Gray Area

This month’s Journal of the American Dental Association includes an interesting article by Gordon Christensen on the topic of gray market and counterfeit dental products. I’m glad that Dr. Christensen has raised this issue, and I want to address it here as well because it’s an important topic that affects many dentists—many of whom may not know it.

Gray market products, as Dr. Christensen explains, “include branded goods intended by the brand owner for one national market that instead are diverted and resold by unauthorized distributors to another market.” Counterfeit products, as we know, are those that are produced by one party and carry a false brand label of another. Dr. Christensen raises the important point that dentists who purchase products at steep discounts, or who entrust their purchasing decisions to staff (who are logically motivated to save the practice money), may be unknowingly using gray market or counterfeit products. Unauthorized distributors that traffic in these products have the ability to offer them at a significantly lower price than legitimate distributors, so a dramatic price difference between one dental distributor and another is a telltale sign. Gray market and counterfeit products can seriously compromise the quality and longevity of a dentist’s work, and can even expose the practice legally.

The only way to ensure that you are using authentic products—whether from 3M ESPE or any other manufacturer—is to order them through a certified distributor. We list ours here on our website, and other manufacturers should be able to provide you with a similar resource. By purchasing through an authorized distributor, you can be confident that your materials are what the label says they are, and that they have been handled, stored and shipped properly.

Bargains are always tempting. But dentists who use gray market and counterfeit products may end up with more trouble than they bargained for. I encourage everyone to read Dr. Christensen’s full piece and revisit their ordering procedures to make sure they are using authentic products.

A counterfeit syringe of Filtek Z250 Universal Restorative (Top) and the real thing (Bottom). Would you know the difference?

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36 comments so far

  1. Mark Hartley on

    As daddy used to say, “If criminals spent as much time thinking about legitimate endeavors as they do on illegal plots, they would be rich.” Two questions. What are the logistical obstacles to an unauthorized distributor becoming an authorized one? Since this counterfeiting constitutes fraud on so many levels, why is enforcement so difficult?

    • 3M ESPE on

      Mark,

      Love the quote. Here are some quick answers , that I could definitely expand upon off-line. When 3M ESPE is approached by business entities to distribute our products, we have a number of questions that need to be answered: quality ,safety,supply chain, value proposition for the customer and market to be served just to begin the conversation. All authorised 3M ESPE distributers meet specific standards to ensure the quality of the 3M ESPE product is maintained throughout the value chain.
      On your second question – 3M ESPE has successfully identified third parties involved in counterfeit activities. These instances have occurred outside the US and the appropriate authoriities have been involved to shut them down. Thanks again for your comment.

    • Bill Neumann on

      Here is a great article on Gray Market from a recent issue of First Impressions magazine.

      http://www.firstimpressionsmag.com/article-apr2010-shadesofgray.asp

  2. Mike Colleran on

    I have come across some of these slime ball dealers that push this stuff at rock bottom prices. What can be done to bring them under penalty of law?

    Of the 3 I have come across, all of them are really some of the worst people I have met. A really bad lot!

  3. 3M ESPE on

    Mike,
    Thank you for your comment. Mark (above) had a similar question. The folks involved in the counterfeitng of dental products have become quite sophisticated. But as I noted, we have been successful in working with authorities outside the US to shut these operations down. Where possible, legal rerpurcussions have followed for those individuals breaking the local country laws.
    Thanks again for your post.

  4. Kai Mueller on

    The interests of dental industry and dentists converge on the topic of counterfeited products, no question. But can you tell me, why it should be in my interest to avoid grey-market products? Let’s assume, that I would be able to differentiate between good products in a ‘bad market’ and vice versa 😉

    • 3M ESPE on

      Hi Kai,
      Thank you for your post. There are many reasons why it is always advisable to purchase your dental consumables from 3M ESPE authorized dealers. The most important one is patient safety. Without the guarantee of quality and storage conditions ( almost all dental consumables have specific shipping and storage requirements ) that is provided by 3M ESPE Authorized distributors you may unwittingly place a sub standard quality product in a patients mouth. The consequences may range from a non setting material to an adverse patient reaction. It is also important to understand that if a dental product is purchased from an unauthorized distributor, the manufacturer will not warranty the product. In addition to these important patient safety issues, there are implications for the dental practice that could range from dissatisfied patient experiences and worse.
      All in all , a dental practice is exposing themselves to significant (unnecessary ) risk when they purchase dental consumables from unauthorized sources. The initial attraction of a low price can often be negated several fold by the consequences mentioned above.
      Thank you very much for your comments.

      • greydealer on

        I hear this argument from manufacturers all the time and the bottom line is this logic of risk to the dentists is an out and out lie. Grey market products are being purchased from authorized dealers, it just happens to be that these dealers do business in other countries. Storage risk, lets look at this logically. Once 3M or any other manufacturer sells their product they have no idea how it is being stored, even an American authorized dealer can improperly store products. Once a product is shipped the first handler is some type of freight company who often store these perishable products incorrectly.

        The only reason the grey market exist is because of this, and I assure you, you will never hear any rep. talk about this. The grey market exists because the large manufacturers can charge the American Dentist 3 to 4 times what they can charge in the oversees markets, so these heavily discounted products will always find a way back to the United States until 3M or any other manufacturer decides that this “safety issue” is more important than profits.

        All they would have to do is charge one price globally and the grey market would disappear overnight. The truth is that will never happen, and more so they want the grey market to exist so that when they have 10,000 z-250’s that only have one year till expiration they can dump them to India or Slovakia so that they don’t have to take the loss.

        Truth.

  5. lori on

    Thanks to you and 3M for the article and the specific examples of what the products look like. It’s great that you shared how offices can identify authorized distributors.

    I work for an authorized distributor and our team works daily to educate the offices of the dangers of gray market. Price is such an important motivator these days and your comment about office personnel working hard to save money is so true.

    Good people are being scammed and it has to stop. Just like anything…if the price seems too good to be true it probably is.

  6. 3M ESPE on

    Lori,
    Thank you for your comment. I’m glad you found value in my post.

  7. Shawn on

    “By purchasing through an authorized distributor, you can be confident that your materials are what the label says they are” I have to disagree with this comment. I have seen the big two dealers selling grey market products also and nothing will ever be done about this as the MFG’s wouldn’t want to lose all the business they do with them.

  8. Warren Bobinski on

    I appreciate your views on this subject Keith. The Grey market has been a concern for many years – the more disturbing issue is the counterfeit now on the market. I recently researched how this product comes into North America and I didn’t seem to have too much trouble sourcing companies overseas that were willing to provide counterfeit product – in all I took bout an hour to find these companies (although I only had contact information and never took it any further, I just wanted to prove a point).
    Great blog!

    Warren Bobinski
    Success in Dentistry and Life.
    dmdrep.com

  9. Anthony on

    I agree with Shawn. When the big companies sell Grey everyone turns their back. Why you may ask? Well because money talks, and the manufactures do no want to lose business from their biggest distributors. Why did these major manufactures cut off so many small dealers in the past few years and refuse to sell to anyone else. I feel it was so monopolize the industry and cut competition just so they can make more money. All the “Big Guys” have so much overhead that they need to sell these products at top dollar. This was not an issue for the small dealers, so they were able to sell the product at a lesser cost, therefore cutting sales from the larger dealers. Grey market is legal, if it wasn’t there would be no Grey market. Those products come from the same factories as any other product made by the manufacture, they have the same composition and make-up no matter where they are being sold. We all know extreme temperature conditions will have an effect on most products, so when it comes to transport and storage of product, it should be fairly obvious that all companies, gray or not, will follow the basic guidelines to ensure the products are not effected. I do not condone counterfeit products. But when it comes to the Grey market, look at the facts instead of being scared into paying more for the say product.

  10. 3M ESPE on

    Hi Anthony,
    Thank you for your comments.
    A couple of things I would like to clarify. While the re- selling of dental products by a third party other than an authorized distributor is not illegal – it is illegal to sell products in the USA that are not registered for sale in the US. This is occurring within the grey market sales arena.
    You commented that ” the products come from the same factories and are all the same and have the same composition and make up”. This is not true. The product name, packaging configuration ,
    Color properties ( for esthetic materials) and chemical compositions can be different depending on global market served. Additionally, you are correct that many materials require specific transportation and storage conditions – it is not safe to assume the product that arrives in the dental office from an unauthorized distributor is the same as one purchased from an authorized distributor.
    Who knows where the unauthorized dealer product has come from, how it was transported / stored
    Or how it will perform in the dental office or more importantly in the patients mouth . This is a potential patient safety issue.

    • Anthony on

      Thank you for the follow up. I’m just trying to get clarification on some of these issues at hand.So what you are saying is, since gray market products are registered for sale in the US, it is perfectly legal. The products that are not registered for sale in the US, “black market” is illegal. Why would a manufacture change the makeup of a product depending on where it is sold. Does a bonding agent bond better in the US than it would in Europe? Wouldn’t a manufacturer manufacture a product that is the same quality no matter where it is being sold?… Just playing a little devils advocate. I feel everyone should know the real true and from both sides on the fence.

      • Keith Haig on

        Hi Anthony,
        It is illegal to sell dental products in the USA that are not registered with the government for sale in this country. Grey market dealers do not purchase their products from the original manufacturer. The well known dental manufacturers make their products to exacting standards that are enforced by government agencies to ensure the safety, quality and efficacy of the final product. These benefits and safeguards cannot be relied upon once the dental product enters the unknown world of the grey market dealer – for the reasons we both highlighted.
        As Dr. Christensen stated in his original article, the cost of dental supplies relative to the overall overhead in the dental office is small and the difference in pricing is just not worth the risk.
        I appreciate your comments and the lively discussion that has resulted. Grey market is a highly charged area of the dental industry and is certainly a good catalyst for debate.

      • Brian on

        Dear Anthony,

        I spent most of my professional life working for one of the two largest dental suppliers. It is true that these suppliers try to leverage the price for more profit. I now have a different vantage point to this problem because I changed my job to a small local distributor this past year. 3M provides us with rigid distribution guidelines, that we meet. These guidelines are for the safety of patients and for the protection the dental office’s investment. Most of the guide lines are set and controlled by the federal government. I can say that 3M wants to see small distributors succeed. 3m specifically provides us with fair pricing, marketing, and training. All you have to do to be a distributor is show that you can meet federal, local, and 3m guide lines.

        All grey market or black market products are not kept in controlled environments. All bonding agents, filling materials, cements and impression materials are directly effected by there environment. As a young representative I hand out sample materials that I would store in my car or garage. I was informed by a dentist that a sample product that I had passed out fell out of his patient. I immediately supplied the dentisy with a new product out of our distribution. The dentist compared the products and found them to handle completely different. We were able to change the handling properties of the filling material only after leaving it my car for 3 days. I covered the cost of the product, dentist time, and a little more for this doctor to keep his patient. All grey market product comes from out dated stock or overseas sources that the environment is never controled. After 20 years in dentistry it would take too much time to go through all the problems I have experienced through grey market.

        It is understandable to want to save money; however, sometimes you can pinch a penny as the dollar is walking out the door.

  11. Warren on

    Its’ great to hear this news right from the manufacturer. I work for a major supplier and its’ funny when someone says there is not enough competition. As a supplier – I have to compete on the street against at least 6 other authorized distributors of most products – there are more choices for dental supplies in my town than grocery stores!
    I also doubt that my company would risk a legal distribution agreement and risk selling products that are not registered for sale in the US. It just doesn’t make sense.
    As Dr. Christianson pointed out very well in his recent article – the cost of supplies relative to the overhead in a dental office is minimal and the difference in pricing is not worth the risk.

    Education is key. This is where I help my customers. The overhead in the majority of the offices I work with is in the low range for most dental clinics – and they get the materials from a completely authorized supplier with no worries. I work hard to find products that match the customers needs – price included.

    If a doctor is not happy with the price of a particular composite material, impression material, or bond – they can shop with several other authorized distributors or look at dozens of alternative highly rated materials.

    A great part of the business from the distribution stand point and a part of our overhead is in educating the reps on not only product but also helping our customers succeed in business. Generally you don’t just get a box of composite or bond – you get excellent advice and full support of the business, staffing, helping with associate posititons, increasing profitability and reducing overhead in all areas – not just supply costs.

    Warren
    Success in Dentistry and Life.
    DMDrep.com

  12. Warren Bobinski - DMDrep on

    Excellent points Brian.
    its a big reason we give out a lot fewer samples as reps – the samples do not meet the criteria for shipping or storage and may cause issues as you have stated with possible liability.

    I ran into a company in Canada today that is notorious for supplying product like this.

    I always remind my docotors that they are providing a health care service – this is a serious business with serious health consequences.

    I remind my doctors that there are at least a half dozen legitimate and competetive choices for every product they buy – probably more choices than they have on groceries!

    If they are still not happy with the price, they should explore other product lines – because most every product has a competitor that also meets the required FDA standards for products that are used in surgery.

    Warren

  13. Arnuld Shaw on

    You are quite right but in this situation quite wrong…..
    Normally buying from an authorized dealer solves this problem.
    BUT, in this situation as I have discovered, we have a small conniving dealer with many gray market contacts selling to the ‘big-boys’ – Henry Schein, Patterson etc….
    I have been fortunate and seen Purchase Orders in this smaller dealer from the ‘big-boys’ for easily $250,000-500,000 !!!
    The way it works….the major dealer purchases their set required levels to get their products and discounts…then they purchase gray-market at greatly reduced levels that really are priced very low, making a far better margins than the authorized manufacturer is offering….
    I have sen it and many people are aware this happens and just turn the blind eye to this….

  14. Anthony on

    Brian,

    How are you so sure that gray market products are not kept in controlled environments? We all know temperature and climate will have a direct effect on the handling of certain materials. If you are in the business, you know this. It is easy for a Dr. to track an ineffective product back to the dealer where they purchased it from. Therefore it would be even easier for that Dr. to discontinue buying from that dealer if there were any issues. Don’t all companies big or small strive to satisfy their customers? Isn’t that the key to a successful business? Gray market dealers do not sell out dated products or products that are effected by temperature. Why?… 1. It is easy for the end user to see the difference in the handling of an effected product. 2. because it is very easy to track down where the product came from therefore losing your customers. 3. They want to stay in business by satisfying their customers.

    Arnuld is right. The “big boys” do buy gray market products. They do this for the obvious reason of increasing profit, and for the other reason, because they know the gray products they are buying, are the same as the non-gray products they sell.

    Just a side thought, do the products being shipped in a 100 degree UPS truck get effected as well?

  15. chip van dalen on

    So let’s actually try and evaluate this issue from an economic standpoint. If a practice actually thinks that saving even 50% on consummables, and you can’t save that on all items due to limited availablity of grey market items, can make a huge financial difference in their practice performance I would suggest that they evaluate their business model. Overhead ratios for consummables to production should be approximately five to six percent. A practice producing $700K would spend about $35,000 to $42,000 on consummables in this instance. The same practice using a 30% grey market product mix at a 50% discount would lower the consummable cost approximately $5,000 annually or $416.00 per month, $26.00 per day or $3.12 per hour.
    If this practice is working at a 70% overhead it spends $490K annually to operate. Broken down by 50 weeks a year, 4 days a week and 8 hours per day yields an hourly overhead of approximately $306.00 per hour. I respectfully submit that a $3.12 per hour savings on consummables is not going to have a meaningful impact on the problem if the practice is not performing financially to the doctors satisfaction.
    Raising revenues should always be the first process to investigate but many offices have no annual business growth goals that are monitored properly. A simple three percent annual net revenue growth through efficiency or business development would yield an additional $21,000 in revenue or a $13.12 per hour increase. As dental professionals, if we can’t work with our customers to find an additional three-to-five percent per year in revenue then we probably do not deserve the business in the first place.

  16. Joe on

    The long and the simple of the matter is this being morally responsible to do the right thing and as all of us know most of the times doing the right thing is not right in business. Companies that have a morals and honor do the right thing. People who are the same will also do the right thing. We as dental professionals can not count on big business to do the right things so we have to just to keep our morals and be the better people. I personally have looked into what has been done to stop the selling of grey products by companies and have come to find they like to talk alot but will not put the money where their mouths are. There is only one company who has actually taken legal action against these companies to sell their products. Anybody can talk about what they are willing to do but just shutting down some small companies who are doing wrong. Are they really making a large impact are just putting a bandaid on a huge cut that requires stitches. All the revunue in the world does not making doing things that are wrong right. All the anger and misunderstanding that happen when trying to deal with these situations just make your situation more difficult. Understand when companies want to be the better people they will put money and lawyers behind the situation and will fix it. Untill then we are just barking at a tree with nothing in it.

  17. Hartford Ct Dentist on

    Greymarket? Now thats scary!

  18. Steve on

    Anthony,
    I love being devil’s advocate and it seems you have taken up my torch. But in response to “How are you so sure that gray market products are not kept in controlled environments?” I respond with, how do these products get back into the US. Generally on a boat, generally waiting to clear customs or be smuggled in. If you know of a shipping company that controls the temperature of boats shipping unauthorized products from other countries I would be surprised. It may not be a guarantee that the products are not kept under climate control but it is a guarantee that you can’t know. It is safe to assume that putting a product into someone’s mouth that hasn’t been regulated by the FDA or approved for sale in the US is probably a bad idea regardless of storage conditions.

  19. Dr. Richard on

    The real issue is that if authorized dealers are selling grey market products then there is no safety for the dental patient at any price. As a dentist I might pay the higher price but receive a grey market product. This perverted product distribution is criminal and yet you all lean back and try to “educate” the dentists to pay the higher price for safety reasons yet no one can really tell if the patient is really getting the safe product or a grey market product.
    Smarten up and eliminate this distribution nightmare and simply Buy Direct from the Manufacturer; it’s the only way to really be safe.

  20. Warren on

    Hi Dr. Richard….I don’t believe the authorized dealers would risk selling grey market at any price. It just doesn’t make sense on any level.
    The major suppliers are public and the sales of these regulated products and the relationships with the customers and suppliers trust would be compromised…why would these companies risk this?

    I am anxious to hear what Keith has to say…

    Warren
    DMDrep.com
    Success in Dentistry and Life.

    • Anthony on

      There is proof out there that authorized dealers, have, or still do buy Grey products. This is fact. Weather or not you want to believe it, or look past it, is your choice.

  21. Anthony on

    Gray market is nothing more than buying products from authorized dealers in a different market, at a fraction of the cost (smart business). If it were “criminal” it would be shut down. What people do not realize is that these manufactures are still producing the products. So why worry about patient safety? Are you saying that a 3M product produced for a different country is unsafe? This is just a scare tactic. Do not confuse the black market with the gray market.

    @ Steve,
    I’m going to say most products get shipped back into the US by air or ocean, like most products that are imported into the US. You eat food that is imported from different countries. Do you spend this much worrying about the environmental conditions in which they were shipped in? We put trust in the integrity of the companies that import such items to make sure it is done correctly. This is the only way a business would prosper.

  22. Dr. Richard on

    Warren:
    Schein is actively involved in a suit brought by the Federal Government that involved vaccines we depend upon for the health of our Children. The government claims that Schein & others have purchased grey market Vaccines and is reselling them as untainted. Either the grey market is OK and safe or it’s not. MAny have said that the major distributors purchase grey and there is evidence that this is true. The major distributors all are authorized it’s only the smaller distributors that have had their authorization dropped or terminated that are being slandered by this scare campaigne aimed at safety but only resulting in higher profits for the authorized dealers. Warren, if you worked for another distributor you story would be a different one.

  23. Warren on

    Dr. Richard…

    I had a big long speech – but then I realized….I am really nobody. Just a guy that spent the majority of his life growing up in a little mom and pop Dental Supply house, and now the last several years working for Schein.

    The way I feel about this really doesn’t matter to anyone but me. I personally wouldn’t promote anything I am not comfortable with is all I am saying.

    It sounds like you may have a lot more at stake in this than I do – I wish you all the best.

    Warren

  24. Steve on

    Dr. Richard,
    I don’t know of the specific Schein suit you speak of and don’t claim it false, however medical and dental are separate divisions. That being said, I don’t know if they purchase Gray market products or not, what I do know is the term “authorized distributor” refers to one who has signed a contract with the manufacturer of a product to store and ship products at optimal conditions and otherwise follow guidelines set forth by the manufacturer. Whether or not they follow that contract…I am not connected enough to know.

    Anthony,
    I see those who are for Gray products are a difficult sell, and I am certainly not going to change your mind, although I enjoy a good debate. But ultimately your food comparison is apples and oranges (pardon the pun). Most dental products lose efficacy if brought over 85 degrees. To clarify, efficacy meaning: shades, polish retention, set times, working times, bond strength, and in RARE cases safety.
    I am generally not worried about the food I purchase because it is less sensitive to environmental conditions. If my apples and oranges get to 100 degrees, they were probably grown at such a temperature and therefore still at their optimal usage condition. Moreover the food products are supposed to be imported unlike dental products not designated for the US.
    On the topic of the following comment: “We put trust in the integrity of the companies that import such items to make sure it is done correctly.” I certainly do put trust in the integrity of the companies that import/export products from this country, and that they are shipped correctly. However, when the product is not intended to be imported, does the shipping company know the conditions that are appropriate? And ultimately, do shipping companies that ship unauthorized materials into the country have the integrity you speak of? No I don’t know the answer to these questions, but the potential is concerning enough that I don’t choose to put this material in a patient’s mouth.
    “So why worry about patient safety? Are you saying that a 3M product produced for a different country is unsafe?” Again it comes down to shipping and storage as well as adherence to expiration and truth in advertising.
    I have addressed shipping and quality control above so I won’t be redundant.
    Many gray market products are relabeled with different expiration dates or advertised as one product when it is really another.
    A dentist friend of mine in New York ordered RelyX Unicem from PA Dental trying to save money and was shipped RelyX Luting 2 (a gray market product). He called and they assured him it was just a variation of Unicem. Assuming storage, expiration, and quality control was adhered to by PA Dental (In my belief not a safe assumption, but your call); then RelyX luting 2 is safe to use and will be an effective dental cement. However he used it to cement a ceramic crown, which later de-bonded and was swallowed by the patient. The patient was then x-rayed and thankfully the crown was swollowed not inhaled, which would require surgery to remove. The patient then returned to the dentist to have the crown re-cemented. If the product was safe for use for the reasons described above, why did it de-bond you may ask? Well because Luting 2 is the gray market equivalent to Luting Plus which is a resin modified glass ionmer cement not designed for ceramic as they are not as strong as a resin cement i.e. unicem, panavia, etc.
    This story also is where the only safety concern in my mind lies. An overheated cement wouldn’t be toxic, but it will be ineffective, as would a mal-advertised cement like in this case.
    Also the chemistries of products are formulated to function together. I understand in many situations a product may be rebranded and sold overseas as the same product, but in some cases it is re-formulated to serve the needs of the market.
    “If it were “criminal” it would be shut down.” Again, it is illegal to sell products that are FDA regulated that are not approved by the FDA. There are several investigations, law suits, and reports underway to do just what you suggest.
    There are many dental offices that survive without purchasing the products. And how much cost is saved if you have to re-cement and re-make a crown? What kind of reputation do you build this way? I choose not to risk my reputation to save a buck.
    Sorry to get so wordy. I felt it was relivant to make a comprehensive argument.

  25. Krisa Drost on

    Steve,

    I have a few questions for you. Would you be willing to e-mail me outside the forum? My email address is kmdrost@mmm.com.

    Thank you,
    Krisa

  26. Vasilis K on

    I have bought from greece a pair of uv blockers glasses 65 euros.In germany its costs 28 euros.AND i ask what is going on.I have contact the company in germany and they answered cant do anythhing.JUST CHAOS

    Vasilis_GREECE

  27. Vasilis K on

    About 3m i have to say that the prices at all the products here in greece was really high and some months ago they have decreased them to half(some).How and why. who knows.

    Vasilis-Greece


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