FDA completes pre-market consultation for cultured pork fat cells from Mission Barns

The U.S. Food and Drug Administration (FDA) has completed its pre-market consultation for a human food product made with cultured pork fat cells, marking another step forward in the regulatory process for cell-cultured food innovation. The agency stated that it has 'no questions at this time' regarding Mission Barns' conclusion that its cultured pork fat is as safe as conventionally produced pork fat.

Mission Barns, a food company focused on cultivating meat for a more secure food system, produces its cultured pork fat by growing belly fat cells from domestic Yorkshire pigs in a controlled environment. The FDA’s review focused on the company’s production process, including cell line development, manufacturing controls, and ingredient safety. However, before the product can reach consumers, it must also comply with regulations from the US Department of Agriculture (USDA), which has oversight of meat and poultry products in the USA.

Following the FDA's regulatory clearance, Mission Barns has announced its first retail launch and restaurant partnership for its cultivated pork fat-based products. The company’s Italian Style Cultivated Meatballs and Applewood Smoked Cultivated Bacon will soon be available at Fiorella, a well-known Italian restaurant group in the San Francisco area, marking the first time cultivated pork products will be offered on a restaurant menu anywhere in the world. Additionally, Mission Barns is preparing for retail distribution through a national supermarket chain, which will become the first US grocery store to carry cultivated meat.

“Food security and the health of our food system is a big challenge we are tackling at Mission Barns,” commented Eitan Fischer, Founder & CEO of Mission Barns. “We are expecting 1.7 billion more humans on our planet in the next 25 years, and we need to innovate in order to find more efficient ways to produce delicious food products to feed the world. First and foremost, consumers won’t eat food that isn’t absolutely delicious—which is why we chose to pursue a fat-first approach.”

The completion of the FDA’s pre-market consultation is a critical step in the regulatory pathway for cultured meat products. Through this process, the FDA evaluates the safety of food derived from cultured animal cells before it can be marketed. The review ensures that food safety requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act) are met.

According to the FDA, all food products under its jurisdiction, including those made with cultured pork fat cells, must comply with the same safety standards as their conventional counterparts. This includes facility registration, adherence to applicable safety regulations, and accurate product labeling to inform consumers.

The FDA also conducted an on-site visit to Mission Barns’ facility, where the pork fat cells are cultured and grown. Additional inspections are planned once commercial production begins, and the agency will continue to oversee the facility to ensure food safety compliance.

The FDA and USDA have established a formal joint agreement outlining their shared oversight of foods made with cultured animal cells. While the FDA is responsible for reviewing the safety of the cell cultivation process and initial food product development, the USDA will regulate the processing, packaging, and labeling of cultivated meat products before they enter the market.

Mission Barns’ first restaurant partner, Fiorella, sees cultivated pork as a potential solution to global food security challenges. “From the ability to source some of my favorite local ingredients to the prices on our menus, the vulnerability of our global food supply chain impacts every aspect of my business,” added Brandon Gillis, Co-founder of Fiorella. “I’ve been keeping tabs on the cultivated meat industry as a potential solution, and after meeting with Mission Barns and tasting its products, I wanted to make sure we created a partnership for this historic moment.”

Mission Barns’ flagship products combine cultivated pork fat with plant-based protein, requiring only a single animal component—a harmless sample taken from a pig—which is then grown using plant-based nutrients in a cultivator. One sample could produce the same amount of meat as millions of farm animals, significantly reducing the environmental footprint of meat production while mitigating the risks associated with disease outbreaks in livestock.

The approval process for cell-based foods remains highly scrutinized as regulators, industry leaders, and consumers evaluate the safety, nutritional benefits, and scalability of these products. Cultured pork fat could play a crucial role in expanding consumer options for sustainable food choices, aligning with broader efforts to reduce the environmental impact of conventional animal agriculture.

The FDA’s completion of its review for Mission Barns’ cultured pork fat adds momentum to the growing cultivated food sector. As regulatory frameworks continue to evolve, companies developing cell-based foods will need to navigate both FDA and USDA requirements to bring their products to market successfully.

More information on the FDA’s pre-market consultations for foods made with cultured animal cells is available through the agency’s Human Food Made with Cultured Animal Cells Inventory. The FDA remains committed to transparency in its approach to regulating these emerging food technologies, ensuring that both innovative and traditional food products meet the highest safety standards.