Food & Dietary Supplements
Human food and dietary supplements — preventive controls, HACCP, allergen and pathogen control, and supply-chain safety.
What this page does not claim
SPEQ decodes published standards and does not determine which apply to your product. An industry’s counts measure SPEQ’s coverage, not the size of its rulebook.
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.
WHY THIS PRODUCT IS HARD TO CONTROL
Volume and time. Food is produced at a scale and consumed on a timescale where testing your way to safety is arithmetically impossible — a pathogen distributed through one lot in a few units will not be found by any sampling plan a plant can afford, and the product is often eaten before a result would return. So the control model inverts: identify the hazards, establish the points where they can actually be controlled, monitor those continuously, and treat the record of control as the evidence. HACCP is not a quality system borrowed from pharma; it is the answer to a problem pharma does not have at this scale.
WHAT QUALITY MEANS HERE
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).
HACCP & sanitation
Critical control points, sanitation, and environmental monitoring for pathogens — the operational core of food safety (Codex, ISO 22000).
Allergen & label control
Allergen management and accurate labelling — undeclared allergens are the single largest driver of food recalls.
Supply-chain & food defense
Foreign-supplier verification (FSVP) and food-defense planning against intentional adulteration across an increasingly global supply chain.
FDA groups food, dietary-supplement, cosmetic & animal-food recalls in one bucket — this count spans that bucket.
STANDARDS SPEQ DECODES · 16
Open the full library →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
GXP DISCIPLINES IN THIS INDUSTRY
Food & Dietary Supplements: frequently asked questions
Quick answers to common questions about GxP in Food & Dietary Supplements.
What regulations govern food manufacturing?
In the US, FDA’s FSMA rules — 21 CFR 117 (preventive controls), 111 (dietary supplements), plus foreign-supplier verification and food-defense requirements. Internationally, the Codex Alimentarius HACCP standard (CXC 1-1969) and ISO 22000, with retailer-driven GFSI schemes adding a private-standard layer.
What is the difference between HACCP and preventive controls?
HACCP centres on critical control points for identified hazards (Codex, ISO 22000). FSMA’s preventive controls (21 CFR 117) build on hazard analysis but require risk-based preventive controls, monitoring, corrective action, and verification that reach beyond classic CCPs.
What causes the most food recalls?
Undeclared allergens — from labelling or changeover errors — are the single largest driver of food recalls, followed by pathogen contamination such as Listeria, Salmonella, and E. coli from sanitation gaps.