Source/Disclosures
Disclosures: Cohen reports collaborating on research with NSF International, receiving compensation from UptoDate, and receiving research support from Consumers Union and PEW Charitable Trusts. Please see the study for all other authors’ relevant financial disclosures.
September 23, 2020
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Some dietary supplements for cognitive enhancement contain unapproved drugs

Source/Disclosures
Disclosures: Cohen reports collaborating on research with NSF International, receiving compensation from UptoDate, and receiving research support from Consumers Union and PEW Charitable Trusts. Please see the study for all other authors’ relevant financial disclosures.
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Over-the-counter dietary supplements that claim to improve mental focus and memory contain unapproved drugs, according to research published in Neurology, the medical journal of the American Academy of Neurology.

“Over-the-counter cognitive supplements are popular because they promise a sharper mind, but they are not as closely regulated as pharmaceutical drugs,” study author Pieter A. Cohen, MD, associate professor of medicine at Harvard Medical School, said in a press release. “Use of these supplements poses potentially serious health risks. Not only did we detect five unapproved drugs in these products, we also detected several drugs that were not mentioned on the labels, and we found doses of unapproved drugs that were as much as four times higher than what would be considered a typical dose.”

Unapproved drugs in cognitive performace supplements
Reference: Cohen PA, et al. Neurology. 2020;doi:10.1212/CPJ.0000000000000960.

Cohen and colleagues searched the NIH’s Dietary Supplement Label Database and Natural Medicines Database for products with labels containing analogs of piracetam. They then purchased the products online and determined their contents by extracting them in methanol and analyzing them with nontargeted liquid chromatography-quadrupole time-of-flight mass spectrometry methods.

A total of 10 supplements were purchased and included in the study. Cohen and colleagues detected two piracetam analogs, omberacetam and aniracetam, in these products, neither of which are approved by the FDA. They also identified three other unapproved drugs: phenibut, vinpocetine and picamilon.

By consuming the recommended serving size of the supplements, patients could be exposed to pharmaceutical-level dosages of the drugs, according to the researchers. This included a maximum of 40.6±0.4 mg of omberacetam, which is typically 10 mg per dose; 502 ± 0.8 mg of aniracetam, which has typical dose of 200 mg to 750 mg; 15.4 ± 0.3 mg of phenibut, which is typically 250 mg to 500 mg per dose; 4.3 ± 0.1 mg of vinpocetine, which is typically 5 mg to 40 mg per dose; and 90.1 ± 0.7 mg of picamilon, which is typically 50 mg to 200 mg per dose.

Cohen and colleagues also found that some supplements contained several drugs that were not on the label, while other products did not contain drugs that were listed on the label.

According to the researchers, 75% of drug quantities did not correspond with quantity labels. They reported that consumers could potentially be exposed to doses up to four times greater than pharmaceutical doses and up to four different drugs when using a single supplement product.

“The effects of consuming untested combinations of unapproved drugs at unpredictable dosages are simply unknown and people taking these supplements should be warned,” Cohen said in a press release.

Although these supplements are listed in official databases, Cohen said this does not mean that label information is correct or that the suggested serving sizes are safe for consumers.

“U.S. law does not permit unapproved pharmaceuticals to be introduced into dietary supplements, but the law places the burden of eliminating those products on the FDA,” Cohen said. “The FDA has issued a series of warnings to companies selling supplements with unapproved drugs, yet such drugs remain openly listed on databases as ingredients in supplements. Our study also raises concerns regarding the quality and legality of supplements listed in supplement databases.”