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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.
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.Read the explainer ↗
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.Read the explainer ↗
03
"Minimal risk" can't stand as the label on your shot
Request 3 of FDA-2025-P-1807. Explained in full in The 32 Points series.Read the explainer ↗
04
Your label should say what the product is and what it does
Request 4 of FDA-2025-P-1807. Explained in full in The 32 Points series.Read the explainer ↗
05
Your legal right to ask FDA to write a rule — used
Request 5 of FDA-2025-P-1807. Explained in full in The 32 Points series.Read the explainer ↗
06
The 10-nanogram DNA limit, and what was measured in the vials
Request 6 of FDA-2025-P-1807. Explained in full in The 32 Points series.Read the explainer ↗
07
Open a safety investigation at HHS
Request 7 of FDA-2025-P-1807. Explained in full in The 32 Points series.Read the explainer ↗
08
A public correction FDA owes you
Request 8 of FDA-2025-P-1807. Explained in full in The 32 Points series.Read the explainer ↗
09
A clinical hold
Request 9 of FDA-2025-P-1807. Explained in full in The 32 Points series.Read the explainer ↗
10
Suspend the authorizations and licenses
Request 10 of FDA-2025-P-1807. Explained in full in The 32 Points series.Read the explainer ↗
11
Which shots are still emergency use, and which are licensed
Request 11 of FDA-2025-P-1807. Explained in full in The 32 Points series.Read the explainer ↗
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.Read the explainer ↗
13
What doctors and patients should be told
Request 13 of FDA-2025-P-1807. Explained in full in The 32 Points series.Read the explainer ↗
14
What the executive branch has already admitted
Request 14 of FDA-2025-P-1807. Explained in full in The 32 Points series.Read the explainer ↗
15
Was the emergency authorization stretched past the law?
Request 15 of FDA-2025-P-1807. Explained in full in The 32 Points series.Read the explainer ↗
16
A remedy matched to each product
Request 16 of FDA-2025-P-1807. Explained in full in The 32 Points series.Read the explainer ↗
17
Enforcement — what FDA can actually do
Request 17 of FDA-2025-P-1807. Explained in full in The 32 Points series.Read the explainer ↗
18
A public report on what went wrong
Request 18 of FDA-2025-P-1807. Explained in full in The 32 Points series.Read the explainer ↗
19
A formal scientific hearing with Yeadon, Lindsay and Latypova
Request 19 of FDA-2025-P-1807. Explained in full in The 32 Points series.Read the explainer ↗
20
The CDC schedule question
Request 20 of FDA-2025-P-1807. Explained in full in The 32 Points series.Read the explainer ↗
21Strong
The gene therapy test package FDA never required
Request 21 of FDA-2025-P-1807. One of the petition's strongest requests.Read the explainer ↗
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.Read the explainer ↗
23
The Pentagon rule proposal from Sept 4, 2024
Request 23 of FDA-2025-P-1807. Explained in full in The 32 Points series.Read the explainer ↗
24
The Pentagon's role in Operation Warp Speed
Request 24 of FDA-2025-P-1807. Explained in full in The 32 Points series.Read the explainer ↗
25
The PCR test authorizations
Request 25 of FDA-2025-P-1807. Explained in full in The 32 Points series.Read the explainer ↗
26
Is a PCR result alone a diagnosis?
Request 26 of FDA-2025-P-1807. Explained in full in The 32 Points series.Read the explainer ↗
27
Cycle thresholds, and why one number changed everything
Request 27 of FDA-2025-P-1807. Explained in full in The 32 Points series.Read the explainer ↗
28
A test result has to be read with symptoms
Request 28 of FDA-2025-P-1807. Explained in full in The 32 Points series.Read the explainer ↗
29
Full transparency on safety data
Request 29 of FDA-2025-P-1807. Explained in full in The 32 Points series.Read the explainer ↗
30
The safety investigation, continued
Request 30 of FDA-2025-P-1807. Explained in full in The 32 Points series.Read the explainer ↗
31
See the full petition on the docket
Request 31 of FDA-2025-P-1807. Explained in full in The 32 Points series.Read the explainer ↗
32
Send it to the Inspector General and Congress
Request 32 of FDA-2025-P-1807. Explained in full in The 32 Points series.Read the explainer ↗