FDA and AAFCO End Their MOU. Here’s What It Means For Your Pet Food Business.

Big news for pet food manufacturers: the regulatory landscape for pet food ingredients is facing a major shakeup this fall. 

The FDA recently announced that it will not renew its Memorandum of Understanding with AAFCO, which set the guidelines for pre-market approval of pet food ingredients.

Here’s what the MOU expiration means for the FDA and AAFCO’s roles in pet food regulation, and how your business might be impacted.

What Was The Relationship Between The FDA and AAFCO Previously?

The FDA and AAFCO have collaborated for 17 years on the kinds of ingredients that are approved for use in animal food. This was thanks to a Memorandum of Understanding (MOU) between the two organizations, which started back in 2007.

The MOU allowed for 7 pathways to get your ingredient approved for use in pet food: 

1. Submission to AAFCO's Ingredients Definition Committee. The FDA performs a scientific review of the submitted information and defines limitations for its use. These names and definitions appear in the AAFCO Official Publication.
2. Prior Sanctioned. Some ingredients were explicitly approved by the FDA and USDA prior to September 6, 1958 (21 CFR 181). The prior sanction is only for a specific use as outlined.
3. Food Additive Petitions. This process is outlined in 21 CFR 571.1. Ingredients approved through this route are only approved for the intended purpose and specific conditions as outlined.
4. Colors approved for use. The labeling requirements of color additives in animal feed can be found in 21 CFR 501.22.
5. Generally Recognized as Safe (GRAS). Most ingredients that are GRAS are only accepted for one intended use or specified species. Not all GRAS ingredients for human food are GRAS for animal feed. GRAS ingredients for use in animal food are listed in 21 CFR 582 and 584. 
6. Self-affirmation of GRAS. These must include the same quantity and quality of data that would be needed for a food additive petition. This information must be public (not confidential) and must be completed prior to marketing of the product containing the ingredient. Not all states recognize self-affirmation of GRAS.
7. Common/usual. Ingredients like sugar, corn, carrots and apples are so commonly understood that a definition is not needed. These are listed on AAFCO’s Common Food Index.

What’s Changing After The MOU Expires?

The MOU will expire on October 1, 2024. When it does, it lays the entire approval process on the FDA. 

That said, the MOU’s expiration doesn’t change much in terms of the regulatory hurdles you might encounter when trying to get an ingredient approved for use in animal feed. All of the same legal processes and requirements still apply and haven’t changed, as far as the FDA has publicly said.

The 7 pathways described above are still available to pursue ingredient approval. However, there is a major change to how pathway #1 will work.

Changes to Pathway #1: Submission to AAFCO’s Ingredients Definition Committee

AAFCO’s Ingredients Definition Committee will no longer play a part in ingredient approval. Instead, the FDA will handle the scientific review of all new feed ingredients.

The current time frame from start to finish for pathway #1 is around 2 years. Unless the FDA hires additional employees to keep up with demand, that process will likely take even longer.

As far as the process goes, moving forward it will be dictated by two guidance documents described below.

Draft GFI #293: FDA Enforcement Policy for AAFCO-Defined Animal Feed Ingredients

This guidance says that the FDA doesn’t plan on taking any action against ingredients listed and defined in Chapter Six of AAFCO’s Official Publication.

In short, if an ingredient is already AAFCO-defined, it will still be accepted for use as long as the ingredient follows the definition.

Draft GFI #294: Interim Animal Food Ingredient Consultation

For ingredients that aren’t AAFCO-defined, the FDA plans on implementing an Animal Food Ingredient Consultation (AFIC) process. AFIC will help the FDA stay aware of new ingredients that are marketed in interstate commerce, and any potential safety concerns associated with them.

AFIC will gather safety information about those ingredients and give the FDA an opportunity to discuss potential safety concerns with the developer — ideally before the ingredient is marketed.

If you plan on bringing a new ingredient to market, or add an additional species or intended use to an existing ingredient, now is the time to do it. Prepare everything outlined on pages 2-3 in GFI #294 and submit it as soon as possible.

We’re expecting a rush of submissions, and it could take 1.5 years or more assuming no further studies are needed to complete the ingredient review. If you need support along the way, Pet Food Compliance is here to help.

The FDA Is Now Taking Public Comments

The FDA opened up a public comment system to gather feedback about the two guidance documents linked above. This is a great opportunity to let the FDA know what worked well for your business under the previous system and what they could do better once the MOU with AAFCO has expired.

The comments the FDA gathers will inform how they handle the transition, and what their role in pet food ingredients will look like going forward. You can take part in the public commenting period until December 9, 2024.