Study finds Russian prescription drugs hiding in "brain boosting" supplements

The packaging of so-called "brain boosting" supplements typically promises buyers exciting results like mental clarity, enhanced creativity, and a razor sharp memory. What you actually get inside of that bottle, is likely to be something quite different.

For instance, it might include a drug licensed in Russia to treat traumatic brain injuries, or one used to treat stroke complications in Europe, according to new research.

An analysis published Wednesday in Neurology: Clinical Practice found that eight cognitive enhancement supplements and two workout supplements contained five potent drugs that are not approved by the Food and Drug Administration. These are supplements, sometimes referred to as nootropics, that are easy to purchase online.

These drugs are licensed in other countries, where they've been used to treat conditions ranging from the aftermath of a stroke to traumatic brain injuries. They include:

• Omberacetam (also called Noopept): used to treat traumatic brain injury in Russia (and in animal models), according to the study.
• Aniracetam: Once used to treat stroke aftermath in Japan, and Alzheimer's in Europe, according to a 2002 paper.
• Vinpocetine: a prescription drug used to treat stroke and cognitive impairments in China, Russia, and Germany. The FDA has waffled on whether this ingredient should be allowed in supplements, but as of 2019 does not allow it.
• Phenibut: a drug used to treat anxiety, but also hyped as a study drug that can cause overdoses in large amounts.
• Picamilon: another Russian prescription drug used to treat neurological conditions.

In the ten supplements the scientists studied, drugs like omberacetam, vinpocetine, and aniracetam were listed directly on the label, despite being illegal for use in supplements in the US.

In two of the supplements, phenibut and picamilon were present but not listed on the label – which means consumers would never know they were there.

The fact that these drugs were present in supplements isn't exactly surprising to Pieter Cohen, the study's first author and a general internist at Cambridge Health Alliance in Boston. Cohen has a history of finding that companies that sell supplements, ranging from workout supplements to sexual energy concoctions, don't always accurately report what's inside.

"If you wanted to shop for some of these supplements with these unapproved drugs on the label, they would be tremendously easy to find," Cohen tells Inverse. "We can't be assured that products that are being sold to improve memory, sharpness, wit, you name it, are free of foreign drugs."

"Right now we have to avoid all supplements that are being marketed as brain boosters," he continues.

The risks of a "brain boost"– Cohen doesn't have the brand names of the drugs tested in the study due to limitations of the chemistry lab he collaborated with. However, he found these supplements by cross-referencing the National Institute of Health's Supplement Label Database and the Natural Medicines Database.

The team searched for products containing piracetam – a drug often marketed as a nootropic — and two analogs of that drug, which have a similar chemical structure to omberacetam and aniracetam. That search turned up 10 results, and the scientists bought the supplements online in 2019 to them in a laboratory.

Those tests revealed evidence of omberacetam and aniracetam, as the labels suggested. But the tests also revealed evidence of the three drugs off the label: vinpocetine, phenibut, and picamilon.

Cohen says that the presence of phenibut in these supplements is particularly concerning. Phenibut has the potential to create dependency. "People have overdosed on it," Cohen notes.

Specifics aside, Cohen points to the potential for harm that can come from mixing these drugs together. One supplement contained three drugs: omberacetam, phenibut, and aniracetam. Another contained four: omberacetam, aniracetam, vinpocetine, and picamilon all in one bottle.

"These drugs are expected to get into the brain and have unpredictable effects..."

The dosage of these drugs can also pose a problem, the study suggests. In some cases, the amount of prescription drugs present in a serving of these supplements (usually one or two scoops of a powder, for instance) is greater than what one might receive if the drug was prescribed legally by a doctor.

That was the case for one "brain enhancement formula supplement." Two capsules, the recommended serving, would give the user a 40-milligram dose of omberacetam, which is often prescribed in 10-milligram doses.

That case was extreme, but the amounts of the other four drugs present in these supplements were "in the realm" of a prescription dose, says Cohen. And, when taken in prescription doses, those drugs can have side effects. Phenibut, for example, can cause side effects including nausea, vomiting, confusion, euphoria, hallucinations, or insomnia.

"These drugs are expected to get into the brain and have unpredictable effects on the brain, given what we know and don't know about how they work," Cohen adds.

What can you do about it? –  Dietary supplements don't have to go through clinical trials to prove that they're effective or safe like drugs do. The idea is that a dietary supplement should contain something you might otherwise come by naturally, which is why they're regulated like food, not drugs.

That's the case for multi-vitamins, for instance, but not for supplements that contain illicit drugs, like those seen in Cohen's study.

The problems begin when supplements, seeking to live up to advertised claims, turn to more potent prescription drugs to deliver the goods. In that case, the FDA can issue a warning letter requiring the supplement to be removed from the market.

Some still slip through the cracks. One 2018 paper found that the FDA had identified 776 adulterated supplements in the agency's own database – some contaminated with prescription drugs. However, the agency only issues voluntary recall letters for 360 of them, leaving more than half on the market.

At the moment, Cohen's advice to steer clear of brain-boosting supplements altogether.

"The FDA is not doing its job enforcing the law," he says.

Partial Abstract:

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

Results: In the 10 products tested, omberacetam 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 un- predictable dosages without clinician oversight in supplements are unknown.