What are the most commonly found unapproved drugs in cognitive supplements and their health risks?
Executive summary
A 2020–2021 analytical study of over‑the‑counter “brain‑boosting” supplements identified five unapproved pharmaceutical drugs—two racetam analogs (omberacetam/Noopept and aniracetam) plus phenibut, vinpocetine and picamilon—hidden in products sold online, sometimes at doses higher than would be prescribed and often without label disclosure [1] [2] [3]. These compounds carry a spectrum of known adverse effects from blood‑pressure changes and insomnia to dependence, sedation and even hospitalizations; the combination of unpredictable dosing and untested mixtures increases the risk of serious harm and drug interactions [4] brain-boosting-supplements-may-contain-unapproved-drugs/" target="_blank" rel="noopener noreferrer">[5].
1. The most commonly detected unapproved drugs in “nootropic” supplements
Laboratory analysis of ten supplements marketed for memory and cognition found omberacetam (often called Noopept) and aniracetam present in products alongside three other unapproved agents—phenibut, vinpocetine and picamilon—making those five the most consistently reported clandestine drugs in the sampled nootropic supplements [1] [2] [6]. Broader analytic reviews and targeted testing have also repeatedly flagged vinpocetine and picamilon in multiple commercial formulations beyond the initial study sample, indicating these two agents frequently appear in adulterated brain‑health products [7].
2. What these drugs are and the health effects associated with them
Racetam analogs like aniracetam and omberacetam are synthetic compounds related to piracetam that lack FDA approval in the U.S.; while racetams have been reported to have low toxicity in some contexts, robust evidence of cognitive benefit in healthy people is limited and safety at unregulated supplement doses is uncertain [8] [9]. Phenibut is a GABAergic drug linked to sedation, agitation, dependence and withdrawal problems and has driven rising poison‑control calls in the U.S., while vinpocetine and picamilon have been associated with cardiovascular effects—both increased and decreased blood pressure—insomnia and other adverse reactions; severe outcomes such as hospitalization and intubation have been recorded in case reports and surveillance data [4] [5] [9].
3. Why the supplement route multiplies danger: dosing, mixtures and interactions
The supplements studied often contained multiple unapproved drugs in single products, sometimes up to four, at doses the authors describe as “supratherapeutic” — in some cases as much as four times higher than typical pharmacy doses reported elsewhere—while labels either omitted these drugs or reported inaccurate quantities, creating a scenario where consumers are exposed to untested combinations and unpredictable dosing that heightens the risk of interactions with prescription medicines or underlying medical conditions [3] [4] [5].
4. Regulatory gaps, industry incentives and divergent views
U.S. law does not permit unapproved pharmaceuticals as ingredients in dietary supplements, but responsibility for removing illegal products rests largely on FDA enforcement after market entry; critics argue this regulatory framework leaves a window for adulterated nootropics to proliferate online [4] [10]. Industry and some researchers note that certain racetams show low toxicity in limited studies, but public‑health commentators and clinicians highlighted by Harvard and Consumer Reports stress that the absence of FDA approval and quality control makes such products unsafe as consumer self‑medication [8] [11] [5].
5. Evidence limits, practical implications and what remains unknown
The primary study purchased and analyzed a small set of products identified through supplement databases (ten products targeted for specific declared racetam analogs), so it documents real and alarming contamination but not the full market prevalence or the full spectrum of adulterants [1] [6]. Comprehensive surveillance and larger market sweeps cited in analytical reviews suggest vinpocetine and picamilon appear in many samples, yet the true national exposure, long‑term harms from chronic low‑dose ingestion, and interaction profiles with common prescriptions remain incompletely characterized in the literature cited [7] [4].