Health Freedom Citizens Petition to FDA: STOP the "Swine Flu" Vaccine Rush to Approval

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.

Read the full text of the Petition is here:

http://www.healthfreedomusa.org/?p=3314

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.

For more information, please sign up for the Natural Solutions Foundation’s Health Freedom Action eAlerts, http://www.healthfreedomusa.org/?page_id=187.

Tax deductible donations to support this legal challenge to the FDA’s rush to approve these vaccines are gratefully acknowledged and may be made here, http://www.healthfreedomusa.org/?page_id=189.

Yours in health and freedom,

Ralph Fucetola, JD

Counsel and Trustee

Natural Solutions Foundation

www.HealthFreedomUSA.org

This Media Announcement issued as a media release on Free-Press-Release.com August 17, 2009
http://www.free-press-release.com/news-citizens-petition-tells-fda-to-stop-vaccine-approval-rush-1250560414.html

August 20, 2009 Update:

Citizens Petition Tracking per USPS.gov:

Label/Receipt Number: EO96 4064 326U S

Class: Express Mail®

Status: Delivered

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.

Detailed Results:

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”

To: [redacted]@fda.hhs.gov

Cc: [redacted]

Subject: Revised Petition to Stay “Swine Flu” Vaccine Approvals@usa.net>

To: FDA Dockets Management Division

Att: [redacted]

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

only.

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

Media Announcement: Citizens Petition tells FDA – STOP the “Swine Flu” Vaccine Rush to Approval

Natural Solutions Foundation

www.HealthFreedomUSA.org

MEDIA ANNOUNCEMENT

From: Ralph Fucetola JD

Natural Solutions Foundation Counsel

Health Freedom Citizens Petition tell FDA:

STOP the “Swine Flu” Vaccine Rush to Approval

Follow this issue on http://www.Twitter.com/HealthFreedomUS

Hashtags: #selfshield #pandemic #noforcedvax #vaccine #healthfreedom

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

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:

Here is what the Petition demands:

Read the full text of the Petition is here:

http://www.healthfreedomusa.org/?p=3314

For more information, please sign up for the Natural Solutions Foundation’s Health Freedom Action eAlerts, http://www.healthfreedomusa.org/?page_id=187.

Tax deductible donations to support this legal challenge to the FDA’s rush to approve these vaccines are gratefully acknowledged and may be made here, http://www.healthfreedomusa.org/?page_id=189.

Yours in health and freedom,

Ralph Fucetola, JD

Counsel and Trustee

Natural Solutions Foundation

www.HealthFreedomUSA.org

August 20, 2009 Update:

Citizens Petition Tracking per USPS.gov:

Label/Receipt Number: EO96 4064 326U S

Class: Express Mail®

Status: Delivered

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.

Detailed Results:

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”

To: [redacted]@fda.hhs.gov

Cc: [redacted]

Subject: Revised Petition to Stay “Swine Flu” Vaccine Approvals@usa.net>

To: FDA Dockets Management Division

Att: [redacted]

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

only.

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

Application FDA-Vaccine-Petition.3.4b1.rev.doc 98K

Application FDA-Vaccine-Petition.3.4b1.yhl.doc 99K

Application Fucetola-Self-Shield.doc 80K

Application Holcomb-MedVeritas6-2009.pdf 158K

Application Laibow-True-Lies.doc 46K

Application Maniotis-Timeline.doc 78K