Ban on Natural Thyroid HRT Rescinded

I’m just home from a week away and came back to several frantic messages and posts about how the FDA has cracked down on unapproved animal-derived, glandular thyroid hormone replacement therapy (HRT). We’re talking naturally desiccated thyroid extracts also known as porcine-derived or natural thyroid therapies including Armour and NP Thyroid.

These formulations of thyroid HRT include T3, the active form of thyroid hormone (aka “the big daddy”). By far, the most popular thyroid hormone replacement is Levothyroxine (Synthroid), which is one of the most prescribed drugs in the U.S. But it’s only synthetic (vs. natural) T4 and inactive (“the lame duck”).

While not tolerated by everyone, the inclusion of T3 is exactly why so many thyroid sufferers, including men, do well on naturally desiccated thyroid.

This announcement sent shockwaves through the thyroid community.

The backlash has been fierce and many have rallied—writing senators and FDA officials, tagging the heck out of them on social, and signing petitions.

Many have referred to this as “a war,” “regulatory capture,” and “medical tyranny.” For over five years, I’ve been extremely vocal about tyranny in the medical community and not going to disagree with those assessments about this situation, which could come back to haunt us later.

I had much of this post written when I found out this morning that as of last night, Dr. Marty Makary, FDA Commissioner, rescinded the ban.

There’s currently a collective exhale in the thyroid community.

The people have spoken. Our voices matter.

But you still may want some context for all of this. Because make no mistake, this is a wake-up call.

Fact:

  • Medications can be taken away
  • Policy can override patient preference
  • Your best defense is building resiliency and self-sufficiency so that you’re not reliant on what’s “in stock” at the pharmacy

When you rely on a pill to function and that pill is vulnerable to regulatory action, you’re not in control of your own health.

I’m not a doctor. I don’t prescribe meds or advise my clients on what to take, how to take them, or how to titrate down. That said, I’ve also been very vocal about the fact that:

  • Indeed, there are risks of long-term thyroid HRT
  • It’s a myth that once you start, you can never stop

In our work together, many of my clients (going back to 2008) either never started thyroid HRT in the first place or were indeed able to get off of it.

As I’ve said for many, many years, I’m not categorically against thyroid meds, especially desiccated thyroid extract, which provides the most biologically thorough thyroid replacement: T1, T2, T3, T4, and calcitonin, which is critical for bone health.

(Speaking of bone health, this post garnered a lot of email from people panicking with fear of bone loss. Please know that there’s a much higher risk with synthetic T4 vs. naturally desiccated T3.)

In my coaching practice, my focus has always been on:

  • Empowering my clients with knowledge, sustained self-efficacy, and non-pharmaceutical options
  • Uncovering root causes of autoimmune triggers, nutrient deficiencies, and gut dysbiosis
  • Investigating environmental factors
  • Supporting thyroid function naturally so that people don’t need meds
  • Focusing on whole-body healing rather than chasing lab numbers alone

If you have a hypothyroidism or Hashimoto’s diagnosis, there is another way. But I digress.

The backstory on the FDA

On August 6, the FDA sent formal letters to manufacturers, importers, and distributors of naturally desiccated thyroid (NDT), notifying them of its intent to take action (deadline: mid-2026).

Why? Because these unapproved products have raised “safety concerns,” which they’ve been harping on for years, such as batch-to-batch inconsistency in potency, potential for impurities or contamination stemming from animal tissue, and the lack of FDA oversight for safety.

On the flip side, I’ve been harping for nearly two decades about the medical establishment’s claim that synthetic thyroid meds (T4-only meds like Synthyroid/Levothyroxine/Levoxyl) are “enough” for everyone. Nothing could be further from the truth!

NDT has been on the market for over a century without going through today’s FDA process—it was widely used in hypothyroid treatment before the FDA even existed.

When the Food, Drug, and Cosmetic Act of 1938 created new safety requirements, older drugs like NDT were grandfathered in. Then, in 1962, a new law required all drugs to be proven effective in controlled trials, even those that had been grandfathered. Technically, that meant NDT should have gone through this process. But the FDA didn’t push it and for decades, it allowed millions to continue using these meds.

In short, the agency simply “tolerated their existence” for decades but wanted to start “enforcing the rules.” They looked the other way because there were no big safety scandals.

Are there any safety scandals now? No.

Most DO NOT do well on synthetic, T4-only meds

The FDA wants you to believe that synthetic T4 (monotherapy) is just as effective if not better than NDT. If this doesn’t display a staggering misunderstanding of what “bioidentical” is, I don’t know what does.

One of the reasons that people don’t do well on synthetic, T4-only meds is that they’re not converting T4 into T3. Remember, NDT gives you T3, although it’s not without risk.

As I said in my post, How to Optimize Thyroid Hormone Conversion

A stunted [thyroid hormone] conversion process can result in misguided treatment and ongoing hypothyroid symptoms, even in the face of best efforts. T4 is mostly inactive (“the lame duck”) and is the forerunner to T3, the predominant and more active hormone (“the big daddy”). If the body is to utilize thyroid hormones properly, the wheels that grease the T4 to T3 conversion need to be well oiled. 

The post goes on to tell you how to optimize conversion.

Yes, NDT drugs are glandulars. And I’ve spoken out against them. I don’t want to talk out of both sides of my mouth. Yes, NDT is far, far superior to synthetic T4. But you may want to read my post, The Risks of Glandular Supplements, where I said…

I understand that Armour (or Nature-Throid, WP-Thyroid, Westhroid, or NP-Thyroid—all pretty much the same prescription drug with different fillers) is naturally desiccated porcine glandular. But there are risks here, too. Still, I’m going to explain why these are the preferred method of administration vs. using over-the-counter glandular supplements.

Speaking of OTC glandulars, which is what I was mostly railing against in this post, you may be asking, as am I, why is/was the FDA trying to crack down on prescriptions vs. nutraceuticals when nutraceuticals are much less regulated?

Nutraceuticals live in a regulatory gray zone—they’re regulated enough to require some oversight, but not nearly as strictly as pharmaceuticals. Although it’s well known that many OTC thyroid glandular supplements contain measurable amounts of T3 and T4, the FDA treats them differently than prescription thyroid meds. NDT is regulated as a drug, so it has to meet strict approval standards for safety, consistency, and efficacy (which again, it never formally did). OTC glandulars, on the other hand, are sold as dietary supplements under a looser set of laws (DSHEA), so the FDA typically only steps in if a product is proven unsafe or grossly mislabeled. This is why supplements are largely untouched…at least for now.

Finally, for those who’ve tried synthetic thyroid HRT, failed to stabilize, and saw improvement with Armour/NP Thyroid, etc., losing their NDT is a threat to their quality of life. This regulatory capture, if enforced later, will leave thyroid sufferers little choice and possibly force them onto a medication that doesn’t even work for the majority of people.

Yes, there is another way—you don’t have to be hogtied to a pill that either could get banned or doesn’t work. You can schedule a Jumpstart session with me to discuss your options—I’d love to connect with you.

Add comment