Dietary Supplement Claims Substantiation
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
Instructors
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.
Additional Recommended Courses
Dietary Supplement Claims Substantiation
This course is 6-Hours. The labeling and promotion of your dietary supplement products are the most visible ways that the Food & Drug Administration and the Federal Trade Commission can track your compliance with federal regulations. A perfect complement to “Dietary Supplement Labeling Compliance”, this course will go over in detail each type of permitted claim that is available to you and the criteria for making each one. We will cover FDA and FTC standards for substantiation, how to build the substantiation for each claim that the FDA and FTC requires you to hold to ensure your claims are accurate and not misleading, and how you can avoid making implied claims which could lead to regulatory enforcement.
Participants will learn 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.
Day: June 26, 2025 & June 27, 2025
Time: 1:00 PM to 4:00 PM Eastern Time Both Days
Cost: $600.00
*Register 3 or more attendees from the same company and receive a 10% discount off each registration*
Attending NSF training sessions does not provide an advantage, nor is it linked in any way to the granting of certification.
Course log in details will be sent in a separate email. Certificate of attendance will be issued upon completion of the course. Completion of the course means being in attendance 95% of the log in time.
Dietary Supplement Labeling Compliance
It is up to dietary supplement manufacturers to ensure their supplement labels are compliant before they go to market, however the regulations can be confusing and difficult to interpret. Label noncompliance can cause your product to be considered misbranded and subject to Food & Drug Administration regulatory action.
Learn about the regulations that govern dietary supplement labeling including what can be considered a dietary supplement.
· Label compliance/noncompliance
· Regulations that govern dietary supplement
· Supplement Facts formatting
· Ingredient Lists
· Permitted claims, enforcement/litigation trends
· Adverse Event Reporting.
· The Regulatory Background and Enforcement
· Mandatory Label Elements
· Voluntary Label Elements
· How to apply the FTC and FDA regulations
· Define dietary supplement
Day 1: December 4, 2025 - 1:00 PM to 4:00 PM Eastern Time
Day 2: December 5, 2025 - 1:00 PM to 4:00 PM Eastern Time
Cost: $600.00
*Register 3 or more attendees from the same company and receive a 10% discount off each registration*
Attending NSF training sessions does not provide an advantage, nor is it linked in any way to the granting of certification.
Course log in details will be sent in a separate email. Certificate of attendance will be issued upon completion of the course. Completion of the course means being in attendance 95% of the log in time