U.S. FDA Completes First Pre-Market Consultation for Cultured Pork Fat Cells

The FDA has completed its first pre-market consultation for cultured pork fat cells. While the agency has no questions regarding the safety of the product, it must still meet USDA regulations before entering the market.

On March 7, 2025, the U.S. Food and Drug Administration (FDA) announced the completion of a pre-market consultation for a human food made with cultured pork fat cells, submitted by Mission Barns. The FDA stated that it has no questions at this time about the company's conclusion that the food made with cultured pork fat cells is as safe as conventionally produced pork fat.

FDA's pre-market consultation process includes reviewing cell line establishment, manufacturing controls, and all inputs used in production. Additionally, the FDA has conducted an on-site inspection at the company's facility and plans to conduct another inspection after commercial production begins.

This marks the first cultured pork fat cell product listed in the FDA's Human Food Made with Cultured Animal Cells Inventory, joining two previously listed cultured chicken cell materials.

Human Food Made with Cultured Animal Cells Inventory.png However, before the product can be marketed, it must also comply with the U.S. Department of Agriculture (USDA) regulations. The FDA and USDA-FSIS have a joint oversight framework for foods made with cultured animal cells, ensuring compliance with safety and labeling requirements.

FDA

USDA-FSIS

Regulates live animals intended for food until they are presented for slaughter.
Oversees cell collection, banking, growth, and differentiation in cultured food production.
Maintains jurisdiction over cultured food from species not covered by Federal Meat Inspection Act (FMIA) or Poultry Products Inspection Act (PPIA) (e.g., seafood other than Siluriformes and game meat).
Regulates all food for animal consumption, regardless of species.

Regulates slaughter and processing of animals covered under FMIA and PPIA (e.g., cattle, swine, poultry).
Assumes oversight of cultured food production at the harvest stage for these species.
Ensures processing, labeling, and inspection compliance for meat and poultry products.

Imports of Human Food Made from Cultured Animal Cells

FDA Regulated Imports

Like all FDA-regulated foods, imported cultured food products, such as those made from fish, seafood, or other non-USDA regulated species, must comply with FDA requirements, including the absence of unapproved additives, facility registration, and importer verification procedures. The FDA may inspect imported products at U.S. ports of entry and detain shipments that appear to violate regulations.

USDA-FSIS Regulated Imports

For cultured meat and poultry products specifically, USDA-FSIS has established an equivalence process. Countries seeking to export these products to the U.S. must demonstrate that their food safety inspection systems provide the same level of public health protection as USDA-FSIS standards. At present, no country has been deemed equivalent for exporting cultured meat or poultry products, meaning commercial imports of these products are not yet permitted.

FDA's Evolving Regulatory for Cultured Food Products

Cultured food technology is advancing, enabling the production of food from animal cells. As manufacturers scale up, the FDA collaborates with USDA-FSIS to ensure product safety and accurate labeling. To support industry stakeholders, the FDA has committed to publishing guidance on pre-market consultations. This guidance will provide more details on safety assessments, labeling requirements, and compliance expectations, while also allowing for public comment.

As the industry continues to develop, the FDA remains focused on ensuring food safety while fostering innovation in the alternative protein sector. The agency’s regulatory oversight aims to balance consumer protection with industry growth, enabling the introduction of novel food technologies into the U.S. market under transparent and science-based safety standards.