Memphis Meats, NAMI: FDA and USDA both have roles to play in regulating cell-based meat and poultry

By Elaine Watson

- Last updated on GMT

Picture: Memphis Meats
Picture: Memphis Meats

Related tags Clean meat cultured meat

Cultured meat (aka ‘clean meat’) is best described as ‘cell-based meat and poultry,’ and both the FDA and the USDA have roles to play in regulating it, argue Memphis Meats and the North American Meat Institute in a letter to President Donald Trump calling for “regulatory clarity” as cell-based products get closer to commercialization.

In a letter​ sent to the White House this morning, Memphis Meats co-founder and CEO Uma Valeti, MD, FACC, and North American Meat Institute (NAMI) president and CEO Barry Carpenter propose “a combined meeting between the White House, USDA, FDA, and both conventional and cell-based meat and poultry industry stakeholders,”​ to thrash out who should regulate cell-based meat and what to call it.

Existing law and practice, coupled with “longstanding precedent​,” demonstrate that the FDA and the USDA both have roles to play, they added, with the FDA best placed to handle pre-market safety evaluations, and the USDA best placed to handle matters thereafter.

FDA has extensive expertise evaluating products produced using cell culture technology, while USDA has a longstanding role in inspecting meat and poultry products, they explained.

“Historically, for evaluations relating to meat or poultry products, USDA has provided input to FDA as part of this process. Given USDA’s expertise in regulating meat and poultry, that role should continue.

“After pre-market safety has been established with FDA, USDA should regulate cell-based meat and poultry products, as it does with all other meat and poultry products, applying relevant findings from FDA’s safety evaluation to ensure products are safe, wholesome, and properly labeled.

 As for nomenclature, they said: “Recognizing a shared desire to support innovation and feed the world, moving forward we will use the term ‘cell-based meat and poultry’ to describe the products that are the result of animal cell culture.”

In a July 26 letter to President Trump, the North American Meat Institute and other meat associations argued that USDA was “uniquely equipped​​” ​to regulate cell-cultured meat, and accused the FDA -which recently argued it was best-placed to oversee clean meat​​​ - of conducting a “regulatory power grab.' ​However​it now appears to see a role for the FDA.

A NAMI spokeswoman told FoodNavigator-USA this morning: "We’ve said all along that we think USDA should regulate these products but that FDA has a role. This letter is consistent with that view."

Cattlemen: 'USCA remains concerned about the use of the term 'meat'

The US Cattlemen's Association said that it had always envisaged a role for the FDA in a statement issued this morning by president Kenny Graner: “We’ve always advocated a three-prong approach in the jurisdiction of this product – involving Congress, USDA, and FDA.

"Today’s announcement is a positive step forward, but there is still work to be done as we look to how these products are ultimately labeled and whether they are included at the meat counter.  USCA will continue to push for accurate labeling that maintains the integrity of the word 'U.S. Beef."

"USCA remains concerned about the use of the term 'meat,' but the commitment to come to the table to propose solutions is a step in the right direction."

The United States is currently the world leader in protein production, including cell-based meats. But we will not maintain that position without regulatory clarity.”

Memphis Meats co-founder and CEO Uma Valeti, and NAMI president and CEO Barry Carpenter

Clean meat turf war

If cultured meat products are regulated exclusively by the USDA - as opposed to the FDA - “they will not see the market in the lifetime of anyone in this room,”​ Polsinelli attorney Stuart Pape told delegates at a packed education session at the IFT annual meeting and food expo in Chicago last month.

Addressing the turf war developing between the two federal agencies over who has primary jurisdiction over meat produced by growing cells in bioreactors (as opposed to animals), Pape argued that “USDA’s experience with traditional meat is not pertinent to cellular meat.”​​

He added: “The notion than an inspection driven regime makes sense for these kinds of foods makes no sense to me… Is a USDA inspector going to stand in David’s ​​[Bowman, cofounder at clean meat start up Mission Barns and fellow speaker at the IFT education session] facility and stare at a bioreactor?”​​

Were USDA to take the lead on safety evaluations, predicted Pape, “This will get slow walked… My view on what makes most sense from a public policy perspective is that this should be FDA regulated.”​​

This is in part because the FDA “already has experience of cellular agriculture on the food and biologics side,” ​​while the USDA is “not used to dealing with new technology," ​he said.

Ultimately however, labeling would likely have to be “a joint effort between USDA and FDA,”​​ predicted Pape.

Echoing comments​​​ made by Gregory Jaffe from the Center for Science in the Public Interest at the FDA meeting, Pape said companies in this space were above all keen to prevent cell-cultured meat from being demonized in the way that biotech crops have been, in part because of a “toxic​​” combination of “no required review, and no disclosure.”​​

GFI-Jessica Almy

Asked by FoodNavigator-USA whether a GRAS determination or a food additive-type process (involving pre-market approval from the FDA) might make sense for cultured meat, Good Food Institute director of policy Jessica Almy said it was “premature to say which of those two pathways makes sense.”​​

She added: “It’s also possible that FDA is going to determine that there is a different kind of pathway to ensure that these products are safe… the real question is does the production process present any new risks for consumers … but what the specifics of an application or a notice would look like are still up in the air.”​​ Read more HERE

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