FDA Extends Comment Period for NDI Draft Guidance

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Interested parties will now have until December 12, 2016 to submit comments on FDA’s revised new dietary ingredient (NDI) draft guidance-a 60-day extension over the previous deadline.

FDA announced this morning it will be extending the public comment period for its revised new dietary ingredient (NDI) draft guidance. The extension announcement, which will be formally published in the Federal Register tomorrow, sets the new deadline for public comments as December 12, 2016-a 60-day extension over the previous deadline.

It’s been nearly two months since FDA released its revised NDI guidance, with industry reaction ranging from resistant to receptive. Several industry associations also requested an extension to the original deadline for public comment (October 17), including the American Herbal Products Association (Silver Spring, MD), the Natural Products Association (Washington, DC), the Council for Responsible Nutrition (Washington, DC), and the United Natural Products Alliance (Salt Lake City).

In its announcement, FDA says it is extending the comment period “in response to requests to extend the comment period to allow interested persons additional time to submit comments.”

Instructions for submitting comments can be found here.


Read more:

Is GRAS Still a Viable NDI Workaround?

How FDA’s NDI Guidance Could Paralyze Industry

Which Ingredient Categories Would Be Hit Hardest by FDA’s NDI Draft Guidance?


Michael Crane
Associate Editor
Nutritional Outlook Magazine