There cannot be product liability exposure for manufacturers of products for which no physical, objective standards exist.
2022-2025 reporting collections available in the form of printable1 books:
Book 1 – Biological product non-regulation
Book 2 – PREP Act, public health emergency, and EUA countermeasure law
Book 3 - Communicable disease control, quarantine, habeas corpus law
Book 4 - Chemical and biological weapons, biological agents, BSATs, vaccines
Unrestricted export of “partially-processed biological products” since 1986.
(Note published May 31, 2025)
Working a bit this morning on Pt. 2 of two-part series2 documenting development of the fake-disease/fake-threat/fake-remedy laws that classify intentionally poisonous, non-regulated substances (vaccines) as legally-authorized medicines rather than prohibited chemical and biological weapons. (Part 1.)
Reading about a provision added through the 1986 Drug Exports Amendments Act, which was passed with the 1986 National Childhood Vaccine Injury Act (which expanded/firmed up national vaccination programs, CDC-ACIP, childhood immunization schedules, liability immunity for manufacturers, VICP compensation scheme, Vaccine Injury Table/VIT etc…) to authorize export to foreign countries of “partially-processed biological products.”
I think those containers would have held, and still do hold, toxic mixtures of microorganisms, organic matter and inorganic chemicals and metals used to propagate vaccine in the target countries’ fermentation and bottling facilities.
I was interested to see the list of targeted countries as of 1986: Australia, Austria, Belgium, Canada, Denmark, Federal Republic of Germany, Finland, France, Iceland, Ireland, Italy, Japan, Luxembourg, the Netherlands, New Zealand, Portugal, Spain, Sweden, Switzerland and the United Kingdom.
Readers can find the 1986 list as passed by Congress and President Reagan in November 1986, PL 99-660, 100 Stat. 3746.
The laws, which are still in effect, are at 42 USC 262(h) — Exportation of partially processed biological products; and 21 USC 382 — Exports of certain unapproved products.
This program, as set up by Congress and President Reagan in 1986, was an early form of “harmonisation” programs and Mutual Recognition Agreements (Watt reporting on MRAs; Latypova reporting on MRAs) adopted after the formal establishment of the European Community through the Maastricht Treaty circa 1993.
A reader posted a comment:
Looking into the vaccine program is like watching someone figure out how to kill ants. They figured out that if you kill the ants you can see, you won’t get the ones you can’t see, but if you convince some of the ants that poisoned bait is something they want, then the ants will take it back to their friends and family and feed it to them willingly.
My reply:
A few weeks ago, upon reading some legal provisions for the third or fourth time (over several years), and seeing them in a better light because of other things I’d learned about in the meantime, I began to see that vaccines are pesticides, in the form that best baits human beings: camouflaged as medicine and using the love parents properly have for their children, to deceive and blind the parents into thinking pesticides are medicines. And also using the love that people properly have for themselves and their neighbors, to deceive and blind them into taking vaccines themselves as adults.
Expanding on the reply, the provisions that help make clear that vaccines are pesticides in a form useful for baiting human beings are 42 USC 262a(g)(2) enacted by Congress and President Bush in 2002 (PL 107-188), implemented by Secretary of Health and Human Services through 42 CFR 73.5(c) and 42 CFR 73.6(c) in 2005 (70 FR 13316)
42 USC 262a, Enhanced control of dangerous biological agents and toxins, (g) Exemptions, (2) Products:
(A) In general
Regulations under subsections (b) and (c) shall exempt products that are, bear, or contain listed agents or toxins and are cleared, approved, licensed, or registered under any of the Acts specified in subparagraph (B), unless the Secretary by order determines that applying additional regulation under subsection (b) or (c) to a specific product is necessary to protect public health and safety.
(B) Relevant laws
For purposes of subparagraph (A), the Acts specified in this subparagraph are the following:
(i) The Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.].
(ii) Section 262 of this title [Public Health Service Act, 42 USC 262, biological products].
(iii) The Act commonly known as the Virus-Serum-Toxin Act (the eighth paragraph under the heading "Bureau of Animal Industry" in the Act of March 4, 1913; 21 U.S.C. 151–159).
(iv) The Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 136 et seq.].
Very brief synopsis: if it were not true that pesticides, animal vaccines, human vaccines and drugs are, by physical composition and physiological effects, “biological agents” meaning “any microorganism (including, but not limited to, bacteria, viruses, fungi, rickettsiae, or protozoa), or infectious substance, or any naturally occurring, bioengineered, or synthesized component of any such microorganism or infectious substance, capable of causing death, disease, or other biological malfunction in a human, an animal, a plant, or another living organism” and “toxins” meaning “the toxic material or product of plants, animals, microorganisms (including, but not limited to, bacteria, viruses, fungi, rickettsiae, or protozoa), or infectious substances, or a recombinant or synthesized molecule, whatever their origin and method of production, and includes any poisonous substance or biological product that may be engineered as a result of biotechnology, produced by a living organism; or any poisonous isomer or biological product, homolog, or derivative of such a substance” [definitions at 42 CFR 73.1] then it would not have been necessary or useful for Congress to carve out — by default classification “unless” overridden by unilateral HHS Secretary order — those four categories as exempt from BSAT laws.
It is true that pesticides, animal vaccines, human vaccines and drugs are, by physical composition and physiological effects, biological agents and toxins.
That’s why the exemptions are written into the laws, and in the form that they’re written.
I plan to expand on this analysis somewhat in Part 2 of the series on BSAT (biological select agents and toxins) law.
Liability for manufacturers and others in the distribution chain for vaccines and other biological products
Sasha Latypova posted a report about FDA “approval” of Moderna’s mNexspike vaccine:
June 1, 2025 - #MAHA-FDA has approved Moderna's "next generation" mRNA shot for covid. (Sasha Latypova)
A reader tagged me with links to two other reports about the same FDA announcement, and asked:
“It’s not clear if this is a medical countermeasure under PREP Act emergency declaration or if it would be subject to liability. I’m guessing it’s still EUA. Any idea Katherine Watt?
My reply:
To the extent this report is about a vaccine being “approved” by FDA, my understanding is that no vaccine manufacturers have ever been or are ever subject to liability for the products they produce, because there are no physical, objective standards for safety, efficacy, purity, manufacturing quality control or any other parameter against which a product can be tested for compliance; there are no valid tests that would demonstrate compliance or non-compliance with such standards (which don’t exist to be applied, because FDA has never established or promulgated any such standards); FDA has no legal obligation to conduct any tests for compliance or impose any enforcement measures; and there is no access to courts or other fact-finding, law-enforcement entities, and no requirement that manufacturers submit to any fact-finding, law-enforcement procedures.
It doesn’t make any legal difference whether a product is an EUA (emergency use authorization) product or a BLA (biologics license application) product, or any other classification, going back to 1902.
There are no physical standards for biologics, no methods to assess their compliance with such standards (which don’t exist) and no procedures or venues for fact-finding or enforcement.
In my view, the BLA/CMC (chemistry, manufacturing and controls) charade and its precursors back to 1902 — false reports, applications, licenses, approvals and other theatrical props suggesting research studies and manufacturing standards, which are exchanged between company officers and FDA officers — is for the purpose of projecting the illusion, among the targeted population, that biomedical researchers and manufacturers have the physical ability to control and stabilize mixtures of microorganisms, human, animal and plant tissues and cells, organic components of cells of living creatures, nutrient solutions, and synthetic inorganic chemicals and metals, and have the physical ability to design such mixtures to have therapeutic value.
The purpose of the pretextual documents is to instill irrational trust and override or block calm, rational assessment of the absurd scientific, technical and medical claims made by biological product purveyors.
In my view, the EUA charade — including the same false documents simulating research studies and manufacturing quality standards — is for the purpose of projecting the same illusion of biomedical diagnostic and manufacturing competency combined with the illusion that something new and dangerous has “emerged” suddenly into airborne, casual-contact transmission, creating an “emergency,” thereby instilling rapid-onset fear and confusion, and more intensely overriding calm, rational assessment of the situation overall, and the measures recommended by health authorities in response.
EUAs are about “faking fakery faster,” to borrow Sasha Latypova’s phrase.
Upon calm, rational assessment and evidentiary review, all the stories told about vaccines (virus lie + contagion lie = vaccine lie), whether under routine conditions such as childhood immunization schedules, or under emergency conditions such as a unilateral HHS Secretary declaration that a public health emergency “exists” completely fall apart.
As the stories fall apart, vaccine hostility rises, and vaccine uptake rates drop.
Related:
How to get printed copies - I don't have a publisher or printing service. Readers can download the PDF files and upload, email or take them on a flash-drive to Staples or another printing company, and they can print and bind the printed pages for you to make physical books.
Part 2 will take a few more weeks to finish, as I continue trying to strike a balance between too much detail and not-enough detail.