That wasn’t a typo, GRAS stands for ‘Generally Regarded as Safe’, the label used by the US Food and Drug Administration (FDA) when it approves the use of a new chemical, food or feed ingredient as safe for its intended use. Beyond the USA, many countries look to FDA GRAS designation as a strong indication that a product has been rigorously tested and reviewed. We are proud to have (finally) received GRAS designation this week for KnipBio Meal.
This designation is the result of a long and rigorous process. Starting as early as 2014, we met with a team from FDA to introduce ourselves, explain our technology and to understand what data they would be looking for in order to gain an eventual approval. The data package we would need to assemble included extensive feed trials, peer-reviewed research papers, an extensive literature review and a detailed description of the KnipBio process to explain why KnipBio Meal is safe and efficacious. The total application, including literature & references reached approximately 1,000 pages.
We submitted the application ~15 months ago. The review process included three separate Q & A’s received from the FDA’s panel of experts requesting additional clarification. While not as tough a hurdle as phased clinical trials needed to get a drug on the market, GRAS designation provides strong evidence that a feed ingredient is safe. It was a frustrating process at times, including (but not limited to!) the overlapping with the longest government shutdown in U.S. history. But...now that we have crossed the finish line I am ecstatic. I think this is going to be a game changer for KnipBio.
This is a big deal. We are now officially able to sell the product with FDA acknowledgement that KBM is safe for finfish. It has been validated by an independent, expert panel. And, as a result of this GRAS notification, KBM joins a very small basket of currently available alternative proteins.
With the growing awareness of the planet’s resource limits, it is increasingly apparent just how much the world needs a vibrant aquaculture industry in the coming decades to assure food security for our expanding human population. Experts are describing the need for proteins to DOUBLE from today’s production within the next 30 years. To satisfy this demand, at least in part, our diets need to further shift to fish because of the dramatic efficiencies in production, a healthier form of protein and of course the taste!
We need to be smarter about what the animals that feed us, eat themselves. There are simply not enough forage fish in the oceans to support projected farmed fish demand. The plant protein alternatives currently on the market provide at best, an incomplete nutritional solution for many of the most popular fish we like to eat. Additionally, there is limited agricultural land remaining that is not protected rainforest. The way forward for aquaculture appears limited without the rise of novel alternative protein sources that are nutritious, scalable, traceable, affordable, sustainable, and safe.
KnipBio Meal has already been shown to be nutritious in numerous feed trials. Because it is made using industrial fermentation, it is inherently scalable and traceable. Since it uses standard industrial fermentation equipment and is made from abundant, low-value byproducts is is affordable and sustainable. GRAS designation now cements KnipBio Meal as a safe protein alternative. I anticipate this will encourage feed manufacturers to use it in their formulas as they work to decrease the amount of fish in the feed. For the first time in the USA, aquafeed manufacturers will have access to a sustainable, affordable fishmeal alternative made from a traceable single cell protein
So what’s next? Having achieved GRAS designation for our first product, we are now looking at submitting a new application for another version of our single cell protein that includes astaxanthin (the carotenoid that makes salmon pink) that is targeted for salmonids and crustaceans. At the same time, as written about previously, I call on my peer companies in the SCP, insect and algal spaces to work together to improve the voice of this emerging sector. Demonstration of safety is critical and we must maintain the trust and confidence with the public. However, we can’t possibly wait multiple years each time a novel ingredient becomes available to be reviewed and eventually approved. The pace of innovation, coupled with the demand from the sector, means the stakes are just too high.