Last May, the U.S. Food and Drug Administration (FDA) warned consumers about a counterfeit version of "ExtenZe," a dietary supplement for male sexual enhancement. The counterfeit product looked similar to the actual product, but contained hidden ingredients that can cause serious harm. This wasn't the first, and certainly won't be the last, adulterated, counterfeit supplement to sully the industry. But what if a new technology could prevent products such as these from ever reaching consumers?

TruTag Technologies spectral microtagsEnter TruTag spectral microtags—a cheap, covert way to tag products using edible silica particles. "So many companies and so many products have a security problem that isn't solved by existing technologies," said Peter Wong, COO of TruTag Technologies. "In the case of nutritional supplements, packaging level security is a big business... but even with all that technology there's still a significant counterfeiting and adulteration problem."

TruTag is part of Skai Ventures, a Honolulu-based venture accelerator of disruptive technologies with biomedical and biodefense applications. The silica product evolved from another of Skai's companies, Eyegenix, which makes artificial corneal implants.

The silica is heat-resistant and FDA GRAS affirmed, but will it turn consumers off if they find out about silica in their supplements? Wong doesn't think so. What many people don't realize is "silica is in Advil, in Equal sweetener and even in Taco Bell meat," he said. "It's a common food additive."

Earlier this year, TruTag became an independent business because of the technology's potential in food and drug, as well as in industrial parts, luxury goods and even furniture coatings and cement products. The company is gaining the attention of venture capitalists and angel investors, too. TruTag was named "Most Likely to Succeed" in the Life Sciences category during Launch: Silicon Valley 2011, the premier product launch platform for emerging tech companies around the globe.

How TruTag microtags work


A strong full-spectrum white light spectrometer captures the reflected light pattern from the silica particles, which can be added to nutritional supplements' coating or inside the supplement itself. The reflected spectral pattern is then matched to the silica microtag's pattern to confirm that the supplement contains the tag.

Depending on the size of the pill, there could be many hundreds or thousands of the particles, which are 75-100 microns small, or about the width of a human hair. "We don't have to look for a needle in a haystack," said Wong. The spectrometer can be programmed to read a certain amount of tags to achieve mathematical certainty for verifying products.

"We've tested it with a prominent nutritional supplement maker, where you sprinkle a small vial of these silica particles in a big vat of tablet coating mix," said Wong. "Think of it as a small pinch of sugar to the frosting mix." As the pill cores are tumbled, the tablet coating's fine mist sprays the microtags onto the pills along with the coating. "Some of them get buried in the first 10-15 minutes of the coating process and some of them land on the surface. We read the ones on the surface."

For capsule products, putting the silica in shell gelatin or the banding solution are options. Or the tags could be placed inside the pill's ingredient mix—if the shells are clear so they can be scanned.

"You could use a lot less silica by mixing it into the pill core, and then it's a forensic use," said Wong, noting that if there's an incident in the field, the pill can be recalled, ground down and identified to discover at which facility it was manufactured and when, and even the exact lot it came from. "We can make up a trillion different spectral patterns," said Wong, likening the pattern to a traditional bar code.

Integrating TruTags in the manufacturing process


The dietary supplements industry faces many of the same challenges as pharma, which make TruTags a natural for safety in the nutritional industry. "Initially we focused on pharmaceuticals, but we have gotten interest from a number of companies in the supplements industry because there are certain manufacturers who really want to differentiate themselves because of the high quality of their ingredients," said Wong.

Interested manufacturers could potentially implement TruTags in less than a year, and the good news is it's relatively inexpensive, adding only fractions of a penny per product, said Wong. Integration happens in three phases.

  1. TruTags works with the manufacturer to understand manufacturing processes and how the tags will be used. This includes answering questions such as: Will they be in loose powder or finished foods? Will they simply be used to identify vitamin A vs. vitamin C, or will they be used in the field or in the lab? The process can take one to three months to complete.
     
  2. TruTags will work with the manufacturer's quality team to design the most cost-effective way to integrate and control use of the product.
     
  3. A testing phase may follow, which FDA guidance does not require, but which most companies conduct to ensure absolute safety for consumers.

Tools to fight supplement adulteration


The path TruTag has followed is similar to how Thermo Fisher Scientific got its start with its portable TruScan and microPHAZIR handheld scanners—developed for one industry and then applied to another. Thermo Fisher's handheld scanners originally were created to help pharmaceutical companies meet GMP standards. The company is now servicing the dietary supplement industry with its solution to identify raw ingredients and stave off potential adulteration with counterfeit materials.

Technologies such as these hold much potential for keeping counterfeit supplements off store shelves, but also for addressing quality issues the moment they occur. "It gets to the heart of two issues in the industry today, which are traceability and adulteration," said Todd Runestad, editor in chief of Functional Ingredients and the New Hope Supply Network, noting that TruTags would be particularly helpful for recalls. "If you had wide scale adoption of a technology such as this you could quickly and easily trace the problem," he said.