U.S. FDA Animal Food Ingredient Consultation (AFIC) - USA - Food & Food Contact Materials

What Is the U.S. FDA Animal Food Ingredient Consultation (AFIC)?

The Animal Food Ingredient Consultation (AFIC) is a temporary transitional mechanism established by the FDA, primarily providing a new federal-level communication channel for companies whose products might previously have pursued market entry through the AAFCO ingredient definition pathway.

AFIC is not a statutory approval procedure like a Food Additive Petition (FAP), nor is it equivalent to the “no questions” process associated with an FDA GRAS Notice. However, companies can use AFIC to formally consult with FDA regarding proposed animal food ingredients. FDA may identify potential safety concerns and provide regulatory and technical feedback.

From a practical perspective, AFIC is significant because it provides an important transitional option for companies seeking formal technical interaction with FDA but that do not currently intend to pursue an FAP or find it difficult to proceed directly through the GRAS Notice pathway.

What Are the Applicable Situations for AFIC?

The substance is a new animal food ingredient, and the company wishes to engage in formal technical communication with FDA at the federal level.
The project would have historically been more closely aligned with the AAFCO ingredient definition pathway but now requires an alternative approach following the end of the AAFCO-FDA joint review mechanism.
The company wishes to have the project status displayed on FDA's publicly available submission list while maintaining protection for core confidential business information.
The company wishes to obtain preliminary confirmation from FDA regarding potential safety issues before planning subsequent AAFCO Official Publication (OP) or state-level market access.

What Is the AFIC Submission Process?

Pre-submission communication: The company may first discuss potential regulatory pathways with FDA and assess whether AFIC is an appropriate option.
Dossier preparation: Prepare comprehensive information covering ingredient definition, manufacturing information, intended use, target animal species, and safety.
Formal submission: Submit the AFIC consultation materials to FDA.
Initial review: FDA conducts an initial completeness review and assigns an AFIC number.
Public posting: Following acceptance, basic information such as the company name, ingredient, intended use, target animal species, and status will be posted on the AFIC online list. During the first 90 days, interested parties may submit additional information regarding product safety and other relevant data, while FDA conducts its technical review in parallel.
Technical review and questions: FDA reviews the ingredient's safety, appropriateness of use, and supporting data and may request additional information or clarification from the company.
Conclusion: If no safety concerns are identified, FDA will issue a Consultation Complete Letter.

What Information Is Required for an AFIC Submission?

An AFIC dossier generally includes the following core modules:

1	Company name and contact information
2	Proposed ingredient name and definition
3	Submission summary
4	Description of the substance
5	Manufacturing information, including a description of the manufacturing process, formulation/composition, batch analysis, stability data, and analytical methods
6	Intended use of the ingredient, including proposed use and target animal species
7	Safety assessment, including target animal safety (including use restrictions, where applicable) and human food safety (where applicable)
8	Copies of cited literature and reports
9	Proposed labeling
10	Other relevant information

Among these, manufacturing processes, specifications and quality control, the rationale for target animal use, exposure assessment, and the overall safety justification are key areas of FDA's review. For ingredients intended for use in food-producing animals, particular attention should also be paid to potential impacts on the human food chain.

How Does AFIC Differ from Other U.S. Feed Ingredient Regulatory Pathways?

Regulatory Pathway	FAP	FDA GRAS	AFIC	SRIS
Reviewing Body	FDA (federal)	FDA (federal)	FDA (federal)	AAFCO and Kansas State University
Submission Fee	An application fee may apply	No FDA-level fee	No fee	Yes, and charged by AAFCO
Overall Cost & Timeline	Long timeline High cost	Moderate timeline Moderate cost	Shorter timeline Relatively low to moderate cost	Generally shorter timeline Moderate cost
Direct Outcome	Inclusion in federal regulations under 21 CFR	FDA “No Questions” letter	Completion of FDA consultation	Inclusion in AAFCO OP
Recognition	Highest	High	No federal approval; state-level acceptance may vary because the ingredient is not necessarily listed in the AAFCO OP*	Broad industry recognition because inclusion in the OP is an effective tool for state-level market access, but it does not constitute federal recognition

It is important to note that the outcome of AFIC generally reflects FDA's federal-level enforcement discretion position, rather than formally adding the ingredient to the Code of Federal Regulations. Therefore, when advancing commercialization, companies should still consider state-level regulatory requirements, AAFCO acceptance, and other relevant factors as part of an overall regulatory strategy.

Key Features of AFIC

Transitional mechanism: AFIC is a temporary supplementary pathway introduced by FDA following the end of the historical AAFCO-FDA cooperation mechanism.
Strong federal communication component: Companies can engage in formal consultation with FDA and obtain technical feedback at the federal level.
Public disclosure combined with confidentiality protection: Project status and basic information may be publicly disclosed on FDA's website, while other confidential business information remains protected.
Facilitates regulatory pathway planning: AFIC can be integrated into a company's subsequent state-level registration, AAFCO strategy, and commercialization plans.

Estimated AFIC Timeline

Step	Estimated Time
Data gap analysis	1–2 months
Dossier preparation and internal confirmation	4–6 months
FDA initial review and assignment of number	Approximately 1 month
FDA technical review and conclusion	Generally at least 6 months; complex projects may take longer (interested parties may submit additional information regarding product safety and other relevant data during the first 90 days)
Total	Generally approximately 11–16 months, depending on product complexity and the number of rounds of supplementary information

The above timelines are experience-based estimates for typical projects. Actual timelines depend closely on the maturity of the underlying data, the number of questions raised during review, product complexity, and the company's response time.

Why Choose CIRS

With over 450 employees, CIRS Group offers one-stop global registration and filing services for new food ingredients to support companies expanding overseas, helping them efficiently and reliably gain market access to the U.S. food ingredient market.

U.S. Local Team: CIRS USA is located in Virginia. We have full-time U.S. food regulatory experts who provide compliance services such as U.S. FDA GRAS, NDI, CAP, Animal Food GRAS, FDA Animal Food Ingredient Consultation, and AAFCO SRIS.

Team of Senior Experts: CIRS Group has 24 Chinese Certified Toxicologists (DCST), 1 European Registered Toxicologist (ERT), and 2 U.S. Certified Toxicologists (DABT). DABT experts can serve as members of the GRAS expert panel, participate in panel meetings, and sign off on GRAS submissions.

Extensive Track Record: The CIRS Food Division has over 15 years of experience in food compliance services and boasts numerous successful cases, including human milk oligosaccharides (2'-FL, LNnT, LNT, etc.), steviol glycosides, inositol, brazzein, lycopene, enzymatically converted steviol glycoside Reb M2, NMN, pasteurized AKK, fungal protein, D-allulose, glucosamine hydrochloride, N-acetylglucosamine (NAG), beta-carotene, zeaxanthin, astaxanthin, PQQ, and etc.

Cross-Regional Coverage: The CIRS Food Division provides global application services for novel food ingredients, covering more than 20 countries and regions, including China, the United States, Europe, Australia, New Zealand, Canada, South Korea, Japan, Brazil, Mexico, Singapore, Malaysia, Thailand, Vietnam, Indonesia, and China Taiwan.

End-to-End Coverage: We manage the entire process—from document organization, data gap analysis, test protocol design, expert review, and dossier preparation to submission and ongoing compliance maintenance. Our proven processes and local resources ensure shorter timelines, transparent costs, and a high first-time approval rate, reducing the costs associated with repeated revisions.

Our Services

U.S. feed regulatory compliance consulting and training
AFIC feasibility assessment and regulatory pathway comparison
Full AFIC dossier preparation and technical data integration
Pre-submission communication support with FDA
FDA question response and supplementary submission support

Get In Touch

CIRS Group can help you identify the correct regulatory route and build a practical approval strategy. Click to contact our food regulatory experts or get in touch with us via service@cirs-group.com.