The Dietary Supplement Health and Education Act (DSHEA) was signed by President Clinton in 1994 when it was estimated we had in the United States over 7,000 dietary supplements. The estimate today is over 80, 000. The Act defined dietary supplements as a vitamin, a mineral, an amino acid, an herb or other botanical, a dietary substance for use by man to supplement the diet by increasing the total dietary intake or a concentrate, metabolite, constituent, extract, or combination of any ingredient described above. The Act mandated the establishment of the Office of the Dietary Supplement in the National Institutes of Health (NIH) and the Dietary Supplement Current Good Manufacturing Practices regulation (21 CFR Part 111) (DSCGMP) to be implemented by the Food and Drug Administration (The FDA). Under the Nutritional Labelling and Education Act (NLEA) signed by President George H.W. Bush , the dietary supplements manufacturers are required to label their ingredients and under Food Allergen Labelling and Consumer Protection Act (FALCPA signed by President George W. Bush , dietary supplement manufacturers are required to label eight allergens and President Joseph Biden signed the Food Allergen Safety, Treatment Education and Research Act (FASTER) and added sesame to the list and now we have nine main allergens required to be labeled. The FDA Food Safety Modernization Act (FSMA) signed into law by President Obama on January 4, 2011. established seven foundational rules (Human Food Rule, Animal Food Rule, Produce Safety Rule, Foreign Supplier Verification Rule, Intentional Adulteration Rule, Transportation rule, and the Accredited Third-Party Certification Rule that has enormous implications for dietary ingredients and dietary supplements. This compressive Dietary Supplements HACCP course covers all applicable laws and regulations related to dietary supplement manufacturing, packing, holding, labeling, distributing and retailing and in depth biological, chemical, and physical hazard analysis to identify hazards, evaluate hazards and control hazards from sources to consumers using current scientific, technical and regulatory understanding of safe production and distribution of dietary supplements and dietary ingredients used to produce them.
On Zoom:
Instructor-Led
Other dates can be arranged.
2024
July 25, 2024, 08:00 AM to 4 PM – PST
July 26, 2024, 08:00 AM to 4 PM – PST
September 19, 2024, 08:00 AM to 4 PM – EST
September 20, 2024, 08:00 AM to 4 PM – EST
2025 Classes
February 10, 11, 2025 – EST
May 22, 23, 2025 – PST
September 4, 5, 2025 – EST
October 16, 17, 2025 – PST
Table of contents
Preface
Module 1. Introduction and History of Food Safety Hazards and Controls
Module 2. The Federal Food and Drug Administration (FDA) and Dietary Supplements
Module 3. The Dietary Supplement Health and Education Act (DSHEA) and the Office of Dietary Supplements
Module 4. The FDA Dietary Supplement Good Manufacturing Practices (DS CGMP 21 CFR Part 111)
Module 5. The FDA Food Safety Modernization Act (FSMA) and Dietary Supplements
Module 6. The Dietary Supplements, Food Allergen and Bioengineered Food Labelling Laws and Regulations
Module 7. Biochemistry of Nutrients and Dietary Supplements
Module 8. Multiomics, Nutrigenomics and Dietary Supplements
Module 9. Microbiological Food Safety Hazards, Microbiome and Microbiomics
Module 10. Chemical Food Safety Hazards Control, Chemoinformatics and Hurdle Technologies
Module 11. HACCP and Prerequisite Programs
Module 12. The Five Preliminary Steps
Module 13. The First Principle of HACCP – Conduct a Hazard Analysis
Module 14. The Second Principle of HACCP – Determine Critical Control Points
Module 15. The Third Principle of HACCP – Determine Critical Limits
Module 16. The Fourth Principle of HACCP – Establish Monitoring Procedures
Module 17. The Fifth Principle of HACCP – Establish Corrective Actions
Module 18. The Sixth Principle of HACCP – Establish Verification Procedures
Module 19. The Seventh Principle of HACCP – Establish Record-Keeping and Documentation Procedures
Module 20. Development, Implementation, Maintenance and Assessment of the HACCP System
Exercise Workbook
Self-Paced:
To be completed in 60 days
Table of contents
Preface
Module 1. Introduction and History of Food Safety Hazards and Controls
Module 2. The Federal Food and Drug Administration (FDA) and Dietary Supplements
Module 3. The Dietary Supplement Health and Education Act (DSHEA) and the Office of Dietary Supplements
Module 4. The FDA Dietary Supplement Good Manufacturing Practices (DS CGMP 21 CFR Part 111)
Module 5. The FDA Food Safety Modernization Act (FSMA) and Dietary Supplements
Module 6. The Dietary Supplements, Food Allergen and Bioengineered Food Labelling Laws and Regulations
Module 7. Biochemistry of Nutrients and Dietary Supplements
Module 8. Multiomics, Nutrigenomics and Dietary Supplements
Module 9. Microbiological Food Safety Hazards, Microbiome and Microbiomics
Module 10. Chemical Food Safety Hazards Control, Chemoinformatics and Hurdle Technologies
Module 11. HACCP and Prerequisite Programs
Module 12. The Five Preliminary Steps
Module 13. The First Principle of HACCP – Conduct a Hazard Analysis
Module 14. The Second Principle of HACCP – Determine Critical Control Points
Module 15. The Third Principle of HACCP – Determine Critical Limits
Module 16. The Fourth Principle of HACCP – Establish Monitoring Procedures
Module 17. The Fifth Principle of HACCP – Establish Corrective Actions
Module 18. The Sixth Principle of HACCP – Establish Verification Procedures
Module 19. The Seventh Principle of HACCP – Establish Record-Keeping and Documentation Procedures
Module 20. Development, Implementation, Maintenance and Assessment of the HACCP System
Exercise Workbook
On Site:
To be arranged onsite or in
Hermosa Beach, Los Angeles, California
Holiday Inn
125 Pacific Coast Highway
Hermosa Beach, CA 90254
Table of contents
Preface
Module 1. Introduction and History of Food Safety Hazards and Controls
Module 2. The Federal Food and Drug Administration (FDA) and Dietary Supplements
Module 3. The Dietary Supplement Health and Education Act (DSHEA) and the Office of Dietary Supplements
Module 4. The FDA Dietary Supplement Good Manufacturing Practices (DS CGMP 21 CFR Part 111)
Module 5. The FDA Food Safety Modernization Act (FSMA) and Dietary Supplements
Module 6. The Dietary Supplements, Food Allergen and Bioengineered Food Labelling Laws and Regulations
Module 7. Biochemistry of Nutrients and Dietary Supplements
Module 8. Multiomics, Nutrigenomics and Dietary Supplements
Module 9. Microbiological Food Safety Hazards, Microbiome and Microbiomics
Module 10. Chemical Food Safety Hazards Control, Chemoinformatics and Hurdle Technologies
Module 11. HACCP and Prerequisite Programs
Module 12. The Five Preliminary Steps
Module 13. The First Principle of HACCP – Conduct a Hazard Analysis
Module 14. The Second Principle of HACCP – Determine Critical Control Points
Module 15. The Third Principle of HACCP – Determine Critical Limits
Module 16. The Fourth Principle of HACCP – Establish Monitoring Procedures
Module 17. The Fifth Principle of HACCP – Establish Corrective Actions
Module 18. The Sixth Principle of HACCP – Establish Verification Procedures
Module 19. The Seventh Principle of HACCP – Establish Record-Keeping and Documentation Procedures
Module 20. Development, Implementation, Maintenance and Assessment of the HACCP System
Exercise Workbook
