FDA releases NDI enforcement discretion draft guidance

May 20, 2022

FDA has released a draft guidance outlining a proposed policy of enforcement discretion regarding the late submission of new dietary ingredient (NDI) notifications. Upon the release of a finalized guidance, companies will be able to electronically submit late NDIs to FDA for a set period (currently 180 days in the draft guidance) without penalty. NDI notifications submitted in this way may include postmarket data such as adverse event reports for products that were marketed without a required NDI notification.

FDA will be collecting comments on the draft guidance until July 19th. The draft guidance is available here.




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