NDI and GRAS

NDI and GRAS

Ingredient Identity provides strategic phased approach to conducting cost-effective feasibility, and efficient evaluations and dossier assembly services for New Dietary Ingredient Notifications (NDIN) and Generally Recognized As Safe (GRAS) Notifications.

NDIN – New Dietary Ingredient (NDI) Notifications

Do you have a New Dietary Ingredient to file with the FDA? Are you sure you need to file an NDI or could your product be considered an Old Dietary Ingredient or ODI? Does the FDA prefer an electronic NDI submission? What are the NDI Notification (NDIN) requirements? There are some exceptions to know about. We can assist in the review, preparation and submission of your NDI with greater success.

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

Current FDA Guidance on NDI Notifications

GRASN – Generally Recognized as Safe (GRAS) Notifications

For a Self-determined GRAS dossiers with an Expert Review Panel or for GRAS Notifications to the FDA, we can assist with the evaluation, development, management and submission from start to finish.

GRAS Self-determined or with Notification Services include:

  Assessing ingredient development and regulatory strategies and requirements
  Literature reviews and research inclusive of all scientific data, protocols and supporting documentation
  Toxicological study and data reviews
  GRAS dossier preparation for either Self-affirmation or Expert Panel Review (including Panel Assembly and Moderation)
  GRAS notification submission to the FDA and Response Support to achieve the GRAS List(optional)
  Dedicated Project Management Platform with Client side access

Current GRAS – FDA GRAS Inventory List