The FDA rejected the studies confirming the safety and effectiveness of the brain-boosting drug piracetam in 2004. Yet 15 years later, piracetam is still widely sold in US despite the FDA’s efforts.
Eli Wolfe wrote this report published in Salon:
A study published this week by JAMA Internal Medicine identified four supplements sold in the U.S. that contain piracetam, and said so on their labels. Two of the products were labeled simply piracetam, while the other two were sold under the names Compel and NeuroPill. Their manufacturers — BPS, Cognitive Nutrition, Nootropics and Relentless Improvement—could not be reached for comment. A fifth company, Specialty Pharmacy, advertised a piracetam product, but the study didn’t find detectable amounts.
Piracetam, which the study’s lead author, Pieter Cohen, called “the godfather of all nootropics” — a term for supplements that are supposed to improve brain power — is prescribed in European countries for various disorders, including dementia and cognitive impairment. But a review of medical research found that there’s little evidence it works, according to the study.
The FDA has repeatedly targeted companies that sell dietary supplements geared toward cognitive enhancement. In February, the agency posted 12 warning letters and five online advisory letters to companies it said were illegally selling products that claimed to cure various illnesses, including Alzheimer’s disease. Scott Gottlieb, the FDA’s commissioner at the time, stated that the letters were part of a broader effort to crack down on the dietary supplement industry.
“Simply put, health fraud scams prey on vulnerable populations, waste money and often delay proper medical care,” Gottlieb said.
But deeper in the press statement, he said that while some companies have stopped selling products after receiving letters, unapproved products continue to be sold to consumers through new websites. The FDA has the power to recall supplements, Cohen said, but when one company stop selling a product another will take its place in the market.
In an email to FairWarning, an FDA official said the agency does not comment on specific studies. Supplement makers are not permitted to make claims about treating diseases, the official said, but the agency has “limited resources to monitor the marketplace for potentially harmful, or otherwise unlawful, dietary supplements.”