BREAKING!! FDA Issues Gene Therapy Guidance While Refusing to Answer if mRNA is Gene Therapy
The agency that “needs more time” just exposed itself
By Interest of Justice | January 12, 2026
On January 11, 2026, the FDA did something remarkable! they accidentally admitted they’ve been lying to the world for five years!
While telling IoJ they “need more time” to answer the FDA Petition on whether mRNA COVID-19 products are gene therapy, they simultaneously issued comprehensive new regulatory guidance for gene therapy products.
Here’s an explanation so you can see this clearly~
What Happened
June 17, 2025 Interest of Justice files Citizens Petition FDA-2025-P-1807—132 pages asking FDA to reclassify mRNA products as gene therapy under their own definition.
December 12, 2025FDA responds: needs “further review and analysis by agency officials”.
January 11, 2026FDA issues “Flexible Requirements for Cell and Gene Therapies” guidance.
January 22, 2026U.S. withdraws from WHO—10 days away
30 days. That’s all it took for FDA to go from “we can’t answer your gene therapy question” to “here’s our comprehensive gene therapy regulatory framework.”
What Happened Yesterday?
FDA Commissioner Marty Makary announced new “flexible regulatory requirements” for Cell and Gene Therapy (CGT) products. The guidance specifies exactly what’s required for gene therapy:
IND submissions under 21 CFR 312
CBER (Center for Biologics) review
BLA (Biologics License Application) submissions
CMC (Chemistry, Manufacturing, Control) data
Long-term follow-up (FDA’s gene therapy guidance specifies 5-15 years)
mRNA COVID-19 products received NONE of these.
FDA’s Own Definition
FDA’s 2020 guidance document “Human Gene Therapy for Rare Diseases” defines gene therapy products:
“The FDA generally considers human gene therapy products to include all products that mediate their effects by transcription or translation of transferred genetic material... Some examples of gene therapy products include nucleic acids (e.g., plasmids, in vitro transcribed ribonucleic acid (RNA))...”
Read that again.
“In vitro transcribed ribonucleic acid (RNA)”
That’s literally what mRNA COVID-19 products are. This isn’t interpretation or opinion! This is FDA’s own definition in their own binding guidance!
Moderna Damn Well Knew! They Told the SEC.
In their Q2 2020 SEC filing—a mandatory legal disclosure subject to federal securities laws—Moderna made a stunning admission..
“Currently, mRNA is considered a gene therapy product by the FDA.”
This wasn’t buried in some obscure document. This was in their securities filing. They were legally required to tell investors the truth about regulatory classification.
BioNTech founder Dr. Ugur Sahin said in 2014…
“One would expect the classification of an mRNA drug to be a biologic, gene therapy, or somatic cell therapy.”
Both manufacturers expected gene therapy classification.
The sudden reclassification as “vaccines” wasn’t science—it was purely regulatory manipulation.
FDA proves IoJ’s point in the lamest way~
Our petition explicitly argued that…
“regulatory flexibility cannot extend to contradicting explicit regulatory definitions” and “definitional flexibility contradicts the rule of law.”
FDA’s response 30 days after saying they need “further review” on our petition, they issued “regulatory flexibility” guidance... for gene therapy.
They literally responded to our regulatory flexibility argument by issuing regulatory flexibility guidance while claiming they can’t answer whether mRNA is gene therapy.
It is obscene.
The Devastating Timeline
Let me make this crystal clear…
Gene therapy requires IND pathway
mRNA products bypassed IND entirely
Gene therapy requires CBER review mRNA to be reviewed as “vaccines”. Gene therapy requires BLA submission. mRNA got Emergency Use Authorization. Gene therapy needs 5-15 year follow-up. mRNA had NO long-term follow-up, gene therapy requires informed consent and the Public were told these were “vaccines”
Every single requirement FDA specifies for gene therapy was bypassed.
The Citizens Petition They Can’t Or Will Not Answer!
Interest of Justice filed a Citizens Petition with FDA asking a simple question. Are mRNA products gene therapy under FDA’s own guidance?
Under 21 CFR 10.30(e)(2), FDA must within 180 days either
Approve the petition
Deny the petition
Provide a “tentative response indicating why the agency has been unable to reach a decision, including the reason for any delay“
FDA’s response?
“We need more time.”
No reason given. No explanation. Just... more time.
And then the very next day, they issued comprehensive gene therapy guidance—proving they’re actively working on gene therapy regulation while claiming they can’t answer whether mRNA qualifies.
This isn’t “needing more time.” This is hiding.
What Costa Rica Has Already Proven
Here in Costa Rica, Interest of Justice achieved something remarkable! we got government officials to admit under oath that COVID-19 products were imported as “investigational” under Article 117 biomedical research laws.
The Vice Health Minister testified… “It’s not a vaccine by the legal definition—only by WHO definition.”
The Constitutional Chamber ruled five times in our favor. The government admitted these products don’t meet the legal definition of vaccines.
Costa Rica said the quiet part out loud.
Now FDA’s own guidance confirms it.
The Global Implications
This isn’t just about the United States.! WHO’s Emergency Use Listing was based on FDA’s classification. Countries worldwide—including Costa Rica—imported these products based on WHO recommendations that relied on FDA’s authorization.
The fraud cascaded globally..
DOD contracts (military authority)
↓
FDA classification (fraudulent)
↓
WHO Emergency Use Listing
↓
National implementations worldwide
↓
Billions of people denied informed consent
If FDA’s classification was fraudulent, the entire chain collapses.
Why We Think This Matters Now!
The United States is set to withdraw from WHO on January 22, 2026—just 10 days away.
This creates a critical window:
WHO’s authority over U.S. policy is ending
But FDA’s regulatory fraud will persist unless challenged
The classification question affects every country that followed WHO/FDA guidance
The evidence we now have—FDA’s own words, Moderna’s SEC filings, the manufacturer admissions—cannot be disputed.
They defined gene therapy. mRNA fits the definition. They authorized it anyway without following gene therapy protocols.
That’s not a regulatory oversight. That’s fraud.
What We’re Doing About It!
Interest of Justice is filing!!!
Formal FDA Response Letter demanding substantive explanation within 14 days
APA Complaint in D.C. District Court for unreasonable delay and arbitrary agency action
Updated Article 75 Notice to State Department documenting unsettled disputes before WHO withdrawal
Costa Rica Constitutional Chamber filings incorporating this evidence
We’ve won five Constitutional Chamber victories in Costa Rica. We have WHO stakeholder status. We have expert witnesses including former Pfizer VP Dr. Michael Yeadon.
And now we have FDA’s own confession!
The Question They Can’t Answer
Here’s what FDA cannot explain…
If mRNA isn’t gene therapy, why does it match FDA’s exact definition?
If mRNA is gene therapy, why didn’t it follow gene therapy protocols?
If classification is genuinely uncertain, why issue gene therapy guidance while claiming to “need more time”?
If Moderna told the SEC that FDA considers mRNA gene therapy, who was lying—Moderna to investors, or FDA to the public?
Their silence IS the answer.
The Largest Experiment in History
Make no mistake about what happened!
Billions of people worldwide received experimental gene therapy products while being told they were getting traditional vaccines. They were denied the informed consent that gene therapy requires. They were denied the long-term safety monitoring that gene therapy requires. They were denied the truth.
And the agency responsible for protecting them is still—to this day—refusing to answer basic questions about what they authorized.
The FDA doesn’t need more time.
The FDA needs to be held accountable!
If anybody wants to help IoJ sue the WHO, one of the bigger lawsuits to be filed NOW in the United States Court, and we’re fundraising pronto!!. If everybody feels like the WHO should be sued, we ask all people in the position to help with fees IMMEDIATELY make a sponsorship to this lawsuit (and the list of critical lawsuits in reality)!
We will hold WHO to account and stop the non vax experiments on humanity. It’s not fast or easy work, but we are CORRECT and will CRUSH THEM IN COURT. CALLING ALL LEGAL FEES SPONSORS NOW - THE BATTLE STARTS TOMORROW BIG TIME.
But legal battles require resources. If you believe in holding these agencies accountable, support our work. The next 10 days before WHO withdrawal are critical. Help us make them count!
It's in the patent clearly marked gene therapy.
Thank you SO MUCH for keeping us posted! Blessings, love and hugs to you all.