FDA gives nod to cell cultured meat company | TSLN.com
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FDA gives nod to cell cultured meat company

By Carrie Stadheim for Tri-State Livestock News
More from FDA:   The regulation of cell culture technology is being done collaboratively and in close partnership with USDA-FSIS for food made from cultured livestock or poultry cells. Under the March 2019 formal agreement, both agencies agreed to a joint regulatory framework wherein the FDA oversees cell collection, cell banks, and cell growth and differentiation. The FDA’s approach to regulating products derived from cultured animal cells involves a thorough pre-market consultation process. While this is not considered an approval process, it concludes when all questions relevant to the consultation are resolved. A transition from the FDA to USDA-FSIS oversight will take place during the cell harvest stage. USDA-FSIS will oversee the post-harvest processing and labeling of human food products derived from the cells of livestock and poultry. This closely coordinated regulatory approach will ensure that cell-cultured products derived from the cell lines of livestock and poultry meet federal regulations and are accurately labeled. Both agencies are working with manufacturers to ensure these products meet all applicable FDA and USDA-FSIS requirements. Advancements in cell culture technology are enabling food developers to use animal cells obtained from livestock, poultry, and seafood in the production of food, with these products expected to be ready for the U.S. market in the near future. The FDA’s goal is to support innovation in food technologies while always maintaining as our first priority the safety of the foods available to U.S. consumers. The FDA has extensive experience in food safety assessment across a wide range of food production technologies, including the use of biological systems and biotechnology. The agency is evaluating new substances all the time as industry practices evolve to meet consumer demands and preferences. Food made with cultured animal cells must meet the same stringent requirements, including safety requirements, as all other food regulated by the FDA. The FDA is ready to work with additional firms developing cultured animal cell food and production processes to ensure their products are safe and lawful under the Federal Food, Drug, and Cosmetic Act. We also plan to issue guidance to assist firms that intend to produce human foods from cultured animal cells to prepare for pre-market consultations. The published draft of this guidance will provide a formal opportunity to the public for comment. We are already engaged in discussion with multiple firms about various types of products made from cultured animal cells, including those made from seafood cells, which will be overseen solely by the FDA. We continue to encourage firms to enter into dialogue with us often and early in their product development phase, well ahead of making any submission to us.

Before entering the U.S. market, the food must meet Other Federal Requirements

On November 16, 2022, the US the U.S. Food and Drug Administration (FDA) completed it’s first consultation for animal cell-cultured protein.

In a news release, FDA said, “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.”

In official comments, FDA Commissioner of Food and Drugs, Robert M. Califf, M.D, Director of the Center for Food Safety and Applied Nutrition Susan T. Mayne, Ph.D., said, “The world is experiencing a food revolution and the U.S. Food and Drug Administration is committed to supporting innovation in the food supply. As an example of that commitment, today we are announcing that we have completed our first pre-market consultation of a human food made from cultured animal cells.



“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.  

Before the food can enter the market, the facility in which it is made also needs to meet applicable U.S. Department of Agriculture (USDA) and FDA requirements, said FDA. 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, they said in their official statement.



The FDA said it 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.

UPSIDE Foods, on its website says it is funded in part by Threshold, Bill Gates, Cargill, and Richard Branson. It also says that Tyson foods is an investor, and that it “inked a historic partnership” with the North American Meat Institute to usher in sensible federal regulation for cultivated meat.

The North American Meat Institute is a trade association representing beef, pork, veal and turkey processors.

NAMI, in conjunction with the New York Beef Council, applied for and was given over $600,000 in Beef Checkoff dollars in 2022 for two veal promotion projects. A third NAMI veal project was funded at about $74,000.

Sarah Little with NAMI said her organization has not entered any kind of partnership with UPSIDE Foods.

She said the two groups did send a joint letter to President Trump calling for regulation to be handled in both the FDA and USDA. At the time, FDA was trying to claim it was solely in its jurisdiction which would have placed conventional meat at a significant disadvantage, said Little.

Later in 2020, NAMI joined another organization which represents cell-based companies, in sending a letter to USDA.

No cell-based protein companies are members of NAMI, according to Little.

NAMI’s official position on cell-based protein is: “With the growing worldwide demand for animal protein, we support a fair and competitive marketplace that lets consumers decide what food products make sense for them.”
 
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:

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.