FDA issues draft guidances on animal food ingredient reviews and seeks public feedback

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The FDA recently announced it has released a set of documents in connection with the transition phase after the FDA’s longstanding Memorandum of Understanding (MOU) with the Association of American Feed Control Officials (AAFCO), which is set to expire on October 1, 2024.

According to the release, any ingredient used in animal food, including pet food, is required to be the subject of an FDA-approved animal food additive petition (FAP) or be generally recognized as safe (GRAS) for its intended use within animal food. Despite the MOU expiring with the FDA, the organization considers AAFCO an important partner and will work closely with AAFCO and state regulatory partners to help ensure the safety of the animal food supply.

The released documents include the following¹:

FDA requests comments on its pre-market animal food review process

The FDA is asking for the public asking stakeholders to address particular questions and requests for information regarding the FDA’s Food Additive Petition (FAP) and the GRAS Notification program. The solicited comments will help the FDA make necessary changes, if any, that can be used to better serve public health as well as improve the path to market for new animal food ingredients.

Comments and information submitted to docket FDA-2024-N-2979 will be intended for consideration by the FDA. The comment period began on August 9, 2024, and will no longer take comments on December 9, 2024. Anyone interested in submitting comments can find instructions on the Federal Register NOA.

Draft Guidance for Industry #293 “FDA Enforcement Policy for AAFCO-Defined Animal Feed Ingredients”

Despite the expiration of the MOU, Draft Guidance for Industry (GFI) explains that the FDA does not intend to initiate enforcement action in response to the interstate marketing of animal food ingredients that are not approved additives or GRAS for their intended use. However, if the ingredients are listed in the ingredient definition chapter of the 2024 AAFCO OP, the FDA has no safety questions or concerns. The GFI #293 also states the FDA will not initiate enforcement of action in the case of the use of animal food ingredient names that are uncommon or unusual but are defined within the AAFCO OP unless the names cause the labels to be misleading or false.¹

Comments will be accepted from now until September 9, 2024. Because this guidance is time-sensitive, the FDA does not plan to extend the 30-day comment period before it starts working on the guidance's final version. Anyone interested can submit an electronic comment for docket FDA-2024-D-2977. Instructions on commenting can be found within the Federal Register Notice of Availability for draft GFI #292.

Draft GFI #294 “Animal Food Ingredients Consultation”

Draft GFI #294 explains an interim Animal Food Ingredient Consultation (AFIC) process for firms to engage with the FDA concerning ingredients that firms may have otherwise utilized in the AAFCO ingredient definition process. The AFIC process would provide another way for firms to consult with the FDA about new animal food ingredients and to review information from developers as well as the public about ingredients and any potential safety concerns, along with the FDA’s AFAP and GRAS Notification program.¹ This process will also include the chance for public awareness and input on the ingredients for which the FDA is providing consultation.

The GFI also explains the FDA would generally not intend to take enforcement action against ingredients that are unapproved animal food additives, if the FDA sent AFIC a ‘consultation complete’ letter. According to the FDA,¹ provided ingredients that are discussed within the letter and there continue to be no concerns or questions about the ingredient's safety.

The FDA began taking comments on August 9, 2024 and will continue to accept comments until September 9, 2024. At this time, the FDA does not plan to extend the 30-day comment period before working on the final version due to the time-sensitive nature of the guidance. Electronic comments can be submitted to FDA-2024-D-2978 and instructions on commenting can be found on the Federal Register Notice of Availability for draft GFI #294.¹

Listening sessions

Along with the establishment of the RFC docket for accepting written or electronic comments, the FDA plans to host multiple virtual stakeholder listening sessions. The sessions will focus on the FDA’s pre-market animal food review programs and questions laid out in the RFC. Those interested in participating in a listening session should email AnimalFoodIngredientRFC@fda.hhs.gov with their first and last name, email address, phone number, and organization/affiliation by September 1, 2024.

Reference

FDA Releases Two Draft Guidances, Seeks Public Comment on Pre-market Animal Food Ingredient Review Programs. News release. The US Food and Drug Administration, August 8, 2024. Accessed August 13, 2024. https://www.fda.gov/animal-veterinary/cvm-updates/fda-releases-two-draft-guidances-seeks-public-comment-pre-market-animal-food-ingredient-review?utm_medium=email&utm_source=govdelivery