Deregulation of biological product manufacturing, mid-1990s to present.

Don't-ask-don't-tell as applied to vaccines and other difficult-to-characterize, highly-susceptible-to-contamination medical-military poisons.

Katherine Watt

Mar 15

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Related Bailiwick reporting and analysis

Dec. 19, 2023 - Legalized FDA non-regulation of biological products effective May 2, 2019, by Federal Register Final Rule, signed by then-FDA Commissioner Scott Gottlieb.
Feb. 5, 2024 - Feb. 9, 2023 Children's Health Defense Q&A, transcript.
Catherine Austin Fitts, speaking Feb. 9, 2023 - “…The financial coup started in 1995. There was a budget deal that busted and I was told by a variety of people that quote, ‘They have given up on the country and are moving all the money out starting in the fall...’ But what is interesting is the month after the bust-up of the budget deal you had the FDA approve Oxycontin. And the HUD, and some of the other agencies, approved predatory lending practices for poor neighborhoods. And suddenly those neighborhoods were being targeted by three things: by Oxycontin and
the pill mills; by unbelievable predatory lending which was driving people out; and finally by SWAT teams that were rounding up and stuffing people into slave labor camps is the only way I can describe it... And a series of things started. I call it the Great Poisoning, that we're bringing down life expectancy... We're going to intentionally bring down life expectancy, because if you cannot get the retirement system on a sound financial footing, and there's no political support for that, then your only other way of balancing the budget is to either bring down life expectancy, and or take the money and run, which is what I think has happened..."
March 12, 2024 - Statutory and regulatory definitions for drugs, biological products, and biosimilars. Information to support further reporting on regulation and non-regulation of biological product manufacturing, sample testing, lot-release, use.

As reported in the March 12 post, in November 1973, FDA issued a set of consolidated regulations governing biological product manufacturing under Section 352 of the Public Health Service Act (42 USC 262), including definitions for key terms.

21 CFR 600.3(h) Biological product means any virus, therapeutic serum, toxin, antitoxin, or analogous product applicable to the prevention, treatment or cure of diseases or injuries of man:
21 CFR 600.3(h)(1) A virus is interpreted to be a product containing the minute living cause of an infectious disease and includes but is not limited to filterable viruses, bacteria, rickettsia, fungi, and protozoa.
21 CFR 600.3(h)(2) A therapeutic serum is a product obtained from blood by removing the clot or clot components and the blood cells.
21 CFR 600.3(h)(3) A toxin is a product containing a soluble substance poisonous to laboratory animals or to man in doses of 1 milliliter or less (or equivalent in weight) of the product, and having the property, following the injection of non-fatal doses into an animal, of causing to be produced therein another soluble substance which specifically neutralizes the poisonous substance and which is demonstrable in the serum of the animal thus immunized.
21 CFR 600.3(h)(4) An antitoxin is a product containing the soluble substance in serum or other body fluid of an immunized animal which specifically neutralizes the toxin against which the animal is immune.
21 CFR 600.2(h)(5) A product is analogous:
(i) To a virus if prepared from or with a virus or agent actually or potentially infectious, without regard to the degree of virulence or toxicogenicity of the specific strain used.
(ii) To a therapeutic serum, if composed of whole blood or plasma or containing some organic constituent or product other than a hormone or an amino acid, derived from whole blood, plasma, or serum.
(iii) To a toxin or antitoxin, if intended, irrespective of its source of origin, to be applicable to the prevention, treatment, or cure of disease or injuries of man through a specific immune process…
21 CFR 600.3(p) The word “safety” means the relative freedom from harmful effect to persons affected, directly or indirectly, by a product when prudently administered, taking into consideration the character of the product in relation to the condition of the recipient at the time.
21 CFR 600.3(q) The word "sterility" is interpreted to mean freedom from viable contaminating microorganisms, as determined by the tests prescribed in Section 610.12 of this chapter.
21 CFR 600.3(r) "Purity" means relative freedom from extraneous matter in the finished product, whether or not harmful to the recipient or deleterious to the product. "Purity" includes but is not limited to relative freedom from residual moisture or other volatile substances and pyrogenic substances…

As noted in the March 12, 2024 post, FDA has never defined the term vaccine through rule-making.

After reading through rule-making documents and thinking about things more the last few days, I now think that vaccines as a biological product class are defined in 21 CFR 600.3(h).

I think vaccines are products “analogous to” viruses, therapeutic serums, toxins and antitoxins, for which FDA has promulgated definitions, and vaccines are probably also covered by a new category of protein added to the list in February 2020.

To wit, in February 2020, at the initiation of fake clinical trials for the biological products unleashed on the world as Emergency Use Authorization “Covid-19 vaccines,” then-FDA Commissioner Stephen Hahn issued a Final Rule (85 FR 10057) revising the definition at 21 CFR 600.3(h), biological product, to align it with statutory changes made by Congress to 42 USC 262 between 1973 and 2019.

The introductory section now reads:

21 CFR 600.3(h) - Biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein, or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings.

And the protein category of biological product has been added to the list of defined biological products:

21 CFR 600.3(h)(6) - A protein is any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size. When two or more amino acid chains in an amino acid polymer are associated with each other in a manner that occurs in nature, the size of the amino acid polymer for purposes of this paragraph (h)(6) will be based on the total number of amino acids in those chains, and will not be limited to the number of amino acids in a contiguous sequence.

“Don’t ask, don’t tell” was a Clinton-era military policy.

"Don't ask, don't tell" (DADT) was the official United States policy on military service of non-heterosexual people. Instituted during the Clinton administration, the policy was issued under Department of Defense Directive 1304.26 on December 21, 1993, and was in effect from February 28, 1994, until September 20, 2011…The act prohibited any non-heterosexual person from disclosing their sexual orientation or from speaking about any same-sex relationships, including marriages or other familial attributes, while serving in the United States armed forces…The "don't ask" section of the DADT policy specified that superiors should not initiate an investigation of a service member's orientation without witnessing disallowed behaviors…” (Wikipedia)

The mechanisms for legalized non-regulation of biological products are very similar in structure to “Don’t ask, don’t tell.”

Briefly, since the mid-1990s, citing authority derived from Congressional acts and Presidential executive orders, the Food and Drug Administration has been quietly eliminating its own regulatory functions through Federal Register rule-making notices and Guidance for Industry publications.

FDA has essentially told biological product manufacturers:

"We're not going to ask you what's in the products that you send out of your factories, and you shouldn't tell us what's in the products that you send out of your factories."

The ostensible reason was to relieve paperwork burdens and costs on pharmaceutical manufacturers. The changes are scientifically pseudo-justified with assertions that manufacturers have developed such excellent internal quality-control processes and technologies, that FDA validation of manufacturer claims about product purity, sterility and safety are no longer needed.

This is nonsense, as are many other FDA claims to be found in Federal Register notices and guidance documents.

Biological products, including but not limited to vaccines, are inherently heterogeneous, impure, non-sterile, immuno-toxic, and unstable.

FDA lawyers, pharmacologists, toxicologists, factory inspectors and product reviewers know those truths. They have known those truths for many, many decades.

The real reason for the rule changes was to enable biological product factories to be more fully converted to non-regulated, black-box poison factories and to increase the toxicity of the poisons distributed from their loading bays.

As I continue working my way through the documents to understand what happened in more detail and write about it more fully, some relevant records are linked below for readers who are also interested in piecing the story together.

Pray the Rosary.

Stop taking vaccines.

Deregulation of biological product manufacturing; 21 CFR 600.3, Definitions; 21 CFR 610.2, samples, protocols, lot-by-lot release; etc.

St. Joseph and the Christ Child. Painting by Guido Reni.

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Templeton Times

Friday, March 22, 2024