Joanna Cosgrove07.05.10
The packaging and labeling look legit and to the eye, the products appear fine. But in an age of adulterated products and sophisticated counterfeiting, having 100% confidence that what’s promised on the package is actually in the supplement can be a dicey proposition – until now. TruTags™, developed by Honolulu, Hawaii-based Cellular Bioengineering, Inc. (CBI), represent a novel – and ingeniously inconspicuous - approach to combating fake supplements.
While investigating new technologies for CBI’s parent company, CBI’s founder, Dr. Hank Wuh, realized the potential of nanoporous silica as an edible microtag useful for direct labeling of food and medicine. After three years of development, the fruit of his work was TruTag, a tiny, custom-manufactured “spectral signature” code that can be applied directly to supplements in biologically inert and edible silica. The unique choice of tag signature is the TruTag key to confirming the authenticity of the product.
“TruTags are added in an amount at a tiny fraction of the allowed limit and contain tiny nanopores (voids) manufactured to produce a unique, custom-manufactured spectral signature chosen from over one trillion possibilities,” explained CBI’s Mike O’Neill, chief technology officer and Product Security Division lead. “TruTag microtags are made of the highest purity silica, “generally recognized as safe” (GRAS) by the FDA. Silica has been safely used as an ingredient in food and drugs for decades at a limit of up to 2% by weight.”
The tags range in size from 50 to 100 micrometers (about the width of a human hair) and are attached on- or in-product. The methods for tagging used do not alter productions speeds of the underlying products and, according to Mr. O’Neill, tablets and capsules are the CBI’s initial focus. “The tags can be applied via industry-standard pan coaters so that they are on the outside of tablets, or mixed into capsule shells during manufacture, allowing tags to be read from the outside of the tablet or capsule,” he said. “TruTags can also be mixed into raw ingredients as a forensic marker to be recovered and read out in a QA lab. The choice is up to the customer depending on their needs, capabilities, product form factor, and budget.”
TruTag readers transmit and capture white light that reflects from the tags. “The spectral composition of the light is analyzed, and the reader provides for interpretation, identification, and authentication of the tag’s unique spectral signatures,” Mr. O’Neill explained. “Line-of-sight is all that is required to read TruTags, meaning that tablets in a clear blister pack, for example, would not need to be removed from the blister pack to be verified. Once the tags are visible to the reader, readout and verification is almost instantaneous.”
CBI is currently trial running TruTags with “a major US nutraceutical company” and has tested its microtags in a variety of different applications both with clear and nominally “opaque” coatings. “This pilot partner was able to apply our tags to their tablets without any change to their existing manufacturing process and without any impact to the look or feel of the coatings,” commented Mr. O’Neill. “We are now in ICH stability testing to see how the tagged tablets perform under accelerated shelf life conditions by applying high heat and humidity.”
The most common means of tracking and verifying products is through packaging and labeling. Radio-frequency identifiers (RFIDs) – which cost about seven to fifteen cents apiece - are another option but are not always practical for small or consumable items. In comparison to each TruTag costs less than a penny.
In addition, TruTags can be attached either to the outside of items to be read, for example, through clear plastic blister packs, or mixed into items as a forensic excipient, to be read as part of an inspection process or investigation by authorized security or quality assurance personnel. “The microtags are encoded with information purely in their depth, rather than along their surface. They can be broken into pieces, with each piece still containing all of the encoded information,” said Mr. O’Neill. “This makes porous silica microtags suitable for products that might be subjected to rough handling. As long as any piece of the tag can be recovered, the information is not lost.”
Because they are an emerging technology, TruTags are currently being marketed in a B2B fashion, though they have the capability of being used anywhere in the supply chain from raw ingredients to retail. “Our market entry is focused on applying the tags to tablets and capsules to be used by the manufacturer for quality assurance, returns monitoring, and cases where counterfeit product is of concern,” he said. “The manufacturer’s QA and Security divisions are outfitted with the TruTag readers and can statistically sample product according to their needs either in-plant, or point monitoring in the distribution chain.”
CBI developed its TruTag technology with the award of a cooperative agreement from the US government to help combat counterfeit drugs. The company also partnered with Silicon Kinetics, Inc. of San Diego, California and its porous silicon labs in Maui.
