So you want to use a novel ingredient in your pet food – awesome!
After all, you’ve done a ton of research. There is great evidence your novel ingredient does wonders for mammalian health. Certainly there’s a myriad of pet supplements using this ingredient on the shelf. Being an entrepreneurial spirit, you put it in your pet food. You even perform research and development; on a small scale of course, because you’re a small company. But you still find 20 animals who thrive using this novel pet food ingredient.
Finally, the formulation is just right and it’s time to market your new pet food product. Being an upstanding, legal-minded pet food manufacturer, you begin the arduous process of registering your product and/or your labels in every state in which you intend to sell.
State after state, you can’t get a single regulator to approve your product. Now, your frustration level is at an all-time high! You know this is a quality ingredient. After all, you’ve done your research, the ingredient has quality sourcing, and you know from the studies on humans and animals as published on PubMed that this is a healthy ingredient.
So what’s your recourse?
Well, the state regulators tell you that it’s not an approved ingredient. Because you are because you are savvy, and you know AAFCO approved the “common and usual “term,” you argue that it’s a “common and usual” ingredient. After all, it’s a common term as used in human food.
But the state regulator tells you that there’s no safety study to prove its safety or efficacy in pet food. You can’t use it.
So then you pay $120 to obtain your own copy the AAFCO OP (official publication) – there must be some way around this!. (Or maybe you reach out to your trade association, Next Gen PFMA, and ask them to read the AAFCO OP for you so you can save that $120 and apply it to registration in another state.) No way is your ingredient allowed. You and your Next Gen representative can’t even come up with an alternative name or heading under which the ingredient may fall.
So what are you to do? Certainly, You can ask your trade association, Next Gen PFMA, to submit an ingredient definition package to the Ingredient Definition Committee of AAFCO. The problem is is once the package is submitted, either the FDA or AAFCO will require a safety study. And if it’s a “common usual” ingredient, there’s no safety study. Everybody knows your ingredient is safe. But there’s no specific data specific to your ingredient in pet food! So in order to get your ingredient approved for use in pet food, you, the small manufacturer, need to spend $100,000 to conduct a safety study.
But wait a minute!
You don’t net that much money in a year. Let alone two years!
So what other options are there? Well if your ingredient has Independent Conclusion of GRAS (generally recognized as safe), and you are operating in a state that does not specifically regulate for or against Independent Conclusion of GRAS, you might be able to get your ingredient approved for your specific use.
Sounds easy – what does it take to achieve Independent Conclusion of GRAS? A committee of independent educated professionals qualified to make a safety determination of your ingredient, at your specified inclusion level, for your specified use, in the specified species, in your specified pet food. Sounds like money. Don’t think it’s that easy, because you still need a few documents to present to the committee for their review. You know, safety documents – there’s the money, if there aren’t any.
Don’t know anybody who can conduct the Independent Conclusion of GRAS determination? At Next Gen PFMA, we do. We actually have a committee of independent, highly trained, educated professionals who can make an Independent Conclusion of GRAS. This is one of the many services offered by Next Gen PFMA, the only trade association representing entrepreneurs, like yourself, of fresh pet food using real ingredients who want to use a novel ingredient.
Don’t have $100,000 to complete a safety study? Can’t convince regulators to let you use your ingredient? Contact us.
Oh, and did I mention, if you try to follow regular channels and submit your ingredient for review either directly to the FDA, or through the Ingredient Definition Committee of AAFCO, it will probably take two years for your ingredient to get approved (once you provide the safety data). Meanwhile, you’re trying to manufacture a food and improve pets’ lives.
