First Cultivated Meat Company gets FDA approval

RNS Number : 7481G

Agronomics Limited

17 November 2022

 

17th November 2022

Agronomics Limited

("Agronomics" or the "Company")

First Cultivated Meat Company Receives Greenlight from Regulator FDA in the US Ahead of Commercialisation

Agronomics (LON:ANIC), the leading listed company in cellular agriculture, is pleased to announce cultivated meat company UPSIDE Foods, Inc. ("UPSIDE Foods"), has received a 'No Questions' letter from the US regulatory body the US Food and Drug Administration ("FDA"), accepting their conclusion that their cultivated chicken is safe to eat. This is a momentous achievement for UPSIDE Foods, and a pivotal moment for the entire cultivated meat industry. This represents the first company to achieve a greenlight from the FDA in the US, and a validation of the sector shifting from research and development, towards commercialisation. We expect this to be the first of many FDA approvals for the sale of cultivated meat in the US.

The FDA's decision is a major milestone in the evolution of the global cultivated meat sector and another step towards the commercialisation of cellular agriculture. The news comes almost two years after the Singapore Food Agency (SFA) gave regulatory approval to Eat Just's cultivated chicken, which is now sold through its subsidiary GOOD Meat. At full-scale commercialisation, cellular agriculture has the capacity to make a meaningful contribution to the world's food production sustainably. It is projected that by 2040, cultivated meat could reach 35% of the global meat market.

This is a timely achievement for the sector given global concerns surrounding food security and climate change, which have come to the forefront in recent years. There is an urgent need to adopt new methods for food production to combat these challenges. The Company remains confident that cell culturing technologies, and cultivated meat produced from these processes, will play a vital role in the coming decades.

Jim Mellon, Co-Founder and Executive Director of Agronomics commented: -

"We are extremely pleased to see the first approval of a cultivated meat product in the US.  Not only is this a massive market, but the FDA is considered one of the most stringent regulatory bodies globally for food safety.

This approval is a landmark event for the field of cellular agriculture and should give investors comfort that the path to commercialisation is now clear. We look forward to news of further approvals from within Agronomics' leading portfolio of companies."

The full announcement is set out below without any material changes.

FDA Completes First Pre-Market Consultation for Human Food Made Using

Animal Cell Culture Technology

Before Entering the U.S. Market, the Food Must Meet Other Federal Requirements

 

Constituent Update

November 16, 2022

The U.S. Food and Drug Administration (FDA) completed its first pre-market consultation for a human food made from cultured animal cells. We evaluated the information UPSIDE Foods submitted to the agency and have no further questions at this time about the firm's safety conclusion. The firm will use animal cell culture technology to take living cells from chickens and grow the cells in a controlled environment to make the cultured animal cell food.

The FDA's pre-market consultation with the firm included an evaluation of the firm's production process and the cultured cell material made by the production process, including the establishment of cell lines and cell banks, manufacturing controls, and all components and inputs. The voluntary pre-market consultation is not an approval process. Instead, it means that after our careful evaluation of the data and information shared by the firm, we have no further questions at this time about the firm's safety conclusion.

The FDA is committed to sharing information about our oversight of human food made from cultured animal cells and today released:

● The FDA's response letter   to the firm

● The FDA's scientific memo that describes our evaluation of the data and information provided by the firm

● The firm's own assessment that their food is safe

In addition to meeting the FDA's requirements, including facility registration for the cell culture portion of the process, the firm will need a grant of inspection from the United States Department of Agriculture Food Safety and Inspection Service (USDA-FSIS) for the manufacturing establishment. Additionally, the food itself requires a mark of inspection from USDA-FSIS before it can enter the U.S. market. As this product comes closer to entering the U.S. market, we are closely coordinating with USDA-FSIS to ensure it is properly regulated and labeled.

The FDA is ready to work with additional firms developing cultured animal cell food and production processes to ensure their food is safe and lawful under the Federal Food, Drug, and Cosmetic Act. We encourage firms to have these conversations with us often and early in their product and process development phase, well ahead of making any submission to us. We are already engaged in discussions with multiple firms about various types of food made from cultured animal cells, including food made from seafood cells that will be overseen solely by the FDA. Our goal is to support innovation in food technologies while always maintaining as our priority the production of safe food. Human food made with cultured animal cells must meet the same stringent requirements, including safety requirements, as all other food.

For More Information:

● Human Food Made with Cultured Animal Cells

● Press Release: FDA Spurs Innovation for Human Food from Animal Cell Culture Technology

 

About Agronomics

Agronomics is a leading listed alternative proteins company with a focus on cellular agriculture and cultivated meat. The Company has established a portfolio of 24 companies in this rapidly advancing sector. It seeks to secure minority stakes in companies owning technologies with defensible intellectual property that offer new ways of producing food and materials with a focus on products historically derived from animals. These technologies are driving a major disruption in agriculture, offering solutions to improve sustainability, as well as addressing human health, animal welfare and environmental damage. This disruption will decouple supply chains from the environment and animals, as well as being fundamental to feeding the world's expanding population. A full list of Agronomics' portfolio companies is available at  https://agronomics.im/ .

About Cellular Agriculture

Cellular Agriculture is the production of agriculture products directly from cells, as opposed to raising an animal for slaughter, or growing crops. This encompasses cell culture to produce cultivated meat and materials, and fermentation processes that harness a combination of molecular biology, synthetic biology, tissue engineering and biotechnology to massively simplify production methods in a sustainable manner.

Over the coming decades, the source of the world's food supply traditionally derived from conventional agriculture is going to change dramatically. We have already witnessed the first wave of this shift with the consumer adoption of plant-based alternative proteins but today, we are on the cusp of an even bigger wave of change. This is being facilitated by advances in cellular agriculture. This change is necessary, given scientists claims that if we maintain existing animal protein consumption patterns, then we will not meet the Paris Agreement's goal of limiting warming to 1.5℃.

AT Kearney, a global consultancy firm, projects that cultivated meat's market share will reach 35% by 2040. This combined with the Good Food Institute's estimate that a US $1.8 trillion investment will be required in order to produce just 10% of the world's protein using this technology, means that we are on the cusp of a multi-decade flow of capital to build out manufacturing facilities. Funding in the field of cellular agriculture is accelerating, however still less than US$ 5 billion has been invested worldwide since the industry's inception in 2016.

For further information please contact:

Agronomics Limited	Beaumont Cornish Limited	Canaccord Genuity Limited	Cenkos Securities Plc	Peterhouse Capital Limited	TB Cardew
The Company	Nomad	Joint Broker	Joint Broker	Joint Broker	Public Relations
Richard Reed Denham Eke	Roland Cornish James Biddle	Andrew Potts Harry Rees Alex Aylen (Head of Equities)	Giles Balleny Max Gould Michael Johnson	Lucy Williams Charles Goodfellow	Ed Orlebar Alistair Walker
[phone] [e-mail]	[phone]	[phone]	[phone]	[phone]	[phone] [phone] [e-mail]

 

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