Food & Dietary Supplements

Human food and dietary supplements — preventive controls, HACCP, allergen and pathogen control, and supply-chain safety.

Browse all 9 standardsAssess your quality system →
WHAT THIS INDUSTRY COVERS

Food & Dietary Supplements covers human food and the supplements regulated alongside it — manufacturing, processing, packing, and holding under preventive-controls and HACCP frameworks. Quality here is food safety: keeping pathogens, allergens, and physical and chemical hazards out of the food supply, and proving the controls that do it.

REGULATORY LANDSCAPE

Anchored by FDA’s FSMA rules (21 CFR 117 preventive controls, 111 for supplements, plus FSVP and food-defense), the Codex Alimentarius (HACCP; CXC 1-1969), and ISO 22000 for food-safety management. Retailer-driven GFSI schemes add a strong private-standard layer on top of the regulatory baseline.

9
Standards decoded
4
GxP disciplines
318
FDA recalls · 12 mo →

openFDA groups food, dietary-supplement, cosmetic & animal-food recalls in one bucket — this count spans that bucket.

WHAT QUALITY MEANS HERE
01

Hazard analysis & preventive controls

A food-safety plan built on hazard analysis with risk-based preventive controls, monitoring, corrective action, and verification (FSMA 21 CFR 117).

02

HACCP & sanitation

Critical control points, sanitation, and environmental monitoring for pathogens — the operational core of food safety (Codex, ISO 22000).

03

Allergen & label control

Allergen management and accurate labelling — undeclared allergens are the single largest driver of food recalls.

04

Supply-chain & food defense

Foreign-supplier verification (FSVP) and food-defense planning against intentional adulteration across an increasingly global supply chain.

GXP DISCIPLINES IN THIS INDUSTRY
GMPGood Manufacturing PracticeGLPGood Laboratory PracticeGDPGood Distribution PracticeQMSQuality Management Systems
STANDARDS SPEQ DECODES · 9
Open in the library →
21 CFR Part 117FDAHIGH INSPECTION RISK
Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food
21 CFR Part 111FDAHIGH INSPECTION RISK
Current Good Manufacturing Practice for Dietary Supplements
Codex CXC 1-1969Codex
General Principles of Food Hygiene
ISO 22000:2018ISO
Food safety management systems — Requirements for any organization in the food chain
21 CFR Part 1, Subpart LFDA
Foreign Supplier Verification Programs (FSVP)
21 CFR Part 121FDA
Mitigation Strategies to Protect Food Against Intentional Adulteration
21 CFR Part 507FDA
Current Good Manufacturing Practice and Preventive Controls for Food for Animals
ISO/IEC 17025:2017ISO
General requirements for the competence of testing and calibration laboratories
ILAC MRAILAC
ILAC Mutual Recognition Arrangement
WHERE QUALITY FAILS
  • Undeclared allergens from labelling or changeover errors
  • Pathogen contamination (Listeria, Salmonella, E. coli) from sanitation gaps
  • Foreign material in product
  • Unverified foreign suppliers entering the supply chain
KEY REGULATORY BODIES
FDACodexISOILAC

Derived from the 9 standards SPEQ decodes for this industry.

FDA ENFORCEMENT
Live recalls across every regulated industry →
GXP DISCIPLINES
The practices that run through this industry →
VALUE-CHAIN SECTORS
The organizations that serve this industry →
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