Lab-Grown Meat Firm Clears FDA Hurdle

Cultured-Cell Meat Product Awaits USDA Inspection Before Entering US Market

Todd Neeley
By  Todd Neeley , DTN Staff Reporter
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A cultured animal-cell meat company recently completed a consultation with the U.S. Food and Drug Administration. (DTN file photo by Nick Scalise)

LINCOLN, Neb. (DTN) -- UPSIDE Foods became the first cultured animal-cell meat company to complete a pre-market consultation with the U.S. Food and Drug Administration last week, as the USDA's Food Safety and Inspection Service continues to work on a proposed rule for labeling such products.

UPSIDE, formerly known as Memphis Meats, will use a cell-culture technology to take living cells from chickens and grow them into food in a controlled environment.

An FSIS spokesperson told DTN the agency continues to evaluate public comments submitted by Dec. 3, 2021, in response to a Sept. 3, 2021, advance notice of proposed rulemaking.

FSIS said it "intends to develop" a proposed labeling rule. The publication date of that proposal is yet to be determined but is expected to be included in the agency's fall regulatory agenda at some point. (…)

The FDA said in a news release last week the consultation process with UPSIDE included evaluating the company's production process and the cultured-cell material produced, including the establishment of cell lines and cell banks, manufacturing controls and a number of other components.

"The voluntary pre-market consultation is not an approval process," FDA said in a news release. "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."


UPSIDE, based in Berkeley, Calif., started in 2015. The company has backing from companies such as Cargill, Whole Foods and Tyson Foods, as well as other investors including Bill Gates and Richard Branson.

The company will need a grant of inspection from FSIS, while the food itself will require a mark of inspection from 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," FDA said.

A FSIS spokesperson told DTN that prior to completing a labeling rule the agency would review and approve labels for any cell-culture meat products under existing requirements.

"During this review, FSIS will ensure labels clearly differentiate cell-cultured products from slaughtered meat and poultry products and bear all mandatory features required by the labeling regulations for meat and poultry products," FSIS told DTN.

Currently, FDA and FSIS follow a joint regulatory framework for cell-cultured meat and poultry products.

In December 2021, meat and poultry groups told USDA they want cultured-meat cell products to be distinctly labeled so as to avoid consumer confusion, in comments submitted to the agency for a proposed labeling rulemaking.


The science of growing protein from cultured animal cells is advancing and the likelihood of commercial sales of proteins derived from them is expected in the near future. Exactly how to define and regulate these products remains a point of contention. Cultured animal cell-derived meat is grown in a laboratory instead of being raised in a pasture and slaughtered as meat.

Agriculture groups said in public comments any labeling of cultured animal cell products should make the distinction clear.

The National Cattlemen's Beef Association, for example, asked USDA to work with lab-grown protein companies to establish "marketable product names" that can be "easily distinguished" from the practice of raising animals and harvesting meat products. NCBA said the agency should adopt "lab-grown" as an "unambiguous description" for cultured animal cells.

FDA oversees the process for collecting and growing the cells and FSIS oversees the process for making meat and poultry products from these cells.

Every firm that makes these products must get approval from each agency, whether or not they follow the same production method as a firm that has received approval, according to FSIS.

Cell-cultured meat and poultry products will be subject to the same food safety, sanitation and inspection regulations as other meat and poultry products, FSIS said.

Read more on DTN:

"Ag Wants Clear Cell-Cultured Meat Label,"…

"Who Will Regulate Lab Meat?,"…

"Defining Meat Gets Complicated,"…

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Todd Neeley

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