April 10, 2013
Counterfeiting is an enormous global problem affecting every industry and product, including nutraceuticals. Recent incidents include fake or adulterated ball bearings,1 military equipment,2 surgical mesh,3 glucose strips,4 cosmetics,5 pharmaceuticals,6 olive oil7 and herbal supplements.8 For many life-critical or ingested products, the specter of counterfeit or diverted products is a major safety and liability concern. Criminal organizations motivated by profits, mild penalties and an unsuspecting customer base have targeted both medicines and supplements. Why? It is fairly easy to manufacture a pill and package that look real, but at a fraction of the actual brand owners cost because the counterfeiter does not have the accrued research and development expense nor the investment in high-quality certified plant and equipment. This is especially true if the counterfeiter is adding little or no actual active or key ingredients.
Further, increasing regulation of nutritional supplements is drawing greater scrutiny, and top-tier brands seek to stand out in an industry that is focusing more on quality. With todays complex global supply chains, quality control (QC) and supply chain management can be difficult, especially as regulation of nutritional supplements continues to march steadily toward those standards also required of pharmaceutical products.
Manufacturers historically have focused product security efforts on packaging-based measures, such as holograms, UV inks, special symbology or complex bar codes. Unfortunately, counterfeiters have been defeating these packaging features for many years. And, even if the package can be verified as authentic, there is no assurance that what is inside the package is real. So, what are security-conscious, quality-minded brand owners to do in the future?
A new level of brand protection and security has emerged called on-dose authentication," where advanced security measures can be applied directly to a tablet or capsule. A variety of technologies have been proposed, from nano-scale embossing, florescent markers and portable chemical analyzers. TruTag Technologies developed TruTags using silica microtags that can serve as covert edible bar codes."
TruTags are made of silicon dioxide (SiO2) or silica. Silica has been used as an excipient in food and drug for decades, primarily as an anti-caking or flow agent, and has been affirmed GRAS (generally recognized as safe) by FDA.
Edible bar codes can be smaller than the width of a human hair and is virtually invisible to the human eye, hiding it from the roving eyes of counterfeiters. One gram of these barcodes can contain approximately 12 million particles, each of which are encoded to create a spectral pattern or code" chosen from a library of millions of unique possibilities. These patterns are essentially labels or ID numbers that can be associated with fields of information in a database. The invisible edible bar codes" can be easily mixed into a tablet coating and sprayed onto the product, applying hundreds of particles over the surface of a pill.
While FDA allows up to 2 percent of total product weight to be silica, only a small fraction of that amount of TruTags is needed in the coating to be effective. And, with a quick scan of that surface by the TruTag reader, a variety of product information, such as product strength, expiration date, manufacturing site, country of authorized sale and lot number, can be confirmed. Thus, a nutraceutical manufacturer can use these as broadly as a traditional printed bar code.
First, this covert, on-dose security measure can directly verify that a product is authentic and confirm that what is inside the package or bottle is not expired. Also, the product-specific information printed on the package can be immediately cross-checked with the information found on the pill, and this verification can be performed in the fieldat a distribution warehouse, shipping dock or retail store.
With this capability, a manufacturer can check against unauthorized diversion across distribution channels or geographic territories. With a few scans, a user can determine whether the product is real, expired, and in the right channel or country. If a sample is red-flagged, the user has the information to properly analyze what went wrong. If product intended for France ends up in the Canadian supply chain, its time to go talk to the French distribution partner with solid, accurate data in hand.
Second, these edible bar codes offer manufacturers greater control over their supply chains. One area that is susceptible to counterfeits and diverted product is the reverse logistics phasereturned product. With product tagged with TruTags, the returns processor can spot check the tablets to make sure they are part of a lot that is within scope for authorized returns. And less returned product means fewer refunds, especially when the returns are not authorized or outright fake.
Third, this microtag solution is a valuable QC tool. As government regulators turn their attention toward the nutritional supplements industry with pharmaceutical standards in mind, technologies that help manufacturers gain a firm grasp on its quality and supply chain are extremely valuable. On the factory floor, the manufacturing team can check and track samples and nutraceutical product prior to packaging. When customer incidents occur, the product can be directly analyzed in the field to confirm the product name, strength lot number and expiration date, regardless of whether it is still in its original packaging, and quality issues can quickly be scoped according to affected lots. A robust product tracking and verification system would be very beneficial when regulators begin investigating any quality or safety incidents.
With complex global supply chains creating opportunities for QC challenges, as well as openings for arbitrageurs, diverters and counterfeiters to exploit, brand owners should look to advanced technologies to protect their products, reputations and customers. On-dose authentication is at the leading edge of protect protection.
References listed on the next page.
1. ElectronicsWeekly.com, Bogus Bearings Look More Real than Real Ones," April 10, 2007
2. Report of the Committee on Armed Services, United States Senate, Inquiry into Counterfeit Electronic Parts in the Department of Defense Supply Chain," May 21, 2012.
3. FDA Safety Alert, Class I Recall and Safety Investigation of Counterfeit Polypropylene Surgical Mesh," June 10, 2010.
4. FDA News Release, FDA Updates its Nationwide Alert on Counterfeit One Touch Blood Glucose Test Strips" December 15, 2006.
5. Daily Mail, The toxic trade in fake make-up: How counterfeit cosmetics containing dangerous levels of arsenic are being sold online to unsuspecting bargain hunters," September 30, 2012.
6. The Economist, Bad Medicine," October 13, 2012.
7. Food Safety News, Food Safety Endangered Worldwide by Increased Food Counterfeiting," October 29, 2012.
8. Daily Mail, Inflating the truth: FDA warns fake herbal sex pills contain Viagra ingredients," May 13, 2011.
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