Like most of life’s great questions, the answer to this one is a resounding, “that depends.” We need to make a distinction right at the top, and that is the difference between a “drug” and a “supplement.” The reason we make this distinction is because the word “drug” is a legally defined word, with implications.
For instance, we found this letter that the FDA sent to a nootropic maker, warning them that if they keep using the word “drug,” there will be consequences.
A drug is something intended to treat, diagnose, or cure a disease or symptom of a disease. And if something is a drug, it’s under the purview of the FDA. If it’s a supplement, the FDA regulates it, but does not “approve it.”
We’ll dive into that distinction, and then talk about what nootropics have been approved.
Approval vs. Regulation
The system is set up to protect consumers. When something calls itself a drug you can be reasonably assured that it has been tested and approved for the applications on its label.
Everything else is a supplement. You can take it if you want, but it isn’t approved by anyone, FDA or otherwise.
Now, that doesn’t mean that the FDA doesn’t regulate these supplements. Because they do, and they do so with vigor (just look at the letter we linked above). But just like there’s a world of difference between “drug” and “supplement,” so there’s a huge difference between “approved” and “regulated.”
Approved means the FDA says it will work for what’s on the label. Regulated just means the FDA checks the purity of ingredients and makes sure the product is safe.Approved Nootropics
Now that we have the definitions out of the way, we need to look at certain nootropics. A lot of products get away with calling themselves drugs by putting in the quotes.
You’ll see something like, “Our nootropics, or ‘smart drugs,’ are proven…” Then, elsewhere on the page they might say that “nootropics have been approved by the FDA…”
But we need to be savvy consumers. Some products that could be called nootropics that have FDA approval include the prescriptions of modafinil and methylphenidate, and over-the-counter drugs like NoDoz®. There are other more obscure nootropics approved for dementia and other neurological disorders.
If a product has FDA approval, they will say so. If they say so and don’t have it, the FDA will let them know. Now, on to the supplements.
Regulated Supplements
Many supplements will put official sounding lingo on their website, like “FDA approved facility.” That’s a little like bragging that your company doesn’t cheat on its taxes. This is because all supplements are required to follow FDA protocols if they want to stay in business in the US.
That being said, some supplements have a better reputation than others, and for good reason. For instance, if a nootropic claims to have 500mg of ingredient x, the FDA only makes sure that they do, indeed, have 500 mg of ingredient x.
The FDA does not regulate whether that ingredient does anything.
So, consumers, we need to check up on ingredients and see if there are any studies backing up the use of an ingredient. Because a supplement having FDA regulation only means that it won’t kill you, and that the ingredients are misrepresented; it doesn’t mean the product will work.
In the End
We have to do our research. Until a product proves so effective that it’s able to apply for FDA approval, we have to accept that it might not be as effective as a drug might be. But that doesn’t mean it won’t be effective for you. Millions of people use nootropics everyday, and they claim to get their money’s worth.
For now, just know that unless something is actual medication, it won’t have real FDA approval, only regulation. But in the end, only you can say if something is worth taking.