Dietary supplements are trusted by millions of Americans to enhance their diets with a wide variety of nutrients, botanicals, and other dietary ingredients. Similarly, many Canadians rely on natural health products (NHPs) like vitamins and minerals, herbal products and homeopathic medicines. As over-the-counter products, they must be safe and all claims made for them well-substantiated.
Both dietary supplements and NHPs have specific regulatory requirements that cover most aspects of formulation, labeling, claims substantiation, good manufacturing practices and adverse event monitoring/reporting. Manufacturers and distributors of dietary supplement and NHPs must clearly understand their responsibilities to assure their products are fully compliant with all applicable regulations. This course provides an overview of the regulatory requirements for dietary supplements in the US and NHPs in Canada.
Learning Objectives
Upon completion of this course, participants should be able to:
- Describe the similarities and differences between dietary supplements and NHPs
- Describe premarket activities required for dietary supplements and NHPs
- Summarize the labeling requirements for dietary supplements and NHPs
- Summarize the types of claims, substantiation and approval requirements for both dietary supplements and NHPs
- Identify key aspects of current Good Manufacturing Practices applicable to both categories of products
- Compare the postmarketing requirements for dietary supplements and NHPs
Target Audience
This is an introductory course for regulatory personnel. It also is appropriate for management, quality assurance, research and development or manufacturing personnel.