Resources and Answers on FDA NDI Draft Guidance

Just over one month ago, FDA released the much-anticipated draft guidance on New Dietary Ingredients (NDIs). Since then, our team has been working hard to assemble information, resources and insights to help you understand the guidance and what it means for your industry and your business. Here are some highlights:

FDA agreed to answer questions about the NDI draft guidance submitted through our SupplySide Community. Here are the answers in full: Part One, Part Two. And here is a slide show we put together on this.

INSIDER managing editor Sandy Almendarez attended the recent UNPA conference on the NDI draft guidance in Salt Lake City and continues to produce articles highlighting what happened. She is covering issues such as NDI vs. GRAS vs Food Additive, why a solvent change triggers a NDI, safety requirements for NDI notifications, and thoughts on Congress' intent when it passed DSHEA (NDI notifications are required by DSHEA). She also covers the comments by FDA's Daniel Fabricant. Sandy's articles, plus articles by many industry leaders, are included in our NDI section of the INSIDER site. Click here to see all of the articles, opinions and insights we have assembled related to the draft guidance.

We have also collaborated with CRN to organize a live webinar on the NDI draft guidance set for Sept 14. For details or to register for that, click here. If you register by Aug 22, you also get access to our expert Q&A session allowing you to submit your questions before the event.

Along with the articles & insight on the INSIDER website, and the discussion & debate on the SupplySide Community, we are also producing a live Town Hall Meeting during SupplySide West that features FDA, AHPA, CRN, NPA, UNPA and a panel of industry leaders. This event is set for Oct. 12, 2-5pm, it includes and encourages your participation, and it is free for anyone with a SupplySide West badge. Click here for details and to reserve your seat (space is limited).

As you can see, we are all over this issue. Our objective is to give you the information and intelligence you need to make good decisions for your business. If you have other needs related to the NDI situation, just let us know!