Washington, D.C.—A new study published in Neurology concluded that “over-the-counter cognitive enhancement supplements may contain multiple unapproved drugs,” drawing industry rebuttal.
The study was conducted by searching two supplement databases for products labeled as containing one of four different drugs not approved for use in the U.S. The 10 products were then purchased and analyzed. As advertised, the products did indeed contain drugs including omberacteam and aniracetam, as well as three additional unapproved drugs the researchers hadn’t searched for. The study noted that several detected drugs were not declared on the label, and several declared drugs were not detected in the products; for those products that declared drug quantities on the labels, 75% were inaccurate.
It was not noted how many cognitive health supplements existed in the database at the time of the search. The researchers stated some limitations, including the fact that the study is not a comprehensive survey of the cognitive health supplement landscape.
The study concludes: “The presence of these five unapproved drugs in supplements, including at supratheurapeutic dosages, suggests serious risks to consumers and weaknesses in the regulatory framework under which supplements are permitted to be introduced in the US. Until the regulatory framework is reformed, clinicians should advise patients that supplements marketed as cognitive enhancement products may contain unpredictable combinations of unapproved drugs.”
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Steve Mister, President and CEO of the Council for Responsible Nutrition, issued a statement, quoted below:
“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. What’s more disturbing is the authors’ sweeping conclusions about the brain health category of dietary supplements based on a narrow selection of ten illegal products found on the internet. Fortunately for consumers, this small collection does not represent the brain health supplement category, as the products identified in the study are not legal dietary supplements, but illegal products containing unapproved drugs. Evidence indicates nutrients are essential for brain health whether achieved through diet or supplementation. Research continues to emerge demonstrating how certain dietary supplements can support brain function in combination with other factors including diet and lifestyle.
“CRN does agree with the study’s conclusion that FDA must increase the effectiveness of its regulation of dietary supplements. Until FDA enforcement efforts predictably and consistently provide deterrence to drive these illegal products from the market, we should not be surprised that they exist in the corners of the internet. CRN urges FDA to take stronger enforcement action against tainted products containing illegal drug ingredients in the marketplace and CRN continues to advocate for more resources so the agency can bolster enforcement. The FDA currently lacks a system to efficiently track products that come to market, which is why we support a mandatory product listing, as it would allow FDA to determine who is using a particular ingredient, what claims are being made on the label, and whether the contact information for reporting an adverse event is properly provided. With a mandatory listing, the agency can better identify when new products are introduced and act more quickly to remove illegal products from the market.”
Mister also pointed out that, just because a supplement database contains “the bad and the ugly” doesn’t mean that the database doesn’t also contain safe, accurately labeled cognitive health supplements. He notes that “databases are not intended to be shopping tools for the public,” and adds that consumers should seek out nationally recognized brands or go to trusted retailers, who are unlikely to sell unapproved drugs—“many products associated with contamination problems…are offered exclusively through unscrupulous online companies,” Mister says.
Mister concludes: “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. The mainstream dietary supplement market is made up of responsible and ethical companies that are dedicated to providing consumers with safe, quality, and beneficial products to improve their health and wellness.”