FDA completes second pre-market consultation for human food made using animal cell culture technology

The US Food and Drug Administration (FDA) has completed its second pre-market consultation for a human food made from cultured animal cells. It evaluated the information GOOD Meat, Inc submitted to the agency and has 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.

GOOD Meat is the cultivated meat division of Eat Just, Inc, a company that applies cutting-edge science and technology on a mission to create healthier, more sustainable foods. GOOD Meat won regulatory approval for its chicken in Singapore in November 2020 and remains the only cultivated meat company in the world with the ability to sell to consumers. Since its launch, the company’s chicken has been featured on menus at local fine dining establishments, roadside hawker stalls and via foodpanda, Asia's leading food and grocery delivery platform. The latest version of GOOD Meat’s cultivated chicken will become available in Singapore soon following its debut at COP27 last year.

It is important to stress that 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, FDA has no further questions at this time about the firm’s safety conclusion. 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 FDA is committed to sharing information about our approach to regulating human food made from cultured animal cells. Information about this pre-market consultation is available on the FDA’s Human Food Made with Cultured Animal Cells Inventory.

Human food produced by GOOD Meat from cultured animal cells must meet the same stringent FDA requirements, including facility registration and applicable safety requirements, as other food. In addition, the company will need a grant of inspection from the United States Department of Agriculture's Food Safety and Inspection Service (USDA-FSIS) for the manufacturing establishment. The food itself also requires a mark of inspection from USDA-FSIS before it can enter the US market. As this product comes closer to entering the US market, the FDA is closely coordinating with USDA-FSIS to ensure it is properly regulated and labeled.

As Jason Dietz revealed at the recent Future of Protein Production Summit, the FDA is ready to work with additional firms that are developing cultured animal cell food and production processes to ensure their food is considered safe and lawful under the Federal Food, Drug, and Cosmetic Act. It encourages firms to engage with the organization often and early in their product and process development phase, well ahead of making any submissions to the agency. The FDA will issue guidance to assist firms that intend to produce human food made from cultured animal cells prepare for pre-market consultations, and the published draft of this guidance will represent a formal opportunity for public comment and discussion. As the FDA continues to support innovation in food technologies, resulting in more choices for consumers in the marketplace, our priority is the safety of food produced through both new and traditional methods.

There have been a string of feel-good stories being announced by GOOD Meat in 2023 already. Not least, it recently announced that it has been given a new, first-in-the-world regulatory approval by the Singapore Food Agency (SFA) for the use of serum-free media for the production of cultivated meat. “Not too long ago, observers thought removing serum was a major limiting step to scaling cultivated meat. I could not be prouder of our team for doing just that and receiving approval to commercialize it. It's yet another step forward for our company, the cultivated meat industry and the health of our planet,” Josh Tetrick, Co-founder & CEO of Eat Just said at the time. “Since Singapore approved GOOD Meat for sale, we knew this moment was next. I am so proud to bring this new way of making meat to my country and to do it with a hero of mine, Chef José Andrés.”

“For many years, I have advocated for innovative and equitable approaches by governments, civil society and the private sector to end hunger, reduce diet-related diseases and slow the effects of climate change," said Dan Glickman, GOOD Meat Advisory Board member and former US Secretary of Agriculture and member of the U.S. House of Representatives. "While I will always support family farmers’ efforts to feed the world, forward-thinking companies like GOOD Meat are tackling food security, nutrition and environmental stewardship in new and exciting ways. Receiving a ‘no questions’ letter from the FDA and a subsequent clearance from the USDA will allow GOOD Meat to scale up manufacturing and begin introducing its products to American consumers. Just as the USA has been a global leader in modernizing conventional food and agriculture techniques, it too can lead in the emerging alternative protein space. Today’s announcement is one such example.”

“Today’s news is more than just another regulatory decision – it’s food system transformation in action," added Bruce Friedrich, President of The Good Food Institute. "GOOD Meat has become the second cultivated meat company to receive the go-ahead from FDA for its cultivated chicken, bringing cultivated meat closer to becoming a real choice for American consumers. Consumers and future generations deserve the foods they love made more sustainably and in ways that benefit the public good – ways that preserve our land and water, that protect our climate and global health, ways that allow for food security. Global demand for meat is projected to increase significantly by 2050. A few governments around the world are beginning to prioritize alternative proteins as a solution that accounts for this growing consumer demand while also achieving national climate and development goals, but far more need to follow suit.”

“As Asia’s leading alternative protein think tank, we’re pleased to see that GOOD Meat’s cultivated chicken—which has been enjoyed by thousands of diners in Singapore over the past few years—is now on track to expand to the USA," said Mirte Gosker, Managing Director of The Good Food Institute APAC. "Amid skyrocketing food demand and diminishing natural resources, it has never been more urgent to scale up manufacturing and distribution of alternative proteins on both sides of the Pacific. This week’s FDA greenlight opens the door to additional regulatory and scientific collaboration between two of the world’s leading innovation hubs and moves cultivated meat one step closer to becoming a truly global business."

"The FDA’s ‘no questions’ letter to GOOD Meat is another significant milestone and point of validation for the cell-cultured/cultivated meat, poultry, and seafood industry," suggested Robert Rankin, Executive Director, Association for Meat, Poultry & Seafood Innovation. "GOOD Meat is among the visionary start-ups advancing the food sector with new methods of producing high-quality, safe products that will help to meet the growing demand for meat, poultry, and seafood through delicious, healthy, and sustainable food options. AMPS Innovation members continue to work closely with government agencies to create a safe, robust, and transparent pathway to market for cell-cultured/cultivated meat. This announcement provides additional evidence that the products developed by AMPS Innovation members will be among the safest, most tested, and well-regulated in the food industry.”