The pet food world was surprised with major news announced last week at the AAFCO Annual meeting. The current agreement between AAFCO and the FDA that has been in place for 5 years (started 2019) allowing AAFCO to utilize the expertise of the FDA-CVM for approval of ingredients to be used in animal food in the USA is coming to an end. The FDA will be launching their own ingredient review process this fall and AAFCO is going to explore other options for approving animal food ingredients. Read on to learn more about how these changes differ from the current process and how they will affect your business.
Key Changes:
End of Partnership:
The Memorandum of Understanding (MOU) for ingredient review between FDA-CVM and AAFCO expires on October 1, 2024, and will not be renewed.
FDA-CVM will no longer collaborate with AAFCO for ingredient safety and utility reviews.
New FDA Process:
The FDA will implement a new review process called the Animal Food Ingredient Consultation Program (AFIC).
This program will handle the review of ingredient definitions and safety independently from AAFCO.
AAFCO's Role Moving Forward:
AAFCO’s Ingredient Definitions Committee (IDC) will review ingredients recommended by the FDA’s AFIC for potential inclusion in the AAFCO Official Publication.
The AAFCO Board of Directors will make recommendations to the membership for voting on new ingredient definitions.
Upcoming Steps and FDA Draft Guidance:
FDA released two Draft Guidances for Industry on August 8th regarding the transition phase for ingredient approvals after the MOU with AAFCO expires in October.
Draft Guidance for Industry #293, FDA Enforcement Policy for AAFCO-Defined Animal Feed Ingredients
FDA does not intend to initiate enforcement on ingredients used in animal foods that are listed in chapter six of the AAFCO 2024 OP or Official Common or Usual Names and Definitions of Feed Ingredients
FDA is not aware of safety concerns that would cause them to request an ingredient withdraw from the AAFCO OP as many have a long history of use in animal food
The policy is intended for review of new ingredients
Draft Guidance for Industry #294, Animal Food Ingredient Consultation (AFIC)
Describes the interim AFIC process for firms to engage with the FDA regarding ingredient approvals that would have gone through AAFCO’s Ingredient Definition process
This will be an additional avenue to receive ingredient approval.
There will be a public comment period for ingredients submitted
A 180-day FDA review period will be observed, after which the FDA will send a “consultation complete” letter to the submitting company
Firms that would like to market ingredients are invited to discuss with FDA whether AFIC fits their proposed ingredient and should contact FDA via email at Animalfoodpremarket@fda.hhs.gov.
Public Involvement:
The draft guidance documents will be open for public comment until September 9th, 2024. To submit an electronic comment, visit webpage https://www.fda.gov/animal-veterinary/cvm-updates/fda-releases-two-draft-guidances-seeks-public-comment-pre-market-animal-food-ingredient-review
Stakeholder listening sessions will be scheduled to provide updates on the AFIC program. Email AnimalFoodIngredientRFC@fda.hhs.gov no later than September 1, 2024, with first and last name, email address, phone number, and organization/affiliation.
Short-term Actions:
AAFCO will revise its Ingredient Definitions Committee procedures to incorporate a review of ingredients that receive a “consultation complete” letter from FDA’s AFIC.
FDA’s AFIC process will begin Fall of 2024
Long-term Considerations:
AAFCO may establish an independent scientific review process and look for new scientific partners such as universities, which would likely be associated with a cost.
AAFCO may review ingredients for acceptance such as those approved from the Canadian Food Inspection Agency or the European Food Safety Authority.
FDA’s current Food Additive Petition and GRAS Notification programs for animal food will be evaluated.
FDA will assess the AFIC process in a year and make adjustments as necessary. If authorities change, legislative changes may be required causing a longer process time.
Summary:
This transition marks a significant shift in how animal food ingredients are reviewed and approved. The FDA will move to a more independent review process, while AAFCO will adapt by potentially revising its own procedures and exploring new scientific partnerships. If you would like further information regarding the AFIC process, we would be happy to answer any questions you may have!