Data published in JAMA Internal Medicine indicated that four brands purchased online contained the unapproved drug, in some cases in doses 10 times the prescribed dose seen in Europe (where piracetam is approved and prescribed for cognitive impairment and dementia, for example).
“Consumers of cognitive enhancement supplements may be exposed to high dosages of a prohibited drug,” wrote Harvard-based Dr Cohen and his co-authors, Igor Zakharevich (now at the University of Colorado) and Roy Gerona (University of California, San Francisco).
“In Europe, prescription piracetam is commonly formulated in 800- and 1200-mg tablets with a usual daily dose for cognitive disorders of 2400 to 4800 mg, with dosing adjusted based on renal function. In this study, we found supplements with individual doses of piracetam exceeding 1500 mg, and daily doses greater than 11,000 mg.”
The study is limited by including only a very small sample size, but the findings raise concerns about the presence of an unapproved drug in products marketed and labeled in dietary supplements.
Piracetam was the subject of an unsuccessful new dietary ingredient notification (NDIN) in 2003-4, and the Agency did send a warning letter in 2012 citing the presence of piracetam as an illegal dietary ingredient.
“Our findings demonstrate that even after the FDA rejected an application to market piracetam as a new supplement ingredient, the drug was nevertheless introduced into the marketplace. Despite FDA warning letters, the products remain on the market,” wrote Cohen, Zakharevich, and Gerona.
“Until the law governing supplements is reformed such that products adulterated with drugs can be effectively removed from the market, clinicians should advise patients that supplements marketed as cognitive enhancers may contain prohibited drugs at supratherapeutic doses.”
FDA: Strengthening the regulation of dietary supplements by modernizing our regulatory framework
In response to Dr Cohen’s new findings, a spokesperson for the FDA told NutraIngredients-USA: “The agency is generally aware that some products marketed as dietary supplements are labeled to contain Piracetam. The FDA prioritizes its actions based on available resources and the level of safety concern identified; the agency faces the challenge of having limited resources to monitor the marketplace for potentially harmful, or otherwise unlawful, dietary supplements. In July 2012, the agency issued a warning letter to a company selling products marketed as dietary supplements that contained Piracetam.
“The dietary supplement market is a growing industry, with sales multiplying ten-fold over the past 25 years and more than half of all Americans taking at least one dietary supplement on a regular basis. This expansion is one reason why in February and April of this year, the FDA announced new efforts to strengthen the regulation of dietary supplements by modernizing our regulatory framework.
“Additionally, a legislative proposal included in the FDA’s fiscal year 2020 budget would require all products marketed as “dietary supplements” to be listed with the FDA and give the agency authority to act against non-compliant products and the manufacturers and/or distributors of such products. This would allow the FDA to know when new products are introduced, quickly identify and act against dangerous or otherwise illegal products, improve transparency, and promote risk-based regulation.”
CRN: “Mandatory product listing that would allow FDA to have a more complete view of the marketplace”
Commenting on the findings, Steve Mister, president & CEO for the Council for Responsible Nutrition (CRN) said that the presence of piracetam in products illegally marketed as dietary supplements is indeed a serious concern.
“Although we note that Dr. Cohen was only able to identify five products labeled as containing this ingredient after his exhaustive search of the Internet, the fact that he was able to obtain them at all demonstrates the potential health risk for consumers,” said Mister.
“We also concur that FDA should significantly increase enforcement against all adulterated products. CRN has strongly advocated for increased funding for FDA. With the strong support of CRN, Congress is currently deliberating an appropriation for FDA that will increase the budget of FDA’s Office of Dietary Supplement Program’s budget next year by $3 million—from $7 to $10 million. Additional resources and staffing will allow increased enforcement against fringe elements of the industry like the ones Dr. Cohen discovered.
“But more than funding is needed. CRN is calling for a mandatory product listing that would allow FDA to have a more complete view of the marketplace. A mandatory listing would enhance existing regulations with more transparency, foster increased enforcement efforts against criminal activity, and would make a safe dietary supplement marketplace even safer. For example, the piracetam products in this study were hiding in plain sight; if these products were on a national database of dietary supplements, FDA could more easily identify them, and target them for removal.”
On the other hand, Mister said that the conclusions of the paper may wrongly lead to misperceptions and inaccurate generalizations about the entire cognitive health category. “Promising science demonstrates that dietary supplements can be beneficial for cognitive health. For example, omega-3 fatty acids, vitamin B and vitamin D are backed by strong scientific research that demonstrates these nutrients are essential to cognitive health,” he said. “Additional science for citicoline, phosphatidylserine, and even caffeine, all support their use for improved cognitive function.”