How should the FDA regulate lab-grown meat?

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COLLEGE PARK, Md. — At Thursday's hearing about regulation of lab-grown meat at the Food and Drug Administration's Center for Food Safety and Applied Nutrition, Gregory Jaffe of the Center for Science in the Public Interest talked a bit about another hot topic in food: GMOs.

Jaffe, CSPI's director of the project on biotechnology, said that before GMOs started to make their way into the food supply, there were no FDA determinations on the safety of those products. Instead, consumers were left to rely on what ingredient developers said was safe to eat. According to recent surveys, Jaffe said, many U.S. consumers do not think GMOs are safe. Manufacturers started reformulating their products to be GMO-free. Some states and then Congress passed laws mandating GMO disclosure. But if the FDA had led with specific regulations to assure consumers that GMOs are safe, Jaffe said, maybe the current marketplace would be different.

"I don’t think anyone wants to see the same thing happening with cultured meat, where products are safe and consumers don’t think that they are safe, or don't believe the developers' determination that they are safe," Jaffe said.

While several manufacturers and scientists are working now to create lab-grown meat, the earliest any company has said it will start selling it is at the end of 2018 — when JUST has said it plans to bring items to the market. This provides time for the federal government to figure out how best to classify and regulate the new types of product. Thursday's hearing allowed public discussion of some of the issues surrounding lab-grown meat, and also provided the opportunity for comments on how it should be regulated. In addition to Thursday's public hearing, there is an online docket where consumers can add their opinions on the issue through Sept. 25.

Scientists, manufacturers, attorneys, industry groups, college students and consumer groups shared differing opinions and ideas during the hearing. But they all agreed on one basic thing: Now is the right time to start these conversations.

Michael Selden, co-founder and CEO of lab-grown fish manufacturer Finless Foods, said that if the industry wants to change consumer behavior, they need to start by working with consumers and getting them to understand the products from the beginning.

"We are not a scooter rental company," Selden said. "We cannot just throw our food on the market and assume that people will trust us. Food is considerably more personal than that. We need to first show people what we are working on and how safe it is in order to gain their trust due to evidence, and get them to believe in what we are making as much as we do."

Credit: Memphis Meats

Many of the companies that are working to develop lab-grown meat welcomed the FDA's involvement in regulating the segment. Isha Datar, executive director of nonprofit cell-cultured food advocacy and fundraising arm New Harvest, said that no matter what the FDA does, it should leave the door open wide enough for future innovations that perhaps nobody has thought about — akin to turning milk into yogurt and cheese.

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"We have to remember that this technology is a toolbox, not an outcome," Datar said. "And in creating a new toolbox for producing foods, we can open up a whole suite of products that we can't fathom today."

Datar said that given the FDA's expertise in regulating other non-food items that are lab-cultivated from cells — like medicines or ingredients like algal oils — the agency is the right place for lab-grown meat to be regulated.

Eric Schulze, vice president of product and regulation for Memphis Meats, described his company's process to create meat products. They take a sample of the cells they want to grow, place the cells in an aseptic environment and encourage growth by feeding them a serum to provide water, amino acids, vitamins, sugars, lipids, trace minerals and specific naturally-occurring protein. Additionally, temperature, pH and oxygen levels are adjusted in the aseptic cultivator used to grow the cells.

Once the cells have grown enough, they are removed from the cultivator, rinsed well and packaged like any other kind of meat.

Schulze said that the FDA's current regulatory framework works well with the process. Instead of looking at everything new as a potential hazard, it looks at the characteristics of the finished product and the safety of its intended uses.

"We believe that this approach provides a high level of premarket oversight, is consistent with longstanding precedent and is appropriate for assessing the safety and quality of cell-based meat," Shulze said.

Several manufacturers and lab-grown meat promotional groups call the end result of this process "clean meat," a term coined by the Good Food Institute. Peter Licari, chief technology officer of JUST — the company formerly known as Hampton Creek — said that the term is apt. Meat grown in a lab, he said, is inherently safer than its counterpart coming from animals. The aseptic environment in which the cells are grown is free from many contaminants, especially those in a slaughterhouse.

"We believe clean meat will be similar to meat we consume today in all important aspects — except that it is produced in an aseptic environment, thus we believe the risk of contamination can be and will be significantly reduced," Licari said. "To effectively culture animal cells, the manufacturer has to invest in a high degree of cleanliness and sterility to assure the culture is not contaminated. This level of control also provides an assurance of the quality of the meat produced. A clean meat facility will be similar to what the FDA sees every day in both biologic and food processing plants. It will not look like a slaughterhouse, but much more like, for example, a clean fermentation-based food processing plant."

Selden of Finless Foods said that his company is also creating a safer version of fish. High levels of mercury in several fish species make them a risky food choice for some consumers. Plastic waste in the ocean also may be making ocean-caught fish less healthy to eat. FDA regulation is an important step in firming up public trust in the products they are producing, Selden said.

"At the end of the day, if we want to change the food supply, we do need the confidence and the trust of the people who will be doing the eating," he said. "We believe that working with [the] FDA is the best way to engender that trust and confidence."

Credit: Hampton Creek

Not everyone was supportive of the FDA's oversight — or of the possibility of bringing lab-grown meat to market, for that matter.

Consumers Union Senior Scientist Michael Hansen said that FDA's current regulatory scheme has far too many voluntary — not mandatory — guidelines. But the biggest loophole, Hansen said, is the way that ingredients can receive "generally recognized as safe" status. As long as scientists can provide proof that an ingredient is safe, he said, it can receive this status — even without the FDA giving the research a second look to ensure that it holds up. An article in April stoked Hansen's fears that lab-grown meat may try to make it to market through the GRAS system, potentially without additional scrutiny.

"Cultured meat products should be required to go through a premarket safety assessment, and the GRAS process is clearly inadequate to assure safety," Hansen said.

And while some manufacturers may want to call these products "clean meat," a telephone survey of more than 1,000 people done by the Consumers Union that Hansen shared on Thursday shows that some consumers disagree. Almost half of consumers — 49% — are fine with calling these products "meat" as long as there is an explanation of how it was produced. Four in 10, however, said it should be labeled as something else.

Consumer respondents were split on label terminology. The most popular was “lab-grown meat,” favored by 35% of consumers, with “artificial or synthetic meat” close behind at 34%. Only 9% liked the term “clean meat."

Maggie Nutter from the U.S. Cattlemen's Association argued that lab-grown products shouldn't be called "meat" at all. That term, she said, should be reserved for protein food items harvested from animal flesh — especially since producers of meats like beef pay in to a checkoff program for promotion.

"They are hijacking our branding for [the] benefit of their own marketing," she said. "We don’t want anything that isn’t beef or meat to be labeled as such."

Several speakers pointed out that because lab-grown meat is such a new science, there haven't been samples made available to determine whether the products are equivalent to traditional meat in function, composition and nutritional value. Those are likely to be coming, which could alleviate a concern voiced by many at the public hearing.

Although there were representatives from many companies, groups and research institutes invited to the hearing, one representative was absent. Nobody from the U.S. Department of Agriculture, which regulates conventional meat, attended as a presenter. Tiffany Lee, director of regulatory and scientific affairs for the North American Meat Institute, said she found the absence disappointing. While her organization supports innovation and new ways to bring the nutrition of meat to consumers, she said the USDA has jurisdiction over ensuring meat is safe and wholesome, and that the lab-grown products should be labeled in a way that presents a level playing field in the marketplace.

"The elephant in the room is that companies producing cell-cultured products want to market those products as meat," she said. "...If these companies wish their products to be marketed as meat ... then production of those items should be regulated by the agency Congress chose when it enacted the Federal Meat Inspection Act. That agency is USDA."