Microsoft Word - SPDS_0918_ERP-Proposal-07-11-2018DMC

1

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 

2

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.  ‐‐‐ 

5

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. 

6

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%

8

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 

9

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 

10

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. 

11

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%

13

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.  ‐‐‐ 

14

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 

15

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. 

16

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%

18

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 

19

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.   

21

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 

22

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.  ‐‐‐ 

23

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. 

26

‐‐‐  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 

27

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 

28

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. 

29

‐‐‐  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.   

30

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