FDA-AAFCO MOU expiration sparks new animal feed ingredient regulations

The U.S. Food and Drug Administration (FDA) and Association of American Feed Control Officials' (AAFCO) longstanding memorandum of understanding (MOU) has expired, leading to a fundamental change in animal feed ingredient enforcement. Feed manufacturers, ingredient suppliers and state regulators face a vital turning point as they adapt to new compliance requirements and enforcement policies in the animal feed industry.

These changes affect the ingredient review process, enforcement actions and regulatory oversight of animal feed ingredients significantly. State regulators and industry stakeholders need to understand the FDA's revised approach to ingredient definitions. The new Animal Food Ingredient Consultation (AFIC) program and updated enforcement policies will shape animal feed safety and innovation future. This piece gets into these changes and their impact on the animal feed supply chain.

Understanding the AAFCO-FDA MOU expiration

AAFCO and FDA's memorandum of understanding (MOU 225-07-7001) has been the lifeblood of animal feed ingredient regulation since its inception almost 20 years ago. This agreement sets clear guidelines that define ingredient review processes and organizational duties. Both organizations have created a framework that helps standardize animal feed ingredients through state regulatory programs.

The 15-year-old framework allowed AAFCO to manage ingredient definition requests with FDA's scientific and technical guidance. Both organizations agreed on specific ways to resolve disputes about ingredient definitions. They also created well-laid-out processes to modify definitions. AAFCO needed FDA's agreement on ingredient suitability before it could adopt new definitions or change existing ones.

Key dates mark the path toward MOU expiration:

• August 2, 2024: Official announcement of non-renewal
• September 1, 2024: Final date for new ingredient definition requests
• October 1, 2024: MOU expiration date

The expiration creates most important changes to the ingredient approval process. The ingredient approval process typically takes three to five years and costs approximately US$600,000 per ingredient. Industry stakeholders must now adapt to the transition period. FDA manages this change through an interim review process within the AFIC  program.

FDA plans to exercise enforcement discretion for ingredients listed in the 2024 AAFCO Official Publication. This strategy ensures continuity for approved ingredients. The agency wants to assess its pre-market animal feed review programs. Their goal focuses on serving public health needs better while creating predictable market paths for new ingredients.

FDA's revised approach to animal feed ingredients

The FDA  recently introduced a detailed new framework that regulates animal feed ingredients. This framework focuses on simplified enforcement policies and clear compliance guidelines. The Center for Veterinary Medicine (CVM) has finalized Guidance for Industry #293 that explains the agency's enforcement approach to ingredients defined in the 2024 AAFCO Official Publication.

FDA has updated its approach to maintain continuity with enhanced oversight measures. The agency will not take enforcement action against ingredients that appear in AAFCO's 2024 Official Publication. This policy covers unapproved food additives and substances generally recognized as safe (GRAS) used in animal feed.

The FDA bases its enforcement decisions on several key factors. The ingredient must appear in the Official Common or Usual Names section of the 2024 AAFCO  Official Publication. The use specifications and limitations need strict compliance. CVM should not have flagged any safety issues. The process should align with good feeding practices defined in 21 C.F.R. § 582.1(b).

Product labels must list ingredients by their common names in descending order based on weight, according to federal regulations. AAFCO definitions serve as the standard reference for common ingredient names in animal feed and pet food products. The FDA allows specific collective terms like animal protein products, forage products, and grain products for livestock and poultry feeds. These collective names cannot appear on pet food labels.

The FDA's enforcement approach balances flexibility with safety requirements effectively. This policy lets manufacturers continue selling ingredients that have proven safety records. The agency can focus its resources on evaluating new ingredients that enter the market.

Transitioning to new regulatory framework

The regulatory transition has altered the map of animal feed ingredient oversight. Major changes have radically changed how ingredients receive market approval through new review pathways and adaptation strategies.

FDA launched the AFIC program in 2020 as an interim pathway for ingredient developers. The program has several key components that streamline the process. Developers can track their pending and completed consultations through an online inventory system. The program allows public docket submissions where scientific data and safety information can be shared. FDA provides consultation complete letters that summarize their safety evaluations. Developers can also engage in pre-submission discussions to identify suitable ingredients effectively.

AAFCO wants to learn about innovative options to maintain its significant role in ingredient regulation. Kansas State University Olathe's proposed scientific review pathway could accelerate the approval process. This new approach might reduce review times from 180 days to 60-90 days. The framework brings together an independent panel of subject matter experts from universities and consulting firms to evaluate various animal species.

The FDA keeps communication lines open through [email protected] to involve stakeholders. Regulators and industry members can maintain ongoing discussions while the review process stays transparent. The FDA shows its commitment to openness by publishing consultation results and keeping public records of pending and completed AFICs.

Federal and state regulators work together under this new framework. This partnership helps enforce rules consistently across jurisdictions and upholds the animal feed industry's traditional safety standards.

Implications for animal feed safety and innovation

Regulatory modernization efforts have altered the map of animal feed safety and state-of-the-art ingredients. The FDA's steadfast dedication ensures pure and wholesome animal feed products for species of all types, including livestock, poultry and companion animals.

This transition brings fresh challenges to ingredient availability in the market. The FDA's regulatory framework covers multiple pathways to approve ingredients. These include the generally recognized as safe (GRAS) provisions and the food additive petition (FAP) process. The GRAS notification review typically takes 270 days to complete. The FAP process needs several years of detailed data collection and analysis.

The animal feed sector embraces state-of-the-art changes through:

• Advanced development pathways
  • Precision nutrition and personalization initiatives
  • Eco-friendly ingredient sourcing practices
  • Technology-driven feed management solutions

Sustainability initiatives and food technology reshape the scene of this industry, especially when you have precision nutrition and ethical sourcing. Many companies now develop alternatives to antibiotic growth promoters. These alternatives include probiotics, prebiotics and enzymes for livestock feed.

The FDA oversees safety through the Animal Feed Regulatory Program Standards (AFRPS).

Animal feed ingredient regulation has entered a new phase that balances safety requirements with innovation. Companies need to prepare for longer approval timelines and higher development costs and they must follow strict safety protocols consistently in this new regulatory world.