Unapproved Drugs Found In Supplements?

“Unapproved” Drugs

Both throughout the paper and in this chart, they repeatedly harp on the “unapproved” nature of this nootropic.  I’ve ran into this same ambiguity online, where people hear unapproved and freak out about something’s safety.  First though, who’s doing this approving?  Well, in the US the FDA has dominion over medical approval.  Anytime you hear a US paper, news story, web site, etc. talk about something being unapproved, they’re usually talking about the FDA’s metric (or the lack thereof).

The FDA has a defined process that any new drug needs to go through.  If you’ve ever heard the phrase “stage 3 clinical trials”, that’s what it usually takes to get their stamp and the ability to claim something is approved.  The FDA doesn’t do these trials pro bono, however, rather they must be paid for and sponsored by pharmaceutical companies.  Companies justify the expense by being able to then sell their approved drug via patents.  That’s why a new drug is only available from the original company, until the patent expires and generics enter the marketplace.

Meanwhile, your supermarket’s supplement aisle is littered with natural substances with the disclaimer “not approved by the FDA.”  Reason being, you can’t patent natural substances that have been on the market for years.  So, with no one willing to sponsor them for trial, they’re going to remain that way.

That’s why you shouldn’t take the phrase “approved”/”unapproved” so seriously as news articles suggest.  Don’t get me wrong, there’s something to be said for the extensive trials that prescription drugs go through.  While they have their own issues, it’s generally a good sign that at least they’re not toxic (Though they can be more informative than supplement surveys alone).  Conversely, just because no pharmaceutical company has sponsored these trials doesn’t mean that something unapproved is unsafe.

For the purposes of this study and the sites reporting on it, the root of my issue is the authors putting the word unapproved in the title, when many/most readers will assume it means it’s dangerous.  It doesn’t, it just means no one has had financial incentive to sponsor FDA clinical trials.

What About the Products Themselves?

The study provides a table of the 10 products they tested listed with sample codes, however, they declined to name the actual products.  I can see why, due to potential legal challenges.  I went hunting to see what I could find by searching for the “Claim on the label” field in the study.  I located a likely product for 3 of those 10, however, I can’t be certain I found the exact ones so I’m loathe to guess.  For the other 7, the taglines were ambiguous and I found multiple possible options but without any of them referencing noopept.

For the 3 I did find, 2 are available on their manufacturer’s site only, so I doubt they’re seeing much traffic (assuming you can even still order them).  The 3rd I did find an active Amazon listing.  The catch, though?  Those 3 active ones are–guess what–the 3 roughly near their actual label values of noopept content, with the worst having ~73% of its claimed amount.  That’s a bit much (I expect +/- 20% from the label claims) but hardly dangerous.  The worst offenders in that table (like sample codes E and I) I couldn’t find a match.

I’m sure the scientists did actually purchase them; however, they must have been in obscure corners of the Internet and certainly not something you’re going to buy by accident in the supermarket supplements aisle.  This means concerns about the general population buying them by mistake are overblown.

Nonetheless, any manufacturer who deliberately adds other psychoactive ingredients–without clearly listing them on the label–is being dishonest and is part of the problem with the nootropics industry.  I’m in support of studies finding bad actors and regulatory bodies putting pressure on them to act with integrity.  What I’m not in favor of is intentionally using misleading language when reporting.

How to Report This Right

Bringing it together then, the data in the study is solid.  The products that were deliberately mixed with other nootropics should be noted.  At the same time, using provocative and misleading headlines just distorts the message.  A much more accurate title is “4 Other nootropics found mixed with piracetam in cognitive supplements.”  The original terminology has too strong of implications.  For any layperson reading those articles, they’d think someone laced their fish oil with heroin or the like.  More precise language will only help the field develop.