Cohen team finds unapproved drugs in cognitive support products
The research, titled “Five unapproved drugs found in cognitive enhancement supplements,” was done by a team led by Dr Pieter Cohen, MD, of Harvard Medical School. Dr Ikhlas Khan, PhD, director of the National Center for Natural Products Research at the University of Mississippi also participated. The paper was published online in the journal Neurology Clinical Practice.
Products found via search of public databases
The researchers planned to analyze memory and cognitive performance products, which lately fly under the banner of ‘nootropics,’ that were purchased online. They chose which products to purchase and test by searching the National Institutes of Health Dietary Supplement Label Database as well as the Natural Medicines Database. For the search terms they used omberacetam (marketed as Noopept), aniracetam, phenylpiracetam or oxiracetam .
All of these ingredients are analogs of piracetam. The US Food and Drug Administration rejected a New Dietary Ingredient Notification on piracetam in 2003, saying that it did not meet the definition of a dietary ingredient. Yet piracetam and its analogs, collectively known as the ‘racetams,’ have been available for sale in one channel or another ever since.
Using the above search criteria, the researchers found 10 products for sale that listed one or more of these ingredients on the labels. The products were purchased in September 2019.
Assortment of illegal ingredients found in products
After analyzing the products, the researchers found that two of the four racetams listed on the labels were actually in the bottles. They were omberacetam, a medication available in Russia used to treat traumatic brain injury, mood disorders, cerebral vascular disease, and other indications, and aniracetam, a drug approved for use to treat dementia in several countries including Italy, Argentina, and China.
In addition, the researchers said they found other unapproved ingredients in the products that are sold as pharmaceuticals in other countries. Some of these were openly listed on the labels. Those were vinpocetine, phenibut and picamilon.
In a controversial ruling in 2016, FDA decided to remove vinpocetine from the market even though the ingredient had successfully gone through the NDI process in the past. Picamilon does not have an NDIN on file, and was the subject of an FDA enforcement action in 2015. Phenibut is in a similar position, and was the subject of three warning letters sent in early 2019.
Some dosages exceed drug levels; combinations unstudied
The present Cohen paper (this is one of a series he has done along similar lines) notes that some of the dosages of these ingredients fall within the approved dosages of these substances when administered as drugs in other countries. In the case of omberacetam, the dose found in the supplement-like products ranged up to four times the pharmaceutical dose. In some cases dosages of the ingredients were listed on the labels, but the researchers found that the majority of these were inaccurate, with actual amounts ranged from 0% to 135% of what was on the label.
“Consumption of these products could expose people to amounts of these drugs four-fold greater than pharmaceutical dosages and combinations never tested in humans: one product combined 3 different drugs (omberacetam, phenibut, and aniracetam) and another product contained 4 different drugs (omberacetam, aniracetam, vinpocetine, and picamilon),” the researchers concluded.
“Despite FDA warnings, these drugs remain openly listed as ingredients in the NIH’s and Natural Medicines’ supplement databases. This might be due to loopholes in the law that permits companies to sell supplements without informing the FDA and the lack of a system for the FDA to track products on the market. In addition, the FDA might not be using all enforcement tools available to remove these products from the marketplace,” the researchers added.
CRN: A few bad products don’t represent whole category
Steve Mister, president and CEO of the Council for Responsible Nutrition, said this seems to be a case of finding what you are looking for. Non compliant products can be found for sale online, no question, but Mister said that doesn’t justify what he called the paper’s generalizations about what a few noncompliant products might say about an entire category.
“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,” he said.
Mister took issue with the apparent dismay the researchers expressed in discovering that these noncompliant products could be found in a search of official databases.
“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. 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,” he added.
Source: Neurology Clinical Practice
Five unapproved drugs found in cognitive enhancement supplements
Authors: Cohen PA, et al.