The workshop, “NDI GUIDANCE II & Substances Generally Recognized as Safe,” will include a presentation from and participation in extended Q&A sessions from Cara Welch, PhD, senior advisor for the Office of Dietary Supplement Programs. The conference, which will include case studies, audience polling and a comprehensive workbook, will address issues and concerns around a large number of the expected and not-expected provisions in the draft guidance, including:
- Official FDA ODI List
- NDI triggers
- 'Master Files'
- Synthetic botanicals
- Impact on probiotics
- 'Manufacturing Changes'
- Budgeting for safety studies
- 'Chemical Alteration'
“Based on our initial analysis, FDA has structured this guidance to create a vastly larger universe of NDIs by virtue of limiting chemical alteration of food and food ingredients in the human diet and by treating most manufacturing changes as a trigger for NDI status,” said UNPA President Loren Israelsen, who will present a detailed overview of the guidance document. “The economic cost to industry could be billions of dollars. Understanding and responding to this FDA policy is an urgent priority.”
- Workshop topics include:
- The revised NDI guidance explained, plus FDA’s real-time responses
- ODI/NDI determinations and associated costs
- The intersection of NDIs and GRAS
- Guidance vs. regulation: FDA’s enforcement game plan
- Does Congress have a role in this process?
- Cost implications and impacts
“With the current comment period set to close Oct. 11, there is a great urgency to examine, understand and prepare comments as well as enhance individual company readiness to deal with NDIs—the No. 1 issue for the dietary supplement industry,” Mr. Israelsen added.
For more information, the agenda, lodging information and to register, view/download the workshop program, or visit the UNPA website.