08.23.16
In response to the Aug. 11 publication of a revised new dietary ingredient (NDI) guidance by the Food and Drug Administration (FDA), the United Natural Products Alliance (UNPA) will conduct a one-day, immersive workshop in Salt Lake City, UT, on Thursday, Sep. 8, to analyze the 102-page document that fundamentally changes the regulatory status of thousands of dietary ingredients and dietary supplements.
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workbook, will address issues and concerns around a large number of the expected and not-expected provisions in the draft guidance, including:
“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.”
“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.
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workbook, will address issues and concerns around a large number of the expected and not-expected provisions in the draft guidance, including: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.
