Cell-cultured food products: US co-regulatory framework & path towards establishing a labeling standard
Cellular agriculture companies are sprinting to develop cell-cultured meat or meat derived from growing animal cells in laboratories. Before these new foods get to our plate, however, manufacturers will need to demonstrate that both the manufacturing process and final cell-cultured product satisfy labeling & regulatory requirements and meet the necessary safety standards. Here, we provide an overview of current US regulations/guidelines and an outlook on the future of regulating cell-based food.
US co-regulatory framework for cell-cultured food products
In March of 2019, the FDA and the Food Safety and Inspection Service of the USDA formally agreed to co-regulate cell-cultured products depending on 1) the type of cell line comprising the product and 2) the stage in manufacture.
Cell-cultured products comprising cell lines derived from animals that are 1) intended for human consumption and 2) currently regulated by the USDA will be subject to co-regulation by the FDA and USDA depending on the stage of manufacture. This includes cell-cultured livestock and poultry products as specified by the Federal Meat Inspection Act and the Poultry Products Inspection Act. The FDA will provide regulatory oversight on all stages of manufacture before cell harvest, including tissue collection, maintenance of cell banks, and cell growth & differentiation. The agency will conduct pre-market safety consultations as well as routine record and facilities inspections. Facilities must be registered with the FDA and comply with the FDA's Current Good Manufacturing Practices and preventive control requirements. The FDA encourages participation in their pre-market consultation process.
Meanwhile, the USDA will oversee manufacturing stages downstream of cell harvest, including product processing, packaging, & labeling. Additionally, the USDA will be responsible for the daily inspection of facilities where cells are harvested and processed. Such establishments must operate under a Grant of Inspection from USDA-FSIS and meet all FSIS regulatory requirements. Facilities must meet requirements for sanitation and have Hazard Analysis and Critical Control Points systems in place. Detailed procedures for transferring regulatory oversight during cell harvest are yet to be announced.
Cell-cultured products made from cell lines derived from animals that are not currently regulated by the USDA (i.e., most seafood except catfish) will be regulated solely by the FDA during both pre- and post-harvest stages of manufacture, including product labeling. Post-harvest oversight will differ substantially from that for cell-cultured meat. For example, the frequency of inspection of food facilities solely under FDA oversight will be lower.
In both cases, it is foreseen that the safety of certain inputs for use in the various manufacturing steps, including cell culture, may be established via the GRAS process based on scientific procedures.
Labeling of cell-cultured food products
Under the March 2019 agreement (Brashears, Yiannis), the FDA and USDA-FSIS will coordinate to establish joint principles for labeling cell-cultured food products to ensure consistency and transparency. Additionally, labeling of cell-cultured food products originating from livestock and poultry will be overseen by the FSIS-USDA, while labeling of cell-cultured products originating from seafood and other animals not currently regulated by the USDA will be overseen by the FDA. Although a final labeling requirement has yet to be established, we can look to existing labeling requirements for conventional meat and public commentary on the labeling of cell-cultured meat for insight into what future regulatory requirements might look like.
Existing labeling requirements for traditionally grown meat
Labeling requirements for cell-cultured products will likely be influenced by their characteristics and similarity to conventional slaughtered products. Current FSIS labeling requirements for conventional slaughtered products, including the use of the terms "meat" and "poultry," take into consideration consumer expectations for the biological, chemical, nutritional, and organoleptic properties of the finished product. If a new product differs from conventional products, a new labeling standard may need to be developed.
Current labeling requirements by the FSIS allow labels that meet legal standards and do not contain special claims to be "generically approved" and exempt from FSIS review before commercialization. Special claims include those that are not factual statements and lack regulatory definitions (i.e., not defined in FSIS regulations or the Food Standards and Labeling Policy Book). Generic approval typically applies for labeling statements with widespread industry and consumer understanding. Due to the novelty of cell culture technology in food, labels for cell-cultured food products will thus likely be regarded as special claims in the label review process.
Summary of public comments on a new labeling requirement for cell-cultured meat
Previous commenting periods about the labeling of cell-cultured products reveal widespread consensus about labeling that indicates whether the product was made using cell culture technology. A commenting period for labeling cultured seafood reflects a similar consensus - many favored labeling that distinguishes traditional farmed or wild-caught products from cell-cultured products. Other comments reflected concerns about the impact of labeling on industry innovation, the need for establishing standards of identity for cultured products, and standards for evaluating claims for cultured products. One petition advocated for a delay in establishing labeling requirements until there is a more complete understanding of the characteristics of cell-cultured products and the proposed labels.
To solicit more information and data that could potentially be used to establish a labeling requirement for cell-cultured products, the FSIS initiated a 60-day commenting period (later extended to 120 days) in September 2021. In the commenting period, some argued against the need for new labeling requirements in the absence of significant differences in the safety or characteristics between the cell-cultured and conventional products, especially due to potential negative consequences on industry innovation (Bond, Camille). Others advocated for terminology to distinguish cell-cultured and conventional products but favored waiting until more information on consumer perceptions of proposed labels. Additionally, there continued to be disagreement about whether "meat" could be used to describe cell-cultured products and the pros/cons of using different qualifiers to distinguish cell-cultured products from conventional products.
Current regulatory review process for labels on cell-cultured products
Overall, more information about proposed labels, consumer reactions to proposed labels, and characteristics of cell-cultured products will likely be important in establishing a label requirement. Periodic re-evaluation of label requirements may additionally be necessary as the development of cell-cultured products progresses and the products become more similar to conventional meat.
Until a final labeling requirement is established, labels for cultured meat will be subject to individual review and approval by FSIS. The FSIS will ensure that labels meet current standards for conventional meat and poultry products. Labeling of cell-cultured seafood and other animals not currently regulated by the USDA will be overseen by the FDA. Possible terms for labeling cell-cultured products include "cultured," "cell-cultured," "cultivated," "cell-based," or "in vitro." Although USDA and FDA will operate from joint principles for labeling cell-cultured products, specific labeling language for cell-cultured meat/poultry and seafood may, in the end, differ. Once the final rule has been made, labels approved for cell-cultured products in advance of the final rule may need to be changed accordingly.
Labeling requirements for bioengineered foods
Depending on the characteristics of the cell-cultured product and the origin of the cells, it is possible that it may additionally be subject to the National Bioengineered Food Disclosure Standard, which the USDA established in December 2018. The deadline for mandatory compliance was January 1, 2022. This means that all foods subject to the Standard must be labeled in accordance with the Standard as of January 1, 2022, except for small food manufacturers, which have one additional year for implementation.
The Standard applies to all foods that are bioengineered or contain bioengineered ingredients, including Arctic Apples & AquaBounty Salmon. Bioengineered foods are defined as foods that contain genetic modifications that could not 1) be generated using conventional breeding techniques or 2) be found in nature. It only applies to foods of animal origin that are subject to the labeling requirements of the Federal Food, Drug & Cosmetic Act (i,e, seafood) and does not apply to products subject to the labeling provisions of the Federal Meat Inspection Act (beef, pork, catfish) and Poultry Products Inspection Act (poultry meat and eggs). As such, bioengineered food disclosure requirements for animal cell-cultured foods only apply to seafood and potentially to cell-cultured products of certain exotic species. Also of note is that incidental additives (e.g., processing aids) are out of the scope of the Bioengineered Food definition.
The Standard allows multiple different forms of disclosure that the food product is bioengineered or contains bioengineered food products. The disclosure may be made by:
text (i.e. "contains bioengineered food ingredients"),
a symbol
electronic or digital link, such as a QR code or phone number that provides access to the disclosure
text message ("Text [command word] to [number] for bioengineered food information.”)
The USDA established the National Bioengineered Food Disclosure Standard in response to the 2016 National Bioengineered Food Disclosure Standard Law, which mandated that bioengineered foods be appropriately disclosed on product packaging and charged the USDA with establishing a standard for doing so. Prior to this law, labeling that indicates whether a food product is bioengineered was voluntary and overseen by the FDA.
Conclusion
To guide innovators in producing cell-cultured products, regulators created a co-regulatory framework involving joint oversight of cell-cultured products by the FDA and USDA. This new framework was accompanied by a description of the regulatory review process for evaluating the labeling of cell-cultured food products. Importantly, a final labeling requirement has not yet been established, and certain details of the co-regulatory framework are to be determined. Labeling and regulatory requirements may be re-evaluated as more companies develop and seek commercialization for cell-cultured products.
Written by Wei Ng, PhD candidate & Helikon Associate. Many thanks to Vince Sewalt for constructive dialogue and feedback!
