FDA Issues Two Draft Guidance Documents on Its Enforcement Policy for AAFCO-Defined Animal Feed Ingredients and the New Animal Food Ingredient Consultation Process

Executive Summary

On August 8, 2024, the Food and Drug Administration’s (FDA’s) Center for Veterinary Medicine (CVM) announced the availability of Draft Guidance for Industry (GFI) 293, FDA Enforcement Policy for AAFCO-Defined Animal Feed Ingredients, and 294, Animal Food Ingredient Consultation (AFIC). At the same time, CVM also requested comments from the public regarding its Food Additive Petition and Generally Recognized as Safe (GRAS) Notification programs to determine whether changes are needed to promote those programs’ efficiency. GFIs 293 and 294 mark a shift in both CVM’s regulation of animal feed ingredients and its relationship with the member organization of state pet food and animal feed regulators, the Association of American Feed Control Officials (AAFCO). The memorandum of understanding between FDA and AAFCO (MOU) will expire on October 1, 2024, after which CVM plans to exercise enforcement discretion under GFI 293 with respect to animal feed ingredients listed in the 2024 print version of the AAFCO Official Publication (OP). CVM also intends to create a new pathway under GFI 294 for animal feed ingredient developers to consult with CVM following the expiration of the MOU and while CVM evaluates its animal Food Additive Petition and GRAS Notification programs. Because GFIs 293 and 294 have a very abbreviated comment period, with comments due September 9, 2024, and because CVM has explained it does not wish to extend the comment period, we encourage interested parties to consider submitting comments immediately. The comment period for CVM’s Request for Comments on Pre-Market Animal Food Ingredient Review Programs ends December 9, 2024.

Background

MOU Between AAFCO and FDA

For several decades, CVM has served as the scientific and technical reviewer for feed ingredients undergoing the AAFCO Ingredient Definition Request process. In 2007, FDA and AAFCO entered into an MOU outlining the contours of this relationship. Under the MOU, AAFCO maintains definitions of various animal feed ingredients and publishes those definitions in the AAFCO OP. AAFCO and CVM jointly review requests for new feed ingredients and requests to modify an existing feed ingredient definition, and CVM advises on the safety and suitability of the feed ingredient for its proposed use.

On August 2, 2024, FDA announced that it will not renew the MOU once it expires on October 1, 2024. FDA also announced that it plans to evaluate its animal Food Additive Petition and GRAS Notification programs to determine whether changes are needed to promote the efficient development and review of new animal food ingredients. CVM released GFIs 293 and 294 to further explain how it intends to handle the transition period following the expiration of the MOU in October 2024.

GFI 293

GFI 293 explains CVM’s proposed policy regarding the marketing in interstate commerce of certain unapproved food additives intended for use in animal feed and animal feeds containing those food additives. It also describes CVM’s proposed policy with respect to animal feed labels that identify ingredients by names defined in the AAFCO OP. When finalized, GFI 293 will replace Compliance Policy Guide Sec. 665 .100 Common or Usual Names for Animal Feed Ingredients.

Enforcement Discretion Under GFI 293

Once the MOU expires, CVM generally does not intend to initiate enforcement action with respect to the food additive approval requirements of the Federal Food, Drug, and Cosmetic Act (FDCA) for an ingredient or animal feed containing that ingredient that is listed in the Official Common or Usual Names and Definitions of Feed Ingredients section of chapter six of the AAFCO 2024 OP.

Under GFI 293, CVM plans to take into account the following factors when deciding whether to initiate enforcement action with respect to the food additive approval requirements of the FDCA:

1. The ingredient is included in the Official Common or Usual Names and Definitions of Feed Ingredients section of chapter six of the 2024 AAFCO OP;
2. The ingredient is used according to the intended use, specifications, and limitations in the definition listed in the 2024 AAFCO OP. If the ingredient definition contains no specifications or limitations on the ingredient’s use, then CVM generally does not intend to initiate enforcement action with respect to its use if the ingredient is used in animal food in accordance with good feeding practice as defined in 21 C.F.R. § 582.1(b); and
3. CVM has no questions or concerns about the safety of the ingredient.

CVM also intends to exercise enforcement discretion with respect to the common or usual names for animal feed ingredients. To the extent an animal feed label bears the name of a food or ingredient that isnot its common or usual name, GFI 293 makes clear that CVM does not intend to initiate enforcement action with respect to use on an animal feed label of the name of an ingredient that is included in the “Official Common or Usual Names and Definitions of Feed Ingredients” section of chapter six of the 2024 AAFCO OP, unless use of the name causes the label to be false or misleading.

In short, CVM does not intend to object to the continued use of the ingredients appearing in chapter six of the print version of the AAFCO OP under the conditions stated above.

GFI 294

GFI 294 establishes the AFIC process to provide an additional pathway for feed ingredient developers to engage with CVM regarding animal food ingredients for which the developer may otherwise have utilized the AAFCO ingredient definition process. The AFIC process differs from the existing AAFCO ingredient definition process as discussed below.

AFIC Process Overview

AFIC will enable CVM to review and identify any potential safety concerns associated with animal feed ingredients. Interested firms should initiate the AFIC process by emailing the following materials to CVM at Animalfood-premaket@fda.hhs.gov:

1. Firm and contact person;
2. Summary of the request;
3. Description of the ingredient (including chemical/ botanical name, composition, physical/ biological/ chemical properties);
4. Manufacturing information (including description of manufacturing, formulations, batch analysis, stability information, and methods);
5. Purpose of the ingredient (intended use and intended target species), along with data to support the intended use;
6. Safety assessment (a narrative summarizing safety studies and exposure assessment), along with target animal safety (including use limitation, if applicable) and human food safety (if applicable);
7. Statement of environmental risk^[1];
8. Copies of cited literature and reports;
9. Proposed labeling; and
10. Any other information considered relevant by the firm.

CVM will then list the substance, intended use, intended species, and submitter on its public-facing AFICs webpage, and stakeholders can provide additional data or information regarding the safety of such ingredients through the GFI 294 docket. CVM stated this process will “facilitate transparency and support public engagement.”^[2]

Upon successful completion of the AFIC process, CVM will upload to the AFICs webpage a “consultation complete” letter summarizing the information it reviewed to conclude whether it has questions about the safe use of the proposed ingredient.

Enforcement Discretion Under GFI 294

According to GFI 294, CVM generally does not intend to initiate enforcement action with respect to the FDCA’s food additive approval requirements for the ingredient or for animal feed containing the ingredient so long as: (1) the ingredient is reviewed and the subject of a “consultation complete” letter under the AFIC process, and (2) is used in accordance with that “consultation complete” letter.

GFI 294 does not address enforcement discretion at the state level, and states may or may not afford similar discretion regarding animal food ingredients for which CVM exercises enforcement discretion under GFI 294. To address this inconsistency, AAFCO passed a resolution last week at its 2024 Annual Meeting proposing that AAFCO’s Ingredient Definition Committee review ingredients subject to an AFICs “consultation complete” letter for acceptance as new official AAFCO animal food ingredients to be included in chapter six of the AAFCO OP.

Key Differences with AAFCO Ingredient Definition Process

The AFIC process differs from the existing AAFCO ingredient definition process in a number of respects. First, the AFIC process would require interested firms to submit a statement of environmental risk to CVM. CVM has explained that approval of a food additive petition is a major federal action that triggers the requirement for environmental analysis under the National Environmental Policy Act.^[3] Though a decision not to enforce the FDCA’s food additive petition requirements under a grant of regulatory discretion is not a major federal action, CVM nonetheless “intends to consider whether the ingredient might pose an environmental risk.”^[4]

Second, unlike the AAFCO ingredient definition process, the AFIC process involves the public disclosure at the beginning of the process of pending animal food ingredients. For added transparency, CVM also intends to post letters that summarize the information FDA reviewed in concluding whether the agency has questions about the safe use of the proposed ingredient. Because the AFIC pending and completed inventories webpages will, before the FDA review is completed, identify information about the substance, intended use, intended species, and submitter, GFI 294 explains that “firms making a submission should not expect that this information will be confidential.”^[5]

Third, the AFIC process allows members of the public to comment on pending ingredients through the FDA docket. This potentially opens the door to consumer and consumer advocate engagement in a broader manner than the existing AAFCO ingredient definition process now allows.

Impact of the AFIC Process on Existing AAFCO Feed Ingredient Requests

With respect to the impact of the new AFIC process on current AAFCO feed ingredient requests, FDA explained that it will continue to provide consultation on AAFCO Feed Ingredient Definition requests it has received as of August 1, 2024, under the AAFCO Feed Ingredient Definition request process.^[6] CVM will also continue to accept AAFCO Feed Ingredient Definition requests for consultation from AAFCO’s investigators until the MOU expires on October 1, 2024. So they can meet that deadline, AAFCO has stated that its investigators will only be able to accept feed ingredient definition requests until September 1, 2024.

CVM has provided scientific and technical assistance to AAFCO for a small number of animal food ingredients that CVM has recommended for inclusion in the AAFCO OP, but for which AAFCO has not completed the Feed Ingredient Definition Request process. CVM is considering an enforcement policy similar to that described in GFI 293 for these ingredients and is seeking public comment on this issue in the docket for GFI 293. CVM intends to describe any such enforcement policy in future guidance.

Pre-Market Animal Food Ingredient Review Programs: Request for Comments

CVM also plans to assess its animal Food Additive Petition and GRAS Notification programs for pet food and animal feed ingredients following the expiration of the MOU on October 1, 2024. In the Federal Register notice announcing this request, FDA posed six questions on which it is seeking input regarding the oversight of animal food ingredients:

1. What do you perceive as barriers and/or benefits to pursuing a Food Additive Petition or GRAS Notification?
2. Are there changes that could make the Food Additive Petition and GRAS Notification programs more feasible, such as regulatory changes, changes to guidance, or changes to FDA policy or processes?
3. Is there information that is currently required to be submitted in a Food Additive Petition or GRAS Notification that you do not think is necessary for evaluating the ingredient?
4. Is there information that is not currently required to be submitted in a Food Additive Petition or GRAS Notification, but should be to better enable FDA’s evaluation?
5. What review process for proposed animal food ingredients would best enable FDA to review their safety?
6. If you have submitted a request for an ingredient definition through the AAFCO ingredient definition process, what was your reason for doing so instead of filing a Food Additive Petition or submitting a GRAS Notification with FDA?

Due Dates for Comments

Comments for GFIs 293 and 294 are due on or before September 9, 2024. CVM has stated that it does not wish to extend these periods.^[7]

Comments submitted in response to Pre-Market Animal Food Ingredient Review Programs: Request for Comments are due December 9, 2024.

What should you do?

We recommend that stakeholders consider commenting on these proposals, focusing in particular on whether the GFI proposals pose any risks, such as litigation risks to stakeholders, CVM may not have considered. Stakeholders may also want to take this opportunity to consider what has and has not worked in the GRAS Notification and Food Additive Petition processes for pet food and animal feed ingredients. For example, is CVM requesting information for animal feed ingredients that the Center for Food Safety and Applied Nutrition (now the Human Foods Program) historically did not request for human food ingredients? If so, is that a problem, or do you view it as a positive, and under what circumstances?

We also reiterate that the comment period for GFI 293 and 294 is very short, and comments are due on those draft documents September 9, 2024.

If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Drug, and Device practice.