NATURAL SOLUTIONS FOUNDATION
The Global Voice of Health & Food Freedom™
www.HealthFreedomPortal.org

Seeking Redress through the FDA: Transparency… What Transparency?

Working in cooperation with Paul G. King PhD [The Know Zone: http://dr-king.com/ ] the Natural Solutions Foundation submitted a Freedom of Information Act (FOIA) request to the Food and Drug Administration (FDA) regarding the labeling of a particular Vaccine, which appears to be even less informative than the labeling provided in the package insert for parenteral drugs and other injectable vaccines.

In addition to not disclosing that vaccines are uninsurable risks, and that they still contain potent so-called “trace” amounts of toxins, this particular drug’s labeling fails to disclose the nature and amount of the “inactive” ingredients in this vaccine, a parenteral drug, to an unprecedented extent. We know that the fully informed consent mandated by international humanitarian laws, such as the Declaration of Helsinki, requires drug labeling transparency!

So we asked the FDA to produce copies of certain records which the Agency should be receiving from the drug company prior to approving the vaccine drug. This includes the types of production records that would reveal the actual composition of the vaccine drug and thus the presence of the unrevealed “inactive” ingredients. We are concerned, for among other reasons, because no parent could ever determine the toxic load to which his or her child is being subjected without full disclosure of the names and the amounts, or percentages, of all the ingredients in a vaccine dose as explicitly required by the FDA’s own regulations.

Early on, we wrote the Agency,

“…our concern centers around the disclosures that … [vaccine] makes to the public; our scientist noted a difference between the label disclosures typical for vaccines and the lesser disclosures about ingredients and “trace” contaminants on the … [vaccine] labeling (i.e., the packaging insert). We want to help the agency assure the public that vaccines, as required by law, are as safe as they can be.”

The regulations require the drug company to disclose on the label “the name of all inactive ingredients” including “the quantity or proportion of all inactive ingredients except that ingredients added to adjust pH or make the drug isotonic may be declared by name and a statement of effect” (see 21 CFR § 201.100(b)(5)(iii)).

Currently, all that the FDA and the manufacturer reveal about the composition of the vaccine dose, outside of the identities and amounts of its active ingredients, is that each dose nominally contains not more than 0.30 microgram (mcg) of formaldehyde per dose.

The FDA Center for Biologics Evaluation and Research (CBER) administrators apparently ignoring the Agency’s own clear labeling requirements for “inactive” ingredients in parenteral drugs set forth in 21 CFR § 201.100(b)(5), not only approved the vaccine with a package insert that fails to disclose the names and amounts of the inactive ingredients (and thus apparently renders this drug
“misbranded” under the applicable law) but also rebuffed our attempts to have CBER personnel disclose those ingredients and their per-dose amounts, directing us to get the information from the manufacturer or by submitting an appropriate request to the FDA under the Freedom of Information Act (FOIA).

We did seek the information directly from the manufacturer, but, as a review of the correspondence with the manufacturer clearly shows, the manufacturer rebuffed our attempts to have it disclose the composition of the vaccine dose in a manner that complies with 21 CFR 201.100(b)(5), thereby continuing the misbranding of the drug.

The FDA has now also rebuffed our FOIA efforts, claiming incongruously that the information, which the Agency admits exists, is a proprietary secret, despite the law that requires disclosure of the names and the per dose amounts or percentages of the inactive ingredients in a parenteral drug such as the vaccine!

We are, of course, appealing the FOIA denial to “exhaust our administrative remedies” so we can bring this matter before the independent United States District Court to continue to seek redress of grievances; to continue to PUSH BACK against the collusion between the Agency and the drug companies, in the interests of transparency and the health of you and your children. This suit, which we will prepare and pursue on behalf of every person in the United States, is in addition to our ground breaking “Stop the Shot Case”, now ready to go back into Federal Court after two previous iterations of the case prevailed on narrow grounds. We are not satisfied. We
want to win on the broadest possible grounds in both cases.

To be able to do this, we must raise sufficient funding to continue the fight to force disclosure of these hidden vaccine toxins. Please make your most generous recurring donations today: https://staging.drrimatruthreports.com/?page_id=189

Yours in health and freedom,
Ralph Fucetola JD
Counsel and Trustee
Natural Solutions Foundation