Recent analysis unfairly maligns and misrepresents cognitive health supplements, says CRN

September 30, 2020

The analysis concluded that over-the-counter cognitive support supplements may contain unapproved drugs, but the researchers specifically searched out and testing supplements that contained unapproved drugs.

A recent study published in Neurology Clinical Practice1 concluded that over-the-counter cognitive support supplements may contain multiple unapproved drugs. Industry, however, takes issue with the results of this study, considering that the researchers specifically sought out supplements through two databases that contained either omberacetam, aniracetam, phenylracetam or oxiracetam; four drugs not approved for human use in the US. These products were then purchased online and analyzed through non-targeted liquid chromatography-quadrupole time of flight-mass spectrometry methods. In the ten products tested, the researchers found omberacteam and aniracetam along with 3 additional unapproved drugs (phenibut, vinpocetine and picamilon).

“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,” said Steve Mister, president and CEO of the Council of Responsible Nutrition (CRN, Washington, D.C.), in a release. “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.”

Mister points out that the illegal products containing unapproved drugs are not representative of the cognitive health supplement space. He also disputes the researchers’ assertions that “consumers cannot obtain accurately labeled cognitive enhancement supplements by selecting supplements using the NIH’s or Natural Medicines’ supplement databases.” Simply put, these databases are not shopping tools.

“They fail to recognize that the dietary supplement databases they examined, as well as the industry’s own voluntary registry, the Supplement OWL, must include the good, the bad, and the ugly to provide an accurate representation of all products on the market,” Mister explained. “No one questions that products that contain illegal drug ingredients are not legal dietary supplements. However, although the analysis demonstrates that illegal products can be found, especially when sought after, it does not mean consumers cannot find safe and high-quality dietary supplement products in the market.”

While online shopping is a viable and common option for purchasing safe and quality supplements, ecommerce is also home to many unscrupulous companies exclusively selling adulterated products online. Mister states that consumers should seek out nationally recognized brands, shop trusted retailers, avoid products that make drug-like claims, and consult their healthcare practitioners before starting a dietary supplement regimen.

“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,” said Mister. “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.”

Reference

  1. Cohen PA et al. “Five unapproved drugs found in cognitive enhancement supplements.” Neurology Clinical Practice, Published online ahead of print on September 23, 2020