NDI and GRAS
REJIMUS provides a 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 As Safe. 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
NHANES and Consumption Data Evaluations
Should you already have the means to prepare your own GRAS Dossier, but you are only in need of accessing current NHANES or other consumption data, or update your dossier with recently published data, REJIMUS can provide the search builds and compilations of desired food types to determine exact consumption values for your intended consumer demographics. These are a fee-for-service structure that will compile the data, tables and applicable food codes to ensure that the FDA can verify the exact same data sets as included in your notification. REJIMUS utilizes the same system the FDA uses in affirming consumption values and therefore total exposures. We take the guesswork out of your dossier!