Microsoft Word - SPDS_0918_ERP-Proposal-07-11-2018DMC
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SPDS Methods Expected for Review AOAC Candidate Method Number Method Title
Method Authors
ECH‐001
Determination of Phenolic Compounds in Dietary Supplements and Dietary Ingredients Containing Echinacea Determination of Ginsenoside Content in Panax ginseng and Panax quinquefolius Root Materials and Finished Products Simultaneous Determination of 30 Ginsenosides in Panax ginseng preparations using ultra performance liquid chromatography Determination of Kavalactones and Flavokavains in Kava Dietary Supplements and Dietary Ingredients HPLC Analysis Method Development for Kavalactones and Flavokavains in Kava Extract Detection of Flavokavines (A, B, C) in Cultivars of Kava Using HPLC Unknown SAMe Method – Submission Pending Unknown Skullcap Method – Submission Pending Determination of active Vitamin B12 (Cobalamin) in Dietary Supplements and Ingredients by Reversed‐phase Liquid Chromatography: Single‐laboratory validation
Michael Chan, Elizabeth Mudge, Paula Brown
GSG‐001
Paula N. Brown, Jamie Finley, Ronan Yu and Michael Chan (BCIT)
GSG‐002
Hee‐Won Park, Gyo In, Sung‐Tai Han, Myoung‐ Woo Lee, So‐Young Kim, Kyung‐Tack Kim, Byung‐ Goo Cho, Gyeong‐Ho Han, and Il‐Moo Chang (Waters) Paula N. Brown, Ying Liu, Jensen A. Lund, Susan J. Murch (BCIT)
KAV‐001
KAV‐002
Yijn Tang and Chris Fiends (Applied Food Sciences, Inc.)
KAV‐003
V. Lebot, T.K.T. Do, L. Legendre
SAM‐001
Joseph Zhou, Sunshineville Health Products
SKU‐001
Sidney Sudberg, Alkemist Labs
Xiao Qiu – Eurofins Supplement Analysis Center, Eurofins Scientific, Inc. Haoshu Zhang – Eurofins Supplement Analysis Center, Eurofins Scientific, Inc. Hillel Brandes – MilliporeSigma Teresa Marsala – MilliporeSigma Katherine Stenerson– MilliporeSigma Hugh Cramer– MilliporeSigma Hong You* – Eurofins Supplement Analysis Center, Eurofins Scientific, Inc.
B12‐001
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Echinacea Expert Review Panel – All Applicants
Echinacea First Last Organization 1 Paula Brown
British Colombia Institute of Technology
coauthor
2 Anton 3 Michael
USP
Bzhelyansky
British Colombia Institute of Technology Mohammad V University in Rabat (Morocco)
coauthor
Chan
4 Nour Eddine
Es‐Safi
5 Kan 6 Holly
Herbalife
He
American Herbal Products Association
Proposed Chair
Johnson Rimmer Tuzimski
7 Catherine 8 Tomasz
US NIST
Medical University of Lublin (Poland)
9 Joseph
Sunshineville Health Products
Zhou
Perspectives of Candidates
Broad Perspectives
25%
25%
Industry Government Academia NGO
12%
38%
3
Specific Perspectives
11%
22%
Reference Standards Research Supplements Trade
33%
34%
Region
22%
Canada Morocco Poland United States
56%
11%
11%
4
Echinacea Expert Review Panel ‐ Statements of Expertise Paula Brown, BCIT I have published 18 validation studies including 3 collaborative studies and 4 OMAs. Dr. Brown has conducted validations on Echinacea, Ginseng, Kratom, Turmeric. She served as the working ‐‐‐ Anton Bzhelyansky, USP Over the last 5.5 years I have been maintaining 150+ USP botanical monographs, including the several identified above; developing new monographs and participating in numerous AOAC Working Groups (chaired the Ginger WG) and ERPs. My prior work included hands‐on development of analytical methods for dietary ingredients and finished dosage forms; both botanical and non‐botanical. ‐‐‐ Michael Chan, BCIT Throughout my educational and professional career, I have obtained extensive experience in the development, optimization and validation of analytical methods for botanicals, natural products and dietary supplements. I have performed and supervised single laboratory and collaborative validation studies analytical methods including methods for the analysis of Aloe Vera, Ginseng, Echinacea, Cranberry, Goldenseal, Turmeric and Kombucha, with several of the methods I have worked on being published and accepted as first action OMA by AOAC. With my strong background and experience in analytical chemistry and statistics I have a thorough understanding of the requirements to review and evaluate method performance characteristics. Additionally, my pharmacognosy training has given a solid foundation in natural products chemistry and the issues associated with analysis of complex sample matrixes. ‐‐‐ Nour Eddine Es‐Safi, Mohammad V University in Rabat (Morocco) Chemist with knowledge of the AOAC Standards Development and Method Approval processes. ‐‐‐ Kan He, Herbalife Kan has been a member of the SPDS for several years and has participated on numerous working groups and is a member of the Aloe Vera ERP. He is also an OA representative to AOAC for Herbalife. Kan can participate on Echinacea, Ginseng, and Kava. ‐‐‐
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Holly Johnson, AHPA Holly E. Johnson Ph.D., is the Chief Science Officer for the American Herbal Products Association (AHPA). She previously served for three years as Laboratory Director for Alkemist Labs, an ISO 17025 accredited natural products testing lab specializing in botanical dietary supplements. Dr. Johnson took her Ph.D. in Pharmacognosy at the College of Pharmacy, University of Illinois – Chicago (UIC), under renowned Pharmacognosist and researcher Dr. Norman Farnsworth. Holly was awarded a National Institutes for Health (NIH) Fellowship and trained at the UIC/NIH Center for Botanical Dietary Supplements. She was a Postdoctoral Research Fellow at the Institute for EthnoMedicine studying the etiology of neurodegenerative disease, and also worked for Waters Corporation conducting technical training and regulatory consulting for pharmaceutical and supplements companies. She is currently a Research Associate with the National Tropical Botanical Garden and serves on AOAC working groups, stakeholders panels and expert review panels for Foods and Dietary Supplements. She is a member of the United States Pharmacoepia’s (USP) Medical Cannabis Expert Panel, the Editorial Board of the Journal of AOAC International, and she serves on the Advisory Boards of the American Botanical Council and the American Herbal Pharmacoepia. Holly has over 20 years experience working with natural products & botanicals and spent many happy years conducting research on medicinal plants and giving courses at the University of Hawaii. ‐‐‐ Catherine Rimmer, NIST I am the coordinator for organic analytes in dietary supplement reference materials at NIST. ‐‐‐ Tomasz Tuzimski, Medical University of Lublin (Poland) I gained experience during experimental work in the laboratory, during courses, writing doctorate reviews, 300 reviews of manuscripts, and editing books. I cooperated with the Department of Food Analysis, Department of Food and Nutrition, Department of Pharmacognosy with Medicinal Plant Unit Medical University of Lublin. ‐‐‐ Joseph Zhou, Sunshineville Health Products I have a lot of testing and methods development experience for echinacea, ginseng and kava, and have been working for AOAC official methods program for many years.
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Ginseng Expert Review Panel – All Applicants
Ginseng First Last
Organization
1 Anton 2 Michael
Bzhelyansky USP
British Colombia Institute of Technology Coauthor (GSG‐001)
Chan
3
Mohammad V University in Rabat (Morocco)
Nour Eddine
Es‐Safi
4 Kan 5 Holly 6 Mimi 8 Aniko 9 Yanjun 10 Joseph 7 Catherine
Herbalife
He
American Herbal Products Association
Proposed Chair
Johnson
The Nature’s Bounty Co.
Park
US NIST
Rimmer Solyom
GAAS Analytical
Herbalife
Zhang Zhou
Sunshineville Health Products
Perspectives of Candidates
Broad Perspectives
20%
20%
Academia Government Industry NGO
10%
50%
7
Specific Perspectives
9%
9%
18%
CRO Reference Standards Research Supplements Trade
46%
18%
Region
10%
10%
Canada Morocco United States
80%
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Ginseng Expert Review Panel – Statements of Expertise
Anton Bzhelyansky, USP Over the last 5.5 years I have been maintaining 150+ USP botanical monographs, including the several identified above; developing new monographs and participating in numerous AOAC Working Groups (chaired the Ginger WG) and ERPs. My prior work included hands‐on development of analytical methods for dietary ingredients and finished dosage forms; both botanical and non‐botanical. ‐‐‐ Michael Chan, BCIT Throughout my educational and professional career I have obtained extensive experience in the development, optimization and validation of analytical methods for botanicals, natural products and dietary supplements. I have performed and supervised single laboratory and collaborative validation studies analytical methods including methods for the analysis of Aloe Vera, Ginseng, Echinacea, Cranberry, Goldenseal, Turmeric and Kombucha, with several of the methods I have worked on being published and accepted as first action OMA by AOAC. With my strong background and experience in analytical chemistry and statistics I have a thorough understanding of the requirements to review and evaluate method performance characteristics. Additionally my pharmacognosy training has given a solid foundation in natural products chemistry and the issues associated with analysis of complex sample matrixes. ‐‐‐ Nour Eddine Es‐Safi, Mohammad V University in Rabat (Morocco) Chemist with knowledge of the AOAC Standards Development and Method Approval processes. ‐‐‐ Kan He, Herbalife Kan has been a member of the SPDS for several years and has participated on numerous working groups and is a member of the Aloe Vera ERP. He is also an OA representative to AOAC for Herbalife. Kan can participate on Echinacea, Ginseng, and Kava. ‐‐‐ Holly Johnson, AHPA Holly E. Johnson Ph.D., is the Chief Science Officer for the American Herbal Products Association (AHPA). She previously served for three years as Laboratory Director for Alkemist Labs, an ISO 17025 accredited natural products testing lab specializing in botanical dietary supplements. Dr. Johnson took her Ph.D. in
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Pharmacognosy at the College of Pharmacy, University of Illinois – Chicago (UIC), under renowned Pharmacognosist and researcher Dr. Norman Farnsworth. Holly was awarded a National Institutes for Health (NIH) Fellowship and trained at the UIC/NIH Center for Botanical Dietary Supplements. She was a Postdoctoral Research Fellow at the Institute for EthnoMedicine studying the etiology of neurodegenerative disease, and also worked for Waters Corporation conducting technical training and regulatory consulting for pharmaceutical and supplements companies. She is currently a Research Associate with the National Tropical Botanical Garden and serves on AOAC working groups, stakeholders panels and expert review panels for Foods and Dietary Supplements. She is a member of the United States Pharmacoepia’s (USP) Medical Cannabis Expert Panel, the Editorial Board of the Journal of AOAC International, and she serves on the Advisory Boards of the American Botanical Council and the American Herbal Pharmacoepia. Holly has over 20 years experience working with natural products & botanicals and spent many happy years conducting research on medicinal plants and giving courses at the University of Hawaii. ‐‐‐ Mimi Park, The Nature’s Bounty Co. I currently hold a position as a senior manager of Analytical R&D and Stability for the Nature's Bounty Co. We are responsible for evaluating, troubleshooting and improving analytical methods for use in the QC laboratory for product release. As a leading dietary supplement company, we have a huge stake in the AOAC methods. We run these methods on a daily basis and have vast interest and knowledge in regards to the performance and challenges with proposed methods. ‐‐‐ Catherine Rimmer, NIST I am the coordinator for organic analytes in dietary supplement reference materials at NIST. ‐‐‐ Aniko Solyom I have more than 30 years of comprehensive experience in analytical method development and validation, using a wide variety of analytical techniques. My expertise is in development and validation of analytical methods with particular emphasis on HPLC, LC‐MS applications and bioactivity guided preparative separation of complex mixtures and analysis of biological samples and dietary supplements. In addition to HPLC technique, I have significant experience with atomic absorption spectroscopy (AA), inductively coupled plasma emission spectroscopy (ICP), photoacoustic spectroscopy (PA), UV‐Vis spectroscopy, elemental analysis, mass spectrometry(MS), gas
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chromatography (GC), GC‐MS, LC‐MS, NMR and wet techniques. Before founding GAAS Corporation/GAAS Analytical, I served as director of the Analytical Core at an NIH funded Botanical Center (Arizona Center for Phytomedicine Research). The Facility focused on quantitation and identification of natural products and dietary supplements, particularly anti‐inflammatory compounds from turmeric, ginger and boswellia. I developed methods to analyze these compounds from the plant materials, extracts, commercially available dietary supplements and from different biological matrices. I also developed and validated new assay methods according to cGLP regulations, to quantify novel cancer drugs in plasma and urine using QQQ LC/MS technique; identifying metabolites of new cancer drugs in plasma and urine using TOF LC/MS technique and calculating pharmacokinetic parameters. I am an active member of AOAC International; I joined the organization in 2002. Currently, I am a member of AOAC’s Stakeholder Panel on Dietary Supplements and member of various working groups. I have participated in multiple AOAC organized collaborative studies (glucosamine, ginkgo, saw palmetto) in order to validate analytical methods to be used by the dietary supplement industry. I was Horwitz advisor of AOAC until the restructuring the Official Methods of Analysis (OMA) process in January 2008, when the role of method advisors and Horwitz advisors was retired. For 5 years I have been serving as a member of the Presidential Task Force on Dietary Supplements of AOAC, and also served as a member of Expert Review Panels of AOAC. I was selected in June 2015 to serve a 5‐year term as the member of USP’s Nonbotanical Dietary Supplements Expert Committee. ‐‐‐ Yanjun Zhang, Herbalife I was trained as a natural product chemist and have been in the field of botanical analysis for over 30 years. Many methods have been developed for analysis of botanicals including the analytical method for ginger, aloin and lutein analysis. I can contribute my expertise in reviewing the test method on botanicals. ‐‐‐ Joseph Zhou, Sunshineville Health Products I have a lot of testing and methods development experience for echinacea, ginseng and kava, and have been working for AOAC official methods program for many years.
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Kava Expert Review Panel – All Applicants Kava First Last Organization 1 Anton Bzhelyansky USP 2 Michael Chan
British Colombia Institute of Technology
3 Steven
Dentali Botanical Sciences
Dentali
4
Mohammad V University in Rabat (Morocco)
Nour Eddine
Es‐Safi
5 Kan 6 Holly 7 Charles 8 Catherine 9 Aniko 10 John 11 Tomasz 12 Joseph
Herbalife
He
American Herbal Products Association
Proposed Chair
Johnson Metcalfe Rimmer Solyom Szpylka Tuzimski
Custom Analytics
US NIST
GAAS Analytical
Merieux NutriSciences
Medical University of Lublin (Poland)
Sunshineville Health Products
Zhou
Perspectives of Candidates
Broad Perspectives
17%
25%
Academia Government Industry NGO
8%
50%
12
Specific Perspectives
8%
25%
CRO Consultant Reference Standards Research Supplements Trade
17%
8%
25%
17%
Region
9%
8%
8%
Canada Morocco Poland United States
75%
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Kava Expert Review Panel – Statements of Expertise Anton Bzhelyansky, USP
Over the last 5.5 years I have been maintaining 150+ USP botanical monographs, including the several identified above; developing new monographs and participating in numerous AOAC Working Groups (chaired the Ginger WG) and ERPs. My prior work included hands‐on development of analytical methods for dietary ingredients and finished dosage forms; both botanical and non‐botanical. ‐‐‐ Michael Chan, BCIT Throughout my educational and professional career I have obtained extensive experience in the development, optimization and validation of analytical methods for botanicals, natural products and dietary supplements. I have performed and supervised single laboratory and collaborative validation studies analytical methods including methods for the analysis of Aloe Vera, Ginseng, Echinacea, Cranberry, Goldenseal, Turmeric and Kombucha, with several of the methods I have worked on being published and accepted as first action OMA by AOAC. With my strong background and experience in analytical chemistry and statistics I have a thorough understanding of the requirements to review and evaluate method performance characteristics. Additionally my pharmacognosy training has given a solid foundation in natural products chemistry and the issues associated with analysis of complex sample matrixes. ‐‐‐ Steven Dentali, Dentali Botanical Sciences Past scientific officer of the International Aloe Science Council and engagement with companies choosing methods of analysis. Support for ingredient with previous employer. Previous experience with the kava industry and chemistry as well as serving as chair of the AOAC kavalactones working group. ‐‐‐ Nour Eddine Es‐Safi, Mohammad V University in Rabat (Morocco) Chemist with knowledge of the AOAC Standards Development and Method Approval processes. ‐‐‐ Kan He, Herbalife Kan has been a member of the SPDS for several years and has participated on numerous working groups and is a member of the Aloe Vera ERP. He is also an OA representative to AOAC for Herbalife. Kan can participate on Echinacea, Ginseng, and Kava. ‐‐‐
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Holly Johnson, AHPA Holly E. Johnson Ph.D., is the Chief Science Officer for the American Herbal Products Association (AHPA). She previously served for three years as Laboratory Director for Alkemist Labs, an ISO 17025 accredited natural products testing lab specializing in botanical dietary supplements. Dr. Johnson took her Ph.D. in Pharmacognosy at the College of Pharmacy, University of Illinois – Chicago (UIC), under renowned Pharmacognosist and researcher Dr. Norman Farnsworth. Holly was awarded a National Institutes for Health (NIH) Fellowship and trained at the UIC/NIH Center for Botanical Dietary Supplements. She was a Postdoctoral Research Fellow at the Institute for EthnoMedicine studying the etiology of neurodegenerative disease, and also worked for Waters Corporation conducting technical training and regulatory consulting for pharmaceutical and supplements companies. She is currently a Research Associate with the National Tropical Botanical Garden and serves on AOAC working groups, stakeholders panels and expert review panels for Foods and Dietary Supplements. She is a member of the United States Pharmacoepia’s (USP) Medical Cannabis Expert Panel, the Editorial Board of the Journal of AOAC International, and she serves on the Advisory Boards of the American Botanical Council and the American Herbal Pharmacoepia. Holly has over 20 years experience working with natural products & botanicals and spent many happy years conducting research on medicinal plants and giving courses at the University of Hawaii. ‐‐‐ Charles Metcalfe, Custom Analytics We are using a UHPLC method to quantitate the lactones and flavokavains ‐‐‐ Catherine Rimmer, NIST I am the coordinator for organic analytes in dietary supplement reference materials at NIST. ‐‐‐ Aniko Solyom I have more than 30 years of comprehensive experience in analytical method development and validation, using a wide variety of analytical techniques. My expertise is in development and validation of analytical methods with particular emphasis on HPLC, LC‐MS applications and bioactivity guided preparative separation of complex mixtures and analysis of biological samples and dietary supplements. In addition to HPLC technique, I have significant experience with atomic absorption spectroscopy (AA), inductively coupled plasma emission spectroscopy (ICP), photoacoustic spectroscopy (PA), UV‐Vis spectroscopy, elemental analysis, mass spectrometry(MS), gas
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chromatography (GC), GC‐MS, LC‐MS, NMR and wet techniques. Before founding GAAS Corporation/GAAS Analytical, I served as director of the Analytical Core at an NIH funded Botanical Center (Arizona Center for Phytomedicine Research). The Facility focused on quantitation and identification of natural products and dietary supplements, particularly anti‐inflammatory compounds from turmeric, ginger and boswellia. I developed methods to analyze these compounds from the plant materials, extracts, commercially available dietary supplements and from different biological matrices. I also developed and validated new assay methods according to cGLP regulations, to quantify novel cancer drugs in plasma and urine using QQQ LC/MS technique; identifying metabolites of new cancer drugs in plasma and urine using TOF LC/MS technique and calculating pharmacokinetic parameters. I am an active member of AOAC International; I joined the organization in 2002. Currently, I am a member of AOAC’s Stakeholder Panel on Dietary Supplements and member of various working groups. I have participated in multiple AOAC organized collaborative studies (glucosamine, ginkgo, saw palmetto) in order to validate analytical methods to be used by the dietary supplement industry. I was Horwitz advisor of AOAC until the restructuring the Official Methods of Analysis (OMA) process in January 2008, when the role of method advisors and Horwitz advisors was retired. For 5 years I have been serving as a member of the Presidential Task Force on Dietary Supplements of AOAC, and also served as a member of Expert Review Panels of AOAC. I was selected in June 2015 to serve a 5‐year term as the member of USP’s Nonbotanical Dietary Supplements Expert Committee. ‐‐‐ John Szpylka, Mérieux Nutrisciences Very active in nutrient and dietary supplement communities from analytical testing angle. Review resume. ‐‐‐ Tomasz Tuzimski, Medical University of Lublin (Poland) The subject of my research were m.in. analysis of vitamins, and other ingredients of medicinal herbs and pharmacognostic raw materials. ‐‐‐ Joseph Zhou, Sunshineville Health Products I have a lot of testing and methods development experience for echinacea, ginseng and kava, and have been working for AOAC official methods program for many years.
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VIII. SAMe Expert Review Panel – All Applicants* SAMe First Last
Organization
1
British Colombia Institute of Technology Mohammad V University in Rabat (Morocco) Ankara University (Turkey)
Michael
Chan
2
Nour Eddine
Es‐Safi
3 Mehmet
Gumustas
4 Holly
AHPA
Proposed Chair
Johnson Rimmer Solyom
5 Catherine
US NIST
6 Aniko
GAAS
7 Jinchuan
Waters Eurofins
Yang
8 Hong
You
*Some of these applicants are uncertain of their attendance. Additional recommendations from OMB are advised.
Perspectives of Candidates
Broad Perspectives
13%
37%
Academia Government Industry NGO
38%
12%
17
Specific Perspective
13%
25%
13%
CRO Reference Standards Research Trade Technology
12%
37%
Region
12%
12%
Canada Morocco Turkey United States
63%
13%
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SAMe Expert Review Panel – Statements of Expertise
Michael Chan, BCIT Throughout my educational and professional career, I have obtained extensive experience in the development, optimization and validation of analytical methods for botanicals, natural products and dietary supplements. I have performed and supervised single laboratory and collaborative validation studies analytical methods including methods for the analysis of Aloe Vera, Ginseng, Echinacea, Cranberry, Goldenseal, Turmeric and Kombucha, with several of the methods I have worked on being published and accepted as first action OMA by AOAC. With my strong background and experience in analytical chemistry and statistics I have a thorough understanding of the requirements to review and evaluate method performance characteristics. Additionally, my pharmacognosy training has given a solid foundation in natural products chemistry and the issues associated with analysis of complex sample matrixes. ‐‐‐ Nour Eddine Es‐Safi, Mohammad V University in Rabat (Morocco) Chemist with knowledge of the AOAC Standards Development and Method Approval processes. ‐‐‐ Mehmet Gumustas, Ankara University (Turkey) My research interests covers analytical chemistry especially pharmaceuticals and chiral compounds. I have been working on determination of SAMe from new developed drug delivery systems and rat plasma by using HPLC. ‐‐‐ Holly Johnson, AHPA Holly E. Johnson Ph.D., is the Chief Science Officer for the American Herbal Products Association (AHPA). She previously served for three years as Laboratory Director for Alkemist Labs, an ISO 17025 accredited natural products testing lab specializing in botanical dietary supplements. Dr. Johnson took her Ph.D. in Pharmacognosy at the College of Pharmacy, University of Illinois – Chicago (UIC), under renowned Pharmacognosist and researcher Dr. Norman Farnsworth. Holly was awarded a National Institutes for Health (NIH) Fellowship and trained at the UIC/NIH Center for Botanical Dietary Supplements. She was a Postdoctoral Research Fellow at the Institute for EthnoMedicine studying the etiology of neurodegenerative disease, and also worked for Waters Corporation conducting technical training and regulatory consulting for pharmaceutical and supplements companies. She is currently a Research
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Associate with the National Tropical Botanical Garden and serves on AOAC working groups, stakeholders panels and expert review panels for Foods and Dietary Supplements. She is a member of the United States Pharmacoepia’s (USP) Medical Cannabis Expert Panel, the Editorial Board of the Journal of AOAC International, and she serves on the Advisory Boards of the American Botanical Council and the American Herbal Pharmacoepia. Holly has over 20 years experience working with natural products & botanicals and spent many happy years conducting research on medicinal plants and giving courses at the University of Hawaii. ‐‐‐ Catherine Rimmer, NIST I am the coordinator for organic analytes in dietary supplement reference materials at NIST. ‐‐‐ Aniko Solyom I have more than 30 years of comprehensive experience in analytical method development and validation, using a wide variety of analytical techniques. My expertise is in development and validation of analytical methods with particular emphasis on HPLC, LC‐MS applications and bioactivity guided preparative separation of complex mixtures and analysis of biological samples and dietary supplements. In addition to HPLC technique, I have significant experience with atomic absorption spectroscopy (AA), inductively coupled plasma emission spectroscopy (ICP), photoacoustic spectroscopy (PA), UV‐Vis spectroscopy, elemental analysis, mass spectrometry(MS), gas chromatography (GC), GC‐MS, LC‐MS, NMR and wet techniques. Before founding GAAS Corporation/GAAS Analytical, I served as director of the Analytical Core at an NIH funded Botanical Center (Arizona Center for Phytomedicine Research). The Facility focused on quantitation and identification of natural products and dietary supplements, particularly anti‐inflammatory compounds from turmeric, ginger and boswellia. I developed methods to analyze these compounds from the plant materials, extracts, commercially available dietary supplements and from different biological matrices. I also developed and validated new assay methods according to cGLP regulations, to quantify novel cancer drugs in plasma and urine using QQQ LC/MS technique; identifying metabolites of new cancer drugs in plasma and urine using TOF LC/MS technique and calculating pharmacokinetic parameters. I am an active member of AOAC International; I joined the organization in 2002. Currently, I am a member of AOAC’s Stakeholder Panel on Dietary Supplements and member of various working groups. I have participated in multiple AOAC organized collaborative studies (glucosamine, ginkgo, saw palmetto) in order to validate analytical methods to be used by the dietary
20
supplement industry. I was Horwitz advisor of AOAC until the restructuring the Official Methods of Analysis (OMA) process in January 2008, when the role of method advisors and Horwitz advisors was retired. For 5 years I have been serving as a member of the Presidential Task Force on Dietary Supplements of AOAC, and also served as a member of Expert Review Panels of AOAC. I was selected in June 2015 to serve a 5‐year term as the member of USP’s Nonbotanical Dietary Supplements Expert Committee. ‐‐‐ Jinchuan Yang, Waters I have developed and published several LC based analytical methods for dietary supplements, and have extensive experience with LC and related techniques. ‐‐‐ Hong You, Eurofins I am currently a Principal Scientist at Eurofins Dietary Supplement Analysis Center. With a Ph.D. degree in Nutrition Sciences, I have more than 10 years experience in analytical method development and validation for various bioactive compounds, which include, but are not limited to carotenoids, xanthrophylls, isothiocyanates, flavonoids, amino acids and vitamins. I am familiar with multiple analytical techniques including HPLC‐DAD/ELSD/FLD/MSMS, GC‐FID/MS, and UV/VIS/FL spectrophotometers. Moreover, I was one of the two reviewers of the AOAC ERP for evaluating Lutein official method of analysis in 2016. I have also reviewed 16 journal manuscripts for Food Chemistry, Food Research International, J of AOAC Int, and J Food Biochemistry, and 16 conference abstracts for Experimental Biology Annual Conference. Eurofins has validated analytical methods and runs routine analysis for anthocyanins, cinnamon, collagen, kratom, lutein, proteins, polyphenols using Folin‐C reagent, vitamin B12, vitamin K, ginger, and free amino acids in dietary supplements or/and food matrices. As a Eurofins representative, I look forward to the opportunity to serve AOAC ERPs again.
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Skullcap Expert Review Panel – All Applicants Skullcap First Last
Organization
1 Michael
British Colombia Institute of Technology Mohammad V University in Rabat American Herbal Products Association
Chan
2 Nour Eddine
Es‐Safi
3 Holly
Johnson Rimmer
4 Catherine
US NIST
5 Yanjun Herbalife *An insufficient number of applications have been received for this Expert Review Panel. OMB recommendations are requested. Zhang
Skullcap Statements of Expertise Michael Chan, BCIT
Throughout my educational and professional career I have obtained extensive experience in the development, optimization and validation of analytical methods for botanicals, natural products and dietary supplements. I have performed and supervised single laboratory and collaborative validation studies analytical methods including methods for the analysis of Aloe Vera, Ginseng, Echinacea, Cranberry, Goldenseal, Turmeric and Kombucha, with several of the methods I have worked on being published and accepted as first action OMA by AOAC. With my strong background and experience in analytical chemistry and statistics I have a thorough understanding of the requirements to review and evaluate method performance characteristics. Additionally my pharmacognosy training has given a solid foundation in natural products chemistry and the issues associated with analysis of complex sample matrixes. ‐‐‐ Nour Eddine Es‐Safi, Mohammad V University in Rabat (Morocco) Chemist with knowledge of the AOAC Standards Development and Method Approval processes. ‐‐‐ Holly Johnson, AHPA Holly E. Johnson Ph.D., is the Chief Science Officer for the American Herbal Products Association (AHPA). She previously served for three years as Laboratory Director for Alkemist Labs, an ISO 17025 accredited natural products testing lab specializing in botanical dietary supplements. Dr. Johnson took her Ph.D. in Pharmacognosy at the College of Pharmacy, University of Illinois – Chicago (UIC), under renowned Pharmacognosist and researcher Dr. Norman Farnsworth. Holly was awarded a National Institutes for
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Health (NIH) Fellowship and trained at the UIC/NIH Center for Botanical Dietary Supplements. She was a Postdoctoral Research Fellow at the Institute for EthnoMedicine studying the etiology of neurodegenerative disease, and also worked for Waters Corporation conducting technical training and regulatory consulting for pharmaceutical and supplements companies. She is currently a Research Associate with the National Tropical Botanical Garden and serves on AOAC working groups, stakeholders panels and expert review panels for Foods and Dietary Supplements. She is a member of the United States Pharmacoepia’s (USP) Medical Cannabis Expert Panel, the Editorial Board of the Journal of AOAC International, and she serves on the Advisory Boards of the American Botanical Council and the American Herbal Pharmacoepia. Holly has over 20 years experience working with natural products & botanicals and spent many happy years conducting research on medicinal plants and giving courses at the University of Hawaii. ‐‐‐ Catherine Rimmer, NIST I am the coordinator for organic analytes in dietary supplement reference materials at NIST. ‐‐‐ Yanjun Zhang, Herbalife I have been working on natural and botanical constituents analysis for a few decades in both academic and industrial environments and have experiences on the titled botanical analysis and would like to contribute my expertise to the botanical analysis community. ‐‐‐
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Vitamin B 12
Expert Review Panel – All Applicants Vitamin B 12 First Last Organization
1 2 3 4 5 6 7 8 9
Mérieux NutriSciences
Sneh
Bhandari
Mohammad V University in Rabat
Nour Eddine
Es‐Safi
Herbalife
Quanyin
Gao
AHPA
Holly
Johnson Joseph Koerner Rimmer Ritruthai Solyom Szpylka Tuzimski Park
AsureQuality New Zealand
George
Phenomenex
Philip Mimi
The Nature’s Bounty Company
US NIST Herbalife
Catherine
Vicha
10 Aniko 11 John 12 Tomasz 13 Jinchuan 14 Hong 15 Garrett
GAAS Analytical
Mérieux NutriSciences
Medical University of Lublin (Poland)
Waters Eurofins
Yang
You
Covance Laboratories
Zielinski
Perspectives of Candidates
Broad Sector
7%
13%
13%
Academia Government Industry NGO
67%
24
Specific Perspectives
7%
CRO Reference Standards Regulators Research Supplements Technology Trade
14%
29%
22%
7%
7%
14%
Region
6% 7%
7%
Morocco New Zealand Poland United States
80%
25
Vitamin B 12
Expert Statements of Expertise
Sneh Bhandari, Mérieux NutriSciences Sneh D. Bhandari is the Director of Chemistry Research & Development at Silliker Inc. and has been part of the Merieux NutriSciences /Silliker for over twenty five years. He directs method development related to food analysis and nutrition labeling including protein nutrition and quality evaluation. He did his doctorate in Nutritional Biochemistry. He has been working use of amino acid as finger print as tool to detect adulteration of skim milk powder. He recently presented his research findings at the 254th ACS National Meeting in Washington, DC, August 20‐24, 2017 in symposium on “Advancing Analytical Methods in Food Forensics & Authentication”. He has been ERP member of SPIFAN from beginning and was chair of Choline working group. He recently successfully completed Folate collaborative study under SPIFAN for the AOAC method 2011.06. He has been helping food industry clients in USA and Canada in evaluation of protein quality for nutrition labeling and other purposes. He organized a session on “Protein Nutrition and Quality Assessment: A Global Perspective” this year at AOAC annual meeting. He also made a presentation on ‘Protein quality evaluation in protein enhanced formulations and nutrition labeling’ at 2017 AOAC annual meeting and also at 5th Annual Protein Trends & Technologies Seminar at Itasca, IL on “Protein and amino acid analysis in relation to nutrition labeling and protein quality”. He has also made presentations on Protein quality evaluation and nutrition labeling for food industry clients and other professional meetings. He has developed and validated various methods in food and dietary supplement analyses including Vitamins A, D, E, K1, K2, Folate, Niacin & fatty acids, artificial colors, non‐caloric sweetners, antibiotics etc. Steering Committee Member of USP Skim Milk Powder Advisory Group (2010‐2015). He was Chair and member of the Amino acid finger print team under USP Skim Milk Powder Advisory Group (2012‐ 2016). Member of USP’s Non‐targeted Methods for Milk Ingredients Expert Panel (2016). He is the Fellow of AOAC, was a member of OMB and various, ERPs, Stakeholder panels and working groups. Earlier he has been member of technical committee C and General Referee for Vitamins. He is also actively involved with AOCS for a long time. He is the author of numerous refereed articles and book chapters and presentations at the professional meetings. ‐‐‐ Nour Eddine Es‐Safi, Mohammad V University in Rabat (Morocco) Chemist with knowledge of the AOAC Standards Development and Method Approval processes.
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‐‐‐ Quanyin Gao, Herbalife
Author of an AOAC First Action Method for Aloin. Participated Protein test method discussion with USP. Submitted LC/MS method to USP for Vitamin B12 testing. Managed routine test for amino acid nutrients. ‐‐‐ Holly Johnson, AHPA Holly E. Johnson Ph.D., is the Chief Science Officer for the American Herbal Products Association (AHPA). She previously served for three years as Laboratory Director for Alkemist Labs, an ISO 17025 accredited natural products testing lab specializing in botanical dietary supplements. Dr. Johnson took her Ph.D. in Pharmacognosy at the College of Pharmacy, University of Illinois – Chicago (UIC), under renowned Pharmacognosist and researcher Dr. Norman Farnsworth. Holly was awarded a National Institutes for Health (NIH) Fellowship and trained at the UIC/NIH Center for Botanical Dietary Supplements. She was a Postdoctoral Research Fellow at the Institute for EthnoMedicine studying the etiology of neurodegenerative disease, and also worked for Waters Corporation conducting technical training and regulatory consulting for pharmaceutical and supplements companies. She is currently a Research Associate with the National Tropical Botanical Garden and serves on AOAC working groups, stakeholders panels and expert review panels for Foods and Dietary Supplements. She is a member of the United States Pharmacoepia’s (USP) Medical Cannabis Expert Panel, the Editorial Board of the Journal of AOAC International, and she serves on the Advisory Boards of the American Botanical Council and the American Herbal Pharmacoepia. Holly has over 20 years experience working with natural products & botanicals and spent many happy years conducting research on medicinal plants and giving courses at the University of Hawaii. ‐‐‐ George Joseph, AsureQuality New Zealand I have extensive experience in nutrients and bio‐active method development, validation for the last 20 Years ‐‐‐ Philip Koerner, Phenomenex I am an analytical chemist with over 29 years of experience, particularly in HPLC, GC and SPE. I have extensive experience in the application of liquid chromatography in the fields of food safety and quality, clinical toxicology, pharmaceuticals, and environmental. I have served on two previous ERPs (Set 1 and
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Set 3) and believe I bring the skill set required for the critical evaluation of the suitability of analytical methods to meet the requirements outlined in the SMPRs. ‐‐‐ Mimi Park, The Nature’s Bounty Company I currently hold a position as a senior manager of Analytical R&D and Stability for the Nature's Bounty Co. We are responsible for evaluating, troubleshooting and improving analytical methods for use in the QC laboratory for product release. As a leading dietary supplement company, we have a huge stake in the AOAC methods. We run these methods on a daily basis and have vast interest and knowledge in regards to the performance and challenges with proposed methods. ‐‐‐ Catherine Rimmer, US NIST I am the coordinator for organic analytes in dietary supplement reference materials at NIST. ‐‐‐ Vicha Rithruthai, Herbalife Please note that the CV has not been updated with Vicha's experience at Herbalife. Vicha has joined Herbalife on 6/2010 as Method Development Chemist. He has developed and validated most of test methods that are currently used at HP1 lab for testing Vitamins and Minerals. He has developed and validated a Vitamin B12 (Cyanocobalamin) test method by LC/MS/MS and also has developed and validated a Methylcobalamin method by LC/MS/MS. He has over 32 years of experience in Quality Control and R&D Analytical labs (12 years of method development and validation experience). ‐‐‐ Aniko Solyom, GAAS Analytical I have more than 30 years of comprehensive experience in analytical method development and validation, using a wide variety of analytical techniques. My expertise is in development and validation of analytical methods with particular emphasis on HPLC, LC‐MS applications and bioactivity guided preparative separation of complex mixtures and analysis of biological samples and dietary supplements. In addition to HPLC technique I have significant experience with atomic absorption spectroscopy (AA), inductively coupled plasma emission spectroscopy (ICP), photoacoustic spectroscopy (PA), UV‐Vis spectroscopy, elemental analysis, mass spectrometry (MS), gas chromatography (GC), GC‐MS, LC‐MS, NMR and wet techniques. Before founding GAAS Corporation/GAAS Analytical, I served as director of the Analytical Core at an NIH funded Botanical Center (Arizona Center for Phytomedicine Research). The
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Facility focused on quantitation and identification of natural products and dietary supplements, particularly anti‐inflammatory compounds from turmeric, ginger and boswellia. I developed methods to analyze these compounds from the plant materials, extracts, commercially available dietary supplements and from different biological matrices. I also developed and validated new assay methods according to cGLP regulations, to quantify novel cancer drugs in plasma and urine using QQQ LC/MS technique; identifying metabolites of new cancer drugs in plasma and urine using TOF LC/MS technique and calculating pharmacokinetic parameters. I am an active member of AOAC International; I joined the organization in 2002. Currently I am member of AOAC’s Stakeholder Panel on Dietary Supplements and member of various working groups. I have participated in multiple AOAC organized collaborative studies (glucosamine, ginkgo, saw palmetto) in order to validate analytical methods to be used by the dietary supplement industry. I was Horwitz advisor of AOAC until the restructuring the Official Methods of Analysis (OMA) process in January 2008, when the role of method advisors and Horwitz advisors was retired. For 5 years I have been serving as member of the Presidential Task Force on Dietary Supplements of AOAC, and also served as member of Expert Review Panels of AOAC. I was selected in June 2015 to serve a 5 year term as the member of USP’s Nonbotanical Dietary Supplements Expert Committee. ‐‐‐ John Szpylka, Mérieux NutriSciences Long term involvement on vitamin analyses with two methods AOAC OMAs. Have researched the remaining additives to dietary supplements both in N.A. and alongside efforts by our labs in Italy. ‐‐‐ Tomasz Tuzimski, Medical University of Lublin (Poland) I gained experience during experimental work in the laboratory, during courses, writing doctorate reviews, 300 reviews of manuscripts, and editing books. I cooperated with the Department of Food Analysis, Department of Food and Nutrition, Department of Pharmacognosy with Medicinal Plant Unit Medical University of Lublin. ‐‐‐ Jinchuan Yang, Waters I have worked on a number of compounds relevant to these compounds by LC/UV/FLU or LC/MS in food and dietary supplement matrices. I have intimate knowledge of LC and LC/MS technologies and have experience in the application of these tech. to complex sample matrices.
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‐‐‐ Hong You, Eurofins
I am currently a Principal Scientist at Eurofins Dietary Supplement Analysis Center. With a Ph.D. degree in Nutrition Sciences, I have more than 10 years experience in analytical method development and validation for various bioactive compounds, which include, but are not limited to carotenoids, xanthrophylls, isothiocyanates, flavonoids, amino acids and vitamins. I am familiar with multiple analytical techniques including HPLC‐DAD/ELSD/FLD/MSMS, GC‐FID/MS, and UV/VIS/FL spectrophotometers. Moreover, I was one of the two reviewers of the AOAC ERP for evaluating Lutein official method of analysis in 2016. I have also reviewed 16 journal manuscripts for Food Chemistry, Food Research International, J of AOAC Int, and J Food Biochemistry, and 16 conference abstracts for Experimental Biology Annual Conference. Eurofins has validated analytical methods and runs routine analysis for anthocyanins, cinnamon, collagen, kratom, lutein, proteins, polyphenols using Folin‐C reagent, vitamin B12, vitamin K, ginger, and free amino acids in dietary supplements or/and food matrices. As a Eurofins representative, I look forward to the opportunity to serve AOAC ERPs again. ‐‐‐ Garrett Zielinski, Covance Laboratories I routinely work with dietary supplement companies (brand owners, contract manufacturers, ingredient companies) regarding acceptable methodology for products depending on need (GMP compliance, meeting internal specs, etc). I also work with these companies to troubleshoot methods and develop method development/validation protocols.
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PROFILES OF SPDS ERP CANDIDATES
First Name Sneh
Last Name
Affiliation
ECHINACEA GINSENG KAVA‐
SAMe
SKULLCAP VITAMIN B 12
LACTONES
Bhandari
Mérieux NutriSciences British Colombia Institute of Technology (BCIT)
x
Paula
Brown
coauthor
Anton
Bzhelyansky
USP BCIT
x
x
x x x
Michael Steven
Chan
coauthor
coauthor
x
x
Dentali
Dentali Botanical Sciences
Nour Eddine
Es‐Safi
Mohammad V University in Rabat (Morocco)
x
x
x
x
x
x
Quanyin Mehmet
Gao
Herbalife Ankara University (Turkey) Herbalife
x
Gumustas
x
Kan
He
x
x
x
Holly
Johnson
AHPA
chair
chair
chair
chair
chair
chair
George
Joseph
AsureQuality New Zealand Phenomenex
x
Philip
Koerner Metcalfe
x
Charles
Custom Analytics
x
Mimi
Park
The Nature’s Bounty Co.
x
x
Catherine Rimmer
US NIST Herbalife GAAS Analytical
x
x
x
x
x
x x x
Vicha Aniko
Ritruthai Solyom
x
x
x
John
Szpylka
Merieux NutriSciences Medical University of Lublin
x
x
Tomasz
Tuzimski
x
x
x
Jinchuan Yang
Waters Eurofins
x x
x x
Hong
You
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