This March, the US Department of Agriculture (USDA) and Food and Drug Administration (FDA) announced that they established the basic framework for regulating “human food products derived from cultured livestock and poultry cells” (also known as cell-based/clean/cultured meat).
The framework puts into writing what was agreed upon in October: that the USDA and FDA will work together and jointly regulate meat produced via cellular agriculture. This will be the first instance where both agencies are in charge of regulating a field of products.
According to the framework, the FDA will oversee initial steps and regulate the collection and growth of cultured cells. Once the cells are ready to become meat (the Harvest stage), the USDA will take charge and regulate the meat production and harvesting steps. Including how the products will be labelled.
Beyond sharing an overview of how they will work together, the announcement from the FDA and USDA didn’t share many new details. Upon reading the framework, there are a few points that really stuck out to me.
Labelling has been one of the major points of contention between conventional meat producers and cell-based meat companies. According to the framework, the USDA will have the final words regarding the labelling of the final cell-cultured meat products. Groups like the National Cattlemen’s Beef Association (NCBA) will claim this as a win. They have always pushed that the USDA should be in charge of meat labelling.
It is important to note, however, that the document mentions that both the FDA and USDA “will develop joint principles for product labelling and claims to ensure that products are labeled consistently and transparently”.
This means that, even though the USDA will be the department labelling the final products, it will be based on previously agreed terms with the FDA. If the FDA has a role in labelling then it may be possible that the joint USDA and FDA consensus will be to label cell ag meat products meat.
The document avoided using terms like meat or protein in order to be as neutral as possible. They just referred to the product in question as a product derived from animal cell cultures. However, even though the framework was very selective about its language, there were several clues in the document.
When it comes to the Harvesting stage of producing cell-based meat, where the USDA takes over from the FDA, the framework states that: “At harvest, [the USDA will] help coordinate the transfer of regulatory oversight from [the FDA], including, but limited to, reviewing information necessary for USDA to determine whether harvested cells are eligible to be processed into meat or poultry products that bear the USDA mark of inspection”.
Perhaps more nuanced than needed, but the language suggests that the product can only be considered meat (at least regulatory-wise) once it’s under the USDA’s control.
The language also suggests that it isn’t a question of whether the USDA will label the cell ag product as meat or not. It will most likely be considered meat. The language shows it will just come down to the quality of what’s produced.
It’s about the quality of the cell ag meat product being high enough to be labelled as meat. Not whether it can be labelled at all.
Poor quality products, even derived from animals, wouldn’t get the USDA stamp of approval to be sold as meat if not at the right quality. It seems likely they will treat meat produced via cells the same way.
When it comes to cell-based meat, language plays an important role in regard to regulation and jurisdictions.
What if, for example, the USDA does not label cell ag meat as meat? This would be an interesting hypothetical situation.
The USDA explicitly has regulatory control over meat, poultry, catfish, and egg products. The FDA regulates all other food products.
If the USDA does not label the product as meat, then why would it be under their jurisdiction to regulate the product? If it’s only recognized as a cell-cultured product that isn’t labelled as meat, could the FDA argue that they have complete jurisdiction over the field?
Considering that many meat and cattlemen associations have an interest in the USDA regulating cell-cultured meats, it seems likely that the USDA will want to have a role to play. And that would require the product being labelled as a meat product.
Beyond beef and chicken, there are still questions of how regulation would look like for other cellular agriculture food products. What about cell-based fish, which is solely regulated by the FDA? Will cell-based fish startups be required to follow a similar regulatory process even if the USDA is not involved?
In addition, there are questions over how acellular products, like animal-free gelatin, egg whites, and dairy proteins, will be regulated. Will they be regulated under current systems that allow products Generally Recognized as Safe (GRAS)? Or would their novel production methods require those startups to take their products through a different type of regulation?
While there are still many questions (and details) to address, it is promising to see that the USDA and FDA both agreed upon the basic regulatory framework for cell-cultured meat. It is now important that regulators communicate clearly with all the respective companies and industries to help grow and support the future of food.