August 17, 2009 – Led by such health freedom luminaries as Gary Null, PhD, Human Nutrition & Public Health Science, Rima E. Laibow, MD, Medical Director of the Natural Solutions Foundation, www.HealthFreedomUSA.org, and Dr. Tedd Koren, DC of Citizens for Health Choice, we filed a formal Citizens Petition to the FDA today expressing our serious concerns about the approval of dangerous Swine Flu vaccines BEFORE ANY SAFETY TESTING IS COMPLETED. A Citizens Petition, unlike an internet petition, is a formal statement of grievance which challenges the government’s actions, asks for specific protection and redress, as provided for by the Constitution of These United States:
“Pursuant to the Constitution of the United States of America, First Amendment, Right to Petition for Redress of Grievances the Federal Food, Drug and Cosmetic Act (FFDCA), 21 U.S.C. §§ 321 et seq., and the Administrative Procedure Act (APA), 5 U.S.C. § 553(e), to amend the FDA’s rules respecting the safety, effectiveness and availability of vaccines said to be useful for swine flu (A-H1N1-09)…”
The goal of this regulatory intervention is to stop FDA’s headlong, dangerous and unjustified rush to approve the so-called “swine flu” vaccination, even before safety testing has been completed. If FDA fails to act on our Petition in a timely fashion, a Temporary Restraining Order (TRO) can be sought from the Federal Courts to stop the alleged “emergency” approval process.
The Petition details, in ten pages of carefully structured and well supported reasoning, the legal and factual basis for a formal stay of the approval process, citing issues of transparency and science-based decision making, which the President claims to be the hallmarks of his Administration. The FDA has failed to follow statutory and case law requirements for the emergency approval of these un-insurable, untested and unproven vaccines which have been recently cited for their potential dangers to health and safety here and abroad.
Within the next couple days, when a formal Docket Number is issued, Natural Solutions Foundation will set up an Action Item to allow the public to express support to “Stay the Shot”, Stop the Swine Flu Vaccine rush to approval. That link will be posted here.
FDA requires a snail-mail copy of a signed document to issue a Citizens Petition docket number. You can track the progress of the document sent today with this US Postal Service tracking number: EO 964 064 326 US.
Here is what the Petition demands:
(a) The first action sought is an emergency Temporary Stay of the pending Vaccine approval applications. The applications should be denied. Petitioners request a Public Hearing. Petitioners are in immanent peril of irreparable harm if the Temporary Stay is not granted immediately.
(b) Additionally, the Petitioners petition the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) to open and accept public comments and include, as part of any approval of the Vaccines, requiring strong warnings to the public of each age groups, geographic location and any other relevant demographics, that a process be developed for individuals to opt out of any mandatory program and that clear instructions be given on the risk and benefits of the vaccine:
“This Vaccine has not undergone FDA safety or efficacy testing and its risks are unknown in all age groups. This Vaccine contains ingredients previously rejected for use in the United State and/or never evaluated by the FDA which have been shown in animal studies to cause significant adverse biological response when injected.”
(c) Furthermore, the Petitioners petition the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) to recommend to all implementing agencies, such as State Departments of Health that the Vaccines not be subject to any legal mandate requiring their use by any class of persons in order for such persons to receive government services, or to work in particular employments, or to travel or to attend any public places or for any other purpose.
(d) The Petitioners petition the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) to recommend to all implementing agencies, such as State Departments of Health that these un-insurable, unproven and untested Vaccines not be subject to any legal mandate, whether direct or indirect, perceived or actual, requiring their use by any class of persons in order for such persons to receive government services, such as schooling, or to work in particular employments, such as first responders or health care workers, or to travel or to attend any public places or for any other purpose.
(e) The Petitioners petition the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) to recommend voluntary Self-Shielding at home in preference to vaccination or removal to FEMA or other relocation facilities in the event of a Declared Pandemic Emergency.
The petitioners believe that halting these approvals is literally a matter of life and dealth since the new vaccines are made with adjuvants based on injected oil-in-water preparations based on squalene which are known to cause profound, chronic inflammatory response throughout the body, leading to ailments similar to those known was “Gulf War Syndrome”. These adjuvants, or immune system irritants, are so toxic that they have been rejected for testing in the US previously and no vaccine containing them has ever been approved in the US.
Your item was delivered at 10:51 AM on August 18, 2009 in ROCKVILLE, MD 20850 to HHS . The item was signed for by P ZIEDMAN.
Delivered, 08.18.2009, 10:51 am, ROCKVILLE, MD 20850
Arrival at Unit, 08.18.2009, 10:37 am, ROCKVILLE, MD 20850
Processed through Sort Facility, 08.18.2009, 4:54 am, GAITHERSBURG, MD 20898
Processed through Sort Facility, 08.18.2009, 2:48 am, LINTHICUM HEIGHTS, MD 21090
Processed through Sort Facility, 08.17.2009, 7:06 pm, NEWARK, NJ 07114
Acceptance, 08.17.2009, 3:27 pm, NEWTON, NJ 07860
Electronic Shipping Info Received, 08.17.2009
August 23, 2009 Update:
After a discussion with FDA on Friday, August 21, 2009, the following email was sent:
From: “Ralph Fucetola JD”
Subject: Revised Petition to Stay “Swine Flu” Vaccine Approvals
To: FDA Dockets Management Division
Dear Mr. [redacted],
Pursuant to the Petition submitted under date of August 17, 2009 and our
discussion of August 21, 2009, I submit herewith the following:
1. [3.4b1.rev] A revised Petition which addresses, by way of Addendum 1.01 and
1.02 the requirements of 21 CFR 10.30 and 10.35, and which includes the
Certification specified in the regulation. Petition includes signature.
2. [3.4b1.yhl] A yellow-highlight copy showing the changes. Only copy #1 above
is submitted for filing; this yellow-highlighted copy is for convenience
3. Copies of the four articles referenced in the Petition, which have been
downloaded from the Internet and saved to be attached to the Petition.
Thank you for your attention to the emergency Citizens Petition. I will
follow-up with a phone call this Monday to confirm your receipt.
Ralph Fucetola JD
Natural Solutions Foundation Trustee
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