Brain-boosting supplements may have high doses of unapproved Rx medications

November 23, 2020 at 2:00 p.m. EST

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Dietary supplements marketed as brain boosters may contain high doses of pharmaceutical drugs that aren’t approved for use in the United States, according to a study published Sept. 23 in the journal Neurology Clinical Practice.

The team of researchers behind the study analyzed 10 supplements with claims of memory enhancement, sharpened mental focus and more. All the supplements were bought online in the United States and were openly labeled as containing ingredients that are considered prescription drugs in countries including Russia, China and Germany.

In three-quarters of the products, labels listed inaccurate quantities of these ingredients. Plus, in some of the supplements, the researchers found other unapproved drugs that were not listed on the product labels.

“I have gotten used to the fact that foreign drugs are being sold directly to consumers as supplements,” says Pieter Cohen, an associate professor of medicine at Harvard Medical School who has conducted other studies that uncovered unapproved drugs in sports supplements and other brain-boosting supplements. “But I was surprised by how many different drugs are being sold in these products.”

Combining different drugs can make them more risky, and some of the combinations in these products have never been studied for safety or efficacy, says Cohen, an internal medicine physician at Cambridge Health Alliance.

“We’re basically completely flying blind when trying to understand what the cocktails of these unapproved drugs would do if you consumed them,” he says.

This is particularly concerning because interest in memory or brain-boosting supplements — also called nootropics — is rising, says Chuck Bell, programs director for the advocacy division of Consumer Reports. Sales of memory supplements almost doubled in value between 2006 and 2015, according to a 2017 report by the Government Accountability Office.

“This report’s findings that consumers may be exposed to high doses of illegal prescription drugs when they use some of these memory supplements is highly, highly concerning,” Bell says. “There is little hard evidence that these products are either safe or effective.”

Here’s what the new study found and what consumers should know about boosting brain power and memory.

The findings

For the new study, Cohen and colleagues looked at two scientific databases — the Natural Medicines database and the National Institutes of Health’s Dietary Supplement Label Database — to identify ingredients that were chemically similar to piracetam, a drug that Cohen has previously found in other brain-boosting supplements.

Piracetam and the similar chemicals that the researchers looked for in this study are not approved for use in the United States but are prescribed to treat dementia, strokes, brain injuries and other neurological issues in some countries in Europe, Asia and Latin America.

Some of the supplements that contained these piracetam-like chemicals (omberacetam, aniracetam, oxiracetam, and phenylpiracetam) contained two to four times the typical pharmaceutical dose of these compounds, according to the study.

Along with the labeled chemicals, the researchers also detected picamilon and phenibut in these supplements. The FDA has previously warned companies that it’s not legal to sell picamilon, which is used in Russia to treat neurological conditions, as a supplement. They’ve sent out similar letters about phenibut, which is used to treat anxiety and sleep problems in Russia.

The dangers

Products containing unapproved drugs are not legally supposed to be sold as supplements. And some of the particular pharmaceutical drugs found in the new study have been associated with serious effects, including increased and decreased blood pressure, insomnia, agitation, dependence, sedation and hospitalization.

The inaccurate dose labeling, high doses and untested drug combinations found in the supplements in this study mean that the risk of potentially serious side effects or interactions with other medications is much greater than when a doctor in another country prescribes these compounds.

For example, a recent report by the Centers for Disease Control and Prevention noted that phenibut, which is marketed online as a treatment for anxiety or as a cognitive enhancer, was linked to a steep rise in calls to poison control centers between 2009 and 2019. One in eight of those cases reported side effects that were life threatening or resulted in significant disability.

In a statement, industry representatives said this new study was not representative of the full market for brain or memory supplements.

“The results of this exercise by Dr. Cohen et al. demonstrate this unfortunate, but unsurprising truth: when researchers — or consumers — with access to an online search engine go looking for illegal products posing as brain health supplements, they are likely to find them,” said Steve Mister, president and chief executive of the Council for Responsible Nutrition. “We encourage the public to avoid taking the findings of this analysis out of context and recognize this small sample is not representative of the brain health supplement category as a whole.”

Cohen, however, argues that if it is easy to find and buy products that contain prohibited ingredients online, there should also be an easy way to flag such products as potentially dangerous and not legally classified as supplements.

The Council for Responsible Nutrition agrees that more could be done to restrict the sale of illegal supplements and urges the Food and Drug Administration “to take stronger enforcement action against tainted products containing illegal drug ingredients in the marketplace,” Mister says.

The FDA recently introduced a tool to warn consumers about potentially unsafe supplement ingredients and has proposed legislation that would require manufacturers to list their products with the FDA, potentially allowing for quicker action on prohibited ingredients, an agency spokesperson says. But because of the way supplements are currently regulated, consumers often don’t know much about the purity, contaminants or even content of these products, Cohen says.

“Overwhelmingly, consumers assume that dietary supplement products will be safe, or they would not be allowed to be sold in stores or other retail channels,” Bell says. “But without a major overhaul of federal law, consumers will continue to be exposed to serious risks.”

Safely boosting brain power

There’s also little to no evidence that these products are effective at boosting memory or the ability to focus, Cohen says. Used at the right dose in the right person, they may offer some marginal benefit for the neurological conditions or brain injuries they are meant to treat, he says. But if there were a clear benefit, Cohen believes, there would probably be FDA-approved versions of these drugs.

In any case, “there’s no way you can get the right dose from buying these unapproved drugs as supplements, because the labels are so inaccurate,” Cohen says.

Supplements for brain health have been found to have no benefits for most people, according to a 2019 report by AARP’s Global Council on Brain Health (GCBH). But there is evidence that connects cognitive problems with documented deficiencies in vitamin B12, vitamin D or folate, according to that report. Because of that, B-vitamin supplementation may help in certain cases, although there’s still insufficient evidence that vitamin D supplements benefit brain health.

In most cases, the healthiest option is to get all required nutrients from food, according to the GCBH. Along with a healthy diet, there’s significant evidence that exercise can improve cognitive performance and memory, as can mental training such as trying to learn a new language.

People who do require treatment for cognitive issues should talk to their health-care providers, says Janessa Graves, an associate professor at the Washington State University College of Nursing, who was the lead author of the CDC report. If there is an appropriate pharmaceutical option, they can identify a regulated, approved drug that might help.

“By avoiding memory supplements, consumers can both save money and avoid unnecessary health risks,” Bell says.

 Copyright 2020, Consumer Reports Inc.

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