USA & New Guidance available for New Dietary Ingredients

Happy Tuesday!

Here’s your weekly must-read update from Rosapharma - contact us with any questions or feedback.

Master Files for NDIN

The FDA has issued a (draft) guidance for utilizing Master Files in new dietary ingredient notifications (NDINs). These Master Files compile information for new dietary ingredients and can be used as a reference for submissions.? It also addresses the FDA's approach to handling trade secrets or confidential commercial information within the file.

Final NDIN Guidance for Procedures & Timeframes

The FDA published the Guidance for Industry “Dietary Supplements: New Dietary Ingredient Notification (NDIN) Procedures and Timeframes". This document aims to be the first of a series of final guidance to deliver clearer direction regarding the NDIN process.?

The document addresses key aspects of the submission and review process, such as who is required to submit an NDIN, how the information should be presented, where to submit it, and the subsequent steps after submission.

FDA Ingredient Directory Updated

The FDA's ingredient directory now includes N-Methyltyramine.

This directory is designed to help manufacturers, retailers, and consumers to stay informed about ingredients available in Dietary Supplements. It includes links to FDA actions and communications, such as evaluation of health claims, safety communications and compliance and enforcement actions.?

It is important to note, however, that the FDA does not approve Dietary Supplements for safety or effectiveness.

--------------

No spam - just the good stuff.

Subscribe to our e-mail newsletter by sending a message to [email protected]