The Food and Agriculture Organization (FAO) of the United Nations has published a new report that comprehensively summarizes the state of the emerging field of cell-based or cultured food. The 146 page report, entitled “Food safety aspects of cell-based food” was issued by the FAO, in collaboration with the World Health Organization (WHO) in March 2023. This follows a 2020 report from the U.S. General Accounting Office on the regulatory framework for cell-cultured meat, which I described in an earlier post on the blog.
According to the FAO’s announcement, the new document “includes a literature synthesis of relevant terminology issues, principles of cell-based food production processes and the global landscape of regulatory frameworks for cell-based food production”. The document also focuses on potential hazards arising from the technology, based on an expert consultation to comprehensively identify possible food safety hazards.
The report devotes an introductory chapter to a description of the technologies used in the development and production of cell-based foods, along with a survey of applicable regulations in about a dozen countries or jurisdictions. The next chapter presents case studies of product development, commercialization and regulation in three countries: Israel, Qatar and Singapore. After a chapter discussing the possible safety hazards that could arise from the technology, the report concludes with a summary of its conclusions and recommendations for a path forward. The conclusions stress the need for application of the appropriate scientific knowledge, including correct terminology, and the need for hazard identification, in order for governments to conduct risk assessments of new products in this field, and the report calls for cooperation among countries to share knowledge and expertise as the field develops.
I’ve only begun to review the report by focusing on the sections dealing with international regulation of cell-based foods. The report summarizes the applicable regulatory frameworks in important jurisdictions like the U.S., Europe, Australia and New Zealand, Japan and other countries, concluding that, in most cases, existing laws and regulations such as those governing “novel foods” would be applicable to the market introduction of cell-based foods in these jurisdictions. I would note, however, that the findings of the report address the state of the industry up to March 1, 2022, and so some of the regulatory descriptions are not fully up to date. In particular, the section on the U.S. framework does not discuss FDA’s voluntary consultation program for human food made from cultured animal cells, under which two products have received “no questions” letters from the FDA in recent months: food products made from cultured chicken cells from UPSIDE Foods (November 2022) and GOOD Meat, Inc. (March 2023) (I plan to discuss this program and these approvals in an upcoming blog post). Strangely, the report also does not address the fact that several related products have been reviewed by FDA under their GRAS Notice program, including the GRAS Notice submitted by Impossible Foods for the soy leghemoglobin from genetically modified microorganisms that it uses to provide texture to its plant-based meat products, which received FDA’s “no questions” letter in July 2018.
I hope to be able to review the FAO report in more detail in the coming weeks, and to post additional comments here on the blog.
D. Glass Associates, Inc. is a consulting company specializing in government and regulatory affairs support for renewable fuels and industrial biotechnology. David Glass, Ph.D. is a veteran of over thirty-five years in the biotechnology industry, with expertise in industrial biotechnology regulatory affairs, U.S. and international renewable fuels regulation, patents, technology licensing, and market and technology assessments. In addition to his work as a consultant assisting industrial biotechnology companies prepare for and comply with government regulations, he has served as Director of Regulatory Affairs for Joule Unlimited Technologies and Vice President of Government and Regulatory Affairs for BioTechnica International. Dr. Glass has extensive experience with the biotechnology regulations of the U.S. EPA and other agencies, and has coordinated or assisted in the preparation and submission of 18 successful Microbial Commercial Activity Notices and several other biotechnology submissions in the U.S. and other countries. Dr. Glass holds a B.S. in Biological Sciences from Cornell University and a Ph.D. in Biochemical Sciences from Princeton University.
Bio-Based Chemicals and Fuels: Business, Policy and Regulation 