The FDA Ban on NDT Explained (Why You Don’t Need To Panic)

Recently, the FDA sent warning letters (1) to manufacturers of natural desiccated thyroid (NDT), thyroid medications like Armour Thyroid and np thyroid, stating that these medications are technically illegal to sell without new approval.

They’ve given these companies 12 months to comply or shut down production.

This is definitely a power play by the FDA, which has long been against the use of NDT formulas, in an effort to push people towards synthetics like levothyroxine and Synthroid.

This means that NDT could theoretically disappear from pharmacy shelves as early as next year, or even sooner if manufacturers decide not to fight it.

If you are one of the hundreds of thousands who rely on NDT for symptom management, this news is… concerning (an understatement of the decade).

But I’m here to tell you that you don’t have to panic.

Here’s why:

#1. This isn’t law (yet).

It’s what’s called an FDA enforcement action, not a ban.

What the FDA is trying to do here is to reclassify NDT as a biologic compound in an effort to better “regulate” it.

This reclassification would require pharmaceutical companies to apply for a biologics license application, which would cost time and money.

The fear is that during this process, patients may lose access to NDT.

And the even greater fear is that NDT manufacturers wouldn’t bother to apply for the license at all, limiting NDT access indefinitely.

Fortunately, recent statements from the FDA head suggested that patients will not lose access to NDT during this process and that there are currently ongoing studies that would prove that NDT is both safe and effective.

The reality is, while there is a non-zero risk your access to NDT medication may be limited, I don’t think it’s very likely.

This brings us to point #2:

#2. There’s a lot of money at stake.

If you look at the top prescriptions fulfilled each year, levothyroxine is consistently at the top of the list (usually #3 or #4 behind cholesterol and blood pressure medications).

For perspective, there are usually around 80 to 100 million prescriptions for levothyroxine filled each year (2), and this number is getting bigger, not smaller.

This isn’t the medication we are talking about today, but it’s important to realize that the thyroid medication market cap is in the billions of dollars per year.

Of the total number of thyroid patients taking medication, about 20% or so are taking NDT formulas.

So even though it’s a much smaller percentage, the market cap is still huge and in the tens of millions of prescriptions filled each year.

That’s a lot of money and a lot of incentive for the manufacturers of NDT medications to continue to provide their product.

For this reason, you may not have to do anything but let them do the fighting for you because of what’s at stake.

#3. The community is pushing back.

We also have to give room for legal challenges, lobbying from patient groups, and pushbacks from other organizations.

In fact, much of the pushback recently has caused what people think is somewhat of a walk back by the head of the FDA.

But to be clear, he did not walk back anything. What he said was this:

The “FDA is committed to pursuing the first-ever approval of desiccated thyroid extract, pending results of the ongoing clinical trials. In the meantime, we will ensure access for all Americans.” (3)

What this means is that your voice and the voices of others matter.

You Can Recreate the Benefits of NDT Yourself

But let’s assume the worst-case scenario… that all forms of NDT are pulled off the market in about 12 months.

You still don’t have to worry.

Why?

Because you can recreate the NDT effect right now, with a couple of over-the-counter supplements, no prescription needed.

shop supplements and supercharge your thyroid

And this is something that most of you should be doing right now anyway, because it sets you up for success even in the event of things like this happening in the future.

In order to do this, you need to understand what makes NDT so special.

Many thyroid patients believe that it’s just the T4 and T3 content that makes it work, and that’s part of the equation, but not at all of it.

Instead, it’s the synergy of multiple other ingredients that all work together:

The T4 content
The T3 content
The T2 content (4)
Thyroid-specific cofactors and peptides – These are found naturally in the thyroid gland
And trace minerals like iodine, selenium, zinc, and copper

Because Armour thyroid consists of ground-up thyroid gland powder, you get everything when you take it in capsule form.

And it’s this combination that makes it work so well; it’s not due to any single ingredient, but the symphony of everything working together.

Some thyroid patients wrongly believe that it’s the “natural sourcing” that matters. It’s not.

I hate to break it to you, but the T4 and T3 found in Armour thyroid (5) are the exact same as the T4 found in levothyroxine (6) and the T3 found in liothyronine/Cytomel (7).

The only difference is their sourcing. One is “natural” and the other is “synthetic”.

Understanding this is critical because it allows you to recreate NDT in a piecemeal type way by adding what levothyroxine and liothyronine do not.

And it turns out that these extra ingredients are all available over the counter.

The DIY NDT Protocol (No Prescription Required)

Recreating this is what I call the DIY NDT protocol.

Since most of you are already taking levothyroxine, you can use that as a base and then build on top of it with a couple of extra ingredients.

Here’s what that looks like:

Start with your base of levothyroxine, which provides the T4 thyroid hormone (I would recommend switching to Tirosint if you can, but levothyroxine works)
From here, you add on T3 thyroid hormone in the form of liothyronine or cytomel.
Next, you add in T2 thyroid hormone, which is available over the counter at 100 to 200 mcg per day.
Next, and this is key, you will add on desiccated bovine thyroid gland powder. This powder is VERY similar to NDT but comes from cows instead of pigs. The main difference is that the T4:T3 content isn’t standardized.
Finally, you finish it off with some added trace minerals like zinc, selenium, iodine, copper, and a little bit of iron if needed. You can get all of these with a simple thyroid support supplement.

Together, you just re-created Armour Thyroid with a handful of supplements and a couple of prescription medications.

And what makes this even better is the fact that you have complete control over every individual piece and dose.

If you need more T3, you can up your dose. If you need less T4, you can simply drop it.

Unlike Armour thyroid, which comes in a static dose, you can individually adjust each thyroid hormone to your preferences.

Bottom Line

Don’t panic.

There is a much greater chance that everything will work out than that everything will go wrong.

But let me be clear by saying it’s still possible that NDT is eventually pulled off the shelf, given how events have occurred.

If you’re worried or just don’t like the idea of being reliant on a medication that is so up in the air, try re-creating your own NDT formula using the steps I just discussed.

And don’t fall into the trap of thinking that NDT is somehow superior to all other thyroid medications.

The truth is that you can feel better on a number of different combinations, including levothyroxine.

If you don’t feel well on your current protocol, check out this article next, which will help you optimize your medication.