Special Counsel Brian Sylvester was quoted in the Food Navigator-USA article, “USDA to launch rulemaking process for labeling of cell-cultured meat,” which discussed how the FDA and the USDA recently announced that they would work together to come up with joint principles to govern the labeling of products under their respective jurisdictions.
Sylvester, a food and drug lawyer who formerly worked at the USDA, said that accurate and neutral labeling terms for meat grown outside animals will be critical to the success of the industry. “Labeling ties in critically to consumer perception and so the success of this sector will turn, in large measure, on the nomenclature used,” he said.
Sylvester also told Food Navigator that more clarity is needed between the respective roles of the USDA and FDA. Under a previous joint agreement between the agencies, the FDA will oversee cell collection, cell banks and cell growth and differentiation with a transition to the USDA oversight at the cell harvesting stages. “More clarity is certainly needed around the handoff process,” he said, “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,” Sylvester said.
Sylvester added that the industry is off to a running start, but is still awaiting more details.
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