Food production is projected to grow 70% by 2050, when the world population reaches 9.7 billion. Fish consumption alone will rise 58%. The agricultural expansion required to meet the world's hunger will increase deforestation and biodiversity loss, and accelerate climate change by increasing the release of carbon into the atmosphere.

To meet this global challenge, XPRIZE is designing a prize competition that will incentivize solutions which create white meat alternatives that replicate or outperform conventional meat in cost and access, environmental sustainability and animal welfare, nutrition and health, and taste and texture — ultimately leading to a future in which both people and the environment thrive.

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Regulatory Landscape

cnatancnatan Posts: 30 XPRIZE
edited October 30 in Key Issues
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.
  1. How much time does it take to obtain FDA approval for a cell-based meat alternative?
  2. 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?
  3. How long is the process of labelling a product (approximately)?
  4. 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?
  5. 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!

Comments

  • NickOttensNickOttens Community Manager Barcelona, SpainPosts: 448 admin
    @Satheshkumar, @MikeSelden, @Murphy, @Rachel, @Didiertoubia, would you be able to help us answer some of these important questions?
  • MurphyMurphy Director, Corporate Development & Strategic Partnerships San DiegoPosts: 1
    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.
  • JMR9JMR9 Professor Emeritus of Food Science Posts: 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.


  • NickOttensNickOttens Community Manager Barcelona, SpainPosts: 448 admin
    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!
  • cnatancnatan Posts: 30 XPRIZE
    @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?
  • davidsandsdavidsands Posts: 6 ✭✭
    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.
  • cnatancnatan Posts: 30 XPRIZE
    @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?
  • kaweikelkaweikel Director of Nutrition Science Posts: 6
    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.
  • NickOttensNickOttens Community Manager Barcelona, SpainPosts: 448 admin
    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?
  • cnatancnatan Posts: 30 XPRIZE
    @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?
  • kaweikelkaweikel Director of Nutrition Science Posts: 6
    Sorry - unfortunately I don't have experience in those areas!
  • NickOttensNickOttens Community Manager Barcelona, SpainPosts: 448 admin
    @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.
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