Mixing and rotating overt, covert, and forensic technologies can thwart counterfeiters.

By Donald J. Dobert
President and Chief Operating Officer
ATL Security Label Systems

It has been said dozens of times already, there is no silver bullet against counterfeiters and diverters. You’ve got to layer, layer, and layer some more. In the photograph below we have illustrated the different “layers” of a 3D hologram. These invisible layers give the security label three color kinetic movement.

These “layers”, which are not immediately known to the counterfeiters, can be mixed and rotated to protect original products and documents. In the example below a German ID card has hologram layers that reveal a pattern when the card is moved back and forth.

In the photo below, courtesy of Graphic Security Systems Corporation, Lake Worth, FL, you can easily see how (during manufacturing) each “layer” is structured with different anti-counterfeiting properties.

Just what exactly does layering mean? What layer comes first, what layers need constant updates, and what layers stay put? Who decides when and when to layer, when to update the layers, and when do you need to inform FDA?
A “mix and rotate” approach brings multiple technologies together in one package. To “mix and rotate” can be compared to software updates. As computer hackers invent new “bugs,” software companies develop new “anti bugs.” Every time you as a brand owner produce your product, you can “mix and rotate” the following security features:

Tamper-evident breakaway closures.
Invisible, hidden markers.
Anticounterfeiting holograms.
Color-shifting inks.
Tamper-evident unit closure.
Mass-serialization.
Two-dimensional bar codes.
RFID chips.
Void security closures or destructible tapes.

Here is an example. Tamper-evident substrates can employ destructible, paper-based face stock or nonreproducible covert security fibers. Distribution can be limited to approved secure suppliers for a secure chain of custody. Tamper-evident substrates can make label removal impossible without visible damage. Such features effectively deter remarking and help ensure product authenticity. They also provide simple in-field authentication.
In addition, color-shifting inks and other covert features can be public signals of authenticity. Invisible forensic markers alone can be used to detect whether a product has been repackaged or relabeled. Such forensic markers may be used in the varnish on the package as well as customized or serialized codes and holograms.
Combining these technologies, the hologram would be an overt feature, the forensic marker would be a covert one, and the code could be either overt or covert, depending on what you are doing with it. Special codes can be purchased or created that pertain to only one product, which tells the manufacturer where it was made, how it was distributed and on what days. While there are codes that are very obvious and basically list manufacture date and product code, there is a wide range of options in customized codes.
A Ubiquitous Example
Modern U.S. currency has changed many times over the past few years. With the exception of the one-dollar bill, all of these notes are obsolete (see photo below). This is because the U.S. government “mixes and rotates” (M&R) its overt and covert techniques to stay one step ahead of the counterfeiters.

Shown below are examples of anti-counterfeiting “layered levels” of the “ever-changing” “face” of U.S. notes. You will notice the different colors when compared to the notes that are now obsolete:

Overt and covert M&R anticounterfeiting measures include fine detail with raised intaglio printing on bills. This allows nonexperts to easily spot forgeries. As a side note, on coins, milled or reeded (marked with parallel grooves) edges are used to show that none of the valuable metal has been scraped off. This detects the shaving or clipping (paring off) of the rim of the coin. However, this does not detect sweating, or shaking coins in a bag and collecting the resulting dust. Since this technique removes a smaller amount, it is primarily used on the most valuable coins, such as gold.
For paper bills, in the late twentieth century, advances in computer and photocopy technology made it possible for people without sophisticated training to easily copy currency. To combat this, national engraving bureaus began to include new (more sophisticated) anticounterfeiting systems such as holograms, multicolored bills, and embedded devices such as strips, microprinting, and inks whose colors change depending on the angle of the light. New technology also includes the use of design features such as the “Eurion Constellation,” which disables modern photocopiers.

Detecting counterfeit bills often isn’t easy to do by eye. One bogus $100 bill believed to have been made in North Korea, for instance, would be nearly impossible for a novice to identify as a fake. It has the security strip on the left side of the bill and a watermark of Ben Franklin (whose portrait is on the bill) on the right-hand side, as well as replicating other security features. However, its paper contains no starch and doesn’t reflect ultraviolet light, which is one sign of a counterfeit.Photo Below. The portrait on a genuine $50 bill (left) compared to a counterfeit. Notice the relative flatness and lack of detail on the fake bill.

Photo Below: The portrait on a genuine $50 bill (left) compared to a counterfeit. Notice the relative flatness and lack of detail on the fake bill.

Photo Below. $50 bill with three security features highlighted. A section of the security thread is visible in the circle near the portrait. The large circle to the right shows the watermark, and below that the color-shifting ink is circled.

There is now a scanner that searches for missing covert features in bogus “Super Dollars.” The device looks at several aspects of the bill to confirm its legitimacy. U.S. paper money is printed with magnetic ink, but that’s also used for many fraudulent bills. On real bills, the ink is distributed in a consistent pattern whose magnetic resonance can be mapped. The magnetic map is stored in the scanner, as well as three other maps containing ultraviolet, infrared, and other measurements taken from legitimate bills. Scanning a bill takes less than one second. If there’s any spike or anomaly in any of the threads of data, the scanner rejects the dollar.

Photo Below. Beginning with Series 2004, $10, $20, and $50 bills received a redesign with several changes to their overall look, notably the addition of more colors (see the picture of the $50 bill above). Probably the most important new security feature is the addition of EURion Constellations, a distinct arrangement of symbols (in this case, numbers) which triggers many color photocopiers to refuse to copy the bill.

SUPER LABELS=SUPER DOLLARS

What I have just described is a “layered” approach in anticounterfeiting. You may not be the government fighting “super dollars,” but then again, you are fighting to protect your brand from counterfeiters. The money a brand owner saves in brand protection and litigation should be considered as “super dollars” to the brand owner. In the process (of saving money), the brand owner will be protecting the public, and he can advertise as such.

PUTTING IT INTO PRACTICE
Here’s how forensic authentication works in a M&R layered approach:
A unique digital code, “ATL 12-IDGJ”, is set-up for a brand.
A digital code is incorporated into the label through multiple-entry points (inks, varnishes, adhesives).
The digital code is also incorporated into (or linked to) the pedigree documentation.
A scanner will indicate that “ATL 12-IDGJ” is the established digital code, allowing traceability.

Such uniqueness cannot be duplicated because the invisible, nondegradable forensic digital code is virtually impossible for the counterfeiters to duplicate. It only takes a second to authenticate a product anywhere in the world.

Today, FDA does not need to know what type of anticounterfeiting measures you are taking. In fact, to protect themselves, brand owners should limit such details to a certain number of trained individuals who are monitoring what features are being used and for how long.
Most important in the anticounterfeiting arsenal is the brand owner’s mindset. Nothing changes until this does. Counterfeiters have the mindset that they can break the laws, provide fake or diluted products, and they do not care if they place the public in harms way. We (you and I) have to assume the mindset that says to the counterfeit, “No, you can’t copy my products.”

Thank you for your time. Donald J. Dobert, President, ATL.

FDA Warns Consumers about Counterfeit Drugs from Multiple Internet Sellers

If you purchase medications from sources that you do not know, and the product you take is purchased on the sole basis of “price”, then I believe you are playing a dangerous game of “you bet your life”.

The Food and Drug Administration (FDA) is cautioning U.S. consumers about dangers associated with buying prescription drugs over the Internet. This alert is being issued based on information the agency received showing that 24 apparently related Web sites may be involved in the distribution of counterfeit prescription drugs.
On three occasions during recent months, FDA received information that counterfeit versions of Xenical 120 mg capsules, a drug manufactured by Hoffmann-La Roche Inc. (Roche), were obtained by three consumers from two different Web sites. Xenical is an FDA-approved drug used to help obese individuals who meet certain weight and height requirements lose weight and maintain weight loss.

Above photos: Counterfeit Xenical, complete with instruction sheet, blister pack with exp. date, and lot serial numbers. What’s missing? ATL’s security labeling/ packaging: This is an invisible (non-degradable) digital forensic code that cannot be duplicated by the counterfeiters.

Photos below: If your prescription medications are not authenticated as genuine, how do you know that (your prescription medications) were not produced (by counterfeiters) on equipment such as this?

None of the capsules ordered off the Web sites contained orlistat, the active ingredient in authentic Xenical. In fact, laboratory analysis conducted by Roche and submitted to the FDA confirmed that one capsule contained sibutramine, which is the active ingredient in Meridia, an FDA-approved prescription drug manufactured by Abbott Laboratories.
While this product is also used to help people lose weight and maintain that loss, it should not be used in certain patient populations and therefore is not a substitute for other weight loss products. In addition the drug interactions profile is different between Xenical and sibutramine, as is the dosing frequency; sibutramine is administered once daily while Xenical is dosed three times a day.

Other samples of drug product obtained from two of the Internet orders were composed of only talc and starch. According to Roche, these two samples displayed a valid Roche lot number of B2306.
Roche identified the two Web sites involved in this incident as brandpills.com and pillspharm.com. Further investigation by FDA disclosed that these Web sites are two of 24 Web sites that appear on the pharmacycall365.com home page under the “Our Websites” heading. Four of these Web sites previously have been identified by FDA’s Office of Criminal Investigations as being associated with the distribution of counterfeit Tamiflu and counterfeit Cialis.

At this point, it appears that these Web sites are operated from outside of the United States. Consumers should be wary, if there is no way to contact the Web site pharmacy by phone, if prices are dramatically lower than the competition, or if no prescription from your doctor is required. As a result, FDA strongly cautions consumers about purchasing drugs from any of these Web sites which may be involved in the distribution of counterfeit drugs and reiterates previous public warnings about buying prescription drugs online. Consumers are urged to review the FDA Web page at www.fda.gov/buyonline/ for additional information prior to making purchases of prescription drugs over the Internet.
The 24 Web sites appear on pharmacycall365.com.
AllPills.net
Pharmacy-4U.net
DirectMedsMall.com
Brandpills.comEmediline.com
RX-ed.com
RXePharm.com
Pharmacea.org
PillsPharm.com
MensHealthDrugs.net
BigXplus.net
MediClub.md
InterTab.de
Pillenpharm.com
Bigger-X.com
PillsLand.com
EZMEDZ.com
UnitedMedicals.com
Best-Medz.com
USAPillsrx.net
USAMedz.com
BluePills-Rx.com
Genericpharmacy.us
I-Kusuri.jp

If you are a brand owner, ATL can show you how to authenticate your products in the field. If you are a consumer, we suggest that you purchase only authenticated prescription drugs from reliable sources.

We thank the FDA for materials used in this article.

You Bet Your Life: The Fakes. A Lesson For You In Loss Prevention.
A counterfeit drug or a counterfeit medicine is a medication or pharmaceutical product which is produced and sold with the intent to deceptively represent its origin, authenticity or effectiveness. For legal drugs, a counterfeit drug may be one which does not contain active ingredients, contains an insufficient quantity of active ingredients, or contains entirely incorrect active ingredients (which may or may not be harmful), and which is typically sold with inaccurate, incorrect, or fake packaging. Fake medicines and generic drugs which are deliberately mislabeled in order to deceive consumers are therefore counterfeit, while a drug which has not received regulatory approval is not necessarily so. Counterfeit drugs are also related to Pharma Fraud.

Most illegal drugs are produced and sold with the intent to deceptively represent its origin, authenticity or effectiveness, at least to some degree. The counterfeiting ranges from drugs which do not contain any active ingredients (e.g., when a bag of lactose is sold as cocaine), to cases where the active ingredients are “cut” with a dilutant or “spiked” with a chemical “enhancer”, to cases where the actual active ingredients differ from the purported active ingredients (e.g., when methamphetamine is sold as cocaine).

You Bet Your Life: Brand Piracy. Prescription and over-the-counter drugs.

Counterfeit legal drugs include falsely-labeled drugs that were previously expired, drugs where the active ingredient is fraudulently diluted, adulterated, substituted, completely misrepresented, or sold with a false brand name. An individual who uses a low quality counterfeit medication may experience a number of dangerous consequences to their health, such as unexpected side effects, allergic reactions, or a worsening of their medical condition. A number of counterfeits do not contain any active ingredients, and instead contain inert substances, which do not provide the patient any treatment benefits. Counterfeit medications may also contain incorrect ingredients, improper dosages of the correct ingredients, or they may contain hazardous ingredients.

The extent of the problem of counterfeit drugs is unknown. Counterfeiting is difficult to detect, investigate, and quantify. What is known is that they occur worldwide and are said to be more prevalent in some developing countries with weak regulatory regimes. It is sometimes estimated that upwards of 10% of drugs worldwide are counterfeit, and in some countries more than 50% of the drug supply is made up of counterfeit drugs. In 2003, the World Health Organization cited estimates that the annual earnings of counterfeit drugs were over $32 billion (US).

The high prices of patented medicines and the great divergence between manufacturing costs and prices are seen as important incentives for counterfeiting, including cases of high quality counterfeiting which can be difficult to detect. Fake antibiotics with a low concentration of the active ingredients can do damage world wide. Courses of antibiotics that are not seen through to completion allow bacteria to regroup and develop resistance.

Above Photo: Which are real and which are fake? Without traceability and authentication, how do you know? Would “You Bet Your Life” on not knowing?

You Bet Your Life: Some Solutions (RFID & Mass Serialization).

There are several technologies that may prove helpful in combating this problem, such as radio frequency identification (RFID). These are electronic devices to track and identify items, such as pharmaceutical products, by assigning individual serial numbers to the containers holding each product. The FDA is working towards an Electronic pedigree (ePedigree) system to track drugs from factory to pharmacy. This technology may prevent the diversion or counterfeiting of drugs by allowing wholesalers and pharmacists to determine the identity and dosage of individual products. Some techniques, such as spectroscopy and Energy Dispersive X-Ray Diffraction (EDXRD) can be used to discover counterfeit drugs while still inside their packaging.Some of the proposed anti-counterfeiting measures present concerns regarding privacy, or the possibility that drug manufactures will seek to use anti-counterfeiting technologies to undermine legitimate parallel trade in medicines. The term “counterfeit” should not be applied to generic drugs that are legally manufactured and sold, and which do not have deceptive labeling concerning the product. According to BBC reports, many of the fake drugs came from the same countries that make normal drugs, especially China and India. In the case of India, while it is against the law to sell fake drugs for domestic use, there is no regulatory regime that applies to the export market.

Graph Above: The top 5 anti-counterfeiting techniques are date codes, various printing, tamper evident, UPC codes, and mass serialization.

China
Many counterfeit drugs sold in the Third World or on the Internet originate in China. The State Food and Drug Administration is not responsible for regulating pharmaceutical ingredients manufactured and exported by chemical companies. This regulatory hole, which has resulted in considerable international news coverage unfavorable to China, has been known for a decade, but failure of Chinese regulatory agencies to cooperate has prevented effective regulation.
The Chinese press agency Xinhua reported that the World Health Organization had established Rapid Alert System (RAS), the world’s first web-based system for tracking the activities of drug counterfeiters, in light of the increasing severity of the problem of counterfeit drugs.

Russia
A few years ago, the Coalition for Intellectual Property Rights, an independent Russian group, conducted a survey that found that 12 percent of the prescription drugs distributed in Russia were counterfeit.

India
According to a report released by the Organization for Economic Co-operation and Development (OECD), 75 per cent of fake drugs supplied world over have some origins in India, followed by 7 per cent from Egypt and 6 per cent from China. It must be noted that India also is a leading source of high quality drugs sold by legitimate drug manufacturers, including most leading brand name drug makers operating in the US and Europe.

United States
The United States has had a growing problem with counterfeit drugs, and to help address it, the U.S. Food and Drug Administration (FDA) holds regular hearings to review trends and problems. The U.S. is an especially attractive market for counterfeiters because 40 percent of worldwide annual prescription drug sales were sold in the United States in 2007.

You Bet You Life: Anti-Counterfeit Platforms.
In 2007, the world’s first free to access anti-counterfeit platform was established in the West African country of Ghana. The platform relies on existing GSM networks in that country to provide pharmaceutical consumers and patients with the means to verify whether their purchased medicines are from the original source through a free two-way SMS message, provided the manufacturer of the relevant medication has subscribed to a special scheme. Still in trial stages, the implementers of the platform announced recently that they are in partnership with Ghana’s Ministry of Health and the country’s specialized agency responsible for drug safety, the FDB (Food & Drugs Board), to move the platform from pilot to full-deployment stage.

An Epedigree is another important system for the automatic detection of counterfeit drugs.

Photo Above: Hard copy of typical pedigree papers.

Photo Above: Pedigree papers can provide traceability of your prescription medications.

States such as California are increasingly requiring pharmaceutical companies to generate and store ePedigrees for each product they handle. On January 5th, 2007 EPCglobal ratified the Pedigree Standard as an international standard that specifies an XML description of the life history of a product across an arbitrarily complex supply chain.

You Bet Your Life: Illegal Drugs.
Illegal drugs can be counterfeited easily because the illegal drug market is an unregulated underground economy that rarely adheres to quality norms or safety standards. While there are some isolated examples of illegal drugs being sold under “brand names” that indicated that certain standards or dosage levels were being adhered to, this is the exception. The illegal “brands” can also be counterfeited by drug dealers who want to be able to sell their product at a higher price.
The use of dilutants in illegal drugs reduces the quality and potency of the drugs, and makes it hard for users to determine the appropriate dosage level. Dilutants include “foodstuffs (flour and baby milk formula), sugars (glucose, lactose, maltose, and mannitol), and inorganic materials such as powder.” The type of dilutants that are used often depend on the way that the drug purchasers will typically consume the drug in a given part of the illegal market. Dr. Hirsch, the New York Medical Examiner, claimed that buying illegal drugs is “… like playing Russian roulette.”

This is why we say that if you take prescription medications without “drug authentication”, you are playing a dangerous game of “You Bet Your Life“.

End.

Below: Article break. Are prices “sky high”?

FDA NEWS RELEASE

For Immediate Release: February 1, 2010

The FDA Requests $4.03 Billion to Transform Food Safety System, Invest in Medical Product Safety, Regulatory Science. FY 2011 request represents a 23 percent increase over FY 2010 budget

The U.S. Food and Drug Administration is requesting $4.03 billion to promote and protect public health as part of the President’s fiscal year 2011 budget a 23 percent increase over the agency’s current $3.28 billion budget. The FY 2011 request, which covers the period of Oct.1, 2010, through Sept. 30, 2011, includes increases of $146 million in budget authority and $601 million in industry user fees.

“The FY 2011 resources will strengthen our ability to act as a strong and smart regulator, protecting Americans through every stage of life, many times each day,” said FDA Commissioner Margaret A. Hamburg, M.D. “This budget supports the ability for patients and families to realize the benefits of science that are yielding revolutionary advances in the life and biomedical sciences.”

The budget request reflects the FDA’s resolve to transform food safety practices, improve medical product safety, protect patients and modernize FDA regulatory science to advance public health. Funding in the FY 2011 request also supports new regulatory authority to regulate cigarettes and other tobacco products received in June 2009. The proposed budget includes support for the FDA’s investment in addressing the challenges of the 21st century. The FDA envisions a transformed U.S. food safety system that focuses on prevention, increased efforts to address medical product safety challenges and a focus on modernizing regulatory science at the FDA.

These four initiatives are the major highlights for the FY2011 budget increases.

* Transforming Food Safety (+ $318.3 million)

The Transforming Food Safety Initiative reflects President Obama’s vision of a new food safety system to protect the American public. The FDA will set standards for safety, expand laboratory capacity, pilot track and trace technology, strengthen its import safety program, improve data collection and risk analysis and begin to establish an integrated national food safety system with strengthened inspection and response capacity.

* Protecting Patients (+ $100.8 million)

The Protecting Patients Initiative advances the Obama Administration’s priorities for safe, quality health care for all Americans. The resources in this initiative will support the safety of drugs, devices, and vaccines, as well as the Nation’s blood supply. The FY 2011 resources will also strengthen the FDA’s ability to act as a strong and smart regulator to address medical product safety challenges in the years ahead.

* Advancing Regulatory Science (+ $25.0 million)

Advancing Regulatory Science builds on President Obama’s commitment to harness the power of science for America’s benefit. During the past two decades, extraordinary investments have led to revolutionary advances in the life and biomedical sciences. Many key discoveries, however, have yet to translate into real therapies for patients. The FY 2011 budget will allow the FDA to begin to strengthen its core scientific capacity. This investment will allow the FDA to identify improved pathways to product development and approval for new technologies that offer promising new opportunities to diagnose, treat, cure and prevent disease.

* Tobacco (+ $215.0 million)

An increase in tobacco user fees will allow the FDA to continue to implement the Family Smoking Prevention and Tobacco Control Act. Preventing youth from using tobacco and helping Americans quit, promoting public understanding of the harmful constituents of tobacco products, developing the foundation of science for regulating tobacco, and regulating tobacco to reduce the toll of tobacco-related disease, disability and mortality are tobacco program priorities for FY 2011.

Point Number 1: Counterfeiters are perfectly willing to eat a legitimate brand owner’s lunch. Anti-Counterfeiting measures take patience and wisdom. Just as “shoplifting is stealing”, counterfeiting is not a victimless crime, “it can be (and is) murder”. — Donfucius

Point Number 2: “Diplomacy is the art of saying “Nice doggie” until you can find a rock.” — Will Rogers

Point Number 3: “My father said there were two kinds of people in the world: givers and takers. The takers may eat better, but the givers sleep better.” — Marlo Thomas

Counterfeiters are copycats.

Point Number 4: “No matter how much cats fight, there always seem to be plenty of kittens.” — Abraham Lincoln

We, as a nation, must take positive action against the counterfeiters.

Point Number 5: “Don’t talk about what you have done or what you are going to do. Do you want to know who you are? Don’t ask. Act! Action will delineate and define you.”
Thomas Jefferson

Point Number 6: “First ask yourself: What is the worst that can happen? Then prepare to accept it. Then proceed to improve on the worst.” — Dale Carnegie

Tough Laws are needed to fast track anti-counterfeiting systems, and stiff fines and jail terms are necessary for those that place the public at risk.

Point Number 7: “I have wondered at times what the Ten Commandments would have looked like if Moses had run them through the US Congress.” — Ronald Reagan

Above: Anti-Counterfeiting measures require tough and decisive actions. We’re not in Mayberry anymore.

Point Number 8: “Wise are those who learn that the bottom line doesn’t always have to be their top priority.” — William A. Ward

The counterfeiting problem is not insurmountable.

Point Number 9: “Don’t let the fear of the time it will take to accomplish something stand in the way of your doing it. The time will pass anyway; we might just as well put that passing time to the best possible use.” — Earl Nightingale

The only thing we have to fear is not doing anything.

Point Number 10: “You never change the existing reality by fighting it. Instead, create a new model that makes the old one obsolete.” — R. Buckminster Fuller

Mindsets. Counterfeiters have the mindset that they can break the laws, provide fake or diluted products, and they do not care if they place the public in harms way. We (you and I) have to have the mindset that says, “No, you can’t do this“. — Donfucius