Preparing and Submitting a GRAS Notification

For Nutraceutical Ingredients Marketed and Imported into the United States

A Comprehensive Service Guide by J&J Compliance Consulting Group (JJCC Group)

Self-affirmed GRAS is on its way out

On Aug 11, 2026, FDA proposed a rule that would make GRAS notification mandatory. Companies could no longer rely on a private, self-affirmed GRAS conclusion without telling FDA. The proposal includes a time-limited, streamlined submission option for substances already on the market under self-GRAS. Comments close Dec 9, 2026. The rule is not final, but now is the time to get your GRAS file in order.

The Governing Regulations: 21 CFR by Industry

The GRAS concept is codified principally in Title 21 of the Code of Federal Regulations. The specific parts that apply depend on the product category and how the ingredient will be used. JJCC Group maps each ingredient to the correct regulatory basis before any work begins.

Part	Content
1	Signed statements and certification
2	Identity, method of manufacture, specifications and physical or technical effect
3	Dietary exposure
4	Self-limiting levels of use
5	Experience based on common use in food before 1958
6	Narrative of the basis for the GRAS conclusion
7	List of supporting data and information

GRAS Requirements Broken Down by Category

A common point of confusion is that GRAS applies to a single thing. In practice, the GRAS determination attaches to an ingredient used under defined conditions, while separate regulatory obligations attach to the nutraceutical category and to the finished product. JJCC Group addresses all three layers.

Nutraceuticals (the Product Category)

“Nutraceutical” is a marketing term, not a single FDA legal category. Depending on formulation and claims, your product is regulated either as a dietary supplement (under DSHEA and 21 CFR Part 111) or as a conventional/functional food (under 21 CFR Part 117). This classification drives whether an ingredient even needs GRAS status: food and beverage ingredients require GRAS or a food-additive approval, whereas dietary-supplement ingredients may instead require a New Dietary Ingredient (NDI) notification. JJCC Group performs the classification analysis first so you pursue the correct pathway.

Ingredients (the Substance Itself)

The GRAS determination is made for the specific substance—its identity, manufacturing process, specifications, and the levels and conditions of intended use. The same ingredient can be GRAS for one use and not another. Requirements include a full chemical and manufacturing characterization, a dietary-exposure (intake) assessment, and a comprehensive safety review demonstrating both technical evidence of safety and common knowledge of that evidence among qualified experts (the “common knowledge” element unique to GRAS).

Finished Products Imported into the USA

Finished nutraceutical products and bulk ingredients imported into the United States face additional layers: Foreign Supplier Verification Program (FSVP) obligations under 21 CFR Part 1 Subpart H, facility registration under the Bioterrorism Act, accurate labeling, and Prior Notice for imported food shipments. The GRAS status of the ingredient does not by itself clear customs—the importer must still satisfy these import controls. JJCC Group coordinates the GRAS dossier with the import-compliance file so the two reinforce each other.

Who Is Responsible for Preparing and Submitting the GRAS Notice?

Responsibility for a GRAS determination rests entirely with the company that wishes to market the ingredient—the FDA does not “approve” GRAS status. There are two lawful routes:

Self-determination (self-GRAS): The company convenes a panel of qualified experts, compiles the safety record, and concludes GRAS without notifying the FDA. This is legal but carries the highest enforcement risk and offers no FDA acknowledgment.
GRAS Notification (GRASN): The company—called the “notifier”—voluntarily submits a GRAS Notice to FDA’s Center for Food Safety and Applied Nutrition (CFSAN). FDA reviews it and, if satisfied, issues a “no questions” letter, which is the market-recognized gold standard of GRAS assurance.

The notifier is legally responsible, but the dossier is built by a multidisciplinary team: toxicologists, an independent GRAS expert panel, regulatory specialists, and (for imports) the U.S. agent and importer. JJCC Group serves as the regulatory project lead—assembling the team, drafting every section, convening the independent expert panel, and submitting the notice on the notifier’s behalf through FDA’s electronic portal.

What a GRAS Notice Includes:

A substance added to food is Generally Recognized As Safe (GRAS) when qualified experts generally agree it is safe for its intended use. That agreement must rest on public data. GRAS status can be based on scientific procedures, or on common use in food before 1958. A GRAS substance is exempt from food additive approval.

Part 1

Pathway assessment:

GRAS, food additive petition or, for supplements, NDIN.

How JJCC Group helps: We draft the entire signed-statement package, confirm the correct statutory basis (scientific procedures vs. common use in food before 1958), prepare the certification language, and ensure the notifier’s authorized signatory and FSVP/U.S.-agent details are correct for imported substances.

Part 2

Safety and toxicology review

including literature searches.

How JJCC Group helps: We compile the chemistry and manufacturing characterization, align specifications with compendial standards (USP/FCC), validate the analytical methods, and document the cGMP manufacturing controls under Parts 111/117 that support a food-grade specification.

Part 3

Dietary exposure modeling.

Estimates the cumulative dietary intake of the substance from all intended uses, typically using NHANES consumption data and conservative exposure modeling.

How JJCC Group helps: We build the estimated daily intake (EDI) model, account for background exposure and overlapping food categories, and produce a defensible margin-of-safety calculation that the expert panel can endorse.

Part 4

Independent expert panel

coordination.

How JJCC Group helps: We assess and document self-limiting factors (taste, solubility, technical function) where they strengthen the safety narrative, and clearly state when none apply.

Part 5

Notice writing and electronic filing

with FDA's Human Foods Program.

How JJCC Group helps: We evaluate whether the pre-1958 pathway is viable for traditional botanicals and, if so, assemble the historical, ethnographic, and trade evidence required to support it.

Part 6

FDA questions and follow-up

through the response letter.

How JJCC Group helps: We conduct the systematic literature review, design and commission any needed toxicology studies, author the integrated safety narrative, and convene an independent expert panel to reach and document a consensus GRAS conclusion.

Part 7

Transition planning

for self-GRAS ingredients under the proposed rule.

How JJCC Group helps: We assemble the complete reference library, obtain full-text studies, prepare the data-availability index, and format the dossier to FDA’s electronic submission standards before filing on your behalf.

Why JJCC Group

J&J Compliance Consulting Group provides end-to-end cGMP regulatory consulting across the pharmaceutical, biotech, medical device, food, and nutraceutical industries. For GRAS work, our team integrates regulatory strategy, scientific writing, expert-panel management, and import compliance under one roof. We do not hand you a template—we deliver a complete, defensible, submission-ready GRAS Notice, manage FDA correspondence through the “no questions” letter, and align your manufacturing and import files (Parts 111, 117, and FSVP) so your GRAS status holds up under inspection and customer audit.

Gap analysis and pathway determination (GRAS vs. NDI vs. food additive).
Full authoring of all seven GRAS Notice parts to 21 CFR 170 standards.
Independent expert panel recruitment and consensus management.
Toxicology study design, exposure modeling, and literature review.
Electronic submission to CFSAN and management of all FDA correspondence.
Coordination of FSVP, facility registration, and import controls for products entering the USA.