- The FDA's action against NDT is an enforcement action, not a law. Manufacturers have 12 months to comply with a new biologics licensing requirement, but access is not being cut off immediately.
- There is strong financial incentive for NDT manufacturers to fight this. The thyroid medication market runs in the billions, and NDT accounts for tens of millions of prescriptions yearly.
- Community pushback is working. The FDA head has stated they are committed to pursuing the first-ever formal approval of desiccated thyroid extract and will ensure patient access during the process.
- You can recreate the benefits of NDT using levothyroxine as a base, then adding liothyronine for T3, over-the-counter T2, bovine thyroid gland powder, and trace minerals like selenium and zinc.
- NDT's effectiveness comes from the synergy of T4, T3, T2, thyroid cofactors, and trace minerals working together. Understanding this lets you build your own equivalent protocol if needed.
Recently, the FDA sent warning letters (1) to manufacturers of natural desiccated thyroid (NDT), thyroid medications like Armour Thyroid and np thyroid, stating that these medications are technically illegal to sell without new approval.
They’ve given these companies 12 months to comply or shut down production.
This is definitely a power play by the FDA, which has long been against the use of NDT formulas, in an effort to push people towards synthetics like levothyroxine and Synthroid.
This means that NDT could theoretically disappear from pharmacy shelves as early as next year, or even sooner if manufacturers decide not to fight it.
If you are one of the hundreds of thousands who rely on NDT for symptom management, this news is… concerning (an understatement of the decade).
But I’m here to tell you that you don’t have to panic.
Here’s why:
#1. This isn’t law (yet).
It’s what’s called an FDA enforcement action, not a ban.
What the FDA is trying to do here is to reclassify NDT as a biologic compound in an effort to better “regulate” it.
This reclassification would require pharmaceutical companies to apply for a biologics license application, which would cost time and money.
The fear is that during this process, patients may lose access to NDT.
And the even greater fear is that NDT manufacturers wouldn’t bother to apply for the license at all, limiting NDT access indefinitely.
Fortunately, recent statements from the FDA head suggested that patients will not lose access to NDT during this process and that there are currently ongoing studies that would prove that NDT is both safe and effective.
The reality is, while there is a non-zero risk your access to NDT medication may be limited, I don’t think it’s very likely.
This brings us to point #2:
#2. There’s a lot of money at stake.
If you look at the top prescriptions fulfilled each year, levothyroxine is consistently at the top of the list (usually #3 or #4 behind cholesterol and blood pressure medications).
For perspective, there are usually around 80 to 100 million prescriptions for levothyroxine filled each year (2), and this number is getting bigger, not smaller.
This isn’t the medication we are talking about today, but it’s important to realize that the thyroid medication market cap is in the billions of dollars per year.
Of the total number of thyroid patients taking medication, about 20% or so are taking NDT formulas.
So even though it’s a much smaller percentage, the market cap is still huge and in the tens of millions of prescriptions filled each year.
That’s a lot of money and a lot of incentive for the manufacturers of NDT medications to continue to provide their product.
For this reason, you may not have to do anything but let them do the fighting for you because of what’s at stake.
#3. The community is pushing back.
We also have to give room for legal challenges, lobbying from patient groups, and pushbacks from other organizations.
In fact, much of the pushback recently has caused what people think is somewhat of a walk back by the head of the FDA.
But to be clear, he did not walk back anything. What he said was this:
What this means is that your voice and the voices of others matter.
You Can Recreate the Benefits of NDT Yourself
But let’s assume the worst-case scenario… that all forms of NDT are pulled off the market in about 12 months.
You still don’t have to worry.
Why?
Because you can recreate the NDT effect right now, with a couple of over-the-counter supplements, no prescription needed.
And this is something that most of you should be doing right now anyway, because it sets you up for success even in the event of things like this happening in the future.
In order to do this, you need to understand what makes NDT so special.
Many thyroid patients believe that it’s just the T4 and T3 content that makes it work, and that’s part of the equation, but not at all of it.
Instead, it’s the synergy of multiple other ingredients that all work together:
- The T4 content
- The T3 content
- The T2 content (4)
- Thyroid-specific cofactors and peptides – These are found naturally in the thyroid gland
- And trace minerals like iodine, selenium, zinc, and copper
Because Armour thyroid consists of ground-up thyroid gland powder, you get everything when you take it in capsule form.
And it’s this combination that makes it work so well; it’s not due to any single ingredient, but the symphony of everything working together.
Some thyroid patients wrongly believe that it’s the “natural sourcing” that matters. It’s not.
I hate to break it to you, but the T4 and T3 found in Armour thyroid (5) are the exact same as the T4 found in levothyroxine (6) and the T3 found in liothyronine/Cytomel (7).
The only difference is their sourcing. One is “natural” and the other is “synthetic”.
Understanding this is critical because it allows you to recreate NDT in a piecemeal type way by adding what levothyroxine and liothyronine do not.
And it turns out that these extra ingredients are all available over the counter.
The DIY NDT Protocol (No Prescription Required)
Recreating this is what I call the DIY NDT protocol.
Since most of you are already taking levothyroxine, you can use that as a base and then build on top of it with a couple of extra ingredients.
Here’s what that looks like:
- Start with your base of levothyroxine, which provides the T4 thyroid hormone (I would recommend switching to Tirosint if you can, but levothyroxine works)
- From here, you add on T3 thyroid hormone in the form of liothyronine or cytomel.
- Next, you add in T2 thyroid hormone, which is available over the counter at 100 to 200 mcg per day.
- Next, and this is key, you will add on desiccated bovine thyroid gland powder. This powder is VERY similar to NDT but comes from cows instead of pigs. The main difference is that the T4:T3 content isn’t standardized.
- Finally, you finish it off with some added trace minerals like zinc, selenium, iodine, copper, and a little bit of iron if needed. You can get all of these with a simple thyroid support supplement.
Together, you just re-created Armour Thyroid with a handful of supplements and a couple of prescription medications.
And what makes this even better is the fact that you have complete control over every individual piece and dose.
If you need more T3, you can up your dose. If you need less T4, you can simply drop it.
Unlike Armour thyroid, which comes in a static dose, you can individually adjust each thyroid hormone to your preferences.
Bottom Line
Don’t panic.
There is a much greater chance that everything will work out than that everything will go wrong.
But let me be clear by saying it’s still possible that NDT is eventually pulled off the shelf, given how events have occurred.
If you’re worried or just don’t like the idea of being reliant on a medication that is so up in the air, try re-creating your own NDT formula using the steps I just discussed.
And don’t fall into the trap of thinking that NDT is somehow superior to all other thyroid medications.
The truth is that you can feel better on a number of different combinations, including levothyroxine.
If you don’t feel well on your current protocol, check out this article next, which will help you optimize your medication.
Scientific References
#1. https://www.fda.gov/drugs/enforcement-activities-fda/fdas-actions-address-unapproved-thyroid-medications
#2. https://clincalc.com/drugstats/Top200Drugs.aspx
#3. https://x.com/DrMakaryFDA/status/1955783788040159558
#4. https://pmc.ncbi.nlm.nih.gov/articles/PMC6068267/
#5. https://www.rxabbvie.com/pdf/armour_thyroid_pi.pdf
#6. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021342s023lbl.pdf
#7. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/010379s054lbl.pdf
The government needs to stay out of my thyroid medicine! I am one of those who stoped converting T4 to T3 after 20years of levo. Armor thyroid saved me. Don’t mess with my meds. At 72yrs old, this is the only medicine I take.
Hi Mary,
The FDA is a double edged sword. They are good in the sense that they require strict guidelines as far as hormone content goes, which is good for patients. But they are bad in the sense that they sometimes try to reach farther than they should, such as in this case.
When you say to sprinkle on some bovine gland powder, how much would you recommend?
Dear Dr. Childs,
I have recently heard about this FDA activity and frankly I have been worried about what I would do without NPThyroid! Thank you for ALL of this information. After being on Synthroid for 20 years, it began not working for me. I was going to a traditional endocrinologist for many years and he also treated my diabetes which I was diagnosed with at the same time as the hypothyroidism. I began feeling BAD (emotionally and physically) and my numbers consistently showed low thyroid. The last time I saw my endocrinologist he was going to prescribe 200 mcg of synthroid. After beginning tp read about my problem, I asked him to add liothyronine. He refused. After 3 years of trial and error, I finally landed on NPThyroid which seems to work for me! Liothyronine made my heart rate go up and I did not tolerate it. Do you think this is because it is synthetic and based on my experience with Synthroid, my body doesn’t seem to work with synthetic? I still do not have an endocrinologist that thinks the way that I think! I go to my internist and he has graciously agreed to follow my suggestions and it’s working for now. I would love to see a doctor of some sort that follows your way of thinking. I’m in Dallas, TX – there has to be someone here, I just have not found them. Do you have advice for me about what to do, should NPThyroid is not available? I read above about supplementing the powdered NDT to Synthroid and Liothyronine or Cytomel – just haven’t had great luck with these.
Hi Jennifer,
Thank you for sharing! What you experienced with Synthroid and liothyronine is not uncommon. It is not that the medication is “synthetic” that makes it problematic, since the hormones in both synthetic and natural options are chemically identical. The difference is more about how your body absorbs and utilizes them and whether you are getting the right mix of T4 and T3 for your needs.
If NP Thyroid ever becomes unavailable, the next best option is usually to recreate what NDT provides by using levothyroxine (T4) together with a small amount of liothyronine (T3). The challenge is finding the right ratio and dose, which often requires trial and adjustment. Some patients do better with compounded T4/T3 combinations for more precise control. You can learn more about re-creating the individual components of NDT here: https://www.restartmed.com/build-your-own-natural-desiccated-thyroid/
Finding a doctor who is open to this approach can make a huge difference. I don’t have anyone to recommend in your area, but this resource may help you find one: https://www.restartmed.com/how-to-find-a-doctor-to-treat-your-thyroid/
FDA Commissioner Marty Makary, M.D., M.P.H. made the statement you referenced under #1. AbbVie started their so-called studies to prove that Armour is as safe and effective as Levothyroxine a couple of years ago, I think they have started 2 or 3 studies and have never gotten past the recruitment stage. See https://ichgcp.net/clinical-trials-registry/NCT06345339 and this VERY SCARY link https://www.raps.org/news-and-articles/news-articles/2025/7/fda-names-biotech-entrepreneur,-stanford-professor
This link may be the most disturbing. This is Dr. Tidmarsh the new CDER chief stating that Tidmarsh has been critical of desiccated thyroid extract, an unapproved drug that was first used to treat hypothyroidism in the 19th century.
“The new FDA needs to remove harmful, useless drugs from the market,” said Tidmarsh on LinkedIn. “Let’s start with desiccated thyroid extract.”
“An unapproved, crude pig tissue extract that is proven worse than synthetic thyroid hormone and harmful,” he added. “Working with the new FDA to remove it permanently from the market.” He doesn’t reference any studies that suggest pig tissue extract is proven worse than synthetic thyroid hormone and harmful.
As far as Dr. Makary’s statement, how does one compare a Biologic to a human drug in research studies? The FDA is not asking for proof of the efficacy between the two drugs even though that is the underlying belief, but how can a biologic be compared to a human drug in a Research Study? Biologics are not even administered the same as human drugs.
The FDA’s Warning Letters that were sent in 2020 are the very reason RLC Labs stopped making Nature-Throid. And, since AbbVie the maker of Levothyroxine and Armour Thyroid, won’t have any trouble is because they already make Biologics and they make Levothyroxine (along with another dozen or so generic drug manufacturers). No wonder they have so many recalls, if a dozen different manufacturers are making the same drug how is a person to know if they are getting the same drug each time?
I cannot take synthetic levothyroxine because it is synthetic T4 and is therefore ototoxic to my ears. NDT is NOT synthetic T4 and does not cause ototoxic damage. As an NDT only patient I would be unable to ever take any form of levothyroxine. This is all pretty scary to someone like me.
Hi K,
Just so you are aware, the T4 found in NDT is the exact same as that found in levothyroxine, the only difference is the sourcing. But to the body, there’s nothing different about the compound. It would be similar to isolating water from a toilet versus water from the ocean, at the end of the day, the molecular compound is stll h2o and the body doesn’t care about the source so long as it’s clean.
This is a point of confusion for many thyroid patients who incorrectly believe that there is something inferior about thyroid medication sourcing. There isn’t. What is true, however, is that NDT provides a more complete thyroid hormone profile that often results in better symptom control, but you can obtain similar benefits by taking multiple thyroid hormones in addition to levothyroxine.
Ok, I hear what you’re saying. I have had vestibular damage from ototoxic medications in the past. To be fair, T3 itself can be ototoxic. Under or over, damage can happen to ears. I tried a very low dose Levo mixed with my NDT and sustained vestibular damage. It is possible that with the extra T4 it pushed me over on T3, since my body was converting AND getting it from NDT. I have actually wondered about this. I honestly hope you’re right. My life would be a lot easier if I could take Levo. Too bad I am too scared to try it again. Vestibular damage is permanent and life altering. Thank you, though. This is giving me food for thought.
Hi K,
Yes, you are correct, but the toxicity is T3 is dose-dependent. That means you can get the same negative side effects by taking too much T3 from any source, whether that be from Cytomel or whether that be from NDT.
Glad you found the information helpful!
The sourcing of the material- My understanding is that some of us have DNA variations that make synthetic formulations hard to process. Our bodies struggle, and it creates a difficult load. I don’t feel good on synthetic thyroid. I also have a hard time with other synthetic things. My DNA is one of those that can’t process synthetic items. While I have been told many times that there is no difference, my body would say otherwise.
Hi Danielle,
It sounds like you are referring to the inactive ingredients, and if that’s the case, what you are seing is true. But the fact that the excipients can cause individual problems says nothing about the efficacy of the active ingredients themselves. If your argument is that some people react negatively to the inactive ingredients, I would agree with you.
If your argument is that there is something inherently problematic about synthetic sourcing, I would not.
As I mentioned previously, once the hormone is created, your body cannot tell the difference between the molecular structure of T4 sourced from levothyroxine or that sourced from NDT. They are identical at the molecular level in the same way that water sourced from the toilet and water sourced from the ocean are identical as well.
There’s no physiological mechanism in your body that can identify the sourcing of any compound. Instead, the body reacts based on the structure of the compound itself.
This is a major point of confusion among thyroid patients because they have been incorreclty taught to believe that sourcing matters, but there’s absolutely no data to support this. This idea stems from the fact that people do better on NDT versus levothyroxine, which is generally true, but the reason for this is explained in the hormone content, not the source.
I am violently allergic to synthetic thyroid meds — what am I going to do? They do sell desiccated thyroid over-the-counter in organic food stores. Is there a way to figure out the dosage using those? This is a disaster for me.
Hi Lora,
This is stressful for sure, but the good news is that you still have options. Even if you don’t tolerate synthetic combination medications, you may still do well on medications such as Tirosint or Tirosint-SOL. These tend to be much cleaner formulations without the typical fillers and dyes that cause reactions for some patients.
If you prefer a more natural approach, there are also over-the-counter desiccated thyroid glandulars that can be used for support. One example is my Thyroid Glandular+, which contains naturally sourced thyroid gland powder and can be found here:
https://www.restartmed.com/product/thyroid-glandular/
I formulated it to contain 150 mg of thyroid gland powder with all of the extracts, hormones, and components you’d expect to find inside your own thyroid gland. Most people use 2-4 capsules per day (300 to 600 mg).
I had thyroid cancer and tried every synthetic available. I would never level. My life was a nightmare. I went to my third doctor and she prescribed Armour Thyroid for me. I have been level now for 10 years. I don’t even level on NP. I am begging that something be done.
After 2.5 years of pleading with Endos for NDT, my fourth consented and it was LIFE CHANGING! The first dose relieved aches, pains, stiffness, inflammation and depression. I felt normal for the first time!
I was on T4/T3. I took supplements including bovine thyroid and T2, additional medications that never helped, and even acupuncture.
But I know my body does better on naturals than synthetics.
Taking a raw dog feeding course taught me that “one element” synthetic vitamins dont support/improve/cure like a natural vitamin whose components synergistically work together.
I believe this is why body responded so positively!
Is there a medication that works for everyone 100% of the time? This is short sighted and cruel.
FYI: AZ congress rep Abraham Hamadeh website sounds like these decisions were more ego/retaliatory than medical. He is asking for the FDA to cease enforcement. Writing my reps to get onboard!
I read that the FDA person wanting to get rid of NDT has left FDA. Was he fired?
Since it is banned, insurance no longer covers it. Since my husband is losing his job due to kidney failure and dialysis, etc., I will not be able to pay for my prescription of NP 75mg any longer. Does anyone know affordable options or more realistically, how long do I have to live?
I take porcine thyroid with rice flour compounded. I literally am allergic to any synthetic medicine I have tried them all. I get to a certain level and my body starts acting like I’m over dosing and my heart goes nuts. I have proof from the medical test that my doctor performed. I don’t understand why they think they have the right to take something natural force people to take synthetic. I will actually die without this. They’re signing my death sentence right now. I don’t know why they have this as their MO but they’re destroying peoples lives.
Hi Theresa,
I understand the frustration, but the good news is that nothing has been taken away yet and I believe it is unlikely that they will. The latest update is that the FDA will draft up guidance outlines for those who manufacture it and that will be released in August of 2026: https://www.fda.gov/media/191621/download?attachment