The U.S. Government Accountability Office (GAO) recently released a report (the “Report”) which issues recommendations regarding FDA and USDA cooperation on regulatory oversight of cell-cultured meat and details the challenges of commercialization where much of the technology for commercial production is either still in development or being safeguarded as a proprietary technology.

In March 2019, the FDA and USDA announced that the FDA would oversee the early phases of cell-cultured meat production (including obtaining cell samples, cell selection and storage, and cell growth) through the point of harvest, at which point oversight would transfer to USDA to regulate food processing, including labeling.

The Report issues a number of recommendations for increased interagency cooperation to prepare for regulation of cell-cultured meat and also identifies a plethora of open questions which pose challenges for commercialization:

• Tissue Collection – What animals will be used collect biopsy samples and how often will biopsies be required?

• Genetic Engineering – Will selection of desirable traits in cells use genetic engineering?

• Antibiotics – Will antibiotics be used, and if so, in what amounts and at what stages of production?

• Growth Medium – What type will be used?

• Scaffold – Will cells need to be attached to scaffolding structure during the growth stage, and if so, will the scaffold be edible?

• Point of Harvest – How will this be defined by FDA and USDA and how will jurisdiction be transferred?

• Scaling up Production – Do firms have the necessary equipment for production at a commercial scale?

• Production Cost – Can firms make an affordable product, in particular where the growth medium represents a significant cost?

• Safety Consideration – Are there new safety hazards and to what degree will this depend on the method of production?

• Production Composition – What will the composition of the eventual products be, including any binding, flavoring ingredients, and plant-based materials?

• Environmental, animal welfare, and health impact – There exists disagreement as to the advantages of cell-cultured meat over traditional meat products.

• Timeline to Market – When will cell-cultured meat be available to consumers?

• Labeling –  How will cell-cultured meat be labeled, and will federal requirements preempt any requirements in place at the state level?  

• Consumer Acceptance – Will consumers purchase cell-cultured meat products?

While cell-cultured meat holds much promise, given the many uncertainties the industry still faces, from both a technology and regulatory perspective, it may be some time before consumers find cell-grown meat in the store.  We will continue to monitor and report on developments that impact the development of he cell-cultured meat industry.