“FSIS and FDA are committed to developing joint principles for the labeling of food products made from the cultured cells of animals under their respective jurisdictions… These principles will aim to eliminate any confusion among consumers … regardless of the species,” said Matthew Michael, a director at USDA’s food safety and inspection service (FSIS), during the 20-minute webinar, which you can watch HERE.
“FSIS plans to develop regulatory requirements for the labeling of products made with the cells of livestock and poultry. These requirements will ensure that the labeling… is truthful and not misleading,” said Michael, who said that as with regular meat & poultry under USDA’s jurisdiction, all product labels of cell-cultured meat and poultry products will be subject to pre-approval from FSIS.
“As with all rulemaking, public comments will be solicited and considered in the development of labeling requirements for these products.”
Asked if there was a timetable for this process, a spokesman said: “Not at this time.”
Quizzed on whether we should read anything into the fact that officials from both agencies referred to 'cell-cultured' meat (as opposed to ‘cell-based,’ ‘cultivated,’ etc) throughout the webinar, he said: "No. ‘Cell-cultured’ is simply the phrase we’ve used to describe the technology since the October 2018 USDA/FDA public meeting.”
What’s in a name? From ‘lab-grown’ to ‘cultivated’ meat
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 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 some media outlets still use the moniker ‘lab-grown’ given that it serves as a quick shorthand to distinguish the products from meat harvested from slaughtered animals.
Attorney: 'The success of this sector will turn, in large measure, on the nomenclature used'
While some commentators will likely continue to refer to meat grown outside animals as ‘fake’ or ‘lab-grown’ regardless of the common or usual name regulators ultimately require firms to use on labels, finding a term that is both accurate and neutral will be critical to the success of the industry, Brian Sylvester, special counsel at law firm Foley & Lardner LLP, told FoodNavigator-USA.
"Labeling ties in critically to consumer perception and so the success of this sector will turn, in large measure, on the nomenclature used."
As for the timetable, he said: "Rulemaking certainly takes time. But considering the record speed with which the regulators have moved so far in this space, I am cautiously optimistic that this rulemaking process will not impede the anticipated timeline for commercialization of these products."
Good Food Institute: 'Often rulemaking takes years'
Elizabeth Derbes, associate director of regulatory affairs at The Good Food Institute (GFI) - which promotes plant-based and cell-cultured meat - added: "We don’t think a rulemaking is necessary, but if USDA proceeds, we would urge them to move expeditiously so that producers of cultivated meat and poultry have clarity as they plan to bring their products to market.
"A comment period can be as short as 30 or 60 days, or can be much longer. The fastest that a rulemaking could move from proposal to effectiveness is at least four or five months, but often rulemaking takes years."
Cell-cultured meat firms encouraged to engage with US regulators ‘early in the product development phase’
When it comes to product safety, cell-cultured seafood remains under the sole jurisdiction of the FDA; while the FDA will work together with the USDA to oversee cell-cultured meat and poultry using existing regulatory frameworks.
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 foods derived from these cells, said Jeremiah Fasano, senior policy advisor at the FDA’s Center for Food Safety and Applied Nutrition.
“We’ll be developing a detailed framework for shared oversight at harvest so that handoff [the transfer of oversight from the FDA to the USDA at the time of harvest] is efficient and provides necessary information.”
Above all, he added, “We encourage firms to begin consultation early in the product development phase rather than waiting until they are close to market entry.”
Derbes at the GFI noted: "This is the clearest indication thus far that FDA believes its extensive guidance provides sufficient clarity and does not intend to do a rulemaking or new guidance to cover the cell culture phase [although Fasano noted during the webinar that 'should we identify a need for regulations or guidance to facilitate oversight [of the cell-culture phase], we will issue them']."
‘More clarity is certainly needed around the handoff process’
Asked what the industry needs now, Sylvester at Foley said: "More clarity is certainly needed around the handoff process… but many other questions remain.
“For example, we know that the agencies are asking developers to engage early and often and that the FDA will conduct premarket consultations to evaluate production materials/processes and manufacturing controls, to include oversight of tissue collection, cell lines and banks, and all components and inputs. But what will be the mechanics of the consultation process and what specific data will FDA expect?"
'We’re definitely off to a running start, but many details remain to be filled in...'
He added: "If a developer is making human food derived from cell lines of USDA-amenable species, what data needs to be shared with FSIS? What will FDA and FSIS inspection of the production facilities look like, and what about import considerations?
“The new FDA page addresses the import question at a high level with regard to finished human food products derived from cell culture technology. But what about the expectations around the importation of cell lines destined for food production?”
Overall, he said, "I think we’re definitely off to a running start, but many details remain to be filled in."
- Learn more about the US regulatory framework for cell-cultured meat, poultry and seafood HERE.
- Read the March 2019 agreement HERE.
- Watch the webinar HERE or below: