August 18, 2016  -  FDA has issued a new Revised Draft Guidance for Dietary Supplement NDIs (New Dietary Ingredients) to replace the 2011 Draft Guidance. This document should be studied carefully as it confirms a narrow definition of Dietary Ingredients, further restricts permissible Grandfathered NDIs, and has articulated new policies on Synthetic Ingredients. It also makes important changes in Notification Procedures.

We post the full text of the document below: