Regulatory Landscape

Prize Designs Feeding the Next Billion
#1

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.

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!

    #2

    @Satheshkumar, @MikeSelden, @Murphy, @Rachel, @Didiertoubia, would you be able to help us answer some of these important questions?

    #3

    Hi Nick, my comments are reserved to the cell-based seafood space, which in the U.S. is regulated by the FDA. I can’t speak confidently to the cell-based meats space as that is regulated by FDA & USDA jointly, as you likely are aware.

    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.

    #4

    HI! Another part of the regulatory landscape for both plant protein products and for cultivated meat products is going to be naming and labeling. In the US all of the products that use surimi (washed minced fish) to make shell-fish like products are labeled as imitation. That is because they are NOT nutritionally equivalent to the product they are replacing. Technically all of the plant milks and plant burger products should have to fall in the same category unless they can meet the nutritional equivalence (which I don’t believe is well defined). And the US congress has just had a bill submitted (a long way from passage) that is moving in that direction.

    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.

    #5

    Thank you both for sharing your insights, @Murphy and @JMR9! I’ll ask @cnatan to follow up.

    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!

    #6

    @Murphy Thank you so much for your insights. As you stated, the FDA in interested in reviewing the process and end product. Can you please elaborate on what reviewing the process means? Is this just related to how safe the production process for example?

    #7

    OK I understand the difficulties with registration.

    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.

    #8

    @JMR9 thank you so much for your insights. What metrics does the FDA use to define plant-based or cell-based products as not being nutritionally equivalent? Are they just using the nutritional baseline of conventional meat products as a reference?

    #9

    Hello!

    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.

    #10

    Thanks, @kaweikel! That’s what we wanted to know.

    @Rhithoy1, @swgriffi, @nznick, @weih, @Elaine71, could you tell us which approach food regulators in your countries take?

    #11

    @kaweikel Thank you for your insights. Can you provide us with some insights on how regulatory bodies for example in Asia and the Middle East view end-product vs process issue please?

    #12

    Sorry - unfortunately I don’t have experience in those areas!

    #13

    @Isabellargandic, @JulieD, @Amy_Proulx, @Novameat, you might be able to help us answer that question for the Netherlands, Australia, Canada and Spain, respectively.

    Any insights you’re able to give us would be much appreciated! Thank you.

    #14

    @kaweikel Can you please provide us with some insights on the FDA/USDA framework that is currently in place right now? Do you happen to know the timeline of product evaluation via this framework for example?

    #15

    Hello everyone, does the FDA need to approve a food product before it is used in a blind taste test?

    #16

    Hello again, if you had a chance to create your own GRAS Panel, what level of expertise would you require and what duties would you assign to panel members?

    #17

    In my limited understanding, the timeline of FDA/USDA approval for food products can very tremendously with the product - is it a new product? or simply a version of an already approved product that was made a different way? What are the safety concerns? What safety data has been provided? Is there a precedent for the type of controls that are needed to ensure consumer safety? For a cell-based meat product, there is no precedent to follow, nor is there a general understanding of all of the potential hazards or how they would be dealt with…for these reasons, among others, regulatory approval would likely take longer than most other types of products. I would also expect that petitioners would need to present a comprehensive safety analysis, which could take some time on their end to prepare. If there a multiple manufacturers looking to gain regulatory approval, it may hasten things along.

    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.

    #18

    The plant based products do not have any regulatory hurdle if all ingredients are already approved in one or another ways. So Impossible Burger had the challenge of a new GMO ingredient that technically needs appropriate approvals (and it is interesting that the GMO issue is hardly mentioned).

    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.

    #19

    @dbeckles, @gbodeker and @HelgaDF, do you have any additional insights on these questions?

    #20

    @kaweikel thank you for your helpful insights. Does the GRAS panel have legal authority of any kind when assessing the safety of a product please?