FDA Can’t Stop, Won’t Stop – Navigating the New Administration

Welcome back to the Food and Chemicals Unpacked podcast. This is Katie Skaggs. I'm here with my co-host Mark Thompson. And today we're excited to present a slightly different kind of episode of Food and Chemicals Unpacked. Today we'll have a short focused conversation with our partner George Misko regarding the various developments at FDA impacting food contact materials since the Trump administration took office back in January 2025. George is an uncontested expert in the regulation of food contact materials. He's advised companies on the regulation of packaging and other food contact substances for over 35 years. He's interfaced with FDA in various ways over the years from pre-market submissions for new products to post-market withdrawal of existing materials and everything in between. We're so glad to have George here to share his expertise. Thank you, Katie. >> George to join us ahead of our paper packaging law seminar. The ninth annual paper packaging law seminar is going to be held on May 6th through 7th in Charlotte, North Carolina, where George will be one of the featured speakers. And one of the highlights we're looking forward to focusing on at the paper packaging law seminar this year is the latest developments at FDA. And so George has been uh kind enough to give us a bit of preview of that discussion here today. So to briefly set the stage, as you know, the Trump administration took office in January with a broad deregulatory agenda that has been characterized by reductions in force at the government level. And on February 13th of 2025, Robert F. Kennedy Jr. was confirmed as Secretary of Health and Human Services or HHS. RFK has been touting his Make America Healthy Again or MAHA agenda and has made a series of announcements in the last week or so indicating that greater regulation and scrutiny of food additives is coming. So, with that context, I we're really looking forward to talking a little bit about uh what's going on at FDA right now. Food Chemicals Unpacked would love to hear from you. If you have comments about this episode or suggestions for topics on future episodes, please write to us at podcast@khlaw.com. And if you have other questions, you can also reach out to us directly. You can reach Katie @skaggs@khlaw.com. And you can reach Mark @thompson@khlaw.com. So, let's get started. Thank you so much for joining us, George. I think it's an interesting kind of angle here on the FDA side of things because from a broader perspective, they have been making this big deregulatory push and doing things like this 10 for 1 regulation executive order. So, back during the first Trump administration, they had a 2 for 1 rule where for every new regulation that an agency was going to put out, they had to get rid of two. And then they amplified that in this administration where it's a 10 for 1. So, the the push seems to be trying to limit the amount of regulation that's out there, but on the food side with RFK Jr., it seems like there's a very significant emphasis on more regulation. And you know, with that, there've been a lot of recent changes at FDA from these kind of firings and rehirings to political shifts and priorities. As Katie mentioned, RFK Jr. has already made quite a few big announcements, the most recent on Wednesday, so March 27th. Secretary Kennedy announced a plan to downsize HHS from 82,000 full-time employees to 62,000. That's a huge and consequential move. RFK Jr. stating that this will be a {quote} streamlining of HHS and eliminating redundancies so that HHS will do more with less. That kind of thing doesn't always work out in practice. He also plans for 28 divisions within HHS to be consolidated down to 15 and also the HHS regional offices are going to be consolidated from 10 down to five. He said that HHS plans to create the Administration for a Healthy America or AHA that will combine several offices and some of them are pretty consequential offices as well. So the Agency for Toxic Substances and Disease Registry or ATSDR and the National Institute for Occupational Safety and Health, NIOSH among others are all going to be brought under this AHA umbrella within the new structure. All that being said, there's a lot of shuffling and people have been kind of wondering how it's going to impact agency activity. So with that, what have you been kind of hearing about the current state of affairs at FDA, in particular the division of food contact notifications? Well, thanks Mark and thanks Katie as well for that nice introduction. Th- This is a very different time for FDA, probably one that I have not seen ever, actually, in the 35 years I've been doing that. And I've lived in DC all my life, so I've followed politics pretty closely, too. A- And nothing like this has ever really occurred. FDA is really experiencing the same tumult as all the other federal agencies are and that, you know, most of you have probably read about you know, over the past few weeks. So, I I would say as far as the current state of affairs, uncertainty. And I get that actually from talking to, you know, contacts that I have at the agency and you know, just seeing how things how things are, how life is for them. A- And you know, the uncertainty is really, first of all, on staffing, you know, because as you indicated, you know, they've already gone through, you know, one around of these things where a bunch of people got fired, most mostly probationary people, and then they brought back a lot of the probationary people. But, you know, it's also I think there's uncertainty as far as the workflow is concerned, too, and it's not only, you know, in terms of a staffing issue per se, that is, you know, who's in the room on any given day, but I think it's also a morale issue, too, because, you know, you can imagine that that someone that's not even in the same agency that you're in is coming through and, you know, essentially taking people down, that that's got to be a difficult thing for morale, and not knowing if, you know, you're next is got to be a difficult thing to deal with, too. And I think that there is a large feeling that what has gone on so far is not done. First, you do have personnel losses by way of attrition, in which positions are not filled, you know, and people retire from the agency. So, that's one thing, you know, that that you're going to have a lack of people as a result of that. In addition, there was it was announced beginning of March, essentially, that there have been buyout offers made to all of the employees at HHS, that is, Health and Human Services, which is the department under which FDA sits. And those buyout offers went to, you know, people at FDA as well. And the buyout is can be up to $25,000, so it's not a small amount of money by any means, and it is certainly being offered as an enticement to get out. How effective that will be, I don't know yet. I guess we will see we'll we will find out. But, certainly is causing some consternation at the agency and some upheaval. So, with all that going on, folks might be wondering, George, is FDA still staffed to accept new FCNs, for example? What's been your experience on that front since January? FCN stands for food contact notifications, and food contact notifications is the essentially the system by which FDA clears, approves if you will, new components or materials that are going to be used in packaging food and and other applications as well that involve something that is in contact with food. And the the the FCN program itself is a statutory requirement. In other words, it's set up by statute in the Federal Food, Drug, and Cosmetic Act to allow the agency to do what they do and also to permit, you know, members of the of industry to submit and others to submit these notifications to the agency. And it comes with a hammer. And the hammer is FDA's got 120 days to review it. If they don't object to the FCN within that period of time, then it becomes effective at that point, which means that you don't need an affirmative approval from the agency. All it takes is FDA not to object to it. And the objection process is not a simple one, either. It's a regulatory process. So, it's a little bit different. As a result of that, there has to be sufficient staffing because that is that that carries a high priority with the agency. So, they need to provide sufficient staffing for that. And my understanding is that they will continue to provide that staffing as one of their top priorities in the agency itself. That being said, I've also understand that the agency is actually down a little bit at this point in the year in terms of the number of FCNs that they're receiving and that they're reviewing. So, as odd as it may sound, this might be a good time to file an FCN if you have one in the wings waiting for you. If they've got the people there to do it and, you know, you can keep them busy, you might as well like keep them busy and file the FCN. So, I I don't see that as a serious problem at this point. Some of the other things that it might be more struck, you know, in terms of voluntary activities that the agency does like, you know, letters of no objection and that type of thing that they might consider. Those might be a little bit more problematic as far as staff is concerned. Yeah, I mean I I think my experience actually on the LNO front, the letters of no objection for recycling technologies, has actually been really good in the last few months. I think the agency realizes that there's a bit of a spotlight on them and they're really putting their best foot forward in terms of trying to get stuff out the door, which is a good showing I think by them. But it's difficult because when you do have, like you were saying George, retirements, people who are feeling like they need to step out in the direction of retirement. I think for example, Patricia Cavazzoni, who was one of the high-ranking Cedar, I think she was the Cedar director, she took early retirement in the beginning of January. And then you also had Dr. Linda Katz, who was heading up FDA's cosmetic division, who also took early retirement or at least took retirement. And so when you lose people who have a lot of institutional knowledge, sometimes it doesn't make it easier for them to make timely reviews of submissions because you're losing some of that institutional knowledge that helps you efficiently consider a particular chemical or a particular use in historical context. One of the things that they have made clear, that is the administration has made clear, is that when they go about checking what federal agencies are involved in, if there are non-statutory kind of projects or programs that the agency is undertaking, it's their intention to prohibit that. That is to stop the agency from doing that work, right? Even if it is for the public good, right? Issuing a non-objection letter to a recycling matter, for example, that's voluntary on the part of the agency. There's no statutory requirement for them to do that. And and if someone sees that, well, gee, this is an opportunity we can cut this work out from the government doing it, and that way that is FDA doing it, and that way, you know, we can we can reassign, you know, man hours to doing something else, then that may proceed. I'm not saying that is going to happen. I'm just saying that that that is a possibility. And it's ironic, too, because, you know, the whole idea behind that is actually to fulfill a need that society has. I think that that people recognize as a whole is an important need. And that's a service to industry as well. So, it it it provides assurances to consumers, which is helpful, and also provides some guidance to the industry with respect to the products that they intend to turn out, even though not statutorily mandated. And kind of >> Before the new administration took office, FDA had started focusing on the safety of chemicals in food and increasing post-market review of those substances. Do you think that's going to change, or do you feel like that's just going to continue on unabated? As that's concerned, you know, Jim Jones, who was the deputy commissioner of the human foods program, that that was his baby. He was the real proponent of that when he came in and took over that job that position. And, you know, he's gone now. He resigned from the agency when that first round of cuts came through because he found it disturbing, I I would imagine. In In any event, though, what's happening to the post-market review program, I haven't heard much about it, you know, since he resigned. However, if there is a new champion that comes on board for that program, then I would imagine that it will it will rise up again, and, you know, it'll be and it will be worked on again. And, you know, we do have people you would think that this would be a natural actually for the people coming in. Makary, who has been nominated and who's I think on the pinnacle of being voted in as the new commissioner of FDA, uh has a strong feeling about food safety and about contamination of food products and that type of thing. Post-market review program fits right into that. And, you know, Robert Kennedy, the Secretary of Health and Human Services, has been very clear you know, where he stands on on these issues of food safety as well. So, I I think it may be that in the FDA will find a, you know, um someone to take on that job and and push it along. How they do all that, I don't know, okay? Cuz, you know, uh already, you know, that they're they're looking at, you know, an agency kind of like trying to find itself in a in a new way because of the staff cuts. And, you know, Jim uh and importantly, I guess, too, Jim Jones made clear before his retirement, and this was a few months ago, actually, that that from his point of view, the post-market review program was only going to work if it had the sufficient funds from Congress to do so. That they needed both personnel, that is, staff, and they needed the budget as well to in order to carry this off successfully. And that would be just creating the program, not even, you know, implementing it so much. So, we're a little bit away from the implementation of that post-market review program. And, you know, and if they don't get the adequate funding and if they lose too many staff, I'm quite honestly, I'm not certain how they're going to how they're going to accomplish that task. Yeah, that's a great segue, George, into, I think, our last question for the day, which, you know, pertains to RFK Jr., the HHS secretary. He made quite a bit of news last week and and continues to with his announcements about changes in FDA regulatory oversight for food in particular. Last week he made an announcement about asking FDA to look into rule making around the grass or generally recognized as safe exemption from the food additive definition under the Federal Food, Drug, and Cosmetic Act. So, what are your thoughts on the likelihood of this, you know, potentially very significant change occurring through rule making? I think it caught a lot of people off guard when he made this announcement to directing FDA to implement a rule making program to see what could be done to eliminate the self-affirmed GRAS position. Self-affirmed GRAS position for those of you that might not be aware is essentially a manner in which someone determines that is a company would determine that a substance is generally recognized as safe and therefore exempt from, you know, FDA regulation per se pre-market clearance by FDA per se and can market that product based upon its own affirmation that the chemical substance or the product itself is GRAS, that is generally recognized as safe. Essentially, you know, it's questionable whether FDA is going to have the authority to eliminate that that pathway, that self-affirmed GRAS pathway without amending an amendment to the Federal Food, Drug, and Cosmetic Act. That's the, you know, that's the enabling statute that allows FDA to do what it does now. Right now, the law provides FDA with jurisdiction, as I said, to authorize only food additives that to be used in food. Okay? And the definition of food additive excludes, specifically excludes substances which are, quote, generally recognized among experts qualified by scientific training and experience to evaluate its safety as having been adequately shown through scientific procedures to be safe under the condi- under the conditions of its intended use. Right, so in other words, if you have a substance that has been found by the qualified experts to be GRAS, that is generally recognized as safe, then it is no longer a food additive, and it's only and it is only food additives over which FDA has that pre-market pre-authorization clearance authority. So, really when you think about it, if it's not a food additive, then what room does FDA have to suggest that something has to be, you know, go through a a clearance process with the agency before it can be marketed, you know, for use in the in the United States. So, and that that limited authority on the part of the agency, I think that's well recognized by general by the chief counsel at FDA and has been, you know, for some time now. We've seen a lot of that kind of abrupt change from tradition, you know, just in the last couple of months. So, what goes on in the future, again, you know, you you we'll we'll see how that works. If there is some sort of authority that is given by Congress, or if FDA somehow conjures up that authority on its own, how in the world is a program like this going to work? For example, would the would businesses which rely on GRAS status for specified ingredients be required to retroactively seek FDA clearance for them now? Right? How's that work? And more importantly, or just as importantly, what's the status of those substances while that process is being undertaken? You know, is a company going to have to remove the product from the from the marketplace until the the clearance is provided by the agency? All open questions, very difficult to see how the agency is going to work that out. Additionally, there are questions as to whether an amendment to require pre-market review would have a time limit on FDA, or if this would be similar to the food additive petition process that the agency already uses for you know for food ingredients per se. If that's the case then you got you got to wonder well geez is it going to take the years and years that it takes them to to to promulgate a food additive regulation? If it does then it's just going to drive up expenses for industry and it's really not going to help either the consuming public or the industry itself. I think it's important to understand and remember that the announcement that was made by Secretary Kennedy does not actually change the picture. That is the legal status of the substances that are that are subject to a self-affirmed GRAS position. They still are considered GRAS under the law and they will remain that way until something changes either on the regulatory front or the legal front. Okay? That doesn't mean that you can just you know walk away and leave it alone and not think about it because you know as as we here at Keller and Heckman have always said you know GRAS is a fluid subject. It's a fluid topic and you know what is GRAS today is not necessarily GRAS tomorrow. It depends on the toxicity data that's available as new safety data develops that indicates that there's a problem or something you need to deal with that and you need to keep on top of it. It's just you know a matter of due diligence and good manufacturing practices in terms of how you go about maintaining your inventory of of materials. So with that in mind we are entering a strange new world and I guess we'll see how it comes out at the end. Your average consumer has no idea about the mechanisms and the levers that are operating behind the curtain that helps the food system operate and that's why we have such a robust and established food system in the United States. It's only when you throw a wrench into those systems and you suddenly don't have a certain food product or a certain consumer product on the market anymore that people start to ask questions about, "Hey, what happened? Why do I no longer get to buy my X or my Y?" And that's when people start asking, "Why did we wreck this system that was already working quite well?" Yeah, uh absolutely, absolutely. I think maybe not at the beginning, that is back in the '20s, but certainly later on in the year through the years, industry came to recognize that uh FDA was very important to you know, their their the confidence that the American public would have in the food industry. Uh and therefore the age you know, the industry has really worked very closely to make sure that there is a cooperative arrangement in terms of industry cooperating with the with FDA and and taking the necessary steps to make sure that their products are safe, right? And as a result of that, you know, it's worked out well for for FDA um because they don't have to bring as many enforcement actions. They just got to get on a bully pulpit and let let the companies know what they want them to do. And nine times more than nine times out of 10, they're they're going to do it or they'll work out, you know, an accommodation that will allow the agency's objectives to be met. Yeah, I mean historically and still notwithstanding all of the social media criticism you may see regarding FDA or whatever it may be doing, it still remains the gold standard for food science and safety assessments on all of these fronts. This is definitely a situation that is challenging for the agency, but I think it's important that people appreciate what the agency has always continued to do, which is making sure that the food supply is safe and setting a good example for other agencies around the world. Yeah, that's very true. I think uh I think FDA is recognized in that way by just about every other food agency in the world. Definitely. Well, George, thanks so much for joining us and and sharing your insights. If you want to hear more from George, if you want to hear more about this topic, please join us at our paper packaging law seminar on May 6th through 7th in Charlotte. You can register on our website. We'll put a link in our show notes. In addition to these latest FDA developments, we're going to talk about the comprehensive overview of the US food contact paper regulations. We'll talk about EU paper packaging laws. We'll give you updates on state-level legislation developments, and we'll be giving practical tips including how to implement GMPs and best practices for when things go wrong with food contact paper. So, please do join us, and thanks again for joining us on Food and Chemicals Unpacked. We'll see you next time.