Latest / FoodTech Stories / The Changing Regulatory Environment for FoodTech Foods
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- Megan Thomas: Welcome to Food Tech Stories. I'm your host, Megan Thomas, a marketing and communications expert who is focused on how emerging technology is adopted in food and agriculture. On each episode, we talk with leaders, innovators, and storytellers who are shaping the future of our food and food system. If you value our content, please consider subscribing. After the recording of this episode, the FDA announced a proposed rule that would eliminate the self affirmed grass pathway and require FDA notification of grass determinations. Additionally, existing self affirmed grass substances would be subject to a one year transition period, and once the final rule becomes effective, manufacturers would have eighteen months to comply. A public comment period is open until december ninth of this year. My guest today on Food Tech Stories is Greg Jaffe, and Greg is president of Jaffe Policy Consulting. Welcome to Food Tech Stories, Greg. ⁓ well thank you, Megan. I'm glad to be here. Wonderful. Well, let's jump right in. How did you start your career? For my whole adult life, I've always been interested in how new science and technology forces changes in laws and regulations. In college, I double majored in biology and in government. And I was looking for some way to combine them. Way back then I wrote my college thesis in both departments titled Recombinant DNA, The Question of Regulation. And this was even before the federal government had the coordinated framework. For any of your listeners who are familiar with biotech regulation in nineteen eighty-six when they had the coordinated framework. I've always been interested in sort of how does science, technologies, force changes in laws and regulations. And I ended up at law school where I became a environmental lawyer. And I came to DC and I went to work at the Department of Justice as an environmental litigator trying to get polluters to clean up. And I spent seven years at Department of Justice and then I moved to EPA in doing Clean Air Act Enforcement. And on one level I really enjoyed that. It was really fun to walk into a courtroom and say, I'm there representing the United States of America, trying to get polluters to clean up on behalf of the public and for the public good. But I spent also a lot of time fighting with lawyers of about legal procedure. Can you take this deposition? Can I get this document? And that didn't excite me. I still like the science and doing that. And so I looked for ways to to get back to science and science policy and science regulation. I went to work for the Center for Science and Public Interest. They were looking for somebody to run their biotech project. I went there and I spent a couple of decades there working on genetically engineered crops and animals and self cultivated meat and cloned animals and nanotechnology, sort of all the controversial food. And ag tech food technologies, how do you regulate them and how do laws change to address that? And how do you ensure safety? And how do you have consumer trust? And that was really interesting to me. And then my career sort of accumulated when I went to US Department of Agriculture, when Secretary Vilsack, who I have the utmost respect for and liked very much, asked me to come on as the chief regulatory officer for the department. I was in charge of all of the regulations in the department, and I was the person we went to talk to with FDA. And EPA about their regulations that impacted food and ag. And I was also the senior advisor for regulatory affairs, but I also was the lead for things like bioeconomy that got into biotechnology and biomanufacturing and bio-based products. I spent a lot of time there with food innovations, precision fermentation and those type of things. That's sort of been the progression of my career and it's really been about how do we again integrate. these new technologies in food and ag in a way that gets them to the marketplace with consumer acceptance and safety and everything. Well, it's so interesting that the way you framed it as being the double major in government and biology, how that really has been that core narrative throughout your career. The fact that you've worked with NGOs as well as with federal agencies like USDA and EPA, what is different about working in an NGO environment than working with a federal agency? For anybody who's out there and thinking about careers and things like that, I think it's great to work in both NGOs and in the federal government. And I also think it's great to work in the industry. Having experiences in all of those areas makes you a better person for the work that you're doing in your career. And I felt that way for myself. Having those different perspectives helps you do your job better. My working in the government helped me work as an NGO for the roles that I had. I've spent my whole career in Washington, DC in all these situations. A couple of things. One, the excellence in the people I've always worked with. The career civil servants, the people in the NGOs are just top notch. Care about their jobs. They have really good credentials and they really work hard in those jobs. And in this political climate we have people who've worked in the government or work in NGOs get the bum rap or people think they're not working well. I totally disagree with that. Especially when I went in as a political appointee at the end in my last job. where you need to rely on the career civil servants. They were just amazing. And they worked long hours and they went the extra mile. I never found anybody who wasn't more than 120% committed to their job. I love working for the government, getting up in court and saying you represent the United States. You're representing the public interest. You're ensuring that human health is protected. You're ensuring that the environment is protected. You're enforcing the laws that have been set by Congress. And you're doing it with all the resources that the federal government brings to that. And the cachet or the trust that people bring with the federal government. That's so different than the working for an NGO or something like that. So I think that's one of the major differences. When you work with an NGO, you're much narrower. You still have a really important role to play, whether that's determining what the facts are and the science and educating people about it and actually giving them the tools to engage with the government or to engage with the marketplace. They play different roles and I like being in both of those roles. They're not trying to do the same thing. They're trying to in some ways to do different things. Taking different approaches potentially to solving the same challenges. Having worked in DC for 30 plus years in this specific domain, what have you seen change during that time? We haven't seen a lot of change. Surprisingly little change sometimes when you think about it in some of these areas. If I take biotech crops, I mean they're generally regulated under the same premises that they were set up to regulate in nineteen eighty-six. They're obviously more streamlined and there are differences about certain things. For the areas in food and ag, there's not as much difference between Republicans and Democrats, for example. That's more of a bipartisan issue than some other issues. So I think we've always seen people moving forward in those. But obviously where emphasis is placed has changed over time. I mean, when I think about one of the most important things that are affecting the food tech sector of things today, COVID had a major impact on the supply chain and the need for resilient supply chains, especially in the food sector. GLP ones have changed diets of consumers and interest in more protein. And you see how that has changed the discussion. In the area of biotech, we've had the National Security Commission on Emerging Biotechnology and emphasis on what China's doing and how do we be economically competitive and how do we bring more manufacturing back to this country has sort of changed how the lens in the last few years has looked for these things. Climate change, sustainability. Have just grown in importance over these many years. It obviously goes through ebbs and flows, but how does agriculture become more sustainable? How do we do more with less resources? How do we address changes in climate than increase pests and droughts? And how do we produce the food we need to produce? And how do we do it in a more sustainable way? I think of sustainability just like I think of it on the continuum. At the end of the continuum is sustainability, but each day we try to become a little closer to that end point. But I also say each day that endpoint moves a little farther. You never achieve sustainability because sustainability always moves itself also. There are always ways to become more sustainable. It's not an endpoint. That has gotten greater importance in consumers' minds, in the government's minds, in the world's mind. That has really affected policy overall. Whether we call it regenerative, whether we call it organic, whether we call it precision fermentation, or it's all kinds of different technologies, all kinds of different products, all kinds of different things in it. But all of us trying to do the same thing, is trying to produce the food that we need to sustain us in a nutritious way and have less impact on the planet than we did the day before. Agriculture does have negative impacts on the environment. I mean, it always has. And so the question is it Is it going to have a negative impact or is it going to? But how do we reduce that negative impact? How do we make it a little better tomorrow than it was yesterday? And thinking them as systems that need to balance with each other. One area that comes to mind as an area that's changed over the 30 plus year time horizon is how people get information is dramatically different than it would have been in the late eighties, early nineties when you might be getting it from some sort of health practitioner or Maybe a magazine you were reading versus social media and other avenues that people have today. Do you see that in your work as well? When you work in an NGO in particular, one of our big issues was transparency. How do we become more transparent? How does the government become more transparent? How does it tell people what it's doing, how it's doing, and why it's doing what it's doing? How does the market more transparent? How do consumers get more information? And you're right. That's changed over time. I have three kids who are now all adults, but when they were growing up, There's a lot of information. One of the questions is how to weed out the bad information from the good information. A concern today is that there is so much information on social media and so many other things that there isn't always good information out there. And sometimes people don't know what is the good information. I still look to the federal government on the whole to provide good information and NGOs and others can provide good information, as well as industry can provide good, useful information, but we also have to have the education and knowledge to sieve through all the information that's out there and make sure that we are taking in the good information and using that for positive and not being swayed by bad information that isn't based on the facts or the science or what's out there. I'm a big proponent of transparency. I've always been a big proponent of transparency, but with the great degree of transparency we have, we still have to provide people with the tools to be able to sift through that information. I like the idea of providing tools and and not every consumer is gonna want the information, but they wanna have something they feel that is d should be disclosed, be disclosed to them. But there you will have some consumers who are like, I wanna find out more. I wanna understand more about this. So it is I think a very key part of successful products and businesses today in this space. So I agree wholeheartedly there. Shifting back over to regulatory and policy change, can you think of a change in policy or regulation here in the US that's had the most profound impact, say over the last three years. I think it's our policy environment that has the biggest effect and the government's willingness to be flexible and adapt existing laws to new technologies and products. Our grass process has a lot of criticisms to it and so forth and so on, but it is flexible enough to address new precision fermentation ingredients or making this a protein, a dairy ingredient that we've gotten from dairy cows and making it in the lab a different way and address any safety concerns that might arise from that. That flexibility to sort of be able to do that, and that's not the same. In Europe, many of those novel ingredients go through a much more long involved regulatory pathway that prevents them from getting to market quickly enough, for example. Nothing reducing feed additives is something I work on. FDA doesn't have a clear pathway for that. So they've tried to sort of figure out how do we address these things that aren't really drugs and aren't really food, but could have lots of benefits to the environment and benefits to cows and so forth. We could think about FDA now is trying to deal with natural dyes as opposed to synthetic dyes. And is there a way that they can expedite their review to get natural dyes on the market to replace those synthetic dyes? And cell cultivated meat would be a clear example of a product that again, the agencies came together, used their flexibility and came up with a memorandum of understanding and a unified way to look at that. And while it may not be ideal They've approved what five, six products so far with that. It seems to work. It seems to have the transparency the industry needs and and seems to ensure the safety that consumers need. One of the biggest advantages of the US system is that willingness of the federal government to work with stakeholders and industry and others and try to figure out how do we deal with some of these new technologies. Now, I'll admit that industry will say it's still not fast enough, cost effective enough, and a host of other things. But in a relative way, that is one of the things that I think is really most important in the last few years as we get these new technologies coming to market. ⁓ US government has a huge remit. There are a lot of stakeholders to take into consideration. I could imagine that it would be difficult to please all the people all the time when creating new regulation. And you mentioned that cell cultivated meat at the federal level, they ⁓ found an effective formula, but there have been states that have legislated against it. I'm just curious what you think about that. I look at the state legislation that's going on. In some ways I look at it, I look at it and say it's not as bad as it could be. None of those legislations try to question the safety of these products. They don't try to put in place a new regulatory safety check by the state. They don't suggest that the federal review of those is in any way incomplete or not accurate. They are getting to whether they want to ban it because they want to protect their meat industry or they want to label it a specific way to provide information to consumers, but also potentially to turn consumers off from that products. But they're not going after the safety determination. And to me, that's very important to keep in mind. Part of that means either the federal government has to stack up and do things like labeling and others with a uniform way so that they preempt the states. And I think that's what will eventually happen here. Some of the state activity, there needs to be better education about really what these products are and what they aren't, where they're going to be in the food supply, what benefits they have. And I think with that education, hopefully some of those bills will have a different outcome. I think that's an important distinction that you speak about safety versus being able to commercially sell or develop those types of products in a specific state. So yeah, it'll be interesting to see how that all plays out, especially since there's so few products made with that. process in the market today. We'll see over time. Should be an interesting space to watch. So we had ⁓ touched on grass or generally regarded as safe. We're speaking in August, early August 2026. So what is the current landscape on this issue, Greg? Well as you know, this is an issue that's been going on for a long time. The Food, Drug and Cosmetic Act says that food additives need to be pre market approved by FDA. And a food additive is really anything added to food. So any new food ingredient it says except For something that's generally recognized as safe, which is where we get the grass. There's this other alternative pathway. Some people call it a loophole that allows products to come in and not go through the food additive pre-market approval process. FDA has a voluntary process to review companies' grass applications and determine whether they have any questions about it. But companies can also self-affirm their grass without coming to FDA. And that's where the real issue lies. This issue, which been going on for a long time with NGOs and You in the organization. The Center for South Science and the Book of Interest that I worked for a number of years ago. It came ahead with RFK Jr. becoming head of HHS and pretty much saying that he was going to change this voluntary grass process and make it mandatory. So he would take this process and make it mandatory and eliminate the self-affirmation part of that process. Supposedly a draft rule was written by the Food and Drug Administration. It went to OMB and OIRA, the Office of Budget and Management and the Office of Information and Regulatory Affairs, the role at in this particular case with any rule or regulation is to have an interagency review, allow all the other agencies, both within the White House offices as well as all the other departments to review that rule to ensure consistency. across the federal government, but that USDA shouldn't be saying something that contradicts with something that FDA says or that EPA says. There's sort of point to that interagency review. And I've been through it and that was part of my role at USDA was to manage that interagency review for all of our regulations at USDA that were going through it. It was sent over to them in December of twenty twenty five and there's something called the regulatory agenda. And the rule was identified there. And back in the beginning of July, they updated the regulatory agenda, saying that this rule was now going to come out. in December of 2026, the proposed rule, not the final rule, the proposed rule. And they gave us a little bit of information. They said that it would affect certain food substances. It didn't say all food substances. So we're not sure what that means or certain uses of food substances. We're expecting that it may not be all grass substances have to be mandatory. There may be some subset, at least that's a thought based on the language. And they also said that they would provide a streamlined, one time limited process to address products that have been in the food supply. We're assuming process foods that have been in this food supply that were self-affirmed grass that didn't come to FDA, that there seems to be there will be some opportunity for those to apply, not necessarily be grandfathered. A lot of times we'll pass a law or regulation and we'll say everything that's in the market before the law regulation is grandfathered in that doesn't need to go through that pro approval process or whatever. It's not clear that that's going to happen here. Instead there may be some period of time when people can submit. something and protect the products that are on the market. We don't know the details. Everything is really hypothesis at this time. But what I can tell you is last week the rule cleared O'Ira. The proposed rule has now been sent back to FDA. And so that means it's ready for publication. I would expect in the coming weeks that FDA will publish this proposed rule. There'll probably be a 60 day comment period at least for the public to comment. And I recommend that all stakeholders and anybody who's interested read it and comment on it. And then they would go about finalizing that rule. So we're still more than a year out before any rule would be finalized. The fact that it cleared OIRA last month suggests that we could see proposed rule much sooner than December. Remind us how if there was a streamlined process, how far back in time would that go for folks who are self-affirmed? Is unclear. There was a part of a sentence which sort of said we will provide a streamlined or they said a one time only opportunity for people to get in an application, a limited time period for getting it in. I don't want to hypothesize because I don't want to give people wrong legal information. I think we will learn a lot more about what FDA is thinking in the coming weeks. Assuming that the self affirmation goes away, what impacts do you think that would have on food tech innovation in the US? I'm hoping that the impact on food tech on one level will be minor. I think that if you talk to most of the big CPG companies and the big players in the market who are producing food, they today don't want a new food ingredient that's not been gone to FDA for grass. They're not real keen to take a self-affirmed grass product anyway. I think with the discussion and chatter that's been going on with the Maha movement and RFK, I think the number of companies and the size of those companies has been getting smaller and smaller and more of them have been saying we're going to protect ourselves from any potential risk and we want you to go to FDA. So I think the number of self-affirmed ingredients is hopefully decreasing and that trend will continue. So hopefully if you change it to no self-affirmation anymore, most people are already doing the grass process at FDA anyway. So there may be little change. I think the biggest concern is that resources have been cut at FDA and the federal government. And if all of a sudden these are all mandated and there is a big influx of these, people are already telling me that the time has been extended in this new administration For these new food ingredients. And if that continues to extend, if it's six months instead of three months or a year instead of six months, you would notice while I do that startups, time is money and waiting a year or a year and a half for a decision instead of six months for that decision can mean the difference between going out of business or getting into the marketplace. If the rule goes as we think it's gonna go and mandates grass, the industry's gonna have to insist on additional resources for FDA to be able to s keep developing and marketing products. And where innovation is needed for maybe new ingredients or delivering new products to consumers that meet their changing needs, including those related to health and nutrition, it could have a dampening effect potentially on those options. So shifting into dealing with the a federal regulatory environment writ large, what would you tell a pre seed seed stage startup founder when they think about regulatory? They need to think about regulatory. The regulatory oversight pathway for your product, I first want to say regulation is complicated and it is not intuitive and it is not obvious and it is not scientific. The rules have lots of different paths. They depend on the product, the production process, how it's going to be marketed, a host of different things, what t what in what claims you wanna make. Understanding what the regulatory process might be for your product very early in the process, I think is critical because you could change how you're producing your product, how you're developing your product in a way that might reduce your regulatory burden or might increase your regulatory burden. Startups need to s engage with consultants like me or others who can help them navigate this and have some at least some initial understanding of what their product might need to go through in terms of federal oversight so that they can make informed decisions as they think about moving their product to commercialization, what steps they need to take or prepare themselves for the regulation. but also to potentially improve their success in that process. So I think that's the first thing. The second one is I would say I talked earlier about how I have the utmost confidence in the people in the government and they love to do their jobs and they have lots of experience and they have a huge amount of knowledge, but they aren't they don't have the time to keep up with the science. They're never going to be at the cutting edge for science that's developing some of these new products. It is really important for the industry to help educate them about that. And that comes to our discussion about transparency. Be as transparent as possible. Publish as much as you can about your products and technology in the public record in peer reviewed journals and things like that. And then consult with them early and often. Consult early about what your product is. Explain what you're doing, how you're doing it. The government's gonna try to figure out what the risks are. Well, you need to help them by explaining what is the production process? What's the pathway? How did you get this product? There needs to have that consultation. So I would say that's the second important thing. And the final one is I would just mention that. Policies and regulations are constantly changing. We just talked about grass. FDA is thinking about a definition of ultra process. Congress is thinking about the Innovative Feed Act and biostimulant changes and things like that. These laws and regulations are constantly changing. And those can have again positive or negative impacts on your product, depending on where you fit on the line of what's changing. Being up to date and keeping an eye out for how policies are changing and how regulations are changing is I think the other thing to keep in mind. thinking about regulatory early in the process, much as startups do customer discovery, they should be taking that same mindset of getting the best information and starting a dialogue early in the process. Sometimes I think there's the perception of, hey, we need to wait till everything's baked and then we can go talk to people about it. But potentially a really key consideration hasn't been taken into account and you run the risk of costly rework. So I think that's Really great advice and something I don't hear people saying a lot. So I appreciate you bringing it up here, Greg. So when it comes to new foods and ingredients, what is one thing that people aren't talking about in the food tech space or in the bioeconomy, but should be? So I mean, I think there's always discussion about how do we get from lab scale to commercial scale, how do we scale up? That has to be dealt with. But I think there needs to be more discussion about how do we build consumer and market trust for these products? What are we replacing? How is this product better? Its functionality, its cost, its taste. Is it meeting a societal purpose? Is it an ingredient just for the sake of an ingredient? Is there a goal in mind here? The people developing these need to think, you said talk about that end product and the end consumer, but also how is it going to be incorporated? Where will this ingredient be a blended product? Will it end up as an ult in an ultra processed food? Will it itself be an ultra processed ingredient? How is it going to be labeled in a neutral way? What claims are going to be made? How do we start building that market for the products, but also that market trust and that consumer trust of the product? It's something that I think people need to talk more about. Absolutely. It's something I'm keenly interested in. There is such an opportunity in the food tech sector for industry and other stakeholders to be talking to consumers earlier in the process. Like the use of AI in certain aspects of product development and consumer foods. Consumers are completely unaware of that, but there is growing pushback on AI usage and its impact on communities. So starting to have those conversations with communities is essential. People do adopt the technologies and ultimately the products that are made with them. We're going to need those innovations to help us address a change in climate constrained supply chains. Not to mention the the things that we want, like more protein and other types of things. Looking to the future, what would you most like to see change in the food tech sector? one of the big issues still is product adoption. And really to do that, we have to scale up with these products. And so scale up needs to be simpler. We need to see more public and private investment to get to that scale up, whether that's investment in infrastructure that's publicly available for different companies to use and utilize as they scale up, whether that's funding for themselves to build the infrastructure they need to test their products. But I think that's one area that's critical here. A second one is a transparent science-based regulatory pathway to the market. I think we have aspects of that, but we always could improve that a faster streamline processes that cost less and are transparent, I think is always beneficial. And for some ingredients and for some products, we have more of that than other ones. We need to move more in that way. And I think similarly, how do we have some global harmonization in those areas? If each country is coming up with different names for the product, you know, let's say cultivated meat is called one thing in the US And another thing in the EU. That still is confusing to consumers because consumers go to different places around the world, but it also it it adds cost to companies. But data's needed to show the safety of these products that we're bringing about. And so I'm not expecting total harmonization and everybody's gonna agree to the decision the US makes and just defer to that. But I think the marketplace is global. And so the more we can have some harmonization of our data requirements and labeling. terminology and other things that will help the industry move forward by reducing some of their costs. All of these it's about how do we get the product to market in a cost effective and cost efficient manner. But I think that's it. We have a lot of good ideas. I think we have a lot of good proof of concept, but how do we bring some of those across the finish line and get those to being wanted by consumers, being wanted by food companies and having a benefit that we can then realize. having that lack of harmonization creates a great deal of complexity for folks who are looking to sell XUS. What body or bodies could actually drive that harmonization? Like is there an existing entity today or how do you see that playing out? What would be the ideal? There are a number of bodies that can do aspects of it. The Codac Elementarius, if you're familiar with them, they're part of the WHO and FAO and they set food safety standards. It's a slow moving process, so it takes years. It's all the countries get together and they're done by consensus. But when you have one, then it is adopted around the world. So that's one place to do some of this. The OECD is also a body that has in historically put together ⁓ standards and policies that can be adopted by countries around the world in some of these spaces and and lead to more harmonization. That's a second thing. And then I think Industry self-regulation. Industry sets standards often. But we've seen that historically, that they've set food safety standards to ensure things have a certain level of food safety all around the world and to allow for trade and things like that. So we can also have other bodies, whether that's industry bodies or even stakeholder groups that include industry and NGOs and others who can set standards that everybody agrees to, consensus that makes movement of products and the marketing of products easier. Well, this has been a very enlightening conversation, Greg. I've enjoyed it. I've learned a few things, which is always good. How can people find out more information about the work that you're doing? I'm now a private consultant, Jaffe Policy Consulting. And the best way to look for me is on LinkedIn, I guess. And they could send me a message there and I always respond to messages. So that would probably be the best way. And there's also a page on LinkedIn for my consulting business, Jaffe Policy Consulting. So I think that would be the best way. Fantastic. Well, thank you for joining me on the podcast. Well, if I do, it's been fun. Thanks for joining us today on the latest episode of Food Tech Stories. Be sure and subscribe to our podcast on your favorite podcast platform and keep an eye out for our biweekly episodes. I'm your host, Megan Thomas, founder of Ladder 17. Food Tech Stories is edited by TJG Media.