REG 510

Introduction to Botanical Products Regulatory Affairs and Compliance

Overview

This course provides a working knowledge of the laws and agencies governing dietary supplements and botanical products in the United States. Students learn to interpret federal requirements and to prepare compliant labeling, claims, and documentation.

Learning Outcomes

  • Interpret U.S. federal regulatory framework in order to ensure botanical products comply with the law.

  • Analyze product labeling and claims in order to identify and correct compliance gaps.

  • Utilize current research to align with claims-substantiation standards in order to support lawful structure-function and health claims.

  • Evaluate adverse-event reporting obligations in order to maintain regulatory compliance.

  • Plan compliant regulatory documentation in order to support product market access.

  • Integrate professional ethics and current literature evidence in order to make sound regulatory decisions in the botanical industry.

More details

Required Course Pack:

  • Online Materials and Library Resources (OMLR)

Required Textbooks:

View the required textbooks for this class, including ISBN, edition, and retail price, by visiting our Required Textbooks page.

Total Course Price:

View the total course price including tuition, fees, course materials, and shipping online here.

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