In the midst of an overview of its latest work overseeing and regulating pet food and feed safety, a Food and Drug Administration (FDA) officer seemed to casually slip in what could be an important announcement for the industry regarding pet food ingredient definitions.
This new development — that a recent reauthorization of two animal drug fee acts essentially deleted a provision in a separate act that mandated FDA to create new pet food ingredient standards and definitions — could have several implications. For one, it could mean an easing or even dissolving of the tension that has arisen in recent years over FDA’s long-term acceptance of ingredient names and definitions developed by the Association of American Feed Control Officials (AAFCO).
Steven M. Solomon, D.V.M., M.P.H, director of FDA’s Center for Veterinary Medicine (CVM), made the announcement during a presentation at the Ninth Annual Feed and Pet Food Joint Conference, held September 17-19, 2018, in St. Louis, Missouri, USA, presented by the National Grain and Feed Association and Pet Food Institute.
The explanation behind this announcement, like most things involving regulations, is fairly complex and full of acronyms. While CVM has played a role in the AAFCO ingredient definition process since the 1980s and tacitly approved the resulting definitions, the arrangement was more formally recognized in late 2007 by a memorandum of understanding (MOU) signed between the two bodies. David A. Dzanis, D.V.M., Ph.D., D.A.C.V.N., provided a full history and explanation of the MOU at that time.
The MOU has been extended four times since then, most recently in fall 2017, yet not without questions and concerns. Namely, FDA was being advised by its legal team over the years that the MOU may not adhere to federal law. “The problem with this cooperative activity is that although the AAFCO process is scientifically rigorous, from FDA’s perspective it is based on enforcement discretion — i.e., not a formally sanctioned procedure for acceptance of new feed ingredients,” Dzanis wrote in late 2012.
That could be because also in 2007, in the wake of the melamine-related pet food recalls earlier that year, the U.S. Congress passed the Food and Drug Administration Amendments Act (FDAAA). The act stipulated, among several elements, that FDA develop new regulations related to pet food, establishing ingredient standards and definitions, processing standards and updated labeling standards.
The law required FDA to develop these within two years, but that deadline was obviously never achieved; subsequently, it was superseded (at least in practice) by passage of the Food Safety Modernization Act (FSMA) in 2011.
Since FSMA regulations related to pet food were finalized a few years ago and are now being implemented, FDA/CVM have returned their attention to modernizing pet food labels, working with AAFCO. But nothing has been heard about potential new processing standards under FDAAA, and the announcement by Solomon was the first word about the ingredient definitions and standards in some time.
During his presentation on September 18, Solomon reviewed the Animal Drug User Fee Act (ADUFA) and Animal Generic Drug User Fee Act (AGDUFA), which were passed in 2003 and 2008, respectively, with updates (ADUFA IV/AGDUFA III) reauthorized in August 2018. The updates provide for new guidance on animal food ingredients, Solomon said, plus increased transparency by FDA via public posting of the number of feed additive petitions and their status in the approval process.
The final bullet point on Solomon’s slide was “deletion of ingredient standards and definitions provision in FDAAA.” He commented that this means FDA “will continue working with AAFCO for that.”
And that was it! Solomon offered no further explanation, and there was no opportunity to question him later about this potentially significant development with pet food ingredients.
We were able to chat briefly with Jenny Murphy, M.S., consumer safety officer with CVM’s Office of Surveillance and Compliance, who also presented at the conference. She said yes, as she understood it, that provision of FDAAA was now gone, but she didn’t know any more. She recommended a colleague for us to follow up with, and we are trying to find out if he has more information. If so, we will post it as soon as we can.
In a later session, Stan Cook, president of AAFCO (and program administrator for the Missouri Department of Agriculture), acknowledged that the organization’s MOU with FDA had been a struggle, but “recent legislation does put us and FDA in a better position, and I think it will solidify our relationship.”
AAFCO’s process for developing and revising ingredient definitions and other elements important to pet food, such as label updates, is far from perfect and exceedingly slow. But for a dynamic industry buffeted by rapidly changing consumer needs and issues like pentobarbital-related recalls (which Solomon also commented on) and the July FDA advisory on grain-free pet foods and cases of canine dilated cardiomyopathy, hearing that a crucial process may be on more solid ground is a positive, even comforting, development.