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20 Years of Regulatory Success, Now Serving Your GRAS & NDI Filings
The same scientific and regulatory team behind two decades of EU Novel Food authorizations, now guiding your ingredient through FDA’s GRAS and New Dietary Ingredient pathways
20+
Years of Global Regulatory & Scientific Expertise
How it Works
Navigate the GRAS, ODI and NDI Pathways With Confidence
Step 1
Ingredient classification
We determine whether your ingredient is already authorized according to the US law or qualifies as an Old Dietary Ingredient, or requires a New Dietary Ingredient notification or a GRAS file before you invest in the wrong pathway.
Step 2
Dossier & notice preparation
Our scientists compile the data in accordance with FDA requirements, covering the identity, composition, exposure and safety, for a GRAS notice, or a NDI notification.
Step 3
FDA submission & filing
We submit your GRAS Notice or NDI Notification to FDA and manage the filing determination.
Step 4
FDA review period
FDA’s clock runs on its own timeline for each pathway: up to 180 days, extendable, for a GRAS Notice, and a minimum 75-day premarket window for an NDI Notification.
Step 5
Market clearance
Your ingredient reaches the US market backed by a GRAS “No Questions” letter, a NDI notification “Acknowledged without objection”, or an ODI file that withstands FDA scrutiny.
From Ingredient to US Market Clearance
Benefits of GRAS, ODI & NDI Consulting With FoodChain ID
Regulatory Pathway Classification
Choose the right FDA route before you invest
Confirm whether your ingredient needs a GRAS Notice, an ODI justification or an NDI Notification before committing scientific and regulatory resources
GRAS Notice Preparation
Build an FDA-ready GRAS Notice the first time
Structure toxicology, exposure and identity data to meet FDA’s GRAS Notification Program requirements and limit requests for extra information
FDA Liaison & Response Management
Respond to FDA questions with confidence
Our scientists manage filing deficiencies, safety objections and clarification requests to keep your GRAS or NDI file moving
NDI Notification Filing
Meet the 75-day premarket clock
Prepare complete identity and safety data so your New Dietary Ingredient Notification avoids deficiency and objection letters
Multi-Market Regulatory Alignment
Extend clearance beyond the US
Leverage your GRAS or NDI file to support parallel Novel Food and other global ingredient filings
Success Stories
Working with the experts was excellent. Communication was smooth and precise. Even when the FDA raised difficult questions, the team remained flexible and highly responsive.
– Shankar Nutricon
Solution
FoodChain ID provided end-to-end GRAS dossier support, combining regulatory expertise with proactive project management, including expert guidance, direct supporting, responding to FDA technical questions, continuous communication, flexible collaboration and efficient coordination.
Extend Your Regulatory Capabilities
More Ways to Strengthen Your US and Global Ingredient Strategy
FoodChain ID’s GRAS, ODI and NDI experts work alongside our broader Health & Nutrition Consulting, R&D and EU Novel Food solutions so ingredient innovation stays connected from formulation through US and EU market clearance.
FAQ
GRAS (Generally Recognized As Safe) applies to substances added to conventional food. For active ingredients of dietary supplements, Old Dietary Ingredient (ODI) status applies to dietary ingredients marketed in dietary supplements in the US before October 15, 1994. New Dietary Ingredient (NDI) notification applies to any dietary ingredient that doesn’t qualify as an ODI.. Each pathway has its own FDA process, documentation and timeline.
After a roughly 45- to 60-day filing determination, FDA’s substantive review runs up to 180 days, with the option to extend as needed under FDA’s GRAS Notification Program.
Not currently. FDA’s GRAS notification process remains voluntary, although companies must be able to substantiate a GRAS conclusion under the intended conditions of use. FDA has proposed making GRAS notifications mandatory for certain uses, so requirements may change once the proposed rule is finalized.
An ingredient qualifies as an ODI if it was sold in dietary supplements in the United States as a dietary ingredient, in the same chemical form, before October 15, 1994, the date DSHEA took effect. Ingredients that meet this bar are exempt from NDI notification.
Industry and FDA guidance point to contemporaneous records such as invoices, bills of lading, sales receipts, product labels, catalogs, advertising materials and affidavits of manufacture that establish the ingredient was sold in dietary supplements in the US before October 15, 1994.
You need an NDI notification whenever your dietary supplement contains a dietary ingredient that was not marketed in the US in dietary supplements before October 15, 1994, and that hasn’t already been the subject of an NDI notification establishing its safety. A NDI notification exemption may apply if the same ingredient has been present in the food supply (for example a substance already GRAS and used in foods).
At least 75 days. The clock starts once FDA confirms your notification is complete, and you may not market the product until that premarket review period lapses without an unresolved objection from FDA.
FDA keeps the full submission confidential for 90 days after the filing date, but after which the notification becomes publicly available, except for any information that is trade secret or confidential commercial information (according to the applicant).
Yes. The same regulatory and scientific team behind our Novel Food application service builds GRAS Notices, and NDI Notifications, so your ingredient strategy stays aligned across the US, EU and beyond.
Our scientists and regulatory specialists manage every FDA communication, from filing deficiency letters to safety or identity objections, and prepare the responses needed to keep your file moving toward clearance.