5.01. US Dietary Supplements Ingredients and Labelling

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
  1. Inspections & Enforcement
• Adverse Event Reporting
• Food Safety Modernization Act (FSMA)
  1. FSMA Rules
  2. 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: