Classify the product and intended use
Determine whether the product is a conventional food or dietary supplement. Review presentation, composition, labeling, and intended use before selecting the applicable regulatory framework.
Assess ingredient identity and hazards
Evaluate ingredient identity, specifications, contamination risks, supplier controls, and suitability for intended use. For dietary ingredients, assess regulatory status and available safety information.
Understand the limits of HACCP
A HACCP plan may support hazard analysis for applicable food operations, but it does not establish Part 111 compliance or demonstrate that a new dietary ingredient is lawful and adequately supported as safe.
Establish appropriate manufacturing and quality controls
For dietary supplements, assess applicable Part 111 requirements for specifications, production and process controls, quality control, records, and related CGMP elements.
Review new dietary ingredient considerations
Determine whether the ingredient meets the statutory definition of an NDI and whether a notification is required. Assess safety evidence for the proposed conditions of use.
Maintain records, deviations, and corrective actions
Document ingredient approval, supplier information, process controls, investigations, product disposition, and corrective action according to the applicable regulatory framework.
How Consultare Inc. Group Can Help
Consultare can support HACCP plan development and review for applicable food operations, hazard analysis, prerequisite programs, supplier and ingredient control, and corrective action. Supplement businesses need separate Part 111 CGMP and ingredient regulatory assessment.
Free Consultation
Need Help Managing Your HACCP Responsibilities?
Whether you are reviewing ingredient eligibility, supplier documentation, quality systems, or regulatory responsibilities, request a free consultation through HACCPServices.com. Discuss your products, suppliers, documentation, and compliance priorities with the Consultare team.
Start Building Your Compliance System
If you prefer to organize and manage your compliance activities yourself, you can also create a free SystemsBuilder account and begin building a structured system for your compliance documentation and processes.