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Regulatory Landscape
cnatan
Posts: 38 XPRIZE
Our most pressing research questions pertain to understanding the regulatory landscape of alternative meat products.
We're interested in your views on the following questions.
We'd appreciate any insights you're able to provide. The more specific, the better!
We're interested in your views on the following questions.
- How much time does it take to obtain FDA approval for a cell-based meat alternative?
- How does the regulatory landscape vary between following regions: USA, Europe, Middle East, Asia, East Asia -- and what regulatory procedure would be best for XPRIZE to follow?
- How long is the process of labelling a product (approximately)?
- Is the end-product what regulatory bodies focus on evaluating or are they evaluating the process in which the product is made at various stages? Does this differ across geographies, and if so, which regulatory group is gold standard? If so, why or why not?
- What are the top regulatory hurdles facing companies across different parts of the world?
We'd appreciate any insights you're able to provide. The more specific, the better!
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Comments
It's a big deal as any sales would require regulatory oversight. We've been told that countries around the world are looking at U.S. FDA for first-mover guidance as the gold standard on food safety and labeling of cell-based seafood. Ideally, both food safety review and labeling would be on parallel, simultaneous pathways, that would allow for sale of cell-based seafood products in 2-3 years. It's an aggressive target for sure.
FDA would be interested in both process and end product.
If the goal is to feed the next billion, I think XPRIZE is right to be deeply interested in regulatory requirements and might want to focus on incentivizing commercialization of products, which requires scale, regulatory, technical, consumer marketing, organoleptic equivalence, etc.
FDA is often risk adverse. I have watched some proposals take up to 13 years for a pretty easy decision. And the non-food but important issue of FDA supporting vaping (e-cigarettes) is now biting them back and may make them more risk adverse. And exactly how you present things to FDA is important. If you claim an extension of current technology, they are less risk adverse -- but if claim new or novel their radar kicks in.
In the meantime, I would also like to invite @michal, @Novameat, @ajacquelin and @Scott_Weathers to join the discussion. You may also be able to answer some of these questions.
Thanks!
That is a small problem compared to what I think is a more interesting problem.
What if we inserted into maize (corn if you will) a protein that replaced zein (a not very nutritious protein> So we tale out zein (possibly by crisper) and put in a protein in tissue specific - seed expression (like the storage protein - zein) that has high levels of lysine (22%), methionine (16%) , isoleucine, threonine and Tryptophan (about 10% each)? This can be done and your resulting protein would be 2.5 times (roughly) more nutritious than milk protein (9, 2, 6, 5 2% respectively). As I said , that is a more interesting problem, leading to a real solution that is maybe mind-boggling.
Take it from there , X Prize, if you wish. FYI we produced and published such a protein 35 years ago. Synthetic biologists can now do better.
Regarding the end-product vs process issue, it depends on the regulatory body. FDA tends to focus on end-product, with concerns about process only if they affect end-product safety. However, the National Organic Program at USDA is much more concerned about process, regardless of whether the end-product is affected.
@Rhithoy1, @swgriffi, @nznick, @weih, @Elaine71, could you tell us which approach food regulators in your countries take?
Any insights you're able to give us would be much appreciated! Thank you.
GRAS is not a requirement by manufacturers, but it is a selling point....many consumers may not be willing to readily purchase an item that has not been deemed safe by the government. The GRAS panel would be responsible for reviewing the GRAS notice and all of its safety information - they should be experts in the field - cell-based meat for example - who would be cognizant of all of the ways in which the production of, and the product itself could affect our health and safety.
The cultivated meat is something new and both USDA and FDA will be involved. How that will work in practice remains to be seen. But there are definitely regulatory hurdles to cover. And there is the issue of how the industry presents itself. Way back when, I believe it was Simplese -- that advertise how state of the art they were and then went to FDA and said they were simply homogenizing something to a finer size (the earlier era of nanotech). FDA reacted based on the advertising and it took forever to approve and by then momentum was lost. And AquaBounty has also suffered from the FDA worrying about new. A real regulatory craziness -- they approved the product and then said to sell it in the US it had to be produced in the US, which the company had nothing in place at the time. So they are still struggling but trying to develop American capacity. So it remains unclear just how the agencies will handle it.
Yes! The competition will run for four years and incentivize the creation of accessible, nutritious, and more environmentally sustainable chicken and fish alternatives. I just posted our proposed Prime Timeline, which contains more details.