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workbook, will address issues and concerns around a large number of the expected and not-expected provisions in the draft guidance, including:

• 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.