On September 8th, the American Herbal Products Association (AHPA) held a one-day intensive event to help herbal and dietary supplement companies “sift through the clutter, the hype and unanswered questions” when it comes to NDI notifications. The event, the AHPA NDI Congress: Crafting an Industry Response and Filing Successful Notifications, took place in downtown Chicago, with CMG’s Alan Feldstein serving as a speaker at this high-profile, interactive industry gathering.

The event was designed to help herbal and dietary supplement companies take the next step in responding to the FDA’s draft guidance on NDIs and to develop and submit NDI notifications for numerous product categories.  According to the Tan Sheet’s coverage of the event, AHPA President Michael McGuffin stated that he is confident FDA will ultimately require notifications strictly for new dietary ingredients, and not all supplements containing those ingredients. McGuffin went on to state that “There is no way that enforceable, final guidance requires every downstream finished product to file an NDI notification or be subject to enforcement action” — adding that “We will build not only opinions but also a strong legal argument as to why that’s inaccurate.”

Speaking at the event, Alan Feldstein addressed the issue that more input is needed from ingredient suppliers, and not just from finished product manufacturers. Feldstein stressed that “a more efficient approach to this whole situation” is that “ingredient firms should file NDI notifications and then spread their costs across finished product manufacturers that purchase the ingredients.” He went on to note that this approach “gives FDA what they want as far as safety issues, and it gives the industry what it needs, which is the ability to conduct its business with the ingredients that have a reasonable expectation of safety.”

The deadline for comments is December 2.