The primary goal of The Thyroid Foundation is to obtain a formal statement from the FDA that clearly states:

• Whether the August 6, 2026 deadline as outlined in the FDA notice to DTE manufacturers in August 2025 threatening to remove Desiccated Thyroid Extract (DTE) from the market will remain in effect in light of Commissioner Makary’s August 13, 2025 tweet promising continued access during the FDA approval process.

Currently, there are 1.5 million Americans currently on DTE products, most of which have not been able to tolerate or have had adverse reactions to FDA approved levothyroxine and/or liothyronine. DTE products have been around for 130 years and were grandfathered in as FDA-regulated treatment options. The top two manufacturers of DTE (Armour and NP Thyroid) are currently in Phase 3 clinical trials vying for FDA approval, but, because these studies take many years to complete, formal FDA approval for these products cannot be feasibly granted by the August 6, 2026 deadline.

Formal FDA guidance is urgently needed to support practitioners, patients, pharmacists, and insurance carriers in planning safe and effective medical care.

Currently, in thyroid clinical practice:

• Insurance carriers are beginning to drop coverage for DTE products, compromising patient access now.
• Pharmacies are electing not to carry DTE product, compromising patient access now.
• FDA never notified physicians, pharmacists, and other DTE prescribers, sending only a letter to manufacturers and distributors. If they expect practitioners and pharmacists to transition patients by a deadline, they need to communicate that formally to practitioners and those prescribing the medication to patients. Many in our community still do not yet know of the impending deadline or need to transition patients. 

Our goal is to get FDA formal written guidance and clarification NOW outlining whether patients will have continued access to these products or if the products will be removed by the August 6, 2026 deadline. 

Limiting treatment options for 1.5 million Americans on DTE products will be catastrophic to thyroid care and we request formal clarification immediately.