Nutraceutical Products Consulting
NDI (New Dietary Ingredient) Notification
An NDI is any substance that was not marketed as a dietary supplement ingredient in the U.S. prior to October 15, 1994. A manufacturer intending to market a New Dietary Ingredient must submit to the FDA documented evidence establishing that the NDI is reasonably expected to be safe as used in the dietary supplement at least 75 days before introduction of the product into commerce.
The NDI notification process is complex. More than 80% of NDI notifications are rejected by the FDA. NDI notifications are most often rejected due to insufficient evidence for safety, the absence of required elements, as well as lack of knowledge and experience with preparing such notifications. AIBMR Life Science’s expertise and experience with successful notifications can greatly increase your chances for success.
Our staff of scientists compile a professional NDI notification dossier for FDA review. Reports include a detailed description of the product, pertinent background information, and safety data including toxicology studies. Lastly, AIBMR Life Sciences provides complete support and follow-up with the FDA.