Senators Hatch and Harkin met with Commissioner Hamburg, Deputy Commissioner for Foods (Mike Taylor), and Assistant Commissioner (Jeanne Ireland) to discuss concerns and specific recommendations with respect to the Draft NDI Guidance. During the meeting, five issues were specifically raised:
- Ingredient v. supplement
- Master list of old ODIs
- Synthetic botanicals
- Food additive-like safety requirements for NDIs
- The chemical alteration question
There was agreement that there is great needs for substantial revisions to the Guidance, clarification on the go-forward process and the dialogue that supposedly will occur between FDA and industry.
No timeline was offered regarding publication of a revised guidance. The only specific agreement was to organize a discussion meeting between FDA and industry on an ODI grandfather list, possibly within the next few weeks. Let’s wait and see. Stay tuned.