NDI and GRAS Notification – A How To - Recording
About This Course
According to the Dietary Supplement Health and Education Act (DSHEA), any company that sells a dietary supplement containing a new dietary ingredient must submit a New Dietary Ingredient Notification (NDIN) to the FDA. In this course we will provide guidance on how to determine when an NDIN is required, what kind of information you will need to include in an NDIN, and common pitfalls. The course is directed toward dietary supplement and food ingredient manufacturers and suppliers who are interested in understanding the basic requirements for NDINs so they can better communicate with regulators and specialists.
Key Learning Objectives
- Assess the need to submit an NDIN and determine if another regulatory pathway is more appropriate
- Understand the similarities and differences in the requirements for an NDIN submission and a GRAS notification to the FDA
- Identify what kind of information and testing to include for a successful FDA review
- Establish safety under the intended use conditions
- Analyze and document information to demonstrate that the intended use will not result in any adverse health effects
- Identify and avoid common issues associated with NDIN submissions through real-world examples
Duration: 105 minutes
Note: A PDF of the presentation will not be distributed for this recording. You'll have access to the recording for 15 days once you complete your registration.