A new bill in the House could finally put an end to the FDA’s regulatory sleight of hand that threatens to eliminate compounded natural desiccated thyroid (NDT) for the 1.5 million Americans who depend on it. Action Alert!
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THE TOPLINE
- The PEAT Act of 2026, introduced by Rep. Michael Rulli (R-OH) and Rep. Diana Harshbarger (R-TN), would block the FDA from classifying a product as a biologic based solely on the presence of a clinically inactive protein — the exact justification the agency has used to reclassify natural desiccated thyroid (NDT) and threaten its availability.
- The FDA’s reclassification of NDT as a biologic hinges on the presence of thyroglobulin, a protein that does not provide any therapeutic benefit — the actual active hormones in NDT are levothyroxine (T4), liothyronine (T3) and reverse triiodothyronine (rT3), small molecules that have nothing to do with biologic regulation.
- For the millions of patients who rely on compounded NDT because synthetic alternatives have failed them, this bill is a crucial piece of health freedom legislation.
For years, ANH-USA has been sounding the alarm about the FDA’s campaign to eliminate patient access to natural desiccated thyroid (NDT). Now, Congress is finally pushing back.
Representative Michael Rulli (R-OH), joined by Representative Diana Harshbarger (R-TN), has introduced the Protecting Equal Access to Thyroid (PEAT) Act of 2026. The bill is straightforward: it would amend the Public Health Service Act to prohibit the FDA from treating a product as a biological product based solely on the presence of a protein that is a clinically inactive component.
If enacted, the bill would retain consumer access to NDT and compounded NDT—a lifeline for countless patients whose lives rely on these medicines.
What the FDA Has Been Doing
As we’ve reported in depth, the FDA issued letters in August 2025 to manufacturers, importers, and distributors declaring that NDT products — including both commercial products like Armour Thyroid and compounded formulations — are unapproved biologics. The agency’s justification? The presence of thyroglobulin, a protein found in porcine thyroid tissue used to make NDT.
Here’s the kicker: thyroglobulin is an inactive ingredient. It provides no therapeutic benefit. The clinical value of NDT comes entirely from the interplay between the natural forms—derived from thyroid glands of pigs or cattle—of three well-understood hormones, T4 (levothyroxine [thyroxine]), T3 (liothyronine [triiodothyronine]) and rT3 (reverse triiodothyronine), the very same versions of the hormones produced by the human thyroid. The FDA’s own guidance has long recognized that a product containing a protein only as an inactive ingredient is not considered a “protein” for biologic classification purposes.
In doing this, the FDA is, in our view, creating a regulatory pretext to remove a medicine that competes with Big Pharma’s synthetic thyroid drugs — drugs that simply don’t work for a significant share of the over 30 million Americans with hypothyroid conditions.
Why This Matters for Patients
Synthetic T4-only drugs like levothyroxine and Synthroid are the standard of care for hypothyroidism in conventional medicine. But the human thyroid produces five hormones — T1, T2, T3, T4, and calcitonin — and for many patients, T4 alone is not enough. A significant portion of the population cannot efficiently convert T4 to T3, and without adequate T3, symptoms like debilitating fatigue, depression, weight gain, and brain fog persist even when labs look “normal.”
Compounded NDT can fill these gaps. Compounding pharmacies can tailor doses, delivery mechanisms, and hormone ratios to match what individual patients need. This is the whole point of compounding — it exists precisely because one-size-fits-all commercial products don’t work for everyone.
If the FDA’s biologic reclassification stands, that option disappears. Biologics cannot be compounded by traditional compounding pharmacies. Patients who have finally found something that works for them would be forced back to drugs that don’t, with no path to the individualized care their condition requires.
What You Can Do
Getting the PEAT Act out of committee and to the floor requires sustained pressure from constituents who make clear to their representatives that this issue matters.
If you or someone you love depends on compounded NDT, your voice carries weight here. Contact your representative and ask them to cosponsor the PEAT Act. Tell them what compounded NDT has meant for your health. Tell them that the FDA’s biologic reclassification is a regulatory maneuver that would harm real patients without any corresponding benefit to public safety.
Action Alert!
