Many unapproved drugs found in ‘brain-boosting’ supplements in US, study warns doses are dangerously high
Over-the-counter cognitive supplements that promise a sharper mind are popular, but they are not as closely regulated as pharmaceutical drugs. A research team now warns that such supplements that claim to improve mental focus and memory may contain unapproved pharmaceutical drugs and in potentially dangerous combinations and doses. They found five such drugs not approved in the US in the supplements they examined. These supplements are sometimes referred to as “smart drugs,” “nootropics,” or “cognitive enhancers.” Not only did the investigators detect several drugs that were not mentioned on the labels of the supplements, they also found doses of unapproved drugs that were as much as four times higher than what would be considered a typical dose.
According to study author Pieter A Cohen, MD, Harvard Medical School, Boston, the use of these supplements poses potentially serious health risks. The supplements could be especially risky if used in combination with prescription drugs or instead of seeking medical advice, he cautions. “We found complex combinations of unapproved drugs, up to four different drugs in a single ‘brain-boosting’ supplement. Finding new combinations of drugs never before tested in humans in over-the-counter ‘smart pills’ is alarming,” Cohen told MEA WorldWide (MEAWW).
Unlike pharmaceutical drugs that must be proven safe and effective for their intended use before they are marketed to consumers, the law does not require the US Food and Drug Administration (FDA) to approve dietary supplements for safety or effectiveness before they reach the consumer. The FDA takes action after the products reach the market if they are mislabeled or contain unapproved products, explain health experts.
For the current analysis, the team searched the National Institutes of Health Dietary Supplement Label Database and the Natural Medicines Database for cognitive supplements that listed drugs similar to piracetam, a drug previously found in supplements but not approved in the US. They were looking for “analogs of piracetam, drugs with a similar but slightly different chemical structure.” Analogs are sometimes introduced into supplements to circumvent laws.
The authors identified 10 supplements, eight that promised to enhance mental function, one that was marketed as “workout explosives” and another that had the words “outlast, endure, overcome” on its label. The contents of each supplement were examined using various methods and measured quantities of each drug present. In the 10 supplements analyzed, researchers detected five unapproved drugs, reveals the study published in Neurology, the official journal of the American Academy of Neurology. Two were analogs of piracetam called omberacetam and aniracetam. The others were the unapproved drugs vinpocetine, phenibut, and picamilon. According to the investigators, the FDA has issued a warning that vinpocetine should not be consumed by women of childbearing age. While all of the risks of these drugs are not known, side effects include increased and decreased blood pressure, agitation, sedation, and hospitalization.
The results further reveal that all 10 supplements contained omberacetam, which is prescribed in Russia for traumatic brain injury and mood disorders. “A typical pharmaceutical dose would be 10 milligrams (mg). The doses in a recommended supplement serving size were as high as 40 mg, four times greater than in pharmaceutical dosages,” the findings state. Some supplements contained more than one unapproved drug. One product combined four of the unapproved drugs.
The study also found that for those products with drug quantities provided on the labels, a majority of the declared quantities were inaccurate. “The fact that these supplements are listed in official databases does not mean the labeling is accurate or the dosage levels of ingredients in these supplements are safe. US 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,” says Cohen. He adds, “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.”
Stating that the effects of consuming untested combinations of unapproved drugs at unpredictable dosages are unknown, Cohen suggests that people taking these supplements should be warned. “We should counsel consumers to avoid over-the-counter smart pills until we can be assured as to the safety and efficacy of these products. We will need to reform the laws before we can be assured that US supplements are safe,” he concludes.
Last year, Cohen and other experts had recommended reforming the Dietary Supplement Health and Education Act of 1994 (DSHEA), so that all new ingredients, rather than only a small subset, are reviewed by the FDA and effective systems are implemented to track the safety of all supplements. “This approach would provide an enhanced safety net for consumers while limiting the ability of unscrupulous companies to profit from the introduction of dangerous products that have bypassed FDA scrutiny,” they had suggested.