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present
“Bringing New Ingredients to Market: FDA Guidance and Developments in
the New Dietary Ingredient Notification Process”
Date: Wednesday, December 10
Time: 2pm EST
Length: 2 hours
There have been many questions about the New Dietary Ingredient (NDI) notification process since it was created by DSHEA. What constitutes a “new dietary ingredient”? If a new manufacturing process is used on an old dietary ingredient, is it necessary to file a notification? What kind of data is required to file a successful notification? Does simply changing the conditions of use (serving size, frequency of use) require the filing of a new notification? FDA has been gathering comments on these critical issues for several years and is expected to publish a guidance document soon. In this live Webinar, FDA’s Dr. Bill Frankos and Dr. Dan Levy will provide insight into FDA’s expectations. Joining Dr. Frankos and Dr. Levy is a panel of experts who will discuss key issues such as how to decide when a NDI notification is necessary, how to meet the “reasonable expectation of safety” standard, and practical approaches to bringing a new ingredient to market. Any company that has introduced a new ingredient since DSHEA or that plans to in the future will find this Webinar extremely valuable. And manufacturers who have included a new ingredient in a product or that plan to will also benefit by understanding this evolving process. Don’t miss this chance to hear first-hand from FDA and a panel of experts how the NDI process and other related matters are changing the way new products come to market.
Webinar Outline
- Historical analysis of the NDIN process
- Legal review: When to file an NDIN
- Practical approaches for bringing new ingredients to market
- New insights into FDA’s expectations for NDINs
- Q&A
Speakers:
- Dan D. Levy, Ph.D., Acting Supervisor, New Dietary Ingredient Review Team, Division of Dietary Supplement Programs, U.S. Food and Drug Administration
- George Burdock, Ph.D., President, Burdock Group
- Bill Frankos, Ph.D., Director, Division of Dietary Supplement
Programs, U.S. Food and Drug Administration
- Claudia Lewis-Eng, partner at Venable LLP
- Andrew Shao, Vice President, Scientific & Regulatory Affairs,
Council for Responsible Nutrition
- Debbie Trinker, Vice President of Regulatory Affairs, Kemin
Health, L.C.
To view speaker bios, click here
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