Battle Over Labeling Will Likely Continue Despite Agreement on Cell-Cultured Meat
The main principles in the agreement are consistent with the initial framework announced in November 2018, including having the transition of oversight occur during the cell harvest stage.
In addition, FDA and FSIS agreed to continue developing a more detailed standard operating procedure to facilitate coordination of shared regulatory oversight. They also revealed that they would be developing joint principles for product labels and claims, which might prove to be a future source of contention based on the current debate over labeling issues.
FDA Oversight Role
Under the agreement, FDA will:
- Oversee tissue collection, cell lines and banks, and all components and input, as well as the proliferation and differentiation of cells through the time of harvest. This premarket consultation process could include issuing regulations or guidance, and conducting inspections. The FDA would consult with FSIS, and share the results.
- Ensure that regulated entities comply with applicable HHS-FDA requirements, particularly those related to the Food Safety Modernization Act (FSMA). This would include facility registration, the Current Good Manufacturing Practices and preventive controls regulation, and requirements applicable to substances that become a component of food or otherwise affect the characteristics of food.
- Develop additional requirements, as needed, for cell bank and cell culturing facility conditions and processes to ensure that biological material exiting the culture process is safe and not adulterated.
- Conduct appropriate inspections and take enforcement action if necessary to ensure that cell bank and cell culturing facilities are in compliance with FDA laws and regulations. The agency also will notify FSIS if objectionable conditions are identified which may result in the production of adulterated or misbranded product, so that FSIS can monitor these conditions during the post-harvest phase.
- At harvest, coordinate the transfer of regulatory oversight to FSIS, including providing information to FSIS on whether harvested cells are eligible to be processed into meat and poultry products that bear the USDA-FSIS mark of inspection.
FSIS Oversight Role
After helping FDA coordinate the transfer of regulatory oversight, and determining whether harvested cells are eligible to be processed into meat or poultry products, FSIS will:
- Require each establishment that harvests cells cultured from livestock or poultry to obtain a grant of inspection, as required by the FSIS regulations.
- Conduct inspection in establishments where cells cultured from livestock and poultry are harvested, processed, packaged or labeled, in accordance with applicable FSIS regulations – including sanitation and physical product inspection, Hazard Analysis and Critical Control Point (HACCP) verification, product testing, and records review – to ensure that resulting products are safe, unadulterated, wholesome and properly labeled.
- Require that the labeling of human food products derived from the cultured cells of livestock and poultry be preapproved and then verified through inspection, as required by FSIS regulations. If necessary, FSIS will develop additional requirements to ensure the safety and accurate labeling of human food products derived from the cultured cells of livestock and poultry.
- Conduct enforcement action, as necessary, to ensure that adulterated or misbranded human food products derived from cultured livestock and poultry cells do not enter or are removed from commerce.
- As part of the information sharing and dual notification component of this agreement, FSIS will notify FDA if objectionable conditions are identified, including conditions which may result in the production of adulterated or misbranded product. This will allow FDA to monitor and address such conditions with respect to pre-harvesting activities.
Battle Over Labeling
In addition to working collaboratively to develop a more detailed standard operating procedure, identify necessary statutory changes, and cooperate on investigations, FDA and FSIS will develop joint principles for product labeling and claims to ensure that products are labeled consistently and transparently.
This was perhaps the most interesting element in this formal agreement. While it delineated that the labeling of cell-cultured meat products would be subject to FSIS preapproval and oversight, it will be worth monitoring how much influence FDA will have in developing the joint principles for labeling. Given that labeling is the primary issue that livestock groups are most interested in, they likely will closely monitor, and attempt to influence, the development of the joint principles.
For instance, although the National Cattlemen’s Beef Association (NCBA) praised the agreement for solidifying FSIS’ lead oversight role in the production and labeling of cell-cultured meat, the group derided it as “lab-grown fake meat products.” Although FSIS will have primary oversight over labeling, the agreement implies that FDA will have input on the standards on which label preapproval and oversight will be based.
This is why traditional livestock groups are focusing on the state level to influence the debate before any forthcoming FSIS labeling regulations on cell-cultured meat products preempt these state laws. A number of states with significant livestock production are considering legislation that would restrict label claims and attempt to apply a specific definition to cell-cultured meat products. Missouri already has enacted a law prohibiting cell-cultured meat products from being labeled as meat.
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