By Mike Montemarano, Associate Editor10.16.20
The Council for Responsible Nutrition (CRN), a trade organization representing the dietary supplements industry, recently took issues with the way an analysis published in Neurology Clinical Practice portrayed the state of the cognitive support supplements category.
The analysis, authored by Pieter A. Cohen, MD, from Harvard Medical School, et al, “Five unapproved drugs found in cognitive enhancement supplements,” stated that its objective was to identify the presence of unapproved pharmaceutical drugs in over-the-counter dietary supplements marketed to improve memory and cognitive function. The authors of the study used two supplement databases to identify products containing either omberacetam, aniracetam, phenylracetam, or oxiracetam, four drugs classified as piracetam analogues which are not approved for human use in the U.S.
Piracetam analogs are used in select countries as medications used to treat a number of neurological disorders or injuries.
The supplement databases used in the study were the National Institutes of Health’s (NIH) Dietary Supplement Label Database, and the Natural Medicines Database.
Racetams don’t have a universally-accepted mechanism of action, though, they are considered nootropics with stimulating effects.
The authors then tested 10 products, using non-targeted liquid chromatography, and were able to detect omberacetam and aniracetam, in addition to three other unapproved ingredients: phenibut, vinpocetine, and picamilon—each of which have been associated with adverse effects in clinical settings, the authors said.
Phenibut is a central nervous system depressant, believed to have anxiolytic effects, though it is not approved or available as a medication in the E.U, the U.S., or Australia. Though it has apparent recreational potential, it is not classified as a controlled substance. Vinpocetine is a man-made chemical resembling an extract found in the periwinkle plant, and while preliminary evidence suggests it may have some neuroprotective benefits, the the U.S. Food and Drug Administration said it is ineligible to be marketed as a dietary supplement. Picamilon is a combination of GABA and niacin, and is sold in Russia as a prescription drug; it has been deemed by FDA as an adulterating agent in dietary supplements.
Several of the detected drugs were not declared on the label of these products, and several declared ingredients were not detected in the products. Many of the drugs that these tested products contained met or exceeded pharmacological doses in the recommended serving sizes. For products with quantities provided on labels, 75% of the declared quantities were inaccurate, the analysis alleged.
“Consumers cannot obtain accurately labeled cognitive enhancement supplements by selecting supplements using the NIH’s or Natural Medicines’ supplement databases,” the authors of the analysis said. “Previous research found similar discrepancies between the information provided in the NIH’s supplement database compared to the actual content of the supplement. Use of these cognitive enhancement supplements poses potentially serious health risks given the unpredictable dosing and lack of clinician supervision.”
CRN Responds
Steve Mister, president and CEO of CRN, said the authors of this study made sweeping conclusions about the brain health category based upon a narrow selection of 10 illegal products on the Internet.
“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,” Mister said. “Fortunately for consumers, this small collection does not represent the brain health supplement category, as the products identified in this 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.”
Additionally, he took issue with the characterization of supplement databases as “shopping tools for the public,” but rather that they are intended to provide a full picture of both high-quality and adulterated substances.
“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 said. “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.”
Despite this, CRN does agree with the study’s conclusion, that the U.S. FDA must increase its enforcement of dietary supplement regulation. “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,” Mister said.
The analysis, authored by Pieter A. Cohen, MD, from Harvard Medical School, et al, “Five unapproved drugs found in cognitive enhancement supplements,” stated that its objective was to identify the presence of unapproved pharmaceutical drugs in over-the-counter dietary supplements marketed to improve memory and cognitive function. The authors of the study used two supplement databases to identify products containing either omberacetam, aniracetam, phenylracetam, or oxiracetam, four drugs classified as piracetam analogues which are not approved for human use in the U.S.
Piracetam analogs are used in select countries as medications used to treat a number of neurological disorders or injuries.
The supplement databases used in the study were the National Institutes of Health’s (NIH) Dietary Supplement Label Database, and the Natural Medicines Database.
Racetams don’t have a universally-accepted mechanism of action, though, they are considered nootropics with stimulating effects.
The authors then tested 10 products, using non-targeted liquid chromatography, and were able to detect omberacetam and aniracetam, in addition to three other unapproved ingredients: phenibut, vinpocetine, and picamilon—each of which have been associated with adverse effects in clinical settings, the authors said.
Phenibut is a central nervous system depressant, believed to have anxiolytic effects, though it is not approved or available as a medication in the E.U, the U.S., or Australia. Though it has apparent recreational potential, it is not classified as a controlled substance. Vinpocetine is a man-made chemical resembling an extract found in the periwinkle plant, and while preliminary evidence suggests it may have some neuroprotective benefits, the the U.S. Food and Drug Administration said it is ineligible to be marketed as a dietary supplement. Picamilon is a combination of GABA and niacin, and is sold in Russia as a prescription drug; it has been deemed by FDA as an adulterating agent in dietary supplements.
Several of the detected drugs were not declared on the label of these products, and several declared ingredients were not detected in the products. Many of the drugs that these tested products contained met or exceeded pharmacological doses in the recommended serving sizes. For products with quantities provided on labels, 75% of the declared quantities were inaccurate, the analysis alleged.
“Consumers cannot obtain accurately labeled cognitive enhancement supplements by selecting supplements using the NIH’s or Natural Medicines’ supplement databases,” the authors of the analysis said. “Previous research found similar discrepancies between the information provided in the NIH’s supplement database compared to the actual content of the supplement. Use of these cognitive enhancement supplements poses potentially serious health risks given the unpredictable dosing and lack of clinician supervision.”
CRN Responds
Steve Mister, president and CEO of CRN, said the authors of this study made sweeping conclusions about the brain health category based upon a narrow selection of 10 illegal products on the Internet.
“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,” Mister said. “Fortunately for consumers, this small collection does not represent the brain health supplement category, as the products identified in this 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.”
Additionally, he took issue with the characterization of supplement databases as “shopping tools for the public,” but rather that they are intended to provide a full picture of both high-quality and adulterated substances.
“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 said. “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.”
Despite this, CRN does agree with the study’s conclusion, that the U.S. FDA must increase its enforcement of dietary supplement regulation. “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,” Mister said.
