FDA introduces new pathway for animal food ingredients following AAFCO agreement expiration 

USA – The U.S. Food and Drug Administration (FDA) has unveiled its final Guidance for Industry (GFI) 294, titled “Animal Food Ingredient Consultation (AFIC),” marking a significant shift in how animal food ingredients are reviewed and regulated. 

The announcement, published in the Federal Register on January 7, 2025, comes in the wake of the expiration of FDA’s longstanding Memorandum of Understanding (MOU) with the Association of American Feed Control Officials (AAFCO) on October 1, 2024.  

The new AFIC process provides an alternative pathway for ingredient innovators to engage with the FDA while addressing safety and regulatory requirements. 

This move is expected to fill the gap left by the terminated FDA-AAFCO ingredient definition process, which had been one of the primary routes for introducing new ingredients to the animal feed market.  

 A modern approach to ingredient consultation  

The AFIC process aims to create a more transparent and streamlined approach for firms developing animal food ingredients. 

Companies can ensure their products meet safety standards by engaging directly with the FDA before reaching the market. 

Unlike the AAFCO process, AFIC incorporates public awareness and input, allowing stakeholders to comment on pending consultations through the Federal Register.  

The FDA emphasised that the guidance reflects its current thinking on the AFIC process, incorporating feedback from stakeholders such as the American Feed Industry Association (AFIA), state food and agriculture departments, veterinary associations, and private citizens.

Among the key revisions in the final guidance are:  

– Clarification that the AFIC process covers any ingredient previously reviewed under the AAFCO definition process.  

– Removal of the requirement for firms to submit environmental risk statements.  

– Adjustments to prevent firms from resubmitting information already provided to the FDA.  

– Editorial changes to enhance clarity and usability.  

The AFIA, a leading voice for the feed industry, lauded the FDA’s move as a step toward regulatory modernisation. Constance Cullman, president and CEO of the AFIA, expressed optimism about the new framework.  

“The AFIA strongly advocated for a clear, modern FDA process that balances regulatory oversight with industry flexibility. We are pleased that several of our recommendations are reflected in this new guidance,” Cullman stated. “This guidance is a step forward, and we look forward to supporting its effective implementation.”  

Cullman emphasised that the AFIC program’s focus on minimising delays and reducing review gaps aligns with the industry’s need for a consistent and efficient pathway to market. 

The association pledged to work closely with the FDA to ensure the program accommodates the diverse ingredients essential to animal nutrition.  

The FDA-AAFCO process, which had been in place for decades, was a cornerstone of regulatory oversight in the feed industry. 

Its termination removed a widely used pathway for bringing safe ingredients to market, prompting the FDA to develop the AFIC program. 

The new guidance aims to prevent market disruptions by establishing consistent standards and reducing delays.  

Through the AFIC program, innovators will submit data demonstrating ingredient safety, with clear requirements outlined in the guidance. This structure ensures the FDA can efficiently evaluate submissions while maintaining safety standards.  

The AFIA and other industry leaders have expressed confidence that the AFIC process will help expedite the introduction of safe, high-quality ingredients, ultimately benefiting manufacturers, consumers, and the broader agricultural sector.

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