Weeding out Over-the-Counter Frauds

How many of us rely on daily Over-The-Counter (OTC) medicines and supplements? What if you found out that many of them are at best absent of active ingredients?

Supplements in OTC medications are not regulated by the Food and Drug Administration (FDA). Therefore, the market is somewhat the Wild West of remedies and life-lengthening elixirs.

Enter Sayo Fakayode, PH.D. He’s a Professor of Chemistry and chair of the Department of Chemistry, Physics & Astronomy at Georgia College and State University. He’s trying to root out fake and toxic consumables outside the government's regulatory reach.

“Our work carries a profound impact on the masses, on humanity itself,” Fakay, as he is known, said. “It's a universal truth: people eat, drink water, and breathe. Yet, amidst these everyday acts, we are unwittingly exposed to a myriad of toxic compounds - heavy metals, arsenic, lead ―lurking in our food, water, and even medications. How do we detect these silent threats? That's the question driving our quest to develop rapid detection methods."

He said Americans spend $480 million annually on over-the-counter medications that don’t require prescriptions, including cough syrup, which he has studied.

“Because it's available, you don't need a prescription. It's the first line of defense. If you're sick, you go to Walmart or CVS. The challenge is because there is not really a strict control from the FDA, there's potential for fake medication out there.”

The problem is global. That’s because most of the medicine is imported from other countries along with the ingredients to make them. These countries often don't have any regulations at all. So, what are the challenges? Choose drugs, and the medication that you paid for may not be doing anything.

Why? Because there's no active component, there's no active ingredient. All you are taking is nothing but sugar. That's a problem health-wise.

“So, one of the things we are trying to do is can we actually quickly analyze and detect or screen a variety of medicines, for example a cancer medication from a quality assurance point of view. It is a very global challenge of administration of medication now, especially now because of the open borders. A lot of people buy things from other countries on the internet.”

“That’s a big issue because people are actually, making good medication, but they're losing money. This situation infringes on the intellectual property of some people. It is a global issue that we are trying to figure out, which is how do we detect this rapidly.”

In Fakay’s work, he employs a variety of methods, one of which is Raman spectroscopy. Over-the-counter medications often contain significant amounts of water due to the syrupy vehicles used in their formulation. Consequently, traditional methods typically involve extracting these active ingredients or components, a task well-suited for chromatography. However, chromatography poses challenges in terms of lengthiness, cost, and the need for specialized instrumentation maintenance. Moreover, it's not practical to bring an HPLC machine to a retail store like Walmart for quick analysis.

“This is where Raman spectroscopy shines. Unlike chromatography, Raman spectroscopy is insensitive to water and offers portability. There are even portable Raman spectroscopy devices available that can be taken directly to locations such as Walmart, allowing analysis without opening containers.”

For quality assurance of medications, particularly in scenarios where it's necessary such as in a clinical trial unit (CTU), Raman spectroscopy provides invaluable capabilities.

“We have demonstrated how to utilize Raman spectroscopy in conjunction with chemometrics, including regression analysis and principal component analysis, to not only screen but also accurately detect the concentration of active components in most over-the-counter samples.”

“Our first published paper, released late last year, utilized the very instrument we employ to swiftly screen medications. What's remarkable is the fusion of Raman spectroscopy and principal component analysis, enabling us to not only differentiate between medications with varying concentrations of active ingredients but also distinguish between adult and infant formulations due to their differing doses. This breakthrough is both fascinating and efficient, offering a rapid, cost-effective, and highly accurate method. We've achieved an impressive 94 percent accuracy rate in predicting medication content. This achievement fills us with immense satisfaction. Furthermore, the paper has already garnered citations in peer-reviewed publications, underscoring the significant impact our research is having within the scientific community.”

Fakay and his team use a HORIBA MacroRAM™, a benchtop Raman spectrometer, for these analyses. The MacroRAM is an easy-to-use macro-Raman spectrometer for fast and reliable Raman analysis. It’s ideal for bulk analysis of solids, liquid solutions, powders, and gels. The MacroRAM provides the flexibility and sensitivity to handle virtually any type of sample. With a compact and robust design including Class 1* laser safety, MacroRAM is perfect for use in most environments, from undergraduate teaching labs to industrial QC and manufacturing.

What other things can be done to prevent this fabrication of impure over-the-counter medications? Does Fakay think the FDA should take control of it?

The FDA is making efforts within its means, but it's crucial to understand the distinction between prescription and over-the-counter medications. While there are stringent controls for prescription drugs, enforcement for over-the-counter medications may not be as rigorous.

This discrepancy could be attributed to various factors, including limited manpower and experienced field experts available for enforcement.

“In my view, we likely screen less than half of the over-the-counter medications available in the United States due to logistical challenges. Screening such a vast array of products, from Walmart to CVS, can be capital-intensive.”

Recognizing this, the question arises: Can we do more?

“Absolutely. It's intriguing to note that shortly after our recent paper was published, I observed recommendations to remove certain over-the-counter medications from shelves due to their ineffectiveness. It's concerning that these medications have been in use for years before their inefficacy was discovered. This underscores the need for increased resources and vigilance to ensure public safety.”

Fakay said it requires a collective effort. Collaboration between federal agencies like the FDA, academic institutions, private laboratories, and funding bodies such as NSF (National Science Foundation) and NIH (National Institutes for Health) is essential.

“By pooling our resources and expertise, we can work towards improving the oversight of over-the-counter medications and safeguarding public health.”

Fakay has another passion. Let’s call it social consciousness. In 2014, Fakay authored a paper advocating for greater participation of minorities in the STEM fields. Although the study is 10 years old, Fakay still has the same concerns.

“I started my career at a predominantly HBCU (Historically Black Colleges and Universities) institution. If you look at the statistics, there's still room to grow. Minorities are still underrepresented in these fields, and the numbers could be better in terms of how many of them we have in the STEM field. So, it is going to take a lot of effort to improve that number.

Follow Us