One of most common questions I get from media and people outside our industry is about how petfoods and ingredients are regulated, particularly in the US. This has been a recurring question ever since the 2007 melamine-related recalls and continuing through more recent Salmonella-related recalls, passage of the Food Safety Modernization Act (FSMA) and, most recently, the release of proposed preventive control rules for feed and petfood under FSMA.
The difficult truth is that this question does not have a sound-bite-like answer, easily and readily understood by most media and consumers. Actually, I would bet that most people in our industry don’t entirely understand this issue, aside from regulatory professionals.
It certainly doesn’t help that the answer is shifting. Besides FSMA and its related rules, another crucial regulatory issue could have significant ramifications, mostly negative, for petfood. That’s the ingredient approval process, used by many petfood manufacturers, set up and operating for 35 years between the Association of American Feed Control Officials (AAFCO) and the US Food and Drug Administration (FDA).
Under a memorandum of understanding (MOU) between AAFCO and FDA, AAFCO’s feed (and petfood) ingredient definitions have essentially been supported and accepted by FDA. The most recent MOU, which was originally signed in 2007, was due to expire this year; in fall 2012, it was extended through September 1, 2015. A lot could happen between now and then that might threaten this continuing collaboration on ingredient definition approvals.
The 2007 petfood recalls spurred passage of the Food and Drug Administration Amendments Act (FDAAA) that same year, which mandated regulations addressing petfood ingredient standards and definitions, processing standards and updated standards for labeling. Those have not yet come to pass, but FDA is now turning its attention back to FDAAA, especially as it reviews the MOU with AAFCO.
Further, despite the fact that the AAFCO ingredient definition process has worked just fine for 35 years, FDA is now questioning it, based on advice from its legal counsel. (Gotta love those lawyers!) Perhaps David A. Dzanis, DVM, PhD, DACVN, a regulatory expert (and former FDA employee), put it best in his “ Petfood Insights” column explaining the tenuous status of the MOU when it was renewed in 2012:
“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. Notwithstanding the fact that federal regulations (21 CFR 10.95) recognize AAFCO as a standard-setting body and allow FDA employees to engage in its activities, FDA was in recent years advised by counsel to forego further involvement with AAFCO on this matter and rather pursue ‘legal homes’ for all allowed feed ingredients.”
As Dzanis explained it then, if the MOU is not renewed or a similar process developed, it would be difficult for AAFCO to continue the feed ingredient definition process. So, to have any new ingredients approved, petfood companies would have to file either a GRAS (generally recognized as safe) notification or a food additive petition directly with FDA. And both those options have serious challenges.
The American Feed Industry Association (AFIA), which is actively addressing this situation, says it now appears FDA is seeking to harmonize the AAFCO process with requirements in the federal Food, Drug and Cosmetic Act – and that would open up another set of difficult questions and issues.
What can petfood companies do? Besides educating yourself, you can become involved and contribute your insights and ideas. AFIA will soon send a form to its members to collect information on what an ideal ingredient approval process might look like and on how regulatory uncertainty is affecting their businesses, especially in terms of investment/innovation, revenue and jobs. (Because FDA has turned to Congress on this matter, AFIA is also now lobbying Congress, too, it says.)
Another way to become educated and involved is to attend Petfood Forum 2014. On Wednesday, April 2, a discussion session led by George Burdock, PhD, of the Burdock Group will delve into this issue and, ideally, inspire members of our industry to step up and have a hand in how petfood ingredients are defined, approved and labeled. The panel for that discussion will include Dzanis, along with Ray Matulka, PhD, of the Burdock Group and David R. Schoneker, an expert in the pharmaceutical and human food sectors, which have gone through (and survived) similar regulatory battles with their ingredients.