Few brain-boosting supplements sold in the US contain an unapproved drug that could cause serious side-effects such as anxiety and depression: Study
The drug called piracetam is not approved by the FDA due to lack of evidence that it improves brain health; The researchers found in varying amounts in five supplement brands
A few US-based brands selling supplements that promise enhanced memory, sharper attention and focus contain an unapproved drug, claim scientists from Harvard Medical School. These brain-enhancing supplements could make users susceptible to anxiety, depression, weight gain and insomnia, warn scientists.
These scientists found the unapproved drug named piracetam in varying amounts in five supplement brands. While brands such as Relentless Improvement, Nootropics, and Specialty Pharmacy sold their product as piracetam, BPS and Cognitive Nutrition sold their supplements labeled as Compel and Neuropill. Though unapproved in the US, the drug is prescribed in European countries to treat brain decline in dementia.
The US Food and Drug Administration (FDA) has not approved the drug due to scant evidence from earlier studies. A review, which analyzed 24 studies that enrolled more than 11,000 patients, found weak evidence to show that piracetam improves cognition.
“It seems kind of bold to put a non-approved substance on the label. It’s horrifying but not terribly surprising,” Dr. David Seres, associate professor of medicine at the Institute of Human Nutrition at Columbia University Medical Center, who was not involved in the study, told STAT.
Brain enhancing supplements or “nootropics” have become increasingly popular. The global brain health supplements market size was valued at USD 6.2 billion in 2018. The global brain health supplements market size is expected to reach USD 10.7 billion by 2025, according to a report by Grand View Research, Inc.
Unlike prescription drugs, supplements are not thoroughly vetted or evaluated, which allows companies to sell dietary supplements without notifying the FDA. "The FDA doesn't oversee product testing or ingredient accuracy — they just look out for supplements that make health claims related to the treatment of specific diseases," says Dr. Gad Marshall, associate medical director at the Center for Alzheimer Research and Treatment at Harvard-affiliated Brigham and Women's Hospital.
But there is a catch. With the Dietary Supplement Health and Education Act, the FDA can halt the sale of products that are unsafe or misbranded. And the FDA has recently warned that cognitive enhancement supplements “may be ineffective, unsafe, and could prevent a person from seeking an appropriate diagnosis and treatment", according to the authors of the study.
Though the FDA has made it clear that piracetam should not be sold as a dietary supplement, Dr. Pieter Cohen, the co-author of the study and his colleagues found the drug listed as an ingredient in five brands. Further, some supplement brands contained about 20% more piracetam than what was listed on the label.
The results revealed something even more concerning. In Europe, people consume a daily dose of 2400 to 4800 mg for cognitive disorders. On the other hand, people taking the supplements in the US were exposed to 830 mg to 11,300 mg of piracetam per day, depending on which brand they bought, says the study.
"As soon as we move into dosages that are much higher than prescription, all bets are off about how these supplements might affect the brain," Cohen told LiveScience. According to Cohen, the FDA has neither seized products containing piracetam, nor warned consumers.
But there is hope. A new registration process proposed by the FDA would require companies to submit supplement labels to the FDA, which will be available for public access. This step could allow the FDA to check labels for unapproved ingredients, issue warnings as needed and keep users informed.
The study has been published in JAMA Internal Medicine.