CRN Pushes Budget Office To Seek FDA Review Of NDI Notification Costs
This article was originally published in The Tan Sheet
The Council for Responsible Nutrition has gone to the White House budget office with its challenge of FDA’s estimate of the cost to comply with its new dietary ingredient notification guidance.
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FDA’s draft 2012-2016 strategic plan for food programs enhances dietary supplement oversight through good manufacturing practices and adverse event reporting requirements, which were imposed since the agency’s previous strategic plan.
Supplement firms already should have compiled the information for a new dietary ingredient notification when they substantiated the safety of the ingredient, FDA says.
FDA's expectation for firms to file new dietary ingredient notifications for all supplements that contain new ingredients "is tantamount to a registration process," industry leaders argue.