Claudia Lewis-Eng is participating in a webinar "Bringing New Ingredients to Market: FDA Guidance and Developments in the New Dietary Ingredient Notification Process" on December 10, 2008.
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 pundits 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 professionals how the NDI process and other related matters are changing the way new products come to market.
- 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
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.