FDA has published a draft guidance on new dietary ingredients notification master files

Apr 8, 2024

The U.S. Food and Drug Administration (FDA) published a draft guidance on the submission of new dietary ingredient notification (NDIN) master files. The master file concept helps ease the burden of submitting multiple NDINs containing the same ingredient. For example, an ingredient manufacturer can create a master file for its ingredient and authorize its clients to refer to the master file in their own NDIN.

Industry stakeholders have advocated for the master file system for years. In 2020, the Council for Responsible Nutrition (CRN; Washington, D.C.), Consumer Healthcare Products Association (CHPA; Washington, D.C.), and the United Natural Products Alliance (UNPA; Salt Lake City, UT) submitted to FDA a proposed framework for a master file system. This proposed framework was proposed framework is modelled after the U.S. Drug Master File. Read the full story here >>