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| john... |
 Posted: Fri Oct 09, 2009 1:13 pm |
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Guest
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http://www.naturalnews.com/027205_vaccines_swine_flu_the_FDA.html
Urgent lawsuit filed against FDA to halt swine flu vaccines; claims FDA
violated federal law
Friday, October 09, 2009 by: Mike Adams, the Health Ranger, NaturalNews
Editor
(NaturalNews) Health freedom attorney Jim Turner is filing a lawsuit in
Washington D.C. mid-day Friday in an urgent effort to halt the distribution
of the swine flu vaccine in America. On behalf of plaintiffs Dr. Gary Null
and other licensed health care workers of New York State, the lawsuit
charges that the FDA violated the law in its hasty approval of four swine
flu vaccines by failing to scientifically determine neither the safety nor
efficacy of the vaccines.
"The suit will seek an injunction against the FDA from approving the
vaccine," attorney Jim Turner told NaturalNews on Thursday evening's Natural
News Talk Hour show. "And the core of the argument is that they have not
done the proper safety and efficacy tests on the vaccine to allow it to be
release at this time."
The suit seeks to not only nullify the FDA's unlawful "approval" of the four
H1N1 influenza vaccines, but to also ask the court to issue an injunction
that would halt any mandatory vaccination requirements.
"The FDA is required by law to establish that a vaccine is safe and
effective before it can be given to the public," said Turner. "We are
arguing that they did not establish that the vaccine was effective, and did
not establish that it was safe. They are trying to get it on the market by a
waiver."
Vaccine / adjuvant combination has never been properly tested
The vaccine / adjuvant combination being referred to as the "swine flu
vaccine" has apparently never been safety tested or approved by the FDA. In
fact, in many cases the vaccine is being sent to clinics, pharmacies and
other health establishments separately from the adjuvant chemical, leaving
it up to each local vaccine retailer to properly mix the vaccine with the
adjuvant, according to information provided by Turner. With hundreds of
millions of Americans potentially being targeted with this vaccine, the
potential for improper mixing, improper dosages, and human error is
alarming.
If the charges described in the lawsuit are true, it means the FDA has
blatantly abandoned medical science and violated its own regulations in
approving not only these four vaccines, but the potentially deadly adjuvant
chemicals as well. To date, the FDA has produced absolutely no scientific
evidence documenting safety tests for any of these swine flu vaccines. There
are no published studies, no records of any clinical trials, and no
publicly-available paper trail demonstrating that any safety testing was
done whatsoever. There is no researcher who has publicly put their name on
the record declaring the vaccines to be safe, and no FDA official has ever
stated that scientifically-valid safety testing has ever been conducted on
the vaccine / adjuvant combinations now being distributed across America.
Normally, when a pharmaceutical achieves "FDA approved" status, there is a
considerable paper trail of scientific scrutiny, peer review, clinical
trials and other supporting evidence. To our knowledge, no such documents
exist for the swine flu vaccines. The FDA's approval of these vaccines
appears to be based entirely on a whim.
"What has been tested?" asked attorney Jim turner. "Where has it been
tested? Who reviewed the test? Who looked at the test and said yes they
proved safety and efficacy? There is no record that we can find that shows
these things have been done."
By approving the four vaccines in the absence of such safety testing, the
FDA itself stands in direct violation of federal law. "There is a law that
they're supposed to follow and they are not following it," Turner added.
Billions of dollars are at stake
Why, then, did the FDA apparently violate the law and push these vaccines
into full public distribution without securing the safety testing required
by law? Turner suspects a profit motive may be involved: "They're charging
$24.95 to get a vaccine. Multiplied by 100 million people, that's a lot of
money. If you do the whole society, you're talking about several billion
dollars."
In fact, the U.S. vaccination push could ultimately target over 200 million
Americans, generating nearly $5 billion in vaccine-related revenues. Cashing
in on those revenues, however, requires three things:
1) Spreading fear about H1N1 swine flu by exaggerating its dangers.
2) Quickly making a vaccine available for sale, even if it has never been
thoroughly tested for safety and efficacy.
3) Aggressively marketing the vaccines before the H1N1 swine flu fizzles out
and can no longer be hyped up as "highly virulent."
All three of these conditions are now being pushed aggressively in the U.S.
by pharma-influenced health authorities at both the state and federal level.
There is a mad, cult-like rush under way to vaccinate American citizens with
an unproven, untested chemical that was thrust into distribution in apparent
violation of federal law. And if this vaccine is not stopped, the price that
may ultimately be paid in terms of lost lives could be quite dire.
It all harkens back to 1976 when a previous formulation of the swine flu
vaccine paralyzed and killed thousands of Americans. Turner was one of the
attorneys instrumental in halting that vaccine, and he fears a repeat
situation could potentially recur today. He told NaturalNews, "[In 1976]
they were intending to inoculate 200 million people. We stopped them... and
somewhere between 40 and 50 million people were vaccinated. What ultimately
brought it down is that a substantial number of people got 'French Polio'
[Guillain-Barre syndrome], a paralysis that goes... through the body, and if
it goes far enough you die."
About health freedom attorney Jim Turner
Jim Turner, with Citizens for Health (www.Citizens.org), is one of the most
accomplished and respected health freedom attorneys practicing today. His
firm, Swankin & Turner, represents businesses and individuals on a variety
of regulatory issues relating to foods, drugs and health.
Donations to support this swine flu vaccine lawsuit are greatly welcomed.
You can donate to Citizens.org on this page:
http://www.citizens.org/?page_id=20
A special fund specifically focused on the swine flu vaccine lawsuit will be
announced here on NaturalNews. Watch this story for an update. |
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| Mark Probert... |
| Posted: Fri Oct 09, 2009 1:13 pm |
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Guest
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On Oct 9, 3:13 pm, "john" <nos... at (no spam) bt.com> wrote:
[quote:0ac87689dd]http://www.naturalnews.com/027205_vaccines_swine_flu_the_FDA.html
Urgent lawsuit filed against FDA to halt swine flu vaccines; claims FDA
violated federal law
Friday, October 09, 2009 by: Mike Adams, the Health Ranger, NaturalNews
Editor
(NaturalNews) Health freedom attorney Jim Turner is filing a lawsuit in
Washington D.C. mid-day Friday in an urgent effort to halt the distribution
of the swine flu vaccine in America. On behalf of plaintiffs Dr. Gary Null
and other licensed health care workers of New York State, the lawsuit
charges that the FDA violated the law in its hasty approval of four swine
flu vaccines by failing to scientifically determine neither the safety nor
efficacy of the vaccines.
[/quote:0ac87689dd]
this is an example of just how evil Null is.
He is an AIDS denialist, a H1N1 denialist, but, sells his potions to
prevent and treat those conditions.
Follow the money.... |
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| Happy Oyster... |
| Posted: Fri Oct 09, 2009 1:21 pm |
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Guest
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On Fri, 9 Oct 2009 20:13:40 +0100, "john" <nospam at (no spam) bt.com> wrote:
[quote:3731a2aa56]http://www.naturalnews.com/027205_vaccines_swine_flu_the_FDA.html
Urgent lawsuit filed against FDA to halt swine flu vaccines; claims FDA
violated federal law
[/quote:3731a2aa56]
That is bullshit.
--
Bettina Raddatz:
"Treu & Glauben, Hinter den Kulissen eines Wirtschaftsskandals"
http://www.ariplex.com/ama/ama_treu.htm |
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| Marcus Aurelius... |
| Posted: Fri Oct 09, 2009 2:39 pm |
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Guest
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Thank you for the original post. The following is the URL for the
Wikipedia article describing the requisites, by law, for "Clinical
Trials".
It appears to many health care providers that the procedures utilized
and approved by the FDA with regard to the Swine Flu vaccine did not
meet these requisites:
http://en.wikipedia.org/wiki/Clinical_trial |
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| Mark Probert... |
| Posted: Fri Oct 09, 2009 2:50 pm |
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Guest
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On Oct 9, 8:39 pm, Marcus Aurelius <alexander... at (no spam) hotmail.com> wrote:
[quote:ef717b0caa]Thank you for the original post. The following is the URL for the
Wikipedia article describing the requisites, by law, for "Clinical
Trials".
It appears to many health care providers that the procedures utilized
and approved by the FDA with regard to the Swine Flu vaccine did not
meet these requisites:
http://en.wikipedia.org/wiki/Clinical_trial
[/quote:ef717b0caa]
Key words: "it appears", synonym for idle speculation. |
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| dr_jeff... |
| Posted: Sat Oct 10, 2009 6:07 am |
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Guest
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john wrote:
[quote:6441fde8a6]http://www.naturalnews.com/027205_vaccines_swine_flu_the_FDA.html
Urgent lawsuit filed against FDA to halt swine flu vaccines; claims FDA
violated federal law
Friday, October 09, 2009 by: Mike Adams, the Health Ranger, NaturalNews
Editor
(NaturalNews) Health freedom attorney Jim Turner is filing a lawsuit in
Washington D.C. mid-day Friday in an urgent effort to halt the distribution
of the swine flu vaccine in America.
[/quote:6441fde8a6]
What health freedom? No one is being forced to get the vaccine.
Jeff |
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| Mark Probert... |
| Posted: Sat Oct 10, 2009 3:53 pm |
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Guest
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On Oct 10, 8:07 am, dr_jeff <u... at (no spam) msu.edu> wrote:
[quote:5a6f671086]john wrote:
http://www.naturalnews.com/027205_vaccines_swine_flu_the_FDA.html
Urgent lawsuit filed against FDA to halt swine flu vaccines; claims FDA
violated federal law
Friday, October 09, 2009 by: Mike Adams, the Health Ranger, NaturalNews
Editor
(NaturalNews) Health freedom attorney Jim Turner is filing a lawsuit in
Washington D.C. mid-day Friday in an urgent effort to halt the distribution
of the swine flu vaccine in America.
What health freedom? No one is being forced to get the vaccine.
[/quote:5a6f671086]
In NY there is a *requirement* that health care workers be vaccinated
against the swine flu. This is consistent with the requirements for
Measles nd rebella, amongst other things. |
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| Jan Drew... |
| Posted: Sat Oct 10, 2009 6:50 pm |
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Guest
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Happy Oyster <happy.oys... at (no spam) ariplex.com>
Has OCD with the words Bullshit, and This is a lie. |
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| Jan Drew... |
| Posted: Sat Oct 10, 2009 6:52 pm |
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Guest
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On Oct 9, 4:33�pm, Mark Probert <mark.prob... at (no spam) gmail.com> wrote:
[quote:b5ce6fff09]On Oct 9, 3:13�pm, "john" <nos... at (no spam) bt.com> wrote:
[/quote:b5ce6fff09]
http://www.naturalnews.com/027205_vaccines_swine_flu_the_FDA.html
Urgent lawsuit filed against FDA to halt swine flu vaccines; claims
FDA
violated federal law
Friday, October 09, 2009 by: Mike Adams, the Health Ranger,
NaturalNews
Editor
(NaturalNews) Health freedom attorney Jim Turner is filing a lawsuit
in
Washington D.C. mid-day Friday in an urgent effort to halt the
distribution
of the swine flu vaccine in America. On behalf of plaintiffs Dr. Gary
Null
and other licensed health care workers of New York State, the lawsuit
charges that the FDA violated the law in its hasty approval of four
swine
flu vaccines by failing to scientifically determine neither the safety
nor
efficacy of the vaccines.
"The suit will seek an injunction against the FDA from approving the
vaccine," attorney Jim Turner told NaturalNews on Thursday evening's
Natural
News Talk Hour show. "And the core of the argument is that they have
not
done the proper safety and efficacy tests on the vaccine to allow it
to be
release at this time."
The suit seeks to not only nullify the FDA's unlawful "approval" of
the four
H1N1 influenza vaccines, but to also ask the court to issue an
injunction
that would halt any mandatory vaccination requirements.
"The FDA is required by law to establish that a vaccine is safe and
effective before it can be given to the public," said Turner. "We are
arguing that they did not establish that the vaccine was effective,
and did
not establish that it was safe. They are trying to get it on the
market by a
waiver."
Vaccine / adjuvant combination has never been properly tested
The vaccine / adjuvant combination being referred to as the "swine
flu
vaccine" has apparently never been safety tested or approved by the
FDA. In
fact, in many cases the vaccine is being sent to clinics, pharmacies
and
other health establishments separately from the adjuvant chemical,
leaving
it up to each local vaccine retailer to properly mix the vaccine with
the
adjuvant, according to information provided by Turner. With hundreds
of
millions of Americans potentially being targeted with this vaccine,
the
potential for improper mixing, improper dosages, and human error is
alarming.
If the charges described in the lawsuit are true, it means the FDA
has
blatantly abandoned medical science and violated its own regulations
in
approving not only these four vaccines, but the potentially deadly
adjuvant
chemicals as well. To date, the FDA has produced absolutely no
scientific
evidence documenting safety tests for any of these swine flu vaccines.
There
are no published studies, no records of any clinical trials, and no
publicly-available paper trail demonstrating that any safety testing
was
done whatsoever. There is no researcher who has publicly put their
name on
the record declaring the vaccines to be safe, and no FDA official has
ever
stated that scientifically-valid safety testing has ever been
conducted on
the vaccine / adjuvant combinations now being distributed across
America.
Normally, when a pharmaceutical achieves "FDA approved" status, there
is a
considerable paper trail of scientific scrutiny, peer review,
clinical
trials and other supporting evidence. To our knowledge, no such
documents
exist for the swine flu vaccines. The FDA's approval of these
vaccines
appears to be based entirely on a whim.
"What has been tested?" asked attorney Jim turner. "Where has it been
tested? Who reviewed the test? Who looked at the test and said yes
they
proved safety and efficacy? There is no record that we can find that
shows
these things have been done."
By approving the four vaccines in the absence of such safety testing,
the
FDA itself stands in direct violation of federal law. "There is a law
that
they're supposed to follow and they are not following it," Turner
added.
Billions of dollars are at stake
Why, then, did the FDA apparently violate the law and push these
vaccines
into full public distribution without securing the safety testing
required
by law? Turner suspects a profit motive may be involved: "They're
charging
$24.95 to get a vaccine. Multiplied by 100 million people, that's a
lot of
money. If you do the whole society, you're talking about several
billion
dollars."
In fact, the U.S. vaccination push could ultimately target over 200
million
Americans, generating nearly $5 billion in vaccine-related revenues.
Cashing
in on those revenues, however, requires three things:
1) Spreading fear about H1N1 swine flu by exaggerating its dangers.
2) Quickly making a vaccine available for sale, even if it has never
been
thoroughly tested for safety and efficacy.
3) Aggressively marketing the vaccines before the H1N1 swine flu
fizzles out
and can no longer be hyped up as "highly virulent."
All three of these conditions are now being pushed aggressively in the
U.S.
by pharma-influenced health authorities at both the state and federal
level.
There is a mad, cult-like rush under way to vaccinate American
citizens with
an unproven, untested chemical that was thrust into distribution in
apparent
violation of federal law. And if this vaccine is not stopped, the
price that
may ultimately be paid in terms of lost lives could be quite dire.
It all harkens back to 1976 when a previous formulation of the swine
flu
vaccine paralyzed and killed thousands of Americans. Turner was one of
the
attorneys instrumental in halting that vaccine, and he fears a repeat
situation could potentially recur today. He told NaturalNews, "[In
1976]
they were intending to inoculate 200 million people. We stopped
them... and
somewhere between 40 and 50 million people were vaccinated. What
ultimately
brought it down is that a substantial number of people got 'French
Polio'
[Guillain-Barre syndrome], a paralysis that goes... through the body,
and if
it goes far enough you die."
About health freedom attorney Jim Turner
Jim Turner, with Citizens for Health (www.Citizens.org), is one of the
most
accomplished and respected health freedom attorneys practicing today.
His
firm, Swankin & Turner, represents businesses and individuals on a
variety
of regulatory issues relating to foods, drugs and health.
Donations to support this swine flu vaccine lawsuit are greatly
welcomed.
You can donate to Citizens.org on this page:
http://www.citizens.org/?page_id=20
A special fund specifically focused on the swine flu vaccine lawsuit
will be
announced here on NaturalNews. Watch this story for an update. |
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| pautrey2... |
| Posted: Sun Oct 11, 2009 1:32 pm |
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Guest
|
On Oct 11, 4:41 pm, Happy Oyster <happy.oys... at (no spam) ariplex.com> wrote:
[quote:f98201f3fd]On Sat, 10 Oct 2009 21:50:51 -0700 (PDT), Jan Drew <jdrew63... at (no spam) aol.com> wrote:
Happy Oyster <happy.oys... at (no spam) ariplex.com
Has OCD with the words Bullshit, and This is a lie.
Jan Drew, like Ralph Paul Autrey, Jr., is a Net stalker, and obsessed. Well, to
take care of them is the job of the attorneys of state.
Here is some more interesting stuff to read:
[/quote:f98201f3fd]
<snip>
Delusion
http://en.wikipedia.org/wiki/Delusion
A delusion, in everyday language, is a fixed belief that is either
false, fanciful, or derived from deception. Psychiatry defines the
term more specifically as a belief that is pathological (the result of
an illness or illness process). As a pathology, it is distinct from a
belief based on false or incomplete information, apperception,
illusion, or other effects of perception.
Delusions typically occur in the context of neurological or mental
illness, although they are not tied to any particular disease and have
been found to occur in the context of many pathological states (both
physical and mental). However, they are of particular diagnostic
importance in psychotic disorders and particularly in schizophrenia,
paraphrenia, manic episodes of bipolar disorder, and psychotic
depression.
On Oct 11, 4:41 pm, Happy Oyster <happy.oys... at (no spam) ariplex.com> wrote:
[quote:f98201f3fd]On Sat, 10 Oct 2009 21:50:51 -0700 (PDT), Jan Drew <jdrew63... at (no spam) aol.com> wrote:
Happy Oyster <happy.oys... at (no spam) ariplex.com
Has OCD with the words Bullshit, and This is a lie.
Jan Drew, like Ralph Paul Autrey, Jr., is a Net stalker, and obsessed. Well, to
take care of them is the job of the attorneys of state.
Here is some more interesting stuff to read:
http://www.transgallaxys.com/~kanzlerzwo/showtopic.php?threadid=4698
quote
Neuer Wirkstoff gegen metastasierten Brustkrebs
000
03.12.2008, 18:07 Uhr
ama
Administrator
[*QUOTE*]
--------------------------------------------------------------------------
Nixons Erben - Krieg gegen den Krebs
------------------------------------
Im Kampf gegen Krebs steht Ärzten seit geraumer Zeit eine ganze Reihe
neuartiger Wirkstoffe zur Verfügung - doch nicht jeder Mediziner weiß,
wann, und unter welchen Bedingungen die Mittel eigentlich wirken.
von Vlad Georgescu
http://news.doccheck.com/de/article/150242-nixons-erben-krieg-gegen-d...
Arzneimittel-Fabrik im Kopf
---------------------------
Neurochirurgen in Hannover möchten Schlaganfall- Patienten künftig mit
Stammzellen helfen. Die genetisch veränderten Zellen werden in einer Art
Teebeutel in das geschädigte Gehirn transplantiert und sollen dort
entzündungshemmend wirken.
http://news.doccheck.com/de/article/150542-arzneimittel-fabrik-im-kopf/
Wegweiser für Herzmuskel-Therapie
----------------------------------
Herzinsuffizienz ist eine der häufigsten Todesursachen unserer Gesellschaft.
Ein Forscherteam zeigt nun erstmals einen Weg auf, wie man Herzschäden
vermeiden oder sogar heilen könnte, in dem man die Aktivität kleinster
RNA-Moleküle, so genannter microRNAs, reguliert.
http://news.doccheck.com/de/article/150582-wegweiser-fuer-herzmuskel-...
Hightech statt Tierversuch
--------------------------
Mit einem 3-D-Biochip ist der Lehrstuhl "Molekularbiologisch-biochemische
Prozesstechnik" von Prof. Andrea Robitzki an der Uni Leipzig zum "Ausgewählten
Ort im Land der Ideen" gekürt worden. Der Chip könnte die Anzahl von
Tierversuchen drastisch senken.
http://news.doccheck.com/de/article/150602-hightech-statt-tierversuch/
Neuer Wirkstoff gegen metastasierten Brustkrebs
-----------------------------------------------
Proteinkinasen befinden sich im Fadenkreuz der modernen Krebsforschung. Seit man
weiß, dass die Eiweißmoleküle bei der Tumorentwicklung eine Rolle spielen,
versucht man, Wirkstoffe zu finden, die überaktive Proteinkinasen hemmen und
damit Krebszellen am Wachstum hindern. Einer dieser Wirkstoffe wird nun im
Rahmen einer weltweiten Phase III Studie an der Klinik für Tumorbiologie in
Freiburg geprüft.
http://news.doccheck.com/de/article/150562-neuer-wirkstoff-gegen-meta...
--------------------------------------------------------------------------
[*/QUOTE*]
.
--
Micha stirbt
"eine sinnvolle Maßnahme der Natur"
------------------------------------------------------------------------------------------------------------
megastark:http://www.thestupiditburns.com***http://www.kindergalaxis.com
/quote
--
Bloomington, Indiana, and it's silent moments...http://www.noir-blanc.com/francais/photographie/boule_12.htm[/quote:f98201f3fd] |
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| Mark Probert... |
| Posted: Sun Oct 11, 2009 1:43 pm |
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Guest
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On Oct 11, 12:52 am, Jan Drew <jdrew63... at (no spam) aol.com> wrote:
[quote:e71bde1004]On Oct 9, 4:33 pm, Mark Probert <mark.prob... at (no spam) gmail.com> wrote:
[/quote:e71bde1004]
I never posted that drivel. |
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| Happy Oyster... |
| Posted: Sun Oct 11, 2009 1:50 pm |
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Guest
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On Sat, 10 Oct 2009 21:52:57 -0700 (PDT), Jan Drew <jdrew63929 at (no spam) aol.com> wrote:
[quote:2ee0852437]"The FDA is required by law
[/quote:2ee0852437]
And so this is a warning letter:
<quote>
Cheerio, my dear bread! The FDA punches cereal fraudvertizing
[*QUOTE*]
--------------------------------------
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA
Department of Health and Human Services
Public Health Service
Food and Drug Administration
Minneapolis District Office
Central Region
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 758-7114
FAX: (612) 3344142
May 5,2009
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Refer to MIN 09 -18
Ken Powell
Chairman of the Board and CEO
General Mills
One General Mills Boulevard
Minneapolis, Minnesota 55426
Dear Mr. Powell:
The Food and Drug Administration (FDA) has reviewed the label and labeling of
your Cheerios® Toasted Whole Grain Oat Cereal. FDA's review found serious
violations of the Federal Food, Drug, and Cosmetic Act (the Act) and the
applicable regulations in Title 21, Code of Federal Regulations (21 CFR). You
can find copies of the Act and these regulations through links in FDA's home
page at http://www.fda.gov.
Unapproved New Drug
Based on claims made on your product's label, we have determined that your
Cheerios® Toasted Whole Grain Oat Cereal is promoted for conditions that cause
it to be a drug because the product is intended for use in the prevention,
mitigation, and treatment of disease. Specifically, your Cheerios® product bears
the following claims ort its label:
• "you can Lower Your Cholesterol 4% in 6 weeks" "
• "Did you know that in just 6 weeks Cheerios can reduce bad cholesterol by an
average of 4 percent? Cheerios is ... clinically proven to lower cholesterol. A
clinical study showed that eating two 1 1/2 cup servings daily of Cheerios
cereal reduced bad cholesterol when eaten as part of a diet low in saturated fat
and cholesterol."
These claims indicate that Cheerios® is intended for use in lowering
cholesterol, and therefore in preventing, mitigating, and treating the disease
hypercholesterolemia. Additionally, the claims indicate that Cheerios® is
intended for use in the treatment, mitigation, and prevention of coronary heart
disease through, lowering total and "bad" (LDL) cholesterol. Elevated levels of
total and LDL cholesterol are a risk factor for coronary heart disease and can
be a sign of coronary heart disease. Because of these intended uses, the product
is a drug within the meaning of section 201(g)(1)(B) of the Act [21 U.S.C. § 321
(g)P)(B)]. The product is also a new drug under section 201(p) of the Act [21
U.S.C. § 321(p)] because it is not generally recognized as safe and effective
for use in preventing or treating hypercholesterolemia or coronary heart
disease. Therefore,under section 505(a) of the Act [21 U.S.C. § 355(a)], it may
not be legally marketed with the above claims in the United States without an
approved new drug application.
FDA has issued a regulation authorizing a health claim associating soluble fiber
from whole grain oats with a reduced risk of coronary heart disease (21 CFR
101.81). Like FDA's other regulations authorizing health Claims about a food
substance and reduced risk of coronary heart disease, this regulation provides
for the claim to include an optional statement, as part of the health claim,
that the substance reduces the risk of coronary heart disease through the
intermediate link of lowering blood total and LDL cholesterol. See 21 CFR
101.81(d)(2),-(3). Although the lower left corner of the Cheerios® front label
contains a soluble fiber/coronary heart disease health claim authorized under 21
CFR 101.81, the two claims about lowering cholesterol are not made as part of
that claim but rather are presented as separate, stand-alone claims through
their location on the package and other label design features. The cholesterol
claim that mentions the clinical study is on the back of the Cheerios® box,
completely separate from the health claim on the front label. Although the other
cholesterol claim is on the same panel as the authorized health claim, its
prominent placement on a banner in the center of the front label, together with
its much larger font size, different background, and other text effects, clearly
distinguish it from the health claim in the lower left corner.
Additionally, even if the cholesterol-lowering claims were part of an otherwise
permissible claim, under 21 CFR 101.81, the resulting claim language still would
not qualify for the use of the soluble fiber health claim. To use the soluble
fiber health claim, a product must comply with the claim specific requirements
in 21 CFR 101.81, including the requirement that the claim not attribute any
degree of risk reduction for coronary heart disease to diets that include foods
eligible to bear the claim. See 21 CFR 101.81(c)(2)(E). However, the label of
your Cheerios® cereal claims a degree of risk reduction for coronary heart
disease by stating that Cheerios® can lower cholesterol by four percent in six
weeks. High blood total and LDL cholesterol levels are a surrogate endpoint for
coronary heart disease; therefore, the cholesterol-lowering claims on the
Cheerios® label attribute a degree of risk reduction for coronary heart disease
because if total and LDL cholesterol levels decline, the risk of coronary heart
disease declines as well.
Misbranded Food:
Your Cheerios ® product is misbranded within the meaning of section 403(r)(1)(B)
of the Act [21 U.S.C. § 343(r)(1)(B)] because it bears unauthorized health
claims in its labeling. We have determined that your website
www.wholegrainnation.com is labeling for your Cheerios® product under section
201(m) of the Act [21 U.S.C. § 321 (m)] because the website address appears on
the product label. This website bears the following unauthorized health claims:
"Heart-healthy diets rich in whole grain foods, can reduce the risk of heart
disease."
This health claims misbrands your product because it has been authorized either
by regulation [see section 343(r)(3)(A)-(B) of the Act [21 U.S.C. §
343(r)(3)(A)(B)]] or under authority of the health claim notificati6n provision
of the Act [see section'343(r)(3)(C) of the Act [21 U.S.C. § 343(r)(3)(G)]].
Although FDA has issued a regulation authorizing a health claim associating
fiber-containing grain products with a reduced risk of coronary heart disease
(21 CFR 101.77), the claim on your website does not meet the requirements for
this claim. For example, under section 101.77(c)(2), the claim must state that
diets low in saturated fat and cholesterol and high in fiber-containing fruit,
vegetable, and grain products may reduce the risk of heart disease. The claim on
your website leaves out any reference to fruits and vegetables, to fiber
content, and to keeping the levels of saturated fat and cholesterol in the diet
low. Therefore, your claim does not convey that all these factors together help
to reduce the risk of heart disease and does not enable the public to understand
the significance of the claim in the context of the total daily diet (see
section 343(r)(3)(B)(iii) of the Act [21 U.S.C.§ 343(r)(3)(B)(iiill].
In addition to the health claim authorized by regulation in 21 CFR 101.77, other
health claims linking the consumption of whole grain foods to a reduced risk of
heart disease have been authorized through the notification procedure in section
403(r)(3)(C) of the Act. Of those authorized claims, the one closest to the
claim on your website states: "Diets rich in whole grain foods and other plant
foods, and low in saturated fat and cholesterol, may help reduce the risk of
heart disease.1" Although the claim on your website also concerns whole grains
and reduced risk of heart disease, it is different from the authorized claim in
significant ways. To meet the requirements of the authorized claim, the claim
must state that diets that are (1) rich in Whole grains and other plant foods,
and (2) low in saturated fat and cholesterol will help reduce the risk of heart
disease) Instead, the claim on your website only states that diets rich in whole
grains can reduce the risk of heart disease, with no mention of other plant
foods or of low saturated fat and cholesterol.
"Including whole grain as part of a healthy diet may ... [h]elp reduce the risk
of certain types of cancers. Regular consumption of whole grains as part of, a
low-fat diet reduces the risk for some cancers, especially cancers of the
stomach and colon."
This health claim misbrands your product because it has not been authorized
either by regulation [see section 343(r)(3)(A)-(B) of the Act [21 U.S.C. §
343(r)(3)(A)(B)]] or under authority of the health claim notification provision
of the Act [see section 343(r)(3)(C) of the Act [21 U.S.C. § 343(r)(3)(C)]].
Although FDA has issued a regulation authorizing a health claim associating
fiber-containing grain products with a reduced risk of cancer (21 CFR 101.76),
the claim on your website does not meet the requirements for the authorized
claim.For example, under section 101.76(c)(2) the claim must state that diets
high in fiber-containing grain products, fruits, and vegetables may reduce the
risk of some cancers. The claim on your website leaves out any reference to
fruits, vegetables, and fiber content. Therefore, your claim does not convey
that all these factors together help to reduce the risk of heart disease and
does not enable the public to understand the significance of the claim in the
context of the total daily diet [see section 343(r)(3)(B)(iii) of the Act [21
U.S.C. § 343(r)(3)(B)(iii)]].
In addition to the health claim authorized by regulation in 21 CFR 101.76, a
health claim linking the consumption of whole grain foods to a reduced risk of
certain cancers has been authorized through the notification procedure in
section 403(r)(3)(C) of the Act. The authorized claim is: "Diets rich in whole
grain foods and other plant foods ... may help reduce the risk of... certain
cancers."2 Although the claim on your website also concerns whole grains and
reduced risk of some cancers, it is different from the authorized claim in
significant ways. For example, the authorized claim states that diets rich in
whole grain foods and "other plant foods" may help reduce the risk for certain
cancers. However,the claim on your website does not mention "other plant foods."
Also, by using the language "especially cancers of the stomach and colon" the
claim on your website emphasizes the relationship between whole grain foods and
stomach and colon cancers as compared to other cancers, suggesting a greater
degree of risk reduction or stronger evidence for the relationship between whole
grain foods and risk of those two cancers. The claim authorized through the
notification procedure does not emphasize the relationship between whole grain
foods and stomach and colon cancer as compared to other cancers.
This letter is not intended to be an all-inclusive review of your products and
their labeling. It is your responsibility to ensure that all of your products
are in compliance with the Act and its implementing regulations.
Failure to promptly correct the violations specified above may result in
enforcement action without further notice. Enforcement action may include
seizure of violative products and/or injunction against the manufacturers and
distributors of violative products.
Please advise this office in writing 15 days from your receipt of this letter of
the specific steps you have taken to correct the violations noted above and to
ensure that similar violations do not occur. Your response should include any
documentation necessary to show that correction has been achieved. If you cannot
complete all corrections before you respond, state the reason for the delay and
the date by which you will complete the corrections.
Please send your reply to the attention of Tyra S. Wisecup, Compliance Officer,
at the address in the letterhead. If you have any questions regarding this
letter, please contact Ms. Wisecup at (612) 758-7114.
Sincerely,
/s/
W. Charles Becoat
Director
Minneapolis District
TSW/cd
1 See "Health Claim Notification for Whole Grain Foods with Moderate Fat
Content," December 9, 2003 (http://www.cfsan.fda.gov/~dms/f1grain2.html).
2 See "Health Claim Notification for Whole Grain Foods," July 1999
(http://www.cfsan.fda.gov/-dms/flgrain2.html).
FOIA Home Page | Most Recent Warning Letters
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | Privacy |
Accessibility
FDA/Freedom of Information
--------------------------------------
[*/QUOTE*]
--
Bloomington, Indiana, and it's silent moments...
http://www.noir-blanc.com/francais/photographie/boule_12.htm |
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| pautrey2... |
| Posted: Sun Oct 11, 2009 3:36 pm |
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Guest
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....is a Net stalker, and obsessed. Well, to take care of them is the
job of the attorneys of state.(http://en.wikipedia.org/wiki/Delusion)
Pot calling the kettle black?
http://en.wikipedia.org/wiki/Pot_calling_the_kettle_black
Delusion
http://en.wikipedia.org/wiki/Delusion
A delusion, in everyday language, is a fixed belief that is either
false, fanciful, or derived from deception. Psychiatry defines the
term more specifically as a belief that is pathological (the result
of
an illness or illness process). As a pathology, it is distinct from a
belief based on false or incomplete information, apperception,
illusion, or other effects of perception.
Delusions typically occur in the context of neurological or mental
illness, although they are not tied to any particular disease and
have
been found to occur in the context of many pathological states (both
physical and mental). However, they are of particular diagnostic
importance in psychotic disorders and particularly in schizophrenia,
paraphrenia, manic episodes of bipolar disorder, and psychotic
depression.
On Oct 11, 6:32 pm, pautrey2 <pautr... at (no spam) gmail.com> wrote:
[quote:318fec0c22]On Oct 11, 4:41 pm, Happy Oyster <happy.oys... at (no spam) ariplex.com> wrote:
On Sat, 10 Oct 2009 21:50:51 -0700 (PDT), Jan Drew <jdrew63... at (no spam) aol.com> wrote:
Happy Oyster <happy.oys... at (no spam) ariplex.com
Has OCD with the words Bullshit, and This is a lie.
Jan Drew, like Ralph Paul Autrey, Jr., is a Net stalker, and obsessed. Well, to
take care of them is the job of the attorneys of state.
Here is some more interesting stuff to read:
snip
Delusionhttp://en.wikipedia.org/wiki/Delusion
A delusion, in everyday language, is a fixed belief that is either
false, fanciful, or derived from deception. Psychiatry defines the
term more specifically as a belief that is pathological (the result of
an illness or illness process). As a pathology, it is distinct from a
belief based on false or incomplete information, apperception,
illusion, or other effects of perception.
Delusions typically occur in the context of neurological or mental
illness, although they are not tied to any particular disease and have
been found to occur in the context of many pathological states (both
physical and mental). However, they are of particular diagnostic
importance in psychotic disorders and particularly in schizophrenia,
paraphrenia, manic episodes of bipolar disorder, and psychotic
depression.
On Oct 11, 4:41 pm, Happy Oyster <happy.oys... at (no spam) ariplex.com> wrote:
On Sat, 10 Oct 2009 21:50:51 -0700 (PDT), Jan Drew <jdrew63... at (no spam) aol.com> wrote:
Happy Oyster <happy.oys... at (no spam) ariplex.com
Has OCD with the words Bullshit, and This is a lie.
Jan Drew, like Ralph Paul Autrey, Jr., is a Net stalker, and obsessed. Well, to
take care of them is the job of the attorneys of state.
Here is some more interesting stuff to read:
http://www.transgallaxys.com/~kanzlerzwo/showtopic.php?threadid=4698
quote
Neuer Wirkstoff gegen metastasierten Brustkrebs
000
03.12.2008, 18:07 Uhr
ama
Administrator
[*QUOTE*]
--------------------------------------------------------------------------
Nixons Erben - Krieg gegen den Krebs
------------------------------------
Im Kampf gegen Krebs steht Ärzten seit geraumer Zeit eine ganze Reihe
neuartiger Wirkstoffe zur Verfügung - doch nicht jeder Mediziner weiß,
wann, und unter welchen Bedingungen die Mittel eigentlich wirken.
von Vlad Georgescu
http://news.doccheck.com/de/article/150242-nixons-erben-krieg-gegen-d...
Arzneimittel-Fabrik im Kopf
---------------------------
Neurochirurgen in Hannover möchten Schlaganfall- Patienten künftig mit
Stammzellen helfen. Die genetisch veränderten Zellen werden in einer Art
Teebeutel in das geschädigte Gehirn transplantiert und sollen dort
entzündungshemmend wirken.
http://news.doccheck.com/de/article/150542-arzneimittel-fabrik-im-kopf/
Wegweiser für Herzmuskel-Therapie
----------------------------------
Herzinsuffizienz ist eine der häufigsten Todesursachen unserer Gesellschaft.
Ein Forscherteam zeigt nun erstmals einen Weg auf, wie man Herzschäden
vermeiden oder sogar heilen könnte, in dem man die Aktivität kleinster
RNA-Moleküle, so genannter microRNAs, reguliert.
http://news.doccheck.com/de/article/150582-wegweiser-fuer-herzmuskel-...
Hightech statt Tierversuch
--------------------------
Mit einem 3-D-Biochip ist der Lehrstuhl "Molekularbiologisch-biochemische
Prozesstechnik" von Prof. Andrea Robitzki an der Uni Leipzig zum "Ausgewählten
Ort im Land der Ideen" gekürt worden. Der Chip könnte die Anzahl von
Tierversuchen drastisch senken.
http://news.doccheck.com/de/article/150602-hightech-statt-tierversuch/
Neuer Wirkstoff gegen metastasierten Brustkrebs
-----------------------------------------------
Proteinkinasen befinden sich im Fadenkreuz der modernen Krebsforschung. Seit man
weiß, dass die Eiweißmoleküle bei der Tumorentwicklung eine Rolle spielen,
versucht man, Wirkstoffe zu finden, die überaktive Proteinkinasen hemmen und
damit Krebszellen am Wachstum hindern. Einer dieser Wirkstoffe wird nun im
Rahmen einer weltweiten Phase III Studie an der Klinik für Tumorbiologie in
Freiburg geprüft.
http://news.doccheck.com/de/article/150562-neuer-wirkstoff-gegen-meta...
--------------------------------------------------------------------------
[*/QUOTE*]
.
--
Micha stirbt
"eine sinnvolle Maßnahme der Natur"
------------------------------------------------------------------------------------------------------------
megastark:http://www.thestupiditburns.com***http://www.kindergalaxis.com
/quote
--
Bloomington, Indiana, and it's silent moments...http://www.noir-blanc.com/francais/photographie/boule_12.htm- Hide quoted text -
- Show quoted text -[/quote:318fec0c22] |
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| Happy Oyster... |
| Posted: Sun Oct 11, 2009 3:41 pm |
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Guest
|
On Sat, 10 Oct 2009 21:50:51 -0700 (PDT), Jan Drew <jdrew63929 at (no spam) aol.com> wrote:
[quote:a43c5da324]Happy Oyster <happy.oys... at (no spam) ariplex.com
Has OCD with the words Bullshit, and This is a lie.
[/quote:a43c5da324]
Jan Drew, like Ralph Paul Autrey, Jr., is a Net stalker, and obsessed. Well, to
take care of them is the job of the attorneys of state.
Here is some more interesting stuff to read:
http://www.transgallaxys.com/~kanzlerzwo/showtopic.php?threadid=4698
<quote>
Neuer Wirkstoff gegen metastasierten Brustkrebs
000
03.12.2008, 18:07 Uhr
ama
Administrator
[*QUOTE*]
--------------------------------------------------------------------------
Nixons Erben - Krieg gegen den Krebs
------------------------------------
Im Kampf gegen Krebs steht Ärzten seit geraumer Zeit eine ganze Reihe
neuartiger Wirkstoffe zur Verfügung - doch nicht jeder Mediziner weiß,
wann, und unter welchen Bedingungen die Mittel eigentlich wirken.
von Vlad Georgescu
http://news.doccheck.com/de/article/150242-nixons-erben-krieg-gegen-den-krebs/
Arzneimittel-Fabrik im Kopf
---------------------------
Neurochirurgen in Hannover möchten Schlaganfall- Patienten künftig mit
Stammzellen helfen. Die genetisch veränderten Zellen werden in einer Art
Teebeutel in das geschädigte Gehirn transplantiert und sollen dort
entzündungshemmend wirken.
http://news.doccheck.com/de/article/150542-arzneimittel-fabrik-im-kopf/
Wegweiser für Herzmuskel-Therapie
----------------------------------
Herzinsuffizienz ist eine der häufigsten Todesursachen unserer Gesellschaft.
Ein Forscherteam zeigt nun erstmals einen Weg auf, wie man Herzschäden
vermeiden oder sogar heilen könnte, in dem man die Aktivität kleinster
RNA-Moleküle, so genannter microRNAs, reguliert.
http://news.doccheck.com/de/article/150582-wegweiser-fuer-herzmuskel-therapie/
Hightech statt Tierversuch
--------------------------
Mit einem 3-D-Biochip ist der Lehrstuhl "Molekularbiologisch-biochemische
Prozesstechnik" von Prof. Andrea Robitzki an der Uni Leipzig zum "Ausgewählten
Ort im Land der Ideen" gekürt worden. Der Chip könnte die Anzahl von
Tierversuchen drastisch senken.
http://news.doccheck.com/de/article/150602-hightech-statt-tierversuch/
Neuer Wirkstoff gegen metastasierten Brustkrebs
-----------------------------------------------
Proteinkinasen befinden sich im Fadenkreuz der modernen Krebsforschung. Seit man
weiß, dass die Eiweißmoleküle bei der Tumorentwicklung eine Rolle spielen,
versucht man, Wirkstoffe zu finden, die überaktive Proteinkinasen hemmen und
damit Krebszellen am Wachstum hindern. Einer dieser Wirkstoffe wird nun im
Rahmen einer weltweiten Phase III Studie an der Klinik für Tumorbiologie in
Freiburg geprüft.
http://news.doccheck.com/de/article/150562-neuer-wirkstoff-gegen-metastasierten-brustkrebs/
--------------------------------------------------------------------------
[*/QUOTE*]
..
--
Micha stirbt
"eine sinnvolle Maßnahme der Natur"
------------------------------------------------------------------------------------------------------------
megastark: http://www.thestupiditburns.com *** http://www.kindergalaxis.com
</quote>
--
Bloomington, Indiana, and it's silent moments...
http://www.noir-blanc.com/francais/photographie/boule_12.htm |
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| pautrey2... |
| Posted: Sun Oct 11, 2009 3:42 pm |
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Guest
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Yawn!
You can dish it out,
but you can't take it.
Image Of The Beast (Aribert Deckers, AKA Yappy R. Oyster):
http://www.collectiondx.com/gallery2/gallery/d/53247-5/1.jpg
On Oct 11, 8:39 pm, Happy Oyster <happy.oys... at (no spam) ariplex.com> wrote:
[quote:f57901da93]On Sun, 11 Oct 2009 18:36:50 -0700 (PDT), pautrey2 <pautr... at (no spam) gmail.com> wrote:
Headline: "Re: ...is a Net stalker, and obsessed. Well, to take care of them is
the job of the attorneys of state.(http://en.wikipedia.org/wiki/Delusion) - Mr.
Oyster?"
...is a Net stalker, and obsessed. Well, to take care of them is the
job of the attorneys of state.(http://en.wikipedia.org/wiki/Delusion)
Pot calling the kettle black?
I told Ralph Paul Autrey, Jr. to cease and desist with his stalking other users.
Now I do it again:
Ralph Paul Autrey, Jr., do cease and desist with your stalking other users!
***************************************************************************
Nobody can say that I did not warn him. He has to bear the consequences of his
crime. It is as simple as that.
.
--
Interview mit dem Autor der "Reimbibel"
Kultur und Wissen
Auslöser war der Besuch von Benedikt XVI. in Auschwitz-Birkenauhttp://www.nrhz.de/flyer/beitrag.php?id=14183[/quote:f57901da93] |
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