A New Dietary Ingredient (NDI) is any substance that was not marketed as a dietary ingredient in the USA prior to October 15, 1994.
Companies intending to market New Dietary Ingredients must submit an NDI Notification (aka 75-day Pre-market Notification) to the FDA Office of Dietary Supplements (ODS) at least 75 days before introduction of the product into interstate commerce, demonstrating that the suggested use of the dietary ingredient as a dietary supplement or as an ingredient in a dietary supplement is reasonably expected to be safe.
The NDI notification process is complex and the FDA rejects more than 80% of those that are filed. NDI notifications are most often rejected due to insufficient evidence for food safety, the absence of required elements, as well as lack of knowledge and experience with preparing such notifications.
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