On August 2, 2024, just a few days before their Annual Meeting, AAFCO announced that the long-standing Memorandum of Understand (MOU) between AAFCO and the FDA1 would not be renewed at the end of its term. Effective October 1, 2024, ingredients destined for use in animal feed (including pet food) in the US have two regulatory pathways – Generally Recognized as Safe (GRAS) and Food Additive Petition (FAP). The AAFCO Ingredient Definition will no longer be an option for new ingredients; however, a new “Animal Food Ingredient Consultation” (AFIC) pathway has been proposed by FDA and is currently open for public comment.2
What does this mean for my ingredient that is currently on the market?
Ending the MOU does not impact ingredients that are notified GRAS with “no questions letters” or approved food additives. If your ingredient is currently used in animal feed based on a finalized AAFCO Ingredient Definition and is listed in the AAFCO Official Publication (Chapter 6) but is not considered GRAS or an approved food additive, the FDA has stated that they do not plan to enforce the FD&C act, provided the use of the ingredient is compliant with the AAFCO Official Publication (OP).3
What does this mean for future ingredients?
Without the MOU in place, the AAFCO Ingredient Definition is no longer an option for authorization for use of an animal feed ingredient. For many ingredients, the notified GRAS pathway or a FAP will be the clearest regulatory process that has the highest likelihood of acceptance by individual States. Other options include an independent (non-notified) GRAS conclusion, approval in specific states based on individual State laws, or the new AFIC pathway.
How does the proposed AFIC pathway compare to an AAFCO Ingredient Definition?
In the previous process, a firm wishing to market an ingredient would work with AAFCO representatives to draft a non-proprietary definition that described the ingredient and to compile a data set demonstrating safety of their ingredient. The safety information was then sent by AAFCO to the FDA-CVM for review. Ingredients that were eligible for the AAFCO ingredient definition pathway were then reviewed by the AAFCO membership and voted on for inclusion in the AAFCO OP. The information submitted in support of the ingredient safety was kept confidential.
Per the guidance released on August 8, 2024, the FDA has indicated that “AFIC could be used for ingredients such as those that make up a significant proportion of an animal’s diet, including plant materials, grains, or human food by-products”.4 A similar dossier of safety information is required (for further details, see I have an ingredient that I would like to use in an animal feed product, what should I do?). Unlike the AAFCO ingredient definitions, information including the substance, intended use, intended species, and submitter will be made public in an inventory of AFICs. Based on the draft guidance, it does not appear that the information made public will be as extensive as a GRAS notice.
What is the result of the AFIC process?
The AFIC process will result in a “consultation completed” letter. This letter reflects the FDA’s opinion that the ingredient when used according to the proposed intended use does not pose any safety issues. However, the ingredient will be considered an unapproved food additive and not legally marketed but will be allowable under enforcement discretion by the FDA. For comparison, the FAP process results in the ingredients’ inclusion in the CFR as an approved food additive, while a notified GRAS is not approval process, but may receive a favorable result of the FDA issuing a “no questions letter” for the ingredient per conditions described in the GRAS conclusion.
I have an ingredient that I would like to use in an animal feed product, what should I do?
When preparing to bring an ingredient to market for use in animal feed, a pre-market consultation with the FDA is strongly recommended. Additional tools, such as an Investigational Food Additive file and potentially an application for Food Use Authorization5, are useful during the research and development of the ingredient.
Additionally, as part of the research and development process for a new ingredient, or as part of the due diligence if purchasing an ingredient from a contract manufacturer, you should collect information on the chemistry, manufacturing and controls (CMC) of the ingredient; batch analysis, safety information from nonclinical studies, and safety information from studies in the target species. GRAS Associates can complete a preliminary gap assessment and assist in identifying the information required for your ingredient.
The FDA has stated that the following will be required for an AFIC, which is very comparable to the data required for a GRAS or FAP:
- firm and contact person
- summary of the request (explain purpose of request, summarize rationale)
- description of the ingredient (chemical/botanical name, composition, physical/biological/chemical properties)
- manufacturing information (description of manufacturing, formulations, batch analysis, stability information, methods)
- purpose of the ingredient (describe intended use and intended target species), including:
• data to support intended use - safety assessment (narrative summarizing cited safety studies and exposure assessment), including:
• target animal safety (including use limitation, if applicable)
• human food safety (if applicable) - statement of environmental risk
- copies of cited literature and reports
- proposed labeling
- any other information considered relevant by the firm
So, what happens next?
The AFIC process is open for public comment until September 9, 2024. The stated intent is to have this process in place as an interim measure while the FDA seeks feedback on the animal GRAS and FAP processes.6
Firms interested in marketing their ingredients for use in animal feed should develop their regulatory strategy in parallel with the research and development of the ingredient. Other proposed legislative changes in the US, including the Innovative FEED Act7 and the PURR Act8, if passed, will also impact animal feed and pet food regulations. Early and regular communications with the FDA will allow for the greatest chance of success for your ingredient in the changing regulatory landscape.
GRAS Associates is excited to support ingredient manufacturers, suppliers, and brands as you navigate through these changes to find your most efficient path to market. Contact us today to find out more about our services.
About the Author
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Kaiti Valm is Program Manager for Nonclinical and Animal Health Services as part of the US Nutra/GRAS Associates team at SGS Nutrasource. She supports clients with safety and efficacy study oversight as well as preparation of GRAS and other regulatory filings. She brings over seven years of experience in pre-clinical research and education in business, zoology, and veterinary medicine. |
References
[2] Federal Register :: Animal Food Ingredient Consultation; Draft Guidance for Industry; Availability
[3] CVM GFI #293 - FDA Enforcement Policy for AAFCO-Defined Animal Feed Ingredients | FDA
[4] Animal Food Ingredient Consultations (AFICs) | FDA
[5] FDA regulatory pathways for animal feed novel ingredients (feednavigator.com)
[6] Federal Register :: Pre-Market Animal Food Ingredient Review Programs; Request for Comments
[7] Innovative FEED Act: The Next Frontier - AFIA
[8] Pet Food Institute Announces Support for New Federal Legislation to Modernize Pet Food Regulation - Pet Food Institute
