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5.01. US Dietary Supplements Ingredients and Labelling

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Written and presented by US Dietary Supplement law specialist and lecturer, Rend Al-Mondhiry, Partner at Amin Talati Wasserman. 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.

Course duration: 1hr 20mins.

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5.01. Agenda
5.01. Defining “Dietary Supplement”
5.01. Allowable Dosage Forms
5.01. Drug Exclusionary Clause
5.01. New vs. Old Dietary Ingredients
5.01. Required Labeling Elements
5.01. Additional Labeling Considerations
5.01. Misbranding
5.01. California’s Proposition 65
5.01. Adulteration Standard
5.01. Good Manufacturing Practices (GMP) Requirements
5.01. Adverse Event Reporting
5.01. Food Safety Modernization Act (FSMA)

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