Key Takeaways:

  • The Food and Drug Administration (FDA) has completed its second voluntary premarket consultation regarding a cell-cultivated meat product, raising no questions about the company's safety conclusions.
  • Acceptance of cell-based food seems to be growing worldwide; however, the United Nations has recommended greater international collaboration to better assess risk and develop a common set of terms.
  • Meanwhile, Italy has taken a different approach, moving to ban the production of cell-based food, in order to protect the country's food industry.

Four months after completing its first premarket consultation, the Food and Drug Administration (FDA) cleared its second premarket consultation for cell-cultivated meat production. We wrote about the first premarket consultation and the authority and the respective responsibilities of FDA and the United States Department of Agriculture (USDA) in regulating cell-cultivated meat products in a previous publication.

GOOD Meat, Inc., has developed cultured chicken cells (Gallus gallus cells) intended to be used as a human food ingredient. The dossier submitted by GOOD Meat to FDA provided details on the safety of its cell line, cell culturing conditions, manufacturing processes, and overall safety of the bulk chicken cell ingredient. GOOD Meat's dossier indicated that the analysis of its representative batches consistently met the specifications for up to six months after production, concluding with reasonable certainty that consuming cultured chicken will result in no harm. Interestingly, GOOD Meat noted that the nutritional profile of its cultured chicken product is similar to that of conventional chicken.

The premarket consultation process spanned over one year: GOOD Meat submitted a summary of its safety assessment on March 4, 2022 (later submitting four amendments), and FDA then published its decision on March 20, 2023. Upon reviewing the safety of GOOD Meat's cultured chicken cell material and production process, FDA did not identify any adulterants in the product and had no further questions regarding the company's safety conclusions. However, GOOD Meat's journey to enter the U.S. market is not over yet. Its cultured chicken product must still pass the inspection process administered by the USDA Food Safety Inspection Service (FSIS). FDA reiterated its promise in a Constituent Update announcing the conclusion of the GOOD Meat consultation that it will issue a draft guidance to assist other firms that intend to prepare food made from cultured cell animals to prepare for the premarket consultation process.

Meanwhile, UPSIDE Foods, which previously cleared the first FDA premarket consultation, submitted supplemental information on February 17, 2023. The supplement described two additional substances used during the production of UPSIDE Foods' cell-cultivated chicken. The two substances included a nutrient intended to support basic cell metabolism and a commonly used substance that has been subject to multiple FDA evaluations. UPSIDE Foods assured FDA that the use of the two substances will not alter the safety or nutrition of its cell-cultivated chicken. In the FDA Additional Response Letter, FDA explained that the agency continues to have no questions regarding the safety of UPSIDE Food's cell-cultivated chicken upon reviewing the submitted information.

On a global scale, the Food and Agriculture Organization of the United Nations (U.N.), in collaboration with the World Health Organization (WHO), developed a joint report (the U.N. Report) to inform consumers and stakeholders about the food safety considerations for cell-based food. The document includes a literature synthesis, case studies, and identification of potential hazards in cell-based food production based on four stages: cell-sourcing, cell growth and production, cell harvesting, and food processing and formulation. The U.N. Report noted that most of the hazards are already well-known and exist in conventionally produced food as well, and that good manufacturing and hygiene practices should be applied for cell-based food safety. Food safety plans would also need to focus on inputs, ingredients, and equipment specific to cell food production, but existing preventive measures and controls are available to address potential hazards.

According to the U.N. Report, further research and development should be done to improve the understanding of the potential benefits of cell-based food production while closely observing any differences from conventionally produced food. The U.N. Report also recommended that competent authorities in food safety across the world collaborate to collect sufficient scientific data for exposure assessment and risk characterization, and to consider appropriate terminologies.

Despite recommendations from the U.N., the Italian government is supporting a bill to ban the production of food and animal feed made "from cell cultures or tissues derived from vertebrate animals." According to the Italian government, the move is designed to protect the country's food industry. If the bill is passed, breaches of the law could lead to fines of up to €60,000. Italy's proposed ban appears to collide with global trends, with Singapore and the U.S. moving towards approving cell-based meat products for commercial sale. Certain European governments, such as the Netherlands, United Kingdom, and Spain, have also invested in the research and development of cell-cultivated meat. It will be interesting to watch the direction these and other countries will take in regulating cell-based food products in the coming months.

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