The False Promise of Smart Pills in a Loosely Regulated Market

by Spencer Andrews

We’ve all had the experience: you receive a targeted ad on your phone or computer which mysteriously seems to read your mind. This happened to me recently when I, a busy law student, began receiving a wave of ads selling supplements which purport to improve brain focus, clarity, and memory. I had been thinking about ways to increase my productivity, and just in the nick of time, a miracle drug appeared to answer my need. As it turns out, the product being advertised was of a little-known class of substances known as nootropics. And as you might expect, nootropics are hardly a miracle drug.

What is a Nootropic?

The word nootropic is colloquially used to describe a wide range of natural and synthetic substances thought to have cognitive enhancing properties. Romanian psychologist and chemist Corneliu Giurgea coined the term nootropic in the 1970s. He first used the term after synthesizing piracetam, a compound which he claimed would improve cognitive functions like memory and learning. Clinical studies have since shown that piracetam is not a dependable cognitive enhancer nor does it have long-term efficacy against cognitive impairment. Nonetheless, it has shown modest efficacy as an anti-depressant, and most recently, it has demonstrated some promise as a neuroprotective drug for patients undergoing coronary bypass surgery. Notwithstanding piracetam’s clinical success, or lack thereof, the term nootropic has since evolved into something else entirely.

Today, the term nootropic is used incredibly broadly — making it hard to identify all of the substances described as nootropics. Many in the scientific community, for example, label well-known, commonly accessible drugs as nootropics. These drugs promote wakefulness and might include ADHD medications, like Adderall and Ritalin, or caffeine and the narcolepsy drug Modafinil. Common drugs such as these have been shown to be safe to consume long-term, but rarely do the companies marketing these drugs describe their products as cognitive-enhancing nootropics. Instead, the substances advertised as miracle nootropic substances are often part of a lesser-known and lesser-studied class of natural substances. These include Gingko biloba extract, Bacopa monnieri extract, and L-theanine; each of which originate from nature but are chemically extracted for their “cognitive enhancing” properties and pressed into pills.

Regulation of Dietary Supplements

Popular nootropic brands like AlphaBRAIN and NooCube are sold in bottles which, at first look like any over-the-counter medication. Upon a closer look, however, the products provide warnings and caveats not found on typical medications.  Each label, under its promises to improve mental speed, clarity, and even problem-solving skills, includes a warning that the previous “statements have not been evaluated by the FDA” and the product is “not intended to diagnose, treat, cure, or prevent any disease.” This is a curious statement, of course, but it is no coincidence.

As it turns out, nootropic products are technically classified by the U.S. Food and Drug Administration (FDA) as “dietary supplements,” not medications. By assuming this title, nootropic companies are able to escape the stringent FDA drug approval process. Dietary supplement companies do not have to provide the FDA with evidence to substantiate safety before or after they market and sell their products. This is because dietary supplements fall in the category of a food, not a drug, and can be pulled from shelves only if the FDA finds that they are harmful. As the FDA explains, “dietary supplements are products intended to supplement the diet. They are not medicines and are not intended to treat, diagnose, mitigate, prevent, or cure diseases.” For more information on the uniquely lax regulation of dietary supplements, read this Bill of Health article published a few years ago.

Efficacy of Cognitive Enhancers

The fact that modern nootropics exist in a liminal regulatory category entices companies selling these products to label their pill bottles with both promises and warnings retracting these promises — a marketing sleight of hand.  When a nootropic company fails to provide proper caveats, the FDA might threaten to pull its products off the market. Just a few years ago, the FDA sent warning letters to the companies selling the nootropics Alpha GPC 50% and Mind Ignite. The problem was not with their ingredients, but rather, with the companies’ promises that their products would “help diseases of the brain such as Alzheimer’s” and serve as “effective alternative(s) to Adderall.” In their statements, the FDA warned that these promises were not backed by empirical studies.

While FDA approval is not the only marker of product safety, it is at least a sign of thorough review. Products marketed similarly to medications but sold as dietary supplements, like most nootropics, deserve some caution before use. Studies have generally found that the active ingredients in common nootropic products, like the substances mentioned above, might provide some minor cognitive enhancing benefits. A recent double-blind study found that subjects taking a natural nootropic substance demonstrated improved task reaction times compared to those in the control group. In sum, it seems that some commonly marketed nootropic substances may increase attention in short stints, but little evidence has been put forward supporting the idea that natural nootropic substances enhance memory or problem-solving skills in healthy adults. Some publications argue that individuals should weigh any modest benefits against the unknown, understudied, and potentially harmful long-term effects of consistent nootropic use.

So what now?

Despite their aggressive advertising campaigns and increasing popularity, nootropic supplements need further study before they can serve as a dependably safe and effective solution to your productivity problems. The bottom line, according to the FDA, is that “if a supplement promises a cure or quick fix for a health problem, it is probably too good to be true.” So if you, like me, are looking for a boost to brain function that is 100% proven, one expert, Dr. Mark Moyad of the University of Michigan, says the answer is likely quality sleep and regular exercise. For now, I’ll stick to those old-school cognitive enhancers.

Spencer Andrews (J.D. 2026) hails from small-town Indiana and worked for three years as a research fellow at the National Institutes of Health (NIH) before attending law school. His background in neuroscience inspired him to dig deeper into the societal impacts of addiction and mental illness in the U.S.

The Petrie-Flom Center Staff

The Petrie-Flom Center staff often posts updates, announcements, and guests posts on behalf of others.

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