Food and Drug Administration Major advanced economies

Last updated 14 Jun 2026 · Full ledger: Hallucination Register · Companion view: Findings by audience

This page indexes the regulations issued by Food and Drug Administration (FDA) that RegLegBrief has built substrate for and tested against named AI subjects. Each regulation row opens the regulation hub where verified findings are listed — AI subject's answer vs. the regulator's verbatim primary-source text, classified against the four hallucination failure modes (inference drift, misstated rule, misattributed, outdated) and the three citation issue types (Contradictory, Pretextual, Fabricated), each with an immutable Citation ID. New regulations are added as they are sponsored or commissioned.

Regulations

Regulation	Status	Findings live
Final Guidance, Sponsor Responsibilities: Safety Reporting Requirements and Safety Assessment for IND and BA/BE Studies IND-SAFETY-REPORTING-SPONSOR-RESPONSIBILITIES-2025	Research Pending	0
Proposed Administrative Order, Bemotrizinol as New Active Ingredient for OTC Sunscreen Monograph PROPOSED-BEMOTRIZINOL-SUNSCREEN-OTC-MONOGRAPH	Research Pending	0
Color Additive Order, Revocation of FD&C Red No. 3 Authorization for Food and Ingested Drugs RED-NO-3-COLOR-ADDITIVE-REVOCATION	Research Pending	0
21 CFR Part 820, Quality Management System Regulation (QMSR) for Medical Devices 21-CFR-820-QMSR-MEDICAL-DEVICES	Research Pending	0
FSMA Section 204, Requirements for Additional Traceability Records for Certain Foods (Food Traceability Rule) FSMA-204-FOOD-TRACEABILITY-RECORDS	Research Pending	0
FDA Food Code 2022 FDA-FOOD-CODE-2022	Research Pending	0
FSMA Final Rule, Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals (21 CFR Part 1, Subpart L) FSMA-FSVP-FOREIGN-SUPPLIER-VERIFICATION	Research Pending	0
21 CFR Part 112, Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (FSMA Produce Safety Rule) 21-CFR-112-PRODUCE-SAFETY	Research Pending	0
21 CFR Part 117, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (FSMA Preventive Controls Rule) 21-CFR-117-PREVENTIVE-CONTROLS-HUMAN-FOOD	Research Pending	0
21 CFR Part 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements 21-CFR-111-DIETARY-SUPPLEMENTS-CGMP	Research Pending	0
21 CFR Part 11, Electronic Records; Electronic Signatures 21-CFR-PART-11-ELECTRONIC-RECORDS	Research Pending	0
21 CFR Part 601, Licensing of Biological Products Under the Public Health Service Act 21-CFR-601-BIOLOGICS-LICENSING	Research Pending	0
21 CFR Parts 210 and 211, Current Good Manufacturing Practice for Finished Pharmaceuticals 21-CFR-210-211-CGMP-DRUGS	Research Pending	0
Proposed Rule, Front-of-Package Nutrition Labeling for Packaged Foods PROPOSED-FRONT-OF-PACKAGE-NUTRITION-LABELING	Research Pending	0
Proposed Rule, Mandatory GRAS Notifications (Eliminating Self-Affirmed GRAS Pathway) PROPOSED-MANDATORY-GRAS-NOTIFICATIONS	Research Pending	0