Regulation of Dietary Supplements and NHPs
Dietary supplements are trusted by millions in the United States 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 must meet appropriate evidentiary requirements.
Both dietary supplements and NHPs have specific regulatory requirements that cover most aspects of formulation, labeling, claims substantiation, good manufacturing practices (GMP) and adverse event monitoring and 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 for NHPs in Canada. Lesson One will consider dietary supplements in the US and Lesson Two will consider NHPs in Canada.
At a Glance
- Target Audience: This is an introductory course for regulatory personnel. It also is appropriate for management, quality assurance, research and development or manufacturing personnel.
- Learning Level: Basic
- Total Length of Course: 3 Hours
- RAC Points: 3
- Pharmaceutical Certificate Elective
- Enrollment Period: 12 months
Learning Objectives
Upon completion of this course, participants should be able to:- Define dietary supplements and NHPs
- Describe the similarities and differences between dietary supplements and NHPs
- Describe premarket activities required for dietary supplements and NHPs
- Summarize the label and labeling requirements for dietary supplements and NHPs
- Summarize the types of claims, substantiation and approval requirements for both dietary supplements and NHPs
- Identify the applicable statutes
- Recognize key aspects of current GMP (cGMP) applicable to both categories of products
- Compare the postmarketing requirements for dietary supplements and NHPs; and
- Explain import and export requirements.
Lesson Titles
- Lesson 1: Dietary Supplements
- Lesson 2: Natural Health Products
This course is also included in:
