{"id":82063,"date":"2026-09-29T09:25:03","date_gmt":"2026-09-29T13:25:03","guid":{"rendered":"https:\/\/stateofthenation.info\/?p=82063"},"modified":"2026-09-29T09:32:21","modified_gmt":"2026-09-29T13:32:21","slug":"beware","status":"publish","type":"post","link":"https:\/\/stateofthenation.info\/?p=82063","title":{"rendered":"

BEWARE!<\/span> <\/span><\/b><\/h1>"},"content":{"rendered":"

The new mRNA flu vaccines, among many others,
\ncan be shipped from secret military facilities…..
\nbecause the FDA has apparently waived the
\nstatutory requirement for the manufacturer’s
\naddress to appear on the carton\/vial.<\/strong><\/h2>\n

<\/p>\n

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Moderna\u2019s mFLUSIVA and SPIKEVAX violate federal labeling law (BLA). The FDA cannot waive statutory requirement for manufacturer address on the carton\/vial.<\/h1>\n

The issue is not limited to mRNA or vaccines in general, many biologics in the US are missing manufacturer\u2019s address, and can be shipped from secret [military?] facilities.<\/h3>\n

Sasha Latypova<\/p>\n

Executive Summary<\/h3>\n

Moderna\u2019s mFLUSIVA is hitting the pharmacies imminently <\/a>and with it, there is another tsunami of deaths and injuries to be expected. I previously wrote about mFLUSIVA\u2019s known toxicity, inducing liver and kidneys into bubbling (fermentation)<\/a>. The information in this post may be crucial for initiating a variety of legal actions. By conducting a broad research across all biologics labels, I found that all mRNA shots<\/strong>, many non-vaccine biologics and traditional vaccines on the market today violate the statute Section 351(a)(1)(B) of the Public Health Service Act (PHS Act), codified at 42 U.S.C. \u00a7 262(a)(1)(B)<\/strong> [Source<\/a>] which mandates that the product\u2019s packaging, carton, vial and product insert plainly list the manufacturer and the specific manufacturing sites(s) address(es). This statutory requirement has no exceptions and does not give the FDA discretion to amend or waive it. It is an unusually strong legal requirement, and for a good reason – because NOTHING ELSE in BLA labeling is mandated by the law! For all other labeling items, such as safety and efficacy claims, the FDA has discretion to determine what data is acceptable.<\/p>\n

This is important for all vaccine mandates – it is my theory that consumers and state law enforcement (AGs) can challenge the products that are being distributed in violation of the interstate commerce law, in-state pharmacy law and consumer protection statutes.<\/p>\n

For mRNA shots, it is even more important – the FDA is claiming they are \u201creal BLA\u201d approvals, yet, at the same time, these products are in violation of this single statutory BLA requirement. This is another proof they are countermeasures and the FDA is lying about these products being fully licensed.<\/p>\n

Main Post<\/h3>\n

BIOLOGICAL PRODUCTS<\/strong> are defined in law as \u201cviruses, serums, toxins, antitoxins and analogous products, including all vaccines\u201d. Of course, all of these are made-up names and are not real definitions. This is because none of these things are really definable, as nature derived products do not have a defined \u201ccomposition of matter\u201d or list of ingredients. Can you make a cup of synthetic orange juice? No! You need to grow and harvest oranges. There is no method to throw reagents together and get the same thing. Thus the composition of orange juice remains nature\u2019s secret and can\u2019t be fully characterized and regulated.<\/p>\n

A few years after the 1902 Virus Toxin Act, the Congress delineated what are not biologics – i.e. drugs. 1906 Pure Food and Drug Act, PL 59-384<\/a> Section 6 defined the term \u201cdrug\u201d as \u201call medicines and preparations recognized in the United States Pharmacopeia-National Formulary [USP-NF]<\/a> 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.\u201d<\/p>\n

Drugs are definable chemical substances<\/strong>. They can be synthesized in a definable process of steps and the final composition can be fully characterized. The identity of the inputs, in-process compounds and final product is known, and can be reliably verified using standard chemical methods. The drug products can also be found less than perfect, and, they can be found \u201cadulterated\u201d, i.e. containing materials that don\u2019t belong in the defined chemical composition.<\/p>\n

The main law that still governs all \u201cbiologics\u201d today (whether truly nature-derived, or just claimed to be for purposes of avoiding meaningful regulation) is the 1902 Virus Toxin Act. In its 1902 Virus, Serum and Toxin Act, PL 57-244<\/a><\/strong> Congress required package labels for viruses, serums, toxins, antitoxins and analogous products – to contain: \u201cthe proper name of the article contained therein, the name, address, and license number of the manufacturer<\/mark>, and the date beyond which the contents cannot be expected beyond reasonable doubt to yield their specific results.\u201d<\/p>\n

More details about the laws [non-] regulating biologics and drugs can be found in this post:<\/p>\n

Let\u2019s review the exact statutory language for FDA-approved biologics labeling (BLA)<\/h3>\n

\u201cNo person shall introduce or deliver for introduction into interstate commerce any biological product unless\u2014<\/strong><\/p>\n

(A)<\/strong> a biologics license under this subsection or subsection (k) is in effect for the biological product; and<\/p>\n

(B) each package of the biological product is plainly marked with\u2014<\/strong><\/p>\n

(i)<\/strong> the proper name of the biological product contained in the package;<\/p>\n

**(ii) the name, address, and applicable license number of the manufacturer of the biological product<\/mark>; and<\/p>\n

(iii)<\/strong> the expiration date of the biological product.\u201d<\/p><\/blockquote>\n

The requirement is found directly in Section 351(a)(1)(B) of the Public Health Service Act (PHS Act), codified at 42 U.S.C. \u00a7 262(a)(1)(B)<\/strong>. [Source<\/a>]<\/p>\n

The FDA implements this statutory requirement through 21 CFR \u00a7 610.61(b)<\/strong>, which provides:<\/p>\n

\u201cThe following items shall appear on the label affixed to each package containing a product:<\/strong><\/p>\n

(a)<\/strong> The proper name of the product;<\/p>\n

(b) The name, address, and license number of manufacturer<\/mark>;<\/strong><\/p>\n

(c)<\/strong> The lot number or other lot identification;<\/p>\n

(d)<\/strong> The expiration date; \u2026\u201d<\/p><\/blockquote>\n

[Source: Legal Information Institute<\/a>]<\/p>\n

There is a parallel requirement for the container label<\/strong> in 21 CFR \u00a7 610.60(a)(2)<\/strong>:<\/p>\n

\u201cThe name, address, and license number of manufacturer.\u201d<\/mark><\/strong><\/p><\/blockquote>\n

[Source: Legal Information Institute<\/a>]<\/p>\n

[Source: 21 CFR \u00a7 610.61 \u2014 Package label<\/a>]<\/p>\n

[Source: 21 CFR \u00a7 610.60 \u2014 Container label<\/a>]<\/p>\n

The PHS Act itself says \u201ceach package … is plainly marked\u201d<\/strong>, whereas the implementing regulation specifies that the information must appear on the package label<\/strong> and, where applicable, the container label<\/strong>. FDA has expressly recognized that the statutory requirement in Section 351(a) is the basis for requiring the manufacturer\u2019s name, address, and license number on biological-product labeling.<\/p>\n

Also, if two or more licensed manufacturers<\/strong> participate in manufacturing the biological product, 21 CFR \u00a7 610.63<\/strong> specifically requires:<\/p>\n

\u201cthe name, address, and license number of each must appear<\/mark> on the package label, and on the label of the container if capable of bearing a full label.\u201d<\/strong> Source: GovInfo<\/a><\/p><\/blockquote>\n

21 CFR \u00a7 610.63 \u2014 Divided manufacturing responsibility:<\/p>\n

\u00a7 610.63 Divided manufacturing responsibility to be shown.<\/mark><\/strong><\/p>\n

If two or more licensed manufacturers<\/a> participate in the manufacture<\/a> of a biological product<\/a>, the name, address, and license number of each must appear<\/mark> on the package<\/a> label<\/a>, and on the label of the container<\/a> if capable of bearing a full label.<\/p>\n

[64 FR 56453<\/a>, Oct. 20, 1999]<\/p><\/blockquote>\n

There are no amendments, waivers or exemptions to this labeling requirement:<\/h3>\n

The current FDA regulations still require the manufacturer name and address be listed on the label and carton [21 C.F.R. \u00a7 610.61(b)<\/strong>]. In fact, there is unusually strong evidence from FDA\u2019s own rulemaking that FDA understood the statutory requirement to be mandatory<\/mark><\/strong>, not something it could simply eliminate through regulation.<\/p>\n

1. Congress expressly preserved the labeling requirement<\/h4>\n

The current statute contains the requirement in \u00a7 351(a)(1)(B)(ii), and the current U.S. Code still contains it essentially verbatim.<\/p>\n

This requirement may be waived investigational<\/mark> biological product currently <\/mark>undergoing investigation (in clinical trials)<\/mark><\/strong> – simply because the requirement is for fully licensed (FDA approved) products, not products still in development. The exact labeling for the product and carton is part of the FDA review and approval process.<\/p>\n

However, the FDA cannot say, for an ordinary licensed commercial biologic, \u201cwe are exempting this product from \u00a7 351(a)(1)(B)(ii)\u201d<\/em>, \u00a7 351(a)(3) does not provide that authority.<\/p>\n

2. FDA\u2019s own 1996 rulemaking confirmed \u201cmandatory\u201d interpretation:<\/h4>\n

There is a very useful piece of FDA\u2019s regulatory history from 1996. When FDA amended the biologics labeling regulations, commenters asked FDA to eliminate the requirement that the manufacturer\u2019s name and address appear on biologic labeling, essentially to harmonize biologics with drug labeling.<\/p>\n

FDA <\/mark>rejected that request, stating<\/mark><\/strong>:<\/mark><\/p>\n

\u201cThe PHS Act, section 351(a), requires that each package of a biological product subject to licensure be plainly marked with the name, address, and license number of the manufacturer.\u201d<\/p><\/blockquote>\n

FDA further explained that its regulation requiring the information on the biologic label was intended to implement that statutory requirement. [Source: GovInfo<\/a>]<\/p>\n

This demonstrates that the FDA itself historically interpreted \u00a7 351(a) as imposing a statutory requirement that could not simply be eliminated through ordinary rulemaking. The 1996 rule also retained<\/strong> the manufacturer name, address and license-number requirements in \u00a7\u00a7 610.60 and 610.61. [Source: GovInfo<\/a>]<\/p>\n

3. Strategic National Stockpile<\/h4>\n

There is a regulation that permits FDA to grant certain labeling exceptions:<\/p>\n

21 C.F.R. \u00a7 610.68 \u2014 Exceptions or alternatives to labeling requirements for biological products held by the Strategic National Stockpile.<\/strong><\/p>\n

However, it says the FDA may grant an exception to specified labeling requirements \u201cnot explicitly required by statute.\u201d<\/mark><\/strong> [Source: eCFR<\/a>] Paragraph (f) expressly says that the Center Director may grant exceptions to \u00a7 610.60 and portions of \u00a7 610.61:<\/p>\n

\u201cto the extent that the requirements in these provisions are not explicitly required by statute<\/strong>.\u201d [Source: eCFR<\/a>]<\/p><\/blockquote>\n

FDA specifically cited \u00a7 351(a)(1)(B) and its requirement for the manufacturer\u2019s name, address, and applicable license number<\/strong>, and stated that the rule <\/mark>does not permit exceptions or alternatives to those requirements<\/mark><\/strong>.<\/mark><\/p>\n

Federal Register, Vol. 72, No. 248 (Dec. 28, 2007), pp. 73589\u201373602 \u2014 GovInfo PDF<\/a><\/p>\n

The relevant passage is on page 73595<\/strong> of the Federal Register states:<\/p>\n

\u201cThis rule does not create exemptions from express statutory requirements or prohibitions regarding medical product labeling.\u201d<\/p><\/blockquote>\n

It then specifically says:<\/p>\n

\u201cFor example, section 351(a)(1)(B) of the PHS Act provides that each package of a biological product must be marked with the proper name of the biological product; the name, address, and applicable license number of the manufacturer of the biological product<\/strong>; and the expiration date of the biological product.\u201d<\/p><\/blockquote>\n

And, most importantly:<\/p>\n

\u201cThis interim final rule does not permit exceptions or alternatives to any of those requirements.<\/strong>\u201d<\/p><\/blockquote>\n

That is probably the strongest administrative-law evidence.<\/p>\n

4. FDA enforcement discretion<\/h4>\n

FDA has enforcement discretion<\/strong> concerning biologics labeling. But an FDA decision not to enforce<\/strong> a requirement is legally different from an FDA determination that the statutory requirement does not apply<\/strong>. Therefore, an enforcement-discretion policy would not necessarily constitute a statutory exemption. It would mean FDA has chosen, as an enforcement matter, not to pursue a violation under particular circumstances.<\/p>\n

5. Moderna mRNA vaccines: mFLUSIVA and SPIKEVAX<\/h4>\n

Note: I believe these products are mislabeled and fraudulently presented to the public as \u201cfully licensed biologics\u201d under PHS Act \u00a7 351(a). In reality, these are EUA Countermeasures, a category of military chemical weapon, wrapped in false labels of \u201csafe and effective vaccines\u201d. They are subject to the PREP Act, which effectively removes all manufacturer regulatory compliance and liability for the duration of the related HHS PREP Act declaration (for covid, active until 12\/31\/2029; for pandemic flu – until 12\/31\/2027). A Citizen Petition asking the FDA to properly label these products as EUA Countermeasures for the duration of relevant PREP Act declaration is pending with the FDA. The Petition gathered over 104K public comments in support of it (largest in history for this legal process), yet the FDA declined to act indefinitely.<\/p>\n

However, for purposes of this discussion, let\u2019s assume that the FDA is telling the truth and that these vaccines are, really-really-we-pinky-swear, fully BLA licensed vaccines, following the BLA laws and not the EUA stuff.<\/p>\n

Moderna\u2019s MFLUSIVA (mRNA-1010), BLA 125869:<\/strong><\/p>\n