FDA publishes final guidance on NDIN procedures and timeframes, with more to follow

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The U.S. Food and Drug Administration published a final guidance for industry titled “Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes: Guidance for Industry.” Industry has been waiting for a final guidance on New Dietary Ingredient Notification (NDIN), but what was published yesterday may have come as a surprise. For one, it did not address any of the outstanding issues industry has been waiting for clarification on, such as master file implementation. Instead, FDA published a concise 16-page document focused on the procedures and timeframe of the NDIN process.

FDA explains that this guidance finalizes Section V of the 2016 draft guidance and that the agency is going to separating the guidance into “discrete sections for ease of use” as suggested by commenters of the 2016 Draft Guidance. The agency did not indicate when the other guidance documents would be published.

The Natural Products Association’s (NPA; Washington, D.C.) president and CEO, Daniel Fabricant, PhD, expressed frustration at the guidance in a press release, calling it “a giant nothingburger that could very well weaken the great value of the NDI process because it leaves so many questions unanswered.” This guidance follows two draft guidance, published in 2011 and 2016. According to NPA, the 2011 draft guidance received over 7,000 comments which were largely ignored in the 2016 draft that subsequently received 700 comments. From NPA’s perspective, the publication of this final guidance undermines the industry’s trust in the NDIN process, which is already problematic, by not addressing what industry really wants to know.

“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,” said Fabricant, in a statement. “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.”

Other trade associations are moderating their reaction in anticipation of the publication of future guidance documents that address industry’s burning questions. “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,” said CEO and president of the Council for Responsible Nutrition (CRN; Washington, D.C.), in a statement.

“Today's release appears to follow CRN's earlier recommendations to split up the earlier 2016 Draft Guidance into separate parts and release then 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."

The same suggestion was made by The American Herbal Products Association (AHPA; Silver Spring, MD) for targeted guidance documents. “AHPA is pleased to see FDA finalize the section on ‘Notification Procedures and Timeframes’ of the agency’s guidance to industry on NDINs. 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,” said AHPA president Michael McGuffin, in a press release. “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.”