The new mRNA flu vaccines, among many others,
can be shipped from secret military facilities……..
because the FDA has apparently waived the statutory requirement for the manufacturer’s address to
appear on the carton/vial.

 

Moderna’s mFLUSIVA and SPIKEVAX violate federal labeling law (BLA). The FDA cannot waive statutory requirement for manufacturer address on the carton/vial.

The issue is not limited to mRNA or vaccines in general, many biologics in the US are missing manufacturer’s address, and can be shipped from secret [military?] facilities.

Sasha Latypova

Executive Summary

Moderna’s mFLUSIVA is hitting the pharmacies imminently and with it, there is another tsunami of deaths and injuries to be expected. I previously wrote about mFLUSIVA’s known toxicity, inducing liver and kidneys into bubbling (fermentation). 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, 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. § 262(a)(1)(B) [Source] which mandates that the product’s 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.

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.

For mRNA shots, it is even more important – the FDA is claiming they are “real BLA” 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.

Main Post

BIOLOGICAL PRODUCTS are defined in law as “viruses, serums, toxins, antitoxins and analogous products, including all vaccines”. 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 “composition of matter” 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’s secret and can’t be fully characterized and regulated.

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 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.”

Drugs are definable chemical substances. 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 “adulterated”, i.e. containing materials that don’t belong in the defined chemical composition.

The main law that still governs all “biologics” 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 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.”

More details about the laws [non-] regulating biologics and drugs can be found in this post:

Let’s review the exact statutory language for FDA-approved biologics labeling (BLA)

“No person shall introduce or deliver for introduction into interstate commerce any biological product unless—

(A) a biologics license under this subsection or subsection (k) is in effect for the biological product; and

(B) each package of the biological product is plainly marked with—

(i) the proper name of the biological product contained in the package;

**(ii) the name, address, and applicable license number of the manufacturer of the biological product; and

(iii) the expiration date of the biological product.”

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. § 262(a)(1)(B). [Source]

The FDA implements this statutory requirement through 21 CFR § 610.61(b), which provides:

“The following items shall appear on the label affixed to each package containing a product:

(a) The proper name of the product;

(b) The name, address, and license number of manufacturer;

(c) The lot number or other lot identification;

(d) The expiration date; …”

[Source: Legal Information Institute]

There is a parallel requirement for the container label in 21 CFR § 610.60(a)(2):

“The name, address, and license number of manufacturer.”

[Source: Legal Information Institute]

[Source: 21 CFR § 610.61 — Package label]

[Source: 21 CFR § 610.60 — Container label]

The PHS Act itself says “each package … is plainly marked”, whereas the implementing regulation specifies that the information must appear on the package label and, where applicable, the container label. FDA has expressly recognized that the statutory requirement in Section 351(a) is the basis for requiring the manufacturer’s name, address, and license number on biological-product labeling.

Also, if two or more licensed manufacturers participate in manufacturing the biological product, 21 CFR § 610.63 specifically requires:

“the name, address, and license number of each must appear on the package label, and on the label of the container if capable of bearing a full label.” Source: GovInfo

21 CFR § 610.63 — Divided manufacturing responsibility:

§ 610.63 Divided manufacturing responsibility to be shown.

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

[64 FR 56453, Oct. 20, 1999]

There are no amendments, waivers or exemptions to this labeling requirement:

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

1. Congress expressly preserved the labeling requirement

The current statute contains the requirement in § 351(a)(1)(B)(ii), and the current U.S. Code still contains it essentially verbatim.

This requirement may be waived investigational biological product currently undergoing investigation (in clinical trials) – 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.

However, the FDA cannot say, for an ordinary licensed commercial biologic, “we are exempting this product from § 351(a)(1)(B)(ii)”, § 351(a)(3) does not provide that authority.

2. FDA’s own 1996 rulemaking confirmed “mandatory” interpretation:

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

FDA rejected that request, stating:

“The 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.”

FDA further explained that its regulation requiring the information on the biologic label was intended to implement that statutory requirement. [Source: GovInfo]

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

3. Strategic National Stockpile

There is a regulation that permits FDA to grant certain labeling exceptions:

21 C.F.R. § 610.68 — Exceptions or alternatives to labeling requirements for biological products held by the Strategic National Stockpile.

However, it says the FDA may grant an exception to specified labeling requirements “not explicitly required by statute.” [Source: eCFR] Paragraph (f) expressly says that the Center Director may grant exceptions to § 610.60 and portions of § 610.61:

“to the extent that the requirements in these provisions are not explicitly required by statute.” [Source: eCFR]

FDA specifically cited § 351(a)(1)(B) and its requirement for the manufacturer’s name, address, and applicable license number, and stated that the rule does not permit exceptions or alternatives to those requirements.

Federal Register, Vol. 72, No. 248 (Dec. 28, 2007), pp. 73589–73602 — GovInfo PDF

The relevant passage is on page 73595 of the Federal Register states:

“This rule does not create exemptions from express statutory requirements or prohibitions regarding medical product labeling.”

It then specifically says:

“For 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; and the expiration date of the biological product.”

And, most importantly:

“This interim final rule does not permit exceptions or alternatives to any of those requirements.”

That is probably the strongest administrative-law evidence.

4. FDA enforcement discretion

FDA has enforcement discretion concerning biologics labeling. But an FDA decision not to enforce a requirement is legally different from an FDA determination that the statutory requirement does not apply. 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.

5. Moderna mRNA vaccines: mFLUSIVA and SPIKEVAX

Note: I believe these products are mislabeled and fraudulently presented to the public as “fully licensed biologics” under PHS Act § 351(a). In reality, these are EUA Countermeasures, a category of military chemical weapon, wrapped in false labels of “safe and effective vaccines”. 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.

However, for purposes of this discussion, let’s 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.

Moderna’s MFLUSIVA (mRNA-1010), BLA 125869:

• BLA 125869 was approved August 5, 2026 under PHS Act § 351(a).
• FDA states that the product is licensed under U.S. Government License No. 2256. U.S. Food and Drug Administration
• FDA’s approved prescribing information says:

“Manufactured for:
Moderna US, Inc.
Princeton, NJ 08540”

and separately:

“US Govt. License No. 2256”

The FDA approval letter says the BLA holder is ModernaTX, Inc., and expressly states that ModernaTX is authorized to introduce MFLUSIVA into interstate commerce under HHS U.S. License No. 2256.

The FDA approval letter identifies multiple manufacturing locations (7), including ModernaTX and other facilities, but the facility information are redacted in the publicly released document. It appears the FDA simply accepted Moderna’s proposal to redact all the information, without any pushback or attempt to enforce the law:

Read more about Moderna’s mFlusiva label in this post.

FDA’s Purple Book identifies:

• BLA: 125869
• Applicant: ModernaTX, Inc.
• License type: 351(a)
• Approval date: August 5, 2026
• U.S. license: 2256
• Product: MFLUSIVA / Influenza Vaccine, mRNA

[Source: Purple Book Search]

FDA’s actual approval letter is even clearer:

“You are hereby authorized to introduce or deliver for introduction into interstate commerce, Influenza Vaccine, mRNA under your existing Department of Health and Human Services U.S. License No. 2256.”

[Source: U.S. Food and Drug Administration]

So §351(a)(1)(B) is directly implicated.

However, the labeling does not say:

“Manufactured by ModernaTX, Inc.”

It says:

“Manufactured for: Moderna US, Inc.”

And Moderna US, Inc. is not the entity identified by FDA as the BLA applicant/license holder. The BLA applicant is ModernaTX, Inc.

Admittedly, the “manufacturer” may not necessarily mean every physical facility:

There is a potentially defensible FDA interpretation that the statutory “manufacturer” is the licensed manufacturer/license holder, rather than every contract facility physically involved in some manufacturing operation. 21 C.F.R. §600.3(t) is broad enough that the legal identity of the “manufacturer” needs to be determined from the BLA and establishment responsibilities—not merely from who physically performs a particular step.

The MFLUSIVA approval letter strongly suggests that ModernaTX, Inc. is the licensed entity responsible for the product, because FDA says:

“under your existing Department of Health and Human Services U.S. License No. 2256”

to ModernaTX. U.S. Food and Drug Administration

So there is a possible argument that:

ModernaTX, Inc. = licensed manufacturer

while:

Moderna US, Inc. = U.S. marketing/labeling entity

and the “US Govt. License No. 2256” appearing on the label identifies the relevant biological license. But that leaves a separate question:

Why does the label say “Manufactured for Moderna US, Inc.” rather than identifying ModernaTX, Inc.?

6. SPIKEVAX (incl mNEXSPIKE) label has the same problem as mFLUSIVA.

MFLUSIVA isn’t the only Moderna biologic using this formulation. The same “Manufactured for” construction appears in the FDA-approved SPIKEVAX and mNEXSPIKE labeling.

For example, the FDA’s SPIKEVAX labeling says:

“Manufactured for: Moderna US, Inc. Princeton, NJ 08540”

and separately:

“US Govt. License No. 2256.”

[Source: FDA]

The 2025 mNEXSPIKE label does the same thing. This makes it less likely that the mFLUSIVA language is an accidental one-off. It appears to reflect an FDA-accepted Moderna labeling convention.

7. The labeling violations are not limited to mRNA shots – they are pervasive in the entire Biologics category, which includes numerous vaccines and non-vaccine products on the market:

I ran an in-depth AI search and downloaded all available labeling and FDA documents for all biologics products approved by the FDA since 2000. The labeling of the manufacturing address is not consistent across the products marketed in interstate commerce, and most of these could be deemed in violation of the law with respect to the manufacturing address/origin of product disclosure.

Across the 561 original BLAs FDA approved from January 2000 through early September 2026 (350 CDER, 211 CBER), the package insert almost never identifies the manufacturing facility as such. Only 24 labels (4%) name a specific manufacturing site (”Manufactured by Merck Sharp & Dohme … At: MSD Ireland (Carlow), County Carlow, Ireland”). These appear to be in compliance with the labeling law. The rest of the biologics on the market in the US are either in complete violation of the manufacturer facility disclosure, or have varying degrees of non-compliance. I will address this in detail in future posts.

Why am I focused on this seemingly “trivial” issue?

It is not trivial at all! The statutory requirement for listing the name and address of the manufacturer (and not some corporate front entity) on the biologics labeling under BLA law is very old (since 1902), very clear (carried without change to all subsequent law) and very strong, without any identifiable exemptions or FDA discretion! Imagine if liquor licenses or winery or brewery licenses were issued to secret locations, that the government redacts. What if your underage child is going to visit a location which has a secret, government-redacted alcohol, tobacco, firearms or weed license? Same logic applies here. For medicinal products, traceability and clear labeling of the manufacturer of record is a foundational principle of consumer safety and provider assurance.

I would like to offer this material and my extensive research on this topic to anyone wishing to support federal, state-level or private litigation on related matters. While suing the FDA or corporations under this framework may be difficult for a private cause of action (the US judicial system prevents citizens from asserting their legal rights in general), there may be some scenarios worth testing.

A state Attorney General can bring a mislabeling lawsuit, naming all products that are violating this, not just mRNA shots or vaccines – and that makes it a broad, non-partisan issue – if anyone has connection, please try to reach out or introduce me.

A class action may be possible.

Finally, we may have a way for anyone facing vaccination mandates (employer or school/child) to challenge the mandate or at least buy some time for yourself in legal uncertainty. Please reach out to me at latypova@hotmail.com if you are in this situation. This applies to all vaccines, not just the mRNA shots. I only ask that you only reach out on this topic, as my email is swamped and my time is limited. Please do not write promoting your website, your substack or any other projects.

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https://sashalatypova.substack.com/p/statutory-labeling-requirement-for