Are Nootropics FDA Approved?

The regulatory system in the US can be a bit confusing for non-Americans, and even for US citizens. In this piece, we’ll look at whether the popular supplement category of Nootropics has FDA approval.

We won’t break down individual products, but instead work with Nootropics as a whole. If you have questions, check the FAQs at the end, or drop us a comment below! Now let’s get to it.

Defining “Nootropics”

It’s a good idea from the start to talk about what Nootropics are. For this article we’ll be building off of my previous piece. In short, when I talk about Nootropics I’m talking about over-the-counter (OTC) supplements. This means:

  • No prescription required.
  • No ingredients that are classified as “drugs.”
  • Widely available across countries and municipalities.

Now let’s move on to a short (very short) history of the FDA and what they do in the US.

What is the FDA?

Standing for “Food and Drug Administration,” the FDA is part of the Department of Health and Human Services, a Cabinet Department. For non-Americans, you can think of the Cabinet Departments like the Council of Ministers or similar body.

The FDA’s functions go back to the mid-19th century, and the agency has gone through several name-changes. Like their name implies, the FDA regulates all non-meat foods, such as:

  • Bottled beverages;
  • Dairy;
  • Grains (cereals, flours, etc.);
  • Fruits and Vegetables;
  • Any food additives (colorings, flavors, spices, etc.);
  • And all foods for infants and babies;

Importantly for our discussion, the FDA also regulates supplements. But it would be a mistake to assume that the FDA actively and proactively examines products and facilities. Because of the sheer number of products and facilities the FDA regulates, most of their actions regarding foods and supplements are taken after a product is brought to market.

What the FDA DOES DO Regarding Supplements:

  • Requires that all supplements include the words “supplement” and “dietary”. (“Dietary” can be replaced by an ingredient name, such as “Iron.”)
  • Requires all ingredients appear on the supplement label.
  • Requires a manufacturer notify the FDA of a new ingredient not present in the market.
  • Responds to complaints or inquiries from consumers, investigating supplements or foods after they come to market.
  • Most importantly for our discussion, the FDA will investigate any product claiming to treat, cure, or diagnose an illness or disease. The FDA uses this language to differentiate between a “drug” and a “supplement.”
  • The FDA does require that supplement producers register their facilities with them. This does not mean much, though (see below).

The most import thing the FDA does regarding supplements is to ensure that they don’t lie about their product. Here’s a direct quote from the FDA website (emphasis my own):

If a manufacturer… makes a structure/function claim…, a claim of a benefit related to a classical nutrient deficiency disease, or a claim of general well-being in the labeling of a dietary supplement, the firm must have substantiation that the claim is truthful and not misleading. [1]

  • One thing to note, however, is the the FDA does not ask for that “substantiation” in advance.


  • Does not require supplement makers supply evidence that their product is safe.
  • Does not enforce labeling or ingredient integrity before a product hits the shelves.

What it All Means

Now we go back to our original question, “Are Nootropics FDA Approved?” Putting everything together, we can arrive at a straightforward, but not very informative, “No.” The problem is that the question isn’t fair to Nootropics, and that’s because the FDA doesn’t approve any supplements. It wouldn’t be fair to ask a Footballer if they have FAA approval to fly a plane. The FAA doesn’t approve of strikers.

It’s a matter of wording that comes down to legal protection. The FDA only “approves” drugs. Things meant to treat or cure a disease, and that’s because when the FDA “approves” of a drug, there is scientific evidence in patient studies with clearly defined terms. Is Disease A cured or treated? Yes or no.

With supplements there is a lot more gray area. The FDA does not actively investigate every single supplement on the market, checking their claims about fat-burning, T-Boosting, or Cognitive Function. They do monitor the market, however, and they aggressively punish supplement makers that run afoul of their label language requirements.

How this Impacts YOUR NOOTROPIC

Going back to my metaphor, as long as no Footballer claims to be a pilot and jumps into the cockpit, the FAA won’t issue any statements. So long as the FDA has allowed a supplement maker to continue selling in the US, you can rest assured that they have what you or I would call “approval,”, but which for legal reasons, the FDA doesn’t call “approval.”

So while the FDA doesn’t actively “approve” of supplements, they do “disapprove” of some. And this disapproval comes with serious consequences.

Examples of FDA Disapproval

To show what it looks like when the FDA does step in, here are a few examples of actual letters the FDA sends to companies that have made false claims:

Reading the letters, it’s clear that any supplement maker who gets in the crosshairs of the FDA has just around two weeks to get right, or the FDA will literally seize their entire company, assets, products, records, everything.

For you, the Nootropic consumer, that means it’s important to look for reputable products that have built trust and reliability in the market.

Great Green Wall Commitment

Perhaps, Dear Reader, you can see why I take our job at the Great Green Wall so seriously. It’s our job to make sure that we’re reviewing not only a company’s physical product, but also reviewing the science and principles behind the company’s product. Our reputation is on the line, too.

That’s why when we put together a “Best Nootropics” article, we’re spending hours researching not just the ingredients in the Nootropic, but the claims behind those ingredients. And when we find fault in the claims or the science, we speak up.

We take great pains to only recommend Nootropics (and other supplements) that won’t ever garner FDA “DIS-approval.” That means supplements that clearly and honestly label their products, have solid scientific evidence for their claims, and stay on the right side of the law.

We can’t speak for all supplements on the market, but we can say that the reviews on our site will always adhere to these standards. And when a supplement doesn’t stack up, we’ll let you know.


What if I find a shady Supplement?

Report it! And you can always drop us a line about subpar companies; our platform can educate and warn millions of people.

My Nootropic says they’re FDA Approved. What do they mean?

I’d check their language. Do they mean “FDA approved facility?” Because that falls under the regulations we mentioned above, and this is a good thing. It means that this Nootropic is made in a facility where the FDA has been proactively invited to their plant. This is the mark of a really good company.

If the FDA regulates supplements, does that mean all supplements work?

No! All it means is that the FDA has determined that the supplement maker hasn’t lied about their product. That’s why supplement makers use language such as “our customers have seen…” or “this ingredient has been shown in the lab…”. It’s important to gather as much information about a supplement as possible, and to remember to consult your physician before beginning a regimen.

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About the Author

Sam is a passionate health and fitness enthusiast who has been interested in supplements, fitness, and wellness for over 10 years. He is the founder of Great Green Wall - the health and wellness brand and has completed multiple fitness certificates, including personal training and nutrition certifications. Sam has been working as a personal trainer for the past three years and is dedicated to helping his clients achieve their fitness goals and lead healthier lifestyles. He believes that a healthy lifestyle is crucial to a happy and fulfilling life and is committed to sharing his knowledge and passion with others.

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