Supplement NDI Draft Guidance Discussions Snagged On Basic Criteria
This article was originally published in The Tan Sheet
Executive Summary
FDA’s dietary supplement division is concerned that firms are not submitting NDI notifications in cases where they should be, while industry stakeholders assert the agency needs to clarify the criteria for determining which products should be the subject of notifications and what information is needed.
You may also be interested in...
Revised NDI Notification Draft Guidance Arrives For Supplement Industry
The draft guidance for a key component of expanding the number and variety of dietary ingredients allowed for use will generate immediate response from across the sector and garner interest from the industry's Capitol Hill allies instrumental in FDA's 2012 decision to revise the draft published a year earlier.
Commissioner Califf's Comments On Supplement Testing Trouble NPA
NPA notes a 2010 comment that an omega-3 fish oil study "may be a lesson of all this food supplement stuff that we need to test them like drugs.” Senator Hatch asks Califf to reign in FDA's practice of using guidances to impose additional rules.
Commissioner Califf's Comments On Supplement Testing Trouble NPA
NPA notes a 2010 comment that an omega-3 fish oil study "may be a lesson of all this food supplement stuff that we need to test them like drugs.” Senator Hatch asks Califf to reign in FDA's practice of using guidances to impose additional rules.