... with 1 in 3 women and 1 in 2 men expected to die
from cancer, it is now being said that dying from cancer will be the
leading cause of death in a few years \... Adding more soy to our food
supply will only increase the yearly cancer deaths, along with the pain
and suffering and heartache that comes from cancer. You can see that no
one is safe from the very many harmful and sometimes deadly side-effects
of eating soy. One can easily conclude that if soy is recommend to any
one, many people could be faced with a reoccurrence of cancer from
eating soy. Recommend soy to anyone and you are participating in
unimaginable pain and suffering to millions, as well as in mass murder.
Like **Dr. Samuel Epstein, MD** of the \"Cancer Prevention Coalition\"
says in the **2003** movie **"The Corporation"** at \...
[[http://www.thecorporation.tv/synopsis.php]{.underline}](http://www.thecorporation.tv/synopsis.php)
, and at \...
[[http://www.thecorporation.com/]{.underline}](http://www.thecorporation.com/)
, \... dying from chemical poisoning is really no different than if a
gun was put to your head and someone else pulled the trigger. Chemical
poisoning is just a lot slower that's all \... Murder is still Murder.

If the Solae Corporation's application is approved, how will the general
public at large, present and past cancer patients, and other people
suffering from serious illness listed in the list of known and ignored
side-effects caused from and by eating soy, under **"[Hidden
Harm]{.underline}"**, be able to avoid these harmful and sometime deadly
side-effects when eating soy ingredients in our food like SPI ??. Safety
starts at the top, with the FDA, and the trust the general public puts
in the FDA to protect them from harmful, toxic, poisonous, and sometimes
deadly ingredients in our food supply. Safety is no accident, and those
in the FDA with the decision making process to deny Solae's application
must exercise their power and deny Solae's application. Also the FDA has
the power to stop further poisoning of our food supply with soy
ingredients like SPI form other soy manufactures as well. With our
objection, and the evidence presented here, we also request that the FDA
rescind and repeal the "Self Determination" ability for corporations to
give soy Self Determined GRAS status.

Pregnant women and their unborn child are at risk from soy ingredients
in our food supply. The toxic ingredient in soy genistein cross the
placenta and blood-brain barrier, "teratogenic," causing birth defects.
The placenta does not represent a barrier to these poisons. See
abstracts in reference section below for documentation of this.

**"[Toxic Load]{.underline}"** means that \... the risk is a function of
dose length, dose strength, and of the physical condition of the
consumer.

**References:** **"The Dose Makes the Poison: A Plain-Language Guide to
Toxicology,"** 2nd Edition, **1996**, by M. Alice Ottoboni., and

**"Principles of Toxicology,"** by Casarett and Doull.

**[Remember]{.underline},** when the Titanic sank early Monday morning
of April 15th, 1912. **It was women and children and the elderly who
were put into the life boats first.** Well, it is kind of in the same
way with soy being put into our food supply without our consent. It is
also women, children, the pregnant women and her fetus and the elderly
who are harmed first, injured first, and injured the worst from soy
being put in our food supply. Kind of psychopathic don\'t you think. See
reference to the **2003** movie **"[The Corporation]{.underline},"**
here page 22.

**\... / 18**

**- 18 -**

**Petition of Objection To**

**[( Docket \# 2004Q-0151 ) - Solae Corporation requests FDA Health
Claim]{.underline}**

**re: Qualified Health Claim: Soy Protein May Reduce Risk Of Cancer**

**Deonaa and Gerald Hernesmaa now urgently urge you, the FDA,** to now
follow the same course of action taken in 1978 and in 1999, and do "The
Right Thing", the "Humanitarian" thing to do, the "Ethical" thing to do,
and that is to deny, to turn down and to decline Solae Corporation's
application for a Qualified Health Claim for soy and cancer, or any
similar application in the future from them or any other corporation or
business, based on but not limited to the documented evidence in this
and other submissions of objection you have received, and the use of the
"*[The Precautionary Principle]{.underline}*".

The use of the Precautionary Principle at \...
[[http://www.biotech-info.net/rachels_586.html]{.underline}](http://www.biotech-info.net/rachels_586.html)
says that people have a duty to take anticipatory action to prevent
harm. If you have a reasonable suspicion that something bad [might be
going to happen]{.underline}, you have an obligation to try to stop it.
Why ??. Because FDA knows of the "Hidden Harm" people are experiencing
from soy ingredients in our food supply. The Precautionary Principle is
not really New. It is captured in common-sense aphorisms down throughout
history, such as "[An ounce of prevention is worth a pound of
cure]{.underline}" \... "[Better safe than sorry]{.underline}" \...
"[Look before you leap]{.underline}" \... "[Error on the side of
caution]{.underline}" \... etc., etc., etc.

**[The Principle of Precautionary Action has 4 parts]{.underline}:**

**1.)** People have a duty to take anticipatory action to prevent harm.
(As one participant at the Wingspread meeting summarized the essence of
the precautionary principle, "If you have a reasonable suspicion that
something bad [might be going to happen]{.underline}, you have an
obligation to try to stop it.").

**2.)** The burden of proof of harmlessness of a new technology,
process, activity, or chemical lies with the proponents, not with the
general public.

**3.)** Before using a new technology, process, or chemical, or starting
a new activity, people have an obligation to examine "a full range of
alternatives" **[including]{.underline} \... the alternative of doing
nothing,** (in order to protect the health and well-being of others.).

**4.)** Decisions applying the precautionary principle must be "open,
informed, and democratic" [and]{.underline} "must include affected
parties."

More and more people are realizing that the original petition submitted
by Protein Technologies International, PTI, requested that the health
claim be made for the soy isoflavones, the plant estrogens found
abundantly in soybeans, provided only weak and conflicting proofs that
isoflavones lower cholesterol and besieged by strong evidence of
toxicity and hormone disruption, the FDA should have thrown out the PTA
petition. It had a duty to do so.

But instead, in 1998 the FDA took the unprecedented step of rewriting
PTI's petition and substituting a claim for soy protein. This step
violated the industry's own regulations. Then the FDA speeded the
decision-making process by reducing the time in which members of the
public could protest to only 30 days. In doing so, they disregarded the
testimony of \... top scientists at the FDA's own National Center of
Toxicological Research \... British government researchers (1998) \...
and other qualified experts \... all of which were providing strong
evidence of danger from allergens, protease, inhibitors, and other soy
components as well as the plant hormones.

It\'s all the more shocking because the FDA never had good evidence of
soy's cholesterol lowering effect to begin with !. The FDA relied almost
entirely on just one study --- a 1995 meta analysis of 29 studies by
James W. Anderson that was sponsored by Protein Technologies
International. Then on Oct. 25, 1999, US FDA allowed a health claim for
soy. By 1995 there was tons of proof that soy had many health hazards
including causing cancer cells to grow. But in 1999, the FDA granted a
Health Claim for soy anyway.

[More and more people are coming to understand that the USA's FDA has a
unique procedure]{.underline} \... It was designed by industry, which
lobbied for its substitution in place of normal GRAS requirements. It is
called \"[self-determination]{.underline},\" meaning that a manufacturer
provides its own evaluation of the \"safety\" of its product. Then the
FDA advertises in the Federal Register, which is not really a widely
read document. If no citizen objects, the FDA [rubber
stamps]{.underline} its approval and a multi-million-dollar win is
showered on the applicant. This then becomes the benchmark for every
other promotion of similar products. The US Center for Food Safety and
Applied Nutrition (CF-SAN ) does [not]{.underline} investigate for
itself, and there rarely is an objection because the ultimate consumer
does not have a clue about the procedure.

**\... / 19**

**- 19 -**

**Petition of Objection To**

**[( Docket \# 2004Q-0151 ) - Solae Corporation requests FDA Health
Claim]{.underline}**

**re: Qualified Health Claim: Soy Protein May Reduce Risk Of Cancer**

**\"This [self-determination procedure]{.underline},\"** referred to
above, is making the soy industry and those supporting it and making
money from soy, very liable to legal action (Class Action Law Suit) from
problems caused by soy being put in our food supply, from soy poisoning
our food supply worldwide. As proof of this, I recommend the following.
Part-3 of \... "The News Research On Why You Should Avoid Soy," "Soy The
Next Asbestos," at \...
[[http://www.mercola.com/article/soy/avoid_soy.htm]{.underline}](http://www.mercola.com/article/soy/avoid_soy.htm)
by Sally Sallon and Mary G. Enig, Ph.D., partly quoted below.

**[Soy - The Next Asbestos ??]{.underline}.**

\-
[[http://www.mercola.com/article/soy/avoid_soy.htm]{.underline}](http://www.mercola.com/article/soy/avoid_soy.htm)
-

**Because the industry is extremely exposed \... contingency lawyers
will soon discover that the number of "[potential
plaintiffs]{.underline}" can be counted in the millions and the pockets
are very, very deep. Juries will hear something like the following:
\"The industry has known for years that soy contains many toxins."**

**"At first they told the public that 1.) the toxins were removed by
processing. When it became apparent that processing could not get rid of
them, 2.) they claimed that these substances were beneficial. Your
government granted a health claim to a substance that is poisonous, and
the industry lied to the public to sell more soy.\"**

**The \"industry\" includes \... merchants \... manufacturers \...
scientists \... publicists \... bureaucrats \... former bond financiers
\... food writers \... vitamin companies \... and retail stores. Farmers
will probably escape because they were duped like the rest of us.** But
they need to find something else to grow before the **[Soy bubble
bursts]{.underline}** and the market collapses: grass-fed livestock \...
designer vegetables \... or hemp to make paper for thousands and
thousands of legal briefs (that are sure to come and will soon follow).

**The negative health risks of soy in our food supply clearly out weigh
any imagined or claimed health benefits**

"\... [Imagine]{.underline} having drugs, (genistein, diadzein),
(beta-Sitosterol), added to our food which have been scientifically
proven, for nearly 25 years, to be carcinogenic [and]{.underline} to
also [cause]{.underline} DNA and chromosome damage in both humans & in
animals. **[Also]{.underline},** imagine these drugs being prescribed
and administered through our food supply **[without]{.underline}** the
individual's **[prior]{.underline}** knowledge or understanding of these
dangers, or **[prior]{.underline}** consent to be exposed to these
dangers. **[Now]{.underline}**, imagine the entire population in many
countries around the world, including ours, consuming these foods \...
with no medical way of tracking dosage, individual reactions, or harmful
side-effects, and, without any concern for some people's **[increased
vulnerability]{.underline}** from being exposed to these drugs, such as
cancer patients. **[Does all this sound a little crazy
??]{.underline}**. Well, I'll tell yeah, this is exactly what is
happening to us when **Soy** is added to our food supply. **Soy**
contains the **"[naturally toxic]{.underline}"** ingredients
**[genistein]{.underline}** and **[daidzein]{.underline}** which have
been scientifically documented, proven, to be carcinogenic,
**[cause]{.underline}** DNA and chromosome damage, and to
**[cause]{.underline}** cancer cells to grow. **Soy** can also
**[cause]{.underline}** non-cancerous tumors to turn cancerous \...".
**Soy** does all this and more, as these are [only some]{.underline} of
the many **[health hazards]{.underline}** associated with eating soy.

**\"\... Money, not truth, drives science -- even at the expense of the
health and lives of the nation\'s citizens \...\"**, by Dr. Phyllis
Mullenix, Ph.D., formerly of Harvard University, Dept. of Neuropathology
and Psychiatry, See \...

**Did Government Approve Citizens as Toxic Waste Sites ?, Are We Being
Poisoned ?, and it is no mistake !!,** at \...
[[http://www.lef.org/fda-museum/8_water/intarticles/fluoride-01-98.html]{.underline}](http://www.lef.org/fda-museum/8_water/intarticles/fluoride-01-98.html)
and
[[http://www.whale.to/b/fl2.html]{.underline}](http://www.whale.to/b/fl2.html)

and
[[http://www.fannz.org.nz/text/mullinex.html]{.underline}](http://www.fannz.org.nz/text/mullinex.html)
.

**\... / 20**

**- 20 -**

**Petition of Objection To**

**[( Docket \# 2004Q-0151 ) - Solae Corporation requests FDA Health
Claim]{.underline}**

**re: Qualified Health Claim: Soy Protein May Reduce Risk Of Cancer**

Deanna and Gerald Hernesmaa are shocked that a publicly held corporation
would seek health **benefit** claims- labeling, without revealing at the
same time to the FDA and to the general public at large, both past and
present scientific research that very clearly documented risks of cancer
causation and cancer cell growth acceleration, and other serious health
problems, by the use of these same products, namely soy and soy
ingredients like soy protein isolate, SPI, being put in our food. People
have the right to know of the health hazards they are being exposed to
with our their consent. Without informing people of this danger, the soy
industry, their supporters, and even the all powerful FDA are viewed as
being corrupt by people who know the truth, by people who have been
injured by soy before they found out the truth about soy. We feel the
"evidence" in this submission shows that the soy industry and its
supporters are willing participants in putting poison in our food
supply, and the unnecessary sickness and death that come from it. We
also feel that the people in authority in the FDA who have the influence
and power of authority to put a stop to this, should put a stop to this,
instead of continuing to allow soy to be put in our food supply.
**Genistein** in soy is a dietary topoisomerase II-poison, it
accumulates in the body over time building up a toxic load and causes
DNA [double strand breaks]{.underline} leading to chromosomal
aberrations and leukemia's. **Genistein** also destroys myelin sheath
protecting nerves, leading to "Alzheimer's and Parkinson's disease", and
learning disabilities as in ADD/ADHD.

The Solae Corporation is in a conflict of interest in making their
application for a Qualified Health Claim for Soy Protein and Cancer.
Like any \"Corporation,\" would. The Solae Corporation's legal
requirement under the law, as a Corporation, is to move product, find
new ways to use soy products, sell as much product to maximize company
profits for its shareholder's, even at the expense of the public good,
and the good of the environmental. See the 2003 movie The Corporation at
\...
[[http://www.thecorporation.tv/synopsis.php]{.underline}](http://www.thecorporation.tv/synopsis.php).
and at \...
[[http://www.thecorporation.com/]{.underline}](http://www.thecorporation.com/)
, and below in this essay. What any business needs is customer loyalty
which also helps a very great deal in maximizing company profits. But
what is pointed out in Helke Ferrie's book "[Hippocrates in the land of
OZ, A Survival Guide for our Golden Age of Medicine]{.underline}," is
that you can't have customer loyalty if the customer can't ignore the
negative side-effects of the drugs they are taking if there is also
natural, low or no side-effect choices available to them. So, one way to
get the customer to ignore the negative side-effects as long as
possible, not tell any one as much as possible about the negative
side-effects. That way when they eventually have them, they will only
turn to the pharmaceutical companies to by drugs to temporarily
counter-act the negative side-effects. The FDA should and needs to
realize that this is exactly what the soy industry is doing. Not telling
people about these negative side effects, many people never realize in
their life time that it was soy and soy ingredients like Soy Protein
Isolate, SPI, that played a major roll in causing their illness and/ or
death. To avoid this terrible problem, there are laws that
pharmaceutical companies must follow to inform people of the
side-effects of their drugs, when they advertise the benefits of a drug.
But, there is no such law requiring the soy industry, manufactures and
sellers of soy products and soy ingredients to inform the consumer about
the many negative and sometimes deadly side-effects of soy and soy
ingredients in our foods supply. This is a violation of the customers
lawful "Right to Know."

**[Legal Definitions]{.underline}**

[[http://www.trufax.org/reports/legal.html]{.underline}](http://www.trufax.org/reports/legal.html)

We feel that the soy industry and those who have the power to stop soy
being put into our food supply are guilt of inflecting untold,
incalculable, "[unimaginable]{.underline}" and needless pain, suffering,
agony and torture onto tens of millions of innocent people around the
world, by their actions, which include but are not limited to the
following legal definitions taken from **Blacks Law Dictionary, 6^th^
Edition, 1990**

> ***[Negligence]{.underline}*:** Omission which a reasonable person,
> guided by ordinary considerations which ordinarily regulate human
> affairs, would do, or the doing of something which a reasonable and
> prudent person would not do; conduct which falls below the standard
> established by law for the protection of others from unreasonable risk
> of harm.
>
> ***[Willful Misconduct]{.underline}*:** Conduct committed with an
> intentional or reckless disregard for the safety of others, or with an
> intentional disregard of a duty necessary to the safety of another\'s
> property.

Because of this, one might conclude that there is \...

> ***[Criminal Gross Negligence]{.underline}*:** Negligence that is
> accompanied by acts of commission, or omission of a wanton or willful
> nature, showing a reckless or indifferent disregard of the rights of
> others, under circumstances reasonably calculated to produce injury,
> or which make it probable that injury will be occasioned, and the
> offender knows or is charged with knowledge of the probable results of
> his acts.

**\... / 21**

**- 21 -**

**Petition of Objection To**

**[( Docket \# 2004Q-0151 ) - Solae Corporation requests FDA Health
Claim]{.underline}**

**re: Qualified Health Claim: Soy Protein May Reduce Risk Of Cancer**

**[Legal Definitions]{.underline}**

Continued

> ***[Criminal Behavior]{.underline}***: Conduct which causes any social
> harm which is defined and made punishable by law, presuming the law
> exists which covers the action
>
> ***[Quasi Crimes]{.underline}***: All offenses not crimes or
> misdemeanors, but that are in the nature of crimes; a class of
> offenses against the public which have not been declared crimes, but
> wrongs against the general or local public which should be punished by
> penalties.
>
> ***[Criminal Homicide]{.underline}*:** Criminal homicide constitutes
> murder when it is committed purposely or knowingly, or committed
> recklessly under circumstances manifesting extreme indifference to the
> value of human life.

Which have Deprived people of their right to \...

> ***[Informed Consent]{.underline}*:** A person\'s agreement to allow
> something to happen, based on full disclosure of the facts needed to
> make the decision intelligently; i.e., knowledge of risks involved,
> alternatives, etc.; the general principle of law embodying the duty to
> disclose to another whatever risks might be incurred from a proposed
> course of treatment, so that a person, exercising ordinary care for
> his own welfare, and faced with a choice of undergoing the proposed
> treatment, or alternative treatment, or none at all, may intelligently
> exercise his judgment by reasonably balancing the probable or possible
> risks against the probable or possible benefits.

Resulting from \...

> ***[Deceit]{.underline}*:** A fraudulent and deceptive
> misrepresentation, artifice, or device, used by one or more persons to
> deceive and trick another, who is ignorant of the true facts.
>
> ***[Misrepresentation]{.underline}*:** Any manifestation by words or
> other conduct not in accordance with the facts; an untrue statement of
> fact; an incorrect or false representation which, if accepted, leads
> the mind to an apprehension of a condition other and different from
> that which exists.

Because of \...

> ***[Fraud]{.underline}*:** An intentional perversion of the truth for
> the purpose of inducing another in reliance upon it to part with some
> valuable thing or to surrender a legal right; a false representation
> of a matter of fact, whether by words ot conduct, by false or
> misleading allegations, or by concealment of that which should have
> been disclosed, which deceives and is intended to deceive another so
> that he shall act upon it to his legal inquiry; anything calculated to
> deceive, whether by a single act or combination, or by suppression of
> truth, or suggestion of what is false, whether it be by direct
> falsehood or innuendo, by speech or silence, word of mouth, or look or
> gesture; fraud comprises all acts, omissions, and concealments
> involving a branch of legal or equitable duty and resulting in damage
> to another.
>
> ***[Fraudulent Concealment]{.underline}*:** The hiding or suppression
> of a material fact or circumstance which the party is legally or
> morally bound to disclose, in order to prevent inquiry, escape
> investigation, or to mislead or hinder the acquisition of information
> disclosing a right of action.
>
> ***[Fraudulent Intent]{.underline}*:** Such intent exists where one,
> either with a view of benefitting oneself or misleading another into a
> course of action, makes a representation which one knows to be false
> or which one does not believe to be true.

**\... / 22**

**- 22 -**

**Petition of Objection To**

**[( Docket \# 2004Q-0151 ) - Solae Corporation requests FDA Health
Claim]{.underline}**

**re: Qualified Health Claim: Soy Protein May Reduce Risk Of Cancer**

**The weed of crime bears [bitter]{.underline} fruit. Does the soy
industry and all its supporters really think they'll all get away with
it ??. Do they really think I, we, wouldn't know ??.**

**[In conclusion]{.underline},** the totality of the publicly available
scientific evidence, ***[Preponderance of evidence]{.underline}*:** on
the harmful and sometimes deadly side-effects of putting soy ingredients
in our food supply like Soy Protein Isolate, SPI, supports the
substance/ disease relationship that consumption of soy
protein-containing foods is associated with an [INCREASED]{.underline}
risk of various cancers, including but not limited to breast cancer in
women and men and young adults, and a variety of cancers in a
[variety]{.underline} of laboratory test animals and farm animals. Even
research proving serious health hazards from the American and Canadian
Cancer Institutes and Societies.

As pointed out earlier as a significant part of our evidence, Solae
Corporation says in their application that their evidence is not
conclusive by their own admission. But they want to persuade, lie, to
people again that soy is safe to eat, when human and animal studies
support epidemiological findings that consumption of soy-protein
containing foods is related to an INCREASE risk of cancers, including
but not limited to breast cancer, prostate cancer, colon cancer.

This is further evidence, extremely important evidence, as solid reasons
to deny, to turn down and to decline Solae Corporation's application for
a Qualified Health Claim for soy and cancer. To endanger peoples health
to known health hazards by submitting evidence in Solae's application
that is not conclusive, is, I suggest, a criminal act of global
proportions, as is explained in quite legal detail further on in this
submission.

In legal terms around the world, a Corporation is a person in law. But
what kind of a person is it ??. In the 2003 movie **"The Corporation,"**
it is pointed out quite clearly that in law a corporation must make as
much money for its share holders as possible, even if it goes against
the public good, the public's well-being of health and safety. In the
movie they quote ways to evaluate the nature of a person, or a
Corporation according to the **WHO, World Health Organization, WHO,
Personality Diagnostic Checklist, ICD - 10 , Manual of Mental Disorders
DSM - IV.** In that Manual it says that when a person satisfies the
following criteria, displays conduct of the following distinguishable
characteristics, than that person and or organization is diagnosed as
having a Psychopath Personality Disorder.

**"[The Corporation]{.underline}"**

[[http://www.thecorporation.tv/splash]{.underline}](http://www.thecorporation.tv/splash.php)

**Produced right here in Vancouver, B.C., Canada**

**Synopsis of the film at \...**
[[http://www.thecorporation.tv/synopsis.php]{.underline}](http://www.thecorporation.tv/synopsis.php).

**A documentary film delves into the "nature" of an Institution**

**Based on the book by Joel Bakan**

**"[The Corporation - The Pathological Pursuit of Profit &
Power]{.underline}"**

[[http://gallery.bcentral.com/Gallery/ProductListing.aspx?GID=5059307&Dept=358159&searchString=&page=1]{.underline}](http://gallery.bcentral.com/Gallery/ProductListing.aspx?GID=5059307&Dept=358159&searchString=&page=1)
.

**[Personality Diagnostic Checklist]{.underline}**

**WHO, World Health Organization ICD - 10**

**Manual of Mental Disorders DSM - IV**

**In law, the Corporation is a "person" \... [But]{.underline}, what
kind of person is it ??.**

**[Subject]{.underline}: The Corporation, ( and its distinguishable
characteristics )**

**Callous unconcern for the feelings of others. Deceitfulness: repeated
lying and conning others for profit**

**Incapacity to maintain enduring relationships. Incapacity to
experience guilt.**

**Reckless disregard for the safety of others.**

**Failure to conform to social norms with respect to lawful behaviors.**

**The Diagnosis: [Psychopath]{.underline}** **Personality Disorder**

**\... / 23**

**- 23 -**

**Petition of Objection To**

**[( Docket \# 2004Q-0151 ) - Solae Corporation requests FDA Health
Claim]{.underline}**

**re: Qualified Health Claim: Soy Protein May Reduce Risk Of Cancer**

So I ask you to consider the following. How will the general public at
large, present and past cancer patients and other people suffering from
those illness listed in the list **"[Hidden Harm]{.underline}"** of
known and ignored side-effects caused from and by eating soy, be able to
protect themselves, and the ones they love from these harmful and
sometime deadly side-effects from soy ingredients in our food like SPI,
if the Solae Corporations application for a Qualified Health Claim is
approved ??. Even those in the FDA want to protect the ones they love as
well. **[Safety starts at the top]{.underline}, with the FDA,** and the
trust the general public puts in the FDA to protect them from harmful,
toxic, poisonous, and sometimes deadly ingredients in our food supply.
**[Safety is no accident]{.underline},** and those in the FDA with the
authority and the decision making process to deny this application from
Solae, also have the power to stop poisoning our food supply with soy
ingredients like SPI, from the Solae Corporation or any soy business or
anyone else.

**Deonaa and Gerald Hernesmaa now urgently urge you, the FDA,** to now
follow the same course of action taken by the FDA in 1979 and in 1999,
and do "The Right Thing", the "Humanitarian" thing, the "Ethical" thing,
and that is to deny, turn down and decline Solea Corporation's
application for a Qualified Health Claim for Soy and Cancer, or any
similar application in the future from them or anyone else, based on but
not limited to the documented evidence in this and other submissions of
objection you have received, and the use of the **"*[The Precautionary
Principle]{.underline}*".**

**"[Propaganda]{.underline}" \...** "is the systemic propagation of a
given doctrine or of allegations reflecting its views and interests;
material disseminated by the advocates of a doctrine.\" The promotion of
**soy** as a miracle food has been both systematic and reflective of the
doctrine of the food industry --- that imitation foods are good for us
and traditional foods are unhealthy. The soy campaign is, in fact, a
case study in the use of propaganda to promote commercial interests," (
above Health, Safety and the Well-being of the general population and
customer base of the soy industry ),
[[http://www.mercola.com/2001/apr/7/soy.htm]{.underline}](http://www.mercola.com/2001/apr/7/soy.htm)
.

**"Strong and Wrong" - [verus]{.underline} - "Weak and Right" \... The
soy industry \... [one of the world's most wealthy, influential and
powerful business organization]{.underline} \...** funds millions of
dollars of soy research and advertising each year in order to increase
sales; [so]{.underline}, what chance is there for [discovers of soy
toxins]{.underline} to get funding to continue their work of **[exposing
the truth]{.underline}** about the many serious and deadly health
hazards of eating soy ??

These 61 abstracts are only some, out of hundreds available in NCBI
PubMed, from the continually growing body of scientific research on the
many "[health hazards]{.underline}" of eating soy, of putting soy in our
food supply. With the scientific evidence that follow, think about all
of these known and ignored "[side-effects]{.underline}" listed here.
Now, you can begin to start counting the number of people, worldwide,
likely to be seriously hurt and/or dying from eating soy simply because
of what these people were told, were tricked into believing, were lied
to, most of the time deliberately, with misinformation, which
"[persuaded]{.underline}" them to [believe]{.underline}, persuaded to
trust, to have false hope, by the soy industry and their supporters,
world wide, which goes something like this \... "Trust us,
[using]{.underline} soy is going to help (you)them, even help save
(your)their life" \... when in reality, soy is slowly and "[violently
killing them]{.underline}".

**The weed of crime bears bitter fruit. Does the soy industry and all
its supporters really think they'll all get away with it ??. Do they
really think I, we, wouldn't know ??.**

**Yours Sincerely,**

Deanna-(Deonaa) and Gerald Hernesmaa

**P. S.** This paragraph is added June 6, 2004 to the email copy. My
wife Deanna-(Deonaa) Hernesmaa died from breast, bone, liver cancer
while and **[from]{.underline}** eating soy ingredients
[like]{.underline} Soy Protein Isolate, SPI, in her food. She died on
Dec. 15, 2002. She also had 3 reoccurrences of cancer while and
**[from]{.underline}** eating these soy ingredients. Because we
**"[never gave our consent]{.underline}"** to have soy ingredients in
her food, based on Dr. Samuel Epstein comments page 17 of this petition
of objection to the FDA, and **"[the evidence]{.underline}"**-(which
includes but is not limited to what is presented here), "\...the
estrogens in soy ingredients and the soy industry who puts them in our
food, poisoned then murdered my wife, in much in the same way the
estrogens in [Hormone Replacement Therapy]{.underline} is killing
women-(with cancers)\...". **[Einstein]{.underline} said,** "\...the
world is a dangerous place to live in, [not]{.underline} because of the
people who are evil, but [because]{.underline} of the people who don't
do anything about it\...".

**Next:**

[61 - Scientific Research Abstract Studies]{.underline}, out of hundreds
available from around the world, (done in vivo and vitro), documenting
the presently known, ignored and yet still denied, (by the soy industry
and its supporters), the many harmful and sometimes deadly side-effects
to human and animal health from putting soy and soy ingredients like Soy
Protein Isolate, SPI, in our food supply, including cancer. **\... /
24**

**- 24 -**

**Petition of Objection To**

**[( Docket \# 2004Q-0151 ) - Solae Corporation requests FDA Health
Claim]{.underline}**

**re: Qualified Health Claim: Soy Protein May Reduce Risk Of Cancer**

**[61 - Research Abstract References]{.underline}**

**Hidden Harm**

Just some out of hundreds of Scientific Research available from around
the world

documenting the harmful side-effects to human and animal

health from putting soy in our food supply.

**Known, Ignored, Still Denied**

New, not in 132 page soy research paper

\-
[[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=14578162]{.underline}](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=14578162&itool=iconabstr)
.

***Carcinogenesis. 2004 Feb;25(2):211-8. Epub 2003 Oct 24.***

**2004 Dietary genistein results in larger MNU-induced,
estrogen-dependent mammary tumors following ovariectomy of
Sprague-Dawley rats, --- *[Allred C.D., Allred K.F., Ju Y.H., Clausen
L.M., Doerge D.R., and others]{.underline}, Department of Food Science
and Human Nutrition, University of Illinois, Urbana, IL 61801, USA.***

> --- Due to the estrogenic properties of soy-derived isoflavones, many
> postmenopausal women are using these compounds as a natural
> alternative to hormone replacement therapy (HRT).
>
> **--- [Genistein at 750 p.p.m. increased the weight of
> estrogen-dependent adenocarcinomas]{.underline}** in ovariectomized
> rats compared with the negative-control animals.
>
> --- [Genistein treatment also resulted in a higher percentage of
> proliferative cells in tumors]{.underline} and increased uterine
> weights when compared with negative-control animals.
>
> --- **[Collectively]{.underline},** these effects are probably due to
> the estrogenic activity of genistein.
>
> **--- [Plasma genistein concentrations in animals fed the
> isoflavone-containing diet]{.underline}** were at physiological levels
> relevant to human exposure. [Estradiol concentrations]{.underline} in
> ovariectomized animals not receiving an estradiol supplement were
> similar to those observed in postmenopausal women.
>
> --- [The data suggest]{.underline} that in an endogenous estrogen
> environment similar to that of a postmenopausal woman, dietary
> genistein can **[stimulate]{.underline}** the growth of a mammary
> **[carcinogen MNU-induced estrogen-dependent mammary
> tumors]{.underline}**.

Page 130, (from the 132 page soy research paper)

\-
[[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15113961]{.underline}](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15113961)
.

***J Nutr.* 2004 *May;134(5):1145-1151.***

**2004 "beta-Sitosterol, beta-Sitosterol Glucoside, and a Mixture of
beta-Sitosterol and beta-Sitosterol Glucoside Modulate the Growth of
Estrogen-Responsive Breast Cancer Cells In Vitro and in Ovariectomized
Athymic Mice," --- *[Ju YH, Clausen LM, and others]{.underline},
Department of Food Science and Human Nutrition and Depart. of Animal
Sciences, University of Illinois at Urbana-Champaign, Urbana, IL 61801
USA, [and]{.underline} Department of Physiology, University of Kentucky,
Lexington, KY 40536; IMAGINutrition, [and]{.underline} MetaResponse
Science, Laguna Niguel, CA 92677, USA.***

> --- Further evidence from [current]{.underline} research that
> beta-Sitosterol, a compound [common]{.underline} in soy oil,
> [and]{.underline} also present in soy protein, can
> [stimulate]{.underline} the growth of MCF-7 [breast
> cancer]{.underline} cells\"
>
> --- [In summary]{.underline}, BSS and MC [stimulated MCF-7 cell
> growth]{.underline} in vitro. Although BSSG comprises only 1% of MC,
> BSSG made MC less estrogenic than BSS alone in vitro. However, dietary
> BSS and MC protected against E(2) - [stimulated MCF-7 tumor
> growth]{.underline} and lowered circulating E(2) levels.

**\... / 25**

**- 25 -**

**Petition of Objection To**

**[( Docket \# 2004Q-0151 ) - Solae Corporation requests FDA Health
Claim]{.underline}**

**re: Qualified Health Claim: Soy Protein May Reduce Risk Of Cancer**

**[References]{.underline}**

**Scientific Abstract from around the world**

Continued

Page 71, (from the 132 page soy research paper)

\-
[[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=14709783]{.underline}](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=14709783)
.

***Exp Biol Med (Maywood).*** **2004 *Jan; 229(1):108-17. ***

**2004 "Effects of genistein or soy milk during late gestation and
lactation on adult uterine organization in the rat," -- *[Hughes CL, Liu
G, Beall S, Foster WG, Davis V.]{.underline}, Department of Medical and
Scientific Services, Quintiles, Inc., Research Triangle Park, North
Carolina 27709, USA.***

**Malnutrition \... [from]{.underline} \... False nutritional beliefs**.

> --- These experiments demonstrate that developmental exposure to
> dietary isoflavones, at levels comparable to the ranges of human
> exposure, modify expression of the estrogen-regulated PR in the uterus
> of sexually mature rats weeks after exposure ended.
>
> --- In utero and lactational exposure to estrogenic agents has been
> shown to influence morphological and functional development of
> reproductive tissues. Thus, consumption of dietary phytoestrogens,
> such as isoflavones, during pregnancy and lactation could influence
> important periods of development, when the fetus and neonate are more
> sensitive to estrogen exposure.
>
> --- In this study, reproductive outcomes after developmental exposure
> to isoflavones were examined in Long-Evans rats maternally exposed to
> isoflavones via a commercial soy beverage or as the isolated
> isoflavone, genistein. ... ... .
>
> --- Since the PR is essential for regulating key female reproductive
> processes, such as uterine proliferation, implantation, and
> maintenance of pregnancy, its increased expression suggests that soy
> phytoestrogen exposure during reproductive development may have
> long-term reproductive health consequences.

Page 57

\-
[[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12738504&dopt=Abstract]{.underline}](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12738504&dopt=Abstract&itool=iconabstr)
.

***Fertil Steril* 2003 *May;79(5):1112-1117.,***

**2003 "Effect of soy-derived isoflavones on hot flushes, endometrial
thickness, and the pulsatility index of the uterine and cerebral
arteries," -- *[Penotti M., Fabio E., and others]{.underline}, Second
Department of Obstetrics and Gynecology of the University of Milan,
Milan, Italy.***

> --- Daily administration of 72 mg of soy-derived isoflavones [is no
> more effective]{.underline} than [placebo]{.underline} in reducing hot
> flushes in postmenopausal women.

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.

***Int J Cancer* 2003 *Jun 20;105(3):312-20.,***

**2003 "Cell-transforming activity and mutagenicity of 5 phytoestrogens
in cultured mammalian cells," -- *[Tsutsui T, Yagi E, and
others]{.underline}, Depart. of Pharmacology, Nippon Dental University,
School of Dentistry Tokyo, Japan***

> --- genistein \... daidzein \... suggesting the possible involvement
> of mutagenicity in the initiation of "[phytoestrogen-induced
> carcinogenesis]{.underline}."

**\... / 26**

**- 26 -**

Petition of Objection To

[( Docket \# 2004Q-0151 ) - Solae Corporation requests FDA Health
Claim]{.underline}

re: Qualified Health Claim: Soy Protein May Reduce Risk Of Cancer

**[References]{.underline}**

**Scientific Abstract from around the world**

Continued

**\* \* \***

**[Frying The Brain]{.underline}**

**With Soy**

**(These next 2 abstracts and many others)**

Page 54, (from the 132 page soy research paper)

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[[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12566171&dopt=Abstract]{.underline}](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12566171&dopt=Abstract)
.

***Neurosci Lett* 2003 *Feb 27;338(2):135-38.*,**

**2003 "Soya phytoestrogens change cortical and hippocampal expression
of BDNF mRNA in male rats," -- *[File SE, Hartley DE, Alom
N.]{.underline},*** **Psychopharmacology Research Unit [and]{.underline}
Biochemical Neuropharmacology Group, Centre for Neuroscience Research,
King\'s College London, Hodgkin Building, Guy\'s Campus, SE1 1UL,
London,**

> **---** [significant reductions]{.underline} were found in
> brain-derived neurotrophic factor (BDNF) mRNA expression in the CA3
> and CA4 region of the [hippocampus and in the cerebral
> cortex]{.underline} in the rats fed the diet containing
> [phytoestrogens]{.underline}, compared with those on the soya-free
> diet.

Page 54

[[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=9387865&dopt=Abstract]{.underline}](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=9387865&dopt=Abstract)
.

***Brain Res Mol Brain Res.,* 1997 *Oct3;49(1-2):71-81.*,**

**1997 "Brain-derived neurotrophic factor is reduced in Alzheimer\'s
disease," -- *[Connor B, Young D, Yan Q, and others.]{.underline},*
Department of Pharmacology, Faculty of Medicine and Health Science,
University of Auckland, New Zealand.**

> **---** [BDNF mRNA is reduced]{.underline} in the human Alzheimer\'s
> disease hippocampus and temporal cortex, and suggest that [a loss of
> BDNF]{.underline} may contribute to the progressive [atrophy of
> neurons]{.underline} in Alzheimer\'s disease.

**\* \* \***

Page 48

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[[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12270219&dopt=Abstract]{.underline}](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12270219&dopt=Abstract&itool=iconabstr)
.

***J Chromatogr B Analyt Technol Biomed Life Sci* 2002 Sep
25;777(1-2):269-79.**

**2002 "Inactivation of thyroid peroxidase by soy isoflavones, in vitro
& in vivo,"-- *[Doerge D.R. & Chang H.C.]{.underline}*,** **Division of
Biochemical Toxicology, National Center for Toxicological Research, 3900
NCTR Road, Jefferson, AR 72079, USA.**

> **---** implications for [reproductive]{.underline} toxicity and
> [carcinogenesis]{.underline} - warrants further investigation
>
> --- further study of auto-immune [thyroiditis]{.underline} in children
> consuming Soy formula is warranted
>
> --- [the results were additive]{.underline} \... joint action of
> estrogenic chemicals \... lead to significant underestimations of
> risk.

**\... / 27**

**- 27 -**

Petition of Objection To

[( Docket \# 2004Q-0151 ) - Solae Corporation requests FDA Health
Claim]{.underline}

re: Qualified Health Claim: Soy Protein May Reduce Risk Of Cancer

**[References]{.underline}**

**Scientific Abstract from around the world**

Continued

Page 48, (from the 132 page soy research paper)

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[[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11888703&dopt=Abstract]{.underline}](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11888703&dopt=Abstract&itool=iconabstr)
.

***Toxicol Lett* 2002 Mar 28;129(3):199-205.**

**2002 "Detection of phytoestrogens in samples of second trimester human
amniotic fluid," -- *[Foster W.G. and others]{.underline}*,** **Center
for Women\'s Health, Cedars-Sinai Medical Center, Los Angeles,
California, USA**

> --- The study describes a method for measuring phytoestrogens daidzein
> and genistein in [amniotic]{.underline} fluid. Such tests are needed,
> the authors assert, because "There is widespread concern that fetal
> exposure to hormonally active chemicals may [adversely affect
> development]{.underline} of the reproductive tract."

Page 48

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.

***Environ Sci Technol* 2002 Apr;36(8):1751-6.**

**2002 ""Something from "nothing" - - eight weak estrogenic chemicals
combined at concentrations below NOECs produce significant mixture
effects," -- *[Silva E. and others]{.underline}*,** **Centre for
Toxicology, Department of Pharmacology, The School of Pharmacy,
University of London.**

> --- Hazard assessments that ignore the possibility of joint action of
> estrogenic chemicals will almost certainly lead to [significant
> underestimations]{.underline} of risk."
>
> [The results were additive]{.underline} \... joint action of
> estrogenic chemicals lead to significant underestimations of risk.

Page 49

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[[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12060828&dopt=Abstract]{.underline}](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12060828&dopt=Abstract)
.

***Environ Health Perspect* 2002 Jun;110 suppl 3:349-53.**

**2002 "Goitrogenic and estrogenic activity of soy isoflavones," --
*[Doerge D.R. and D.M. Sheehan]{.underline}*,** **Division of
Biochemical Toxicology, National Center for Toxicological Research,
Jefferson, Arkansas, USA.**

> --- Although safety testing of natural products, including soy
> products, is not required, the possibility that widely consumed soy
> products may cause harm in the human population via either or both
> estrogenic and goitrogenic activities is of concern."

Page 51

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[[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12093826&dopt=Abstract]{.underline}](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12093826&dopt=Abstract)
.

***Hum Reprod* 2002 Jul;17(7):1692-703.**

**2002 "Infant feeding with soy formula milk: effects on the testis and
on blood testosterone levels in marmoset monkeys during the period of
neonatal testicular activity," -- *[Sharp R.M. and others]{.underline}*,
MRC Human Reproductive Sciences Unit, Centre for Reproductive Biology,
37 Chalmers Street, Edinburgh EH3 9ET, UK.**

> --- Infant male marmoset monkeys were fed either soy-based or
> milk-based formula. The neonatal testosterone rise was suppressed in
> the soy-fed monkeys. Levels of isoflavone in the monkey diets were
> 40-87% of that reported in 4-month human infants fed a 100% soy-based
> formula diet.
>
> --- "It is therefore [considered likely]{.underline} that similar, or
> larger, effects to those shown here in marmosets may occur in human
> male infants fed with SFM \[soy formula milk\]."

**\... / 28**

**- 28 -**

Petition of Objection To

[( Docket \# 2004Q-0151 ) - Solae Corporation requests FDA Health
Claim]{.underline}

re: Qualified Health Claim: Soy Protein May Reduce Risk Of Cancer

**[References]{.underline}**

**Scientific Abstract from around the world**

Continued

Page 69, (from the 132 page soy research paper)

\-
[[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12297547&dopt=Abstract]{.underline}](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12297547&dopt=Abstract&itool=iconabstr)
.

***Bio Reprod* 2002 *Oct;67(4): 1285-96.***

**2002 "Neonatal exposure to genistein induces estrogen receptor
(ER)alpha expression and multioocyte follicles in the maturing mouse
ovary: evidence for ERbeta-mediated and nonestrogenic actions," --
*[Jefferson W.N., Couse J.F., Padilla-Banks E., Korach K.S., Newbold
R.R.]{.underline}*,** **Developmental Endocrinology Section, Laboratory
of Molecular Toxicology, Environmental Toxicology Program, National
Institute of Environmental Health Sciences, Research Triangle Park,
North Carolina 27709, USA.**

> --- These data taken together demonstrate alterations in the ovary
> following neonatal exposure to genistein. Given that human infants are
> exposed to high levels of genistein in soy-based foods, this study
> indicates that the effects of such exposure on the developing
> reproductive tract warrant further investigation.

Page 52

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.

***Neurotoxicol Teratol* 2002 Jan-Feb;24(1):5-16.**

**2002 "Neurobehavioral effects of dietary soy phytoestrogens," --
*[Lephard E.D. and others]{.underline}*,** **Neuroscience Center, 633
WIDB, Brigham Young University, Provo, UT 86402, USA.**

> --- short interval of consumption can significantly
> [alter]{.underline} sexually dimorphic [brain]{.underline} regions,
> anxiety, learning and memory \... [Alzheimer's]{.underline} disease,
> especially in women.

Page 51

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[[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12032332]{.underline}](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12032332)
.

***Proc Natl Acad Sci USA* 2002 *May 28;99(11):7616-21.***

**2002 "The phytoestrogen genistein induces thymic and immune changes: a
human health concern ?," -- *[Yellayka S. and others]{.underline},***
**Department of Veterinary Biosciences, University of Illinois, Urbana,
IL 61802, USA.**

> --- Use of soy-based infant formulas and soy/isoflavone supplements
> has aroused concern because of potential estrogenic effects of the soy
> isoflavones genistein and daidzein. Here we show that s.c. genistein
> injections in ovariectomized adult mice produced dose-responsive
> decreases in thymic weight of up to 80%. Genistein\'s thymic effects
> occurred through both estrogen receptor (ER) and non-ER-mediated
> mechanisms, as the genistein effects on thymus were only partially
> blocked by the ER antagonist ICI 182,780. Genistein decreased
> thymocyte numbers up to 86% and doubled apoptosis, indicating that the
> mechanism of the genistein effect on loss of thymocytes is caused in
> part by increased apoptosis. Genistein injection caused decreases in
> relative percentages of thymic CD4(+)CD8(-) and double-positive
> CD4(+)CD8(+) thymocytes, providing evidence that genistein may affect
> early thymocyte maturation and the maturation of the CD4(+)CD8(-)
> helper T cell lineage. Decreases in the relative percentages of
> CD4(+)CD8(-) thymocytes were accompanied by decreases in relative
> percentages of splenic CD4(+)CD8(-) cells and a systemic
> lymphocytopenia.
>
> --- In addition, genistein produced suppression of humoral immunity.
> Genistein injected at 8 mg/kg per day produced serum genistein levels
> comparable to those reported in soy-fed human infants, and this dose
> caused significant thymic and immune changes in mice.
>
> --- Critically, dietary genistein at concentrations that produced
> serum genistein levels substantially less than those in soy-fed
> infants produced marked thymic atrophy.
>
> --- [These results raise the possibility]{.underline} that serum
> genistein concentrations found in soy-fed infants may be capable of
> producing thymic and immune abnormalities, as suggested by previous
> reports of immune impairments in soy-fed human infants.

**\... / 29**

**- 29 -**

Petition of Objection To

[( Docket \# 2004Q-0151 ) - Solae Corporation requests FDA Health
Claim]{.underline}

re: Qualified Health Claim: Soy Protein May Reduce Risk Of Cancer

**[References]{.underline}**

**Scientific Abstract from around the world**

Continued

Page 71, (from the 132 page soy research paper)

\-
[[http://www.giftinfo.uni-mainz.de/EXCLI/volumes/Vol1/2002volume1pp8-14.pdf]{.underline}](http://www.giftinfo.uni-mainz.de/EXCLI/volumes/Vol1/2002volume1pp8-14.pdf)
.

***EXCLI Journal* 2002*;1:8-14 (ISSN 1611-2156), received: Dec 19,*
2002*, accepted Dec 29,* 2002*, published Dec 30,* 2002*.***

**2002 "Dietary topoisomerase II-poisons: contribution of soy products
to infant leukemia ?," -- *[Jan G. Hengstler, Carolin K. Heimerdinger
and others]{.underline}*,** **Institute of Legal Medicine, Department of
Molecular Toxicology, University of Leipzig, Johannisallee 28, 04103
Leipzig, Germany; Institute of Toxicology and Department of Gynecology,
University of Mainz, Mainz, Germany**

> --- DNA [double strand breaks]{.underline} leading to chromosomal
> aberrations & leukemia's.
>
> --- Further studies on the role of dietary topoisomerase II-poisons
> are "[urgently]{.underline}" required.

Page 49

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.

***Cancer Res* 2002 May 1;62(9):2474-7.**

**2002 "Dietary genistein negates the inhibitory effect of
[tamoxifen]{.underline} on growth of estrogen-dependent human breast
cancer (MCF-7) cells implanted in athymic mice," -- *[Ju Y.H. and
others]{.underline}*,** **Department of Food Science and Human
Nutrition, University of Illinois at Urbana-Champaign, Urbana, Illinois
61801, USA.**

> --- Geistein [overwhelmes]{.underline} the effects of Tamoxifen,
> Therefore [Caution]{.underline} is warranted \...
>
> \-\-- Use of "[dietary isoflavone supplements]{.underline}" by
> postmenopausal women "[with breast cancer]{.underline}" is increasing.
>
> --- Dietary genistein negated or [overwhelmed]{.underline} the
> inhibitor effect of tamoxifen on MCF-7 tumor growth, lowered E2 levels
> in plasma, and increased expression of E-response genes (e.g., pS2,
> PR, cyclin D1) in ovariectomized and athymic mice.
>
> --- "Therefore, **[caution is warranted]{.underline}** for
> postmenopausal women consuming dietary genistein while on TAM therapy
> for E-responsive breast cancer."

Page 51

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[[http://www.soyonlineservice.co.nz/immune.htm]{.underline}](http://www.soyonlineservice.co.nz/immune.htm)
,

\-
[[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12032332&dopt=Abstract]{.underline}](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12032332&dopt=Abstract&itool=iconpmc)
.

***Proc Natl Acad Sci* USA 2002 May 28;99(11):7616-21.**

**2002 "The phytoestrogen genistein induces thymic and immune changes: a
human health concern ?," -- *[Yellayka S. and others]{.underline}*,**
**Department of Veterinary Biosciences, University of Illinois, Urbana,
IL 61802, USA.**

> **--- Thymic & immune abnormality**
>
> --- Genistein injections in ovariectomized adult mice produce
> dose-responsive decreased in **thymic** weight of up to 80%. Genistein
> decreased thymocyte numbers up to 86% and doubled apoptosis.
>
> --- There was a corresponding reduction in **splenic** cells.
>
> **--- The does that caused significant thymic and immune changes in
> mice [was comparable to]{.underline} those reported in soy-fed human
> infants.**
>
> --- "These results raise the possibility that serum genistein
> concentrations found in soy-fed infants may be capable of producing
> thymic and immune abnormalities, as suggested by previous reports of
> immune impairments in soy-fed infants."
>
> ---
> [[http://www.mercola.com/2002/jun/8/soy.htm]{.underline}](http://www.mercola.com/2002/jun/8/soy.htm)
> , **"[Soy Weakens Your Immune System]{.underline}" \...**
>
> **--- Dr. Mercola's Comment \...** "It is quite amazing that this
> study was actually published, as the findings were quite negative for
> Soy, and yet [it was funded]{.underline} by the [United Soybean
> Board]{.underline} and the [Illinois Council on Food and Agricultural
> Research]{.underline} ."

**\... / 30**

**- 30 -**

Petition of Objection To

[( Docket \# 2004Q-0151 ) - Solae Corporation requests FDA Health
Claim]{.underline}

re: Qualified Health Claim: Soy Protein May Reduce Risk Of Cancer

**[References]{.underline}**

**Scientific Abstract from around the world**

Continued

Page 51, (from the 132 page soy research paper)

\-
[[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11875621&dopt=Abstract]{.underline}](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11875621&dopt=Abstract&itool=iconabstr)
.

***Arch Toxicol* 2002 Feb;76(1):23-9.**

**2002 "Transplacental transfer of the phytoestrogen daidzein in DA/Han
rats," -- *[Degen G.H. and others]{.underline}*,** **Institut fur
Arbeitsphysiologie an der Universitat Dortmund, Ardeystrasse 67, 44139
Dortmund, Germany.**

> --- **the placenta [does not]{.underline} represent a barrier**
>
> --- The research found indications of **a rapid transfer of daidzen
> from the mother to the fetus**, but also that efficient extraction of
> daidzein from the maternal blood occurs. "Since dietary phytoestrogens
> account for a significant proportion of human exposure to potential
> endocrine modulators, and since the placenta [does not]{.underline}
> represent a barrier to daidzein or related estrogenic isoflavones, the
> consequences of these exposures early in life should be examined and
> monitored carefully."

Page 52

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.

***J Soc Gynecol Investig* 2002 Jul-Aug;9(4)238-42.**

**2002 "A pilot study of the effects of phytoestrogen supplementation on
postmenopausal endometrium," -- *[Balk J.L. and others]{.underline}*,**
**Department of Obstetrics, Gynecology, and Reproductive Sciences,
Magee-Womens' Hospital, University of Pittsburgh, Pennsylvania 15213,
USA.**

> --- women \... hot flushes, night sweats, and vaginal dryness "[did
> not]{.underline}" improve in the soy group.
>
> --- This was a double-blinded, randomized, placebo-controlled trial
> comparing the effects of 6 months of dietary phytoestrogen
> supplementation versus placebo in postmenopusal women.
>
> **--- "Phytoestrogens did not cause stimulation of the endometrium**.
> Insomnia was more frequent over the 6-month study in the soy group,
> [where as]{.underline} - hot flushes, night sweats and vaginal dryness
> improved from baseline in the [placebo]{.underline} group "[but
> not]{.underline}" in the soy group."

Page 70

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.

***Cancer Epidemiol Biomarkers Prev.* 2002 *Dec;11(12):1674-7*.**

**2002 "Dietary soy and increased risk of bladder cancer: the Singapore
Chinese Health Study," -- *[Sun C.L., Yuan J.M., Arakawa K., and
others]{.underline},* USC/Norris Comprehensive Cancer Center, University
of Southern California Keck School of Medicine, Los Angeles, California,
USA.,** [[canlan@hsc.usc.edu]{.underline}](mailto:canlan@hsc.usc.edu) .

> --- Bladder Cancer - (You can bet that the soy industry isn't
> promoting the results of this study !.)
>
> --- The Soyfood--bladder cancer risk association did not differ
> significantly between men and women and was not explained by other
> dietary factors.
>
> --- The Soy-cancer relationship became stronger when the analysis was
> restricted to subjects with longer (\> or =3 years) duration of
> follow-up. [To our knowledge]{.underline}, this is the
> [FIRST]{.underline} epidemiological report on the effect of dietary
> Soy on bladder cancer risk.

**\... / 31**

**- 31 -**

Petition of Objection To

[( Docket \# 2004Q-0151 ) - Solae Corporation requests FDA Health
Claim]{.underline}

re: Qualified Health Claim: Soy Protein May Reduce Risk Of Cancer

**[References]{.underline}**

**Scientific Abstract from around the world**

Continued

Page 70, (from the 132 page soy research paper)

\-
[[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12089239&dopt=Abstract]{.underline}](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12089239&dopt=Abstract&itool=iconnoabstr)
.

***J Clin Oncol, Volume 20(13), July 1,* 2002*, 3040-3042.***

**2002 "Safety Issues of Soy Phytoestrogens in Breast Cancer
Patients," - [*de Lemos M*.]{.underline},** **Vancouver, BC, Canada**

> --- [Risks versus Benefits]{.underline} \... breast cancer patients
> should be informed that phytoestrogens have the potential to stimulate
> tumor growth.
>
> --
> [[http://www.jco.org/cgi/content/full/20/13/3040]{.underline}](http://www.jco.org/cgi/content/full/20/13/3040)
> \... **Safety Issues of Soy Phytoestrogens in Breast Cancer Patients**
>
> **Mário de Lemos**
>
> **Vancouver, British Columbia, Canada**
>
> **To the Editor:**
>
> --- The results of Van Patten et al [^[1]{.underline}^]() confirmed
> previous findings [^[2]{.underline}^]() that soy phytoestrogens have
> minimal efficacy for menopausal symptoms in breast cancer patients.
> **However, I am concerned that patients in neither study were
> apparently informed of the potential stimulatory effects of
> phytoestrogens on breast tumor.** [^[3]{.underline}^]() Similar
> omission would have raised ethical concerns if pharmaceutical drugs
> were involved.
>
> --- At concentrations below 10 mol/L, phytoestrogens can stimulate
> breast tumor growth ^[[4]{.underline}]()-[[15]{.underline}]()^ and
> antagonize the antitumor effects of tamoxifen,
> ^[[7]{.underline}](),[[9]{.underline}]()^ particularly in an
> environment of low endogenous
> estrogen.^[[3]{.underline}](),[[11]{.underline}]()^ In contrast,
> phytoestrogens inhibit breast tumor growth and enhance the antitumor
> effects of tamoxifen at concentrations above 10 mol/L.
> ^[[5]{.underline}](),[[6]{.underline}](),[[8]{.underline}](),[[9]{.underline}](),[[11]{.underline}]()^
> In humans, serum phytoestrogen concentrations attained after acute or
> chronic intake of phytoestrogens were much lower than 10 mol/L.
> ^[[1]{.underline}](),[[16]{.underline}](),[[17]{.underline}]()^
>
> --- Without long-term human data, cancer risk assessments need to be
> cautious and assume that substances that promote tumor growth in
> preclinical studies may pose similar risks clinically.
> [^[18]{.underline}^]() Hence, to weigh the potential risks versus
> benefits before using phytoestrogens for unproven indications, breast
> cancer patients should be informed that phytoestrogens have the
> potential to stimulate tumor growth.

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\-
[[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12520091&dopt=Abstract]{.underline}](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12520091&dopt=Abstract)

***Mol Med* 2002 *Nov;8(11):742-9.***

**2002 "Early exposure to genistein exerts long-lasting effects on the
endocrine and immune systems in rats," -- *[Klein S.L., Wisniewski A.B.,
Marson A.L., Glass G.E., Gearhart J.P.]{.underline}*, The W. Harry
Feinstone Department of Molecular Microbiology and Immunology, The Johns
Hopkins Bloomberg School of Public Health, Baltimore, Maryland 21205,
USA.**

> --- Discussion: These data illustrate that exposure to genistein
> during pregnancy and lactation exerts long-lasting effects on the
> endocrine and immune systems in adulthood. Whether exposure to
> phytoestrogens during early development affects responses to
> infectious or autoimmune diseases, as well as cancers, later in life
> requires investigation.

**\... / 32**

**- 32 -**

Petition of Objection To

[( Docket \# 2004Q-0151 ) - Solae Corporation requests FDA Health
Claim]{.underline}

re: Qualified Health Claim: Soy Protein May Reduce Risk Of Cancer

**[References]{.underline}**

**Scientific Abstract from around the world**

Continued

Page 66, (from the 132 page soy research paper)

\-
[[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12639286]{.underline}](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12639286)
.

***J Med Food* 2001 *Spring;4(1):39-47***

**2001 "Effects of Genistein Isoflavone (4\',5\',7-Trihydroxyisoflavone)
and Dexamethasone on Functional Characteristics of Spermatozoa," --
*[Kumi-Diaka J, Townsend J.]{.underline}, Florida Atlantic University,
Department of Biological Sciences, College of Liberal Arts and Sciences,
2912 College Avenue, Davie, FL, 33314.***

> --- Genistein, alone or in combination with dxm, significantly
> interfered with percentage sperm motility and [caused significant
> detachment]{.underline} of sperm heads

Page 43

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[[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11297868&dopt=Abstract]{.underline}](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11297868&dopt=Abstract)
.

***Reprod Toxicol* 2001 Mar-Apr;15(2):105-10.**

**2001 "Placental transfer of the soy isoflavone genistein following
dietary and gavage administration to Sprague Dawley rats," -- *[Doerge
D.R. and others]{.underline}*,** **Division of Biochemical Toxicology,
National Center for Toxicological Research, U.S. FDA, Jefferson, AR
72079, USA.**

> --- **Placental transfer to the [foetal brain]{.underline}**
>
> --- Genistein was found to **"[cross" - the rat placenta and reach the
> fetal brain]{.underline}** in doses similar to those observed in
> humans.

Page 44 and 67

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[[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11573864&dopt=Abstract]{.underline}](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11573864&dopt=Abstract&itool=iconabstr)
.

***Ann Pharmacother* 2001 *Sep;35(9):1118-21,***

**2001 "Effects of soy phytoestrogens genistein and daidzein on breast
cancer growth," -- *[de Lemos M.L.]{.underline}*, *British Columbia
Cancer Agency, Vancouver, BC, Canada.***

> --- [Stimulate]{.underline} breast cancer growth !!. [Yes]{.underline}
> !!.
>
> --- CONCLUSIONS: Genistein and daidzein may stimulate existing breast
> tumor growth and antagonize the effects of tamoxifen.
>
> --- Women with current or past breast cancer "[should be aware of the
> "risks" of potential tumor growth]{.underline}" when taking soy
> products.

Page 65

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[[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11714112&dopt=Abstract]{.underline}](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11714112&dopt=Abstract&itool=iconabstr)
.

**Cancer Causes & Control. 12(9):837-845, 2001 Nov.**

**2001 "Incidence of squamous neoplasia of the cervix and vagina in
women exposed prenatally to diethylstilbestrol (United States)," --
*[Hatch EE. Herbst AL. Hoover RN. Noller KL. Adam E. Kaufman RH. And
others.]{.underline}*,** **Division of Cancer Epidemiology and Genetics,
National Cancer Institute, Bethesda, MD, USA.**

> \-\-- Women exposed prenatally to diethylstibestrol **(DES)** have an
> [excess risk]{.underline} of clear-cell adenocarcinoma of the vagina
> and cervix. The findings support an association between in-utero DES
> exposure and high-grade squamous neoplasia.

**\... / 33**

**- 33 -**

Petition of Objection To

[( Docket \# 2004Q-0151 ) - Solae Corporation requests FDA Health
Claim]{.underline}

re: Qualified Health Claim: Soy Protein May Reduce Risk Of Cancer

**[References]{.underline}**

**Scientific Abstract from around the world**

Continued

V

Page 47, (from the 132 page soy research paper)

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[[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11431339&dopt=Abstract]{.underline}](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11431339&dopt=Abstract&itool=iconfft)
.

***Cancer Res* 2001 Jul 1;61(13):5045-50.**

**2001 "Soy diets containing varying amounts of genistein stimulate
growth of estrogen-dependent (MCF-7) tumors in a dose-dependent manner,"
-- *[Allred C.D., Yu Y.H., Virant S.M., and others]{.underline}*,**
**Department of Food Science and Human Nutrition, University of
Illinois, Urbana, Illinois, USA**

> \-\-\-- Depending on processing, soy protein isolates, SPI's,
> [vary]{.underline} widely in concentrations of genistein
>
> --- Cell proliferation was greatest in tumors of animals given
> estrogen or dietary genistein (150 and 300 ppm).

. --- Here we present new information that [soy protein
isolates]{.underline} containing increasing concentrations of genistein
[stimulate the growth]{.underline} of estrogen-dependent [breast cancer
cells]{.underline} in vivo in a dose-dependent manner.

Page 47

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[[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11577007&dopt=Abstract]{.underline}](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11577007&dopt=Abstract&itool=iconabstr)
.

***Carcinogenesis* 2001 Oct;22(10):1667-73.**

**2001 "Dietary genistin stimulates growth of estrogen-dependent breast
cancer tumors similar to that observed with genistein," -- *[Allred C.D.
Chang J.,and others]{.underline}*,** **Department of Food Science and
Human Nutrition and Division of Nutritional Sciences, University of
Illinois, at Urbana-Champaign, IL 61801, USA.**

> --- Genistin, the glycoside form of genistein, is converted to
> genistein by human saliva.
>
> --- The glycoside genistin, like the aglycone genistein, can
> [stimulate]{.underline} estrogen-dependent breast cancer cell growth
> in vivo.
>
> --- [Removal of genistin or genistein]{.underline} from the diet
> caused tumors to [regress]{.underline}.

Page 67

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[[http://www.eurekalert.org/pub_releases/2001-11%20uoia-efi110101.php]{.underline}](http://www.eurekalert.org/pub_releases/2001-11 uoia-efi110101.php)
, and \...

\-
[[http://www.headliner.nl/headliner.php?c=us&abbr=eurekalert&id=187]{.underline}](http://www.headliner.nl/headliner.php?c=us&abbr=eurekalert&id=187)
, and \...

> \-
> [[http://search.eurekalert.org/e3/query.html?col=ev3rel&qc=ev3rel&qt=estrogen+found+in+soy+stimulates+human+breast-cancer+cells&x=21&y=6]{.underline}](http://search.eurekalert.org/e3/query.html?col=ev3rel&qc=ev3rel&qt=estrogen+found+in+soy+stimulates+human+breast-cancer+cells&x=21&y=6)
> .

***J Nutr - (Nov.), Carcinogenesis - (Oct.), Cancer Res - (July), 3
studies funded by National Institute of Health, an ElurekAlert Press
Release., Nov 1,* 2001*.***

**2001 "Estrogen found in soy stimulates human breast-cancer cells in
mice," -- *[William G. Helferich]{.underline}*,** **University of
Illinois, USA**

> --- "[Caution]{.underline} is warranted \... for women with breast
> cancer"
>
> --- The findings in **3 studies** found that genistein in various
> forms [stimulates]{.underline} tumor growth.
>
> --- They also suggest that women with estrogen-dependent brest cancer
> or predisposition to it may want to reduce their consumption of soy
> products with a high isoflavone content.
>
> --- In the paper in Carcinogenesis, the researchers compared the
> isoflavone in its two forms, as a glycoside (genistin, as it appears
> in plants) and aglucone (genistein). They found that both forms
> produced similar tumor growth rates, and that the conversion of
> genistin in the body [begins with contact with saliva]{.underline} in
> the mouth.
>
> --- In Cancer Research, Helferich compared soy protein isolates
> containing varying levels of isoflavones.
>
> --- The researchers found that estrogen-dependent tumor growth
> increases as the isoflavone content increased in the soy-containing
> diet.
>
> --- Researchers used athymic mice that lacked the ability to reject
> human cancer cells.

**\... / 34**

**- 34 -**

Petition of Objection To

[( Docket \# 2004Q-0151 ) - Solae Corporation requests FDA Health
Claim]{.underline}

re: Qualified Health Claim: Soy Protein May Reduce Risk Of Cancer

**[References]{.underline}**

**Scientific Abstract from around the world**

Continued

Page 43, (from the 132 page soy research paper)

\-
[[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11738518&dopt=Abstract]{.underline}](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11738518&dopt=Abstract&itool=iconabstr)
.

***Reprod Toxicol* 2001 Nov;15(6):647-63.**

**2001 "Effects of dietary genistein exposure during development on male
and female DC (Sprague-Dawley) rats," -- *[Declos K.B., Bucci T.J.,
Lomax L.G. Latendresse J.R., and others]{.underline}*, Division of
Biochemical Toxicology, NCTR, Jefferson, AR, USA**.
[[bdelclos@nctr.fda.gov]{.underline}](mailto:bdelclos@nctr.fda.gov)

> --- Genistein is a naturally occurring isoflavone that interacts with
> estrogen receptors and multiple other molecular targets.
>
> --- Human exposure to genistein is [predominantly through consumption
> of soy products]{.underline}, including soy-based infant formula and
> dietary supplements.
>
> --- A dose range-finding study was conducted as a prelude to a
> multigeneration bioassay to assess potential toxicities associated
> with genistein consumption.
>
> --- "Dietary [genistein]{.underline} thus produced effects in multiple
> estrogen-sensitive tissues in males and females that are generally
> consistent with its estrogenic activity.
>
> --- These effects occurred - [within]{.underline} - exposure ranges
> achievable in humans."

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.

**Environ Health Perspect 2001 Mar;109 Suppl 1:5-20.**

**2001 "Cross-species and interassay comparisons of phytoestrogen
action," -- *[Whitten P.L., Patisaul H.B.]{.underline}*, *Department of
Anthropology, Emory University, Atlanta, Georgia 03022*, USA.**

**Humans are affected at [lower doses]{.underline} than rodents.**

> --- "In vivo data show that phytoestrogens have a wide range of
> biologic effects at doses and plasma concentrations seen with normal
> human diets. Significant in vivoresponses have been observed in animal
> and human tests for \... bone \... breast \... ovary \... pituitary
> \... vasculature \... prostate \... [and]{.underline} serum lipids."
>
> --- The doses reported to be biologically active in humans (0.4\--10
> mg/kg body weight/day) [are lower than]{.underline} the doses
> generally reported to be active in rodents (10\--100 mg/kg body
> weight/day), although some studies have reported rodent responses at
> lower doses.
>
> --- However, available estimates of bioavailability and peak plasma
> levels in rodents and humans are more similar. Steroidogenesis and the
> hypothalamic-pituitary-gonadal axis appear to be important loci of
> phytoestrogen actions, but these inferences must be tentative because
> good dose-response data are not available for many end points.
>
> --- The similarity of reported proliferative and antiproliferative
> doses illustrates the need for fuller examination of dose-response
> relationships and multiple end points in assessing phytoestrogen
> actions.

Page 43

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[[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11389053&dopt=Abstract]{.underline}](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11389053&dopt=Abstract)
.

***Cancer Res* 2001 Jun 1;61(11):4325-8.**

**2001 "Uterine adenocarcinoma in mice treated neonatally with
genistein," -- *[Newbold R.R., Banks E.P., Bullock B., and
others]{.underline}*,** **Developmental Endocrinology Section,
Laboratory of Toxicology, Environmental Toxicology Program, Division of
Intramural Research, National Institute of Environmental Health
Sciences, Research Triangle Park, NC, USA.**

> --- Genistein in soy was found to be [more]{.underline} carcinogenic
> than DES, especially during "critical periods of differentiation \...
> the use of soy-based infant formulas in the absence of medical
> necessity and the marketing of soy products designed to appeal to
> children should be closely examined."

**\... / 35**

**- 35 -**

Petition of Objection To

[( Docket \# 2004Q-0151 ) - Solae Corporation requests FDA Health
Claim]{.underline}

re: Qualified Health Claim: Soy Protein May Reduce Risk Of Cancer

**[References]{.underline}**

**Scientific Abstract from around the world**

Continued

Page 66, (from the 132 page soy research paper)

\-
[[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=11335767]{.underline}](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=11335767)
.

***Pediatrics.* 2001 *Apr;107(4):E45. ***

**2001 "Severe nutritional deficiencies in toddlers resulting from
health food milk alternatives," -- *Carvalho NF, Kenney RD, Carrington
PH, Hall DE., Scottish Rite Pediatric and Adolescent Consultants,
Childrens Healthcare of Atlanta, Atlanta, Georgia 30342-1600, USA****.*
[[drnorm@aol.com]{.underline}](mailto:drnorm@aol.com)

**Malnutrition \... [from]{.underline} \... False nutritional beliefs**.

Infants on Soy milk and Rice milk with severe nutritional deficiencies

> --- It is widely appreciated that health food beverages are not
> appropriate for infants. Because of continued growth, children beyond
> infancy remain susceptible to nutritional disorders. We report on 2
> cases of severe nutritional deficiency caused by consumption of health
> food beverages. In both cases, the parents were well-educated,
> appeared conscientious, and their children received regular medical
> care. Diagnoses were delayed by a low index of suspicion. Because
> nutritional deficiencies are uncommon in the United States, US
> physicians may be unfamiliar with their clinical features.
>
> **\* Case 1.)** 22-month-old male child, with a history of chronic
> eczema and perceived milk intolerance, he was started on a rice
> beverage after weaning. Observed typical features of kwashiorkor:
> generalized edema, hyperpigmented and hypopigmented skin lesions,
> abdominal distention, irritability, and thin, sparse hair. kwashiorkor
> impairs cellular immune defenses and electrolyte imbalances with
> ongoing diarrhea.
>
> **\*\* Case 2.)** a 17-month-old black male, Growth and height arrest
> after 9 months on soy milk.
>
> --- Reported regression in gross motor milestones, patient was unable
> to crawl or roll over.
>
> --- Generalized hypotonia, weakness, and decreased muscle bulk were
> present.
>
> --- Was diagnosed with rickets. Clinical features of rickets present
> on examination included: frontal bossing, an obvious rachitic rosary
> (photographed), genu varus, flaring of the wrists, and lumbar
> kyphoscoliosis. The published radiographs are diagnostic of advanced
> rickets, showing diffuse osteopenia, frayed metaphyses, widened
> epiphyseal plates, and a pathologic fracture of the ulna.
>
> --- The serum alkaline phosphatase and parathyroid hormone level was
> markedly elevated . Phosphorus was low, calcium was low normal , the
> 25-hydroxy-vitamin D level was low

Page 44

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.

***Cancer Detect Prev* 2001;25(6):527-32**.

**2001 "Effects of the dietary phytoestrogens daidzein and genistein on
the incidence of vulvar carcinomas in 129/J mice," -- *[Thigpen J.E. and
others]{.underline}*,** Comparative Medicine Branch, National Institute
of Environmental Health Sciences, Research Triangle Park, North Carolina
27709, USA

> **--- Within [one]{.underline} month**, the incidence of vulvar
> **carcinomas** in mice fed a modified soy protein diet was
> significantly increased over those of mice fed control diets.
>
> **--- Within 3 months**, the incidence of vulvar **carcinomas** in
> mice fed the soy protein diet was significantly increased over those
> of mice fed other control diets.
>
> **--- "[We concluded]{.underline}** that dietary levels of
> [daidzein]{.underline} and [genistein]{.underline} were associated
> with an increase in the incidence of vulvar [carcinomas]{.underline}
> in mice \... "

**\... / 36**

**- 36 -**

Petition of Objection To

[( Docket \# 2004Q-0151 ) - Solae Corporation requests FDA Health
Claim]{.underline}

re: Qualified Health Claim: Soy Protein May Reduce Risk Of Cancer

**[References]{.underline}**

**Scientific Abstract from around the world**

Continued

Page 46, (from the 132 page soy research paper)

\-
[[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11873863&dopt=Abstract]{.underline}](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11873863&dopt=Abstract&itool=iconabstr)
.

***Endocr J* 2001 Dec;48(6):655-63.**

**2001 "Neonatal exposure to genistein reduces expression of estrogen
receptor alpha and androgen receptor in testes of adult mice," --
*[Shibayama T. and others]{.underline}*,** **Core Research for
Evolutional Science and Technology, Japan Science and Technology
Corporation, Kawaguchi, Saitama.**

> --- "Our results exhibited that the disruption of gene expression
> continued for long term such as \... **[3 months after]{.underline}**
> administration of genistein \... even if no effect was found at
> conventional reproductive-toxicological levels. We have shown that
> neonatal administration of weak estrogenic compound (genistein)
> **affects male reproductive organs at molecular levels in
> adulthood**."

Page 44

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[[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11694625&dopt=Abstract]{.underline}](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11694625&dopt=Abstract&itool=iconabstr)
.

***J Nutr* 2001 Nov;131(11):2957-62.**

**2001 "Physiological concentrations of dietary genistein
dose-dependently stimulate growth of estrogen-dependent human breast
cancer (MCF-7) tumors implanted in athymic nude mice," -- *[Ju Y.H. and
others]{.underline}*,** **Department of Food Science and Human
Nutrition, University of Illinois at Urbana-Champaign, Urbana, IL 61801,
USA.**

> --- Genistein [stimulated]{.underline} breast tumor growth and [cell
> proliferation]{.underline} in mice in a dose-responsive manner.

Page 42

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[[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10917909&dopt=Abstract]{.underline}](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10917909&dopt=Abstract&itool=iconfft)
.

***J Nutr* 2000 Aug;130(8):1963-70.**

**2000 "Mass Spectrometric determination of Genistein tissue
distribution in diet-exposed Sprague-Dawley rats," -- *[Chang H.C.,
Churchwell M.I., Delclos K.B., and others]{.underline}*,** **Division of
Biochemical Toxicology, National Center for Toxicological Research,
Jefferson, AR 72079, USA.**

> **--- Genistein** administered to mice via **[maternal milk or
> fortified feed]{.underline}** showed dose-dependent increases in total
> **genistein [concentration]{.underline}** in the
> **[brain]{.underline}**, liver, mammary, ovary, prostate, testis,
> thyroid and uterus.
>
> --- Female liver contained the highest amount of genistein (7.3
> pmol/mg tissue) and male whole brain contained the least (0.04
> pmol/mg).
>
> --- These results for measured amounts of genistein, present as
> aglycone and conjugates, in putative target tissues provide [a link
> with other studies]{.underline} in which blood concentrations and
> physiologic effects of genistein are measured.

Page 40

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[[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10737721&dopt=Abstract]{.underline}](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10737721&dopt=Abstract)
.

***Cancer Lett* 2000 Feb 28;149(1-2):171-9.**

**2000 "Influence of perinatal genistein exposure on the development of
MNU-induced mammary carcinoma in female Sprague-Dawley rats," -- *[Yang
J. Nakagawa H., and others]{.underline}*,** **Department of Pathology
II, Kansai Medical University, Moriguchi, Osaka, Japan.**

> --- ". . . perinatal genistein is an endocrine disrupter and increases
> the multiplicity of MNU-induced mammary carcinoma in rats."

**\... / 37**

**- 37 -**

Petition of Objection To

[( Docket \# 2004Q-0151 ) - Solae Corporation requests FDA Health
Claim]{.underline}

re: Qualified Health Claim: Soy Protein May Reduce Risk Of Cancer

**[References]{.underline}**

**Scientific Abstract from around the world**

Continued

V

Page 40, (from the 132 page soy research paper)

\-
[[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10762754&dopt=Abstract]{.underline}](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10762754&dopt=Abstract)
.

***Eur J Cancer* 2000 Apr;36(6):796-802.**

**2000 "Genistein induces apoptosis and topoisomerase II-mediated DNA
breakage in colon cancer cells," -- *[Salti G.I., Grewal S., Mehta R.R.,
Das Gupta T.K., and others]{.underline}*,** **University of Illinois at
Chicago, College of Medicine, Department of Surgical Oncology, Chicago,
USA**

> **--- DNA breakage** in colon cancer cells occurred **-
> [within]{.underline} 1 hour -** of treatment with genistein.

Page 39

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[[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10425307&dopt=Abstract]{.underline}](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10425307&dopt=Abstract)
.

***Oncol Rep* 1999 Sep-Oct;6(5):1089-95.**

**1999 "Maternal exposure to genistein during pregnancy increases
carcinogen-induced mammary tumorigenesis in female rat offspring," --
*[Hilakiviv-Clarke L. Cho E. Onojafe I. Raygada M. and
others]{.underline}*,** **Research Bldg., Lombardi Cancer Center,
Georgetown University, NW, Washington, DC, USA**.

> --- There is an [increased breast tumor risk]{.underline} from foetal
> exposure to Soy \... [Carcinogen-induced]{.underline} mammary
> tumorigenesis.

Page 38

\-
[[http://www.soyonlineservice.co.nz/immune.htm]{.underline}](http://www.soyonlineservice.co.nz/immune.htm)
.

\-
[[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10086720&dopt=Abstract]{.underline}](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10086720&dopt=Abstract&itool=iconabstr)
.

***Leukemia* 1999 Mar;13(3)317-20.**

**1999 "Infantile leukemia and soybeans--a hypothesis," -- *[Abe
T.]{.underline}*,**

> --- Genistein from soybeans contributes to **DNA [strand
> breaks]{.underline}** and may be "largely responsible" for **infantile
> acute leukemia, (IAL).**

Page 37

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[[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10207614&dopt=Abstract]{.underline}](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10207614&dopt=Abstract&itool=iconabstr)
.

***Arch Toxicol* 1999 Feb;73(1):50-4.**

**1999 "The phytoestrogens coumoestrol [and]{.underline} genistein
induce structural chromosomal aberrations in cultured human peripheral
blood lymphocytes," -- *[Kulling S.E. Rosenberg B. and
others]{.underline}*,** **Institute of Food Chemistry, University of
Karlsruhe, Germany. Sabine.Kulling@chemie.uni-karlsruhe.de**

> --- cause [Chromosomal]{.underline} aberrations \... chromatid breaks
> \... gaps \... interchanges

**\... / 38**

**- 38 -**

Petition of Objection To

[( Docket \# 2004Q-0151 ) - Solae Corporation requests FDA Health
Claim]{.underline}

re: Qualified Health Claim: Soy Protein May Reduce Risk Of Cancer

**[References]{.underline}**

**Scientific Abstract from around the world**

Continued

Page 35, (from the 132 page soy research paper)

.
[[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10022277&dopt=Abstract]{.underline}](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10022277&dopt=Abstract&itool=iconabstr)
.

**Toxicol Lett. 1998 Dec 28;102-103:349-54.**

**1998 "Dietary phytoestrogens and their role in hormonally dependent
disease," --- *[Strauss L., Santti R., Saarinen N., Streng T., Joshi S.,
Makela S.,]{.underline}* Institute of Biomedicine and Medicity Research
Laboratory, University of Turku, Finland.**

> --- Although epidemiological studies suggest that diets rich in
> phytoestrogens may be associated with low risk of breast and prostate
> cancer, **there is no direct evidence for the beneficial effects of
> phytoestrogens in humans.** It is plausible that phytoestrogens, as
> any exogenous hormonally active agent, might also cause adverse
> effects in the endocrine system.
>
> **--- Epidemiological studies suggest that diets rich in
> phytoestrogens (plant estrogens), particularly soy and unrefined grain
> products, may be associated with low risk of breast and prostate
> cancer.** It has also been proposed that dietary phytoestrogens could
> play a role in the prevention of other estrogen-related conditions,
> namely cardiovascular disease, menopausal symptoms and post-menopausal
> osteoporosis.
>
> --- However, there is no direct evidence for the beneficial effects of
> phytoestrogens in humans.
>
> --- All information is based on consumption of phytoestrogen-rich
> diets, and the causal relationship and the mechanisms of phytoestrogen
> action in humans still remain to be demonstrated.
>
> --- In addition, the possible adverse effects of phytoestrogens have
> not been evaluated.
>
> --- It is plausible that phytoestrogens, as any exogenous hormonally
> active agent, might also cause adverse effects in the endocrine
> system, i.e. act as endocrine disrupters.

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.

***Med Hypotheses* 1998 *Jun 50:6 457-64***

**1998 "Xenoestrogens significantly enhance risk for breast cancer
during growth and adolescence," -- *[Ardies C.M. and Dees
C.]{.underline}*,** **Department of Biological and Exercise Sciences,
Northeastern Illinois University, Chicago 60625-4699, USA.**

> --- Specifically, we hypothesize that during periods of high growth
> rates and during breast development the sensitivity of breast cells to
> estrogenic compounds is sufficiently great for xenoestrogens to
> significantly enhance risk for breast cancer.
>
> --- Breast cancer is one of the most common forms of cancer observed
> in women, and endogenous estrogen is thought to play a major role in
> its development.
>
> --- Because of this, any conditions or exposures which enhance
> estrogenic responses would result in an increased risk for breast
> cancer.
>
> --- The role of xenoestrogenic compounds, such as DDT, in the etiology
> of breast cancer is still very controversial. In the following paper
> we discuss recently-published observations by ourselves and others
> which indicate that xenoestrogens may play a significant role in the
> development of breast cancer.

**\... / 39**

**- 39 -**

Petition of Objection To

[( Docket \# 2004Q-0151 ) - Solae Corporation requests FDA Health
Claim]{.underline}

re: Qualified Health Claim: Soy Protein May Reduce Risk Of Cancer

**[References]{.underline}**

**Scientific Abstract from around the world**

Continued

Page 36, (from the 132 page soy research paper)

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.

***Mutat Res* 1998 Aug 31;405(1):41-56.**

**1998 "p53, mutations, and apoptosis in genistein-exposed human
lymphoblastoid cells," -- *[Morris S.M. and others]{.underline}*,**
**Division of Genetic and Reproductive Toxicology, National Center for
Toxicological Research, Food and Drug Administration, Jefferson, AR
72079, USA**

> --- cellular damage [and]{.underline} *DEATH*, [genistein]{.underline}
> in Soy is a [chromosomal]{.underline} mutagen
>
> --- The phytoestrogen, genistein, is a naturally occurring isoflavone
> found in soy products.
>
> --- On a biochemical basis, genistein is a competitive inhibitor of
> tyrosine kinases and the DNA synthesis-related enzyme,
> topoisomerase-II (topo-II).
>
> --- Exposure of mammalian cells to genistein results in DNA damage
> that is similar to that induced by the topo-II inhibitor and
> chromosomal mutagen, m-amsa.

V

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.

***Am J Clin Nutr* 1998 Dec;68(6 Suppl):1431S-1435S.**

**1998 "Effects of soy-protein supplementation on epithelial
proliferation in the histologically normal human breast," --
*[McMichael-Phillips D.F. and others]{.underline}*, Depart. of
Epithelial Biology, Paterson Institute for Cancer Research, Christie
Hospital NHS Trust, Manchester, United Kindgom**

> --- Soy foods [stimulates]{.underline} breast proliferation \... after
> just 14 days
>
> --- Forty-eight women with benign or malignant breast disease were
> randomly assigned a normal diet either alone or with a 60 gram soy
> supplement containing 45 mg isoflavones, taken for 14 days.
>
> --- The [proliferation]{.underline} rate of breast lobular epithelium
> \... significantly increased \... after just 14 days \... of soy
> supplementation \... when both the day of menstrual cycle & age of
> patient were accounted for. Thus short-term use of dietary soy
> containing isoflavone levels found in modern soy foods
> [stimulates]{.underline} breast proliferation.
>
> --- Our results may be interpreted that genistein is a chromosomal
> mutagen and that p53 functional status affects the recovery of
> chromosomal mutants, possibly by signalling cells into the apoptosis
> pathways.

V

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[[http://www.soyonlineservice.co.nz/Refs/Helf.htm]{.underline}](http://www.soyonlineservice.co.nz/Refs/Helf.htm)
.

\-
[[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=9848512]{.underline}](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=9848512)
.

***Cancer Res* 1998 *Sep 1;58(17):3833-8., [and]{.underline} Cancer Res*
1999 *Mar 15;59(6):1388*.**

**1998 "Estrogenic effects of genistein on the growth of estrogen
receptor-positive human breast cancer (MCF-7) cells in vitro and in
vivo," -- *[Hsieh C.Y., Santell R.C., Haslam S.Z., Helferich
W.G.]{.underline}*, Department of Food Science and Human Nutrition,
Michigan State University, East Lansing 48824, USA.**

> --- Proliferation of cultured human breast cancer cells \... Dees
> concluded that \' women [should not]{.underline} consume particular
> foods, (eg. soy-derived products), to prevent breast cancer\'.
>
> **--- [IN SUMMARY]{.underline},** genistein can act as an estrogen
> agonist in [vivo]{.underline} and in [vitro]{.underline}, resulting in
> the proliferation of cultured human breast cancer cells (MCF-7) and
> the induction of pS2 gene expression. Here we present new information
> that dietary genistein stimulates mammary gland growth and enhances
> the growth of MCF-7 cell tumors in ovariectomized athymic mice.
>
> **--- [Dr Craig Dees]{.underline}** of Oak Ridge National Laboratory
> has also found that soy isoflavones cause breast cancer cells to grow.
>
> --- He reported that \'low concentrations of genistein may stimulate
> MC-7 cells to enter the cell cycle\'. Dees concluded that \' women
> [should not]{.underline} consume particular foods, (eg. soy-derived
> products), to prevent breast cancer\'.

**\... / 40**

**- 40 -**

Petition of Objection To

[( Docket \# 2004Q-0151 ) - Solae Corporation requests FDA Health
Claim]{.underline}

re: Qualified Health Claim: Soy Protein May Reduce Risk Of Cancer

**[References]{.underline}**

**Scientific Abstract from around the world**

Continued

V

Page 33, (from the 132 page soy research paper)

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.

***Environ Health Perspect* 1997 Apr;105(Suppl 3):633-636.**

**1997 "Dietary estrogens stimulate human breast cells to enter the cell
cycle," -- *[Dees C. and others]{.underline}*,** **Health Sciences
Research Division, Oak Ridge National Laboratory, Tennessee, USA**

> --- [Stimulates]{.underline} human [breast cancer cells]{.underline}
> to enter the cell cycle
>
> **--- Dietary estrogens were found to increase enzymatic activity
> [leading to]{.underline} breast cancer**. "Our findings are consistent
> with a conclusion that dietary estrogens at low concentrations do not
> act as antiestrogens, but act like DDT and estradiol to stimulate
> human [breast cancer cells]{.underline} to enter the cell cycle.

Page 32

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.

***Lancet.* 1997 *Jul 5;350(9070):23-7.,***

**1997 Exposure of infants to phyto-oestrogens from soy-based infant
formula, -- *Setchell K.D., Zimmer-Nechemias L., Cai J., Heubi J.E.,*
Clinical Mass Spectrometry Center, Children's Hospital Medical Center,
Cincinnati, Ohio, 45229, USA.**

> --- [Soy]{.underline} has glycosides of [genistein]{.underline} and
> [daidzein]{.underline} or plant based chemicals that mimic estrogen
>
> --- The daily exposure of infants to isoflavones in soy
> infant-formulas is 6-11 fold higher on a body-weight basis than the
> dose that has hormonal effects in adults consuming soy foods.
>
> --- Circulating concentrations of isoflavones in the seven infants fed
> soy-based formula were 13000-22000 times higher than plasma oestradiol
> concentrations in early life, and may be sufficient to exert
> biological effects, [whereas the contribution of isoflavones from
> breast-milk and cow-milk is negligible]{.underline}.

Page 34, (from the 132 page soy research paper, attachment)

***Food Chem Toxicol* 1997 Jun;35(6):605-13.**

\-
[[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=9225019&dopt=Abstract]{.underline}](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=9225019&dopt=Abstract&itool=iconabstr)
.

**1997 "Induction of micronuclei, DNA strand breaks and HPRT mutations
in cultured Chinese hamster V79 cells by the phytoestrogen coumoestrol,"
-- *[Kulling S.E. and Metzler M.]{.underline}*,** **Institute of Food
Chemistry, University of Karlsruhe, Germany.**

> --- Coumoestrol and genistein caused - DNA [strand
> breaks]{.underline} - in cultured hamster cells.

Page 34

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.

***Nutr Cancer* 1997;28(3):236-47.**

**1997 "Phytoestrogen concentration determines effects on DNA synthesis
in human breast cancer cells," -- *[Wang C. and Kurzer
M.S.]{.underline}*,** **Department of Food Science and Nutrition,
University of Minnesota, St. Paul 55108, USA.**

> --- **[Stimulates]{.underline}** growth of tumors \...
> [Suppress]{.underline} enzymes [protective]{.underline} of breast
> cancer
>
> --- Soy intake caused [larger]{.underline} mammary fat pad
> [tumors]{.underline} to occur in mice.
>
> --- "Our data suggest the possibility that, at typical concentrations
> in humans, phytoestrogens and related flavonoids and lignans may
> **[stimulate]{.underline}**, rather than inhibit, **[growth of
> estrogen-dependent tumours]{.underline}**."
>
> --- Soy intake caused larger mammary fat pad tumors to occur in mice.
> **Soy feeding appeared to [suppress enzymes protective]{.underline} of
> breast cancer.**

**\... / 41**

**- 41 -**

Petition of Objection To

[( Docket \# 2004Q-0151 ) - Solae Corporation requests FDA Health
Claim]{.underline}

re: Qualified Health Claim: Soy Protein May Reduce Risk Of Cancer

**[References]{.underline}**

**Scientific Abstract from around the world**

Continued

Page 34, (from the 132 page soy research paper)

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.

***Nutr Cancer* 1997;29(1):48-54.**

**1997 "Effects of dietary menhaden oil, soy, and a cyclooxygenase
inhibitor on human breast cancer cell growth and metastasis in nude
mice," -- *[Connolly J.M. and others]{.underline}*,** **Division of
Nutrition and Endocrinology, American Health Foundation, Valhalla, NY
10595, USA.**

> --- Phytoestrogens at levels close to probable levels in humans were
> found to [stimulate]{.underline} cellular changes
> **[leading]{.underline} to breast cancer**.

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.

***Teratog Carcinog Mutagen* 1997;17(1):29-43.**

**1997 "Effect of various genotoxins and reproductive toxins in human
lymphocytes and sperm in the Comet assay," -- *[Anderson D. Dobrzynska
M.M., Basaran N.]{.underline}*,** **Department of Genetic and
Reproductive Toxicology, BIBRA International, Carshalton, Surrey, United
Kingdom.**

> --- **DNA damage to human sperm \...**
>
> --- "The integrity of DNA is necessary [not only]{.underline} for the
> noncancerous state, but also for the accurate transmission of genetic
> material to the next generation."
>
> --- Human sperm exposed to the phytoestrogen **daidzein** had
> **[reduced]{.underline} DNA integrity.**

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.

***Klin Padiatr.* 1996 *Nov-Dec;208(6):323-6.,***

**1996 Hypocalcemic tetany in \'alternative\' soy milk nutrition in the
first months of life, -- *[Anil M, Kiess W.]{.underline},* *Abteilung
Allgemeine Padiatrie und Neonatologie, Justus Liebig Universitat
Giessen.***

**Malnutrition \... [from]{.underline} \... False nutritional beliefs**.

> --- A 14 weeks old infant was admitted to the intensive care unit with
> life-threatening hypocalcemic-hyperphosphatemic spasms.
> Hypocalcemia-hyperphosphatemia was found to have been caused by
> feeding a high phosphate/ low calcium soy milk. The daily uptake of
> calcium was calculated to have been 3.3-6 mmol that of phosphate 30
> mmol.
>
> --- The parents strongly believed that soy milk formulas were
> equivalent to breast milk and cow\'s milk formulas and lived on a
> strictly [vegetarian diet]{.underline}. Therapy with calcium (at an
> initial dose of 2.25 mmol/kg/day) and 1.25 OH vitamin D3 (Rocaltrol,
> 0.25 microgram/day) [normalized]{.underline} Ca, PO4, vitamin D and
> parathyroid hormone levels rapidly.
>
> --- Vegetarian feeding had led to life-threatening hypocalcemic
> hyperphosphatemic spasms in the infant.
>
> **--- [We conclude]{.underline}:.** Vegetarian feeding had led to
> life-threatening hypocalcemic - hyperphosphatemic spasms in the
> infant, as well as, [malnutrition]{.underline} and [false nutritional
> beliefs]{.underline} have to be included as a potential cause of early
> hypocalcemia in infants.

**\... / 42**

**- 42-**

Petition of Objection To

[( Docket \# 2004Q-0151 ) - Solae Corporation requests FDA Health
Claim]{.underline}

re: Qualified Health Claim: Soy Protein May Reduce Risk Of Cancer

**[References]{.underline}**

**Scientific Abstract from around the world**

Continued

Page 33, (from the 132 page soy research paper)

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.

***Cancer Epidemiol Biomarkers Prev* 1996 Oct;5(10):785-794.**

**1996 "Stimulatory influence of soy protein isolate on breast secretion
in pre-and postmenopausal women," -- *[Petrakis N.L. Barnes S. and
others]{.underline}*,** **Department of Epidemiology and Biostatistics,
University of California, San Francisco 94143-0560, USA.**

> --- Twenty-four, (24), normal pre- and postmenopausal white women,
> ages 30 - 58 were studied for one year.
>
> --- The authors noted that "the findings [did not]{.underline} support
> our a priori hypothesis" that soy protected Asian women against breast
> cancer.
>
> --- "Instead, this pilot study indicates that "[prolonged
> consumption]{.underline}" of soy protein isolate has a "[stimulatory
> effect]{.underline}" on the premenopausal female breast \...
> [genistein]{.underline} and [daidzein]{.underline} in Soy protein
> isolate (SPI).

Page 31

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.

***Prostate* 1994;24(2):67-78.**

**1994 "Developmental estrogenization and prostatic neoplasia," --
*[Santti R. and others]{.underline}*,** **Department of Anatomy,
University of Turku, Finland.**

> **--- Estrogens, more susceptible to prostate cancer later in life**
>
> --- The association of estrogens with benign prostatic hyperplasia and
> prostatic cancer has been widely studied, but no conclusive evidence
> exists for a role of estrogens in prostatic disease. This paper
> reviews the literature and describes studies which have sought to show
> a correlation of estrogens and alterations in the prostates of humans
> and experimental animal models.
>
> --- Using the developmentally estrogenized mouse model, we propose an
> alternative role for estrogens as a predisposing factor for prostatic
> diseases: estrogen exposure during development may initiate cellular
> changes in the prostate which would require estrogens and/or androgens
> [later in life]{.underline} for promotion to hyperplasia or neoplasia.
>
> --- Thus, the critical time for estrogen action would be during the
> development of the prostatic tissue.
>
> --- We further suggest that estrogen-sensitive cells may remain in the
> prostate and be more responsive to estrogens [later]{.underline} in
> life or less responsive to the normal controlling mechanisms of
> prostatic growth.
>
> **--- [In other words]{.underline},** exposure of the developing male
> child to phytoestrogens in soy may make him more susceptible to
> [prostate]{.underline} cancer later in life.

Page \... 30

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.

\-
[[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=8314908&dopt=Abstract]{.underline}](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=8314908&dopt=Abstract&itool=iconfft)
.

***J Cell Sci* 1993 Apr;104 part 4:961-73.**

**1993 "Odd chromosome movement and inaccurate chromosome distribution
in mitosis and meiosis after treatment with protein kinase inhibitors,"
-- *[Nicklas R.B. and others]{.underline}*,** Department of Zoology,
Duke University, Durham, NC 27706.

> --- Genistein, a protein kinase inhibitor, caused [errors]{.underline}
> in "chromosome orientation" from grasshopper spermatocytes..

**\... / 43**

**- 43 -**

Petition of Objection To

[( Docket \# 2004Q-0151 ) - Solae Corporation requests FDA Health
Claim]{.underline}

re: Qualified Health Claim: Soy Protein May Reduce Risk Of Cancer

**[References]{.underline}**

**Scientific Abstract from around the world**

Continued

Page 59, (from the 132 page soy research paper)

\-
[[http://www.soyonlineservice.co.nz/immune.htm]{.underline}](http://www.soyonlineservice.co.nz/immune.htm)
.

\-
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.

***Cell Immunol* 1993 *Nov 152:(1) 271-8.***

**1993 "Induction of mouse thymocyte apoptosis by inhibitors of tyrosine
kinases is associated with dephosphorylation of nuclear proteins," --
*[Azuma Y., Onishi Y., Sato Y., Kizaki H.]{.underline}*,** **Department
of Biochemistry, Tokyo Dental College, Chiba, Japan.**

> **--- DNA fragmentation [and]{.underline} cell *DEATH***
>
> --- Incubation of mouse thymocytes with the protein tyrosine kinase
> inhibitors herbimycin A and methyl-2,5-dihydroxycinnamate induced a
> decreased and altered profile of nuclear phosphotyrosine proteins in
> parallel with an increase in internucleosomal DNA fragmentation and
> cell death [dose-dependently]{.underline}.
>
> --- No change in the profile of cytoplasmic phosphotyrosine proteins
> was observed. DNA fragmentation was dependent on the synthesis of RNA
> and protein, suggesting that the inhibition of tyrosine
> phosphorylation of the nuclear proteins induces apoptosis.
>
> --- DNA fragmentation was enhanced by simultaneous incubation with
> phorbol esters capable of activating protein kinase C.
>
> --- Genistein, another inhibitor of protein tyrosine kinase, induced
> DNA fragmentation [more rapidly]{.underline} than herbimycin A, but
> there was no predominant alteration of phosphotyrosine proteins in
> early incubation, suggesting that genistein may induce apoptosis by a
> mechanism other than direct inhibition of protein tyrosinekinase
> activity.

V

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[[http://www.mercola.com/article/soy/avoid_soy.htm]{.underline}](http://www.mercola.com/article/soy/avoid_soy.htm)
, **Foot Note #53.**

**#53. Bulletin de L\'Office Fédéral de la Santé Publique, no. 28, July
20, 1992.**

**1992 *"Bulletin de L'Office Federal de la Santé Publique*," No 28,
July 20, 1992.**

> --- The Swiss Health Service estimates that **100 grams of soy
> protein** provides the estrogenic equivalent of the **contraceptive
> pill.**

Page 29

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.

***Toxicology* 1992;72:135-149.**

**1992 "Validation of Two In Vitro Test Systems of Estrogenic Activities
with Zearelenone Phytoestrogens and Cereal Extracts," -- *[Mayr U.,
Butsch A.]{.underline}*,** **Institut fur Tierernahrung, Universitat
Hohenheim, Stuttgart, Germany.**

> --- disease \... in all kinds of farm animals \... inherent health
> risk \... to man cannot be excluded.
>
> --- "Ingestion of these compounds causes diseases of the \...
> reproductive system \... reversible and irreversible infertility \...
> and abnormal fetal development \... **in all kinds of farm animals**.
>
> --- [Furthermore]{.underline}, an inherent health risk to man cannot
> be excluded." This paper contains graphs showing the crossover of
> phytoestrogens from estrogenic to antiestrogenic to toxic.

**\... / 44**

**- 44 -**

Petition of Objection To

[( Docket \# 2004Q-0151 ) - Solae Corporation requests FDA Health
Claim]{.underline}

re: Qualified Health Claim: Soy Protein May Reduce Risk Of Cancer

**[References]{.underline}**

**Scientific Abstract from around the world**

Continued

Page 29

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[[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=1330289&dopt=Abstract]{.underline}](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=1330289&dopt=Abstract&itool=iconabstr)
.

***Cancer Res* 1992 Nov 15;52(22):6200-8.**

**1992 "Effects of genistein on the growth and cell cycle progression of
normal human lymphocytes and human leukemic MOLT-4 and HL-60 cells," --
*[Traganos F., Ardelt B., and others]{.underline}*,** **Cancer Research
Institute, New York Medical College, Valhalla 10595**

> --- The results suggest that genistein "is expected to be a
> [strong]{.underline} immuno-suppressant.
>
> --- Genistein (GEN) is an isoflavone [known to inhibit
> both]{.underline} tyrosine protein kinases [and]{.underline} DNA
> topoisomerase II.
>
> --- The effects of GEN on cell proliferation and cell cycle kinetics
> of [human myelogenous leukemia]{.underline} HL-60 and lymphocytic
> [leukemia]{.underline} MOLT-4 cell cultures were studied, and the data
> were compared to results obtained with normal human lymphocytes
> stimulated to proliferate with phytohemagglutinin.

Page 29.

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.

***Transplantation* 1991 Feb;51(2):448-50.**

**1991 "Evidence that genistein, a protein-tyrosine kinase inhibitor,
inhibits CD28 monoclonal-antibody-stimulated human T cell
proliferation," -- *[Atluru S., Atluru D.]{.underline}*,** **Department
of Anatomy and Physiology, Kansas State University, Manhattan 66506**

> --- Genistein [blocks]{.underline} the production of T cells,
> [needed]{.underline} for the immune system.
>
> --- The authors conclude: " \... that genistein is a
> [powerful]{.underline} immuno-suppressive agent \..." and suggest that
> it has a potential use in the treatment of allograft rejection.

Page 28

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.

***Cancer Res* 1989 Sep 15;49(18):5111-7.**

**1989 "Inhibitory effects of the tyrosine kinase inhibitor genistein on
mammalian DNA topoisomerase II," -- *[Markovits J., Linassier C., and
others]{.underline}*,** **Laboratorie de Pharmacologie Moleculair, URA
158 du CNRS, U 140 de I'NSERM, Institute Gustave Roussy, Villejuif,
France.**

**--- Genistein [stimulates]{.underline} double strand DNA breaks.**

> --- Our results show that genistein (a) inhibits the decatenation
> activity of DNA topoisomerase II and (b) [stimulates]{.underline} DNA
> topoisomerase II-mediated [double strand breaks]{.underline} in pBR322
> DNA on sites different from those of
> 4\'-(9-acridinylamino)methanesulfon-m-anisidide, etoposide, and
> 2-methyl-9-hydroxyellipticinium.
>
> --- Finally, [genistein treatment]{.underline} of DC-3F cells results
> in the occurrence of protein-linked [DNA strand breaks]{.underline} as
> shown by DNA filter elution. Viscometric (lengthening) studies
> demonstrate that genistein isn't a DNA intercalator. Genistein is
> therefore an interesting compound because it induces cleavable
> complexes without intercalation.
>
> --- Taken together, our results show that genistein is an inhibitor of
> both protein tyrosine kinases and mammalian DNA topoisomerase II. This
> could be accounted for by the sharing of a common structure sequence
> between the two proteins at the ATP binding site.

**\... / 45**

**- 45 -**

Petition of Objection To

[( Docket \# 2004Q-0151 ) - Solae Corporation requests FDA Health
Claim]{.underline}

re: Qualified Health Claim: Soy Protein May Reduce Risk Of Cancer

**[References]{.underline}**

**Scientific Abstract from around the world**

Continued

Page 84

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[[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=2868833&dopt=Abstract]{.underline}](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=2868833&dopt=Abstract&itool=iconabstr)
.

***Comp Biochem Physiol A.* 1986*;83(1):67-70***

**1986 "Effects of postnatal protein undernutrition on myelination in
rat brain," -- *[Egwin P.O., Cho B.H., Kummerow F.A.]{.underline},***
Egwim PO, Cho BH, Kummerow FA.

> --- Damages the myelin to sheath around the nerves.

. --- "[A more pronounced retardation]{.underline}" in the initiation,
progression and capacity of [myelination]{.underline} in postnatal "[Soy
Protein]{.underline} [under-nutrition]{.underline} was indicated."

> --- Pups were subjected, from birth, to - [protein
> under-nutrition]{.underline} by feeding the lactating dams 8% casein
> (CS) or - 8% [Soy Protein (SP) diet]{.underline} - up to weaning; the
> weanlings were fed the same diets until 6 weeks of age. At 3 and 6
> weeks of age, **[myelin]{.underline} was isolated from the brains and
> characterized**. The quantities of myelin and its content of
> cholesterol, galactolipids and phospholipids, were significantly
> depressed in the 8% CS and 8% SP groups but not when soy protein was
> fed at the same level as casein (25%) in the control. Furthermore, the
> severity of the deficits in myelination showed a differential pattern
> depending on the type of dietary protein fed. At weaning, the deficits
> with the 8% SP diet were 1.5-2.0-times greater than with the
> corresponding casein diet.

. --- "[A more pronounced retardation]{.underline}" in the initiation,
progression and capacity of [myelination]{.underline} in postnatal "[Soy
Protein under-nutrition was indicated]{.underline}."

Page 84

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[[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=2432794&dopt=Abstract]{.underline}](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=2432794&dopt=Abstract&itool=iconabstr)
.

***Am J Pathol* 1986 *Dec; 125(3):620-4.***

**1986 "Effect of prenatal iron deficiency on myelination in rat pups,"
-- *[Yu G.S., Steinkirchner T.M. Rao G.A., Larkin E.C.]{.underline},***

> --- Phytates in Soy are known to [block]{.underline} iron absorption
>
> --- In this study, a histopathologic examination of the brain from
> [iron-deficient or iron-supplemented]{.underline} rat pups was carried
> out. Pups were obtained from female rats, which were fed an
> iron-deficient or iron-supplemented diet during both pregnancy and
> lactation. Immediately after anesthesia and the collection of blood,
> pups were fixed by intracardiac infusion of 2% glutaraldehyde. Brain
> and cervical spinal cord were fixed, embedded in paraffin, and cut at
> 6-mu thickness. **[Myelin was identified using Luxol fast blue
> stain]{.underline}.** As compared with controls (hematocrit, 30.8%),
> 11-day-old iron-deficient pups (hematocrit, 11.9%) showed reduced
> myelination in the spinal cord.

. --- Although myelination increased somewhat in the iron-deficient
17-day-old pups (hematocrit, 8.5%), the amount of "[myelin]{.underline}"
in the spinal cord and white matter of cerebellar folds "[was
reduced]{.underline}" as compared with that of the corresponding
controls.

> **--- [THESE OBSERVATIONS SHOW]{.underline} -** the importance of
> prenatal iron adequacy in myelinogenesis.
>
> ( The unborn child also gets what the mother eats. Here is another
> good reason to avoid Soy in pregnancy.)

So to try and bend the scientific evidence to try to make it fit what
the soy industry and the pharmaceutical companies want it to look like,
that soy supposedly prevents cancer, is doing the same thing the
pharmaceutical companies did for over 20 years before June 2002, when
the studies on Hormone Replacement Therapy, HRT, were stopped because
these studies were proving that HRT was causing the very illness in
women, including cancer, that the pharmaceutical companies were claiming
and saying that HRT prevented. This is what we feel can be called crimes
against humanity in the extreme. Soy being used as a weapon of mass
destruction, devastation, unimaginable pain and suffering, heart ache
and death !!.

**\... / 46**

**- 46 -**

Petition of Objection To

[( Docket \# 2004Q-0151 ) - Solae Corporation requests FDA Health
Claim]{.underline}

re: Qualified Health Claim: Soy Protein May Reduce Risk Of Cancer

**[References]{.underline}**

**Scientific Abstract from around the world**

Continued

\-
[[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=7192012]{.underline}](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=7192012)
.

***Scandinavian Journal of Gastroenterology,* 1980*; 15(4):497-502***

**1980 "The effects of long-term feeding of soya flour on the rat
pancreas," --- *[McGuinness E.E, Morgan R.G., Levison D.A. and
others]{.underline}***

> --- Pancreatic cancer
>
> --- Rats were fed raw and heated soya flour for up to 2 years.
>
> --- The rats fed raw soya flour all developed pancreatic hypertrophy
> and hyperplastic and adenomatous nodules. Four of 26 rats fed raw soya
> flour continuously and 1 of 5 rats fed raw soya flour for 2 days each
> week developed pancreatic cancer.
>
> --- Preheating the soya flour seemed to protect against the pancreatic
> hyperplastic and neoplastic changes.
>
> --- But long periods of heat and pressure also required (130 degrees
> Celsius) to deactivate the carcinogenic trypsin inhibitors in soya
> flour denatures the soy proteins to the point that they become
> virtually useless.
>
> --- Then one either chooses less heating, resulting in more surviving
> trypsin inhibitors, or more heating, resulting in useless protein.
> **[William Jarvis, Ph.D.]{.underline},** Department of Health
> Promotion and Education, **[Loma Linda University]{.underline}**, Loma
> Linda, California, USA.

Page 26

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[[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=570914&dopt=Abstract]{.underline}](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=570914&dopt=Abstract&itool=iconabstr)
.

***Endocrinology* 1978 Nov;103(5):1860-7.**

**1978 "Phytoestrogen interaction with estrogen receptors in human
breast cancer cells," -- *[Martin M.P., Horwitz K.B., and
others]{.underline}*,**

> --- Phytoestrogens can markedly enhance tumor cell proliferation. The
> interactions of phytoestrogens with estrogen receptors were studied in
> the human breast cancer cell line, MCF-7.
>
> --- The compounds tested were \... coumestrol \...
> [genistein]{.underline} \... and formononetin and the mycotoxins,
> zearalenone and its reduced derivative, zearalenol. All but
> [formononetin]{.underline} compete for binding of \[3H\]-estradiol to
> unfilled cytoplasmic estrogen receptor or unfilled nuclear estrogen
> receptor sites.
>
> --- The phytoestrogens are also biologically active; [they can
> markedly enhance]{.underline} tumor cell proliferation.
>
> --- In summary \... phytoestrogens interact with the [estrogen
> receptors]{.underline} of human breast cancer cells in culture and,
> therefore, may affect estrogen-mediated events in these cells.

**\* \* \***

These 61 abstracts are only some, out of hundreds available in NCBI
PubMed, from the continually growing body of scientific research on the
many "[health hazards]{.underline}" of eating soy, of putting soy in our
food supply. With the scientific evidence that follow, think about all
of these known and ignored "[side-effects]{.underline}" listed here.
Now, you can begin to start counting the number of people, worldwide,
likely to be seriously hurt and/or dying from eating soy simply because
of what these people were told, were tricked into believing, were lied
to, most of the time deliberately, with misinformation, which
"[persuaded]{.underline}" them to [believe]{.underline}, persuaded to
trust, to have false hope, by the soy industry and their supporters,
world wide, which goes something like this \... "Trust us,
[using]{.underline} soy is going to help (you)them, even help save
(your)their life" \... when in reality, soy is slowly and "[violently
killing them]{.underline}".

More at Soy Online Service \...
[[http://www.soyonlineservice.co.nz/]{.underline}](http://www.soyonlineservice.co.nz/),
[and]{.underline} W.A.P.F \...
[[http://www.westonaprice.org/splash_2.htm]{.underline}](http://www.westonaprice.org/splash_2.htm)
.

\...