You don’t know Mark Witkowski. You’ve probably never heard of his unit. But you sure will be glad he’s there.
Witkowski works for the U.S. Food and Drug Administration. He’s a chemist with the Trace Examination Section of the Forensic Chemistry Center. His job is to make sure the food, drugs and supplements you consume aren’t tainted or counterfeit, and he uses Raman spectroscopy to do that.
And it’s a bigger problem than you imagine.
Witkowski earned his doctorate from Kansas State University in analytical chemistry. His focus was infrared spectroscopy. And he uses those tools to help police the food and drug chain.
Unscrupulous actors will counterfeit expensive drugs because of its economic value. That includes lifestyle drugs like Viagra, Cialis, Lipitor, or vital drugs like Hyzaar, a blood pressure medication, Tamiflu, a vaccine for influenza, and Plavix, a blood thinner. Selling imitations of these drugs can earn someone a hefty profit.
Dietary supplements are also a common target of investigators. Witkowski said there are many examples of supplements that claim weight loss and properties for treating erectile dysfunction. Those products might contain drug substances instead of natural products.
Baby formula provides an example of food tampering. The formula, as many parents know, is expensive. Sometimes people will buy the formula, remove it from its packaging, replace it with another substance, like flour, then take it back to the store and get a refund. The formula ends up back on the shelf. Individuals have substituted Tylenol in the same way, according to Witkowski.
The FDA has a law enforcement branch called the Office of Criminal Investigations. That group opens investigations into criminal activities. It provides the Trace Examination Section with samples from its investigations into counterfeit or tainted drugs for analysis.
“The Trace Examination Section is responsible for identifying unknown particles in injectable products, dietary supplements, (pharmaceuticals) and suspect adulterated food products,” Witkowski said. “If there’s a suspicion of adulteration, tampering or counterfeiting, or that it has it been manipulated in such a way that it’s not what it purports to be, we investigate it.”
The Trace Examination Section uses Raman spectroscopy for counterfeit and unknown particle analysis.
“Typically, we derive formulation information on a counterfeit product,” he said. “We may have to do individual product analysis from a tablet formation. We use a combination of infrared spectroscopy and Raman spectroscopy to identify different components that are used to make the tablet. The goal is to be able to look at what’s being used to make that particular counterfeit formulation and to compare it to an authentic product to prove it wasn’t made by the actual manufacturer.”
Raman has its advantages. It’s a non-destructive technique and preserves the evidence.
We can analyze the tablet as is,” he said. “And in some cases, the particles themselves we are analyzing could be very small, and Raman allows us to analyze small particles that infrared spectroscopy wouldn’t.”
The lab uses HORIBA Scientific’s LabRAM IR2, a micro-Raman spectrometer to identify the particles. The instrument also includes infrared spectroscopy.
The lab also has a HORIBA’s XploRA PLUS, a Raman spectrometer with intelligent sampling automation, called the ParticleFinderTM module.
“The XploRA PLUS will provide us with the ParticleFinder application,” Witkowski said. “To do it by traditional Raman microcopy can be fairly time consuming, because you have to do it a section at a time and over the entire sectioned area. The ParticleFinder application will help us to survey a large particle field very rapidly by automatically locating, then doing Raman on select particles only, so that the chemical information derived from that will be used with the optical microscopy to give us the amount of unknown particles in a particular sample.”
From there, the division writes up its results and submits the report to the investigator. That information, along with the investigative information, could ultimately end up being used as evidence in court.
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