While the USDA and the FDA have outlined a regulatory framework for foods containing cultured meat and seafood cells, they have not yet nailed down the nomenclature.
The labeling of meat and poultry from cultured cells is in the USDA’s remit, while the labeling of seafood (except catfish) from cultured cells is in the FDA’s remit. However, the agencies are developing joint principles for labeling and claims to ensure consistency.
In the ANPR (the 60-day comment period ends in early November), the USDA asks stakeholders questions such as:
- 'If meat or poultry products... containing cultured animal cells were to be labeled with the term 'culture' or 'cultured' in their product names or standards of identity...would labeling differentiation be necessary to distinguish these products from other types of foods where the term 'culture"' or 'cultured' is used, such as cultured celery powder'?
- 'Should FSIS establish a regulatory standard of identity... for foods comprised of or containing cultured animal cells?'
- 'What nutritional, organoleptic, biological, chemical, or other characteristics, material to consumers’ purchasing and consumption decisions, vary between slaughtered meat or poultry products and those comprised of or containing cultured animal cells?'
- 'Should any of the definitions for 'meat,' 'meat byproduct,' or 'meat food product' found in 9 CFR 301.2 be amended to specifically include or exclude foods comprised of or containing cultured animal cells?'
Cell-cultured, cultivated, slaughter-free, cell-based, clean, lab-grown, synthetic, fake…
When it comes to terminology, opinions among key stakeholders vary, with some startups favoring ‘cell-based’ or ‘cell-cultured,’ and others favoring ‘cultivated’ or ‘slaughter-free.’ ‘Clean meat’ is still used by some commentators, although critics of the term say it carries the tacit implication that the regular stuff is 'dirty.'
Other terms such as ‘fake meat’ and ‘synthetic/artificial meat’ are more typically deployed by opponents of the technology although many media outlets still use the moniker ‘lab-grown.'
UPSIDE Foods: 'It's critical that consumers understand that they are purchasing a real meat, poultry or seafood product'
The Alliance for Meat, Poultry, and Seafood Innovation (UPSIDE Foods, Eat Just, BlueNalu, Finless Foods, Fork & Goode, Artemys Foods, Orbillion Bio) and the North American Meat Institute said the ANPR was an "important step in gathering information from the industry and the public to inform a labeling framework that fosters transparency, consumer confidence, and a level-playing field while also aligning with longstanding law and policy.”
UPSIDE Foods (formerly Memphis Meats) - which typically uses the term ‘cell-cultured' in its communications - told FoodNavigator-USA it looked forward to submitting comments, although it did not nail down its preferred term, adding: "Labeling will be an important component of our broader focus on meeting high standards for transparency and openness about our products."
In a submission filed with the FDA earlier this year about seafood, the company stressed that cell-cultured meat and seafood products must be clearly distinguished from plant-based meat and seafood, so “consumers understand that they are purchasing a real meat, poultry or seafood product and not another product like a plant-based alternative."
UPSIDE Foods' consumer research, conducted in partnership with marketing firm NorthStar, indicated that "use of 'cell-cultured' also conveyed differentiation with plant-based proteins," it added.
Eat Just: 'Our preference is cultivated meat, followed by cultured meat'
Eat Just – which has already launched meat from animal cells grown outside of animals in Singapore under the GOOD Meat brand, and has just announced plans to build a manufacturing facility in Qatar – told FoodNavigator-USA that consumers can be put off by anything with the word 'cell' in it, however.
“Our recent preference is cultivated, followed by cultured. Consumer research and polling has shown ‘cell-based’ is among the least desirable terms.”
GFI: 'We prefer cultivated'
Laura Braden, lead regulatory counsel at the Good Food Institute - a nonprofit that promotes plant-based, fermentation-based, and cell-cultured meat - told us that it "would be premature for either USDA or FDA to prescribe a particular term for cultivated meat labels at this stage."
But she added: "We prefer 'cultivated' as a modifier for seafood and meat made from animal cells because that term best combines differentiation from conventional products with consumer appeal."
What happens next?
When it comes to product safety, the FDA is working with the USDA to oversee cell-cultured meat and poultry using existing regulatory frameworks; while cell-cultured seafood (except catfish) remains under the sole jurisdiction of the FDA.
Under a joint agreement announced in March 2019, the FDA will oversee cell collection, cell banks, and cell growth and differentiation, with a transition to FSIS (USDA) oversight to occur during the cell harvest stage. FSIS will then oversee the production and labeling of meat and poultry derived from these cells.
USDA: ‘Current FSIS regulations requiring sanitation and Hazard Analysis and Critical Control Point (HACCP) systems are immediately applicable’
In its ANPR, the USDA said that, “Other than new labeling regulations concerning this product, FSIS does not intend to issue any other new food safety regulations for the cell-cultured food products under its jurisdiction. Current FSIS regulations requiring sanitation and Hazard Analysis and Critical Control Point (HACCP) systems are immediately applicable and sufficient to ensure the safety of products cultured from the cells of livestock and poultry.”
It also noted that to avoid holding up the commercialization process, it would review labels submitted by cell-cultured meat brands before the rulemaking process is completed on the understanding that they may need to be changed down the road to comply with its final regulations, which is good news for startups in the space, said Brian Sylvester, special counsel at law firm Covington & Burling LLP.
"Rulemaking of this nature can take years," he told FoodNavigator-USA. "USDA's willingness to review and approve labeling for USDA-regulated cell cultured foods, at this stage, is welcome news and demonstrates great flexibility in accommodating new technologies into the existing regulatory framework, consistent with USDA and FDA precedent.
"To the extent companies have also been working with FDA on premarket safety, then it's conceivable that USDA-regulated companies who are 'all ready to go' may commercialize cell cultured foods prior to USDA finalizing its labeling rules."
Attorney: USDA and FDA plan to align on labeling principles
But he added: "Although we do not think that FDA needs to issue new labeling rules for cell cultured foods under its purview, FDA did issue a Request For Information last October on the labeling of foods comprised of or containing cultured seafood cells. FDA and USDA plan to align on key labeling principles and so we think the USDA rulemaking could have a significant influence on what naming conventions FDA will ultimately view as truthful and not misleading for FDA-regulated cell cultured foods.
"In particular, we anticipate FDA and USDA will align on such issues as -- what terms should be used to convey the nature or source of the food, what level of detail concerning production method should be disclosed and where, and what labeling terms should be applied to hybrid foods produced from both conventional and cell cultured sources. From a labeling perspective, this analysis would consider the same issues across both agencies – specifically, what labeling information is necessary to ensure that consumers are not misled."
FDA ‘intends to issue draft guidance on the pre-market consultation process’
Asked about what progress the FDA is making on the areas it is responsible for (cell collection, cell banks, cell growth and differentiation etc), an FDA spokesperson told FoodNavigator-USA that it “intends to issue draft guidance on the pre-market consultation process,” although it did not provide a timeline, adding: “The FDA is actively working in this space and consulting with a number of companies interested in bringing cultured animal cell food products to the US market.
"We cannot comment on the status of individual consultations that are in progress. However, FDA intends to communicate publicly once the FDA consultation is complete.”
'We do not expect there will be a need for any detailed public announcement of particular procedures'
Asked about the transfer of jurisdiction from FDA to USDA at the cell harvest stage, the spokesperson said: “FDA and USDA-FSIS continue to work together to prepare for shared oversight of cell culture facilities involving cultured livestock or poultry cells used for human food.
"Given that the agencies currently coordinate on oversight in the field in a number of situations, and that both agencies intend to use existing authorities and tools, we do not expect there will be a need for any detailed public announcement of particular procedures.”