NDI and GRAS

new dietary ingredient and generally recognized as safe

NDI and GRAS

REJIMUS 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 Notifications (GRASN).

NDIN – New Dietary Ingredient Notifications

The Federal Food, Drug, and Cosmetic Act (the FD&C Act) require that manufacturers and distributors who wish to market dietary supplements that contain “new dietary ingredients” notify the Food and Drug Administration about these ingredients.

Generally, the notification must include information that is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing a new dietary ingredient will reasonably be expected to be safe under the conditions of use recommended or suggested in the labeling.

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 requirements (NDIN)? 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 Notifications

“GRAS” is an acronym for the phrase Generally Recognized ASafe. Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act), any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excepted from the definition of a food additive.

For 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
  Dossier preparation for either Self-affirmation or Expert Panel Review (including Panel Assembly and Moderation)
  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