Description
eLearning Course
Written and presented by US Dietary Supplement law specialist and lecturer, Rend Al-Mondhiry, Partner at Amin Wasserman Gurnani. This course is for anyone wanting to supply dietary supplements in the USA. Critical issues covered include the definition of a dietary supplement, permitted ingredients and dosage forms, mandatory and non-mandatory label statements, claims that may be made, manufacturing and GMP, adulteration, and specific standards such as California’s Proposition 65 and the Food Safety Modernization Act.
Ingredient requirements
- Defining “Dietary Supplement”
- Allowable Dosage Forms
- Drug Exclusionary Clause
- New vs. Old Dietary Ingredients
Labeling
- Required Labeling Elements
- Additional Labeling Considerations
- Misbranding
- California’s Proposition 65
Quality and Safety
- Adulteration Standard
- Good Manufacturing Practices (GMP) Requirements
- Inspections & Enforcement
- Adverse Event Reporting
- Food Safety Modernization Act (FSMA)
- FSMA Rules
- FSMA Enforcement Tools
What you get
- Course notes
- Templates, resources, and SOPs (where relevant)
- Case studies
- Pre-recorded content available on demand
- Certificate
*10% GST is added if we are billing an Australian company
Course sample:
