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FDA Sets Its Sights on Clean Meat Regulation
GFI attended the FDA’s public meeting on foods produced using animal cell culture technology on July 12th. Speakers presented a strong case for the FDA’s ability to regulate clean meat. Policy Director Jessica Almy gave remarks during the public comment section.

Answering the call for regulatory guidance, speaker after speaker reviewed how the U.S. Food and Drug Administration will be able to use their current expertise and regulatory framework both to encourage innovation and to ensure consumer safety.

Here’s your rapid-fire review of the key points from each session:

Industry and consumers look to the FDA

FDA Commissioner Dr. Scott Gottlieb opened the day noting that the FDA is committed to keeping the food system safe as well as supporting innovation in America’s food supply. He emphasized that the FDA has already played a role in the introduction of many novel practices and is well versed in cell culture technology and the medical applications that have preceded its use in food production. “Past experience with novel technologies and our extensive background in cell culture technology in the medical product space will help inform our approach to evaluate the safety of these cell-based food products.” Dr. Gottlieb characterized the meeting as the beginning of a robust dialogue on new products, new ingredients, and new methods of manufacturing.

“This is not our first rodeo.”

Dr. Susan Mayne, Director of the Center for Food Safety and Applied Nutrition (CFSAN) at the FDA, made it clear that, as has been the case with past innovations, the Food and Drug Administration is well versed and ready for clean meat. “These are the early days, but FDA has been preparing for this for quite a time,” she said. “The FDA is ready to face the challenges and to support the promise of this and other emerging technologies.” Dr. Mayne also said that the FDA had been meeting with food companies for several years and that she had prioritized attending the FFT conferences in 2017 and 2018. Noting that the FDA regulates 80% of the food supply, she quipped, “This is not our first rodeo.”

“Preventing food safety problems rather than reacting to them”

William Jones, Acting Director for CFSAN’s Office of Food Safety, provided an overview of the regulatory framework for food safety at the FDA under the food safety modernization act, which increased focus on “preventing food safety problems rather than reacting to them.” He enumerated the existing regulatory tools and detailed how existing standards are well equipped to regulate clean meat, given the existing full range of monitoring, inspection, compliance, and enforcement tools at its disposal.

“Properties of the substance—not the process—are what matters”

Jeremiah Fasano from CFSAN’s Division of Biotechnology and GRAS Notice Review shared examples of past experience that the FDA has with cell cultured products, including yeast, algae cultivated to make omega 3 fatty acids, and mycoproteins. “Notwithstanding the fact that manufacturing process can have impacts on safety, properties of the substance—not the process—are what matters,” he said.

“There are no great mysteries when it comes to cell culture.”

After a short break, Professor Paul Mozdziak from North Carolina State University provided an overview of animal-derived cell culture technology. The message delivered many times over was that this technology has been in play for decades. “There are no great mysteries when it comes to cell culture—this technology has been around for a very long time.” He emphasized the upstream and downstream implications for maintaining the final integrity of products as food is unique from biotech applications.

From left to right: Gregory Jaffe, Center for Science in the Public Interest; Michael Selden, Finless Foods; Rhonda Miller, American Meat Science Association; Peter Licari, JUST; Eric Schulze, Memphis Meats; and Isha Datar, New Harvest

A stakeholder’s perspectives panel rounded out the morning.

“This technology is a toolbox, not an outcome.”

New Harvest Executive Director Isha Datar spoke first, reviewing the different goals and constraints for the use of cell culture for regenerative medicine versus food production. She reiterated that this is just the beginning: “This technology is a toolbox, not an outcome.”

“Collaboration and open dialogue...can ensure a safe and reliable food system”

Memphis Meats Vice President of Product and Regulation Eric Schulze said that at Memphis Meats, “We believe that collaboration and open dialogue between regulators and industries can ensure a safe and reliable food system and foster innovation to feed the world’s growing population.”

It will not look like a slaughterhouse”

Chief Technology Officer of JUST Peter Licari was clear on his perspective: the FDA’s existing framework can be easily adapted to cell-based products for use as food. These are procedures the FDA has seen and evaluated for safety. “A clean meat facility will be similar to what the FDA sees every day in both the biologics and food processing plants. It will not look like a slaughterhouse, but much more like a clean, fermentation-based food processing plant.”

“Meat scientists are very much engaged”

Texas A&M Professor Rhonda Miller spoke on behalf of the American Meat Science Association (AMSA), enumerating unknowns on the post-production side, and said that AMSA strongly supports additional research and that “meat scientists are very much engaged and willing to do this and excited about the technology.”

We need the confidence and trust of the people”

Finless Foods CEO and Co-Founder Michael Selden emphasized the benefits for consumers. Finless Foods aims to provide real fish meat—but without the plastics and the mercury—by simply changing the production process. He underscored the importance of establishing a transparent, thorough, and evidence-based regulatory process. “If we want to change the food supply, we need the confidence and trust of the people who will be doing the eating.”

“FDA opinion is critical”

Director of the Project on Biotechnology at the Center for Science in the Public Interest Gregory Jaffe wrapped up the morning panel by focusing on how the correct regulatory path can affect consumer perceptions. “FDA opinion is critical to consumer acceptance of this technology.” He stressed that the FDA must ensure that cell lines are and remain free of microbial contamination and that the assertions about the safety of clean meat are independently verified by the federal government.

Additional stakeholders weighed in.

The open comment period after lunch provided a range of perspectives. Here is what GFI and two clean meat companies had to say:

Benjamina Bollag, co-founder and CEO of Higher Steaks, a European-based clean meat company, emphasized that Higher Steaks is connecting with both FDA and other global regulatory bodies to ensure their products meet and exceed global safety standards. Emphasizing that clean meat offers the opportunity to efficiently create meat without the use of antibiotics, she said, “at Higher Steaks, we are striving to ensure our protocols are as simple as possible. By simplifying the protocols, it should be easier to evaluate the safety of the components."

Co-founder, President, and CEO of clean cell seafood company BlueNalu Lou Copperhouse pointed out that the same guidelines used today have been used for the past few decades from live animals are relevant to products that are cell cultured as well. “It’s my strong belief that the FDA already has robust guidance and documentation already in place that supports the manufacture of seafood products as well as meat and poultry products that utilize cell culture technology.” He recommended that the FDA develop a model program for clean seafood, meat, and poultry companies.

GFI’s Director of Policy Jessica Almy also took the mic. “The United States has a robust food regulatory regime that is more than capable of ensuring that clean meat is safe and truthfully labeled.” One of Jessica’s key points was that the right regulatory path to market will ensure consumer safety and confidence without being onerous for producers.

Policy Director Jessica Almy

Jessica shared that the National Academies last year produced a report on the products of biotechnology. Researched and written by more than a dozen top scientists and peer-reviewed by an additional 17, the report recommended that regulatory agencies develop a “single point of entry” into the regulatory system to streamline the regulatory approval process for clean meat and other products like it.

At GFI, we’ve been thinking about the regulatory framework and talking to stakeholders about how clean meat should be regulated for the past couple years. Our best thinking is that FDA is well situated to regulate. We are delighted that the FDA clearly agrees and very much appreciate the agency’s giving all stakeholders this opportunity to participate in what was a very encouraging day of sharing.

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