USDA, FDA Agree to Jointly Regulate Cell-Based Meat Products

“To ensure the regulatory system protects consumers while fostering innovation, it is imperative that the agencies coordinate and collaborate in their efforts,” wrote Memphis Meats CEO Uma Valeti, MD, and NAMI CEO Barry Carpenter.

Under their proposed framework, FDA would have oversight over pre-market safety evaluations for cell-based meat and poultry products, with USDA providing input. “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,” they wrote.

“Such a regulatory framework is not new and plays into the strengths and experience of FDA and USDA,” they noted. They agreed that cell-based meat products “are an ‘and,’ and not an ‘or’ solution” to the world’s protein needs. “We support a fair and competitive marketplace that lets consumers decide what food products make sense for them and their families.”

They also agreed to stop the name-calling. “Moving forward we will use the term ‘cell-based meat and poultry’ to describe the products that are the result of animal cell culture,” they wrote. The meat industry took offense at the term “clean meat,” which suggested conventional meat was not. On the other hand, cattle growers and others in the meat industry had disparaged cultured meat, calling it “lab-grown fake meat,” “Frankenmeat,” and other colorful names.

Sharing the Sandbox

Subsequently, in October 2018, FDA and USDA convened a joint meeting at USDA headquarters to explore the regulatory framework, potential safety hazards, and labeling and claims issues surrounding animal cell culture technology. More than 600 people attended the two-day meeting, in person and remotely.

“We fully anticipate that both FDA and USDA will have active roles in the regulatory oversight of cell-cultured products,” Dr. Gottlieb said in his opening comments. Speaking with reporters afterwards, Perdue suggested a joint oversight framework might be drafted relatively quickly. “If we can get this done in 2019, I would think that would be probably pretty fast for federal purposes,” he said. “We will be moving posthaste after this meeting to more clearly define that.”

Despite conciliatory comments from the agency heads, many industry and consumer stakeholders held to their previous positions. For example, Kevin Kester, president of the National Cattlemen’s Beef Association, said “lab-grown, fake meat labels should be held to the same standards as other meat labels. Given that the goal of these products is to compete directly with real meat, only USDA oversight can adequately ensure this outcome.”

Jessica Almy, policy director at the Good Food Institute, a nonprofit that supports companies producing “clean and plant-based food products,” said no new regulations were needed. “FDA has a clear and strong precedent to address safety premarket. And FDA can provide a single point of entry for regulation.”

And while NAMI partnered with Memphis Meats in proposing joint FDA/USDA oversight, Mark Dopp, NAMI’s senior vice president, argued that “primary jurisdiction regarding the regulation of cell-based meat products rests with USDA.”

Regulatory clarity is essential, said Eric Schulze, vice president of Memphis Meats. “Without a clear, predictable, and timely framework, this industry cannot succeed. Any delays in moving forward would jeopardize the U.S.’s standing in the world as the leader in protein production and responsible, science-based food innovation.”

Until the federal regulatory landscape is clarified, states may be free to exercise their own oversight authority. In June 2018, Missouri enacted legislation that prohibits “misrepresenting a product as meat that is not derived from harvested production livestock or poultry.” The law applies to existing plant-based meat substitutes and future cell-based meat and poultry products.