American Herbal Product Association (AHPA) President Michael McGuffin will discuss how marketers of new dietary ingredients (NDIs) can successfully meet their NDI notification requirements at the American Conference Institute's (ACI's) second annual Legal, Regulatory and Compliance Forum on Dietary Supplements and Nutritionals being held June 18 to 19 at the Carlton Hotel in New York.
McGuffin will be part of a three person panel and will present on "Strategies for Filing NDI Notifications with No FDA Objections - Try and Try Again." The panel is scheduled at 9:30 a.m. on Wednesday, June 18, and also includes Ashish Talati (Amin Talati LLC) and Claire Kruger, Ph.D., DABT (Spherix Consulting).
"There is a false impression in the supplement industry that the NDI notification system is a bound-to-fail effort for most companies," noted McGuffin. "In fact, more than half of submissions that are in full compliance with the current NDI regulations are filed by FDA without substantive objections on the initial submission, and this rate increases with attentive resubmissions when needed."
McGuffin will provide data derived from the AHPA NDI Database that demonstrates companies can effectively navigate the NDI notification system by avoiding common pitfalls and persistently addressing the Food and Drug Administration's (FDA) concerns. The AHPA NDI Database is a subscription-based repository of the more than 700 NDI notifications that have been submitted to FDA since 1995.