openFDA API Rules

x-name: openFDA Usage Rules
description: Operational, security, and compliance rules for the openFDA API.
rules:
  - id: api-key-required-at-scale
    statement: An API key is recommended for any sustained or production-grade usage.
    rationale: >-
      Without a key, requests are limited to 240/min and 1,000/day per IP. With
      a key the daily ceiling rises to 120,000.
    severity: required
  - id: https-only
    statement: All requests must be made over HTTPS.
    severity: required
  - id: not-clinical-grade
    statement: Data must not be used for individual clinical care decisions.
    rationale: openFDA explicitly disclaims clinical and production validation.
    severity: required
  - id: no-public-alerts
    statement: Do not use openFDA as the source of public health alerts.
    rationale: FDA does not update recall status post-classification; alerting belongs to FDA channels.
    severity: required
  - id: pagination-cap
    statement: Results pagination is capped at skip=25,000 and limit=1,000.
    severity: advisory
  - id: respect-rate-limits
    statement: Implement exponential backoff on HTTP 429 responses.
    severity: required
  - id: causality-disclaimer
    statement: Adverse event reports do not establish causation between product and reaction.
    severity: required