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FDA in ‘critical milestone’ for cell-cultured meat in US

The US Food and Drug Administration (FDA) has completed its first pre-market consultation of a cell-cultured chicken product made by UPSIDE Foods, a development that has been hailed a “critical and inspiring milestone in the history of cultivated meat” by stakeholders.

The completion of this voluntary consultation process does not mean UPSIDE Foods’ product has been approved for the market. Instead, it means that FDA officials evaluated data and information provided by UPSIDE Foods (previously known as Memphis Meats) about its product. Based on this information, the FDA had no further questions about the firm’s safety conclusion.

However, a joint statement issued by Robert M. Califf, commissioner of food and drugs at the FDA and Susan T. Mayne, director of the Center for Food Safety and Applied Nutrition (CFSAN) positioned the development as a step forward for US food innovation.

“The world is experiencing a food revolution and the US Food and Drug Administration is committed to supporting innovation in the food supply [...] whilst always maintaining as our first priority the safety of the foods available to US consumers.”

GFI: ‘A strong precedent for other nations to follow suit’

Non-profit organisation, the Good Food Institute (GFI) said the announcement was “a critical and inspiring milestone in the history of cultivated meat and alternative proteins”.

Ilya Sheyman, CEO of GFI, said: “We anticipate that this news will usher in a new wave of investment, talent, and B2B technological innovations, and we’re excited to propagate this milestone in many other countries around the world. The US is a pivotal market and this sets a strong precedent for other nations to follow suit and be leaders in reimagining the global meat supply.”

Last year, Singapore became the first country in the world to approve cell-cultured meat when the Singapore Food Agency approved San Francisco startup Eat Just’s cell-based meat chicken product.

FDA ready to work with other cultured meat firms

The US FDA said it was ready to work with additional firms developing cultured animal cell food and production processes to ensure their products were safe.

It plans to issue a guidance document to assist other cell-cultured firms prepare for pre-market consultations. The draft version of this guidance will be open to the public for comment.

“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,” added the FDA.

Closeup of cultivated meat in containers © AdobeStock/Wirestock Creators

A collaborative approach for cell-cultured meat approval

As part of the consultation, the FDA evaluated UPSIDE Foods’ production process and the cultured cell material, including cell lines and cell banks, manufacturing controls, and all components and inputs.

The regulation of cell culture technology in the US is being done collaboratively, with the FDA working closely with the US Department of Agriculture Food Safety and Inspection Service (USDA-FSIS).

According to a formal agreement dating from March 2019, cell-cultured meat falls under a joint regulatory framework wherein the FDA oversees cell collection, cell banks, and cell growth and differentiation. During the cell harvest stage, oversight falls under the responsibility of the USDA-FSIS, for the post-harvest processing and labelling of food products.

“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 labelled. Both agencies are working with manufacturers to ensure these products meet all applicable FDA and USDA-FSIS requirements,” said the FDA in a statement.

Next steps for UPSIDE Food

UPSIDE Food must also complete other federal regulatory requirements before being able to commercialise its cell-cultured chicken. For instance, the factory must meet the relevant requirements set by the USDA and the FDA and will need a grant of inspection from the USDA-FSIS for the harvest and post-harvest portions. The product itself will require a USDA mark of inspection.