NEW DIETARY INGREDIENT (NDI)
A New Dietary Ingredient (NDI) is a dietary ingredient that was not marketed in the United States in a dietary supplement before October 15, 1994. A company must submit and NDI when a dietary supplement contains only dietary ingredients that have been present in the food supply as an article used for food in a form in which the food has not been chemically altered or there is a history of use or other evidence of safety establishing that the dietary ingredient, when used under the conditions recommended or suggested in the labeling of the dietary supplement, will reasonably be expected to be safe and, at least 75 days before being introduced or delivered for introduction into interstate commerce. Unfortunately, many companies who apply for an NDI Notification are rejected by the United States Food and Drug Administration (FDA) due to poor understanding of the notification’s requirements. In the first nine months of the 2017 fiscal year, the FDA objected to almost 88% of NDINs whereas the following year decreased to 56%.
REJIMUS can assist your company in the review, preparation, and submission stages of your NDI with greater success. If you are unsure what the status of your ingredient is, REJIMUS can also help determine whether your ingredient is considered an Old Dietary Ingredient (ODI) or a New Dietary Ingredient. Please feel free to contact us if you have any questions regarding NDIs or NDINs.
Electronic New Dietary Ingredient Notification filing services include:
• Reviewing the historical use and safety of the ingredient
• Literature reviews and analysis of all scientific data, protocols and supporting documentation
• Electronic NDI packet preparation and submission to FDA with Response Support
• Dedicated Project Management Platform with Client-side access