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August 18, 2025 18 mins

A century-old medication suddenly deemed unsafe? The FDA's unexpected crackdown on desiccated thyroid extract (DTE) has left 1.5 million Americans questioning their treatment options and wondering about the true motivations behind this regulatory move.

Desiccated thyroid extract—ground-up pig thyroid glands turned into pill form—has been helping patients feel human again since the late 1800s. These natural thyroid medications contain both T4 and T3 hormones, making them particularly valuable for patients who struggle with conversion issues. When synthetic options like Synthroid (which contains only T4) leave patients with normal lab results but persistent symptoms, DTEs have historically provided relief.

The FDA's recent letters to manufacturers reclassify these medications as biologics, placing them in the same category as vaccines and monoclonal antibodies. This move requires manufacturers to complete Biologics License Applications within just 12 months—a process typically costing over $100 million and requiring extensive clinical trials. For medications that represent only 6% of the thyroid market, this financial hurdle is effectively insurmountable.

The timing and nature of this decision raise serious questions. Why, after more than a century of safe use, is the FDA suddenly concerned about medications that have helped millions? Could the fact that 1.5 million DTE users would be funneled toward synthetic options produced by pharmaceutical giants be relevant? While the FDA cites concerns about standardization (DTEs are dosed in "grains" rather than micrograms) and purity, many patients and practitioners see this as a thinly veiled attempt to eliminate patient choice and competition.

As a functional medicine practitioner, I understand that thyroid health doesn't exist in isolation. Mineral balance, adrenal function, gut health, and toxic burden all play crucial roles in thyroid function. If you're currently using DTE, don't panic—work with a knowledgeable provider to develop a transition plan. Testing like Hair Tissue Mineral Analysis can reveal underlying factors affecting your thyroid health, allowing for targeted support as you navigate these changes.

Your body deserves more than a one-size-fits-all approach. Visit harmonyhubhealth.com to book a consultation and create a personalized plan that addresses the root causes of your thyroid concerns while navigating this changing regulatory landscape.

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Episode Transcript

Available transcripts are automatically generated. Complete accuracy is not guaranteed.
Speaker 1 (00:01):
Welcome to Harmony Hub Health, where my mission is
to provide comprehensive,affordable, integrative care
that addresses the root cause ofhealth issues.
At the Hub, the focus is onindividual patient journeys.
I strive to optimize health,vitality and longevity,
fostering a community where eachperson can thrive in body, mind
and spirit.

(00:21):
Today I'm going to talk aboutthe world of desiccated thyroid
extract, also known as DTEs.
It's the old school pig derivedthyroid medicine that's been

(00:44):
helping people feel like humansagain for over a century.
But now the FDA has decided tocrack down and the timing has me
raising an eyebrow.
Is this really about safety oris it just another move by big
pharma to hog pun intended allthe hormones and keep a monopoly
on thyroid medications likeSynthroid?
We're going to dig in becausethe debate over pig pills,

(01:07):
patient choice and profitmargins is really heating up in
my head.
Desiccated thyroid extract,known as the DTEs think Armour
Thyroid, np Thyroid, natureThroid.
You know they all have rootsstretching back to the late
1800s.
They're made from dried andpowdered animal thyroid glands,
often porcine pig.

(01:28):
It contains a blend of T4, t3,and some other thyroid
components.
Over time, syntheticlevothyroxine, which is
synthetic T4, and lyothyronine,which is synthetic T3, overtook
DTE in popularity because of bigpharma, but, despite its

(01:48):
historical use, the majority ofUS patients now use synthetic
hormone replacements.
It's covered by their insurance.
In 2024, about 94% of some 24million thyroid replacement
users received syntheticlevothyroxine, while only about
1.5 million, or 6%, do rely onthose DTEs.

(02:13):
And you would think, after 100plus years of helping people,
desiccated thyroid extractswould be considered a safe bet.
It's been over 100 years.
It's literally the OG thyroidmedicine pig thyroid ground up,
turned into a pill.
I know it doesn't sound verysexy at all, but very effective
for millions of people.

(02:34):
Absolutely, it is effective,and it has been for over a
hundred years.
But now, in 2025, the FDA,clutching their pearls,
announces that these naturalmedications are unsafe and not
approved anymore.
They need to come off of theshells, and this is where I have
to roll my eyes.
For as long as I've been aprescriber which has been what

(02:57):
the last 15 years um, armorthyroid has been a great
treatment.
It does mix um some natural T4and T3, even some extras like T2
in some of these DTEs, and formany people it worked when
synthetics like levothyroxinedid not.
I mean, these medicines havebeen used before women even had

(03:21):
the right to vote.
I have seen so many patientsthat have a conversion problem.
They cannot convert T4 to T3.
But the FDA is suddenlytreating it like a sketchy new
fad supplement that you'd findon TikTok.
On August 6, 2025, the FDAissued letters to manufacturers,

(03:41):
importers and distributors ofunapproved animal-derived
thyroid products.
The agency states that theseproducts lack FDA-approved
biologics license applicationthis is known as BLA and they
pose a safety, purity, potencyand consistency concerns.
And I have to agree, you know,sometimes dosing isn't perfectly

(04:05):
consistent, but neither isStarbucks coffee and we're all
still addicted.
One of the quirks of desiccatedthyroid extract is how it is
dosed.
Unlike Synthroid, which comesin neat little microgram pills
like 25 micrograms, 50micrograms DTE is dosed in
grains.
So yes, it sounds like we'remeasuring rice at a health food

(04:25):
store, but it is a little bitmore precise.
So one grain is about 60 to 65milligrams of DTE.
That typically contains 38micrograms of T4, 9 micrograms
of T3, give or take depending onthe brand.
So dosing can be anywhere fromhalf a grain to several grains
per day, depending on the brand.
So dosing can be anywhere fromhalf a grain to several grains
per day, depending on thatperson's needs.

(04:49):
And FDA is saying that grainsaren't standardized enough.
And okay, fine, grains do sounda little wild west compared to
milligrams and micrograms.
But let's not forget, millionsof people have been dosing this
way for over a century withoutspontaneously combusting.
In fact, patients andpractitioners often prefer

(05:11):
greens because you can titratethese doses in small increments,
like a quarter of a green, halfa green, to fine tune how a
patient feels.
And DTE already contains T3.
So people who don't convert T4to T3, they can really feel the
difference and the dosingflexibility often beats that one

(05:32):
size fits all Synthroid script.
So, yes, grains might not fitBig Pharma's shiny standardized
pill chart, but for patients whofinally got their energy, their
metabolism and their sanityback, grains make perfect sense.
The FDA is also saying thatbecause it comes from pigs.
You know there can be someimpurities, but I don't see them

(05:53):
pulling bacon off the shelfeither.
And then they're saying wedon't have modern clinical
trials.
But all that translates to meis well, big pharma didn't pay
to run billion-dollar studies.
I think the biggest plot twistis now the FDA just reclassified

(06:13):
these as biologics.
This is the same category asvaccines and monoclonal
antibodies.
That means that compoundingpharmacies can't even touch it.
Big Pharma just pulled the rugout from natural thyroid and the
FDA is holding the flashlight,since it's classified as a
biologic.
I mean, this is the same bucketas insulin.
Okay, companies that make itwould need to file for this BLA

(06:38):
to keep it on the market, whichsounds simple right, just fill
out some paperwork.
No, the BLA requires that youhave extensive clinical trials.
So companies would need to runlarge, modern studies proving
safety, efficacy and consistency.
And yes, even though thismedicine has been used for 100
plus years, we're talkingmulti-million dollar studies

(07:01):
that only big pharma can afford.
But smaller DTE makers there'sno way They'd have to prove
every single batch is consistentin potency, purity and quality.
That means super tight labcontrols and reporting, which is
very expensive.
It would mean kicking out thegrains and moving to milligrams
and micrograms.

(07:21):
They would have to modernizedosing standards that satisfy
the FDA and they would have tocollect ongoing safety data and
report adverse effects long-term.
But the FDA is only given 12months for all of this to happen
, and a BLA is not cheap.
It's estimated to range from$100 million plus just to get a

(07:43):
biologic through the pipeline.
So for these medications likeDTE, which already has a tiny
share of the thyroid market.
It is financially impossible.
A company could get DTE FDAapproved under a BLA, but you'll

(08:05):
never be able to do that within12 months, which is the
timeline of getting itcompletely off the market,
unless big pharma, you know,decides to bankroll it.
This move basically pushessmaller thyroid manufacturers
out of the game and this is whya lot of patients are calling
foul, because it looks like asafety measure, but it really

(08:25):
looks more like big pharmahogging the whole hormone trough
.
And I felt like before bigpharma already had the monopoly.
Think of 24 million Americansthat take thyroid medications.
94% of those are takinglevothyroxine.
You know, that's Synthroid andall of its generics.
6% are on a DTE.
This is what they've shown in2024.

(08:47):
And that's still 1.5 millionpeople who actually feel better
on pig thyroid.
But if they take the DTEs offthe market, that's also 1.5
million new customers funneledright into Big Pharma's
Synthroid Monopoly.
So if you're thinking, hmm,that's convenient, same me too.

(09:10):
So what do patients do now thatthere's only 12 months to figure
out the next plan?
And most thyroid warriorsalready know that thyroid
doesn't live in a vacuum.
So functional medicine does seethyroid function as a pillar of
health that's deeply influencedby your minerals, your adrenals
, your gut health toxins.

(09:32):
So this is how I'm going tohelp my patients navigate what
to do next.
Because levothyroxine cannormalize your labs, but it can
also leave you feeling like azombie.
That's because many patientscannot convert T4 into T3, which
is the active thyroid hormoneand the DTEs.

(09:53):
They bypass that issue becauseit already has that natural T3.
And this is what makes patientsfeel so good.
You often hear people say, oh,I'm on Synthroid.
My doctor said my labs lookgood, but I don't feel good, I'm
still exhausted, I still havehypothyroid symptoms On those
DTEs.
They feel like a functioninghuman again.

(10:15):
So when the FDA says, oh, don'tworry, just switch back to
Levothyroxine, people are notbuying it.
Says, oh, don't worry, justswitch back to live with
thyroxine, people are not buyingit, literally or figuratively.
So how do we navigate the next12 months and what would you do?
Most people are already seeinga functional medicine provider
because they did not want thesynthetics.
They did not want the synthroid.

(10:36):
But maybe you haven't.
Maybe this was just somethingbecause your doctor was really
smart and put you on thisbecause it's been around for
over 100 years.
But if you are a thyroidwarrior, you already know that
your thyroid doesn't live in avacuum.
Functional medicine does seethis holistically that your

(10:56):
thyroid function as a pillar ofhealth.
It's deeply influenced by yourminerals, by your adrenals, by
your gut health, by toxins.
This is why I love that HTMA,which is the hair tissue mineral
analysis test, and we use it tomeasure long-term mineral
patterns and toxic metal loads.
Usually I do find low selenium,which you need to convert T4 to

(11:20):
T3, or I find high mercurythat's blocking those thyroid
enzymes.
And guess what?
Synthroid cannot fix that?
It can't fix any of that.
So what you can do to navigatethis thyroid soap opera.
Number one is talk to yourprovider, especially one who
actually listens.
That's where the hint comes.

(11:40):
In Functional medicinepractitioners, we are the
listeners, because thistransition plan really matters.
It's how your whole metabolism,how your whole body, is going
to function.
If you are not seeing afunctional medicine provider, I
would love to see you at HarmonyHub Health.
Number two is demand betteroptions.
Call your representatives.

(12:01):
I've already seen multiplepetitions going around.
You can sign that to make somenoise.
Remember the squeaky wheelright Always gets oiled If
enough patients push back.
The FDA has been known toreconsider.
So you can see a functionalmedicine provider to help
support your thyroid naturally.

(12:21):
You can see a functionalmedicine provider to help
support your thyroid naturally.
That would mean, you know,looking at your mineral balances
, you know selenium helpsconvert T4 to T3.
Zinc supports hormoneproduction.
Magnesium calms your adrenalsand helps your thyroid enzymes
and detox.
So HTMA can reveal hidden heavymetals that slow your thyroid

(12:43):
down.
You want to think whole bodyhealth.
You know thyroid health is soconnected to the stress that
you're living under, the guthealth, your liver and how it
detoxes, and even your sleep.
So we need to fix the terrain,not just the lab number.
The FDA says it's all aboutsafety.
Big Pharma says it's all aboutscience.

(13:04):
Patients say it's all aboutchoice.
So your body is not a businessplan.
If you feel best on DTE, youdeserve access, I think, period.
So is this really aboutprotecting patients or is it
protecting Synthroid's marketshare?
Tell me.
My eyebrow was raised becauseI'm really feeling suspect.

(13:25):
If the FDA has you stressed outabout your thyroid meds, please
just take a big deep breath.
You do have options, but youalso need a plan.
This is not the time to DrGoogle your way through thyroid
chaos.
At Harmony Hub Health, Ispecialize in functional
medicine, thyroid optimization.
That means that I look justbeyond your normal labs to get

(13:47):
to the root the mineralbalancing your gut health, your
adrenal support and helping younavigate without the DTEs, even
if it means synthetictransitioning.
You don't have to stumblethrough this change alone.
I can help review your currentthyroid treatment and options.
I can test deeper with HTMA,more thorough lab testing,

(14:11):
toxins and a lot more.
We can create a personalizedplan that actually makes you
feel like you again.
So book your thyroidconsultation today at Harmony
Hub Health.
You can go towwwharmonyhubhealthcom.
You can see me virtually or youcan see me in person at Monarch
Beauty and Spa in Manchester,maryland, so I can help you keep

(14:34):
your thyroid and your lifebalanced, fda drama or not.
You could even send me a emailat Michelle.
That's M I, c, h, e, l E atharmonyhubhealthcom.
The information on this podcastis for educational purposes
only and it's not intended asmedical advice.
Please do not start, stop orchange your thyroid medication

(14:56):
without talking to yourhealthcare provider.
Everyone's health situation isunique and what works for one
person may not work for another.
And let me be clear please donot start raising your own pigs
to DIY your own thyroid pills inyour kitchen?
No-transcript.
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