The FDA has introduced its intention to ban pure desiccated thyroid medicines used safely by thousands and thousands of hypothyroid sufferers, leaving them with solely an artificial model that’s a lot much less efficient. Motion Alert!
Take heed to the audio model of this text:
THE TOPLINE
- The FDA has acknowledged it plans to take away all pure desiccated thyroid (NDT) merchandise from the market inside 12 months, impacting thousands and thousands who depend on NDT for efficient thyroid hormone substitute.
- Regardless of a long time of protected use and minimal opposed occasion stories, the FDA calls for pricey approval processes that NDT producers can’t realistically meet.
- This enforcement is a part of a broader and long-term sample of proscribing entry to pure and compounded medicines, limiting affected person alternative, and consolidating pharmaceutical business management.
In a devastating blow to well being freedom, the FDA has introduced it desires to get rid of entry to all types of pure desiccated thyroid (NDT) drugs—together with compounded and industrial merchandise corresponding to Armour Thyroid. In an August 6, 2025 letter to producers, importers, and distributors, the company declared these long-used medicines to be “unapproved biologics” and warned that they are going to be topic to enforcement. The FDA has mentioned it would enable solely 12 months of “enforcement discretion” earlier than the ban takes impact, presumably to offer sufferers time to “transition” to FDA-approved artificial thyroid medicine.
This may take away a crucial choice for thousands and thousands of sufferers with hypothyroidism, a situation by which the thyroid doesn’t produce sufficient hormone to maintain wholesome bodily features. An estimated 30 million People have hypothyroidism, and 10–29% of them depend on NDT as their main hormone substitute remedy. That’s as many as 8 million individuals.
Why NDT Issues
NDT is produced from dried, floor pig thyroid glands and accommodates the complete spectrum of thyroid hormones—T1, T2, T3, T4, and calcitonin—carefully mirroring what the human thyroid produces. Artificial, FDA-approved alternate options include just one hormone (both T4 or T3). For a lot of sufferers, significantly those that can’t effectively convert T4 into T3, artificial medicine merely don’t work. Switching these sufferers to a T4-only drug can imply a return of debilitating signs: excessive fatigue, melancholy, weight acquire, mind fog, and extra.
Compounded NDT is much more important for individuals who want personalized dosages or supply programs to match their distinctive hormonal wants—one thing mass-produced medicine can’t do. When thyroid glands aren’t functioning correctly, they hardly ever cease producing hormones fully—they’re producing the mistaken ranges of hormones. Medical doctors should decide the right way to right these imbalances based mostly on noticed hormone ranges in every affected person. Moreover, hormone ranges can fluctuate. That is why the one-size-fits-all FDA-approved choices aren’t adequate for a lot of sufferers.
The FDA’s Skinny Justification
The FDA claims NDT has not been reviewed for security and efficacy and warns about dangers corresponding to inconsistent efficiency and viral contamination. However the company’s personal information reveals simply 500 opposed occasions reported between 1968 and 2025—about 9 instances a yr. That is hardly proof of a public well being risk that warrants eliminating an choice thousands and thousands of sufferers depend on.
The true impediment shouldn’t be security—it’s the company’s demand that NDT undergo the Biologics License Software (BLA) course of. NDT merchandise had been, for many of this century, grandfathered in as pre-1938 medicine (that’s, medicine in use earlier than the passage of the Meals, Drug & Beauty Act of 1938), however a 2010 legislation handed by Congress modified the definition of a “biologic” to incorporate proteins, which, based on the FDA, places NDT and different thyroid hormone medicine into the biologics class.
Like the brand new drug approval course of, the BLA course of shouldn’t be acceptable for NDT. NDT is a posh, naturally derived substance, not a single artificial molecule, making it troublesome and intensely costly to navigate the BLA pathway. That’s one cause no firm has sought approval, and why this enforcement motion is successfully a everlasting ban.
Medical trials are much more infeasible for compounded drug merchandise. Medical trials can’t be performed on compounded medicines given the extremely diversified and individualized doses and supply mechanisms used. That is the entire level behind compounded drugs: to customise medicines to satisfy particular person sufferers’ wants.
Chances are you’ll be questioning: why is that this occurring beneath the management of RFK Jr. and Dr. Marty Makary? First, NDT has been within the FDA’s crosshairs for years—this crackdown was already set in movement lengthy earlier than they took workplace. Second, the authorized points are difficult: as a result of NDT is now labeled as a “biologic” relatively than a drug, altering its regulatory pathway would require an act of Congress, not a choice by the administration alone.
A part of a Greater Sample
This isn’t an remoted incident. The FDA has been systematically eliminating entry to pure medicines that fall outdoors the pharmaceutical business’s mannequin. Bioidentical hormones, compounded peptides, and homeopathic medicines are all beneath assault, with the identical “lack of FDA approval” rationale, no matter their observe data of security and affected person profit.
By insisting that FDA approval is the one reliable commonplace for entry, the company is appearing much less like a protector of public well being and extra like a gatekeeper for Large Pharma, consolidating the market right into a handful of high-cost, patent-protected merchandise whereas stripping sufferers and practitioners of remedy decisions.
What’s at Stake and Name to Motion
If this ban goes ahead, numerous sufferers might be pressured onto medicine that don’t work for them, with actual penalties for his or her well being, livelihoods, and high quality of life. The FDA is successfully telling these sufferers: Your expertise doesn’t matter. Your physician’s judgment doesn’t matter. Solely our approval does.
We should act now to cease this ban and protect entry to NDT. ANH-USA is mobilizing to push again towards the FDA’s overreach and defend your proper to decide on the remedy that works greatest for you. We’re arduous at work on a white paper that may set out methods that we imagine will shield entry to NDT within the short-, medium- and long-term — no matter which administration is in energy. We’re additionally working to deliver collectively the various vary of residents, customers and practitioners. Within the meantime, please ship this crucial Motion Alert to the FDA and your consultant in Congress.
In a devastating blow to well being freedom, the FDA has introduced it desires to get rid of entry to all types of pure desiccated thyroid (NDT) drugs—together with compounded and industrial merchandise corresponding to Armour Thyroid. In an August 6, 2025 letter to producers, importers, and distributors, the company declared these long-used medicines to be “unapproved biologics” and warned that they are going to be topic to enforcement. The FDA has mentioned it would enable solely 12 months of “enforcement discretion” earlier than the ban takes impact, presumably to offer sufferers time to “transition” to FDA-approved artificial thyroid medicine. This may take away a crucial choice for thousands and thousands of sufferers with hypothyroidism.
Write to the FDA and Congress, telling them to cease the assault on pure thyroid!