Adulteration and counterfeiting are a blight to the supplement industry, leaving in their wake a damaging combination of dangerous health implications and eroded confidence in natural products and the companies that produce them. Many companies opt to stay ahead of potential problems by investing in sophisticated technologies designed to detect adulterants early in the production phase before they ever make it into finished products. Bloomingdale, IL-based NOW Foods did just that when it invested in the Spectrum One FT-IR and Assure ID software suite technology from Perkin Elmer of Waltham, MA.
“Recalls make everyone in the industry look like bad players,” said Andrea Champagne, an analytical scientist at NOW Foods. “It has a severe psychological impact on the customers. People begin to think every similar product is unsafe.”
NOW Foods wanted to attack the issue of adulterated food with vigor. The company, which has produced high-quality nutrition supplements since 1962, needed to mitigate risk for the retailers that sell their products and the consumers who trust the brand. “For our industry, it seemed that the mindset was that everyone knew adulteration was a problem, but the hope was that it would just never happen to them,” said Katrina Emmel, an analytical scientist at NOW Foods. “But we wanted to take a leadership role on this issue. We wanted to know for a fact that this wouldn’t happen to us.”
While the U.S. Food and Drug Administration orders that adulterated products be removed from the market, it also directed manufacturers to fix the problem, which it calls the industry’s biggest threat. For NOW Foods, addressing the threat meant creating a cost-effective solution—a test that could be repeated on a large scale and interpreted by in-house personnel who did not have advanced science degrees. The answer was an in-house protocol. The real question, though, was how to create it—and with what.
The company took its first step by assessing what it already had. A crucial part of the company’s progress was relying on instrumentation and software created by PerkinElmer. NOW Foods already had the PerkinElmer Spectrum One FT-IR spectrometer in its laboratory. Fourier Transform Infrared Spectroscopy, commonly referred to as FT-IR, collects data on solids, liquids or gasses, obtaining an infrared spectrum that can be qualitatively analyzed. FT-IR historically had been used for analytical testing of substances such as polluted soil and biodiesel blends, but NOW Foods wanted to apply this instrumentation to an innovative method of material qualification.
“FT-IR is one of the most established types of instrumentation we have in our facilities,” Ms. Champagne said. “The instrumentation itself is not the novel solution, but our approach using AssureID is.”
AssureID compares similarities and differences in the spectral data and delivers an easy-to-read printout—an assessment of whether a sample “passed” or “failed” the test. “Since substances create unique wavelength patterns, our FT-IR suite generates what amounts to a molecular fingerprint,” said Jerry Sellors, PerkinElmer’s Infrared Product Planning Manager. “AssureID software effectively transforms a layman into a reliable high-tech detective by comparing the sample’s FT-IR spectrum against authentic samples to decide if it is likely to be contaminated—just like an analytical spectroscopist in the lab.”
Alternative testing methods could have yielded the results NOW Foods required but at the cost of nearly $1,000 for each test and a turnaround time of several days by expensive third party chemists, the company needed a more efficient solution. NOW Foods determined it could achieve answers in five minutes instead of five days—a valuable, reliable and speedy outcome for a business that manufactured products based on a just-in-time delivery model.
The company said that with PerkinElmer’s hardware and software in place, testing is smooth and easy. Researchers place a sample in powder or pulverized form onto a metal plate. The instrument then runs the test in less time than it takes to toast a bagel. Using AssureID, the test detects the differences between the spectra of raw ingredients and adulterated materials with greater accuracy than more expensive testing methods.
“The one thing that allows a relatively non-qualified technician to do this is the AssureID software platform,” said Michael Lelah, technical director of NOW Foods. “That’s what makes the technology truly turnkey.”
Ms. Champagne noted that each supplement category has its own unique adulteration concerns. “For men’s virility we are concerned specifically with the PDE-5 inhibitors, substances like Viagra, Cialis, Levitra and their analogues,” she said. “Sport’s Nutrition is at risk for anabolic steroid and prohormone adulteration. Testosterone, boldenone or Superdrol would be some of the adulterants we are concerned with here. Diet and weight control supplements have a variety of adulteration concerns, most prevalent are sibutramine, ephedra and various stimulants.”
To stay ahead of fraudulent suppliers who were aggressively formulating new ways of spiking ingredient lots, NOW Foods needed a testing solution that could encompass all potential adulterants. Spectrum One FT-IR analyzes core chemical structures of materials being tested. The shell of an adulterant may change; what’s inside stays the same.
“The players who are adulterating these products are changing characteristics outside the core structure,” Mr. Lelah said. “They’re not changing the core structure because that is what makes a certain material, like a steroid, work. What this means is that the ability to manipulate the chemistry of a substance does not impact our ability to detect it. We’ll always be ahead of their shell game.”
In more than two years of testing each ingredient lot of specific classes of ingredients susceptible to adulteration with the Spectrum One/Assure ID method, the NOW Foods team has detected no adulterated lots (confirmed positives). “It’s important to identify potential problems at the earliest stage possible,” Mr. Lelah said. “By catching any potential ingredient problems before they go into manufacturing, it’s less costly for our suppliers to remedy and doesn’t inconvenience retailers or consumers.”
Regarding the future challenges adulteration poses to companies like Perkin Elmer that provide detection technologies, Mr. Sellors said he wholly expected fraudsters to adapt their methods. “The challenge with problems of this nature is while it’s often possible to setup and validate methods to screen against known or suspected adulterants, it is a dynamic problem so the ability to easily refine the specificity and sensitivity of the technique will be important.”