Counterfeit medicines are a serious public health problem that puts human lives at risk and undermines the credibility of health systems. Approximately 10% of the $800 billion annual global pharmaceutical market is thought to be counterfeit.  The global counterfeit food threat is estimated at almost $50 billion. The U.S. Food and Drug Administration inspects less than 2 percent of the food coming into the country, while 13 percent of America's food is imported. Over 80% of the active ingredients for drugs sold in the United States are made abroad, primarily in Asia.

Counterfeiting affects both expensive and cheap products and generic and branded ones. As international criminal organizations become more sophisticated, packaging security is proving inadequate. Additionally, when consumer safety and quality issues arise, the ability to (i) confirm product authenticity, and (ii) track and identify the source and scope of the issue, is critical to managing potential liability and brand damage.

TruTag™ microtags are manufactured starting with high-purity silicon and completely oxidized by a high-temperature bake to form silica, also known as silicon dioxide (SiO2). Silica is "generally recognized as safe" (GRAS) by the FDA, and has been in wide use for many years in a range of food products and pharmaceuticals. For example, it is added in small amounts to aid with the thickening of coatings or the free-flow of powders and granulations.

In October 2011, the FDA issued final guidance regarding on-dose authentication solutions like TruTag™ microtags entitled: "Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting" in which the FDA recommends the use of well-studied materials, such as substances that are GRAS (like pure GRAS silica TruTag microtags). Click here for a copy of the FDA guidance.

The TruTag™ difference is that a unique optical signature is manufactured into the tags without the use of additional additives or markers. This allows the pure silica tags to be added to coatings and applied to the exterior of edible goods, or added to ingredients such as powders and used as a forensic marker, to be read and verified as part of an investigation or inspection process by authorized security or quality assurance personnel.