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Getting a new ingredient into the U.S. animal food market requires more than a safety file. The regulatory landscape has shifted significantly since 2024, and understanding which pathway fits your ingredient, and what each one actually delivers, is where most companies get stuck. QSS helps you work through that before you commit.
The Animal Food Ingredient Consultation (AFIC) is a voluntary interim process established by FDA's Center for Veterinary Medicine (CVM) under Guidance for Industry #294, finalized in January 2025. It was created after the Memorandum of Understanding between FDA and AAFCO expired on October 1, 2024, opening a regulatory gap in how new animal food ingredients are reviewed and defined.
A completed consultation, confirmed by CVM through a consultation-complete letter, provides enforcement discretion for your ingredient under the described conditions of use. It is important to understand, however, that this is not a GRAS determination or food additive approval.
Under the FD&C Act, an ingredient that is not GRAS for its intended use remains a food additive requiring premarket approval. AFIC is a consultation and enforcement-discretion tool, best understood as an interim or parallel step rather than a standalone authorization. QSS works with your team to assess where AFIC fits in your overall regulatory strategy and prepares your submission to meet CVM's requirements under GFI #294.
Your ingredient’s profile, safety data, and timeline all affect which pathway or combination of pathways makes sense. QSS evaluates your ingredient against the available U.S. animal food ingredient options, including GRAS, AFIC, and the food additive petition, and advises on the right approach before you invest in a dossier.
A complete AFIC submission requires more than a safety summary. QSS prepares your full submission in line with GFI #294, including the proposed ingredient name and definition, identity and manufacturing information, intended use and use rate by target species, and a safety assessment addressing both target animal safety and, where applicable, human food safety for food-producing animals.
Every SRIS submission is required to go through an AAFCO product investigator before reaching the review team. QSS coordinates that step, The safety narrative is the core of your submission. QSS develops a rigorous assessment that summarizes the scientific basis for your ingredient’s safety under its intended conditions of use, covering target animal safety, exposure assessment, and human food safety residue considerations where applicable.making sure the submission is complete and properly routed before formal review begins.
Once CVM (FDA’s Center for Veterinary Medicine) posts your ingredient to the AFIC public inventory, interested parties have 90 days to submit safety data or comments. QSS monitors the comment period, reviews any submissions that could affect your consultation, and advises on how to respond if CVM requests additional information.
CVM (FDA’s Center for Veterinary Medicine) may request clarification or additional data during its review. QSS manages that communication, keeps your file moving, and ensures your responses are consistent with your original submission.
If your company is pursuing AFIC alongside a GRAS notification or food additive petition, QSS coordinates your regulatory submissions to avoid duplication and ensure consistency across filings.
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The Animal Food Ingredient Consultation (AFIC) is a voluntary interim consultation process through which your company can engage FDA CVM (FDA’s Center for Veterinary Medicine) about the safety of a new animal food ingredient. A consultation-complete letter provides enforcement discretion, meaning CVM generally does not intend to take action against the ingredient used under the described conditions. GRAS is a formal safety determination under the FD&C Act that exempts an ingredient from the food additive definition entirely. AFIC does not establish GRAS status or constitute food additive approval. For companies needing the strongest long-term regulatory standing, GRAS notification or a food additive petition provides a more durable foundation, and AFIC can be pursued as an interim or parallel step.
AFIC was established by FDA CVM (FDA’s Center for Veterinary Medicine) under GFI #294 to address the regulatory gap created when the MOU between FDA and AAFCO expired on October 1, 2024. Under that MOU, CVM had provided the scientific review underpinning AAFCO ingredient definitions. AFIC provides a direct CVM consultation route while FDA evaluates potential longer-term changes to its animal food ingredient programs.
Under GFI #294, your submission must include a proposed ingredient name and definition, identity and manufacturing information, intended use and use rate for each target species, and a safety assessment. The safety assessment must address target animal safety, including any use limitations, and human food safety where the ingredient is used in food-producing animals. CVM conducts a completeness review within approximately 30 days of receiving the submission before posting it to the public AFIC inventory.
Yes. Once CVM determines your submission is appropriate and complete, the ingredient is posted to the public AFIC inventory, which identifies the substance, intended use, intended species, and submitter. Interested parties then have 90 days to submit safety data or comments. Legitimately confidential commercial information and trade secrets are protected under FDA’s standard confidentiality rules, but the core submission details will be publicly visible.
CVM conducts an initial completeness and appropriateness review within approximately 30 days of receiving a submission. Following that, the ingredient is posted to the public inventory with a 90-day comment period. Beyond those windows, there is no binding decision deadline, and consultations may remain pending while CVM reviews the submission and any public comments. A complete, well-structured submission reduces the likelihood of delays at the completeness review stage or from follow-up data requests.
Yes. AFIC and GRAS are not mutually exclusive. Some companies pursue both in parallel, using AFIC to engage CVM and obtain enforcement discretion in the near term while a GRAS notification establishes a more durable federal safety determination over time. QSS can assess whether a combined strategy makes sense for your ingredient and coordinate the filings to avoid inconsistencies.
No. A consultation-complete letter means CVM has reviewed your submission and has no remaining safety questions under the described conditions of use. It provides enforcement discretion but does not constitute food additive approval or a GRAS determination. An ingredient used in animal food that is not GRAS for its intended use remains a food additive under the FD&C Act. Companies seeking the strongest regulatory foundation should consider whether a GRAS notification or food additive petition is the appropriate next step.
No. AFIC is described by FDA as an interim process, established while CVM evaluates potential changes to its broader animal food ingredient programs. The regulatory framework for animal food ingredients is actively evolving. QSS tracks those developments and keeps your ingredient strategy aligned with the current landscape.