You already know about natural desiccated thyroid (NDT). You’ve done the research. You’ve read the forums, the studies, the patient communities. And some of you have discovered that levothyroxine isn’t working for you. You know why your body isn’t converting T4 to T3 efficiently, or you simply feel better when you get both hormones together, the way your thyroid was designed to produce them.

The problem isn’t knowledge. The problem is everything else that gets in the way of actually getting a prescription for NDT and filling it!

Maybe your doctor won’t prescribe it because they don’t trust the quality. Maybe you’ve been on Armour Thyroid or NP Thyroid and were surprised by an unexpected change in the formula that affected your response to the medication. Maybe you’ve started wondering where the pigs come from and how the manufacturing is monitored. Maybe you’ve read that the FDA is moving toward requiring a Biologics License Application (BLA) for NDT products and you’re wondering whether current brand names will still be available down the road. And lately, with tariffs and supply chain disruptions in the news constantly, you’ve started to wonder whether a medication sourced outside the U.S. could become hard to get.

Every one of those concerns is legitimate. A new NDT medication, Amerithroid™*, has been developed and, according to the manufacturers, it addresses these concerns.

The challenges around NDT

Natural desiccated thyroid has a complicated reputation in the medical community – and honestly, some of it is deserved. Not because the science doesn’t support combination T4/T3 therapy (it does, for a significant subset of patients), but because the NDT category has had quality problems that gave skeptical physicians ammunition to resist prescribing it.

Inconsistent potency from batch to batch. Supply shortages that left patients rationing pills. Reformulations – changes to inactive ingredients, binders, or manufacturing processes – that altered how the desiccated thyroid extract medication behaved in patients’ bodies, often without any communication to patients or prescribers. Unclear sourcing: where exactly did the pigs come from? Were the glands processed domestically or overseas? What standards governed that processing?

For a hypothyroid patient who doesn’t get relief on synthetic treatment and knows NDT might help, navigating a doctor who has seen these problems firsthand – or heard about them from colleagues – can be difficult. But practitioners aren’t always wrong to be cautious. At times, the challenges facing NDT have given them reasons to be.

Informed and empowered patients often feel this most acutely. You’ve researched conversion pathways and read clinical literature and come into appointments knowing more about your condition than some practitioners. Yet you have been met with objections from your providers when asking for a trial of NDT.

What’s going on with the FDA and NDT?

If you’ve been following the issue, you’ve seen discussion about the FDA’s Biologics License Application (BLA) pathway, the controversies and changing deadlines, and what it means for NDT medications. Here’s the plain-language version.

Thyroid medications derived from animal sources were recently designated as biologic products under U.S. law. The FDA has signaled that in order to legally manufacture and market NDT drugs, manufacturers need to pursue formal BLA approval – a rigorous review process covering safety, efficacy, and manufacturing standards. Most companies currently marketing NDT products, including established brands, are operating under a legal framework that allows products that predate the modern FDA approval system to remain on the market while the regulatory landscape evolves.

About Amerithroid

Amerithroid is made in the United States, in a U.S.-based, continuously FDA-inspected facility. The active pharmaceutical ingredients (API) are sourced domestically. The porcine thyroid material used to produce Amerithroid comes from U.S. supply chains, and is not imported from countries with different agricultural, veterinary, or manufacturing standards.

As a domestically manufactured, domestically sourced NDT medication, Amerithroid is not subject to the same geopolitical and logistical risks as drugs that depend on imported ingredients or overseas processing.

Given the regulatory environment, patients are interested in whether their NDT drug will obtain BLA approval and remain available long-term.

Oliva Therapeutics, the company behind Amerithroid, is explicitly committed to pursuing FDA approval and is actively planning and investing for the regulatory future.

Oliva has deep roots in the thyroid space through its legacy connection to Jerome Stevens Pharmaceuticals – the family-owned company whose brand name levothyroxine – Unithroid – earned the first FDA approval for levothyroxine tablets. Oliva’s also recently relaunched Thyquidity® (Levothyroxine Sodium Oral Solution), a liquid thyroid medicine for people with absorption issues, sensitivity to tablet fillers, or who have difficulty swallowing pills.

According to Daniel Akeson, CEO of Oliva: “The launch of Amerithroid is years in the making and builds on my family’s deep connection to patients with hypothyroidism and our commitment to quality U.S. manufacturing of pharmaceutical products.”

Amerithroid comes in the following doses:

• 15 mg / 1/4 grain

• 30 mg / 1/2 grain

• 60 mg / 1 grain

• 90 mg / 1 1/2 grain

• 120 mg / 2 grain

• 180 mg / 3 grain

• 240 mg/4 grain

• 300 mg / 5 grain

Some other information about Amerithroid:

• Continuous FDA inspection: Amerithroid is manufactured in a facility under continuous FDA oversight.

• Batch testing of both ingredients and finished product. Every lot of Amerithroid is tested against U.S. Pharmacopeia (USP) standards, not just the raw porcine thyroid going in, but the actual tablets coming out.

• Full traceability. Every component of Amerithroid, including the API, has a clear chain of custody, documenting where your medication came from.

• Identifiable pills. Amerithroid tablets carry a distinct Oliva leaf imprint. This allows you to confirm that the pill you received is actually Amerithroid.

• Pharmacy substitution protection. Prescribers can specify Amerithroid DAW (Dispense As Written), which helps ensure that when your doctor prescribes Amerithroid, the pharmacy can’t swap it for a different product.

Countering NDT resistance

If you’ve met resistance in getting NDT prescribed because your provider has concerns about consistency or quality, Amerithroid offers specific evidence to help address those concerns.

Here’s how Amerithroid addresses some of the more common provider objections:

• “NDT potency is inconsistent.” Amerithroid is batch-tested against USP standards for both active ingredients and finished product in a continuously FDA-inspected facility.

• “I don’t know where the ingredients come from.” Amerithroid’s active pharmaceutical ingredient (API), is sourced in the U.S., and the medication is manufactured in the U.S.

• “It’s not FDA approved.” No NDT medications are currently FDA-approved. Amerithroid, however, is actively working toward FDA BLA approval and full compliance.

Coming into the conversation armed with this information – and perhaps sharing this article with your care team – may help move a conversation that’s been stuck.

Who may want to learn more about Amerithroid?

Amerithroid may be an option worth discussing with your healthcare provider if you are considering natural desiccated thyroid (NDT) medication and have questions about manufacturing, sourcing, or product consistency. Every thyroid medication has its own formulation, manufacturing process, and regulatory considerations, so the best choice depends on your individual medical history, symptoms, and treatment goals.

You may wish to ask your healthcare provider about Amerithroid if:

• You’ve been interested in trying an NDT medication, but your healthcare provider has expressed concerns about product quality or consistency.

• You’ve taken other brands of NDT in the past and noticed changes in your symptoms and thyroid test levels -- including thyroid-stimulating hormone -- that you believe may have coincided with a product reformulation or supply interruption.

• You’d like more information about how your thyroid medication is manufactured or where its ingredients are sourced.

• You have questions about how evolving FDA regulations could affect the future availability of NDT medications.

• You’re concerned about how factors such as supply chain disruptions, tariffs, or import restrictions could affect availability of your NDT medication.

As with any thyroid medication, Amerithroid is not the right choice for everyone. Your healthcare provider can help determine whether an NDT medication—or another form of thyroid hormone replacement—is the most appropriate treatment based on your thyroid condition and laboratory results,

How to access Amerithroid

Amerithroid is covered by many commercial insurance plans, with copay assistance available for eligible patients. A direct-to-patient cash-pay option with home delivery is also available from a mail-order pharmacy, Health Warehouse, at good prices. It’s available in various dosage sizes, and 30, 60, and 90 quantities.

https://www.healthwarehouse.com/amerithroid-60mg-1-grain.

For more information on Amerithroid, visit amerithroid.com.

Final thoughts

People with hypothyroidism are often among the most informed and engaged patients in healthcare. Many of us have spent years learning about lab testing, treatment options, and the differences between thyroid medications because getting the right care hasn’t always been straightforward. The journey often has involved asking for additional testing, discussing symptoms that don’t match lab results, exploring alternatives when treatment isn’t working, and seeking clear information about the medications they take.

The arrival of Amerithroid represents another option for patients who benefit from natural desiccated thyroid (NDT) therapy. Manufactured in the United States using U.S.-sourced porcine thyroid and produced in FDA-inspected facilities, Amerithroid was developed to address many of the concerns patients have raised in recent years about quality, manufacturing transparency, and long-term availability of NDT medications. While no thyroid medication is the right choice for every person, having another carefully manufactured option gives patients and healthcare providers more flexibility when selecting treatment.

Choosing an NDT medication is one part of successful thyroid care. Equally important is having a healthcare provider who understands the nuances of thyroid disease, monitors symptoms alongside laboratory values, and is willing to adjust treatment when needed. Regular follow-up, comprehensive and regular thyroid testing, and individualized dosing remain essential regardless of which medication a patient takes.

This is where specialty thyroid care can make a meaningful difference. If you are looking for quality thyroid care, I recommend Paloma Health, where clinicians focus on hypothyroidism and Hashimoto’s disease, giving you access to providers who are experienced with the full spectrum of thyroid treatment options, including levothyroxine, combination T4/T3 therapy, and, when clinically appropriate, natural desiccated thyroid medications such as Amerithroid. Rather than following a one-size-fits-all approach, Paloma providers evaluate your symptoms, medical history, and thyroid laboratory results together to develop a personalized treatment plan.

Paloma Health offers a convenient way to discuss whether NDT is appropriate for your individual situation. Through virtual appointments, ongoing medication management, at-home thyroid blood testing, and regular follow-up, you can receive expert guidance without the need for repeated referrals or long waits for specialty care. As new thyroid medications become available, having access to clinicians who stay current with evolving research and treatment options can help patients make informed decisions with confidence.

Amerithroid doesn’t eliminate the need to advocate for yourself. But it does provide another treatment option for natural desiccated thyroid therapy. Combined with knowledgeable, individualized medical care, it represents another step toward giving people with hypothyroidism more choices—and greater confidence—in managing their thyroid health.

For three decades, I have had the privilege of connecting with tens of thousands of people living with hypothyroidism. I have heard from patients who finally found relief after years of exhaustion, brain fog, weight changes, hair loss, and the frustrating feeling that they were not being heard. I have also heard from patients who felt their symptoms dramatically improved on natural desiccated thyroid (NDT) medication and then lived with constant anxiety about availability, reformulations, recalls, shortages, and the future of these products. Because I have walked my own thyroid journey while advocating for others -- and taking NDT myself for 20+ years -- the launch of Amerithroid feels deeply personal.

When I first learned that Amerithroid was being introduced as an American-made natural desiccated thyroid product, my reaction was simple: excitement mixed with relief. For many patients, this is not about chasing a trend or rejecting other therapies. It is about having options. Hypothyroidism is not experienced the same way by every person, and treatment should leave room for individualized care. The fact that another NDT product is entering the marketplace at a time when patients have been worried about access and continuity of treatment is significant!

What makes this moment especially meaningful is the broader uncertainty surrounding desiccated thyroid medications. Federal regulators have publicly discussed concerns about the oversight, consistency, and future regulatory pathway for animal-derived thyroid products, creating understandable anxiety among patients who rely on them. Professional thyroid organizations continue to recommend levothyroxine as the standard first-line treatment while also acknowledging that some patients and their clinicians choose NDT as part of a personalized treatment plan. Against that backdrop, the arrival of a new manufacturer willing to invest in this category sends a powerful message: patients who use NDT have not been forgotten.

Over the years, I have received countless emails that begin with the same sentence: *“I finally found a thyroid medication that works for me.” Sometimes that medication is levothyroxine. Sometimes it is a combination of T4 and T3. Sometimes it is an NDT product. As a patient advocate, my motto has always been the same: The best thyroid medication for you is the one that best resolves your symptoms, safely. My role is not to pick a winner. Instead, I want to help you access accurate information, ask informed questions, and work with knowledgeable healthcare professionals to find the treatment that helps you feel and live well!

Amerithroid represents another opportunity for those conversations to happen!

I am particularly encouraged by the emphasis on domestic manufacturing. Patients have become increasingly aware of where their medications come from and how they are produced. After years of supply-chain disruptions across many areas of healthcare, the phrase “American-made” carries emotional weight. It suggests accountability, proximity, and a commitment to serving patients here at home. While no medication should be judged solely by its country of origin, I understand why so many people find reassurance in knowing that the team of Jerome Stevens and Oliva Therapeutics is investing in U.S.-based production.

My excitement also comes from the stories I imagine will follow. I think of the woman who has spent months calling pharmacies trying to locate her prescription. I think of the man who worries every time he hears another rumor about NDT being pulled off the market. I think of the newly diagnosed patient who wants to discuss all available treatment options with a clinician rather than feeling boxed into a single path. For each of these individuals, a new product launch can represent hope, stability, and the feeling that someone is paying attention.

That said, I believe enthusiasm should always be paired with honesty. Amerithroid is a prescription medication, and NDT drugs are not the right choice for everyone. And, of course, any change in therapy should be discussed with your healthcare professional, followed by appropriate monitoring of symptoms and laboratory values. Thyroid treatment is highly individualized, and what works beautifully for one person may not be the best option for another. Responsible advocacy means celebrating new possibilities while respecting the importance of medical guidance and evidence-based care.

What I find most inspiring is the sense of community surrounding this launch. The thyroid patient community has long been one of the most informed, persistent, and compassionate groups I have encountered. People share lab experiences, encourage one another through setbacks, and fight tirelessly for better care. They ask difficult questions about ingredients, dosing, quality, insurance coverage, and long-term access because they have learned that self-advocacy matters. Seeing that community respond with curiosity and optimism to Amerithroid reminds me why I began this work in the first place.

As I reflect on this moment, I keep returning to a simple truth: progress in thyroid care is rarely about a single product. It is about expanding choices, improving quality, supporting research, strengthening communication between patients and clinicians, and ensuring that people feel seen and heard throughout their journey. Amerithroid will ultimately be evaluated by patients, healthcare professionals, and real-world experience over time. But today, I believe it deserves recognition as an important new development for a community that has often felt uncertain about the future of NDT therapy.

I have spent many years advocating for thyroid patients to have access to safe, effective, and individualized treatment options. The launch of Amerithroid does not end that work, but it does give me renewed optimism. It tells me that innovation is still happening, that manufacturers are still listening, and that patients still have a voice in shaping the future of thyroid care. For those reasons, I am genuinely excited to watch this next chapter unfold—and I look forward to hearing the stories of the people whose lives it may help improve.

For more information about the launch of Amerithroid, see my article

As those of us in the hypothyroidism community who take natural desiccated thyroid (NDT) medications know, this past year has been a total rollercoaster. In August 2025, the FDA issued a surprise “crackdown” and deadline change that signaled a summer 2026 end of availability for NDT drugs Armour Thyroid and NP Thyroid. For patients who have already failed on synthetic alternatives, the prospect of losing the only medication that kept us functional was a nightmare!

However, the situation has shifted once again!

On March 11, 2026, the FDA quietly revised its guidance, offering a significant policy reversal and a temporary reprieve for NDT users. While the long-term future of these medications remains technically unsettled, this update offers immediate breathing room and a return to patient-centered care.

Here are the five essential takeaways you need to know about this regulatory pivot.

1. The Hard Deadline Has Vanished

In August 2025, the FDA set a strict enforcement deadline of August 2026. After that date, any NDT product without a formal Biologics License Application (BLA) would have effectively become illegal to market and sell. This created a crisis because most NDT manufacturers were only in the earliest stages of the multi-year BLA process, making the 2026 deadline an impossible hurdle.

The March 2026 update has completely removed this hard deadline. Instead of facing an imminent ban this summer, NDT medications are now under what the FDA calls a “monitoring posture.” This provides immediate relief, signaling that your medication will not be pulled from pharmacy shelves in August.

2. A Pivot to “Risk-Based Enforcement”

The FDA’s language has shifted from an aggressive stance of “these products must go” to a more collaborative “these products can stay while we work this out.” The agency is now utilizing risk-based enforcement, meaning they will prioritize actual safety concerns rather than administrative timelines.

This softening of the FDA’s position is widely attributed to high-level leadership changes and political pressure. Significantly, the shift followed the abrupt departure of George Tidmarsh, MD—a known, outspoken opponent of NDT—from the agency. With new signals of support from FDA Commissioner Dr. Marty Makary and HHS Secretary RFK Jr., the agency is finally acknowledging the necessity of patient access. However, it is important to remember that NDT medications remain technically “unapproved” as they work through the formal BLA process.

3. The Burden of Choice Returns to Patients and Doctors

One of the most distressing parts of the 2025 guidance was the “What you should do” section, which explicitly directed us to transition away from NDT and switch to synthetic T4 alternatives. In a major win for patient autonomy and the sanctity of the doctor-patient relationship, the FDA has deleted this entire section.

The agency has replaced its mandate to switch medications with a neutral, supportive recommendation: “talk to your doctor.” Furthermore, the FDA now officially acknowledges that manufacturers are actively pursuing formal approval through clinical trials. This shift validates the experience of the thousands of patients who advocated for their right to choose the medication that works for their unique biology.

4. The New Battleground is Insurance, Not Just Regulation

While the regulatory threat has receded, a new financial obstacle has emerged that threatens access from a different angle. We are entering a period of divergence where a drug may be legal to sell, but nearly impossible to afford. CVS/Caremark, one of the nation’s largest pharmacy benefit managers (PBMs), has announced it will remove NDT medications from its formulary starting April 1, 2026.

This means that while the FDA has secured your legal right to the medication, your insurance provider may refuse to pay for it. For many in our community, this creates a significant financial barrier despite the FDA’s policy retreat.

5. NDT vs. Synthetic Levothyroxine – Why the Struggle Matters

The reason for the massive patient uproar over the last year is deeply personal: for a meaningful subset of the hypothyroid population, synthetic T4 (levothyroxine) is simply insufficient.

Unlike synthetic T4-only medications, NDT provides a combination of both T3 and T4 hormones. For many, this combination is the biological key to resolving symptoms that synthetic versions leave behind. This isn’t about “preference”—it’s about a frightening future where patients were faced with losing their quality of life. Access to NDT is critical for managing:

• Brain fog and energy levels: The T3 component is often the “spark” that restores cognitive clarity.

• Metabolic health: Many patients find weight management nearly impossible on T4-only protocols.

• Mood and mental health: Quality of life is often tied directly to the hormonal balance provided by NDT.

The “What’s Next” Action Plan for Patients

If you currently rely on NDT for your health, here are the actionable steps you should take to protect your access as we navigate this transition:

• Consult your physician before April 1: If your insurance or pharmacy benefit is managed through CVS/Caremark, you must discuss the upcoming formulary change immediately.

• Explore formulary exceptions: Work with your doctor to file a “medical necessity” appeal. If you have failed on levothyroxine in the past, your doctor can document this to help you maintain coverage.

• Check independent and mail-order pharmacies: If your primary pharmacy stops carrying NDT or if costs skyrocket, look into independent pharmacies and mail-order options, which often provide more flexible out-of-pocket pricing.

• Monitor your supply: Ensure you have a consistent supply of your medication as you navigate these new insurance hurdles.

More Information

For a deeper dive into these regulatory changes and to ensure you are on the right path for your health, read my article at the Paloma Health website for the full details now.

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We’ve heard quite a bit lately about the current administration’s “theories” on what could trigger autism spectrum disorder (ASD) in children. (And yes, much of it has little scientific backup to support it.)

What you’re probably NOT hearing is that recent research has pointed to a well-studied and demonstrated connection between maternal hypothyroidism (that’s an underactive thyroid when pregnant) and the risk of autism in the child.

You can read the background in my detailed September 2025 piece for Paloma Health, “Move Over Tylenol and Vaccines: Mom’s Thyroid May Be the Real Culprit!”

Recently, the Journal of Clinical Endocrinology & Metabolism published an open access article on November 25, 2025 titled “Maternal Thyroid Hormone Imbalance and Risk of Autism Spectrum Disorder” that makes the case even more strongly!

This study found that children were more likely to be diagnosed with autism spectrum disorder when their mothers experienced hypothyroidism -- low thyroid hormone levels -- during pregnancy. The risk of ASD is greatest when thyroid problems existed both before pregnancy and continued during the pregnancy.

AND, the risk increases the longer the thyroid imbalance lasts during the pregnancy, suggesting a clear “dose-response” pattern.

The good news: Mothers with chronic hypothyroidism whose hormone levels were well controlled during pregnancy did not show an increased risk, highlighting that the imbalance itself—rather than the diagnosis alone—matters most.

The overall study results support current clinical guidance: monitoring thyroid hormone levels during pregnancy and treating imbalances promptly may help reduce the risk of developmental challenges, including ASD.

What Can You Do Before or During Pregnancy?

• Have your thyroid checked before pregnancy. If you are planning to conceive, ask your healthcare provider to check your thyroid hormone levels, especially if you have a history of thyroid disease, autoimmune conditions, infertility, or irregular menstrual cycles.

• Monitor your thyroid levels early and throughout pregnancy. Thyroid hormone needs can change during pregnancy, so testing in early pregnancy—and repeat testing each trimester, at minimum—can help ensure levels stay in a healthy range.

• Follow your thyroid treatment plan closely. Take your prescribed thyroid medication exactly as directed and attend follow-up appointments to confirm hormone levels are well controlled.

• Do not assume medication automatically means that your thyroid levels are normal. Even if you are on treatment, blood tests are essential to confirm that thyroid hormones are balanced during pregnancy.

• Ensure adequate iodine intake. Iodine is essential for thyroid hormone production. Use iodized salt and follow prenatal vitamin recommendations, but avoid excess supplementation unless advised by your provider.

• Start prenatal care as early as possible. Early prenatal visits increase the chance that thyroid imbalances and other health conditions affecting fetal brain development are identified and treated promptly.

• Discuss your full health history with your provider. Share information about prior thyroid problems, fertility treatments, autoimmune conditions, or previous pregnancy complications so care can be individualized.

• Maintain overall pregnancy health practices. Follow guidance on nutrition, sleep, stress management, and avoidance of smoking, alcohol, and illicit substances, all of which support healthy neurodevelopment.

• Attend all recommended follow-up appointments. Ongoing monitoring allows providers to adjust treatment quickly if thyroid levels shift during pregnancy.

• Remember that risk is modifiable, not predetermined. Most women with thyroid conditions can have healthy pregnancies, and maintaining balanced thyroid hormone levels is a proactive step that may help reduce ASD risk.

I have been sharing information about this issue for more than 10 years, and it’s so frustrating to me that it’s not common knowledge among women — and their doctors! (Not to mention public health officials!!)

I even co-authored a book with “Hypothyroid Mom” Dana Trentini in 2016, Your Healthy Pregnancy with Thyroid Disease. And yes, the book was very clear about the link between maternal hypothyroidism and autism, as well as ADHD.

Why aren’t public health officials — who are rightfully focused on reducing the rate of ASD in children — DOING SOMETHING about this proven issue! Why is it not being discussed as part of current autism initiatives?

The solution is straightforward and cost-effective, after all. Test the thyroid prior to becoming pregnant, again in early pregnancy, and then several times throughout the pregnancy, and, most importantly, OPTIMIZE treatment for hypothyroidism throughout. It won’t prevent all cases of autism, but it will prevent some of them! (And, will help prevent miscarriage and premature delivery, low milk supply and post-partum depression, as well as fatigue, weight gain, depression, and a long list of hypothyroidism symptoms! (Seriously, it’s a no-brainer!)

So, here’s the choice. Get several thyroid blood tests during a year and monthly thyroid medication if needed (which can be as inexpensive as $4 a month)? Or go through the lengthy, life-changing and costly process of managing a diagnosis of autism in a child?

Even the profit-obsessed health insurance “providers” should be able to see which approach is more cost-effective. (If they don’t plan to deny coverage for evaluation and support for ASD in children, that is.)

In the meantime, for you Mama Bears out there who want to reduce the risk of autism in your children: TEST YOUR THYROID AND TREAT YOUR THYROID!

If you’ve been following the chaos around Natural Desiccated Thyroid — NDT — buckle up, because the story just got wild! 😳

This summer, out of the blue, the FDA suddenly moved the deadline for NDT’s biologic approval up by three years — from 2029 to 2026. No warning. No explanation. And that could leave more than a million hypothyroid patients taking NDT with no access to their medication!

And here’s where it gets crazier.

At the time, Dr. George Tidmarsh, head of the FDA’s drug division, was also named to temporarily run the biologics division. That’s almost never done. Then — boom — right after he took over, this shocking deadline appeared, threatening to wipe NDT off the market completely!

Patients were panicking. Pharma companies were furious. Doctors were calling foul. And get this — earlier in the year, Tidmarsh had already posted a pretty vitriolic rant on LinkedIn calling natural thyroid “dangerous” and saying it should be banned.

So yeah, it looked, well, personal. It certainly wasn’t something that was in patients’ best interest, that’s for sure.

Another plot twist. There was such an outcry that the FDA head Marty Makary posted on X Twitter that the FDA would ensure patient access to NDT. Huh? And then Secretary Kennedy shared that post.

Ummm....looked like kind of a walk-back, but nothing official.

Then came the latest development: last Friday, investigative reporters at STAT News — https://www.statnews.com/2025/11/02/fda-george-tidmarsh-regulator-kevin-tang — revealed that Tidmarsh allegedly had a vendetta against a pharma investor named Kevin Tang. Tang is a player in a number of drug companies, and, surprise surprise, turns out that Tidmarsh has been allegedly talking down about these companies and products on Linked In.

Fierce Pharma actually has a full rundown at https://www.fiercebiotech.com/pharma/cder-chief-tidmarsh-resigns-deleted-linkedin-post-blasting-lupkynis-prompts-aurinia-lawsuit, including this tidbit:

…Tidmarsh purportedly used his role at CDER to push the FDA to “effectively remove” desiccated thyroid extract (DTE) products from the U.S. market earlier this year, Aurinia’s lawyers argued. DTE products are used to treat hypothyroidism.

This move, which Aurinia’s legal team suggests was targeted, cut off a key source of income for the Tang-affiliated company American Laboratories, the lawsuit claims.

Tidmarsh then allegedly tried to leverage the situation to “extort and solicit a bribe from Mr. Tang in exchange for Dr. Tidmarsh using his power to reverse or otherwise mitigate the adverse impact on Mr. Tang, Tang Capital, and American Laboratories,” the suit continues.”

Bingo!

Tidmarsh was put on administrative leave on Friday, but then, one of Tang’s company sued Tidmarsh on Sunday. Tidmarsh then immediately resigned from the FDA. Now, the scandal’s blowing up across biotech media.

So, what does that mean for thyroid patients? 🤔

If this was all part of a personal grudge, maybe — just maybe — the FDA will go back to the original 2029 timeline and stop putting thyroid patients at risk.

But until the FDA says something official… we’re all still waiting.

#naturaldesiccatedthyroid #NDT #GeorgeTidmarsh #FDA #CDER #naturalthyroid #thyroiddrugs #KevinTang #fiercepharma #thyroid #hypothyroidism #desiccatedthyroid #STATNews #biotechscandal #vendetta

🚨 What if your thyroid medication disappears next year? 🚨

The FDA has fast-tracked major changes that could remove Natural Desiccated Thyroid (NDT) drugs—like Armour, NP Thyroid, generics, and compounded versions—from U.S. pharmacies as early as mid-2026! Patients who rely on NDT for symptom relief may lose access—or face skyrocketing costs.

In this video, we break down:

✅ What the FDA’s announcement about 2026 biologic status for NDT means for NDT users

✅ Why NDT is different from levothyroxine

✅ The timeline for the potential ban

✅ What YOU can do right now to protect your access!

📢 TAKE ACTION TODAY!

✍️ Sign the petition: https://www.change.org/p/save-ndt-protect-women-s-health-and-patient-choice

📞 Call Congress: (202) 224-3121

📞 Call the FDA: 1-888-INFO-FDA

📧 Email: FDAAdvisory@fda.hhs.gov

Your voice matters. Stay informed, stay proactive, and help protect access to NDT!

NEED MORE INFORMATION?

Bookmark my just-updated article at Paloma Health on the NDT issue. The article is regularly updated with new information.

https://www.palomahealth.com/learn/natural-desiccated-thyroid-drugs

Are you following the situation regarding natural desiccated thyroid (NDT) drugs, like Armour Thyroid and NP Thyroid?

Here’s an interesting timeline to ponder.

July 29th: The White House fired Dr. Vinay Prasad, Director of CBER, the Center for Biologics Evaluation and Research, the division of the FDA responsible for biologic drug oversight and approvals. (Note: The firing was apparently at the urging of Laura Loomer.)

July 30th: The FDA put Dr. George Tidmarsh in as “Acting” Director of CBER. Tidmarsh was already serving as Director of CDER, the Center for Drug Evaluation and Research. (Having one person as director of both CDER and CBER is highly unusual, by the way.)

August 6th: The FDA issued guidance and a letter to NDT manufacturers that indicated that the new deadline for NDT biologic approval would be “one year” — so presumably August 2026 — instead of 2029 as previously indicated. The FDA guidance also urged providers and patients to switch to “FDA-approved” thyroid medications (namely synthetic levothyroxine). This came as a surprise to the manufacturers — not to mention the patients and health care providers — who were all operating on the understanding that the deadline would be 2029.

August 10th: Since the firing, Dr. Makary and RFK Jr. were fighting to get Dr. Prasad back in his job. And on August 10th, Dr. Prasad was reinstated as Director of CBER. Dr. Tidmarsh returned to being Director of CDER only.

August 13th: The FDA’s Dr. Makary issued his X post, which was re-posted by HHS Secretary RFK Jr., indicating a potential softening on the stance towards NDT and the deadline.

So, why does it matter that Dr. Tidmarsh was the person in charge of the FDA's CBER over the 10-day period during which the biologic approval deadline was moved from 2029 to 2026?

The thyroid patient community needs to know that Dr. Tidmarsh is a vehement and vocal critic of NDT drugs. Eight months ago, Dr. Tidmarsh posted the following on his LinkedIn profile:

As you can see, Dr. Tidmarsh is clearly not a fan of NDT. I should also note that some aspects of this post are quite misinformed. For example, while NDT is not "approved" by the FDA, it is FDA-regulated. NDT did not need to go through the FDA approval process because NDT was in use long before the FDA was established. Along with many other drugs in use in the first half of the 20th century, NDT was "grandfathered" and allowed to be prescribed without a new drug application and FDA approval.

NDT has also not been "proven worse than synthetic thyroid hormone." In fact, research has shown that it is a safe alternative form of thyroid hormone replacement to treat hypothyroidism and meets the unique treatment requirements of a subset of people with hypothyroidism. Want to see for yourself? Read https://www.frontiersin.org/journals/endocrinology/articles/10.3389/fendo.2023.1309159

Finally, NDT is not "harmful." It’s been safely used for more than 100 years. And, no thyroid hormone replacement medication is inherently harmful! What can be harmful is overmedication, undermedication, or an inability to absorb the medication. And those risks are applicable to all thyroid hormone replacement drugs--both synthetic and NDT.

While the decision-making process behind the FDA’s surprise announcement on August 6, 2025, is not publicly known, it certainly raises questions about what role Dr. Tidmarsh played in the situation. Did Tidmarsh himself decide to change the deadline and push out the issuance of the guidance and the August 6th letter? If he did, were Dr. Makary and Secretary Kennedy even aware of it? And, if they were aware, why would they support cutting three years off the timeframe, which would likely force hundreds of thousands of thyroid patients to take a medication that doesn’t work for them?

If they weren’t aware, were the posts on X after-the-fact damage control and clean-up of a major mistake by Dr. Tidmarsh, driven by his unexplained vendetta against NDT?

At first, I thought it was good news that Dr. Tidmarsh was no longer in charge of CBER, but I did some more research, and it may not be good news for the thyroid community.

Who will oversee NDT? CDER or CBER?

To understand what impact Dr. Tidmarsh might have on the fate of NDT, we need to understand whether he will have responsibility for the drug. So, the question is, while the FDA is classifying NDT as a biologic, does NDT fall under the authority of Tidmarsh’s CDER or Prasad’s CBER? At first, I assumed it would be CBER, as CBER oversees "biologics," but it's a tricky question, because NDT is in a grey zone. So, I looked into it further.

Because it’s derived from an animal tissue source, the FDA is classifying NDT as a biological product, meaning it's a drug derived from animal tissue rather than synthetic chemistry.

But, at the same time, most thyroid hormone drugs, including synthetic T4 (levothyroxine) and T3 (liothyronine), are treated as “small-molecule drugs” and they fall under CDER, not CBER. Thyroid hormone replacement medications are treated as endocrine drugs, not vaccines, blood, or gene therapy (which fall under CBER.)

And, even though desiccated thyroid is derived from glandular tissue, it is still considered a therapeutic product for a chronic endocrine condition, which aligns with the CDER’s mandate.

The FDA guidance and letters were on the main FDA letterhead, not CDER or CBER, so at present, it isn’t clear which department at the FDA released that information or will be overseeing it going forward.

But, given the evidence, NDT may fall under CDER, overseen by Dr. Tidmarsh.

If that’s the case, will Dr. Tidmarsh continue in some way to achieve his stated goal: to “remove [NDT] permanently from the market?” Or will he willingly go along with the FDA’s plans for biologic approval on a more reasonable and medically-sensible timeline that won’t leave NDT patients without any available natural thyroid medication?

But we still have the question: What if NDT falls under Dr. Prasad’s CBER? What about Dr. Prasad? Unlike Dr. Tidmarsh — who has made his antipathy to NDT quite public — we don't know how Dr. Prasad feels about NDT drugs. I haven’t located any speeches, blogs, or social posts where he talks about NDT, or even thyroid medication in general. We do know that Dr. Prasad doesn't support orphan drugs, but if NDT falls under his jurisdiction, does he consider NDT to be an orphan drug? Dr. Prasad is also quite mainstream in many ways and is very much a fan of having mountains of “evidence-based” data for decision-making. This suggests to me that, like many conventional physicians, his default preference for treating hypothyroidism would be synthetic medication, which has been the subject of more studies than NDT. I suspect he is in favor of NDT going through the approvals process. But perhaps he does not support enacting the ban so quickly and forcing patients onto synthetics?

I’m going to keep digging to find out as much as possible, but right now, we can only speculate. We will hopefully learn more as we seek to determine who has jurisdiction over NDT, and closely watch the decisions coming out of the FDA going forward.

Positive news -- at least it seems that way -- about natural desiccated thyroid (NDT).

There haven't been any formal public statements, just social media posts on X (see above). But FDA Commissioner Marty Makary has seemingly reversed course.

He posted about NDT that "we will ensure access for all Americans."

HHS Sec'y RFK then responded to Makary favorably regarding the post.

NBC has an article about it.

https://www.nbcnews.com/health/health-news/fda-warns-unapproved-thyroid-pills-says-ll-ensure-access-rcna224972

It appears that the FDA might be saying that they will hold off on banning NDT until there's approved NDT on the market.

We're going to keep trying to get further information about the situation, and what it specifically means, because there are still many questions, i.e.,

• When WILL the ban go into effect?

• Will the FDA and govt. guarantee that it will not go into effect until at least 2 FDA-approved NDT drugs are available?

• Will compounded NDT be affected in the meantime?

Of course, "government by tweet" is not official, so I want to see formal FDA confirmation of this, as the only "official" communications from the FDA are the letters and public statements indicating a mid-2026 NDT ban.

But, in the meantime, it looks like public outreach and social media furor have had an impact, and we have a "stay of execution" for now. But don’t let up! Keep signing the petitions that are circulating, and calling.

We do NOT want this to be a situation where we’re promised access, and then, surprise, as in the past, the threat to pull it out from under us comes back again!

Over at the Paloma Health blog, I just updated a comprehensive article that provides the background — going back to 2022 — on the FDA’s attack on natural desiccated thyroid (NDT) drugs. It’s a worthwhile read, and gives you the history of the issue, as well as action points you can take to help protect the availability and affordability of NDT!

READ THE ARTICLE NOW!

Please sign the Change.org petition to protect patient access to natural desiccated thyroid!
https://www.change.org/p/save-ndt-protect-women-s-health-and-patient-choice

First of all, write and call your members of Congress and Senators.

Do it now and do it as frequently as you possibly can!

Make them fully aware that the FDA is trying to take a drug, one that has already been safely in use for 100 plus years, OFF the market.

Make them aware that the FDA wants to force you to take synthetic drugs that, for most of you who are taking natural thyroid, you have already taken unsuccessfully in the past.

The drug they are trying to force NDT patients to take is one that has not worked for those patients.

You can use democracy.io to send emails to your reps and senators.

You can also visit congress.gov and they have an address box that you can enter and a list of your senators and representatives will come up or call the Capitol switchboard 202-224-3121 and they will connect you to your reps and senators.

I'll keep you posted as I learn more.

The FDA is saying they will allow for a 1 year period for patients to switch from NDT to synthetic medication. After that, they will force those manufacturers without approval to stop selling their NDT medication. They will also ban compounded NDT at that time.

I currently don't have estimates as to when there may be NDT brands that have received biologic approval from the FDA, but it's possible it may not be until AFTER the 1 year deadline.

I also predict that whoever gets the first NDT biologic drug approval -- and I suspect it will be AbbVie's Armour Thyroid -- will raise the prices significantly, so that pricing is commensurate with other more expensive biologic drugs.

Here's the summary of the FDA action:

https://www.fda.gov/drugs/enforcement-activities-fda/fdas-actions-address-unapproved-thyroid-medications

Here's the letter (PDF) the FDA sent to the various NDT manufacturers:

https://www.fda.gov/media/188081/download

Here's my coverage from back in 2022, when the FDA first started talking about this:

https://www.palomahealth.com/learn/natural-desiccated-thyroid-drugs

NDT - WHAT CAN YOU DO?

I want to clarify a few things.

First, this NDT ban/biologic approval is NOT a "political issue." It's not a Trump or Biden issue. This FDA action was already in progress under the Biden administration, back in 2022, when I initially reported on it. AND, the rumblings about this from the FDA started more than a decade earlier. In fact, the FDA tried to take NDT off the market back in 2009, but we successfully fought it at that time.

Back in 2022, when the FDA said they were classifying NDT as a biologic that needed biologic approval, they said that it would be enforced after 2029 (presumably so that there was time for NDT to go through the Biologic Licensing process with the FDA.) They have now tightened up the timeline, and are saying that enforcement/ban will take place as early as mid 2026, a year from now.

My opinion is that this is not political -- it's financial. AbbVie already makes the top-selling brand name synthetic (Synthroid) and top-selling NDT (Armour.) They have the very deep pockets and experience to get biologic approval for a drug, as they make a number of biologics.

So, the FDA says this drug that's on the market and used safely for 100+ years now is suddenly a "biologic." This can, in the short term, force people to take synthetics, including Synthroid.

Meanwhile, when Armour (and others?) gets approval, they can then be legally sold and marketed. The first (and potentially only) drug approved will likely have a monopoly on the NDT market for quite a while.

NDT will then be an approved biologic. In a market where biologics typically cost THOUSANDS of dollars a month. It's a win-win for some drug manufacturers -- not so much for thyroid patients who may be forced off their NDT, or who may not be able to afford "FDA-approved" NDT.

At this time, it is unclear whether AbbVie (or Acella, maker of NP Thyroid or anyone else) WILL have biologic approval by the deadline.

Nor do we know what prices manufacturers will charge when they go out to market with "FDA biologic approved" NDT. Most other biologics (think AbbVie's Humira) are extremely expensive, costing thousands of dollars per month cash price. Many are not covered by insurance or Medicare, and when they are covered, copays are often prohibitively high.

Also, to clarify, because they are designating NDT as a biologic that requires approval, they are also saying that compounding of NDT in the U.S. would be against the law once the ban is in full effect.

If -- and that's a big if -- you could personally order NDT manufactured outside the U.S. , you would be importing an illegal drug and that would likely not work under the "personal use" policies. If -- again, a big if -- it was allowed into the US, it would likely be subject to tariffs, which at that point could be 100 to 200%. (Tariff rates are not clarified on imported drugs for mid 2026 at this point, as they change frequently with every announcement.)

I'll be digging into this further to try to find out what can be done. In the meantime, I urge you to do the following:

* Write AND call your Rep/Member of Congress

* Write AND call your two Senators

You can use https://democracy.io to send those emails.

Visit https://www.congress.gov/members/find-your-member and type your address into the search box. A list of your representatives and their contact information will appear! Or, you can call the Capitol switchboard at (202) 224-3121 to be connected to your member’s office.

Make them aware that the FDA is looking to take a drug that has been safely used for 100+ years OFF the market, and force you to take a drug that (for most of you on NDT) you've ALREADY taken unsuccessfully in the past and which has failed to treat your hypothyroidism!!

Start by learning about the six important things to know about how to heal from long COVID!

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Wouldn't you like natural ways to help relieve fatigue, support your thyroid, rev up your hormones, help balance blood sugar, and minimize carb and sugar cravings? If so, these botanical supplements are the real deal!

I put together this short video with a quick rundown of my faves.

I've also done a two-part article with more details on the benefits of these botanicals for thyroid patients. They're online at:

• The Best Botanicals for Unresolved Thyroid Issues: Part 1

• The Best Botanicals for Unresolved Thyroid Issues: Part 2

To commemorate thyroid awareness, you can also get a fantastic 25% off a special Botanical Thyroid Solutions Set featuring these four incredible products — plus free shipping — throughout the month of January!

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I had the wonderful opportunity to do a 50-minute interview with Dr. Donna Hurlock, author of a new book, Patient-Focused Hypothyroidism Treatment. In this wide-ranging interview, Donna offers innovative and eye-opening insights on important topics that affect thyroid health, including:

• The Old Way vs The New/Conventional Way of Diagnosing and Treating Hypothyroidism

• The Cost of Thyroid Treatment, vs. the Cost of Treating Cholesterol, High Blood Pressure, Diabetes, Etc.

• How Should You Measure the Outcome of Hypothyroidism Treatment?

• Why Do Conventional Doctors Focus Only on the TSH Test?

• Managing Her Own Hypothyroidism

• The Difference Between a Suppressed TSH and Overmedication

• Donna Hurlock’s Challenge to the Medical Establishment: "Prove to Me That TSH Measures Thyroid Function"

• Blood Sugar Measures the "Function" of Insulin, What Measures the "Function" of Thyroid Medication?

• The Question to Ask Your Prospective Doctor

• Endocrinologists Who Won't Prescribe T3 or Natural Desiccated Thyroid

• Do Most Patients Need Added T3?

and much more!

If you’ve ever wondered why doctors seem to revere the TSH test, and ignore symptoms, you won’t want to miss this interview!

Watch It On YouTube!

Learn more about Dr. Donna and her life-changing new book at Dr. Donna Hurlock’s website, www.doctorhurlock.com.

And if you’re interested in getting a copy, grab a copy now at Amazon.com, or your favorite online bookseller!

March 22, 2023 — Do you, your friends, or family members experience significant PMS? Do you have painful periods? Mood swings? Bloating? Cravings? Menstrual migraines? Cramps? Whole World Botanicals (WWB) — a company that brings therapeutic Peruvian botanicals to the U.S. market — is coming out with a new product, Royal Moon™, specially designed to help with the range of PMS symptoms and painful periods. Royal Moon™'s primary ingredient is WWB's Royal Maca® (the BEST maca on the market, in my opinion. Royal Maca® has been safely and effectively used for several decades). Royal Moon™ also includes small amounts of magnesium, and turmeric, for added benefits.

Whole World Botanicals is doing an informal trial, and as part of the trial, they're offering a free 3-month supply of Royal Moon™ (valued at around $100!). In exchange, all they ask is that trial participants fill out a simple survey (it will take you about 5 minutes) at the start of taking Royal Moon™, take the supplement regularly through the 3 months, and fill out a followup survey at the end of the 3-month trial (again, about 5 minutes of your time.)

To Participate

Are you eligible to participate? Here are the criteria:

• Participants must have menstrual periods

• Participants need to STOP taking/using any estrogen, or estrogenic supplements for a full month before starting Royal Moon.™ (A participant who is on birth control pills, has an IUD with estrogen, takes any form of estrogen, or takes estrogenic supplements will need to STOP and wait a full month before starting the Royal Moon™ trial.)

• Note: If a participant is on a progestin-only (“mini-pill”) birth control pill, or has a progestin-only (i.e., Mirena™) or non-hormonal IUD (like a copper IUD), they can participate in the trial without waiting

If you have a teen or young adult daughter with PMS and menstrual pain, or you or a friend/family member fit the criteria and want to test out this incredible product, it's a great way to get a free 3-month supply — and experience relief from symptoms! (And there’s absolutely NO obligation after the trial, no shipping costs, and no hidden costs. It’s totally free!)

FYI, for years, many women have been using the same Royal Maca® that's in Royal Moon™ for their PMS and painful periods — as well as a host of other hormonal imbalances such as perimenopause and menopause — with great success. (I used Royal Maca® throughout my perimenopause and menopause, and now post-menopausally, I still do. In fact, I can’t live without it!) Royal Moon™ is formulated and packaged in such a way as to focus on the specific needs of women with PMS/painful periods.

If you're interested, please send me an email at marys@wholeworldbotanicals.com to learn more.

There are limited spaces available in the trial, and the spaces will go fast, so reach out as soon as possible to ensure a spot and a free 3-month trial of Royal Moon™!

Since the 1970s, conventional dogma has said that hypothyroidism treatment is optimal when a patient has a "normal" TSH level, even if the patient's symptoms persist. Dr. Donna Hurlock, who is hypothyroid herself, knows that this misguided approach leaves both patients and practitioners frustrated and searching for solutions.

During her decades of medical practice treating women's hormonal challenges, Dr. Hurlock developed and finetuned the innovative hypothyroidism diagnosis and treatment protocols featured in her just-published book, Patient-Focused Hypothyroidism Treatment.

This valuable guide for patients and practitioners reviews the overt and subtle clinical signs and symptoms of hypothyroidism and explains why the current lab-based guidelines often leave patients misdiagnosed and undertreated.

You'll also get detailed information on how to safely and successfully dose thyroid hormone replacement to not only relieve symptoms while avoiding overmedication but also to prevent many long-term complications of undertreated hypothyroidism. Whether you're a thyroid patient or practitioner, Patient-Focused Hypothyroidism Treatment is a practical and life-changing roadmap to true wellness!

Patient-Focused Hypothyroidism Treatment is available as a paperback and eBook at your favorite book retailers. For more information, a free excerpt, the table of contents, and more, go to: www.doctorhurlock.com.

“Patient-Focused Hypothyroidism Treatment is a long-overdue and necessary return to common sense in hypothyroidism diagnosis and treatment. Women with hypothyroidism can feel well again, thanks to the valuable guidance and breakthroughs Dr. Hurlock shares in this practical, life-changing guide.”
~ Mary Shomon

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