Natural Solutions Foundation
www.HealthFreedomUSA.org
Media Release
07/16/10 Update: New NO FLU VAX Action Item:
http://salsa.democracyinaction.org/o/568/p/dia/action/public/?action_KEY=4376
07/13/10 Update: FDA Email Interchange: we will NOT withdraw our Petition!
02/17/10 Update: FDA Delays Response to Petition: What pandemic emergency?
http://drrimatruthreports.com/?p=4722
09/04/09 Update: Funding the “Stop the Shot” TRO
http://drrimatruthreports.com/?p=3452
Action Items:
Action item to Support the Citizens Petition, Individuals Sign Here:
http://salsa.democracyinaction.org/o/568/campaign.jsp?campaign_KEY=27791
Action item to Support the Citizens Petition, Organizations Sign Here:
http://salsa.democracyinaction.org/o/568/campaign.jsp?campaign_KEY=27793
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Media Release of August 31, 2009
“After holding emergency petition from doctors & health freedom groups for nearly 2 weeks, FDA today issued docket number… Petition demands no “Swine Flu” H1N1 Vaccine approval without safety testing…”
Washington, August 31, 2009 – Prominent natural health personality Gary Null PhD, joined by renowned doctors such as Rima E. Laibow MD and Tedd Koren DC, along with NGOs (nongovernmental organizations) including Natural Solutions Foundation, Foundation for Health Choice and the Institute for Health Research, submitted an emergency Citizens Petition to the Food and Drug Administration (FDA) on August 17, 2009. Because the public health issues are so serious, the Petition demands an immediate Stay of any government approval of the “Swine Flu” H1N1 Vaccine without safety testing.
The Petitioners further demanded strict warnings regarding the potential dangers of this uninsurable, untested and unproven vaccine which contains dangerous adjuvants such as Mercury, Aluminum and Sqaulene, a substance whose toxicity when injected is well known and which has never before been approved for use in the United States. Injected squalene, in fact, has been denied clinical tests in the US because the FDA reviewers felt that it was too toxic even for testing as part of a vaccine.
After sitting on the emergency Petition for nearly two weeks, FDA today issued a docket number, accepting the filing both under 21 CFR 10.30 (Citizen Petition) and 21 CFR 10.35 (Stay of Action). The Docket Number is FDA-2009-P-0418.
Citizens’ Petitions are grounded in the First Amendment Right to Petition the government for redress of grievances. The Administrative Procedures Act and various agency regulations provide formats for Citizen Petitions and many Agency regulatory actions are initiated as a result of such petitions.
Several legal actions have been brought in Federal Court in various states by concerned citizens over the past few weeks, seeking to enjoin forced vaccinations with the untested H1N1 pandemic vaccines. Last week one federal judge denied a bid for a temporary restraining order, but giving the plaintiffs two weeks to submit further evidence of potential harm. Other pending legal actions are awaiting hearings.
These other actions, while meritorious, have serious legal flaws which the current Citizens Petition avoids, increasing its chance of success. Taking the initial step of engaging the Agency through a Citizens Petition instead of immediately seeking judicial intervention, as the Petitioners here have done, meets the requirement of Federal Law that Petitioners must “exhaust administrative remedies” before seeking relief in Court. While accepting the filing under the “Stay of Action” regulation, the FDA has indicated that it will not treat the application as an “emergency” which permits the agency to take 180 days to respond, well beyond the targeted time frame for the implementation of widespread vaccination with the untested vaccine, either through compulsory or voluntary vaccination. The Petition asks that no vaccine be approved without adequate safety testing. On July 23, 2009, FDA announced its intent to approve pandemic H1N1 vaccine in the absence of any safety testing. Current tests are for dosage response and employ vaccines which lack squalene and other adjuvants, or immune irritants such as aluminum.
Maj. Gen. Albert N. Stubblebine (US Army, Ret.), President of Natural Solutions Foundation remarked, “The FDA just does not get it! Delaying public hearings and failing to take into consideration the considerable dangers of the untested pandemic vaccine shots is simply not acceptable. This is neither an example of “transparent government”, nor “change in which we can believe”. The Courts will have to determine if the FDA has the authority to act in this manner.”
The Citizens Petition will be posted at the government’s www.Regulations.gov web site within the next few days. In the meantime, a copy has been posted at www.HealthFreedomUSA.org/?p=3314
Ralph Fucetola JD, Counsel to the Natural Solutions Foundation and primary author of the Petition amplified General Stubblebine’s comments:
“For over one hundred years, since the case of Jacobson v Commonwealth, the Federal Courts have been available to challenge inappropriate FDA approval of dangerous drugs, including vaccines. We are confident that Federal judicial authority will tell the FDA that it cannot approve the vaccines without safety testing. No drug can be approved unless there is significant scientific agreement that the benefits outweigh the foreseeable risks. Without safety testing there can be no rational risk/benefit analysis.
“Remember the 1976 ‘Swine Flu’ vaccine fiasco and the near unleashing of a world-wide Avian Flu pandemic earlier this year by a drug company vaccine ‘accident.’ Unleashing an untested vaccine on the world is tantamount to engaging in a terrorist act that will result in just the pandemic the authorities claim they want to avoid.
“I know there are Federal Judges with the courage to stop this headlong rush to disaster. Unlike the FDA with its drug-company-employee revolving door policy, the Federal Courts are not afraid to confront failures of the Agency to adhere to the law. We will know in a few days if the Courts will ‘Stay the Shot’ since, in the words of the Supreme Court in the 1905 Jacobson case, ‘…if it be apparent or can be shown with reasonable certainty that … vaccination… would seriously impair …health or probably cause …death.’ the Courts will act.”
Dr. Rima E. Laibow, MD, the Natural Solutions Foundation’s Medical Director emphasized the seriousness of the dangers from the H1N1 vaccines:
“Never before has squalene been approved for use in a drug in the United States. But once before, when it was allowed in certain military vaccines, more than 60,000 soldiers were hospitalized because of being injected with it in a condition widely known as “Gulf War Syndrome”. A Federal Court, in 2004, forbade its involuntary use by United States troops (Doe v Rumsfeld, Civil Action No. 03-707 USDC for District of Columbia).
“This new vaccine has, literally, 1,000,000 times more squalene than that experimental military vaccine, known as “Vaccine A” had. The attempt to rush this dangerous vaccine into the bodies of the public without safety testing is a violation of US law, regulation and medial ethics and must be condemned.”
The Foundation and its allies promise further action to “Stop the Shot!” They urge all concerned persons to go to the following web page to register their support for the Citizens Petition: http://www.HealthFreedomUSA.org/?p=3312
Donations to support this action may be made at:
http://www.HealthFreedomUSA.org/?p=189
Natural Solutions Vaccine Portal:
http://www.HealthFreedomUSA.org/?p=3085
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Free-Press-Release.com link:
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We will NOT Withdraw our Petition!
Date: Tue, 13 Jul 2010 10:15:45 AM EDT
From: Ralph Fucetola
To: [redacted]@fda.hhs.gov>
Subject: Citizens Petition: FDA Docket No. FDA-2009-P-0418
Dear Mr. [redacted],
Further to my communication of June 30, 2010, resubmitted below, the noted Citizens Petition is not withdrawn. The National Health Emergency as declared by the office of the President remains in effect; the “novel” H1N1 infective material is being admixed into the annual seasonal influenza vaccination without separate, independent safety testing, allowed by the agency.
This email is submitted in supplementation of the Citizens Petition.
Sincerely,
Ralph Fucetola JD
All rights, public and private, reserved …
—— Original Message ——
Received: Wed, 30 Jun 2010 08:04:11 PM EDT
From: Ralph Fucetola
To: [redacted]
Subject: Citizens Petition: FDA Docket No. FDA-2009-P-0418
Dear Mr. [redacted],
This note is to acknowledge the courteous call today from you and your
colleagues, regarding the above noted Citizens Petition, entitled, “In the
Matter of the A-H1N1-09 ‘Swine Flu’ Vaccines”
We also acknowledged the letter from FDA over signature of Dr. Midthun dated
February 16, 2010 indicating that the FDA needed further time to respond to
the Citizens Petition due to “the existence of other FDA priorities” than what
was then (and remains) a presidential national health emergency.
You requested that I withdraw the petition. As best as I understood from the
call, the arguments advanced to withdraw were, approximately,
1. Due to the results of the November court decision. It was not clear to me
whether you were referring to the NY State action that temporarily stayed the
NY health care worker mandate (that stay expired some months ago; parts of the
NY mandate had been previously suspended just prior to our hearing in US
district court last November and parts of the state mandate structure have
been reinstated since then) or whether you were referring to the Federal court
case, where the judge told us, in effect, since the plaintiffs were no longer
under mandate, they had no standing, but could return to court if again
mandated. That is the status as we currently see it.
2. The petition asks for a temporary stay of approvals of the vaccines; since
the vaccines were approved, the request is moot. We are reviewing the petition
to determine whether it seeks additional redress.
We did briefly discuss the end of part of the public emergency, but I am not
sure that you advanced that as a reason to withdraw the petition. If I did not
understand the grounds advanced, kindly let me have the benefit of your
further elucidation.
I also mentioned that we remained very concerned about the admixing of the
H1N1 virus complex into the annual flu vaccine and were concerned that the
govt had not addressed the hundreds of miscarriages that may be associated
with the swine flu vaccines.
I must therefore repeat that I cannot consider withdrawing the petition
without consulting with our counsel since the petition is mentioned in the
revised litigation that may be filed soon. We are having a phone conference
this Friday. I expect to reply to the request to withdraw during the week
after the Independence Day holiday.
Sincerely,
Ralph Fucetola JD
Natural Solutions Trustee
