WASHINGTON—The Council for Responsible Nutrition (CRN) and Phoenix-based Virgo Publishing will host a Webinar, “Bringing New Ingredients to Market: FDA Guidance and Developments in the New Dietary Ingredient Notification Process,” on Wednesday, Dec. 10, from 2 to 4 p.m., EST.
Bill Frankos, Ph.D., director, Division of Dietary Supplement Programs, FDA, will be one of the featured speakers and will provide the agency’s perspective on what kind of data is required to file a successful new dietary ingredient (NDI) notification, as well as offer insight into other expectations from the agency. Frankos will be joined by George Burdock, Ph.D., president, Burdock Group; Claudia Lewis-Eng, partner, Venable LLP; Andrew Shao, vice president, scientific & regulatory affairs, CRN; and Debbie Trinker, vice president of regulatory affairs, Kemin Health.
The Webinar will provide a historical analysis of the NDI notification process since its inception by the Dietary Supplement Health and Education Act (DSHEA), and will include a legal review of the process as well as offering practical, actionable approaches for bringing NDIs to market.
“There are still a lot of questions surrounding this process including what steps companies should take in order to make sure they are meeting FDA’s expectations,” Shao said. “While not everything can be answered in this two hour Webinar, it is our goal to provide clarity along with substantive guidance and help companies feel they are up-to-date and well-informed about this process, particularly as we anticipate FDA will soon publish a guidance document on this topic.”
Jon Benninger, director of business development for Virgo Publishing, added, “There are a lot of questions about the new Dietary Ingredient Notification Process and this is a great opportunity to get guidance from FDA and industry experts in the know.”
Registration fees are $149 for CRN members and $199 for non-CRN members. Each registration fee provides access from one log-on location; however, companies can choose to have as many participants as desired in the room participating in the Webinar. The audio portion of the Webinar can be accessed through the internet or by phone. The registration fee also includes unlimited access to the on-demand recording of the Webinar for one year. This is the third Webinar produced by CRN and Virgo. The first two Webinars, addressing the GMP (good manufacturing practice) rule and managing the supply chain, are available for purchase on-demand.
To find further details on the speakers, the agenda, and registration information, please visit Virgo Publishing’s online training and education site, Nutrilearn.com, at Nutrilearn.com/ndin_webinar/.