Some “brain boosting” supplements may contain drugs not approved by the Food and Drug Administration in potentially dangerous combinations and doses, a study published Wednesday finds.
Among the supplements billed as "nootropics" or "smart drugs" — which promise improvements in mental focus and memory — are some that contain not only the unapproved drugs included on the label, but also unapproved pharmaceuticals that aren’t even listed, according to the study published in Neurology Clinical Practice.
The pills, experts say, may therefore be risky to take.
“We don’t know how these drugs will affect human health,” said the study’s lead author, Dr. Pieter Cohen, an associate professor at the Harvard School of Medicine and a general internist at Cambridge Health Alliance. “In some cases, there is a mixture of drugs combined in the same product that have never been tested together.”
The specific compounds the researchers focused on are approved in other countries, though not in the United States, Cohen said. But the doses on some of the labels were three times higher than what is recommended in those countries. And testing showed that the doses in some cases were even higher than what was listed on the label, he said.
“The thing about every compound, regardless of where it comes from, is that too much can kill you,” he said. “Even caffeine, one of the safest compounds, can kill you if the dose is high enough.”
To take a closer look at supplements touting improvements to cognition, Cohen and his colleagues searched two databases, the National Institute of Health’s (NIH) Dietary Supplement Label Database and the Natural Medicines Database for products listing four unapproved drugs as ingredients: omberacetam (also known as Noopept), aniracetam, oxiracetam or phenylpiracetam.
The search by Cohen and his colleagues turned up 10 supplements, which the researchers bought and tested using a technique called mass spectroscopy. Some contained not only one or more of the four unapproved drugs, but also several other unapproved pharmaceuticals that weren’t listed on the products’ labels, meaning people taking the supplements would have no way of knowing what they were putting in their bodies.
One of those unlisted pharmaceuticals, picamilon, is a drug that is approved in other countries to block seizures, Cohen said. Another, phenibut, is approved in Russia and is also an antiseizure medication. This drug, Cohen added, is known to be addictive.
Cohen didn’t disclose the names of the supplements he and his colleagues scrutinized.
Unlike pharmaceuticals, supplements aren’t strictly regulated by the FDA.
While pharmaceutical companies must prove to the FDA that newly developed drugs are safe and effective for their intended use before they are marketed to consumers, current laws do not require the same for supplements. The FDA may take action against a supplement maker after a product is on the market if it is mislabeled or contains unapproved drugs.
The new study adds to the list of supplement categories that have been shown to contain actual drugs, said Dr. Melinda Ring, executive director of the Osher Center for Integrative Medicine at Northwestern University’s Feinberg School of Medicine.
Earlier studies turned up three categories of supplements — those for sex enhancement, body building and weight loss — that were most likely to be contaminated by actual drugs, she said.
“This adds cognitive enhancement, brain boost, to the list,” Ring said. “People considering them, as well as health professionals if they know a patient is taking them, should be cautious.”
The study underscores “the importance of working with a health professional who can help guide the patient to reputable supplements rather than patients trying to do this on their own, particularly when it comes to supplements in this category,” she said. “Just because these ‘smart drugs’ are in a natural product doesn’t mean there is no risk. The compounds can have adverse effects.”