AMS Spring 2023

Upside Foods Finally Lands FDA Nod for its Cultivated Meat

6K SmarTech

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In a win for Upside Foods (and chickens), the Berkeley, California-based company received a nod from the U.S. Food and Drug Administration (FDA) for its cultivated meat. The recently announced decision makes Upside Foods’ cell-based product the first in its category to complete the FDA’s pre-market consultation for human food made using animal cell culture technology.

In a statement released on November 16, 2022, the FDA revealed that after evaluating the information submitted by Upside Foods, there are “no further questions” about the product’s safety. This is not, however, an approval process. In addition to meeting the FDA’s requirements, including facility registration for the cell culture portion, the startup’s manufacturing facilities will need a grant of inspection from the Department of Agriculture Food Safety and Inspection Service (USDA-FSIS).

Additionally, the food itself requires a mark of inspection from USDA-FSIS before it can even enter the U.S. market. For now, the two agencies are coordinating to ensure that cultured meat is properly regulated and labeled as it comes closer to commercialization. This collaborative work is part of a March 2019 agreement that ensures all checkups for food made using animal cell culture technology comply with the framework established by both regulatory authorities and are safe for human consumption.

Now that the FDA’s pre-market consultation process is finished, Upside Foods will transition to the USDA-FSIS oversight, which will take place during the cell harvest stage. During this step, the department will oversee the post-harvest processing and labeling of human food products derived from the cells of livestock and poultry.

The Ba-kawk bawk letter

For Upside Foods, the FDA’s decision was cause for celebration. Deemed “historic news,” the “No Questions Letter” from the FDA accepting Upside’s safety conclusion led to “an open letter to chickens.” Indeed, to honor this world-first regulatory milestone, Upside decided to share the news with those who will benefit most, chickens. The heartfelt response highlights the importance of cultivated meat for the future of animals and chickens in particular.

Company founder and CEO Uma Valeti published the open letter in the New York Times on November 18, 2022, in what he defines as “the chickens native bawk-filled language.” In the Times open letter, Valeti – a trained cardiologist and lifelong animal lover – wrote, “In the future, we might be eating just as much meat as we always have. But a lot fewer animals are going to have to suffer for it. We wanted you, the chickens of the world, to be the first to know. And we hope it brings a smile to your beaks.”

Upside Foods fried chicken made from cultivated animal cells. Image courtesy of Upside Foods.

Food catch-up

Upside Foods selected chicken as its first commercial offering because it’s the most commonly eaten meat in the U.S. and is quickly becoming the meat of choice worldwide. Every year, Americans consume an estimated eight billion chickens — or roughly 100 pounds per person — which has doubled since the 1970s. Unfortunately, this growth in demand has been accompanied by an exponential increase in high-intensity industrial chicken farming resulting in more animal suffering.

According to PETA, chickens raised for their flesh, better known as “broiler” chickens by the meat industry, suffer from serious health problems, including chronic respiratory illnesses and bacterial infections. In addition, reports have found that two-thirds of analyzed chicken meat was infected with salmonella and other dangerous contaminants.

Upside Foods has cultivators custom-made for animal cells harvesting. Image courtesy of Upside Foods via LinkedIn.

Instead, Upside Foods’ chicken is cultivated directly from animal cells. Neither vegan nor vegetarian, this meat is made without the need to raise and slaughter billions of chickens. At full commercial scale, Upside says it could use a small number of animal cells to cultivate the same amount of poultry meat that could come from hundreds of thousands of traditionally farmed birds.

In addition, the startup states that cultivated meat production at scale is expected to use less water and land than conventionally-produced meat. Thanks to its controlled environment, which is subject to high standards of testing for safety and quality control, it even has the potential to help reduce the risk of harmful bacterial contamination.

Cultured meat is made by harvesting muscle cells from animals, then making sure they multiply, differentiate, and finally grow to form muscle tissue thanks to bioreactors. However, that’s not all companies like Upside Foods need to create ready-to-eat meat cuts. Most newcomers to the alternative meat industry shape the harvested cells by using 3D printing technologies.

Scoring the nod it needed

With its FDA “green light,” Upside Foods is paving the way for other firms developing cultured animal cell food. For example, Wildtype, a startup creating sushi-grade cultivated salmon, announced in 2022 that it expects to bring its product to market via soon-to-be-announced fine dining restaurant partners following the completion of the FDA’s pre-market consultation process.

Following its latest decision, the FDA announced it is ready to work with other cultivated meat firms to ensure their products are safe and lawful. In addition, the agency stated that products obtained from animal cells are expected to be ready for the U.S. market shortly and that its goal is to support innovation in food technologies, which might even include processes like bioprinting geared towards the food industry.

Over the last few years, enthusiasm for these “clean meats” has grown. Spearheading this food revolution was Singapore, when it made headlines after becoming the first country in the world to approve a cultured meat product for commercial sale in 2020. Instead, Europe and the U.S. have presented several challenges in the last few years with securing regulatory approvals for cell-based meats. But now, in regulatory terms, it seems Upside’s “No Questions” letter marks a significant step towards a new era in meat production where Americans will soon have fresh alternative meat.

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