Updated 9:20 AM EST, Friday March 8, 2024

Washington, DC—The U.S. Food and Drug Administration (FDA) announced its final guidance for industry titled Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes: Guidance for Industry to help manufacturers and distributors of new dietary ingredients (NDIs) and dietary supplements prepare and submit new dietary ingredient notifications (NDINs).

The guidance has a Q&A format about the NDIN submission and review process. Topics covered include:

  • Who needs to submit an NDIN?
  • How should the information be organized and presented?
  • Where should an NDIN be submitted?
  • What happens after an NDIN is submitted?

FDA explained: "The guidance finalizes Section V (“NDI Notification Procedures and Timeframes”) of the 2016 revised draft guidance in addition to several related questions from other sections of the draft guidance. This approach of separating the 2016 revised draft guidance into discrete sections for ease of use is responsive to comments received on the draft guidance."

FDA’s New Dietary Ingredient Final Guidance is “Giant NothingBurger”

That was the takeaway from the Natural Products Association (NPA). Calling the guidance "a major disappointment," NPA explained that it focuses on frequently asked questions about the NDI submission and review process, and stems from draft guidance dating back to July 2011.

“This process is critical for consumer safety, industry innovation, and the regulatory regime, and by all counts this guidance misses the mark. It is a giant nothingburger that could very well weaken the great value of the NDI process because it leaves so many questions unanswered,” said Daniel Fabricant, Ph.D., NPA President and CEO. “The agency previously issued two sets of draft industry guidance that were intended to inform potential submitters regarding the content and formatting of the NDI notification. After the 2011 guidance was published, the agency received over 7,000 comments which were largely ignored in the 2016 draft guidance. The dearth of significance in the 2016 guidance precipitated an additional 700 comments to the docket.

"Yet once again, the agency has chosen to kick the can down the road on the decisions that are most important to consumers and to the market. In the face of this inaction, NPA will continue to ask the FDA to develop a tangible plan for domestic enforcement of NDI guidelines. Too many companies are going to market without submitting an NDI notification for their ingredient because another firm has done the hard work, covered the costs, and submitted a notification, of which a large portion is public. This ‘piggybacking’ is unacceptable and does not allow the agency the opportunity to review their manufacturing processes or product specifications. This should raise bright red safety flags.” 

CRN welcomes progress toward gaining clarity of FDA's expectations

Council for Responsible Nutrition (CRN) President and CEO Steve Mister also offered comments in response to FDA's announcement yesterday on NDIN guidance: "CRN welcomes FDA's announcement today of a Final Guidance related to the procedures and timeframes for NDA submission. It has been nearly eight years since FDA published the last Draft Guidance, and we welcome any progress toward gaining clarity of FDA's expectations for these NDI notifications.

"CRN previously communicated various concerns and recommendations to the FDA regarding the New Dietary Ingredient (NDI) notification process. Today's release appears to follow CRN's earlier recommendations to split up the earlier 2016 Draft Guidance into separate parts and release them individually rather than trying to address all aspects of the NDI process at once.

"Throughout our communications, CRN has consistently advocated for a more collaborative approach with the FDA to develop changes to the NDI notification process, suggesting that the industry could serve as a valuable resource in decision-making. We will be examining the Guidance with our Regulatory Affairs Committee and responding to FDA as appropriate."

AHPA looks forward to FDA’s issuance of additional clarifying sections of guidance

The American Herbal Products Association (AHPA) also commented on the news: “AHPA is pleased to see FDA finalize the section on ‘Notification Procedures and Timeframes’ of the agency’s guidance to industry on NDINs," said AHPA President Michael McGuffin in a blog post. "This action is consistent with a suggestion AHPA made during an in-person meeting at FDA’s office in 2012, specifically suggesting that FDA address the issue of NDIN guidance with a section-by-section based approach. We were told by FDA leadership at that time that such an approach would ‘be confusing.’ However, the final guidance issued today – though still subject to detailed internal and member review – appears to be clarifying rather than confusing. We look forward to FDA’s issuance of additional clarifying sections of guidance on this important regulatory matter.”

Comments Encouraged

NPA is encouraging industry stakeholders to comment on the docket related to this final guidance at any time. The public may submit electronic or written comments related to this final guidance at any time. Public comments can be submitted electronically to Regulations.gov with the docket number: FDA-2023-D-5280. Written comments should be identified with the docket number: FDA-2023-D-5280 and the title of the guidance document and submitted to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.1061, Rockville, MD 20852.

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