51: Can We Save Natural Desiccated Thyroid? – The Fight for Patient Access with Jeff Moshal

So today on Modern Thyroid and Wellness Podcast, we are kind of getting an inside scoop. I am talking with Jeff Moshel, the CEO of Genus Life Sciences, the company that manufactures and makes Ren Thyroid and is working extremely diligently to move it through the FDA approval process. If you all are not aware of what is going on in this space, listen up and strap in. So, as many of you know, but sadly, not everyone, natural desiccated thyroid medications like Ren Thyroid, like Armour, like NP, have been around long before the FDA approval process even existed and were essentially grandfathered in for the last 200 years. I mean, they have been around since the late 1800s and the FDA approval process started in the 40s, 50s, 1900s. So until now everything has been fine. And Ren Thyroid has been moving towards the FDA approval process, which is incredibly exciting for so many reasons. In part, I view it as an essential step in evolving access to better thyroid care. Progressive thyroid care, progressive thyroid medications. Many of you know, desiccated thyroid completely changed my life. It they gave me back my life and if I lost access to my own Ren Thyroid medication, I would be devastated and unwell. In August of 2025, the FDA came out and started sending letters to clinicians telling them that these medications would no longer be available for prescribing and to start to transition their patients off of them and onto synthetic forms of medication like levothyroxine and cytomel, which is not an easy undertaking. 1.5 million Americans are on natural desiccated thyroid and rely on these medications, most of which have failed treatment with other methods. And so this is their ticket to their health and vitality. And to lose access to these medications in August of 2026 would be devastating. Manufacturers also received letters to begin to stop manufacturing these meds. And the FDA said until these medications are FDA approved, they will no longer be accessible after August 2026. Sadly, multiple NDT medications are in the middle of the FDA approval process, but they will not be finished by August 2026. There simply is no way there will be a gap of likely years before these meds will be approved because it takes a long, long time. It's a big effort. So we essentially, myself and every key person in this industry has come together and formed what's called the Thyroid Health alliance to unanimously, in a united manner, try to get a commitment from the FDA to say we'll wait to remove these medications from the market until at least two companies have been approved. So far, we have received back a tweet from the commissioner of the FDA saying, don't worry, don't worry. We'll keep these meds in circulation until they are FDA approved. But in my opinion, and in the opinion of many people in this space, even if it's not who we're about to speak with, I would love a little more formal commitment than a simple tweet. So we are continuing on with our mission. If you'd like to get involved, please, please do. If you're a practitioner or a patient or someone that just advocates for thyroid, Please go to thyroidhealthalliance.org and complete the three step process of supporting our mission. We would appreciate it and be again, we can't lose access to these meds and we need more than a simple tweet of a commitment to ensure that people like myself and like thousands of my patients will continue to have access. So thyroidhelpalliance.org I am chatting today with Jeff Moshel of Genus Life Sciences, the makers of Ren Thyroid, which as many of you know, I am so incredibly excited about. So let's dig in. Before we dig into this interview, I want to be super open and transparent with you that I am a paid consultant for Ren Thyroid. And and honestly, I'm so grateful, excited and honored to be in this position. I want to be on the ground floor of the Thyroid revolution. And I think the more I can directly have contact with these companies that have the potential to shift the paradigm of research, of medications that are offered, of FDA approval. I want to be as involved as possible and I want to help direct so that we end up in the place that we all deserve, that our children deserve. So wanted to throw that out there before we dig in. Welcome to Modern Thyroid and Wellness, the podcast that explores the intricate dance between health, wellness and thyroid, unraveling the threads that weave our vitality together. I'm your host, McCall McPherson, and I'm so thrilled to guide you on this journey to optimal wellness. Jeff, I'm so excited that you're here today. Thank you for taking the time. I know this is out of your ordinary realm of what you do as the CEO of Genus, but thank you so much for being here today. Tell me a little bit about the history of Genus, how it came about, what you all specialize in your mission. Just tell us more and get us started.

Well, McCall, thanks for having me on. First of all, good to see you. So thank you for that Genus. I founded Genus with a couple of other guys back in 99, so we've been around for 26 years. Located in Allentown, Pennsylvania, about an hour and a half north of Philadelphia. We have three factories up there manufacturing pharmaceuticals. We develop, manufacture, package, market, the whole gambit. So we a specialty pharmaceutical company, and we do all dosage forms other than sterile in house. So we'll manufacture and develop tablets and capsules and liquids, powders, solutions, suppositories, creams and ointments. Everything other than sterile. So no injectable or ophthalmics. We do work on those products, but those we outsource. And over the years, 26 years of being in business, we've morphed in terms of our strategy. And our main strategy is actually getting unapproved drugs approved. So a lot of people don't know what an unapproved drug is. That's a prescription drug that's prescribed by doctors, taken by patients, but actually hasn't been approved by the fda. So the question would be, how is that possible? That's a very good question, and it's one I haven't been able to answer yet. But the reality is these products are on the market. How they got to the market is a mystery. I mean, some of them are like, for example, oral solutions when there's a tablet available. So I could understand, maybe there was a pediatric need or a geriatric need. FDA turned a blind eye because a solution was needed and it couldn't be administered any other way. But there are a lot of pro. There used to be thousands of products that were actually unapproved. And FDA came out with a guidance in 2006 and then again in 2011. And the guidance basically said, listen to industry. Listen guys, pharmaceutical companies being the guys, we want you to get these products approved. So those people who have these unapproved drugs, we're going to incentivize you to get these approved. We're going to work with you. And once there's an approval, we'll put in the guidance, which they did, that will allow the unapproved companies a 12 month grace period, meaning after approval, we'll Give unapproved companies 12 months to get out of the market. In reality, FDA has given a lot more time than that. But we saw this as an opportunity in terms of our main strategy. And we happen to be the lead company in the US we're the number one company in the United States of getting unapproved drugs approved. We have six new drug approvals following the strategy and one new animal drug, which means seven products. Nobody's even got half of that in terms of taking an unapproved drug through the approval process. So that's a little bit about genus. I mean, we also have a little generic division and a little branded division separate to taking unapproved drugs to the approval process.

I love it. And this is particularly pertinent right now for a few different reasons for thyroid people especially. Right. Natural desiccated thyroid has been an unapproved, an un FDA approved medication that's been in use for over a hundred years in this case. I know how this happened in particular. I don't know about the other drugs, but it's basically desiccated thyroid medications preceded the FDA approval process. And so they've been around for years and years and years. A century, basically. They were around in the 1800s and they were the mainstay of treatment for a really long time. And now obviously we're so excited that you all are taking those medications that historically have not been FDA approved and moving them through the FDA approval process. That is absolutely our hope and excitement for sure. Because natural desiccated thyroid meds are around because a lot of people have not been able to get well on T4 based medications like levothyroxine, synthroid, tyrosine. In your perspective, why do you think that people gravitate towards natural desiccated thyroid medications like Ren Thyroid as opposed to the T4 based medications? Do you have any ideas? I can certainly chime in as well, obviously. Right.

So that's a very interesting question and somewhat difficult to answer because proper clinical trials haven't yet been completed by anybody, but they are in the process of being performed. In addition, one of FDA requirements is to have the natural desiccated products properly characterized. Okay. And the hundreds of different items that are actually in the thyroglobulin as opposed to the synthetic product. So those answers will actually come out through the approval process. But what we found, I mean, obviously clinically, and you know this, is that certain people don't convert into T4 to T3 as well as others. So those people definitely need and a little bit extra of T3 so the combination product is beneficial to them. The other thing is just in terms of the huge amount of data that's out there, I was looking the other day in 2017, there was a study or survey of almost 12,000 patients that had switched from T4 to the natural desiccated product and double the amount. So two times of the double the amount of the patients that switched preferred the natural product compared to T4 alone. Synthetic T4, mainly due to all the symptoms being improved. But the reality is people don't really know why that happens. Is it because of this T1 or calcitonin or other things in the natural product, or is it just because the additional T3 that's out there. But these will come out over the next few years as we progress through the approval process.

I love it. Let's back up a little bit. And I want you to share with people. I should have led with this, so I apologize. But share with people a little bit about what natural desiccated thyroid even is like. For someone that maybe has never even heard of these medications or isn't familiar with them at all, how are they different than the medications that, you know, 89% of Americans get prescribed when they go to their doctor to get treated for hypothyroidism?

Right, Right. Good question. So as you. As you had alluded to and mentioned previously, the natural desiccated thyroid product has been around since the 1880s. Right. And if someone had hypothyroidism, this is what they were given. There was no synthetic T4, synthetic T3 up until, I believe the 1950s is when someone was able to synthesize T4, which is levothyroxine, and T3, which is leothyronine. And that was an unapproved drug, by the way. That was only approved in 2000.

Wow. I had no idea.

Yeah. So for 50 years, Abbie was selling Synthroid and other things synthetically unapproved. So it's an interesting market, and that's a massive market. Think about how many people are on synthetic T4 and T3. So what the natural desiccated product is, it's derived from the porcine gland. Okay. And that gland is harvested once pigs are slaughtered. And within that gland is thyroglobulin. And within the thyroglobulin, it's T4 and T3 naturally at a ratio of 4 to 1. In the human, the human ratio, I believe, is 14 to 1. I'll have to double check that. So the porcine ratio is a little bit more stronger, basically a 4 to 1 ratio. But that's been used, as we've said, for over 100 years with great results. It's a natural source, and it was there way before the synthetic products were on the market.

Right. And, you know, it's interesting, I think in medicine, we adopted T4 so readily and ubiquitously, mainly because it's really long acting, it's easy to control. You can skip a day and your levels don't grossly shift. But in that mainstream change, I think that we lost account for the people that don't respond to one single class of medication. You know, to. To presume that everyone will do well on one single medication isn't really applicable in other areas of medicine. Right. Like for cholesterol medication, hypertension medication, antibiotics. We don't just have one option for these people. We have nuanced options of all different kinds. And that's accepted in medicine as the norm. But it's interesting that thyroid has almost accepted and held onto this one form of medication. Now 89% of people are on it. And if they don't respond to a levothyroxine based drug, the answer, sadly, in medicine and what keeps so many people sick like myself for many years was, well, if you're not better from levothyroxine, it's not a thyroid problem, it's something else. Right. And that's not the case in every other aspect of medicine. So I'm not sure why we've so pervasively adopted that in this area. I myself was on Synthroid and was spending 16 hours a day in bed. So it wasn't until.

One of the answers there is is the way medical professionals are trained. Right? So once the synthetic products were improved in 2000, that whole next generation is trained on that synthetic product as being the approach to go forward. And that's the reality. So yes. And you know, the good thing is that we heard the FDA commissioner tweet a month ago that they working very closely with companies to get this product approved. They understand the importance of getting it approved. So that's really a good sign. And they did acknowledge there are 1.5 million people, which is 6 million scripts. It's a lot of scripts in the big population currently taking the natural thyroid products. So it's an important product to get approved and it will get.

Yeah, I hope that. I know we've spoken about this and I know you're very incredibly optimistic. I personally hope that the FDA might come out with like a little more formal announcement that hey, these people don't need to worry about losing access. Because for those of you who listening, on August 25th or 26th of this year, the FDA came out and stated, look like practitioners need to be transitioning their patients off of desiccated thyroid by next year. They have 12 months to do so. So start now because we're going to remove any non FDA approved drugs from the marketplace. Which is a little sad because there are companies like Ren Thyroid that are in the process of starting and beginning the FDA approval process. That takes years. Right.

And so, I mean We're a little bit further on than starting. We've been working on it for seven years.

Right, right. I didn't want to put a time stamp on it, but you know, I think so many 1.5 million people up. You know, I've read a stat up to 4 million people rely on these medications. I know so many of my patients do certainly, and myself included, I take Ren thyroid and so I don't want to lose access to that. It completely changed and revolutionized my life and gave me my life back. So I'm really hopeful that we'll continue to work towards that. For anyone listening that might want to get involved, we've created what's called the Thyroid Health alliance to just communicate with our congressman and petition and stay up to date on the latest of this. And you can find out more@the thyroidhealthalliance.org, not com.org and you can sign up to be part of our little movement. How are you all navigating this landscape? What are you feeling like? Do you feel pretty confident that hey, the FDA is going to come through, we don't need to worry so much. I'm curious your take.

So the way I look at it is number one, we need to work on things that we can control and that is getting the product approved as soon as we can. So that's our main focus. Right. Going forward and getting it approved. We did see obviously the FDA notice, but as I mentioned a week or so later, the comments from the FDA commissioner gave us a little bit of a comfort level or more than a little bit actually at decent comfort level that FDA will not only work with the companies and see the importance of getting the struct approved, but also in that comment by the commissioner he did mention that there will remain access to these products. So obviously we can't speak to to FDA's thinking, but that was a positive comment by the commissioner.

Yeah, I agree. So much of the history of these medications and I think, I mean I have no idea, I'm not the fda. But perhaps why they want these medications to get FDA approved and more regulated is because a long, long time ago, especially the first half of century when they were first developed, they were pretty wildly unstable, unpredictable, uncontrollable. So much of that changed in about the 80s, but medicine's view, clinicians view of these meds is that they continue to be wildly unstable and predictable. I do not find that at all in my patient population. When I use great NDT meds like Renthyroid for sure But I'm curious if you could tell us from a manufacturing perspective, tell us what safety measures are in place to ensure consistency, safety efficacy of these medications.

Right. So that's a very good question. Thank you. What I want to talk about a little bit is in addition to answering that is what we feel the benefits of RIN Thyroid are. So we've been working on this project since 2017, actually eight years. And the reason for that is it took that amount of time to qualify a quality reliable source which begins from the collection of the porcine glands. So we actually started off in China, backed away from that pretty quickly because most of the Asian porcine actually test poses to African swan food. The African swine tube isn't active, but it's in the DNA. So forget about that. We moved away. We then went to a European source and eventually decided. And actually out of the three companies, us being one of them, attempting to get the product approved, we the only company that has a US based porcelain source. And while we wanted to do that, number one is to keep manufacturing in the US in terms of the raw material. But number two is we felt the controls around quality being in the US is better, but not only better, it's easier for us to manage. So where this starts is at the slaughterhouse, right? You have to work with slaughterhouses that are porcine only traceability from the time the pig is born in terms of what that pig has eaten, what that pig has received regarding medication, and that's all traceable and trackable, and then the controls on how they extract the gland. So being in the US we audit these slaughterhouses because of them. So that's step number one. Right. Step number two is you have to assure that there are no viruses in these glands, no porcine viruses. So we test every single batch for any known virus that could exist that comes from porcelain. And I'm not sure, I can't speak to the other companies, but that's a huge task and we do that. Right. In addition, we did what was called a viral clearance study. So we chose four model viruses and we did this with the approval and in discussion with FDA and their concurrence that are the hardest viruses to clear. And we had to show them that our process cleared these viruses via heat and chemical process that we have in our manufacturing steps. And that was done successfully. So there's absolutely no issue with viruses in our product. That's number one. Number two, obviously the slaughterhouses are USDA approved for human consumption, right? So people are eating the pork that comes out of these facilities and that's once again controlled within the US So huge. We then have the glands go to another company in the US that turns them into a powder and then we take that powder and make the tablets at our facility in the US So it's vertically integrated within the US no other company can say that. Right. Very, very important to keep everything in the US not only in terms of quality, but to keep the manufacturing base here. Right. Important economically for the US Some advantages that we feel that we have on our product is most of the other companies, if not all of them, they having a company take the glands and making powder and then mixing that powder with dextrose or lactose. Okay. And then that mix comes over to the company to make tablets. The negative of that is if that mix isn't perfectly uniform, there's nothing the company can do with those tablets. Improve the uniformity. We get raw thyroid powder and do the mixing in house in the US at our own facility. So what we finding is when we have the assays of our product, which should be 100%, we're getting between 98 and 102% on every batch. Some of the other companies are getting 91%, 109%. So that's another huge advantage. Another advantage that I'm just thinking of right now is, is first of all we've added two other strengths. A 45 milligram and a 75 milligram.

I'm excited about that.

Yeah. So we have more strengths and open to adding whatever physician based fields will be easier for them to administer. Right. Prescribe. But the other thing that's very important because it's a natural product that has T4 and T3 naturally, those ratios can vary. And we've developed a manufacturing process that we will have less than a 5% difference between the T4 and the T3. So we have a tablet. T4 could be 99%. T3 will be 102%. When we tested some of the other product, they'll have T4 92% and T3 108%. That's a 16% difference. That's massive. That actually takes that product into a different bracket. So what you think you're prescribing and a 15 milligrams, really a 30 milligram or a 20 milligram. So that's a huge advantage that we have that I don't believe anyone else is doing. And I hope you answered your question by the way.

You did, you did so well. And like the predictability and control Piece is everything in thyroid. You don't want variance, you want to control for that factor. And that's how you get successful outcomes with improving people's quality of life. So it's so incredibly important so you all start to finish entirely American based. I love that.

Why it's important as well is when you prescribe a drug use, assuming there's 100% in the product. Right. FDA does it now between 90 and 110%. But this is a narrow therapeutic index product. Right. So little changes have an effect on the patient. So when you you prescribing 100%, you don't want it to be 92%.

Right.

Or 108%. And what's worse, because it says two actives, really what you don't want is the one to be 92 and other one to be 108. So we've solved that issue.

I love that. And the other thing too is I think for us to evolve in medicine out of this concept of desiccated thyroid being unstable and reliable, we need it to be stable and reliable. We need to feel confident in what we're prescribing is what patients are getting. And I will add that I personally visited your manufacturing facility last year in 2024 and completely tight ship, everything is together. I was thoroughly impressed. So hats off to you and thank you.

And what was interesting about that day is FDA showed up surprisingly and we got through that. The audit was on thyroid actually, and we got through with no issues at all. That was right.

It went from being a very relaxed visit to being really intense about 10 minutes after I got in. But I still got to tour whole facility. Thank you for hosting me and it means a lot for me to go in and dig deep and make sure everything's on the up and up for my patients and my people and my followers. So thank you so much. Is there anything else that we should know in closing that maybe we haven't talked about yet?

I can't think of anything, but I'm sure as soon as I get off the phone, about 20 thoughts will come to my mind.

Maybe we'll have to do it again.

We'll do it again.

A follow up, right? Exactly. Well, thank you so much, Jeff, for being here today, for sharing your knowledge. Thank you on behalf of myself and millions of thyroid patients everywhere for your work in supporting us in evolving thyroid care and making medications that truly change people's lives available.

Appreciate it and thanks for your time. Nicole.

Okay, a little more housekeeping. All of this because Ren Thyroid is an actual medication and we have to meet certain requirements through the fda. This is not an ad. This is not an interview that was paid for from Ren Thyroid. I'm simply sharing this information with you, but yet I still need to read you the following thing. Thyroid hormone drugs, including Ren Thyroid should not be used either alone or in combination with other drugs for the treatment of obesity in patients with normal thyroid function. Normal doses for daily hormone replacement are not effective for weight loss. Larger doses may cause serious or even life threatening events, especially when used in combination with certain other drugs to reduce appetite. Ren Thyroid should not be used for male or female infertility. Taking too much Ren Thyroid may affect your cardiovascular system, especially if you're elderly or have heart problems. Tell your doctor immediately if you have signs of chest pain, increased pulse, palpitations, excessive sweating or any other unusual event. Tell your doctor about any other medical medical conditions you may have, especially heart disease, diabetes, clotting problems or adrenal and pituitary problems. Tell your doctor about the medications you take, especially anti coagulants, diabetes drugs, oral contraceptives or biotin. Your medications may have to be changed while you're taking Ren Thyroid. If you have diabetes, monitor your blood sugar levels and or the glucose in your urine and immediately tell your doctor if there are changes. This is not a complete list of risks. For more information, please talk to your doctor and visit renthyroid.com for full prescribing information.