The FDA under the leadership of Acting Commissioner Kyle Diamantas is poised to eliminate access to compounded natural desiccated thyroid. For patients who depend on individualized thyroid treatment, the consequences could be devastating. Action Alert!
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THE TOPLINE
- FDA is maintaining its position that natural desiccated thyroid (NDT/DTE) is a “biologic”, not a conventional drug, which means compounded NDT would not be permitted.
- The policy could affect a large patient population: FDA estimates about 1.5 million patients received animal-derived thyroid prescriptions in 2024; some patients depend on NDT because synthetic thyroid medicines or standard commercial formulations do not meet their individual needs.
- We must urge Congress to pass the Protecting Equal Access to Thyroid Act of 2026 (PEAT Act, H.R. 8630), which would prevent a medicine from being classified as a biologic solely because it contains a clinically inactive protein, preserving a legal pathway for compounded NDT.
The Food and Drug Administration has issued a new statement on “unapproved” animal-derived thyroid medications, often called desiccated thyroid extract (DTE) or natural desiccated thyroid (NDT).
In an August 5 letter to industry, FDA said it is still working on guidance explaining how it plans to enforce its policies for these medicines and how manufacturers might seek approval for them.
Crucially, the FDA has reiterated that animal-derived thyroid medicines are biological products (“biologics”) and therefore cannot legally be compounded. Unless Congress acts, patients could lose access to compounded NDT as well as other commercially available products.
Why Is NDT Under Threat?
Millions of Americans rely on thyroid hormone replacement, and FDA estimates that about 1.5 million patients received prescriptions for animal-derived thyroid medicines in 2024.
For some patients, standard synthetic thyroid drugs work well. But they do not work for a significant share of the over 30 million Americans with hypothyroid conditions. We’ve explained why in prior articles.
Some patients feel best on NDT products such as Armour Thyroid. Others rely on compounded NDT because they need a dose, formulation, or combination that commercially manufactured products do not provide. The FDA’s actions threaten access to both kinds of products.
As ANH has previously explained, FDA is treating NDT as a biologic because it is derived from animal thyroid tissue and contains proteins, including thyroglobulin. Biologics are governed by a different regulatory law than conventional drugs. But the FDA’s interpretation is in our view simply incorrect. As ANH has pointed out, thyroglobulin is not what gives NDT its therapeutic effect. The active thyroid hormones are primarily T4 and T3 and these are incredibly well and easily characterized. FDA affirms that biologics have to be treated differently to conventional, synthesized drugs because “most biologics are complex mixtures that are not easily identified or characterized”. This reasoning just doesn’t apply to NDT.
Traditional pharmacy compounding is permitted for drugs under the Federal Food, Drug, and Cosmetic Act. But FDA’s position is that NDT falls under the Public Health Service Act instead. In FDA’s view, that means compounded NDT is illegal.
So even if a pharmaceutical company eventually wins FDA approval for a commercial NDT product, that would not necessarily protect patients who need customized compounded versions. Those patients could simply lose their medicine.
This Is About Real Patients, Not Regulatory Categories
For someone who has finally found a thyroid treatment that works, being forced to switch is not a minor inconvenience.
Thyroid treatment can be highly individual. Even small changes in dose or formulation can mean a return of fatigue, brain fog, weight changes, mood problems, temperature sensitivity, and other symptoms that can make everyday life difficult.
Patients who have spent months or years working with their doctors to become stable should not suddenly be told that their treatment is unavailable because FDA has placed it in a different regulatory box.
These issues are all-too-real for many patients, including ANH’s own Meleni Aldridge. Check out the clip below from our upcoming podcast series, The Mike Drop.
The goal should be safe, high-quality NDT with room for doctors and patients to choose individualized treatment when needed. Instead, FDA bureaucrats are replacing the clinical decision-making of doctors and patients.
Congress Can Stop This
The Protecting Equal Access to Thyroid Act of 2026 (PEAT Act, H.R. 8630) directly addresses the legal argument FDA is using against compounded NDT.
The bill would make clear that a medicine cannot be classified as a biological product solely because it contains a clinically inactive protein.
If Congress passes the PEAT Act, it could help preserve a pathway for compounded NDT and protect patients from being forced off treatments that work for them.
Take Action Now
Patients should not have to choose between accepting a treatment that does not work for them and going without the medicine they depend on.
FDA has made its position clear. Now Congress must act to protect access to natural thyroid medicine before patients lose it.
Action Alert!
