Dietary Supplement Claims Substantiation


Virtual Learning
January 30 – 31, 2024

Virtual Classroom Training

2 days

Virtual Learning
August 8 – 9, 2024

Virtual Classroom Training

2 days

Virtual Learning
December 12 – 13, 2024

Virtual Classroom Training

2 days


About This Course

The labeling and promotion of your dietary supplement products are the most visible ways that the Food & Drug Administration (FDA) and the Federal Trade Commission (FTC) can track your compliance with federal regulations. A perfect complement to our training, “Dietary Supplement Labeling Compliance,” this course will detail each type of permitted claim available to you and the criteria for making each one.

Key Learning Objectives

At the end of the course, you will know and understand:

  • FDA and FTC claim substantiation standards
  • How to build the substantiation for each claim that the FDA and FTC requires to ensure your claims are accurate and not misleading
  • How to avoid making implied claims which could lead to regulatory enforcement
  • How public knowledge of FTC and FDA enforcement actions affect business performance
  • Enforcement/litigation trends and other responsibilities of dietary supplement manufacturers such as structure/function claim notification

Who Should Attend?

Attend this FDA and FTC Claim Substantiation Course if you work in:

  • Management
  • Marketing
  • Quality control/assurance
  • Packaging
  • Sales
  • Laboratory operations
  • Product development
  • Suppliers and distributors
  • Regulatory affairs
  • Legal


Nicole Leitz - Nicole Leitz has more than 20 years of experience in the 21 CFR regulated industries. She has written and presented numerous training sessions on quality system elements and best cGMP practices to corporate clients and at national conventions. Nicole is also an experienced remediation consultant. She has advised, and written documentation such as SOPs and WIs and has completed root cause investigations, CAPAs and complaints for corporate clients.

Nicole has a Master of Science degree in organic chemistry from Bucknell University and a Bachelor of Science in ACS chemistry from Hope College.