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:
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:
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:
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]
What the FDA DOES NOT DO:
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:
False Claims
Labeling Violations
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.
FAQs
Report it! And you can always drop us a line about subpar companies; our platform can educate and warn millions of people.
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.
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.