FDA and USDA Create Framework for Cell-Cultured Meat Regulation, But Labeling, Social License Still Uncertain

The US Department of Agriculture and the US Food and Drug Administration have established an inter-agency framework for regulating food items produced using cellular agriculture methods of meat and poultry production.

Details on the framework are scant, but it comprises a formal agreement between the federal agencies about how they will regulate cell-cultured meat products with the USDA overseeing food processing, labeling, and distribution while the FDA will oversee inspections and safety checks.

“We don’t want this new technology to feel like they’ve got to go offshore or outside the United States to get a fair regulatory protocol,” Secretary of Agriculture Sonny Perdue said at a North American Meat Institute event last year. The government’s quick response will likely assuage investors’ and cell-cultured meat startups’ concerns over whether their new technology could crumble over a regulatory roadblock.

The agencies have made a fast effort to figure out the status of cell-cultured meat as a number of legal battles over whether alternative protein products can be labeled as meat have bubbled up in heavy beef production states; Missouri recently passed a bill for food companies to make it clear if meat was sourced from an animal or not and Nebraska, Virginia, and Tennessee are debating similar proposals.

Notably, the inter-agency agreement is silent on the labeling issue. If the companies choose to create a formal labeling rule for cell-cultured meat products, one or both agencies will have to develop proposed regulations on the issue that will be circulated for public comment before being finalized. If the USDA and FDA create a formal labeling rule for cell-cultured meat, the state-based laws will be overturned based on the federal agency’s superior jurisdiction.


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This situation is already mirroring the GMO labeling debate, where Vermont fired the first shot in GMO labeling by proposing a bill that would require companies selling products containing GMO ingredients to label the packages as such. After several states followed suit, Congress passed a law that required the USDA to develop a nationwide GMO labeling standard that requires labeling disclosures. After the agency hit a number of delays in finalizing these rules, they debuted in December 2018.

Will Consumers Accept Cell-Cultured Meat?

The debate over which agency should regulate this novel category of products has been a protracted one, with cell-cultured startups advocating for USDA regulation for a number of reasons, including wanting consumers to accept the product as being as close to conventional meat as possible.

Gaining consumer acceptance – or social license as some call it – is a critical step in the commercialization of cell-cultured meat products, as biotech companies learned through GMO products. A social license is what allows a company to access a marketplace and operate freely; it affords the holder the ability to operate with minimal-to-no constraints, whether they be regulatory or based on public acceptance.

Cell-cultured meat companies are attracting large stacks of venture cash from some very big names including Tyson Ventures and Bill Gates, but these companies still have a ways to go when it comes to testing the consumer waters.

As many as 66% of Americans are willing to try cell-cultured meat, according to a survey of 1,185 adults by Faunalytics, a nonprofit animal rights research organization, but only 25% of survey respondents had heard the terms “clean meat,” “cultured meat,” or “in-vitro meat.”

And when it comes to marketing, the survey revealed that the most effective strategy was to highlight the negative aspects of conventional meat production such as slaughter and farming livestock at an industrial scale. This means that cell-cultured meat companies may opt to base the majority of their marketing and branding on a conversation about the ills of conventional meat production as opposed to a discussion about the science behind their product. This is already a pervasive tactic among plant-based protein companies like Impossible Foods, which suggests that consuming its product can “Save Earth.”

The use of the term “clean meat” to describe food products cultured in a lab is also an early branding strategy to cast the cutting-edge technology in a socially acceptable light. If cell-cultured meat is dubbed clean meat, then by latent implication conventionally-produced meat is, well, dirty.

Notably, neither the USDA nor the FDA has referred to these products or the technologies behind them as “clean meat,” using the term “cell-cultured” instead.

But the verdict isn’t out yet on whether cell-cultured meat will be the environmental panacea that these companies promise. A group of researchers at Oxford University released a study last month indicating that mass-scale cell-cultured meat production could have equal if not worse environmental impacts compared to conventional meat production.

How to Obtain Social License

There are probably far more biotech-derived products on supermarket shelves than consumers realize. Corn and soy are some of the most commonly discussed, but there are many others including non-browning arctic apples and Simplot’s Innate potatoes that are less prone to spotting through RNAi technology. And various alternative meat products including cell-cultured meat and the plant-based Impossible Burger use genetic tools. But as we saw with GMOs, consumers can be rather fickle when it comes to dolling out their acceptance and even more importantly, their grocery dollars.

At the 2016 Ag Innovation Showcase, an hour-long panel dedicated to discussing then-emerging CRISPR Cas9 technology focused largely on this same issue. In light of the severe public backlash against GMO, how can startups, investors, and other proponents of gene-editing technologies earn this social license? Panel participant and director of The Center for Food Integrity Roxi Beck suggested starting with the consumer and listening to what they are saying about the technology even if it means embracing skepticism or scientifically incorrect points of view.

Semantics also matter.

“Looking back at GMO, there are situations where the public was asking, ‘Should we be doing this?” and we would answer it by saying, ‘We can—and here’s how,’” said Beck. “Can, how, and should are very different questions. We need to be where the people are when they are looking for information and paying attention to the words they are using—even if they are words that we may not like.”

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