FDA plans to ban Natural Desiccated Thyroid – why this matters for Hypothyroidism and Hashimoto’s patients
If you rely on natural desiccated thyroid (NDT) medication such as Armour Thyroid, NP Thyroid, Nature-Throid or Natural Thyroid, this news could have a serious impact on your health and quality of life.
The FDA has announced plans to remove most unapproved, animal-derived (porcine) thyroid medications from the market within 12 months.
What are Natural Desiccated Thyroid Medications?
Natural desiccated thyroid (NDT) is derived from the dried thyroid glands of pigs. It contains a natural balance of thyroid hormones (T4, T3, T2, T1 and calcitonin). Many patients find NDT more effective than synthetic T4-only medications such as levothyroxine.
NDT has been in use for over 100 years and was one of the first available treatments for hypothyroidism.
The FDA’s Grandfathered Rights & Sudden Policy Shift
Historically, these medications were “grandfathered in” under the 1938 Food, Drug, and Cosmetic Act. This means they were considered safe and effective based on long-standing use and did not require modern FDA approval.
In 2020, the FDA agreed to give manufacturers time to reclassify NDT products as biologicals and apply for a Biologics License Application (BLA) – a lengthy but achievable process. The deadline given for this was 2029.
Now, without allowing the full transition period, the FDA is moving to remove these medications from the market altogether. This reversal leaves most manufacturers without the time or resources to complete the new approval process that they had started. This would result in nearly all NDT options in the U.S. being wiped out completely.
How many people could be affected?
According to recent prescription data:
- In 2024, according to the FDA approximately 1.5 million patients in the U.S received NDT prescriptions.
- Around 8.8% of new thyroid prescriptions are for desiccated thyroid extract (DTE) (source)
- Hypothyroidism affects 9.5% to 11.7% of Americans (source)
Why This Ban Matters for Patients
For many with Hypothyroidism or Hashimoto’s, synthetic thyroid medication alone doesn’t fully relieve symptoms such as fatigue, brain fog, depression, and weight changes. As a Nutritional Therapist I often talk about alleviating symptoms with dietary and lifestyle changes, but medication is part of that picture, it’s not an either or scenario.
NDT can be life-changing, helping patients feel more energetic, mentally clear, and emotionally balanced. Meaning they can work, contribute to society, have a meaningful and fulfilling home life.
Removing access to NDT:
- Ignores decades of safe use and positive patient outcomes
- Forces patients into a one-size-fits-all treatment approach
- Risks worsening symptoms and reducing quality of life
This isn’t a safety recall, it’s a regulatory reclassification that could remove a vital treatment choice. Let me be perfectly clear NDT medications are safe, there is no question of that.
How does this affect me if I’m not in the U.S?
There are other companies that produce NDT in other countries, however the loss of NDT in the U.S would increase demand exponentially. This could leat to a shortage of NDT medications at least in the short term and also an increase in price. It may also prove difficult to ship to some destinations, depending on regulations.
So even if this doesn’t affect you (or someone you love) right now, it may do in the future.
How You Can Help Save NDT
The thyroid community is rallying to protect access to these essential medications. Here’s how you can take action:
- Sign the Petition – Add your voice to urge the FDA to honour the original agreement and protect patient access. → Sign here!
- Share Your Story – Explain why NDT is vital to your health. Personal stories have power, use your social media platforms to raise awareness. Alternatively if you’d like to remain anonymous and you’re happy for me to share your story across my social media platforms, I can do that, email them to helen@helenmallaburn.com
- Spread the Word – Share this post with friends, family, and online support groups so more patients are aware and can act.
Final Thoughts
We deserve the right to work with our healthcare providers to choose the thyroid treatment that works best for our bodies. As a Nutritional Therapist I’m all about individualised health care! The loss of NDT would be a devastating setback for patient choice and individualised care.
You can find the full FDA announcement here.
