Cellular Agriculture - Cultured cell products for human and animal food - An overview of FDA and USDA regulatory oversight

In a joint webinar released on July 24th, 2020, representatives from the US Food and Drug Administration (FDA) and Department of Agriculture (USDA) presented the current framework for “Regulatory Oversight of Cultured Animal Cell Human and Animal Food Products”.

‘Cultured animal cell products’ (also known as products of cellular agriculture, cultivated products, clean meat, slaughter-free, cell-based meat) use an innovative approach to food production, harvesting a small number of cells from living animals and growing them in controlled environments to create food, such as burgers, chicken nuggets, tuna steaks, and many more.

Typically in the US, FDA oversees the manufacture and sale of food additives, ingredients, and other food products, with the exception of some meat, poultry, and egg products, which are under USDA jurisdiction. However, in March 2019, the FDA and USDA established a formal agreement which described the intent to share the oversight of human food produced using these novel cell-based technologies. The FDA and USDA will work together to ensure that all products of cellular agriculture entering the US food supply will be safe and labeled properly.

The division of responsibility, as outlined in the webinar and in the joint agreement, is as follows:

- FDA Center for Veterinary Medicine (CVM) will provide oversight for cell-based animal foods incorporating cultured cells from all animal species.

- FDA Center for Food Safety and Applied Nutrition (CFSAN) will exclusively provide oversight for cell-based human foods incorporating cultured cells from fish and seafood, with the exception of Siluriformes (catfish).

- FDA CFSAN and USDA Food Safety and Inspection Service (FSIS) will share oversight for cell-based human foods incorporating cultured cells from livestock, poultry, and catfish.

Under the shared oversight framework, FDA will be responsible for activities pre-harvest and USDA will be responsible for activities post-harvest. Harvest is defined as the time when cells are removed from the controlled and sterile cell culture environment, are no longer maintained in a living state, and are subjected to conventional food processing methods.

Pre-harvest activities that FDA will oversee include: premarket consultations with individual firms, evaluation of inputs (including tissue collection, cell lines and other materials), assessment of cell banking processes, and inspection of manufacturing facilities. Companies will be expected to register their facilities, manufacture their products according to current Good Manufacturing Principles (cGMP), and abide by preventative control regulations.

Post-harvest activities that USDA will oversee include: evaluation of facilities, product inspection, and approval of labels. Manufacturers and processors must develop and implement sanitation standard operating procedures (SOPs), a Hazards Analysis and Critical Control Point (HACCP) plan, and written product recall procedures. All companies will be required to implement these procedures and pass inspection to gain a USDA mark of inspection for their products. Labels, including any claims, will require pre-approval from USDA. Although some USDA inspection methods may be customized to address unique aspects of cell culture technologies, it is expected that inspection of cellular agriculture food establishments will be similar to inspection in traditional meat and poultry processing establishments.

FDA and USDA intend to work together and share information throughout the process. The departments are currently working on relevant guidance documents, including those related to cell banking, manufacturing, and labeling.

The overall goal of both FDA and USDA is to ensure a safe, unadulterated, and properly labeled product. Firms are encouraged to contact FDA and USDA early in their development process. The relevant contacts are:

FDA-CFSAN AnimalCellCultureFoods@fda.hhs.gov

FDA-CVM AnimalFood-Premarket@fda.hhs.gov

USDA-FSIS Matthew.Michael@usda.gov