Industry Application: Edible Security Microparticles Protect Daily Wellness Products from Adulteration and Counterfeiting

Founded in 1996, Daily Wellness, Honolulu, HI, manufactures branded, clinically-validated dietary supplements including FertilityBlend natural fertility supplements for men and women and Asensia, a hormone balancing supplement. 

“Besides creating high-value products, we have earned our customers’ trust by having well-known and highly regarded research institutions independently validate the efficacy and safety of our formulas,” said Denny Kwock, president and chief executive officer of Daily Wellness. 

Daily Wellness has expanded beyond the North American market into Europe, Asia, and the Middle East. However, the company knows that such global expansion will mean less visibility and control over product distribution in these dynamic and often chaotic environments compared to typical domestic channels. The potential for product compromise could possibly threaten a brand like Daily Wellness, which has spent over 10 years building a high-quality image and gaining the trust of consumers worldwide. It became clear that a robust diagnostic and security enforcement tool was necessary to reduce risk and ensure that the company’s branded nutraceutical products were not sold outside of the authorized territories and that all products on the shelves were genuine. 

Daily Wellness investigated several security options such as barcodes, holograms, invisible inks, radio-frequency identification (RFID), and other package security features. However, Kwock was concerned that these products could be copied or removed, and in the event of product compromise, it may be nearly impossible to diagnose the specific source of the security issue within the distribution chain. The need for product verification and traceability ultimately led Daily Wellness to work with TruTag Technologies, a supplier of on-dose traceable security. 

A Permanent Solution 

TruTag, Emeryville, CA and Kapolei, HI, is a product identity solutions company that has developed covert, edible silica microparticles pictured above for use in solid oral dosage products such as capsules and tablets. These microparticles become a permanent product component and provide verification and traceability throughout the product lifecycle. 

Using a proprietary process, TruTag etches the silica microparticles to create a computer-programmed pattern only detectable by proprietary devices. This pattern forms a multiplex spectral array that can only be decoded using TruTag’s spectral detection units (or readers). In addition to product verification, these codes can provide information on a product’s manufacturing plant of origin, which line of equipment was used to make it, and its intended geographic sales territory. TruTag offers decoding services, but customers also have the option to purchase the readers and perform authentication in the field. 

“Our microparticles are typically deployed for the pharmaceutical industry, but we are receiving a growing number of requests from manufacturers of premium branded supplements and food products,” said Kent Mansfield, president of TruTag. “When brand-name nutraceutical products gain market share and expand quickly into new channels, they are at risk of product compromise because of higher price points and better margins. These qualities attract counterfeiters and other opportunists within the distribution and retail markets.” 

A Perfect Match 

Despite both companies having major operations in Hawaii (TruTag’s cGMP microtag production facility is in Kapolei), Daily Wellness and TruTag hadn’t begun a working relationship with each other until 18 months ago. Kwock was concerned that it might be difficult to integrate an on-dose security feature to his company’s manufacturing processes and formulas, but TruTag quickly put him at ease. “At first, most of our clients don’t realize is how small a quantity of our product is used to integrate this security feature into a solid dosage form,” said Mansfield. “Each microparticle measures 25 to 75 micrograms, and the loading percentage onto a solid oral product can be less than a quarter of a percent and even lower depending on the application.” TruTag has developed two primary methods for integrating these machine-readable microparticles into solid dosage forms. The first method incorporates the microparticles during the tablet film-coating process, either mixing them into the product’s existing base coat or into a clear overcoat applied after the base coat. The second method incorporates the microparticles into the formulation during the blending stage or into the ink printed on the capsule. Each of these methods is fairly easy for manufacturers to deploy. 

Because Daily Wellness products come in both tablets and capsules, Kwock agreed to run a few pilot batches to determine how the microparticles would blend with the fortocertifimulations and if the company would need to make any changes to the existing manufacturing process. “We were happy to discover that integrating the TruTag silica microparticles had very little impact on our standard operating procedures and manufacturing processes,” said Kwock. During these pilot runs, TruTag used different loading densities and tested the products at different points in the manufacturing process to ensure that all the units of each batch contained the microparticles. The resulting blend had the consistency required to ensure that every final product unit could be identified using the readers. 

“Once we saw how easy it was to add the microparticles, we were convinced that TruTag offered the best authentication solution for our products,” said Kwock. “The fact that TruTag already had the certifications needed for regulatory clearance made it a very simple choice.” The ease with which the microparticles can be incorporated into an existing product formulation allows companies to quickly deploy this on-dose security solution. According to Mansfield, if a dietary supplement is fully developed and already on the market, the pilot testing takes one to three months to perform. 

Kwock pointed out that the microparticles also provide marketing benefits. “In addition to protecting our customers and minimizing problems in our distribution channels, our exclusive international sales partners love this added security feature, which gives us an edge during negotiations.” 

A Value-Added Feature 

After integrating the microparticles into the company’s manufacturing process, Kwock wanted Daily Wellness customers to know that their supplements included an on-dose authentication feature. As a result, Daily Wellness product labels now include a notification stating that the supplements are protected by TruTag. This is the first such co-branding in the nutraceutical industry. 

“Most companies, in my experience, don’t want to broadcast what kind of product security mechanism they use because they fear bad actors might figure out how to copy or remove it,” said Mansfield. “And, really, that is a well-founded fear because, for many years, typical package security solutions have been easily copied or destroyed, which prompted frequent technology turnover in the industry over the last couple of decades. And when those newer technologies become compromised, the cycle begins again. What we and Daily Wellness have surmised is that letting potential opportunists know that TruTag microparticles are in the product can act as a deterrent because it’s too complex of a solution for anyone to unravel and attempt to duplicate.”