The supplement aisle is rife with “nootropics,” “smart drugs” and “cognitive enhancers” that claim to help increase brain performance. But new research suggests some of those products also contain unapproved drugs that aren’t listed on the label.
The study, published Wednesday in Neurology, found five unapproved pharmaceutical drugs — in potentially dangerous combinations and doses — in over-the-counter brain supplements.
“Over-the-counter cognitive supplements are popular because they promise a sharper mind, but they are not as closely regulated as pharmaceutical drugs,” said Pieter Cohen, a physician and associate professor at Harvard Medical school and author of the study.
“Not only did we detect unapproved drugs in these products, we also detected several drugs that were not mentioned on the labels, and we found doses of unapproved drugs that were as much as four times higher than what would be considered a typical dose,” Cohen added.
The study combed through both the National Institutes of Health Dietary Supplement Label Database and the Natural Medicines Comprehensive Database for cognitive supplements. They identified 10 different supplements to more closely examine, including eight which promised to enhance mental function.
In each of those supplements, the researchers found at least one unapproved drugs. They included analogs of a drug called piracetam, as well as three other unapproved drugs: vinpocetine, phenibut, and picamilon. There isn’t clear evidence on the side effects of all of those drugs, but the study’s authors say they could affect blood pressure, among other potential risks. The Food and Drug Administration has previously warned that vinpocetine should not be consumed by women of childbearing age.
Cohen, who has extensively studied the safety and regulation of supplements, warned that supplements could be especially risky if used in combination with prescription drugs or instead of seeking medical advice.
“Use of these supplements poses potentially serious health risks,” he said. (Cohen was sued by a supplement maker for libel and slander. He won the defamation trial in late 2016.)
Cohen also criticized the FDA for not doing enough to ensure unapproved drugs aren’t found in over-the-counter products. The agency, under the Dietary Supplement Health and Education Act of 1994, is not allowed to review dietary supplements for safety before they’re made available for consumers to purchase. The agency is, however, allowed to intervene when supplements or ingredients in them are flagged as potentially harmful to health.
“The FDA is aware of these ingredients, so why have they not acted firmly and definitively to remove them from the market place?” he asked.
In response to a request for comment, an FDA spokesperson pointed STAT to a 2019 statement on plans to protect consumers from unlawful ingredients in supplements, including recent efforts geared at “modernizing our regulatory framework to meet the demands of this growing industry.”
The FDA also launched a new tool last year to alert the public about ingredients that appear to be illegally marketed in dietary supplements.
“We will not stand by and allow these companies to compromise the health of the very people who are seeking out supplements to aid in their well-being,” the agency said.