On February 9, 2023, FDA held an open forum for members of the public to provide comment related to the Feed Ingredient approval process. The process which is currently in place involves participation both from FDA CVM and AAFCO. I submitted a suggested process which would hopefully speed up approval time, thus enabling greater numbers of health active ingredients to be included in pets’ diets. Following is the visual presentation and accompanying transcript.
Hello, my name is Greg Sunvold. My PhD is in Nutritional Science and I have been associated with the pet food industry now for over 30 years. Thank you for the opportunity to offer what I hope will be taken as constructive comments. I have no intentions other than to further build on the greatness of this industry and further collaboration with regulatory partners.
I titled this “Preserving the Good and Building for the Future” because I think there are some prudent regulatory processes in place currently. And I think that further leveraging these processes can address what many in this industry would consider a growing avalanche of new ingredients that need to be appropriately reviewed and approved to meet the growing recognition of not only meeting the nutritional needs of the pet but also the increased attention toward improving the health of these wonderful companion creatures.
As I mentioned, there is a growing need to increase the number of ingredients offered in pet foods. From my point of view, there are a couple of reasons why the number of ingredients needed in pet foods continues to grow:
- The trend towards humanization of pet foods. In other words, I want what I eat myself to be available for my pet.
- The growing importance of promoting health in these creatures. Just like human food trends of including more healthy ingredients in our diets, we continue to recognize the health benefits of many of these same ingredients for our pets.
While it is not perhaps pleasant to say, I believe that many folks believe the current approval system for getting a feed ingredient approved for use in complete foods is both slow and expensive. Rather than complaining about this, the following is a suggested approach to leveraging current regulatory processes in a more efficient way (ie, faster and reduced cost).
For the proposed solution, I offer a general description of the current and future approach to the feed ingredient definition process. On the left the current process is described:
#1: AAFCO is responsible to maintain feed ingredient definitions through its Official Publication which is revised and approved annually.
#2: FDA provides guidance on what are acceptable or unacceptable claims based on alignment with human food claims.
While both organizations I’m sure always want to improve, it seems that this relationship is healthy with both parties seeking each other’s input. Personally, I like the methodical cadence set forth by AAFCO and including FDA’s input and collaboration, as well as industry’s input. That method gives a lot of room for input to new regulations and guidance statements. Of course, all things can be improved. In this case, the need for more rapid approvals and reduced cost burden on industry are needed.
As a result, I propose that in the future the process looks something like this:
#1 and #2 stay the same – again building on the good in the current processes
#3 – Remove the requirement for a pet-specific GRAS document for substances (ingredients) that currently have a GRAS non-object letter for human use.
#4 – A list of concerning substances for pets be put together. This could be developed by FDA with input from AAFCO which would include substances such as theobromine, onions, garlic, xylitol, etc. In fact, FDA has already started such a list found under the website titled, “Potentially Dangerous Items for Your Pet.” You can find that under the www.fda.gov website. Or click on the link found this presentation.
#5 – If a new feed ingredient submitted to AAFCO for purposes of gaining a feed ingredient definition has an FDA non-objection letter for human use and it is not mentioned on the list of concerning substances to pets, then it will be approved for use in pet foods and given an AAFCO feed ingredient definition.
However, if there is no non-objection letter from FDA for use in human food or if it is on the list of concerning substances for pets, then the new ingredient must go through the current system of establishing an FDA GRAS non-objection letter for pets and AAFCO review process.
The point of the future approach is to leverage the current FDA GRAS non-objection letter for humans as a means of speeding the ingredient’s approval for use in pet foods as long as there is no more than ordinary risk associated with its use in either dog or cat species.
This next slide is intended as a graphical means of portraying the same information as laid out in the previous slide.
On the left, is the current process of obtaining a pet specific FDA GRAS that then go through the AAFCO Feed Ingredient Definition process.
On the right, is the proposed future process which allows an ingredient supplier to bypass the requirement to obtain a non-objection letter on GRAS dossier specific to pets, as long as no previous concern has been raised about the ingredients use specifically in pets.
In sum, all of us have the same goal: insure the best pet health. Part of achieving that goal is protecting pets from ingredients that could have detrimental effects on health outcomes. Another part of achieving that goal is to assure timely allowance of using new ingredients that can enhance pet health and eliminate unnecessary financial burdens to those ingredients’ approval.
In closing, it is my hope that the ideas expressed here will be thoughtfully considered in how they may help achieve the above goal. If desired, I welcome further dialogue on these ideas. A public record of this information will be available on my personal blog site: www.microbiomenexus.com. Thank you.