03.06.24
The Council for Responsible Nutrition (CRN) welcomed FDA’s Final Guidance on the procedures and timeframes for filing New Dietary Ingredient Notifications (NDINs).
“It has been nearly 8 years since FDA published the last draft guidance, and we welcome any progress toward gaining clarity of FDA's expectations for these NDI notifications,” said CRN President and CEO Steve Mister.
CRN previously communicated various concerns and recommendations to the agency regarding the NDIN process, he noted.
“Today's release appears to follow CRN's earlier recommendations to split up the earlier 2016 draft guidance into separate parts and release them individually rather than trying to address all aspects of the NDI process at once,” said Mister.
He added that CRN has consistently advocated for “a more collaborative approach” with FDA to develop changes to the NDI notification process, “suggesting that the industry could serve as a valuable resource in decision-making.”
CRN will be examining the guidance with its Regulatory Affairs Committee and responding to FDA as appropriate, Mister said.
“It has been nearly 8 years since FDA published the last draft guidance, and we welcome any progress toward gaining clarity of FDA's expectations for these NDI notifications,” said CRN President and CEO Steve Mister.
CRN previously communicated various concerns and recommendations to the agency regarding the NDIN process, he noted.
“Today's release appears to follow CRN's earlier recommendations to split up the earlier 2016 draft guidance into separate parts and release them individually rather than trying to address all aspects of the NDI process at once,” said Mister.
He added that CRN has consistently advocated for “a more collaborative approach” with FDA to develop changes to the NDI notification process, “suggesting that the industry could serve as a valuable resource in decision-making.”
CRN will be examining the guidance with its Regulatory Affairs Committee and responding to FDA as appropriate, Mister said.
