On April 3, 2024, FDA issued a draft guidance for industry on New Dietary Ingredient Notification Master Files for Dietary Supplements. This guidance provides recommendations on the use of Master Files for New Dietary Ingredient Notifications (“NDINs”). The recommendations reflect input received from the public and industry in response to FDA’s 2016 revised draft guidance (Dietary Supplements: New Dietary Ingredient Notifications and Related Issues).
NDIN Master Files
Master Files, used in the approval processes of human and animal drugs, devices and other FDA-regulated products, contain material sponsors voluntary submit to FDA to provide confidential, detailed information about facilities, processes, and/or articles used in manufacturing, processing, packaging, and storing FDA-regulated products. Without disclosing the confidential information in the Master File, the Master File’s owner may authorize other parties, such as other applicants or sponsors, to reference information contained in the Master File to support an FDA submission. FDA can then review the confidential information in the Master File, but the other applicant or sponsor cannot. Master Files can thereby benefit both Master File owners, by providing a means to protect the disclosure of confidential information or trade secrets, and NDIN submitters with a right of reference to the Master File, by allowing them to refer to data already on file with FDA instead of having to develop the data themselves and resubmit it in each NDIN for the same ingredient.
NDIN Master Files, which can contain identity, manufacturing, and/or safety information relating to an NDI, a dietary supplement containing an NDI, or both, can be used in the notification process for NDIs discussed in Covington’s March 6, 2024, client alert regarding FDA's New Dietary Ingredient Notification Procedures and Timeframes Final Guidance.
Guidance on NDIN Master Files
The guidance is intended to help industry comply with the requirement to submit NDINs by describing how to submit and use Master Files:
- What should be submitted and where, including an identification of the submission as an NDIN Master File, a description of the contents, the contact information for the owner and any authorization the owner wishes to make at the time of filing the Master File;
- How the owner should identify information that is trade secret or confidential commercial information exempt from public disclosure;
- How to update or close an NDIN Master File;
- How the owner can authorize others to reference the Master File; and
- FDA’s role in reviewing and administering NDIN Master Files, including when FDA will conduct a substantive review of the Master File.
FDA is accepting comments on the draft guidance until June 3, 2024, through FDA’s Docket (FDA-2024-D-0706).
If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Beverage, and Dietary Supplements practice.
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