This article was published in the May/June 2025 issue of Pet Food Processing. Read it and other articles from this issue in our May/June digital edition. 

Speakers often open sessions with a general remark that “we are living in a world of rapid change that has never been seen before.” The phrase is used so frequently that it has become jaded and tired, but how else do we describe the current state of pet food regulations? 

Last year, we saw the termination of the memorandum of understanding (MOU) between the US Food and Drug Administration (FDA) and the Association of American Feed Control Officials (AAFCO). In the fall, we watched as the FDA developed a new Animal Food Ingredient Consultation (AFIC) process. And then, we saw a new collaboration forged between AAFCO and Kansas State University’s Olathe Innovation Campus (KSO), dubbed the Scientific Review of Ingredient Submissions (SRIS) pathway, to provide a new animal food ingredient submission pathway. 

Pet food on retail shelves

Industry regulations are supposed to help companies bring new ingredients and new products to market, but some of the proposed changes could make the process more of a challenge. 

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Already this year, the FDA Center for Veterinary Medicine (CVM) has undergone significant change, committing to “close the loophole” in the Generally Recognized as Safe (GRAS) food pathway and review the food additive petition (FAP) process, setting new wheels in motion. In line with the Trump administration’s priorities of reducing the size of government, Health and Human Services Secretary Robert F. Kennedy, Jr. has also vowed to dramatically reduce the staff across HHS, and the latest cuts threaten the CVM’s ability to carry out its mission. 

These changes have significant implications for manufacturers of pet food and ingredients. There are several definitions of “change,” and it would be wonderful if these developments met this one: “replace (something) with something else, especially something of the same kind that is newer or better.” Only time will tell.

 

CVM moves toward efficiency 

In 2019, new appropriations, which the American Feed Industry Association (AFIA) had long advocated for, were enacted, allowing the CVM to hire more staff and improve its capacity for animal food ingredient reviews. The Animal Drug User Fee Act IV passed in 2018, requiring the FDA to review performance goals and commitments designed to improve the timeliness and predictability of animal food ingredient reviews. This led to the FDA’s release of Guidance for Industry 262 (GFI 262) in late 2020. 

GFI 262 provided clarity for both animal FAP and GRAS notification reviews, supporting the agency’s goals of facilitating better communication with stakeholders to bring safe, new animal food ingredients to the market. The document also outlined guidelines for the use of foreign data in both the FAP and GRAS pathways. 

“Recent workforce reductions, specifically in the CVM, are threatening to turn back time on progress,” wrote Louise Calderwood of the American Feed Industry Association.

Once again, in fiscal 2020, the AFIA successfully advocated for a $5 million appropriation to hire 12 new staff members at the CVM. This funding coincided with a major reorganization that created the CVM Division of Animal Food Ingredients (DAFI), which allowed the staff to focus exclusively on ingredient submission reviews. Previously, responsibilities were spread among compliance and regulatory drafting duties, but the creation of the DAFI sparked efficiency, which only further advanced as new staff were hired and trained. These changes to expedite reviews and streamline the processes were met with support from the pet food and animal food industries, as they replaced an outdated system with one that was, indeed, “newer or better.” The best kind of change. 

While the process is still far from perfect, over the last three years, ingredients reviews, though still challenging, have been progressing more quickly for manufacturers seeking to bring new products to the market. Now, recent workforce reductions, specifically in the CVM, are threatening to turn back time on that progress.

 

FDA creates AFIC 

In early 2023, the AFIA participated in a virtual public meeting on the CVM’s role in the AAFCO feed ingredient definition process, citing the long-standing success of the shared responsibility created by the FDA-AAFCO MOU. AFIA’s remarks noted that the review system, supported by the MOU, created confidence across the food chain that animal feed and pet food products are safe — an essential requirement for our industry’s customers. 

Despite AFIA’s support for the review system, in October 2024, the FDA terminated its MOU to conduct safety reviews of new animal food ingredients through AAFCO and quickly replaced it with the interim AFIC process, a measure intended for animal food ingredients that would have used the prior AAFCO ingredient definition process. AFIC will be used to review these ingredients while the FDA evaluates and implements changes to the animal FAP and GRAS notification programs. 

The AFIC process requires the submission of data supporting the ingredient’s intended use and safety. Following the FDA review and approval, ingredients that have undergone the AFIC process will be posted on the FDA website, identifying the substance, intended use, intended species and submitter. Firms making a submission through the AFIC process should not expect that this information will be kept confidential. It is too early to tell if the AFIC process is “newer and better,” but the AFIA is optimistic that the procedure will work while the FDA conducts its thorough review of the FAP and GRAS systems.

 

AAFCO proposes new review process

As the FDA withdrew its support for the AAFCO Ingredient Definition Request process, AAFCO quickly developed a collaboration with KSU to support a method to review products coming to the marketplace. Once operable, for a fee, firms can enter submissions for ingredient reviews by a scientific panel comprised of subject matter experts from universities across the United States and independent consultants. 

The new AAFCO process, which is slated to open this fall, is designed to ensure diversity and representation across all animal species as the panel evaluates potential ingredient submissions from industry and provides recommendations back to the AAFCO membership for final approval. Once approved, ingredients will then be included in AAFCO’s Official Publication. 

AAFCO is promoting this new pathway as one that meets the requirements of FDA’s current GRAS notification program, while also addressing Kennedy’s concerns about the lack of oversight in the GRAS process. State regulators have indicated that they will accept ingredients approved through the SRIS process, while historically, they have been reluctant to register products that had undergone the self-GRAS review process, so there is hope that the new process may be “newer and better.” 

 

FDA commits to reviewing FAP, GRAS

FDA sign

The Food and Drug Administration is at the center of a number of regulatory changes affecting the pet food industry including the ingredient review process. 

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The FDA is currently reviewing the FAP and GRAS programs to determine if changes are needed to better serve public health and improve the pathway to market for new animal food ingredients. The AFIA provided detailed feedback to the FDA, addressing the animal food industry’s frustrations with the cumbersome ingredient review processes. 

Specifically, the CVM requested input on the benefits, barriers, suggested changes and improvements to the FAP and GRAS notification processes. The AFIA requested changes to improve the efficiency of reviews, lower the unnecessary regulatory hurdles for data submissions, and provide comprehensive guidance tailored to animal food ingredient reviews. 

The AFIA will continue to monitor the FDA’s progress as it moves forward with the evaluation. This is certainly an opportunity for “newer and better” changes but may also be contingent on the agency having the proper staffing to support its review work.

 

Changes in GRAS

In March, HHS Secretary Kennedy confirmed that the FDA will review the current GRAS process. Currently, under the current GRAS process, manufacturers may determine, based on scientific evidence, that a substance is safe for its intended use in food and does not require pre-market approval from the FDA. In contrast, for food additives, the FDA determines the safety of the ingredient through the FAP process, while GRAS determination can be made by qualified experts outside of government, using publicly available data. 

Companies may voluntarily submit an ingredient for a “notified” GRAS review, which may result in a “no questions” letter, indicating that the FDA did not have concerns about the GRAS status of the ingredient. Historically, this pathway has been extremely cumbersome for animal food ingredients. To date, fewer than 40 ingredients have successfully navigated the course to a successful conclusion of a notified GRAS product. 

Regardless of whether a substance is deemed to be GRAS or if its safety is established through the FAP process, the FDA’s safety determination is always limited to the ingredients’ intended conditions of use.

If upcoming changes to the FDA’s GRAS review process eliminate unnecessary barriers currently in place, the new process would absolutely be “newer and better,” something the AFIA would welcome. But if the self-GRAS process is closed and the remaining notification process continues to have inconsistencies compared to human food GRAS reviews, it would be an example of a “change for the worse.”

 

Looking forward

“Animal food companies need certainty in the regulatory environment if they are to invest time, money and resources into bringing new ingredients to the marketplace,” wrote Louise Calderwood of the American Feed Industry Association.

As the pet food manufacturing industry continues to monitor the evolving regulatory landscape, we will closely watch changes to the structure and function of federal agencies as well as new regulatory proposals. 

Animal food companies need certainty in the regulatory environment if they are to invest time, money and resources into bringing new ingredients to the marketplace. If the current leadership’s end goal is to help these companies think about America first when marketing their products, we must support changes that will cut regulatory red tape for the better, not make the environment unattractive and cumbersome to business leaders. 

With so much change going on, the industry has the opportunity now to speak up to the FDA and AAFCO about how these changes will impact their ability to operate or compete in a global marketplace. The AFIA will continue to keep its members apprised of these changes and represent them in stakeholder meetings. For more information, visit afia.org

Read more news from associations and agencies in the pet food sector.