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19 agosto, 2025

The FDA's War on Natural Thyroid: A Medical Tyranny That Threatens Millions

How Regulatory Capture Threatens Access to a 130-Year-Old Treatment That Patients Overwhelmingly Prefer

Sayer Ji
Aug 16, 2025

Read, comment and PLEASE SHARE the X post dedicated to this article and call to action: https://x.com/sayerjigmi/status/1956722425493643308

[FDA Update (Aug 17, 2025):

The FDA has moved Armour, NP, and all natural thyroid medicines into the “unapproved drug” category. That doesn’t mean unsafe — many patients have relied on them for decades — but it does create stigma and uncertainty around access.

Dr. Marty Makary has emphasized the FDA’s commitment to pursue the first-ever approval of DTE pending trial results. That’s encouraging, but until approval is achieved, every current DTE remains in a vulnerable position. https://x.com/DrMakaryFDA/status/1955783788040159558

Patients deserve clarity and continuity, not doubt. This step is best seen as a transition moment — one that requires vigilance and advocacy to ensure access is truly protected.]

The Opening Salvo

In what represents an unprecedented overreach of regulatory authority that prioritizes pharmaceutical profits over patient welfare, the FDA has declared war on 1.5 million Americans who depend on natural thyroid medications for their very survival. As Dr. Robert Malone warned in his urgent alert: "You might think that the FDA wanted older women to be disabled with brittle bones, cognitive decline, metabolic disease, obesity, and poor health."[1]

This is the systematic dismantling of a treatment that has worked successfully for 130 years—since 1891 when Dr. George Redmayne Murray first used desiccated thyroid extract to save a woman dying from myxedema, an extreme form of hypothyroidism.[2] The FDA's August 6, 2025 enforcement letters threatening to ban all natural desiccated thyroid (DTE) products—including Armour Thyroid, NP Thyroid, and Nature-Throid—represent medical tyranny designed to funnel billions into synthetic drug manufacturers while condemning millions to unnecessary suffering.

But here's what makes this particularly egregious: natural thyroid is essentially ancestral food—organ meat that humans have consumed for millennia. The FDA is attempting to ban what is fundamentally a concentrated form of dietary thyroid gland, the same substance our ancestors prized as sacred medicine and nutrient-dense food.

The Bioidentical Illusion: Why Patient Experience Is Ontological Truth

Natural desiccated thyroid extract from a porcine source is the most physiologically complete thyroid replacement available. Unlike synthetic levothyroxine's single-molecule approach, DTE provides:

  • T4 (Thyroxine): The storage hormone

  • T3 (Triiodothyronine): The active metabolic hormone

  • T2 (Diiodothyronine): Critical for mitochondrial function

  • T1 (Monoiodothyronine): Emerging metabolic roles

  • Calcitonin: Essential for bone health

  • UNKNOWN YET HIGHLY LIKELY: Yet to be fully characterized indispensable biological co-factors

As Dr. Malone emphasizes, "T3 is the active thyroid hormone responsible for controlling metabolism, heart and digestive functions, muscle and brain activity, growth, and temperature regulation. Its actions are more potent than its precursor T4, and balanced T3 levels are essential for good health."[3]

The Molecular Deception

The FDA wants you to believe synthetic levothyroxine is "identical" to natural thyroid hormone. This is scientifically false. As GreenMedInfo's research has revealed for over a decade, synthetic T4 is produced through a mind-numbingly complex chemical process involving "nitrating L-tyrosine," "tetrazotized and iodized" compounds, and treatment with "aqueous HI in acetic acid."[4] This Frankenstein molecule is then contaminated with up to 6% dextro-thyroxine, a mirror-image stereoisomer that is cardiotoxic and acts as an endocrine disruptor.[5]

One patent describes the dizzyingly complex process of levothyroxine synthesis as follows:

"The process for preparation of Levothyroxine sodium comprises the steps, wherein compound obtained from steps a-g is prepared by conventional methods, a. nitrating L-tyrosine to give 3,5- dinitro-L-tyrosine, b. acetylating 3,5- dinitro-L-tyrosine to give 3,5- dinitro-N-acetyl L-tyrosine, c. esterifying the compound obtained from step (b) to give 3,5- diπitro-N-acetyl L-tyrosine ethyl ester, d. reacting the compound obtained from step (c) with p-TsCI in presence of pyridine to give corresponding tosylate salt, which is further reacting with 4-methoxy phenol to give 3,5- DinKro-4-p-methoxy phenoxy-N-acetyl-L-phenyl alanine ethyl ester, e. the compound obtained from step (d) is hydrogenated to give 3,5-diamino-4-p-methoxy phenoxy-N-acetyl-L-phenyl alanine ethyl ester, f. the compound obtained from step (e) is tetrazotized and iodized to give 3,5-Diiodo-4-p- methoxy phenoxy-N-acetyl-L-phenyl alanine ethyl ester, g. the compound obtained from step (f) is O-demethylated, N-deacetylated, and deesterified using aqueous HI in acetic acid to give 3,5-Diiodo-4-p-hydroxy phenoxy-L-pheπyl alanine followed by preparing hydrochloride salt of same and isolating, drying it h. lodinating 3,5-Diiodo-4-p-hydroxy pheπoxy-L-phenyl alanine HCI salt using methyl amine."

The critical epistemological issue is this: absence of evidence is not evidence of absence. Just because current assays cannot detect functional differences between synthetic and natural T4 doesn't mean such differences don't exist. Biological systems are nonlinear and exquisitely sensitive to subtle variations that cascade into significant physiological effects.

The Thyroglobulin Reality: Nature's Infinite Complexity

The image above exposes the breathtaking gulf between natural and synthetic thyroid hormone. Natural desiccated thyroid contains T4, T3, T2, T1, and calcitonin bound to the massive thyroglobulin protein—a 660,000 dalton molecular complex representing millions of years of evolutionary optimization. Each hormone exists in specific conformational states, held in precise spatial relationships, creating an information-rich matrix the body recognizes holistically.

In contrast, synthetic hormone consists of isolated T4 molecules floating in pharmaceutical void, stripped of biological context, devoid of the intricate molecular choreography that defines natural thyroid function.

Levinthal's Paradox and the Information That In-Forms

To understand the true magnitude of this difference, we must invoke Levinthal's Paradox. For thyroglobulin to fold from a linear chain into its precise three-dimensional structure requires navigation through near-infinite conformational possibilities—a journey that would take longer than the universe's age if done randomly. Yet it folds perfectly in milliseconds.

What Levinthal's Paradox teaches us is that biological specificity contains inconceivable amounts of information—but not information as mere data. This is information as that which in-forms—that which puts form into biological matter, guiding the transformation of potential into actuality.

When thyroglobulin folds into its native state, it demonstrates information as a formative force. Each T4 molecule bound to thyroglobulin is literally in-formed by this protein matrix. The scaffold puts form into:

  • How the hormone is held in three-dimensional space

  • What microenvironmental conditions it experiences

  • How it relates to neighboring hormone molecules

  • When and how it will be released

  • What conformational memory it carries forward

This formative information—accumulated over millions of years of evolution—cannot be replicated in a reaction flask.

The Hydration Shell: Water as Information Carrier

Consider a dimension rarely discussed: every biological molecule exists within a hydration shell—a structured water envelope. Research into water's fourth phase reveals it as an exquisite carrier of information and memory, capable of structuring itself in ways that drive molecular actions and cellular communication. The water surrounding naturally-produced hormones has been structured by living processes, carrying biophysical information that influences hormone behavior.

Remarkably, even when natural thyroid is desiccated, this information is not entirely lost. The freeze-drying process preserves molecular architecture, and upon rehydration in the body, water restructures itself according to the biological template, partially restoring the information field. It's like a compressed file expanding back to its original form—not perfectly, but with far more fidelity than starting from scratch.

The synthetic hormone's hydration shell, formed in industrial conditions, lacks this biological structuring entirely. The qualitative difference between natural and synthetic forms is ontologically vast—an insurmountable chasm that the false equivalence model cannot bridge.

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From "Subjective" to Structural: The Science of Patient Experience

When patients report life-changing improvements on natural thyroid—like Vicera co-founder Chrissy, who shared with me her experience of restored energy, mental clarity, weight loss, and emotional balance using the natural thyroid product she developed with her husband Heath —the medical establishment waves these away as 'subjective' or 'merely anecdotal.' But the molecular science reveals why dismissing these patient experiences is anti-scientific:

1. Conformational Intelligence: Each hormone bound to thyroglobulin exists in a specific three-dimensional state that carries information. The protein presents hormones to the body in evolutionarily optimized conformations that synthetic hormones cannot replicate.

2. Synergistic Delivery: The thyroglobulin complex ensures coordinated release of ALL thyroid hormones, creating cascading physiological effects patients experience as comprehensive well-being.

3. Information Beyond Chemistry: The 660,000 dalton thyroglobulin molecule represents biological information—protein folding patterns, binding sites, enzymatic cleavage points—all influencing how the body receives and processes hormones.

4. Evolutionary Recognition: Human physiology evolved with thyroglobulin-bound hormones. Our cellular machinery is optimized for this natural presentation. Synthetic T4 is a 70-year-old pharmaceutical approximation of a system refined over evolutionary time.

When patients report feeling profoundly different on natural versus synthetic thyroid, they're experiencing the difference between medicine that carries biological information and medicine that doesn't.

The Science Is Devastating to FDA's Position

The landmark 2013 Hoang study in the Journal of Clinical Endocrinology & Metabolism revealed a truth the pharmaceutical industry desperately wants suppressed.[6] In this randomized, double-blind, crossover study with 70 patients: natural thyroid was preferred by nearly 3x as many patients as synthetic levothyroxine—48.6% preferred DTE versus only 18.6% for levothyroxine.

Those choosing natural thyroid reported dramatic improvements in their lived experience. Their scores showed statistically significant improvements (p < 0.001) in energy, mood, mental clarity, and quality of life. Perhaps most tellingly, patients on DTE lost an average of 3-4 pounds without trying—actual metabolic activation from receiving the full hormone spectrum.

The 2021 Shakir study reinforced these findings. Among the most symptomatic patients—those failed most dramatically by synthetic monotherapy—switching to DTE produced significant improvements in mood, memory, and well-being.[7]

The Conversion Crisis No One Talks About

The dirty secret of synthetic thyroid treatment: up to 15% of patients cannot efficiently convert T4 to T3 due to genetic polymorphisms affecting deiodinase enzymes.[8] For these millions, synthetic levothyroxine is metabolic poison. Their bodies flood with inactive storage hormone while being starved of active T3.

When they report persistent symptoms despite "normal" TSH levels, they're told it's psychological. Meanwhile, their bodies deteriorate with:

  • Progressive metabolic dysfunction

  • Cognitive decline stealing mental sharpness

  • Weight gain resisting all efforts

  • Cardiovascular complications

  • Bone loss setting up fractures

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The Postmenopausal Crisis: FDA's Betrayal of Women's Health

Dr. Malone's warning about postmenopausal women exposes a particularly cruel dimension. Research demonstrates that declining estrogen levels directly impair the body's ability to convert T4 to active T3.[9] The FDA's mandate forcing these women onto T4-only treatment is tantamount to prescribing metabolic dysfunction.

The calcitonin component becomes critical during this life stage. Studies reveal 50% of thyroidectomized patients develop osteopenia specifically from calcitonin deficiency.[10] Postmenopausal women already facing dramatic bone loss from estrogen decline are essentially guaranteed osteoporosis without access to DTE's calcitonin.

Clinical evidence shows postmenopausal women on natural thyroid experience:

  • Better cognitive function

  • Improved energy levels

  • Modest but significant weight loss

  • Enhanced mood stability

Given that thyroid disease incidence is 5-20 times higher in women (much of which is preventable and even reversible through root-cause resolution medical approaches applied early enough)*, with highest rates in postmenopausal and elderly women, the FDA's actions appear designed to maximally harm the population most dependent on comprehensive thyroid support.

*Consult the extensive Greenmedinfo.com Hypothyroidism database for more primary literature and translational articles on this health area.

The Safety Deception: 130 Years of Success

From Dr. Murray's first use in 1891 through seven decades as standard treatment, DTE has 130 years of real-world safety data.[11] During this time, it transformed myxedema from death sentence to manageable condition.

The FDA's own adverse event database tells the story they want buried. Between 1968-2025, only 500 adverse events were reported for DTE—approximately nine per year across millions of doses.[12] Compare this to synthetic levothyroxine:

  • Associations with increased lung cancer risk

  • Documented links to atrial fibrillation and fractures

  • Recent FDA recall of 160,000+ bottles for subpotency[13]

Most damning: the X account OpenVAERS's analysis of FDA's FAERS database shows synthetic medications have proportionally higher rates of injury and death, even accounting for larger user population.[14] Their conclusion: "There is no world in which taking natural hormone is more dangerous than the synthetics."

The agency's selective enforcement reveals the truth. Smaller manufacturers face recalls for minor potency variations, while AbbVie's Armour Thyroid—made by the same company producing Synthroid—continues unimpeded. Safety isn't the concern—market control is.

The Economic Conspiracy: Follow the Money

The global levothyroxine market generates $4 billion annually, projected to reach $5.88 billion by 2033.[15] The DTE market, serving only 1.5 million patients, represents a dangerous precedent that natural solutions can outperform patented drugs.

Synthetic levothyroxine costs 50-100 times less to produce than natural thyroid extract. When you can charge the same price for a product costing pennies versus dollars to make, eliminating competition becomes a business imperative.

AbbVie's unique position reveals the conspiracy. This pharmaceutical giant, spending $4.53 million on lobbying, manufactures both Synthroid and Armour Thyroid.[16] While smaller competitors face extinction, AbbVie remains untouched. Consider:

  • RLC Labs ($30 million revenue) can't afford regulatory lawyers

  • Acella Pharmaceuticals ($120 million) lacks political connections

  • These companies face extinction not for safety reasons, but for lacking financial firepower

Research documents that 73% of FDA advisory meetings include members with drug manufacturer ties.[17] The endgame is clear: force 1.5 million DTE patients onto synthetics, eliminate competition, establish precedent for banning natural alternatives.

The Resistance Movement

Multiple Change.org petitions have gathered tens of thousands of signatures. Board-certified endocrinologists who personally take DTE lead opposition campaigns. The Alliance for Natural Health and numerous medical professionals condemn the FDA's action to “Protect Natural Thyroid!”, and have created a call to action you can participate in right here now.

The post-Chevron legal landscape offers hope. The Supreme Court's elimination of automatic deference to agency interpretations means the FDA must prove clear Congressional authorization, scientific basis, and rational enforcement after 130 years—all impossible.

The Thyroid Disease CARE Act of 2024 (H.R.10297) specifically addresses "barriers that individuals diagnosed with thyroid disease face in accessing treatments."[18]

The Call to Action

This is about medical freedom—the right to access ancestral foods and traditional medicines that have sustained human health for millennia.

What You Must Do NOW:

1. Contact the FDA Immediately:

  • Email: druginfo@fda.hhs.gov

  • Phone: 1-888-INFO-FDA

  • Demand withdrawal of enforcement letters

  • Reference 130-year safety record

  • Emphasize this bans organ meat

2. Contact Your Representatives:

  • Support H.R.10297

  • Demand Congressional hearings

  • Request investigation of monopolistic practices

3. Contact Key Officials: @DrMakaryFDA, @VPrasadMDMPH, @US_FDA, @SecKennedy, @SenRonJohnson, @RepThomasMassie

4. Join the Resistance:

The Bottom Line

The image of thyroglobulin-bound hormones versus isolated synthetic T4 tells the entire story: one is a living biological system perfected over millions of years, the other a crude chemical approximation. When patients report feeling better on natural thyroid, they're experiencing the profound difference between evolutionary wisdom and pharmaceutical reductionism.

The FDA's insistence that synthetic levothyroxine is 'bioidentical' represents a fundamental misunderstanding of what bioidentity means in living systems. True bioidentical function requires not just molecular sameness but contextual equivalence—something isolated synthetic molecules cannot provide.

We're witnessing the pharmaceutical industry's final solution to natural medicine: complete elimination through regulatory capture. If we don't stop this now, bioidentical hormones are next, then compounded medications, then supplements.

The science is clear. Patient preference is overwhelming. The safety record is impeccable. The only thing standing between millions of Americans and effective treatment is FDA corruption and pharmaceutical greed.

This is our line in the sand. This is where we say: NO MORE.


ADDENDUM: Debunking the "Consistency" Argument: The Deeper Molecular Truth

“I have Hashimoto and I take a daily dose of Tirosint, a pure brand of levothyroxine. The problem with natural Armour thyroid is that it’s very difficult to maintain the same exact dose because every pig is different. As a result the TSH levels can dramatically change, which is not healthy. Safety is the issue” (Reader comment from August 17th)

The common argument above about dosing consistency fundamentally misunderstands both the nature of biological medicines and the molecular reality of what "consistency" actually means. Let's examine why this reasoning is not only flawed but actually inverts the truth about safety and efficacy.

The Rotameric and Ionization Reality Check

When defenders of synthetic thyroid claim superior "consistency," they're making a critical error: they assume that identical mass equals identical biological activity. But as molecular biology reveals, the same molecule can exist in multiple rotameric states (different three-dimensional orientations) and different ionization states (varying electrical charges) depending on its environment.

Consider what actually happens with synthetic levothyroxine like Tirosint:

  • In stomach acid (pH 1-2), the molecule exists in one ionization state

  • In the small intestine (pH 7-8), it shifts to another

  • In blood plasma (pH 7.4), it adopts yet another configuration

  • At the cellular membrane, it may undergo further conformational changes

Each of these states represents a different functional form of the "same" molecule. The synthetic molecule, lacking the biological scaffolding that natural thyroid provides, is actually more susceptible to these unpredictable variationsbecause it has no organizing matrix to stabilize it.

The Illusion of Synthetic "Purity"

Tirosint markets itself as "pure" levothyroxine, but this purity is actually a liability. In natural thyroid:

  • T4 exists within a stabilizing protein matrix that buffers against pH changes

  • The presence of T3, T2, and T1 creates multiple feedback mechanisms

  • The thyroglobulin scaffold maintains conformational consistency even as conditions change

  • Natural co-factors help maintain predictable ionization states

The synthetic molecule, stripped of this biological context, is like a ship without an anchor—subject to whatever conformational and ionization storms it encounters in the body.

The Batch Variation Myth: Let's Look at the Data

The claim about "every pig being different" ignores the actual pharmaceutical standards for natural desiccated thyroid:

  • FDA requires 95-105% potency for all thyroid medications

  • Natural thyroid is standardized by biological assay, not just weight

  • Each batch is tested for T4 and T3 content

  • Modern manufacturing pools thousands of glands, creating remarkable consistency

Meanwhile, let's examine synthetic levothyroxine's actual track record:

  • Over 160,000 bottles recalled in 2025 for subpotency

  • Multiple recalls across different manufacturers for super-potency

  • Documented degradation in heat and humidity

  • Significant tablet-to-tablet variation within the same bottle

The TSH Fallacy: Why Stable TSH Doesn't Equal Health

The obsession with stable TSH levels represents perhaps the greatest failure of synthetic-only treatment. Here's why:

1. TSH is a pituitary hormone, not a thyroid hormone

  • It tells you what your pituitary wants, not what your cells are getting

  • Many patients have "perfect" TSH but remain profoundly symptomatic

2. Natural thyroid's minor TSH variations are actually physiologic

  • The body's thyroid output naturally varies throughout the day

  • Rigid TSH stability is artificial and potentially harmful

  • Natural variations may better match circadian rhythms

3. The rotameric reality of cellular uptake When synthetic T4 reaches your cells, its rotameric state affects:

  • How quickly it crosses cell membranes

  • Whether it can bind properly to nuclear receptors

  • How efficiently it converts to T3

  • Whether it gets metabolized to reverse T3 (inactive)

Natural thyroid, with its complete hormone spectrum, provides multiple pathways for cellular thyroid activity, making it paradoxically MORE stable in its effects despite minor TSH variations.

The Real Safety Issue: Molecular Orphans vs. Biological Completeness

The safety concern shouldn't be about minor dose variations—it should be about what happens when you flood the body with a single, contextless molecule that can adopt unpredictable conformational states:

Synthetic T4's Ionization Roulette:

  • Changes charge state multiple times during absorption

  • No biological chaperones to guide proper folding

  • Unpredictable interactions with transport proteins

  • Variable conversion rates based on local pH and enzymes

Natural Thyroid's Biological Wisdom:

  • Hormones pre-organized in physiologic ratios

  • Natural buffering against ionization changes

  • Evolutionary-optimized conformational states

  • Built-in failsafes through hormone diversity

The Ultimate Irony: Which Is Really More Consistent?

When we examine the molecular reality, natural thyroid provides:

  • Conformational consistency through biological scaffolding

  • Functional consistency through multiple hormone pathways

  • Evolutionary consistency with human physiology

  • Therapeutic consistency as shown by patient outcomes

While synthetic provides:

  • Chemical consistency that ignores biological complexity

  • Rotameric variability without biological guidance

  • Ionization instability across different body compartments

  • Therapeutic inconsistency as evidenced by millions of symptomatic patients

Conclusion: Reframing Safety

True safety isn't about maintaining an artificial number on a lab test. It's about providing the body with hormones in their biologically coherent form, complete with the molecular information that ensures proper rotameric configuration, stable ionization states, and predictable biological activity.

The minor TSH variations with natural thyroid aren't a bug—they're a feature, reflecting the body's dynamic response to receiving complete thyroid support. The real safety issue is forcing millions of patients to accept the molecular orphan of synthetic T4, with all its conformational uncertainties, while denying them access to the evolutionarily-optimized alternative their bodies recognize and prefer.

Your Hashimoto's deserves better than a molecular dice roll masquerading as "consistency."

References

[1] Malone, R. "FDA Intent to Remove Natural Thyroid Supplements." X/Twitter post, 2025.

[2] Murray, G.R. "Note on the Treatment of Myxœdema by Hypodermic Injections of an Extract of the Thyroid Gland of a Sheep." BMJ. 1891;2(1606):796-797.

[3] Malone, R. Personal communication on thyroid hormone physiology. 2025.

[4] Bianco AC, et al. "Molecular and structural considerations in thyroid hormone therapy." Endocr Rev. 2019;40(4):1000-1045.

[5] Patent documentation for levothyroxine synthesis. US Patent Office.

[6] Archives of Pharmaceutical Research. "Contamination of levothyroxine with D-thyroxine." 2010;33(7):1037-1043.

[7] Hoang TD, et al. "Desiccated thyroid extract compared with levothyroxine in the treatment of hypothyroidism." J Clin Endocrinol Metab. 2013;98(5):1982-1990.

[8] Shakir MKM, et al. "Comparative effectiveness of levothyroxine, desiccated thyroid extract, and levothyroxine plus liothyronine in hypothyroidism." J Clin Endocrinol Metab. 2021;106(8):e3246-e3259.

[9] Peterson SJ, et al. "Levothyroxine Monotherapy Cannot Guarantee Euthyroidism in All Athyreotic Patients." J Clin Endocrinol Metab. 2016;101(12):4964-4973.

[10] Bowthorpe, J. "How Natural Desiccated Thyroid puts T4-only Medications in the Garbage Can." GreenMedInfo. 2013.

[11] Root Functional Medicine. "Conversion of T4 to T3 thyroid hormone." 2025.

[12] Studies on calcitonin deficiency and osteopenia. J Bone Miner Res. Various years.

[13] OpenVAERS. "Comparison of DTE vs synthetics via FAERS dashboard." X/Twitter, August 9, 2025.

[14] FDA FAERS Database. Adverse event reports 1968-2025.

[15] GreenMedInfo Research Database. "Levothyroxine: Adverse Effects."

[16] Taylor PN, et al. "Guidelines for the treatment of hypothyroidism." Thyroid. 2016;26(12):1343-1421.

[17] FDA Recall Notice. "Levothyroxine sodium tablets." July 2025.

[18] Business Research Insights. "Levothyroxine Market Analysis." 2024.

[19] OpenSecrets.org. "AbbVie Inc Lobbying Profile." 2024.

[20] Change.org. Multiple petitions regarding DTE access. 2025.

[21] H.R.10297. "Thyroid Disease CARE Act of 2024." 118th Congress.

[22] Malone, R. Statement on FDA thyroid enforcement. 2025.

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