The FDA's Natural Desiccated Thyroid Reversal: A Victory for Medical Freedom
Aug 18, 2025Author: Jeffrey Wacks, MD
A Week That Showed the Power of Patient Advocacy
In a stunning display of regulatory overreach followed by rapid retreat, the FDA provided a perfect example of why medical freedom remains under constant assault—and why fighting back works.
On August 6th, 2025, the FDA sent letters threatening enforcement action against Natural Desiccated Thyroid (NDT) manufacturers, moving the compliance deadline from 2029 to August 2026. Just one week later, after intense public backlash, FDA Commissioner Dr. Marty Makary reversed course, posting on X that the agency would "ensure access for all Americans."
FDA is committed to pursuing the first-ever approval of desiccated thyroid extract, pending results of the ongoing clinical trials. In the mean time, we will ensure access for all Americans.
— Dr. Marty Makary (@DrMakaryFDA) August 14, 2025
This wasn't just a bureaucratic correction—it was a victory for the 1.5 million Americans who depend on these century-old thyroid medications.
The Assault on Time-Tested Medicine
Natural Desiccated Thyroid represents everything that threatens the modern pharmaceutical establishment. Derived from pig thyroid glands, NDT has successfully treated hypothyroidism for over 100 years, containing both T4 and T3 hormones in ratios many patients find more effective than synthetic alternatives.
But NDT's strength—its long history of safe use—became its regulatory weakness. Because these medications predate modern FDA approval processes, they're classified as "grandfathered" drugs that are regulated but not "approved." This technicality made them a target for agencies prioritizing bureaucratic compliance over patient outcomes.
The timing is revealing. The FDA letters were sent during a 10-day period when Dr. Sarah Tidmarsh was Acting Director of the Center for Biologics Evaluation and Research. Tidmarsh had previously posted on LinkedIn: "The new FDA needs to remove harmful, useless drugs from the market. Let's start with desiccated thyroid extract."
When patients have a medication that works—often after years struggling with synthetic alternatives—removing that option isn't protecting public health. It's abandoning the principle that medicine should serve patients, not regulatory convenience.
Our Response to Dr. Tidmarsh on the Utility of NDT in the Treatment of Primary Hypothyroidism
With all due respect to Dr. Tidmarsh, her statement on NDT is ridiculous. There is no strong data that shows that NDT is inherently harmful. The concerns are theoretical and surround quality control and consistency concerns, which are legitimate, but that is not what she is saying. It is one thing to say "Levothyroxine monotherapy is the standard of care in conventional endocrinology," but she is misleading the public by saying the drug itself is so unsafe that the FDA needs to intervene and ban it from the market. This is completely false. Hoang et al.1 showed that NDT was superior to Levothyroxine in terms of weight loss and patients tended to prefer this treatment. In general, patient satisfaction is higher with NDT over LT4 monotherapy.2,3,4 Studies show NDT is particularly effective for the treatment of hypothyroidism in Levothyroxine-unresponsive patients.5,6 At the very least, NDT is noninferior to levothyroxine monotherapy and in our opinion should be part of the standard of care for levothyroxine-unresponsive patients. Dr. Tidmarsh's statement is a reflection of establishment bias and institutional arrogance - it has no basis in science.
The Power of Pushback
The remarkable reversal demonstrates the power of organized patient advocacy. Within days, social media erupted with opposition from patients, doctors, and advocates. Functional medicine doctor Will Cole warned that "millions rely on these for hypothyroidism who don't respond well to synthetic thyroid pharmaceuticals." Dr. Robert Malone called it "terrible news—particularly for postmenopausal women."
This grassroots response, amplified by the "Make America Healthy Again" movement's focus on natural treatments, created enough pressure to force the FDA's hand. In an era when regulatory agencies often seem insulated from public opinion, this rapid reversal shows that persistent advocacy still works.
The Broader Pattern
The NDT controversy fits a troubling pattern of regulatory agencies prioritizing control over choice. Whether it's restrictions on compounded medications, attacks on supplement freedom, or limits on alternative treatments, there's a consistent thread of agencies working to narrow rather than expand patient options.
This approach misunderstands medicine's nature. Patients aren't identical; what works for one may fail for another. The goal should be expanding the toolkit available to patients and physicians, not constraining it for administrative convenience.
Vigilance Required
While the FDA's reversal is encouraging, this fight is far from over. The agency committed to pursuing formal approval of NDT medications, but the biologics approval process is lengthy, expensive, and uncertain. Smaller manufacturers may lack resources to navigate this process, potentially leaving patients with fewer options and higher costs.
The underlying regulatory mindset that led to this controversy hasn't changed. The impulse to restrict rather than protect access to time-tested treatments remains embedded in our system. Without continued vigilance, future attacks on medical freedom are virtually certain.
The Principle at Stake
Beyond thyroid medications lies a fundamental question: Should regulatory agencies have power to remove treatments that patients and doctors find effective, simply because they don't fit current administrative processes?
The answer should be no. Medical regulation's purpose should be ensuring patients have access to safe, effective treatments—not forcing uniformity for its own sake. When agencies use power to narrow patient options rather than protect patient welfare, they're exceeding their proper role.
Medical freedom isn't about eliminating safety standards; it's about preserving the right of patients and physicians to choose treatments that work, even if they don't fit bureaucratic preferences or pharmaceutical profit models.
Conclusion: The Fight Continues
The FDA's NDT reversal represents a victory for medical freedom, but also a reminder of how precarious that freedom remains. In one week, we saw how quickly decades of patient access can be threatened—and how powerful organized advocacy can be in defending it.
This should serve as a wake-up call for anyone valuing medical choice. The agencies claiming to protect us are capable of restricting our options when it serves their institutional interests. Only sustained public pressure and political accountability can keep them focused on their proper mission.
The fight for medical freedom isn't won with a single victory—it requires eternal vigilance. The NDT reversal shows us both the threat we face and the power we have to resist it. The question is whether we'll stay engaged enough to use that power when the next attack comes.
Because it will come.
References:
- Hoang TD, Olsen CH, Mai VQ, Clyde PW, Shakir MK. Desiccated thyroid extract compared with levothyroxine in the treatment of hypothyroidism: a randomized, double-blind, crossover study. J Clin Endocrinol Metab. 2013;98(5):1982-1990. doi:1210/jc.2012-4107
- Peterson SJ, Cappola AR, Castro MR, et al. An Online Survey of Hypothyroid Patients Demonstrates Prominent Dissatisfaction. Thyroid. 2018;28(6):707-721. doi:1089/thy.2017.0681
- Toloza FJK, Espinoza Suarez NR, El Kawkgi O, et al. Patient Experiences and Perceptions Associated with the Use of Desiccated Thyroid Extract. Medicina (Kaunas). 2020;56(4):161. Published 2020 Apr 3. doi:3390/medicina56040161
- Pepper GM, Casanova-Romero PY. Conversion to Armour thyroid from levothyroxine improved patient satisfaction in the treatment of hypothyroidism. Journal of Endocrinology, Diabetes & Obesity. 2014;2:1055-60.
- Heald AH, Premawardhana L, Taylor P, et al. Is there a role for natural desiccated thyroid in the treatment of levothyroxine unresponsive hypothyroidism? Results from a consecutive case series. Int J Clin Pract. 2021;75(12):e14967. doi:1111/ijcp.14967
- Shakir MKM, Brooks DI, McAninch EA, et al. Comparative Effectiveness of Levothyroxine, Desiccated Thyroid Extract, and Levothyroxine+Liothyronine in Hypothyroidism. J Clin Endocrinol Metab. 2021;106(11):e4400-e4413. doi:1210/clinem/dgab478
