September 18, 2025 – Hypothyroidism is a common endocrine problem affecting mostly women. If untreated, it leads to impaired quality of life and function. The standard therapy for hypothyroidism, as recommended by the American Thyroid Association® (ATA), is synthetic levothyroxine, a safe and effective therapy. The US Food and Drug Administration (FDA) regulates levothyroxine medications to ensure bioavailability, dose equivalence, potency, and purity. A subset of patients with hypothyroidism elect to take desiccated thyroid extract (DTE) as therapy for their hypothyroidism. DTE is produced from purifying and drying the thyroid glands of pigs. In addition to this porcine source, bovine and ovine preparations have been available. Although DTE was the first therapy for hypothyroidism, prior to the synthesis of levothyroxine, DTE has never been regulated by the FDA. This is because the use of this product predates the current approval process and because DTE is an animal-derived product. While it is not recommended by the ATA as first-line therapy, the ATA recognizes that it is the treatment of choice for some patients. As such, the ATA supports the principle of personalized patient therapy.
Recently the FDA issued a statement of concern regarding the unregulated nature of these products and on August 6, 2025 sent letters to DTE manufacturers announcing their intention to ban DTE from the marketplace. In this communication, they suggested that patients work with their physicians to transition to FDA-approved products over a 12 month period. The ATA is aware that some patients taking DTE may not wish to transition to an alternative thyroid hormone replacement.
The FDA is now proposing that manufacturers of DTE submit an application through a regulatory pathway outlined under section 505 of the Federal Food, Drug, and Cosmetic (FD&C) Act, which applies to biologic products. The ATA supports evidence-based patient guidance, supported by high quality clinical research on the safety and efficacy of thyroid hormone replacement products. The ATA also supports regulations that ensure medication purity and consistency. The FDA’s identification of significant violations of current good manufacturing practice for DTE products is alarming. However, removal of the DTE from the marketplace during a potentially lengthy biologics license application would leave patients without access to DTE for an unknown period of time.
The ATA supports the principle of patient access to all safe and effective therapies for hypothyroidism. A regulatory approach that ensures the highest standards for DTE safety and reliability will ultimately benefit patients. The ATA is committed to working with the FDA, clinicians providing care for patients with hypothyroidism, patients, patient support organizations, and industry partners to ensure that safe and effective personalized hypothyroidism treatment remains available to all. The ATA is the leading professional medical society focused on thyroid diseases with recognized expertise in their treatment. The expertise of ATA was highlighted by the FDA in their recent statement. ATA’s vision, “Optimal Thyroid Health for All,” guides the organization in all areas, especially in the production of resources for clinicians and patients which are available through its website.
About the American Thyroid Association® (ATA)
The ATA® is dedicated to transforming thyroid care through clinical excellence, education, scientific discovery and advocacy in a collaborative and diverse community. ATA® is an international professional medical society with over 1,700 members from seventy countries around the world.
The ATA® promotes thyroid awareness and information through its online Clinical Thyroidology® for the Public (distributed free of charge to over 12,000 patients and public subscribers) and extensive, authoritative explanations of thyroid disease and thyroid cancer in both English and Spanish. The ATA® website www.thyroid.org serves as a trusted clinical resource for patients and the public looking for reliable thyroid-related information.
AMERICAN THYROID ASSOCIATION® , ATA® , THYROID® , CLINICAL THYROIDOLOGY® , and the distinctive circular logo are registered in the U.S. Patent and Trademark Office as trademarks of the American Thyroid Association® , Inc.