Five unapproved drugs found in cognitive enhancement supplements

Objective To identify the presence of unapproved pharmaceutical drugs in over-the-counter dietary supplements marketed to improve memory and cognitive function.

Methods Supplements were identified by searching 2 supplement databases for products labeled as containing either omberacetam, aniracetam, phenylracetam or oxiracetam, 4 drugs not approved for human use in the US. Products were purchased online and analyzed using non-targeted liquid chromatography-quadrupole time of flight-mass spectrometry methods.

Results In the 10 products tested, omberacteam and aniracetam were detected along with 3 additional unapproved drugs (i.e., phenibut, vinpocetine and picamilon). By consuming recommended serving sizes, consumers could be exposed to pharmaceutical-level dosages of drugs including a maximum of 40.6 ± 0.4 mg omberacetam (typical pharmacologic dose of 10 mg), 502 ± 0.8 mg of aniracetam (typical pharmacologic dose 200–750 mg), 15.4 ± 0.3 mg of phenibut (typical pharmacologic dose 250–500 mg), 4.3 ± 0.1 mg of vinpocetine (typical pharmacologic dose 5–40 mg) and 90.1 ± 0.7 mg of picamilon (typical pharmacologic dose 50–200 mg). Several detected drugs were not declared on the label, and several declared drugs were not detected in the products. For those products with drug quantities provided on the labels, 75% (9/12) of declared quantities were inaccurate. Consumers could be exposed to up to four-fold greater than pharmaceutical dosages and as many as 4 unapproved drugs when using individual products.

Conclusions Over-the-counter cognitive enhancement supplements may contain multiple unapproved drugs. The health effects of consuming untested combinations of unapproved drugs at unpredictable dosages without clinician oversight in supplements is unknown.