Alexandria, VA — The Alliance for Natural Health USA (ANH-USA) today announced the release of a new position paper outlining a three-part plan to preserve patient access to Natural Desiccated Thyroid (NDT), a lifeline for hundreds of thousands of Americans with hypothyroidism who do not respond well to synthetic thyroid drugs.
The paper comes in response to recent actions by the U.S. Food and Drug Administration (FDA), which has classified NDT as a biologic—effectively banning compounded forms of the medicine. In an August 6, 2025 letter to manufacturers, importers, and distributors, the agency declared compounded and commercial NDT products to be “unapproved biologics” and warned that they will be subject to enforcement.
Although FDA Commissioner Dr. Marty Makary recently signaled openness to approving commercial NDT products, approval could take years—and there is no guarantee that approved products will meet patients’ needs, especially for hormone profiles and dosing available only through pharmacy compounding.
ANH-USA’s position paper outlines three key steps to protect NDT access:
- Short-term: Reclassify NDT as a drug, rather than a biologic, to allow pharmacy compounding of NDT products.
- Medium-term: Secure FDA enforcement discretion for GMP-manufactured NDT products to ensure continued patient access during the approval process.
- Long-term: Pass federal legislation to create a durable legal carveout for NDT, safeguarding compounded and commercial versions alike from shifting FDA priorities.
“FDA action to remove natural desiccated thyroid from the market denies critical, life-saving care to millions who have safely relied on NDT for years,” said Jonathan Emord, ANH-USA’s General Counsel. “Synthetic substitutes are wholly inadequate replacements,” he continued. “There is no sound justification for declaring NDT a biologic drug unavailable for compounding. The action is motivated by drug company interests that seek to force individuals who have safely relied upon NDT to shift to drug company synthetics that are not comparable and carry with them significant side effects. ANH is acting to keep NDT available through state compounding pharmacies.”
Despite encouraging signals from the FDA, approval of commercial NDT products could take years, and there is no guarantee they will meet the needs of patients who require individualized dosing only compounding can provide. Without swift action, patients could be left in limbo—stripped of access to medicines that have sustained them for decades.
Ron Hoffman M.D., ANH-USA’s Board President and Medical Director, added: “As a practicing physician for over three decades, natural thyroid formulations have been an indispensable tool in management of my hypothyroid patients.”
Dr. Hoffman continued, “Many have complained that synthetic T4 formulations have not alleviated their hypothyroid symptoms. Only when treated with natural thyroid have they achieved clinical euthyroid status. Emerging science validates their safety and efficacy when T4-only medications don’t meet patients’ needs. Restricting their availability would represent a serious threat to their continued well-being. Especially concerning are limitations to be imposed on custom formulations by compounding pharmacies, who offer options for individualized dosing, hypo-allergenic vehicles, and time-release preparations.”
ANH-USA is calling on policymakers, regulators, and the public to stand with patients who rely on NDT and take immediate action.
The full position paper is available here