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FDA-2025-P-1807
Gene therapy or vaccine? FDA still hasn't said.
IoJ's citizen petition asks FDA to classify the COVID mRNA products under its own definitions — and 31 more things that follow from the answer.
The case
IoJ asks FDA whether the COVID mRNA products are gene therapy under FDA's own definitions, plus 31 requests that follow from the answer.
Where it stands
FDA didn't deny it. On Sept 15, 2026 it asked for supporting evidence, and IoJ filed it on Sept 29. FDA still hasn't decided.
What's next
IoJ's federal mandamus asks a judge to make FDA decide. The 32 Points series will explain each request, one by one.
June 17, 2025
Filed
32 requests, nine months of work.
Sept 15, 2026
FDA didn't deny it
CBER asked for supporting evidence.
Sept 29, 2026
Evidence filed on time
The supplement went in by FDA's deadline.
The 32 Points
Tap any card.
Each request, in plain English. The four marked "Strong" carry the case.
01Strong
Reclassify the shots as gene therapy and apply the full gene therapy rules
Request 1 of FDA-2025-P-1807. One of the petition's strongest requests. Episode in preparation.
02Strong
FDA's own guidance defines what these products are, and the Secretary has to say so
Request 2 of FDA-2025-P-1807. One of the petition's strongest requests. Episode in preparation.
03
"Minimal risk" can't stand as the label on your shot
Request 3 of FDA-2025-P-1807. Episode in preparation.
04
Your label should say what the product is and what it does
Request 4 of FDA-2025-P-1807. Episode in preparation.
05
Your legal right to ask FDA to write a rule — used
Request 5 of FDA-2025-P-1807. Episode in preparation.
06
The 10-nanogram DNA limit, and what was measured in the vials
Request 6 of FDA-2025-P-1807. Episode in preparation.
07
Open a safety investigation at HHS
Request 7 of FDA-2025-P-1807. Episode in preparation.
08
A public correction FDA owes you
Request 8 of FDA-2025-P-1807. Episode in preparation.
09
A clinical hold
Request 9 of FDA-2025-P-1807. Episode in preparation.
10
Suspend the authorizations and licenses
Request 10 of FDA-2025-P-1807. Episode in preparation.
11
Which shots are still emergency use, and which are licensed
Request 11 of FDA-2025-P-1807. Episode in preparation.
12Strong
Does the PREP Act shield still cover a gene therapy product?
Request 12 of FDA-2025-P-1807. One of the petition's strongest requests. Episode in preparation.
13
What doctors and patients should be told
Request 13 of FDA-2025-P-1807. Episode in preparation.
14
What the executive branch has already admitted
Request 14 of FDA-2025-P-1807. Episode in preparation.
15
Was the emergency authorization stretched past the law?
Request 15 of FDA-2025-P-1807. Episode in preparation.
16
A remedy matched to each product
Request 16 of FDA-2025-P-1807. Episode in preparation.
17
Enforcement — what FDA can actually do
Request 17 of FDA-2025-P-1807. Episode in preparation.
18
A public report on what went wrong
Request 18 of FDA-2025-P-1807. Episode in preparation.
19
A formal scientific hearing with Yeadon, Lindsay and Latypova
Request 19 of FDA-2025-P-1807. Episode in preparation.
20
The CDC schedule question
Request 20 of FDA-2025-P-1807. Episode in preparation.
21Strong
The gene therapy test package FDA never required
Request 21 of FDA-2025-P-1807. One of the petition's strongest requests. Episode in preparation.
22Strong
Up to 15 years of follow-up, and who is owed it
Request 22 of FDA-2025-P-1807. One of the petition's strongest requests. Episode in preparation.
23
The Pentagon rule proposal from Sept 4, 2024
Request 23 of FDA-2025-P-1807. Episode in preparation.
24
The Pentagon's role in Operation Warp Speed
Request 24 of FDA-2025-P-1807. Episode in preparation.
25
The PCR test authorizations
Request 25 of FDA-2025-P-1807. Episode in preparation.
26
Is a PCR result alone a diagnosis?
Request 26 of FDA-2025-P-1807. Episode in preparation.
27
Cycle thresholds, and why one number changed everything
Request 27 of FDA-2025-P-1807. Episode in preparation.
28
A test result has to be read with symptoms
Request 28 of FDA-2025-P-1807. Episode in preparation.
29
Full transparency on safety data
Request 29 of FDA-2025-P-1807. Episode in preparation.
30
The safety investigation, continued
Request 30 of FDA-2025-P-1807. Episode in preparation.
31
See the full petition on the docket
Request 31 of FDA-2025-P-1807. Episode in preparation.
32
Send it to the Inspector General and Congress
Request 32 of FDA-2025-P-1807. Episode in preparation.