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Donfucius Says: March 25th, 2015. Random Bits Of Wisdom.

  1. “As a child my family’s menu consisted of two choices: take it or leave it!” — Buddy Hackett
  2. “Nature gave men two ends – one to sit on and one to think with. Ever since then man’s success or failure has been dependent on the one he used most.”Donfucius
  3. Preach the Gospel at all times, and when necessary use words.” — Aaron Rogers Quoting Francis of Assisi
  4. “Diplomacy is the art of saying “Nice doggie” until you find a rock.” — Will Rogers
  5. “Before they invented drawing boards, what did they go back to?” –Patti Molloy
  6. “The way we’re going… if I called up another pitcher, he’d just hang up the phone on me.” — Any Brewers Manager
  7. “When someone is impatient and says I haven’t got all day,” I always wonder, “How can that be? How can you not have all day?” — George Carlin
  8. “We’re fools whether we dance or not, so we might as well dance.” — Old & Wise Japanese Proverb
  9. “Blessed are the cracked – for they are the ones who let in the light.” — Donfucius
  10. “Good judgment comes from experience, and a lot of that comes from bad judgment.” — Will Rogers
  11. “I don’t mind how much my Ministers talk, so long as they do what I say.” — Margaret Thatcher


ATL's Quality Corner

Archive for October, 2008

The Tainted Baby Formula/ Milk Tragedy – From Wisconsin To China. Is It Zhende (Real) Or Jiade (Fake)? How To Fight Back.

October 17th, 2008
Chinese Child Lies In Hospital - Victim Of Tainted Milk

Chinese Child Lies In Hospital - Victim Of Tainted Milk

A hundred years ago, babies who couldn’t be breast-fed usually didn’t survive. Today, although breast-feeding is still the best nourishment for infants, infant formula is a close enough second that babies not only survive, but thrive. Commercially prepared formulas are regulated by the Food and Drug Administration.
The safety of commercially prepared formula is also ensured by the agency’s nutrient requirements and by strict quality control procedures that require manufacturers to analyze each batch of formula for required nutrients, to test samples for stability during the shelf life of the product, to code containers to identify the batch, and to make all records available to FDA investigators.
The composition of infant formula is similar to breast milk, but it isn’t a perfect match, because the exact chemical makeup of breast milk is still unknown. Human milk is very complex, and scientists are still trying to unravel and understand what makes it such a good source of nutrition for rapidly growing and developing infants. John C. Wallingford, Ph.D., an infant nutrition specialist with FDA’s Center for Food Safety and Applied Nutrition, says that “infant formula is increasingly close to breast milk.”
More than half the calories in breast milk come from fat, and the same is true for today’s infant formulas. This may be alarming to many American adults watching their intake of fat and cholesterol, especially when sources of saturated fats, such as coconut oil, are used in formulas. (For adults, high intakes of saturated fats tend to increase blood cholesterol levels more than other fats or oils.) But the low-fat diet recommended for adults doesn’t apply to infants.
“Infants have a very high energy requirement, and they have a restricted volume of food that they can digest,” says Wallingford. “The only way to get the energy density of a food up is to have a high amount of fat.” While greater knowledge about human milk has helped scientists improve infant formula, it has become “increasingly apparent that infant formula can never duplicate human milk. Human milk contains living cells, hormones, active enzymes, immunoglobulins and compounds with unique structures that cannot be replicated in infant formula.”

Illicit Baby Formula In Wisconsin
In 2007 a New Berlin (Wisconsin) grocery wholesaler was under investigation by the FBI on suspicion of buying and selling large quantities of stolen infant formula. Among other things, FBI agents saw approximately 200,000 cans of infant formula, some of which bore indicia (indications) of having been stolen. The FBI indicated that the company regularly received shipments of suspected stolen formula and repackaged the formula before it was sold.
The company “cleaned” the cans by removing store labels and price tags, wiped dust from the cans, repacked the cans into cartons of six, and shrink-wrapped the cartons. One search of trash at the firm’s warehouse (by agents in 2006) revealed that the company had sold more than 17,000 cans of infant formula over an unknown time period. These illicit sales would have generated more than $200,000 in revenue. More about safety risks below (at formula safety).

The China Tragedy. A Blow To Free Society.

Fear Grips Parents Over Tainted Milk & Baby Formula

Fear Grips Parents Over Tainted Milk & Baby Formula

In China, recent deaths related to tainted baby formula should trigger an alarm on more than one front. In the Chinese language, there is one pair of words that you hear constantly: zhende (meaning real, authentic), and jiade (meaning fake, imitated). This pair of words is especially important when shopping, as it depicts the difference in quality between brand name and counterfeit goods. But beyond a difference in quality, zhende and jiade also imply a difference between trust-an unwritten contract-and distrust-the absence of such contract. The deadly, ongoing scandal with tainted baby formula signals an erosion of Chinese trust in supposedly high quality, brand name products-zhende-and a setback to the development of a contract society.

The Chinese economy is growing by double digits. Their citizens hope that this will develop into a “reform and opening” to bring a higher standard of living. Part of this standard of living is symbolized in brand name products. Both small and large cities alike, with the support of officials at all levels, have stores emblazoned with names like Nike and Adidas, among others. Many of these stores and products are jiade (fake). The labels may be inscrutably similar, but the quality will almost assuredly be different. To domestic consumers willing to spend the money on the real deal, however, there is an unspoken contract: we are willing to pay if you are willing to deliver. When it comes to the well being of children, parents are universally willing to pay for zhende (authentic).

The company that is responsible for the tainted baby formula (we will call Comp-X) has essentially become a counterfeit of itself. During months of questions, tests, and reports from both parents and at least one pediatrician, the company continued to sell a product that was not zhende (authentic). Many believe that the Olympics propaganda and journalistic “security” measures stifled coverage of the fake baby formula, the “tainted product”. China is not yet a free and open society, so I believe that China’s period of strict censorship actually provided the company with a real (zhende!) opportunity. It was an opportunity they did not seize.

Hong Kong Police Check Shelves For Counterfeited Baby Formula And Tainted Milk Powder

Hong Kong Police Check Shelves For Counterfeited Baby Formula And Tainted Milk Powder

Above: Logo Of Product Being Removed From Chinese Stores

Above: Logo Of Product Being Removed From Chinese Stores

Comp-X did not quietly recall their tainted formula. They did not instruct health care centers to warn parents of babies with kidney stones that their children’s formula may be playing a role. Instead, Comp-X bribed noisy victims, ironically, with offers of more of their products. The responsibility that Chinese citizens expect from Comp-X was absent. Customers expect to fulfill their part of a public contract with Comp-X through paying more. In return, they expected a product that was not jiade (fake). Yet, for months, infants were suffering the result of Comp-X’s broken contract.

Inspection And Testing Of Counterfeited Milk Powder/ Baby Formula

Inspection And Testing Of Counterfeited Milk Powder/ Baby Formula

This is not the first deadly crisis involving baby formula. In 2004, 13 children died after being repeatedly fed formula that, unbeknownst to their parents, contained no nutrients whatsoever. The difference between the two crises, however, again illustrates the larger problem. The perpetrators of the 2004 incident were the makers of a counterfeit, off-brand product-jiade (fake). This time around, the perpetrator is Comp-X, a brand long held as zhende (authentic).

The difference between buying zhende (authentic) and jiade (fake) generally just means the difference between enjoying a treat and suffering upset stomach. For others, buying zhende or jiade can mean the difference between a year’s salary and a herd of dead livestock, as in cases of counterfeit animal feed. In 2004, although no parent wished his or her child ill, the price of buying jiade was a child’s life. Now, however, to the horror of millions, and a huge setback in the development of a contract society, the lines have blurred.

Why Target Baby Formula?
In the United States, baby formula is one of the more popular items with counterfeiters because of the ease of selling it. It has great street value. There are a lot of young mothers who are willing to pay 50 cents on the dollar for stolen formula. There is a high demand because baby formula is expensive. The consumers buying the stolen formula are young parents with not a lot of money to spend. Today, stolen formula is sold at places like flea markets or over the Internet. This poses a health risk because baby formula is temperature-sensitive.

Formula Safety
The conditions in which counterfeiters are warehousing perishable goods (including those with an expiration date) can be dangerous-even fatal-to consumers. Some baby formula has been stored in garages with rodents running across storage facilities that have no temperature controls whatsoever. When it gets hot the baby formula will break down in nutritional value if it is kept out of its correct temperature range.

The counterfeiters are good at hiding their craft. As part of their operations, the counterfeiters will clean, repackage, and re-label goods to make them appear as legitimate products. They will also switch labels, particularly if items are damaged or out of date. They think nothing of switching labels from one brand of formula to another. Counterfeiters also make counterfeit labels. (see article dated October 8th, 2008, “The Bucket Shops”).

In some cases counterfeiters may even sell the products back to the retailer, unbeknownst to them. And frequently, counterfeiters will sell the products via Internet Web sites, such as eBay. The ease with which criminals can use the Internet to sell the stolen goods now makes it more difficult to investigate these crimes.

Fighting Back

In addition to working with law enforcement, many retailers are trying to make it harder for counterfeiters to disguise the origin of the product. Many of them now stamp their product with their company name and logo, and a store number so that the retail source of the product can be identified if uncovered in a theft or for other purposes, such as a product recall.

Above: Parents In China Worry - The Chain Of Custody Has Been Lost And Children Are At Risk

Above: Parents In China Worry - The Chain Of Custody Has Been Lost And Children Are At Risk

Combating The Counterfeiters. ATL Security Solutions: Each member of the supply channel has to understand that the solution must be a collaborative, united effort to assure the safety of products that pass through their hands. This includes confirming the legitimacy of the item’s source; the doctor, wholesaler, ADR, distributor, manufacturer, and API (Active Pharmaceutical Ingredient) sources.

All it takes is one bad apple: It could be one counterfeiter; one diluted product; one re-dated product; one product with fake labels; one false repackaging run… if any of these events occur, and the secure supply channel is broken, the patients are at risk.

ATL Security Labeling Systems (TM) has a solid product line to assist you in the detection of counterfeiting and diversion. Our brands make it more difficult to steal.
From the pedigree papers to the end user, our SecurBook (TM) labels can provide a complete (100%) supply channel authentication. Identical forensic markers on (pedigree papers, bulk containers, individual units) can be scanned and read to ensure 100% accuracy. This will verify that the brand has not been counterfeited. Patented, portable-scanning units can verify and authenticate in the field.

How Does This Work? ATL Pharma utilizes the unique technology of IDGLOBAL. This consists of custom forensic markers with digital data for tracking. Specific ATL SecurBook labels contain an invisible and non-degradable forensic marker. When applied (or linked) to pedigree documentation, packaging, and containers, the supply channel becomes “secure”, because all “digital data” scans must match as identical. If they match, brand authentication and anti-counterfeiting are ensured. This is why we call ATL brands the “Secur” product line.

Invisible (Non-degradable) Forensic Marker Is Your Assurance Of Brand Authenticity

Invisible (Non-degradable) Forensic Marker Is Your Assurance Of Brand Authenticity

ATL can provide custom solutions tailored to your specific supply channel.
Other ATL Pharma brands include:
SecurLock: Tamper-Evident breakaway closure;
SecurDetek: Invisible, Hidden Page Marker;
SecurMark: Anti-Counterfeiting holograms;
SecurStretch: Tamper-Evident Unit Closure;
SecurPly: Booklets for soft squeeze tubes;
PharmaVoid: Security Closure/ Destructible Tapes;
Triple-Ply: Three-Tier overt and / or covert levels of anti-counterfeiting;
D2 WAO: Wrap-Around style (up to 19 panels) that fit most cylinders-
(U.S. Patent Applied For).

Brand protection (safeguarding the public) doesn’t cost much more than the labels and packaging in use today. If you are a brand owner, why not do the right things. Provide your customers with layered anti-counterfeiting overt and covert protection.

Remember always: “It is a terrible thing to see and have no vision.” Helen Keller

Ringo-John-George-Paul. Counterfeit Beatles Albums.

October 16th, 2008

Above: Two Beatles albums from the “Capitol” days. Did you know there were thousands of counterfeit Beatles albums before Capitol (B.C.)?

I came across an absolutely fascinating article written by Frank Daniels in 2002. It was all about “The Beatles” early albums B.C. (Before Capitol). As I read this I wondered: “If counterfeiters will go through these extreme measures to flood the market with fake records, then I had better be very careful when buying medicines or safety related items.” Here are parts of Mr. Daniels writings:
Fakes and Fantasies
A counterfeit or fake record is one that attempts to pass itself off as a genuine record that was actually issued by a legitimate record company at one time. Sometimes, counterfeits do not look exactly like the genuine copies that they mimic but are slightly different. A fantasy record or sleeve is one that pretends to be a rare and otherwise unknown item. However, no legitimate record company ever pressed or printed an item like that one.

A pirate copy of a record is a counterfeit that is made while the legitimate record is still selling. These lower quality “knock-offs” are intended to dupe people into buying them at a lower price than the genuine record album would cost. While Vee Jay and Swan (Record Companies) were still producing Beatles records, there was certainly no need for anyone to make “pirate,” “counterfeit,” or “fantasy” records on those labels. However, during the late 1960′s demand arose for Beatles records on those two labels. Counterfeiters filled that void, making counterfeit copies of “Introducing the Beatles” and of the Swan “She Loves You” single. The 1970′s and ’80′s saw even more counterfeits being circulated. Since there were no legitimate copies selling, these counterfeits are — strictly speaking — NOT “pirate” copies, even though they were not being sold as “collectors’ items.”

“She Loves You”/”I’ll Get You” – (Counterfeit) Swan 4152: white label with red print or black label with silver print.

It has been believed for some time that “thin print” copies with quotation marks were reissues available in 1966 and 1967 (just before Swan Records folded in 1967). These rumors are false, for Swan had a contract to release the single for two years and stopped pressing “She Loves You” in 1965. There are two common issues of these fakes: (1) The matrix numbers are stamped into the trail-off by machine. Unlike the genuine Swan issues, the matrix numbers are only 1/16″ high, and neither the “Reco-Art” nor “Virtue Studio” company information appears in the matrix. (2) The matrix numbers are etched by hand, otherwise as above.

The “stamped matrix” fakes have been promoted as reissues. Even though these fakes are almost as common as the ‘black label’ issues and are not genuine, public opinion for years that they were genuine has caused them to sell for $40 to $50 each. The “etched matrix” fakes have been recognized as counterfeits and usually sell for under $10.
Some counterfeit/fantasy copies of the white and red label “She Loves You” were pressed in red vinyl. These tend to sell for about $20, twice as much as the more common black vinyl counterfeits.

“Please Please Me” – “Ask Me Why” – (Fantasy) Vee Jay 498 sleeves: Since the Beatles were complete unknowns in the USA in early 1963, Vee Jay Records never issued a picture sleeve for their first release. Bootleggers have filled the void by producing fantasy sleeves. Each of the above sleeves first appeared after 1980. The first sleeve, shown above, features an early photo of the group. Like the actual single, the sleeve misspells “Beatles,” using two T’s. There are promotional markings on the reverse side, as though the sleeve had accompanied original white/gray label promo copies. In reality, the sleeve came about 20 years too late.

The second sleeve sports four drawings of the Beatles that Vee Jay actually did produce. These are the drawings that appear inside “Songs, Pictures, and Stories”. On this fantasy sleeve, the brackets logo was used, even though Vee Jay hadn’t come up with it in early 1963. The group’s name is also spelled correctly.

“From Me to You” – “Thank You Girl” – (Fantasy) Vee Jay 522 sleeves. As with the above single, there were no original picture sleeves accompanying the Beatles’ second single for Vee Jay. Bootleggers have produced at least two fantasy sleeves for the record. Again, both sleeves are of recent origin. The first sleeve is a pale imitation of the genuine sleeve to Vee Jay 581, with the photograph flipped around. The second sleeve uses the photo from the 1982 re-release of “Love Me Do.” This second-generation picture is blurry.

“Please Please Me” – “From Me to You” -(Counterfeit) Vee Jay 581 sleeves. The first of these sleeves is actually a counterfeit/fantasy item, not intended to fool someone but to simply occupy the missing place of a rare item in someone’s collection. The sleeve is clearly unlike the genuine sleeve, for the group’s name appears here in green (above photo, top) and in red on the original sleeve. The sleeve on the bottom is a different matter! Look at the top (opening) of the sleeve. Genuine copies of the VJ 581 sleeve have the slick cut so that the corners at the top are slightly rounded; copies that have the corners cut square are counterfeits.

Clearly Counterfeit Covers
Let’s first look at some fakes that are clearly identifiable just from the cover:

The cover is ugly and yellowed. The photograph is clearly a second-generation copy. The word “STEREO” is printed on the front cover (since the counterfeiters did not actually own a stereo cover). These fakes date to the late 1960′s.

Below: Here’s another “easy loser.” There are no genuine copies of the LP with a brown border around the album. Most likely, these were semi-fantasy items that were never intended to pass themselves off as genuine. Since they first appeared in the mid-to-late 1970′s, some people have forgotten that they are fakes.

Clearly Counterfeit Labels
The vast majority of counterfeit copies of “Introducing the Beatles” cannot be easily identified by their covers alone. Chances are, though, if it claims to be in stereo and claims to have “Love Me Do” in the titles on the back, it’s a phony. The best test to determine whether your item is genuine is to look at the symbols that are stamped into the matrix of the record. Since this can be difficult — even confusing for some — we’ll take the next best route: to look at the labels.

Above: This is an all black label with large brackets. These were first introduced in the late 1970′s, along with fakes of “Songs, Pictures, and Stories” and “Hear the Beatles Tell All”. The label is of higher quality than some of the “rainbow label” fakes, but since the artist name and title are separated by the spindle hole, it’s a clear fake. Also, during the 1960′s, Vee Jay never released a “large brackets” version of an “all black label.” Finally, these usually come in covers claiming that the record is in stereo; the label does not say “STEREO” — another sign of a counterfeit. Some “all black” counterfeit labels from the same period list “Ask Me Why” and “Please Please Me” — since the counterfeiters did not own copies that had “Love Me Do” and “PS I Love You” on them.

Above: This style counterfeit label was very popular — some copies date back to the 60′s. Notice the thin print on the catalog number. Like the other fakes, the mono catalog number is shown on the label; the bootleggers did not have stereo copies to copy from. That’s why the songs are in mono, too. Here, we see again the telltale sign — that the word “STEREO” is absent, and the title and artist name are separated by the spindle hole. Either one of these is the sign of a fake.

Above: By the late 1970′s, some copies of the same style fake as the one above were being made sloppily. Notice that the label is not the right size. Part of the color band is missing around the label’s edge. Otherwise, it exhibits the same counterfeit characteristics as the label above.

Above: This counterfeit, from the early 1980′s, looks slightly better. The colors in the color band are more realistic. However, the word “STEREO” is still missing, and the cover this record came with claimed it was in stereo. It’s also got the title and artist’s name separated. Another fake.

Above: Here’s another fake, again slightly more professional looking. This one came out during the mid 1980′s. Once again, though, we have a brackets label copy without “STEREO” (and the cover promised us stereo). And even more clearly, the title and artist’s name are separated by the spindle hole in the middle. A disappointing effort.

Above: This counterfeit was color photocopied from a genuine MONO copy of the LP, so the title and artist’s name are in the right place. The colors are strange, but it would fool most people. It came in a “stereo” cover, though, so again something is wrong. Notice that the color green is missing from the label. The record also lists “Please Please Me” and “Ask Me Why,” since that’s the kind of genuine copy that was being photocopied. The label also has a large pressing ring, a kind not found on genuine 1964 releases.

Fast Forward To 2008

Many thanks go to Mr. Frank Daniels for his highly interesting work on different Beatles counterfeits. As he pointed in 2002, counterfeiters were running wild when a buck was to be made. Today, why would you risk buying prescription medicines and “genuine” OEM auto parts that cannot be authenticated as “the real goods”?

If you are a brand owner, it doesn’t cost much to secure packaging and provide consumers with labeling that has “layered” overt and covert anti-counterfeiting protection.

If you are a consumer, we encourage you to ask manufacturers what they are doing to protect you from purchasing counterfeited goods. After all, if there are “hundreds” of Beatles counterfeits, it is logical to assume that there are thousands of chances that you are purchasing “fake”, “illicit”, “diverted”, or “diluted” prescription medications. Fight back. Insist on brand protection.

It’s time to take bold leadership and protect the public. Mark Twain said it best: “Keep away from people who try to belittle your ambitions. Small people always do that, but the really great make you feel that you, too, can become great, and your ideas have merit.”

ATL’s Twelve (Cold-Chain) Anti-Counterfeiting Tips

October 4th, 2008

Recently, in Philadelphia, I spoke to pharmaceutical and bio-technology companies (the makers of life saving vaccines). I recommended a 12 step approach to strengthen their cold-chain (the logistical system of safely delivering their products). My advice to them was that they understand the following:
1. Cold chain system weaknesses;
2. Quality System Management of the cold chain;
3. Risk Management Tools (including FMEA – Failure Modes & Effects Analysis);
4. Cold chain variation (Mean & Standard Deviation);
5. The “68-95-99.7 Rule” (and the law of large numbers);
6. Out of specification “assignable causes”;
7. Packaging and equipment validation (including IQ-OQ-PQ);
8. The risks of measurement error (Repeatability & Reproducibility);
9. Layering of anti-counterfeiting techniques;
10. How counterfeiters attack, their use of bucket shops;
11. M&R (mix and rotate) overt and covert anti-counterfeiting measures;
12. Forensic Codes (invisible, digital, and non-degradable) for “fail-safe” authentication.

Why not contact ATL for a free “honest to goodness, no obligation conversation” about your supply chain? We feel that we have solid experience in anti-counterfeiting. Our main focus is not that you buy something from ATL, rather that you learn from knowledgeable people about the perils of counterfeiting. We consider it our mission to help you protect the public. We would like to consider it your mission to take a leadership role and do the right thing.

Penn State football coach, Joe Paterno, said it best:
“Success without honor is an unseasoned dish; it will satisfy your hunger, but it won’t taste good.”

Donald J. Dobert – President, ATL