- On March 7, 2025, FDA announced that is has no questions regarding a human food product made from cultured pork fat cells, finding that the defined production process results in a product that is as safe as comparable foods produced by other methods. The cultured cells are produced in a controlled environment using belly fat cells from domestic Yorkshire pigs to create cultured pork fat.
- In addition to a pre-market consultation, FDA has inspected the facility where pork fat cells are cultured and grown and intends to conduct additional inspections after commercial production begins and on an ongoing basis. Before the product can be marketed for use in food, it must also meet USDA regulations as outlined in the joint agreement between USDA and FDA establishing the agencies’ shared oversight of food made with cultured animal cells.
- FDA’s pre-market consultation process for food made with cultured animal cells allows developers to work with the Agency on a case-by-case basis to ensure they are producing food that does not violate the Federal Food, Drug, and Cosmetic Act. During the process, FDA evaluates the production process and resulting cell material, including the establishment of cell lines and cell banks, manufacturing controls, and reviews all components and inputs.
- This is the third product made using cultured animal cells for which FDA has concluded it has no questions regarding the safety, following the first for a product made from cultured chicken cells in 2022. Keller and Heckman will continue to provide updates on the development of cell cultured meat products.
© 2025 Keller and Heckman LLP
National Law Review, Volume XV, Number 79