When you think of U.S. animal agriculture, I bet “cultured” livestock cells didn’t pop into your mind, but it may be getting closer to a grocer near you.
With all the clamoring about climate change and agendas to limit animal agriculture, the FDA, which is “responsible for the safety and security of our nation’s food supply,” comes out with a very scientific press release that caught many choking on that turkey leg: “FDA Spurs Innovation for Human Food from Animal Cell Culture Technology.” Yum!
Kudos for the brilliant use of (rooster) “spurs,” Robert M. Califf, M.D., commissioner of food and drugs within the FDA, and Susan T. Mayne, Ph.D., director at the Center for Food Safety and Applied Nutrition. No doubt training on SEO (search engine optimization) has helped.
In what seems like a job interview, the agency announced that they have “completed their first pre-market consultation of a human food made from cultured animal cells.”
“The agency evaluated the information submitted by UPSIDE Foods (formerly Memphis Meats) 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,” they wrote. Transparency pundits wonder what information was evaluated.
Then the press release tells us about some vague inspection process and assures the consumer that their people are on it. “Before this food can enter the market, the facility in which it is made also needs to meet applicable 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 continues, “Under the March 2019 formal agreement, the FDA and USDA-FSIS 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, and 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 …
“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. 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. 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.”
UPSIDE Foods (upsidefoods.com) in the animal-rich area of Berkeley, CA, and its $50 million, 53,000-square-foot Engineering, Production and Innovation Center (EPIC) facility in Emeryville, CA, is designed to produce hundreds of thousands of pounds of this bio-reactor cultivated meat of any species.
“This is a watershed moment in the history of food,” said Dr. Uma Valeti, CEO, former cardiologist and founder of UPSIDE Foods, in a statement.
“We started UPSIDE amid a world full of skeptics, and today, we’ve made history again as the first company to receive a ‘No Questions’ letter from the FDA for cultivated meat. This milestone marks a major step towards a new era in meat production … We’re proud to have the support of world-class investors, food industry leaders and visionaries alike, including SoftBank Group, Temasek, Norwest and Threshold Ventures, Tyson Foods, Bill Gates, Sir Richard Branson, Kimbal Musk and Whole Foods.”
According to Time Magazine, “The Nov. 16 ruling, which comes after a rigorous evaluation period, is the first and biggest of three hurdles that must be cleared before the Berkeley-based company can sell its ‘cultivated’ – the industry’s preferred term – chicken in grocery stores and restaurants, but it likely paves the way for scores of similarly-made products, ranging from lab-grown beef to steaks, foie gras and even cultivated mouse treats for cats.”
For a fascinating background, look at this story: fda.gov/food/cfsan-constituent-updates/fda-completes-first-pre-market-consultation-human-food-made-using-animal-cell-culture-technology.
by Troy Bishopp
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