FDA issues Guidance on Interim Animal Food Ingredient Consultation (AFIC) Process

Background

AAFCO is an independent organization that has been guiding state, federal, and international feed regulators with ingredient definitions, label standards, and laboratory standards.  Since 2007, FDA has provided a letter of concurrence regarding the suitability of feed ingredients reviewed by AAFCO before the organization formally issued a definition for the feed ingredient in its Official Publication.  In August 2024, FDA announced that it would not be renewing its longstanding MOU with AAFCO. Instead, FDA developed the AFIC process to provide FDA review of new ingredients in animal feed that do not meet the technical criteria for GRAS.  At the same time, FDA is assessing its animal Food Additive Petition and GRAS Notification programs to determine if changes are needed to promote the efficient development and review of new animal food ingredients.  

The Animal Food Ingredient Consultation Process

As FDA continues to reassess the animal Food Additive Petition and GRAS Notification programs, the AFIC process is available to support firms developing animal food ingredients that would have otherwise utilized the AAFCO ingredient definition process.  To participate in the AFIC process, firms will need to provide certain information to support the consultation, including:

• The firm name and contact person;
• The proposed ingredient name and definition;
• A summary of the request explaining the purpose of the request and summarizing the rationale;
• A description of the ingredient (i.e., the chemical or botanical name, composition, physical/biological/chemical properties);
• Manufacturing information, including a description of the manufacturing process, formulations, batch analysis, stability information, and methods; 
• The purpose of the ingredient, including a description of the intended use and target species with data to support the intended use;
• A safety assessment for target animal safety (including use limitations) and human food safety (if applicable), including a narrative summarizing cited safety studies and exposure assessments;
• Copies of cited literature and reports;
• The proposed labeling; and 
• Any other information considered relevant by the developing firm.

FDA intends to post inventories of pending and completed AFICs on its website, which will identify the substance, intended use, intended species, and submitter.  Other sensitive information may be kept confidential under FDA’s Freedom of Information Act policies. 

Additionally, FDA will allow interested parties to provide additional data or information regarding the safety of ingredients posted on FDA’s website within 90 days of the ingredient being posted.  Information submitted after the 90 days may not be considered as part of the initial review.  Once FDA has completed its review, it will issue a consultation-complete letter and post the ingredient, its intended use, intended species, submitter, and consultation-complete letter to the AFIC website.

Enforcement Discretion for AFIC-Cleared Ingredients

All animal food substances that are not GRAS for an intended use are considered a food additive that requires FDA approval through regulation.  However, the AFIC guidance clarifies that FDA does not intend to initiate enforcement action with respect to the food additive approval requirements for ingredients that are the subject of a consultation-complete letter under the AFIC process.  Notwithstanding this policy, FDA will evaluate the safety of any ingredient if it identifies a concern with respect to the ingredient.

Next Steps

We will continue to monitor FDA’s updates to the animal Food Additive Petition and GRAS Notification programs.  Please reach out to us with any questions.

Authored by Maile Gradison, Brian Eyink, and Erin Pannek.