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.
Specific topics will include:
• How to determine whether you need to submit an NDIN to the FDA
• How to decide what kind of testing is required for an NDIN
• How to establish safety under the conditions of intended use
• How to compile the necessary documentation for a successful FCN
• How to avoid common pitfalls associated with preparing an NDIN
Instructor: Brad Lampe
Please note a PDF of the recording will not be available.
You will have access to the recoding for 15 days once you complete your registration.
Certificate of participation are not issued for recorded courses.
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