Positioning of new CMH quality mark as it relates to Certification of Medical-grade Manuka honey used in LMP wound care dressings versus other brands.

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1 Positioning of new CMH quality mark as it relates to Certification of Medical-grade Manuka honey used in LMP wound care dressings versus other brands. Overview Links Medical Products Inc. (LMP) wound care products containing certified medical-grade Manuka honey will display a CMH mark to identify those products as meeting a distinct, independently verified standard to assure customers of a level of purity and chemical composition that may not exist in competitive wound care products containing Manuka honey. Introduction A great deal of information is available through the internet about Manuka honey, but when performing a search using the words medical-grade Manuka honey very little scientifically based information is apparent. And what information some entities may provide often lacks any detailed explanation of their definition of medical-grade and any significant proof to justify use of the term in reference to Manuka honey in medical products. In fact, there is a significant amount of unreliable information about Manuka honey in general and about medical-grade Manuka honey specifically. Laboratory examination of one of the competitive products showed the honey used in that product was not pure Manuka honey, but had been blended with at least one other variety of honey. In addition, Manuka honey sold to retail consumers has often been found to be mislabeled. The UK press reported on this abuse in an article in the UK Telegraph on July 1, 2014 as follows: And now further evidence has come to light about Manuka Honey being frequently mislabeled, with consumers paying well over the odds for common-or-garden honey when they think they are getting the rare stuff from New Zealand. Only one of the seven samples tested by a laboratory was found to have the requisite levels of the active ingredient. This study comes just a year after it was found that there was more honey labeled as Manuka on UK shelves than was produced in a single year. As evidence suggests, a reliable definition and standard is needed to attest to the purity and chemical composition of Manuka honey used in medical applications after it leaves New Zealand and put into final product form.

2 Page 2. CMH positioning (cont.) Definition of Manuka honey Authentic Manuka honey is harvested from hives dedicated to bees that gather nectar from the flower of the Manuka bush (Leptospermum scoparium) native only to New Zealand. The characteristics of Manuka honey have been well defined by Professor Peter Molan (University of Waikato) and others. Its use in medical applications is also well documented in various reports and studies - (see references). Most all types of honey contain some level of peroxide, the strength of which is sometimes measured and referred to as peroxide activity (PA). Because of this, honey has been applied to wounds for literally thousands of years. However, the PA of honey is short-lived and not considered to be of significant value in modern wound care. Manuka honey does contain peroxide, but what has made it the most valued honey in modern wound care is its content of non-peroxide elements not found in other honeys - specifically methylglyoxal (MG) and dihydroxyacetone (DHA). While Manuka honey may exhibit some PA, it is the non-peroxide activity (NPA) created by MG that defines the unique chemical composition of Manuka honey. About MG and DHA Only in the last few years have scientists (T. Henle, et al) firmly established Manuka honey from the Leptospermum scoparium bush contains high levels of the compound MG. MG and its precursor DHA have been proven to be those elements that most significantly differentiate Manuka honey s unique properties from those of other honeys. DHA also comes from the Leptospermum scoparium bush and, as a precursor, is entirely responsible for MG formation in Manuka honey. Because the amount of MG is formed by the DHA present in Manuka honey, the DHA level must be of sufficient quantity to maintain and sustain the characteristic levels of MG over the shelf life of a product. (See journal abstracts at the end of this paper for more details related to discovery of MG in Manuka honey and the importance of DHA content.)

3 Page 3. CMH positioning (cont.) Definition of Certified Medical-grade Manuka honey (CMH) Due to the lack of facts and information covering test data and standards verifying the purity and chemical composition of the Manuka honey used in a number of products in the marketplace, LMP has established a defined certification process, designated by the CMH mark. The CMH mark provides assurance to healthcare professionals that the LMP products they employ in wound care applications have met a set of stringent and consistent requirements for purity and composition. The CMH mark completely differentiates LMP medical-grade Manuka honey from competitive wound care products by setting a standard for medicalgrade quality. To define the standard for medical-grade Manuka honey, LMP established a distinct set of process methods and controls. The honey is also referred to an independent laboratory to verify authenticity. The CMH mark is further backed by LMP s compliance with well established GMP standards. Specific process protocols include Controlled Storage - meets GMP standards for the receiving, storage and removal from storage of the product before beginning product manufacturing. Part of this process also verifies the receiving of the raw Manuka honey only from LMP s supplier in New Zealand. Fine Filtration fine filtration includes removal of any extraneous materials that may be present. Homogenization assures uniformity of the raw honey and reduces the potential for crystallization. Post production sterilization follows process protocol for sterilization as required for medical products.

4 Page 4. CMH positioning (cont.) Certification Testing Before processing by LMP, the Manuka honey is subjected to extensive testing by Minerva Scientific, an independent UK based laboratory, conforming to ISO/IED standards. In major countries around the world, ISO/IED is the standard laboratories must meet and hold accreditation for in order to be recognized as technically competent. In nearly all cases, suppliers and regulatory authorities will not accept test results from a non-accredited lab. The standard is composed of five elements: 1. Scope 2. Normative References 3. Terms of Definitions 4. Management requirements 5. Technical requirements The two main sections in ISO/IED are: 1. Management Requirements and Technical Requirements primarily relate to operation and effectiveness in the management of quality systems in the lab. 2. Technical requirements relate to those elements determining correctness and reliability of the specific tests and calibrations performed in the lab. The specific tests used for medical-grade Manuka honey verify and certify purity and composition. The basis of these tests were substantiated through established data and protocols cited by the New Zealand government related to the definition and protection of Manuka honey and communication from an independent New Zealand laboratory performing work associated with the New Zealand Manuka honey industry. The tests used to assure wound specialists of CMH marked medical-grade Manuka honey include those required to guarantee authenticity. Tests include the measurement of methylglyoxal (MG) and dihydroxyacetone (DHA), a precursor to MG content.

5 Page 5. CMH positioning (cont.) Specific tests include Manuka honey authentication - Measure unique viscosity profile by parameters - Pollen analysis of Manuka like characteristics by microscopy MG and DHA Analysis - MG level is tested using high performance liquid chromatography and related lab procedures based on the work of Thomas Henle (et al) discoverer of MG in Manuka honey. (See journal abstracts at the end of this paper for more details related to specific test methods for MG/DHA.) The presence of MG indicates composition beyond the NPA of the honey. And the MG content must be tested prior to any processing so the test is not compromised by final product production.. Most producers of medical-grade Manuka honey use the traditional inhibition bioassay for the measurement of NPA. LMP measures the actual MG in its honey by using sophisticated instrumental techniques. In this way, LMP can be confident the required MG component of Manuka honey is present. This assay method for CMH is completely different from the traditional inhibition bioassay. Experience has shown the testing of honey products containing gelling agents using the inhibition method is not advisable because there is prevention of diffusion by the gelling agents giving falsely low results. Note: LMP s wound care dressings also carry the authorized CE mark necessary for marketing in the European Economic Area (EEA) and the European Free Trade Association (EFTA) countries. Sold worldwide, the products have also been cleared for marketing through the United States Food and Drug Administration (FDA). Conclusion The CMH mark on LMP wound care dressings assures healthcare professionals the products bearing the mark do, in fact, contain authentic medical-grade Manuka honey and have been tested and certified as meeting the high standards required for wound care application. Reference abstracts for MG and a short list of other references follows

6 Abstracts and other references Definitive papers on MG Discovery of MG in Manuka honey and significance of DHA Identification and quantification of methylglyoxal as the dominant antibacterial constituent of Manuka (Leptospermum scoparium) honeys from New Zealand Mol Nutr Food Res 2008 Apr;52(4):483-9 Elvira Mavric, Silvia Wittmann, Gerold Barth, Thomas Henle Abstract link: The origin of methylglyoxal in New Zealand manuka (Leptospermum scoparium) honey Carbohydr Res May 26;344(8): doi: /j.carres Epub 2009 Mar 21. Adams CJ1, Manley-Harris M, Molan PC Abstract link: Testing Manuka honey for MGO and DHA Studies on the formation of methylglyoxal from dihydroxyacetone in Manuka (Leptospermum scoparium) honey. Carbohydr Res 2012 Nov 8;361:7-11. Epub 2012 Aug 8. Julia Atrott, Steffi Haberlau, Thomas Henle Abstract link: Additional References Molan, P. (2013). The use of manuka honey to promote wound healing. L.O.G.I.C (Linking Opportunities Generating Inter-Professional Collaboration): The Official Journal of The New Zealand College of Primary Health Care Nurses, NZNO, March 2013, Lu J, Carter DA, Turnbull L, Rosendale D, Hedderley D, et al. (2013) The Effect of New Zealand Kanuka, Manuka and Clover Honeys on Bacterial Growth Dynamics and Cellular Morphology Varies According to the Species. PLoS ONE ; 8(2):e Seckam A, Cooper R. (2013) Understanding how honey impacts on wounds: an update on recent research findings. Wounds International Vol 4 Issue 1 Eric N Hammond EN, Eric S Donkor, ES (2013) Antibacterial effect of Manuka honey on Clostridium difficile. BMC Research Notes 2013, 6:188 Gethin GT1, Cowman S, Conroy RM. The impact of Manuka honey dressings on the surface ph of chronic wounds. Int. Wound J Jun;5(2): All contents Copyright Links Medical Products, Inc All Rights Reserved.