The ODSP notes in the draft that its recommendations expand upon and replace master file recommendations included in its 2016 revised NDIN draft guidance based on input from the public and industry.

The 2016 draft guidance and the 2011 document it revised were met with widespread questions and opposition from the supplement industry; the ODSP in 2023 said it would provide separate guidance documents on “discrete sections” of the requirement as stated in 21 CFR 190.6. (Also see "US FDA Plans To Publish NDI Notifications Revised Draft Guidance In Sections" - HBW Insight, 2 August, 2023.)

This is the second guidance document discussing some rather than all of the NDIN requirements the Dietary Supplement Health and Education Act of 1994 imposed on the industry to notify the agency with evidence of a reasonable assurance of safety for the intended use of a dietary ingredient which wasn’t part of the US food supply prior to the act’s passage or is being used for food in a chemically altered form. The first separate guidance came in a final guidance published in March on procedures and timeframes for NDINs to comply with requirements. (Also see "US FDA Narrows Guidance For New Dietary Ingredient Notifications To Magnify Compliance" - HBW Insight, 6 March, 2024.)

Comments on the draft guidance – docket FDA-2024-D-0706 – submitted through 60 days after its publication in the 4 April Federal Register will be considered by the agency.

US FDA’s NDIN Master File Draft Guidance Notes ‘No Presumption’ To Keep Information Confidential

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