Companies
FDA cultivated meat pilot program
- Country
- United States
premarket-pathway
us
Coverage
| CN | EU | US | |
|---|---|---|---|
| regulatory-legal | ✓ | ✓ | ✓ |
Regulatorsfdaefsanmpa
Verifiable facts
| Fact | Value | Source |
|---|---|---|
| Affiliation | The FDA and USDA-FSIS maintain a joint regulatory framework established in 2019 for the oversight of human food produced from cultured livestock and poultry cells. FDA oversees cell collection, banks, growth, and differentiation, while USDA-FSIS oversees harvest, processing, packaging, and labeling. | fsis.usda.gov · fda.gov |
| Research focus | FDA conducts pre-market consultations to evaluate the production process, manufacturing controls, cell lines, and safety of human food derived from cultured animal cells. | fsis.usda.gov · fda.gov |
| Facility | Shellmound Plant (UPSIDE Foods, Emeryville, CA) and the JOINN Biologics US Inc. plant (GOOD Meat partner, Richmond, CA). | congress.gov |
| Grant | National Science Foundation (NSF) has issued roughly $5 million in research grants and the USDA National Institute of Food and Agriculture (NIFA) has issued approximately $12 million in research grants for cell-cultivated meat projects over the last 10 years. | congress.gov |
| Publications | The FDA maintains an inventory of completed pre-market consultations for human food made with cultured animal cells, including safety narratives and scientific evaluation memos. | cfsanappsexternal.fda.gov · content.govdelivery.com · fda.gov |
| Principal staff | Jeremiah Fasano (FDA liaison for the formal agreement with USDA-FSIS). | fsis.usda.gov |
Independent sources: cfsanappsexternal.fda.gov · congress.gov · content.govdelivery.com · fda.gov · fsis.usda.gov
Technologies
| Name | Cluster | Risk | |
|---|---|---|---|
| Regulatory sandboxes for biotech | regulatory-legal | Medium | → |
Compiled by BIOECON from primary sources.
Compliance
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