Labeling deceits and omissions and fake informed consent for vaccines and other legalized biological and chemical weapons.
Analysis of South Carolina's S.54: Medical Informed Consent Act
Orientation for new readers; American Domestic Bioterrorism Program; Tools for dismantling kill box anti-law
Notes:
Labeling deceit and labeling omissions are about labeling biological products, including vaccines, with ill-defined words and arbitrary units of measure and units of potency to deceive users into holding false beliefs: that package contents are identifiable, measurable, stable, non-toxic and therapeutic.
Labeling deceit and omissions represent only a small fraction of the many layers of legalized deceit and omissions that have comprised biological product manufacturing, communicable disease control, and vaccination law at any given time since 1902 and up to the present moment.
Pulling on any thread of deceit, in any layer at any time, leads to other layers of deceit. It's not possible to fully describe any layer, in any single report. I encourage readers who want to better understand other layers of deceit surrounding any word, phrase, unit of measure, or unit of potency described below or in other Bailiwick reporting, to pull the threads.
Deepen vaccine hostility.
Help more people stop taking vaccines and stop vaccinating babies and children.
Pray the Rosary.
A Medical Informed Consent Act bill (S. 54) was introduced in the South Carolina state Senate on Jan. 14, 2025, proposing amendments to South Carolina's current Emergency Health Powers law (Title 44, Chapter 4, enacted in 2002) and related provisions in other sections of South Carolina state law.
I looked at the draft Medical Informed Consent Act, focusing on proposed changes to SC Code 44-4-520, Vaccinations and Treatment.
Based on my knowledge of how federal law addresses biological product and vaccine package labeling and informed consent to enable and hide intentional poisoning programs by disguising poisoning campaigns as regulated pharmaceutical product manufacturing, distribution and use, I think people who are knowledgeable about how to neutralize this state law proposal, neutralized it before introduction.
It would still be good if it passed, if only because other amendments proposed by S.54 would require notification to product recipients that they and their survivors can't prosecute or sue anybody if they're injured or killed, by defining the term Indemnified product.
Indemnified product means any product including, but not limited to, a covered countermeasure, for which the manufacturers and distributors are shielded from direct civil or criminal liability to consumers for personal injuries and damages resulting from the use of the product as determined by state or federal law.
That's notification by South Carolina lawmakers, to South Carolina people, that US-HHS, US-DoD, US-FDA, US-NIH, US-CDC, US-ASPR, US-BARDA, US-DARPA, (and all other federal government officers); Pfizer, BioNTech, Moderna, National Resilience, Rentschler (and all other vaccine manufacturers); and South Carolina pharmacists, nurses and doctors are all jointly licensed to maim and kill using all vaccines (which are all indemnified products) and countermeasures, under biological product laws that legalize manufacture of biological and chemical weapons, deceptive labeling of packages, and use of the products to torture, maim and murder recipients.
When people understand that FDA licenses, authorizations and approvals for manufacture and use of indemnified products are licenses to kill, those people stop taking vaccines and stop vaccinating babies and children.
Analysis
The current South Carolina law relating to Vaccinations and treatment (S.C. Code 44-4-520, adopted in 2002), does not include a section defining informed consent.
S.C. Code 44-4-520 currently reads:
Vaccinations and treatment.
(A) During a state of public health emergency, DHEC may exercise the following emergency powers, in addition to its existing powers, over persons as necessary to address the public health emergency:
(1) to vaccinate persons as protection against infectious disease and to prevent the spread of contagious or possibly contagious disease;
(2) to treat persons exposed to or infected with disease; and
(3) to prevent the spread of contagious or possibly contagious disease, DHEC may isolate or quarantine, pursuant to the applicable sections of this act, persons who are unable or unwilling for any reason (including, but not limited to, health, religion, or conscience) to undergo vaccination or treatment pursuant to this section.
(B) Vaccinations or treatment, or both, must be provided only to those individuals who agree to the vaccinations or treatment, or both.
(C)(1) Vaccination may be performed by any qualified person authorized by DHEC.
(2) To be administered pursuant to this section, a vaccine must not be such as is reasonably likely to lead to serious harm to the affected individual.
(D)(1) Treatment must be administered by any qualified person authorized to do so by DHEC.
(2) Treatment must not be such as is reasonably likely to lead to serious harm to the affected individual.
HISTORY: 2002 Act No. 339, Section 24, eff July 2, 2002.
With S.54, South Carolina lawmakers are proposing to add informed consent provisions to S.C. Code 44-4-520.
Section 44-4-520. Vaccinations and Treatment
(A) For purposes of this section, "informed consent" means a written document that is signed and dated by an individual; or, if the individual is a minor, by a parent or legal guardian; or, if the individual is incapacitated or without sufficient mental capacity, by a designated health care agent pursuant to a health care power of attorney, that at a minimum includes:
(1) an explanation of the vaccine or treatment that is written in language that is understandable to the average lay person;
(2) a description of the potential risks and benefits resulting from vaccine or treatment, along with a realistic description of the most likely outcome;
(3) a statement acknowledging risks associated with the vaccine or treatment if the vaccine or treatment is an indemnified product as defined in Section 44-1-55(A)(7) [another amendment proposed by S.54 but not yet in South Carolina state law]; and
(4) language that clearly indicates that the individual agrees to the administration of the vaccine or treatment, that the individual has had time to thoughtfully and voluntarily accept or decline the vaccine or treatment free from coercion.
The proposed S.54 amendments would also add a new provision to Section 44-4-520 on "safety and efficacy" review and "adverse event monitoring."
...(F) The safety and efficacy of vaccines, tests, and treatments performed and administered as provided in this section must be reviewed and adverse events monitored by the department. References to evidence-based data determined to validate vaccines, tests, and treatments including, but not limited to, VAERS data must be prominently posted on the department's public website.
The proposed South Carolina state law language about informed consent for vaccination and treatment mirrors federal law for all biological products since 1902 and for EUA countermeasures since 2003.
Federal biological product and EUA laws are written to exempt manufacturers and regulators from having to label products with information about the specific identity and quantity (mass, volume, concentration) of biological material inside packages of biological products.
For biological products (all vaccines) and for EUA products, proper name, manufacturer name and address, and general descriptions are the only enforceable and enforced legal requirements.
South Carolina lawmakers will, if S.54 passes, embed this limited general information format, mirroring federal law in state law, by limiting the required information to "an explanation of the vaccine or treatment that is written in language that is understandable to the average lay person."
This is related to what Sasha Latypova and I have pointed out: it's not possible for anyone to give informed consent without having specific information about what, exactly, is in the individual package presented to a specific recipient at a specific time and place.
Biological product labeling laws are written to require general, but not specific information, because the specific contents of any given package of biological material at any given moment in time, cannot be specifically known, identified or fully characterized at all.
Scientific identification and measurement methods are capable of only partial characterization of biological organisms and living systems not because of limits to scientific knowledge or technology that may someday be overcome, but because of the inherent variety and instability of biological organisms themselves. Assessment methods destroy the samples to obtain the limited information that can be gleaned. Each aliquot differs from each other aliquot, even those drawn from the same batch. And each aliquot differs from itself at earlier or later moments in its existence.
It's also related to what Sasha Latypova and Mike Yeadon have both pointed out: there is no way to establish any "dose" by mass or volume of injected biological material, because all injected biological material interacts in a unique way and for an unpredictable, indeterminate amount of time with the biological processes of each specific recipient.
Living organisms are in a state of constant change. They're born and they grow. They take in nutrients, use energy, change form, excrete waste. They communicate and cooperate with other living organisms. They decay, fragment and die.
At any given moment all along the biological product propagation and manufacturing chain, all of those processes are underway in vaccine batches and bottles.
The biological events unfold at active, rapid speeds when the living organisms are at room temperature or body temperature within a laboratory processing container.
The events occur at slower rates when the living organisms are suspended, encapsulated, refrigerated or frozen.
The events resume — rapidly again — when the living organisms are defrosted, diluted, warmed, mixed and injected into another, larger living organism.
Since there's no way for any public health-military officer, manufacturer, regulator or vaccinator to know the specific identity of what's in any package at any given time, because biological products are unstable mixtures of living and non-living matter, and no way to predict how each specific living body will respond to the material after injection, there's no way for any of them to tell the recipient what the product is or what effect it will have.
Poisoners among US public health, military, scientific, medical, legal and financial officers have known these facts from the beginning of the modern vaccination era.
That's why they have written and executed laws to exclude identity information from product labels for all viruses, serums, toxins, antitoxins and vaccines since the virus-toxin law enacted by Congress in 1902 [see below, section titled Leapfrogging Mutual Exemptions] and also from all labels and "fact sheets" for EUA products since the emergency countermeasures law enacted by Congress in 2003.
Oct. 22, 2020 FDA VRBPAC meeting: Marion Gruber, Director, FDA Center for Biologics Evaluation and Research CBER Office of Vaccines Research and Review (OVRR), transcript at p. 37:
In order to issue an EUA, the FDA must determine, among other things, that the product may be effective and that the known and potential benefits of the investigational product outweigh its known and potential risks.
Use of an investigational COVID-19 vaccine under an EUA is not subject to informed consent requirements.
However, vaccine recipients need to be provided a fact sheet, and that describes the investigational nature of the product, the known and potential benefits and risks of the product, available alternatives, and there is the option to refuse vaccination.
Gruber was correctly reporting on the legal requirements: regulators and manufacturers are legally-authorized to omit specific identity information from EUA product fact sheets, which are substitute or false informed consent documents containing only general information, descriptions, or explanations.
Congress enacted the omission provision in 2003 (PL 108-136, NDAA FY2004 at 117 Stat. 1686) and the provisions entered into the Food Drug and Cosmetic Act (US Code Title 21 at 21 USC 360bbb-3(e)
Congress enacted substitute or fake informed consent provisions to continue to hide labeling omissions; to continue to hide the non-existence of legal requirements, since 1902, that biological product manufacturers and regulators identify and publish (on labels and other printed material) the specific contents of vaccine and other biological product packages.
21 U.S. Code §360bbb–3(e)(1)(A)(ii), Authorization for medical products for use in emergencies, Conditions of authorization, Unapproved product
(A) Required conditions
With respect to the emergency use of an unapproved product, the Secretary, to the extent practicable given the applicable circumstances described in subsection (b)(1), shall, for a person who carries out any activity for which the authorization is issued, establish such conditions on an authorization under this section as the Secretary finds necessary or appropriate to protect the public health, including the following:
(ii) Appropriate conditions designed to ensure that individuals to whom the product is administered are informed—
(I) that the Secretary has authorized the emergency use of the product;
(II) of the significant known and potential benefits and risks of such use, and of the extent to which such benefits and risks are unknown; and
(III) of the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.
Emergency Use Authorization letters for COVID-19 vaccines corroborate the legalized omission of specific identity information from product labels.
See, for example, Dec. 11, 2020 letter, Denise Hinton, FDA to Elisa Harkins, Pfizer, published at 86 FR 5204:
“Product Description
The Pfizer-BioNTech COVID-19 Vaccine is supplied as frozen suspension in multiple dose vials; each vial must be diluted with 1.8 mL of sterile 0.9% Sodium Chloride Injection, USP prior to use to form the vaccine. After dilution, each vial contains 5 doses of 0.3 mL per dose. The Pfizer-BioNTech COVID-19 Vaccine does not contain a preservative.
Each 0.3 mL dose of the Pfizer-BioNTech COVID-19 Vaccine contains 30 mcg of a nucleoside-modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2.
Each dose of the Pfizer-BioNTech COVID-19 Vaccine also includes the following ingredients: lipids (0.43 mg (4-hydroxybutlyl)azanedyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.05 mg 2[(polyethylene glycol)-2000]-N,N-ditetradyecylacetamide, 0.09 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.2 mg cholesterol), 0.01 mg potassium chloride, 0.01 mg monobasic potassium phosphate, 0.35 mg sodium chloride, 0.07 mg dibasic sodium phosphate dihydrate and 6 mg sucrose. The diluent (0.9% Sodium Chloride Injection) contributes an additional 2.16 mg sodium chloride per dose.
The dosing regimen is two doses of 0.3 mL each, 3 weeks apart.”
The December 2020 Product Description by FDA and Pfizer-BioNTech uses the indefinite article "a nucleoside-modified messenger RNA..." and provides no information about how to validate the claimed mass and concentration of an indeterminate product (30 mcg per 0.3 mL dose) or convert from the claimed mass and concentration of the indeterminate biological product to predictable effects.
Again, this is because mass and concentration of unstable, dynamic mixtures of living and dying organisms and fragments of their cells cannot be validated — there are no scientific techniques, equipment or methods that don't fully destroy each sample — and because effects cannot be predicted accurately and specifically: effects vary immeasurably through the interaction of the injected material with itself before injection and with the recipient's own living body after injection.
FDA, Pfizer and vaccinators provide no information about the specific molecular structure of the claimed RNA molecules, because RNA molecules are not stable and, if present at all, are present in a variety of ever-changing forms in the package, interacting with, transforming and being transformed by all the other listed contents, which also may or may not be in the bottle at any given moment while the contents are active, growing, living and decaying.
The Dec. 2020 Fact Sheet given to recipients includes a list of names of substances, including unspecified "mRNA."
What are the ingredients in the Pfizer-BioNTech COVID-19 Vaccine?
The Pfizer-BioNTech COVID-19 Vaccine includes the following ingredients:
mRNA, lipids, ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 2 [(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 1,2-Distearoyl-sn-glycero-3- phosphocholine, and cholesterol), potassium chloride, monobasic potassium phosphate, sodium chloride, dibasic sodium phosphate dihydrate, and sucrose.
Publicly-available manufacturing contracts, such as the Pfizer Statement of Work produced during Brook Jackson’s False Claims Act case, and publicly-available regulatory application documents redact all information that would further reveal the unstable, mixed, unspecified, unidentifiable nature of vaccine contents.
Even after the fake FDA "approval" of the Pfizer-BioNTech Biologics License Application (BLA) in August 2021, for example, the Comirnaty label for the vial simply describes the contents as "one dose of 0.3 mL."
Screenshot from FDA Purple Book, Comirnaty entry, 2023-2024 Formula
Some records:
2003.11.24 PL 108-136 NDAA EUA adding 21 USC 360bbb-3 emergency use 10 USC 2370a note
2020.10.22 FDA VRBPAC Meeting Transcript CBER OVRR Gruber Fact Sheet No Informed Consent
2020.07.21 DOD ATI Pfizer Technical Direction Letter Statement of Work OTA-W15QKN-16-9-1002 35 p (redacted)
2025.01.01 SC Code 44-4 Emergency Health Powers current version
2025.01.14 South Carolina Senate Bill 54 Medical Informed Consent Act
Leapfrogging mutual exemptions
Tracking the two separate legal pathways for "biological products" and for "drugs" from the opening of the legal hole for biological products through 1944.
BIOLOGICAL PRODUCTS - Viruses, serums, toxins, antitoxins and analogous products, including all vaccines.
1902 Virus, Serum and Toxin Act, PL 57-244
Congress required package labels for viruses, serums, toxins, antitoxins and analogous products - to contain:
“the proper name of the article contained therein,
the name, address, and license number of the manufacturer, and
the date beyond which the contents cannot be expected beyond reasonable doubt to yield their specific results.”
Congress required no information about product identity, mass, volume or other physical or chemical qualities or quantities.
That was the opening of the legal hole through which unidentified, unidentifiable, mixtures of unstable, foreign biological substances would be legally labeled as medicines and legally injected into people to poison, sicken and kill them for the following 120+ years.
DRUGS
1906 Pure Food and Drug Act, PL 59-384
Section 6 defined the term "drug" as "all medicines and preparations recognized in the United States Pharmacopeia-National Formulary [USP-NF] for internal or external use, and any substance or mixture of substances intended to be used for the cure, mitigation, or prevention of disease of either man or other animals."
Section 7 provided that, for drugs sold under USP-NF-recognized names, a drug would be deemed adulterated under either of two conditions:
if it "differs from the standard of strength, quality, or purity, as determined by the test laid down" in the USP-NF "official at the time of investigation" with exemptions for drugs whose "standard of strength, quality or purity" was "plainly stated on the bottle, box, or other container" even if the standard differed from the standard determined by the USP-NF test, or
if the product's "strength or purity fall below the professed standard or quality" stated on the package under which it was sold.
Section 8 defined misbranded as applying to all drugs "the package or label of which shall bear any statement...regarding such article, or the ingredients or substances contained therein which shall be false or misleading in any particular."
The 1906 Pure Food and Drug Act also deemed drugs misbranded if demonstrated to be "an imitation of or offered for sale under the name of another article;" in packages that had had original contents removed and substituted with other contents; or if the package label failed to list the "quantity or proportion of any alcohol, morphine, opium, cocaine, heroin, alpha or beta eucaine, chloroform, cannabis indica, chloral hydrate, or acetanilide, or any derivative or preparation of any such substances."
Unpacking the resulting status of biological products under the Pure Food and Drug Act:
Biological products were not sold under names recognized by the USP-NF, and — as biological products subject only to the 1902 law — were not required to be labeled with any specific, identifying information about ingredients or substances.
Since there were no specific "statements about the article, ingredients or substances" on biological products at all, there were no statements that could be assessed or deemed "false or misleading."
Adulteration and misbranding provisions were therefore not applicable to biological products.
DRUGS
1938 Federal Food, Drug and Cosmetic Act - (PL 75-717)
Congress in 1938 passed the Federal Food Drug and Cosmetic Act (FDCA), repealing and replacing the 1906 Pure Food and Drug Act, and carrying forward the comprehensive inapplicability of drug manufacturing, labeling and distribution regulations to biological product manufacturing, labeling and distribution activity, through Sec. 902(c):
"Nothing contained in this Act shall be construed as in any way affecting, modifying, repealing, or superseding the provisions of the virus, serum, and toxin Act of July 1, 1902."
For drugs already in use, the FDCA maintained most of the 1906 rules for drugs.
The 1938 FDCA deemed a drug sold under a USP-recognized name to be adulterated if
“…its strength differs from, or its quality or purity falls below, the standard set forth in such compendium" to be determined by "tests or methods of assay set forth in such compendium…” 1938 FDCA Section 501
For drugs already in use, 1938 FDCA required labels to contain:
“...the name and place of business of the manufacturer, packer, or distributor; and
...an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count...
adequate directions for use...
adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application…” 1938 FDCA Section 502
For drugs already in use, 1938 FDCA deemed a drug to be misbranded if its labeling was:
“...false or misleading in any particular...” 1938 FDCA Section 502
The 1938 FDCA also provided for several exemptions and waivers to be promulgated by the Secretary of Agriculture at his discretion, including conditions under which any otherwise applicable requirement "is not necessary for the protection of the public health."
For new drugs — drugs not already in use by 1938, that manufacturers wanted to begin selling — the 1938 FDCA required applicants to provide the Secretary of Agriculture with
“…reports of investigations...to show whether or not such drug is safe for use...
a full list of articles used as components of such drug...
a full statement of the composition of such drug...
a full description of the methods used in, and the facilities and controls used for, the
manufacture, processing and packaging of such drug...
samples of such drug and of the articles used as component thereof as the Secretary may require and...
specimens of the labeling proposed to be used for such drug.” 1938 FDCA Section 505(b)
New drug applications would become effective, allowing introduction of the drug into interstate commerce, automatically on the sixtieth day after filing, unless the Secretary issued an order refusing to permit the application to become effective.
For new drug applications, the 1938 FDCA authorized the Secretary to issue an order refusing to permit the application to become effective, upon finding
“that the submitted test results were inadequate to demonstrate safety, or
that the submitted tests results demonstrated the drug to be unsafe, or
that "the methods used in, and the facilities and controls used for, the manufacture,
processing, and packing of such drug are inadequate to preserve its identity, strength, quality and purity.” 1938 FDCA Section 505(d)
BIOLOGICAL PRODUCTS
1944 Public Health Service Act (PL 78-410)
With the 1944 Public Health Service Act, Congress reinforced the separation of biological product regulation from drug regulation that had already been put in place in 1902 and 1906 and reinforced in 1938:
PHSA 351(g): Nothing contained in this Act shall be construed as in any way affecting, modifying, repealing, or superseding the provisions of the Federal Food, Drug and Cosmetic Act.
Through the 1944 PHSA, Congress added to the list of biological products, which up until then included "virus, therapeutic serum, toxin, antitoxin or analogous product" the phrase "arsphenamine or its derivatives (or any other trivalent organic arsenic compound)." PHSA 351(a)
Through the 1944 PHSA, Congress left in place the very short list of required package markings, limited to:
the proper name of the article contained therein
the name, address and license number of the manufacturer, and
the date beyond which the contents cannot be expected beyond reasonable doubt to yield their specific results. (1944 PHSA Section 351(a)(2))
Through the 1944 PHSA, Congress left in place the legal hole through which poisons could be manufactured, labeled without specific identification or quantification of contents, distributed and used, disguised as standardized, regulated medicinal products.
At Section 351(d) Congress introduced the phrase "continued safety, purity, and potency" falsely described as "standards" biological product manufacturing processes must be "designed to insure" for licenses to be issued, even though no such standards had ever existed, and no manufacturing, testing or regulatory compliance procedures had ever been designed to insure them.
Such standards can never exist, and such manufacturing processes can never be designed or used, because biologically-active biological organisms cannot be stabilized, standardized, purified, or rendered safe to inject into another living creature, or rendered potent or effective for anything other than untraceable poisoning.
Related:
Feb. 9, 2023 - On the significance of 21 USC 360bbb-3(k): "use" of EUA products "shall not constitute clinical investigation."