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Food Navigator-USA Quotes Brian Sylvester Extensively on Just-Announced FDA-USDA Meeting for Cell Cultured Meat
Brian P. Sylvester, special counsel in Wiley Rein’s Food, Drug and Medical Device and Consumer Product Regulation practices, was quoted extensively by Food Navigator-USA in a September 10 article concerning Monday’s announcement that the USDA and FDA will host a joint meeting on cell-based meat. The meeting seeks to explore how the sector might be regulated and how such products should be described on food labels, and comes on the heels of a slew of developments, including (1) a letter to the White House co-signed by the North American Meat Institute (Meat Institute) and Memphis Meats proposing a dual FDA-USDA regulatory pathway, (2) the imminent creation of a coalition or trade association for the burgeoning sector and (3) a late-breaking agreement by start-ups in this space to refer to their product as “cell-based” in lieu of “clean” meat.
Commenting on the joint agency announcement, Mr. Sylvester told Food Navigator-USA that the upcoming meeting was an “exciting development” given the turf battle that appeared to be brewing between the FDA and USDA. He added that possible dual oversight for the industry could potentially track the path of cloning technology whereby the FDA conducted a pre-market risk assessment and the USDA took over day to day oversight and labeling. Mr. Sylvester also indicated that FDA’s paradigm for reviewing the technology could be “similar to the voluntary consultation process for biotechnology” [whereby developers consult with FDA on safety issues and can ask FDA to review their scientific and regulatory assessments and secure a “No Questions” letter if the Agency is satisfied].
Asked whether USDA should be involved at all given FDA’s clear familiarity with cell-based production facilities, Mr. Sylvester noted that while “FDA certainly would be capable” of regulating the sector on its own, “the realities of the marketplace and political climate” essentially mandated that the two agencies work together. He added that “USDA would likely lean heavily on the FDA as it pertains to this technology.” As to the nature of USDA inspection under a dual jurisdiction paradigm, Mr. Sylvester explained that “inspectors wouldn’t be standing in a room staring at a bioreactor, but what [such inspections] might look like will be fleshed out and better understood during [the upcoming] consultation process” with FDA and USDA.
Finally, on the issue of labeling, Mr. Sylvester believes “cell based meat” – the new preferred terminology chosen by the sector -- is more feasible than “clean meat” from a regulatory perspective because it does not imply any value judgments or disparage conventional meat, but notes “the jury is still out” on the absolute best term that will meet regulatory muster and resonate with consumers.
To read the article, click here.