On September 3, 2021, the U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) published an advanced notice of public rulemaking (ANPR) to solicit comments and information regarding the labeling of cell-cultured meat and poultry products.

By way of background, in 2019, FSIS and the U.S. Food and Drug Administration (FDA) agreed to jointly oversee the production of cell-cultured products from animals traditionally under FSIS jurisdiction (livestock, poultry, and catfish). Under the agreement, FDA is charged with overseeing cell collection, growth and differentiation, while FSIS is responsible for cell harvesting, processing, packaging, and labeling. FDA is also entirely responsible for the regulation of cell-cultured seafood products other than catfish (as these foods are traditionally regulated by FDA), although the agencies agreed to develop joint principles for labeling to ensure a consistent approach. To that end, the ANPR states that FSIS will consider comments submitted in response to FDA’s Request for Information (RFI) on the labeling of cell-cultured seafood. (See RFI Blog Post).

Through the ANPR, FSIS is seeking comment on a broad range of questions related to labeling of cell-cultured meat and poultry products, including the foundational question of whether labeling should differentiate cell-cultured products from traditionally slaughtered products, and if so, what terms should be used.  A detailed list of questions regarding cell-cultured labeling options for which FSIS is soliciting comments can be found in the ANPR. Additionally, FSIS is requesting economic data and consumer research so that it can better understand the animal cell culture industry. Questions of particular interest to FSIS (e.g., expected number of market entrants) can again be found in the ANPR.

FSIS will review the labels of any cell-cultured meat or poultry products that are marketed before rulemaking is completed and ensure that the cell-cultured products are clearly differentiated from slaughtered meat and poultry products, although such labels may need to be changed once final regulations are implemented.  Comments to the ANPR are due by November 2, 2021.  Please let us know if you are interested in submitting comments in response to this ANPR.