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The Spoon

Daily news and analysis about the food tech revolution

FDA

RFK Jr. Deals Blow to Future Food Startups With Push to Have FDA Drop Self-Affirmed GRAS Provision

U.S. Secretary of Health and Human Services Robert F. Kennedy Jr. has directed the Food and Drug Administration (FDA) to eliminate the “self-affirmed” Generally Recognized as Safe (GRAS) provision, aiming to enhance transparency and oversight in the approval of food ingredients.

Under the current GRAS rule, companies can independently determine the safety of new food ingredients without mandatory FDA notification or public disclosure. This self-affirmation process has been criticized for allowing substances with potentially unknown safety data to enter the U.S. food supply without adequate oversight.

Kennedy’s initiative seeks to close this loophole by requiring companies to publicly notify the FDA and submit safety data for new ingredients. He stated that eliminating this pathway would ensure that ingredients introduced into foods are safe, thereby enhancing consumer confidence and contributing to public health. ​

Eliminating the “self-affirmed” GRAS rule could pose significant challenges for fermentation-based and future food startups, potentially delaying innovation and increasing financial burdens. Emerging companies, especially those developing novel proteins through precision fermentation and cell cultivation, typically rely on the current GRAS framework to streamline the regulatory process and bring new products quickly to market. Without this pathway, startups may face lengthy FDA review periods and higher costs associated with extensive safety testing and regulatory compliance.

It also might just result in massive delays in food product introduction for brands big and small. Like many of the departments within government currently being gutted by Trump and Elon’s DOGE purges, the FDA has seen drastic cutbacks in the number of employees, which as a result makes the higher level of oversight required by the elimination of the GRAS provision pretty untenable. Some commenters, like former FDA head of food (and recent Food Truths guest) Susan Mayne, see the the push towards greater food oversight and less overall manpower as challenging to reconcile.

Trump, RFK Jr., and the FDA Overhaul: A Food Truths Deep Dive with Helena Bottemiller Evich

In a recent episode of the Food Truths podcast, host Eric Schulze sat down with Helena Bottemiller Evich, longtime food policy and food system journalist, to discuss the changes taking place at the FDA under the new administration and the just-appointed head of Health and Human Services, Robert F. Kennedy Jr. Evich, the founder and editor-in-chief of Food Fix, has spent over 15 years tracking the intricacies of food regulation, giving her unique insight to decipher the early signals that come from the agency responsible for overseeing 80% of the U.S. food supply.

According to Evich, the FDA (which is under the department of HHS) is undergoing one of the most significant shakeups in its history, marked by mass layoffs, regulatory uncertainty, and a leadership philosophy that prioritizes aggressive restructuring over continuity. Evich says the administration has adopted an approach akin to “creative destruction,” implementing indiscriminate firings and buyouts that have disproportionately affected the agency’s food regulatory functions.

“If there is a strategy to how they are firing people at FDA, and what the like long-term plan is, I have not seen it,” said Evich.

Mixed Signals for MAHA

One of the casualties of these cuts that concerns Evich the most is within the FDA’s Post-Market Assessment Office, which was responsible for reviewing food chemicals already on the market. Many of the employees in this department were newer hires, making them particularly vulnerable to mass layoffs. This move, she argued, could significantly slow down efforts to strengthen oversight of food additives—a key issue that has been gaining bipartisan attention.

While the indiscriminate firings, such as those in the office that review food chemicals additives, may align with the shock and awe approach being deployed across government agencies by the Trump administration, it also runs at cross purposes with one of the key Make America Healthy Again (MAHA) policy goals of RFK Jr., which has oversight of the FDA, CDC, and NIH in his new role.

While contradictory and self-defeating political maneuvers are nothing new to Trump’s chaotic style of governance, Evich thinks Trump is likely to back RFK Jr. to enforce some of these efforts despite the cutbacks. Kennedy’s push to reduce chemical additives and support for other traditionally more progressive concerns led to Trump adopting some of these issues, which Evich believes helped him at the ballot box.

“I think even President Trump’s most ardent critics would acknowledge that one thing he’s really good at is detecting where there’s energy,” said Evich. “And MAHA has shown itself to be like an animating force. And there are some people who think that the RFK endorsement of Trump and the adoption of MAHA as part of the Trump platform helped get Trump over the finish line in November.”

Impact on the Future of Food Landscape

Schulze and Evich also discussed how the administration’s priorities might affect food innovation, particularly in areas like cultivated meat and precision fermentation. Given the administration’s apparent preference for a “back-to-nature” approach to food, Evich expressed skepticism about whether emerging food technologies would receive strong support.

“There seems to be a real strain of naturalism in this administration,” she said. “If you’re championing raw milk and calling for the removal of synthetic food additives, it’s hard to see how that aligns with embracing new food technologies.”

She also noted that Florida Governor Ron DeSantis’s recent ban on cultivated meat could indicate how other conservative-led states might approach food innovation under this administration.

The Road Ahead for the FDA

Looking forward, Evich emphasized that much remains uncertain. The confirmation of Dr. Marty Makary as FDA Commissioner will be a key development to watch, as he has expressed concerns about antibiotic resistance, the microbiome, and ultra-processed foods. Meanwhile, the newly formed MAHA Commission, tasked with examining the drivers of chronic disease, could shape the administration’s long-term food policy.

“I’m going to be watching really closely for what Marty Makary says in his confirmation hearing,” said Evich. “He’s the FDA commissioner pick, and he has said a lot about food—easily, he has more of a food record than any modern FDA commissioner. He has lots of food mentions in his book. He’s really concerned about antibiotic resistance, the microbiome, ultra-processed foods, and food allergies. Watching Marty Makary, what he says, and watching this MAHA commission—who’s on it, what they’re looking at—is key. This is supposed to be in the first 100 days, and I believe they have to issue recommendations within 180 days.”​

“The big question,” Evich said, “is whether this administration will actually implement stronger food regulations or whether this will just be rhetoric that ultimately leads to little action.”

It was a really good conversation with lots of insights about potential directions for the future of the FDA and other key departments overseeing food and health, so take a listen! You can subscribe to the Food Truths podcast on Apple Podcasts, Spotify, or wherever you get your podcasts.

What The Heck is RFK Jr. Doing at the FDA?

Washington State University Receives First-Ever FDA Approval for Gene-Edited Pigs for Human Consumption

Earlier this month, Washington State University (WSU) received the first-ever approval from the U.S. Food and Drug Administration for gene-edited pigs for human consumption.

That consumption will be delivered in the form of German-style sausage, which will be used in on-campus catering services that raise funds for the WSU meat judging team. The pigs were processed at the WSU Meat Lab – WSU is a land-grant university, and much of the research on campus is focused on agriculture and nature sciences – and during the processing of the meat, the U.S. Department of Agriculture inspected the meat.

The approval marks the first time the U.S. FDA has approved a gene-edited pig for entry into the food supply chain. The approval is the culmination of two years of research led by Jon Oatley, a professor in WSU’s School of Molecular Biosciences in WSU’s College of Veterinary Medicine.

“The original intent in making these animals was to try to improve the way that we feed people,” he said. “And we can’t do that unless we can work with the FDA system to get these animals actually into the food chain.”

Oatley used CRISPR gene-editing technology to improve genetic traits in the livestock. As readers of the Spoon know, CRISPR accelerates the process through which changes to an organism’s DNA can occur as compared to other methods such as through selective breeding. And unlike transgenics (or what is often called GMO or genetic modification), CRISPR doesn’t introduce genetic materials from other organisms.

Oatley and his team gene-edited the pigs to enable them to sire offspring with traits from another male pig. This technique, called surrogate sires, allows the male animals to produce sperm carrying the genetic traits of donor animals. The surrogate sires are first edited to be sterile by knocking out their specific gene related to male fertility. From there, the animals are implanted with another male pig’s stem cells to create sperm with the desired traits of the donor male.

The long-term goal for Oatley and other CRISPR researchers is to use this high-tech form of selective breeding to disseminate valuable genetic traits in livestock. Those traits could be improved meat quality, higher protein density, disease resistance, or enhanced ability to withstand changing environmental conditions.

Oatley and his team used the investigational food use authorization process for five gene-edited pigs to demonstrate that food made from the gene-edited animals is safe to eat and is now working toward FDA approval for a line of gene-edited pigs. The pigs’ offspring, which aren’t gene-edited, have not yet received FDA approval at this point for human consumption.

Former US Defense Official: Cell-Cultured Meat & Other Future Food Technology is Critical For US National Security

Last week, the future food industry was abuzz with the news that China had put cell-cultured meat and other future food technologies in its five-year plan.

According to Matt Spence, the former Deputy Assistant Secretary of Defense for Middle East Policy under the Obama administration, this type of move shouldn’t be all that surprising given how critical many leaders in emerging economies view food innovation to their national security.

“What what used to keep me up at night when I was at the Defense Department running Middle East policy was what type of attack is ISIS is going to launch?” said Spence last month, speaking on a panel (moderated by yours truly) at the Consumer Electronics Show. “How to plan for war with Iran? How are we thinking about going after Osama bin Laden?”

According to Spence, who is now managing director for investment and advisory firm Guggenheim Partners, what worried leaders around the region was very different.

“When I talked to leaders in the region, what kept them up at night was ‘do I have enough food and water to feed my population?’. They are realizing they have a way of producing meat that people want more of as they get wealthier, and others are appetites and demand for luxury change. And the equation doesn’t add up unless we do something new.”

While Spence himself may have come away from these conversations with a greater conviction that food technology is an essential part of a national security framework, the US still has no comprehensive plan around building a food future nearly seven years after he left the State Department. That’s not to say some parts of the US government responsible for food regulation and policy haven’t been slowly progressing on regulatory frameworks for some future food. Still, like with many things driven by US agencies, it’s all relatively piecemeal, and there’s no real cohesive strategy to it.

Maybe that will change. There are signs, after all, that the US government sees this as important, such as the recent grant given to Tufts to create an alt-protein center of excellence. But again, these are small gestures compared to the all-in approach we’ve seen from China, Israel, Taiwan, and other countries.

But who knows? As the Biden administration takes another swing at a slimmed-down Build Back Better bill in 2022 and works on other spending priorities in the second half of his term, let’s hope he and others in his administration begin to work on developing a more comprehensive, forward-looking plan to build a more sustainable food future. I’ve even written down a few ideas he could use to get started.

According to Spence, the timing is good for cell-cultivated meat and other future food technologies to begin making a difference.

“There’s a technology and a change we can make every day by what we eat, and I’m hard-pressed to find other areas of national security that there is that type of ready solution available.”

Just click play below if you want to watch the Future of Meat panel from CES 2022 to hear Matt Spence and others.

The USDA Is Seeking Comments About What to Call and How to Label Cell-Based Meat

It looks like the US government is getting serious about putting cell-based meat on consumer plates.

That’s because on Thursday, the USDA’s Food Safety and Inspection Service (FSIS) announced it had opened a 60 day period in which it will solicit comments to questions put forth in an advance notice of proposed rulemaking (ANPR).

Some of the topics/questions the FSIS is looking for feedback on include (italicized text excerpted from the notice):

Product name: “Should the product name of a meat or poultry product comprised of or containing cultured animal cells differentiate the product from slaughtered meat or poultry by informing consumers the product was made using animal cell culture technology? If yes, what criteria should the agency consider or use to differentiate the products? If no, why not?

Terminology: What term(s), if any, should be in the product name of a food comprised of or containing cultured animal cells to convey the nature or source of the food to consumers? (e.g., “cell cultured” or “cell cultivated.”)

What do about hybrid farmed/cell-based: If a meat or poultry product were comprised of both slaughtered meat or poultry and cultured animal cells, what unique labeling requirements, if any, should be required for such products?

Can cell-based meat use meat terminology to describe products? Should terms that specify the form of meat or poultry products (such as “fillet”, “patty”, or “steak”) be allowed to be included in or to accompany the name or standard of identity of foods comprised of or containing cultured animal cells?

I expect this process to be somewhat contentious. The powerful lobbying group, the National Cattlemen’s Beef Association (NCBA), has shown it’s not a fan of cell-based meat production and will certainly have some thoughts to share during this process. Opponents can be expected to claim that applying terms and product names familiar to consumers from their consumption of traditionally farmed meat to cultured meat will be misleading.

This most recent move by the USDA is part of a process kickstarted way back in 2018 when the USDA and the FDA announced they were beginning to develop regulatory frameworks for the cell-based meat industry.

The division of oversight described in the initial announcement is referenced in yesterday’s announcement:

Under the agreement, FDA will oversee cell collection, growth, and differentiation of cells. FDA will transfer oversight at the cell harvest stage to FSIS. FSIS will then oversee the cell harvest, processing, packaging, and labeling of products.

Since those early days in 2018, cell-based meat has moved off the bench and into pilot production across the globe. Countries like Singapore have outpaced the US in opening regulatory glide paths for making cell-based meat available to consumers. Hopefully this news is a sign that the day when we can buy cell-based meat in the US will be here soon.

FDA Approves Perfect Day’s Animal-Free Whey Protein as Safe to Eat

Perfect Day, the startup using fermentation to create animal-free dairy proteins, has officially received approval for its proprietary whey protein from the Food and Drug Administration (FDA). In a letter, the FDA writes that it has “no questions” that β-lactoglobulin — Perfect Day’s proprietary protein for its flora-based products — is Generally Recognized As Safe (GRAS).

Perfect Day submitted the notice to approve β-lactoglobulin to the FDA on May 20, 2019, so it’s taken roughly 10 months for the FDA to officially approve it. The protein is created by fermenting a genetically modified strain of the yeast Trichoderma reesei. Said yeast is submerged in media, where it ferments and excretes the β-lactoglobulin protein. The whole solution is then put through a centrifuge to separate out the protein, which is then filtered and dried to create a raw product. Add fat and water, and you’ve got something that’s essentially animal-free milk — and can be used to make ice cream, cheese, and basically anything that contains dairy.

In the FDA letter, Perfect Day plants an important stake in the ground. The company “concludes that the protein characterization data shows that the sequence of β-lactoglobulin produced by fermentation is identical to commercially available bovine-produced β-lactoglobulin.”

In short, Perfect Day claims that its flora-based milk is essentially the same thing as the milk from a cow you’d buy in the store. The FDA backs that up — at least to some extent — when states in the letter that β-lactoglobulin needs the same allergy labeling as milk. It is, at least for those with dairy allergies, the same thing.

The FDA hasn’t approved Perfect Day to sell its protein willy-nilly. The letter explicitly states that the β-lactoglobulin protein is “not intended for use in infant formula or in products subject to regulation by the United States Department of Agriculture.” But Perfect Day is free to sell its flora-based dairy protein to larger CPG companies to make animal-free products, as it had planned to do all along.

According to Ryan Pandya, Perfect Day’s CEO, this GRAS certification hasn’t affected their go-to-market timeline one way or another. He wrote to me that “we were expecting to secure the certification,” and had essentially been preceding under the assumption that it would be granted. Since the FDA has already approved fermented ingredients to replace animal products in the past — like Impossible Food’s blood-like heme — it’s not a reach that Perfect Day’s dairy proteins are considered GRAS.

Waiting for the GRAS letter may not have been holding up Perfect Day’s plans, but COVID-19 could still wreak havoc on their timeline. Pandya didn’t reveal any specifics about the pandemic’s effects, only noting that they are “adjusting our plans as needed.”

Perfect Day released its first product — animal-free ice cream — last year and plans to announce its first commercial partnerships in early 2020 (as in, any day now).

When it Comes to Identifying the Source of Foodborne Illness, The Future is Now

Foodborne illnesses are not only an unpleasant personal experience for millions of Americans each year, they’re a logistical concern for businesses, with the potential to drive and keep people (and their dollars) away for good. As our food supply becomes increasingly global, the ability to accurately and quickly identify the source of any pathogen causing a foodborne illness has become exponentially more difficult. To ensure the safety of what we eat, the Food and Drug Administration (FDA) plans to build upon its early success with digital technology and whole-genome sequencing for its New Era of Smarter Food Safety.

Whole-genome sequencing

At its simplest, a genome is the information a cell needs to create an organism. Since an organism’s genome is as unique as a fingerprint, sequencing that genome is the first step in being able to quickly identify just what is making a person sick. Scientists generate the sequence by gathering samples of a particular food in a sterile environment, mashing it up, and conducting the genome analysis. The result is the fingerprint for that specific entity.

The problem is, having this information on hand at the local level is useful only under very limited circumstances. For instance, it would be enough if a group of people became ill after eating a single meal with food sourced locally, in a single sitting at a single event. With a few calls, it might be possible to identify the food causing the illness and take steps to keep it from being shipped to new locations.

More common is the case in which a number of people with nothing in common at first become ill within days of one another. Making a match between the pathogen causing the illness and the pathogen in each food involved is still fairly straightforward – if everything is sourced locally. But what if some of the food comes from sources across the globe? How are the fingerprints for those foods going to be of use in stopping the spread of the illness to additional locations when there is no way to readily communicate with other localities?

GenomeTrakr

So, to bring whole-genome information into play on a global scale, the FDA created a United States-based open-source distributed network of labs in 2013. The result is GenomeTrakr – the stuff of foodie-sci-fi. It makes whole-genome sequences from foods around the world available globally. Any health agency, anywhere on the network, can upload data from a pathogen causing illness in their locality and receive information about entities that match or closely approximate that sequence. In effect, the power of the digital fingerprinting and related DNA sampling now in use in law enforcement  can be put to work for foodborne illness outbreaks by either making a match or reporting that the match is likely to be found within a certain cluster of “related” genome sequences. This game-changing use of whole-genome sequencing has already helped to halt the spread of global foodborne pathogens several times.

A digital framework

But global genome sequencing is still not all that is needed to safeguard the food supply – and your health. Being able to readily access a whole-genome sequence  can tell you which food is the culprit, but how do you know where the food originated, what path it took from field to plate, and where any additional product is currently located on its journey from field to plate?

The FDA’s remedy to this part of the challenge is to digitize the records kept at each step of a food’s journey through the global system. Rather than filling out a paper form that remains local or creating a paper-based dossier that travels with a food shipment, each step along the way will be documented in a globally accessible, digital format. The result will be a system that complements the GenomeTrakr by making it possible to trace the source of a foodborne pathogen to its point of origin in minutes rather than weeks or months.

Why does it matter? It matters because ready access to the genome, the origin, and the trail it traveled will make it possible to stop the flow of this food through the system: It will keep additional people from becoming ill.

A blueprint

As the first step in the FDA’s Strategic Blueprint for this New Era of Smarter Food Safety, agencies and companies from all parts of the food sector met in October to discuss the logistics of the new approach and offer input.  Considerations ranging from ownership of the data to concerns about data transfer were among the many raised. These issues are not not only vital to the integrity of the data in the system, but will also result in a system we can count on when we sit down to eat.

 

FDA Makes First Step Towards Regulating CBD-Infused Food and Drink

You just got one step closer to being able to legally purchase CBD-infused chocolates, sugar, beer and more.

Today the Food & Drug Administration (FDA) released a statement announcing a new action plan to jumpstart regulations for “the lawful marketing of appropriate cannabis and cannabis-derived products.” Basically, the FDA is taking initial steps towards regulating foods and drinks infused with CBD, the non-hallucinogenic compound in cannabis.

According to the statement, the FDA will create an internal agency to explore pathways to legalization for CBD as a dietary supplement or food ingredient. It will also host a public hearing on the topic on May 31.

This is kind of a big deal. In December of 2018, Congress passed the Farm Bill, which removed hemp-derived CBD from the Controlled Substances Act and made it legal for sale. However, since the FDA hasn’t yet approved CBD as food safe, it’s technically still illegal to sell food or drink products containing the substance.

Companies were selling CBD-infused edibles anyway, with little to no consequences. That is, until New York City, Maine, and Ohio cracked down on purveyors earlier this year. For a while it seemed like the FDA was going to really hard-line CBD regulation.

But with this new agenda, the FDA seems to be taking a step back and genuinely seeking a clear pathway to create a regulatory framework for CBD-infused foods. The forthcoming hearing is an important first step. It will not only legitimize CBD as a food ingredient, not a drug. It will also get the ball rolling and start the process for legally regulating CBD as a food and drink additive.

However, the agency also took pains to point out they will not tolerate the sale of CBD as a health product. The statement noted that the FDA has issued “multiple warning letters” to companies marketing CBD products “with egregious and unfounded claims that are aimed at vulnerable populations.” Those include claims that cannabidiol could cure cancer or reverse Alzheimer’s. This strict stance could make things tricky for product developers, as CBD has become something of a darling for the wellness community, who treats it as the next miracle natural ingredient, like turmeric or charcoal. Clearly edibles companies are going to have to be very cautious about what they claim their products can do.

FDA Commissioner Scott Gottlieb is stepping down this month, so it makes sense he’s trying to get a regulatory framework for CBD in place before he leaves. Of course, regulatory processes have a lot of red tape and move notoriously slowly, so it’ll probably be a while before CBD actually gets the FDA stamp of approval.

But with this new agenda, the FDA is at least taking the first step towards catching up with public opinion when it comes to CBD. If they do eventually approve CBD as a food-safe ingredient — and I don’t see why they wouldn’t — we’ll likely see Big Food companies like Starbucks and Coca-Cola rolling out CBD-infused products of their own. In fact, they’re probably already working on them.

One final note: It’s sort of ironic that we’ve had several public hearings on cultured meat — a relatively new technology that’s not even to market yet — before we had one on CBD, a substance that’s relatively widely available and has a market that’s projected to hit $22 billion by 2022. Maybe it’s because CBD is still stigmatized as a “drug.” Regardless, once it gets FDA approval the CBD market will explode. And now that “when” is looking sooner than ever.

FDA Chief Scott “An Almond Doesn’t Lactate” Gottlieb Resigns

Scott Gottlieb, the Commissioner of the Food and Drug Administration, and better known around The Spoon as the guy who brought the debate over what to label “meat” and “milk” to national attention, announced his resignation from THE FDA today. It will go into effect next month.

In the age of Trump, it’s easy to assume an ulterior motive for any sudden prominent agency head departure. But according to The Washington Post, Gottlieb wanted to spend more time with his family in Connecticut, and the White House did not ask for his resignation.

Whatever the reason, we’ve spilled our fair share of ink covering Mr. Gottlieb’s tenure at the FDA, as he thrust the agency into the debate over which government body should oversee the regulation of emerging lab-grown or “cultured” meat products and what they should be called. He even held a public meeting on the topic to take comment as it developed those new regulations. Meat lobbying groups were insistent that only products derived from animals that were born, raised and slaughtered could be labeled as meat.

Given that cultured meat is still a ways off, Gottleib’s prominent work in the space was more of an attempt to get ahead of an issue before it literally hit the market, and to a certain extent, he succeeded. The FDA and USDA later agreed to a framework that divvied up regulatory responsibilities for the forthcoming cultured meat, and he did bring the labeling debate to national attention.

But Gottlieb probably got a little more attention than he wanted when he extended the labeling debate over to “milk.” At a Politico Summit last summer, Gottlieb said the FDA would start more strictly enforcing existing rules around what could be marketed as milk, a move that could spell trouble for the booming plant-based milk industry. FDA guidelines say that milk comes from a lactating animal, which made Gottlieb quip “An almond doesn’t lactate.” This joke caught the ear of Stephen Colbert, who mocked Gottlieb, saying ““If it ain’t from a mammal, you can’t call it milk; it has to be ‘soy juice’ and ‘almond sweat.”

USDA and FDA Will Tag Team Regulation of Cell-Based Meat

Last Friday, we got one step closer to figuring out the regulatory future of cell-based meat.

The U.S. Department of Agriculture (USDA) released a statement stating that they would work together with the Food and Drug Administration (FDA) to oversee production of what they called “cell-cultured food products derived from livestock and poultry.” The statement comes almost a month after the two organizations led a joint meeting to focus on regulation and labeling of the new technology.

We knew from the get-go that the two organizations would work together on the regulation of this new technology, so that part isn’t exactly news. But the statement also outlines exactly which roles each organization will take on. From the USDA (bolding our own):

Agencies are today announcing agreement on a joint regulatory framework wherein FDA oversees cell collection, cell banks, and cell growth and differentiation. A transition from FDA to USDA oversight will occur during the cell harvest stage. USDA will then oversee the production and labeling of food products derived from the cells of livestock and poultry. 

So the FDA will oversee everything from gathering the tissue to cultivating it (growing it into enough muscle fibers to eat). Once the meat is complete, the USDA will take over and oversee the process of labeling. This division “leverage[s] both the FDA’s experience regulating cell-culture technology and living biosystems and the USDA’s expertise in regulating livestock and poultry products for human consumption.”

True enough, the USDA typically oversees meat at the point of slaughter. Since there’s no slaughter when meat is cultured outside the animal, it makes sense that the closest equivalent would be the point of “harvest” in which the cells are done reproducing and ready to be processed and eaten.

Dr. Mark Post with the world’s first burger made of cells grown in a lab.

Sentiment seems to be positive about the new division of power. Initially, cell-based meat companies advocated for the FDA to be the primary regulatory body involved, but they seem to be okay with this arrangement. Jessica Almy, the Director of Policy of the Good Food Institute, a non-profit which supports meat and dairy alternatives, issued a statement writing that “This announcement is an exciting indication that FDA and USDA are clearing the way for a transparent and predictable regulatory path forward.”

Big Beef is also pleased(ish) with the division. In a statement emailed to Food Dive, The National Cattlemen’s Beef Association wrote: “This announcement that USDA would have primary jurisdiction over the most important facets of lab-produced fake meat is a step in the right direction.”

In the end, it seems that the USDA will have the trickier job of the two. Labeling is one of the most contentious issues surrounding cell-based meat: In the last few years alone, it has been called in-vitro, lab-grown, cultured, clean, and, most recently, cell-based meat. Traditional meat companies are pushing back on calling it meat at all (see “fake meat” reference above). The fact that USDA has the power in the labeling department could mean an uphill battle for cell-based companies who want to use the term “meat”.

But the USDA’s timeline to deciding on a name for the stuff is ticking down. JUST, Inc. is still planning to bring a cell-based poultry product to market by the end of 2018, provided it gains regulatory approval. With just over a month remaining, it seems ambitious that they will indeed be able to get the regulatory thumbs-up to meet their goal.

Progress may be slow, but all involved — traditional and cell-based meat companies — seem pleased that the government is taking steps to address this new technology. However, there’s still a lot to work out. It remains to be seen what information the two organizations will share, how and to what extent they’ll collaborate, and, of course, what we’re going to call the stuff.

The public comment period of last month’s meeting has been extended will be open until December 26th. Speak now, or forever hold your peace (of steak).

Allergy Fears and Transparency Among Issues at latest USDA/FDA Meat-ing

Earlier this week, scientists, entrepreneurs, and concerned members of the public got together to discuss the future of cell-based (also called “cultured” and “lab-grown”) meat during a joint meeting put on by the U.S. Department of Agriculture (USDA) and the U.S. Food and Drug Administration (FDA). According to the FDA news release, the meeting was intended to “focus on the potential hazards, oversight considerations, and labeling of cell cultured food products derived from livestock and poultry.”

The FDA held the first meeting on cultured meat back in July, and while it succeeded in starting the conversation around regulation of meat grown outside an animal, not much was concluded. From the people I spoke to who attended the meeting, everyone agreed that something had to be done to regulate this new edible technology, but no one could agree exactly what — or even what to call it.

Watching recordings from the meeting and scanning through Twitter, one topic seemed to be the most divisive, contentious, and downright critical: labeling. It’s where I think that the real stakes (steaks?) are: nomenclature will be a determining factor in consumer perception of this new technology. Here are a few interesting points that came up during the meeting:

Labeling is actually a health concern

“We cell-based food producers do need to use the terms ‘fish’ and ‘meat’,” said Michael Selden, the CEO of cultured seafood company Finless Foods. “If one is allergic to animal-based seafood, that person has a high probability that they’ll be allergic to the seafood made with our technology.”

His company is working to create fish meat that is identical, on a cellular level, to traditional fish. If they succeed, labeling cultured salmon something like “cell-based artificial salmon product,” consumers with a life-threatening allergy to salmon might not realize that it posed just as big a threat.

Given, not all that many consumers are allergic to meat and seafood. But it’s still an important point: cultured meat is meat on a molecular level.

Photo: Flickr, by Adactio

Should labeling address how the product is made?

“It’s clear that consumers care about the way that their food is produced,” said Liz Holt of the Animal Legal Defense Fund. If cultured meat is required to disclose all the substances that went into it, should traditional meat be held to the same standards?

As of now, meat companies can choose whether or not to display information about the animal’s life and diet, such as “grass-fed” or “free-range.” They don’t have to disclose what the animal ate, or where it was raised.

Some consumers might not want to know exactly what type of life the cow in their bargain ground beef had before making its way onto their plate. Specht’s point shows that more information is generally good — but sometimes the consumer doesn’t want or need it.

Cell-based meat wants its own labels

Both sides of the table agreed on one thing: cultured meat should be labeled differently than traditional meat. Cultured meat startups want to indicate to the consumer that their product is meat, but is also different than meat from a slaughtered animal.

Peter Licari, CTO of JUST, said that there should be a regulatory nomenclature that “sufficiently differentiates cell-cultured products from traditional meat products but appropriately acknowledges these products as meat.”

What exactly that elusive final term will be — one that effectively communicates both that the product is meat, but not meat from a slaughtered animal — isn’t clear. But companies and regulatory bodies need to figure it out pretty quickly. JUST is still planning to be the first company to bring cultured meat to market by the end of this year, and Finless Foods will launch its cell-based tuna in 2019. By 2021 Mosa Meats and Memphis Meats will join them.

Isha Datar of New Harvest said it best, speaking at the meeting: “This is not just a product, but a new paradigm for food production.” Now the FDA and USDA need to figure out what to call it.

The FDA Wants Your Opinion on What Should be Called “Milk”

Have you ever gone to the grocery, bought a carton of milk only to get home and find that you grabbed soy milk instead of the more traditional cow’s milk? The Food and Drug Administration (FDA) wants to know!

FDA Commissioner Scott Gottlieb posted a statement on his organization’s website today saying that his agency is seeking public comments on the ongoing debate over what can and can’t be labeled as “milk.” In explaining the rationale for this discussion about labeling, Gottlieb writes:

The rising demand for plant-based products, like soy-based alternatives to cheese and nut-based alternatives to milk, has created a growing number of new food choices in supermarket aisles. However, these products are not foods that have been standardized under names like “milk” and “cheese.” The FDA has concerns that the labeling of some plant-based products may lead consumers to believe that those products have the same key nutritional attributes as dairy products, even though these products can vary widely in their nutritional content. It is important that we better understand consumers’ expectations of these plant-based products compared to dairy products.

Earlier this year, Gottlieb indicated that his agency would begin to enforce the existing regulation around what can be marketed as milk. Gottlieb made headlines when he noted that the current standard for defining milk is that it comes from a lactating animal before going on to say “almonds don’t lactate” (a comment soundly mocked by Stephen Colbert).

While you may not have your own late night talk show, you can make your voice heard on the topic. As Gottlieb goes on to explain, the FDA is reaching out to the public for comment on the topic:

We’re on a fast track to take a fresh look at the labeling of products that are being positioned in the marketplace as substitutes for dairy products. And, today, we’ve taken the first step in this process by issuing a request for information (RFI) in the Federal Register to solicit comments and feedback from the public to gain more insight into how consumers use plant-based alternatives and how they understand terms like “milk” or “cheese” when used to label products made, for example, from soy, peas or nuts. We’re interested to know if consumers are aware of, and understand, the nutritional characteristics and differences among these products — and between these products and dairy — when they make dietary choices for themselves and their families.

While it’s being framed as a discussion around consumer information and protection, the whole debate smacks more of protecting existing industries. Sales of plant-based milks are up while cow milk sales have dropped. Dairy and other agricultural associations have lobbied Gottlieb to enforce the existing regulation. Forcing plant-based “milks” to instead refer to themselves as “beverages” on all their branding could have a negative impact on sales.

Milk isn’t the only product label looking at being disrupted. There is a whole other debate raging about what can and can’t be called “meat” as cell-based meat and other plant-based meat alternatives come to market. The lines there are similarly drawn, with traditional ranchers and cattelmen lobbying to keep the status quo.

And just so there’s no confusion on this, if you have thoughts on the topic of “milk,” you can visit the Federal Register tomorrow, Sept. 28, and leave a comment.