How to Legally Export New Food Ingredients to the U.S.: Frequently Asked Questions on GRAS Notice

Navigating the regulatory landscape for exporting food and feed ingredients to the United States requires a clear understanding of the FDA compliance pathways, safety assessments, and procedures.

Based on the legal framework in the United States, compliance for new food ingredients in the United States currently follows four primary pathways:

• Food Additive Petition (FAP)
• Color Additive Petition (CAP)
• Generally Recognized as Safe (GRAS)
• New Dietary Ingredient Notification (NDIN, NDI notification)

In this article, we have summarized the most frequently asked questions on FDA GRAS Notices.

1. What will happen to existing Self GRAS notices if Self GRAS is phased out?

The FDA is expected to establish a simplified transition pathway. Rather than requiring a completely new dossier, the FDA will likely to ask for a limited set of supplementary documents to complete FDA filing.

2. Does Self GRAS have an expiration date?

No. A Self GRAS does not have a fixed validity period and generally remains effective indefinitely. However, the safety assessment should be updated whenever there are significant changes to the intended conditions of use; use levels; or manufacturing process.

3. Can CIRS handle GRAS, NDI, and CAP submissions for of clients?

Yes. CIRS provides one-stop regulatory services for novel food and feed ingredient approvals worldwide. The projects are supported by CIRS’s U.S. subsidiary and FDA-qualified toxicology experts. CIRS has extensive experience on FDA GRAS projects and maintains a 100% success rate across a wide range of FDA GRAS ingredient categories. Contact us at service@cirs-group.com if you need any assistance or have any questions.

4. How can we determine whether an ingredient requires a GRAS notice or NDI notification?

It depends on the ingredient's intended end use:

• GRAS applies to ingredients intended for conventional foods, such as beverages, confectionery, bread, chocolate, and other traditional food products.
• NDI applies to ingredients intended exclusively for dietary supplements, including tablets, capsules, and other supplement dosage forms.

If an ingredient has obtained a GRAS notice and has been commercially marketed in conventional foods, it may qualify for an exemption from the NDI notification when subsequently used in dietary supplements.

5. Can an ingredient be used directly in dietary supplements solely based on a GRAS notice?

No. A GRAS notice alone is not enough. Companies must also demonstrate that the ingredient has been commercially marketed in the U.S. food supply. Evidence of actual commercial marketing is generally required before the ingredient may qualify for an exemption from the NDI notification for dietary supplement use.

6. If an ingredient is not included in the GRAS inventory, how can it be legally used in dietary supplements?

There are two options:

Option 1: Submit an NDI notification, which is appropriate if the ingredient is intended only for dietary supplements.

Option 2: Obtain a GRAS notice, bring the ingredient to market in conventional food and then introduce it to dietary supplements under the applicable NDI exemption.

7. Why are color additives not covered under the GRAS pathway?

Under U.S. law, color additives are regulated separately. If the intended technical function of a substance is coloring, it must be approved through a Color Additive Petition (CAP) rather than a GRAS notice.

8. Can ingredients such as lycopene or β-carotene, which serve both nutritional and coloring functions, be submitted through GRAS?

Yes. The applicable regulatory pathway depends on the intended technical effect:

• If the ingredient is marketed primarily as a food ingredient or nutrient, and not for coloring purposes, it may be eligible for the GRAS pathway.
• If its intended technical function is to impart color, a CAP is required.

9. If an ingredient is microencapsulated, does the original GRAS notice become invalid?

Generally, no. Microencapsulation is considered a commercial processing technology. A new GRAS notice is generally unnecessary, provided that all encapsulating materials (e.g., maltodextrin and coating materials) are themselves authorized for food use under applicable U.S. regulations.

10. After obtaining GRAS status, does a modification to the manufacturing process require a new GRAS notice?

It depends on the nature of the change.

• Minor adjustments (e.g., process parameter optimization that does not affect the ingredient’s chemical identity, purity, or impurity profile) generally do not require a new GRAS notice.
• Major changes (e.g., changing extraction solvents, replacing the production microorganism, or modifying the synthesis pathway in a manner that could affect safety) generally require a new GRAS notice.

Driven by a global wave of food innovation, regulatory compliance and market access for novel food ingredients and additives have become critical hurdles for companies expanding internationally. Under this circumstance, CIRS Group has prepared the White Paper Series on Global Novel Food and Feed Ingredient Submissions, with the aim to help businesses navigate the evolving global regulations and accelerate global expansion.

Our inaugural release - Guide to U.S. GRAS Notification -  delivers an actionable, in-depth breakdown of the US FDA's Generally Recognized as Safe (GRAS) pathway. Please click here to view more details.

CIRS Successful Cases

CIRS Group boasts a proven track record and industry-leading expertise for new food ingredient.

With extensive experience in novel foods, functional ingredients, synthetic biology, and advanced nutrients, we have provided seamless, end-to-end compliance solutions for over 1,000 food enterprises worldwide.

Our public case studies and service capabilities span key high-growth sectors, including but not limited to:

D-Allulose (D-psicose)

● CIRS Assists Zhongda Hengyuan’s D-psicose in Achieving GRAS Notice

● CIRS Assists Shandong Fuyang in Quickly Obtaining Substantial Equivalence for D-Allulose as a New Food Ingredient in China!

● CIRS Successfully Supports China’s First Official Approval of D-psicose

Mycoprotein from Fusarium venenatum

● CIRS Helps Fushine Biotech Successfully Obtain Approval for China’s First Mycoprotein from Fusarium Venenatum

2’-FL

● CIRS Helps Tianjin Hesheng Successfully Obtain US GRAS Notice and China New Food Additive Registration for Its 2’-FL

● CIRS Assists Client in Gaining GRAS Notice for 2’-Fucosyllactose (2’-FL)!

3’-SL

● CIRS Assisted Meihua Group in Securing First NHC Approved 3’-SL

N-Acetylglucosamine (GlcNAc)

● CIRS Assists Runhan in Obtaining GRAS Status for Its GlcNac

SAMe-DT

● CIRS Helps Shandong Freda’s SAMe-DT Successfully Complete FDA NDI Notification

Astaxanthin

● CIRS Assists Shandong Weiyan in Obtaining GRAS Status for Its Astaxanthin

Zeaxanthin

● CIRS Supports Enhe Aiju’s ZeaVida® Zeaxanthin Obtain FDA GRAS Notice

β-carotene

● CIRS Assists VDK in Securing GRAS Status for β-carotene

PQQ

● CIRS Assists Maiggic in Rapid Approval of PQQ Disodium Salt for Substantial Equivalence

Enzymatically converted rebaudioside M2 (RebM2)

● CIRS Assist Client in Receiving "No Questions" FDA GRAS Notice

Click here to view more about our successfully cases.

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.