USDA Requests Comments on the Labeling of Cell Cultured Meat and Poultry Products

On September 3, the U.S. Department of Agriculture’s (USDA’s) Food Safety and Inspection Service (FSIS) released an advance notice of proposed rulemaking (ANPR) to solicit comments on the labeling of meat and poultry products produced using cultured cells derived from animals (“cell cultured products”) under FSIS jurisdiction.[1] Importantly, the ANPR makes clear that companies may market cell cultured products in the United States before FSIS finalizes its rulemaking on this topic, but that label changes could be necessary at a later stage to conform to final requirements for companies that choose to come to market earlier. This alert briefly summarizes FSIS’s proposed approach to regulating cell cultured products, outlines the key elements of the ANPR, and analyzes the implications of this development for industry.

What are cell cultured products and how are they regulated?

Cell cultured products are produced using animal cell culture technology. Through this technology, meat, poultry, and seafood can be produced ex vivo, or grown outside the animal. A March 2019 MOU between FDA and USDA outlines how the U.S. will regulate cell cultured products within the existing regulatory framework.[2] Labeling of alternative protein products, like cell cultured meat and poultry, has emerged as a hot button issue, prompting a petition urging FSIS to revise definitions of meat and beef to exclude cell cultured products,[3] and prompting several states, like Louisiana, Missouri, and Mississippi to pass laws addressing the marketing of cell cultured meat and poultry products with “meaty” terms. Against this backdrop, USDA and FDA have committed to jointly develop principles for product labeling and claims, with the stated goal of ensuring that all cell cultured products are labeled “consistently and transparently.”[4]

How is FSIS approaching new labeling requirements for cell cultured products?

Under the FSIS paradigm (and unlike FDA), labels containing special statements and claims must be submitted to FSIS for review and approval before use. FSIS proposes to subject the labels for cell cultured products under FSIS jurisdiction to the same process as special statements or claims.

In the ANPR, FSIS explains that if a new method of production or processing alters the biological, chemical, nutritional, or organoleptic properties of meat or poultry such that the resulting product no longer aligns with consumers' expectations, then the Agency must establish new label requirements to meet consumers' expectations. This is consistent with past FSIS labeling actions: in 1995, FSIS concluded that mechanically separated poultry (MSP) differed materially in physical form, texture, and ingredients, e.g., bone content, from other boneless poultry products produced by hand deboning techniques, so FSIS implemented a new standard of identity for MSP; by contrast, in 2004, FSIS determined that new labeling requirements were not necessary for meat derived using advanced meat recovery (AMR) systems because AMR product was compositionally comparable to meat derived by hand deboning, and also had the same appearance and texture when prepared in line with existing Agency requirements. FSIS will consider similar issues for cell cultured products.

What information did FSIS request?

While stakeholders can comment on any topic relevant to USDA’s regulation of cell cultured product labeling, the ANPR identifies fourteen specific questions on which the Agency is seeking comment. These questions cover the following key topics:

• Should USDA require that product name of cell cultured products inform consumers that the product was made using animal cell culture technology? If so, what terms should be used to convey this information (e.g. “cultured” or “cell cultured”)?
• How should USDA regulate the labeling of products comprised of both cell cultured meat and non-cultured meat?
• Should USDA establish regulatory standards of identity for cell cultured products? If so, should terms for slaughtered meat and poultry products established by common usage (e.g., “Pork Loin”), statute, or regulation be included in these standards of identity?
• Should USDA amend its regulatory definitions of the terms “meat,” “meat byproduct,” “meat food product,” “poultry product,” or “poultry food product” to specifically include or exclude cell cultured products?
• Are cell cultured products likely to use label claims for which USDA should develop new regulations or guidance?

USDA also requested that stakeholders submit economic and consumer research data regarding the potential impact of cell cultured product labeling on consumers’ perceptions of cell cultured products and the potential economic impacts of the cell cultured meat industry.

These topics largely mirror the topics FDA raised in its October 2020 request for information (RFI) on labeling of products made with cell cultured seafood.[5]  Consistent with FDA and USDA’s commitment to develop joint principles for the labeling of cell cultured products, the ANPR states that USDA will consider comments received in response to FDA’s RFI to the extent they are relevant to USDA’s rulemaking.

Will FSIS consider cell cultured product labels submitted prior to the final rulemaking?

Stakeholders may wish to start marketing cell cultured meat or poultry products before FSIS finalizes this rulemaking. The ANPR states that stakeholders who market cell cultured products during this time will need to submit their labels to FSIS for pre-approval. The ANPR emphasizes that these labels will not be eligible for generic approval. FSIS plans to verify that these labels “clearly differentiate cell cultured product from slaughtered meat and poultry products.” The ANPR also clarifies that any labels approved during this time may need to be revised in the future to ensure compliance with FSIS’s final labeling regulations.

What implications does the ANPR have for industry?

This ANPR marks a key milestone in the development of a comprehensive federal regulatory framework for cell cultured foods oversight in the United States. While this rulemaking will likely take at least a few years to complete, FSIS's willingness to review and approve labeling for cell cultured foods in the interim demonstrates great flexibility in accommodating new technologies into the existing regulatory framework.

Because FDA and USDA plan to align on key labeling principles for cell cultured products, any actions FSIS takes in response to this ANPR could significantly influence the naming conventions FDA will ultimately view as truthful and not misleading for a wide range of FDA-regulated alternative protein foods, including, for example, cell cultured seafood, plant-based meat products, and fermentation derived dairy analogues. In particular, FDA and FSIS may seek to align on key issues such as the terms that should be used to convey the nature or source of the food, the level of detail concerning production methods that should be disclosed and where, and the labeling terms that should be applied to hybrid foods produced from both conventional and cell cultured sources.

Interested stakeholders should provide FSIS with any relevant information that will help facilitate the development of a fair and effective labeling framework for cell cultured products. Stakeholders have until November 2, 2021 to submit comments on the ANPR.

If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Beverage, and Dietary Supplements practice.