FDA's approval of Upside's chicken as safe to eat is just the start of the beginning for cultured meat
There was so much excitement – justifiably so – about what the FDA's approval of Upside Foods' chicken could mean for the cultivated meat revolution that what it actually means, and what actually happened, somehow got blurred in a few headlines.
LinkedIn almost blew up with the shares, reposts and messages of congratulations from the global alt-protein sector - and quite rightly so. "I’ve been looking forward to this day for a long time," enthused Uma Valeti, CEO & Co-founder of the San Francisco, Bay Area company. "The 'No Questions' letter from the FDA accepting our conclusion that our cultivated chicken is safe to eat means Upside is one step closer to being on tables everywhere. There's still a lot of work to do, but we're celebrating this historic moment for Upside and for the food system."
"The agency evaluated the information submitted by Upside Foods as part of a pre-market consultation for their food made from cultured chicken cells and has no further questions at this time about the firm's safety conclusion," the FDA revealed in its statement. However, before this food can enter the market, the facility in which it is made also needs to meet applicable US Department of Agriculture (USDA) and FDA requirements. In addition to the FDA's requirements, including facility registration for the cell culture portion, the manufacturing establishment needs a grant of inspection from USDA-Food Safety and Inspection Service (FSIS) for the harvest and post-harvest portions and the product itself requires a USDA mark of inspection.
"It's one step closer and one more country, and more steps to cross but this is overall good for the cultivated industry," concurred Sandhya Sriram, CEO & Co-founder of Singapore's Shiok Meats, which was the first nation to approve cultured meat products for sale, with Eat Just being one of the first companies to sell its lab-grown chicken there.
"The FDA’s 'No Questions' letter is a major milestone towards eventual market approval," agreed Andrew Tindall, an Associate and Patent Attorney at Mewburn Ellis. Regardless of the further regulatory steps remaining before the cultivated meat can be sold to consumers, this development does at least mean cultivated meat is closer to the US market than ever before.
"As the USA is the world’s leading consumer and producer of chicken, approval in this market is highly prized, and steps toward acquiring this are major achievements. Observers may wonder if this indicates a generally favorable attitude at the FDA, and whether the USA will join Singapore as a friendly regulatory environment for cultivated meats. It also will be interesting to see to what extent this trend is followed by regulators in key markets such as in Europe and China. Regardless, the future of food has gotten a little bit closer, even if there is still a while to wait before we can have a taste.
"We anticipate that the FDA’s historic determination will accelerate research and development of cultivated meat, not only in the USA but globally, serving as an example for other governments around the world to follow as they develop their own cultivated meat regulations," insisted Jessica Almy, Vice President of Policy, Good Food Institute. "The USA has the know-how, the institutions, the resources, and the momentum to lead the way. Having such a prominent regulator move efficiently to 'greenlight' Upside Foods’ cultivated chicken could have ripple effects throughout the world."
"Not only does this provide a greenlight in terms of a regulatory path to follow for the field, but it also validates that the technology is safe for the public," added Professor David Kaplan, Tufts University, who leads a team awarded US$10 million from the USDA to establish the first-ever National Institute for Cellular Agriculture at Tufts University. "From a scientific perspective, this should also give momentum to both academic and corporate efforts to continue to move the technology forward based on quality science to generate safe and healthy foods for consumers.”
The Alliance for Meat, Poultry & Seafood Innovation applauded the FDA’s announcement. "The FDA’s decision reflects a thoughtful, rigorous and science-based process that took place over the course of several years," its statement read. "During this time, Upside Foods provided the agency with the safety and supporting information that UPSIDE used to determine its cultivated/cell-cultured chicken is safe and may proceed down the regulatory pathway. AMPS Innovation looks forward to continued progress by these and other companies to help expand safe and delicious food options for consumers and help support a more sustainable food supply."
Momentous as the FDA announcement was, this is only the start of the beginning.
The most urgent concern for the industry is how to achieve sufficient scale to meet what is hoped will be burgeoning consumer demand, making cost one of the biggest barriers to widespread consumer uptake.
According to CRB Group, emerging cell-based manufacturers will face challenges with cost and profit targets, given that their facilities produce a modest yearly output – 10,000 lbs is currently at the higher end of production – compared to traditional protein companies that are processing one million chickens a day. Right now, these are two different worlds.
At the top of the list is how to scale today’s production to the point where, not only is it commercially viable, but it can take a serious bite out of the animal meat market. Scaling up to achieve commercial viability will require addressing three major challenges. These are significantly reducing the costs of culture media, equipment, and clean rooms; increasing productivity and throughput of both growing cell cultures and final product by improving upstream and downstream processes; and addressing product differentiation to meet expanding consumer expectations.
COP27 climate negotiations look set to conclude with steady – if not stellar – progress on reaching a consensus as to how the world can avoid catastrophic climate change. However, one area almost absent in the outcomes so far is how we can reduce the environmental impact of animal agriculture, which is estimated to make up 20% of global greenhouse gas emissions – that’s more than the entire global transport sector. When produced at scale using renewable energy, though, cultivated meat is projected to generate a fraction of the emissions and require a fraction of the land and water of conventional meat production. Meat made in this way could produce up to 92% less emissions, and use up to 95% less land and 78% less water when compared to conventional beef production.
"A shift toward cultivated meat has the potential to bring massive benefits for climate, food security, public health, biodiversity, and regional bio-economies that create new jobs and livelihoods," said Bruce Friedrich, President of the Good Food Institute. "With a clear path to market and significantly more public investment in R&D and commercialization incentives, the dawning of cultivated meat gives our global food system much brighter days ahead.”
Currently, Singapore is the only country worldwide to legally allow the sale of cultured meat products for human consumption, but the US announcement could spur other countries to accelerate regulatory efforts. Israel is a world leader in cultivated meat, with more than 10 companies that raised over a third of the world's investments in 2021, but the Ministry of Health has not yet approved the sale of cultivated meat. "In order for Israeli consumers to be able to enjoy the products, and for Israeli companies to be able to open their production plants here and not abroad, the Ministry of Health should follow the FDA's lead as soon as possible," suggested Alla Voldman, VP of Strategy & Policy at GFI Israel.
Regulations aside, there are some other important hurdles that were addressed succinctly by Richard Owen, Principal Bio-Scientist at Cambridge Design Partnership in Raleigh, North Carolina. He advised we need to think differently to scale up efficiently. "We know we can make cultured meat, but the costs and scale mean it isn’t yet an everyday item," said Owen. "Pharma-style processes and equipment just aren’t designed for food-based products and so won’t get the sector where it needs to be. We need a mix of new thinking, processes, and products. Rather than focus on pharma, technology should be brought in from other sectors, such as the brewing, textiles, and food ingredients industries, as their process throughput and manufacturing costs are closer to what’s needed for this market. Ingredients and structural components must be fully defined and standardized before cell bio-fermentation can become a high throughput, low intervention process, like brewing or baking."
Owen also said we need to get the branding right. "Cultured meat companies have a lot of heavy lifting to do to educate the consumer," he added. "Meat in its raw state is often considered a generic product; only after cooking does it normally appear as a brand. Linkage to other existing brands is one option, such as endorsement by well-known chefs or restaurants. Other options include trying to emulate exotic breeds such as Wagyu beef, ostrich, or kudu (antelope). First-movers will have an advantage; later entrants may have to specialize to grab and retain a niche."
There is another major hurdle to clear, and one that few were discussing in all of the exuberance. In 2018, the FDA was close to gaining sole regulatory jurisdiction over cultured meat and poultry products. The biotech process by which these products are made falls squarely in FDA’s oversight. Then, a few companies who were engaged in these endeavors lobbied Congress and the White House to give USDA joint jurisdiction. "These companies wrongly assumed that an impasse between FDA and USDA would hold up their products," revealed Scott Gottlieb, Partner, New Enterprise Associates. "The principal company engaged in that lobbying effort, in my view, lacked accurate information on the state of negotiations that were underway, where that process stood, and how close FDA was to assuming sole oversight. The result of that lobbying effort resulted in the current policy – FDA oversees the review of the products and USDA oversees their marketing. And now, five years later, the first product is poised to reach the market. It’s a fair bet that, under pressure from the traditional cattle and poultry industry, USDA is going to insist – over time – on marketing conditions that deny the cultured meat industry the commercial advantages its products could offer. It’s a regrettable outcome. And one beneficiary will be the cultured seafood industry, which falls entirely under FDA’s jurisdiction (FDA alone regulates the seafood industry). These cultured seafood products face no similar obstacles and constraints that’ll likely come from the joint jurisdiction that exists for cultured meat and poultry. Stay tuned."
For now, though, the industry must take what it gets – and the FDA announcement is a big boost. The sector is further forward than it was this time last week. Cultured chicken products from Upside Foods are safe to eat.
"Since our earliest days, our top priority has been to ensure the safety and quality of our products," concluded Eric Schulze, Vice President of Regulatory and Public Policy at Upside Foods. "FDA sets the standard for global acceptance of new food innovations, and we are incredibly grateful for the agency's rigorous and thoughtful process to ensure the safety of our food supply. We're also extremely proud to have played a leading role in helping to champion the framework for how cultivated meat, poultry and seafood are regulated in the USA."
We are extremely grateful that Eric Schulze is one of more than 75 speakers at The Future of Protein Production Summit, taking place online on 21/22/23 February 2023. You would think the FDA's announcement would be a hot topic, but that's 12 weeks and that is a long time in alt proteins these days. Who know who would have followed Upside into the history books by that time?
And certainly it's good news for chickens. It’s estimated that there are more than 50 billion chickens raised for meat in the world each year. That works out to about 136 million chickens killed each day worldwide. The USA is the third most prolific country for chicken farming. There are about nine billion chickens raised for slaughter in the USA each year. An additional 305 million hens are kept for commercial egg production.
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