FDA
21 CFR / FSMA / Food Code 2022
FDA Food Regulations
U.S. Food and Drug Administration · Most human food other than meat, poultry and processed egg products
FDA regulates food facilities under the Federal Food, Drug, and Cosmetic Act as amended by the Food Safety Modernization Act. The core operational rule is 21 CFR Part 117 (Preventive Controls for Human Food), supplemented by commodity-specific rules for juice and seafood HACCP, produce safety, intentional adulteration, sanitary transportation, and foreign supplier verification.
Key points
- Facilities must register with FDA every even-numbered year and renew between October 1 and December 31.
- A Preventive Controls Qualified Individual (PCQI) must prepare or oversee the food safety plan.
- Reportable Food Registry submissions are required within 24 hours of determining a reportable food.
- FSMA 204 Food Traceability Rule requires Key Data Elements at Critical Tracking Events for foods on the Food Traceability List.
21 CFR Part 117 — Preventive Controls for Human Food
Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls.
Other Key FDA Rules
Commodity and activity-specific regulations.