BilberryExtractLaboratoryGuidancePublishedbyABC-AHP-NCNPRBotanicalAdulterantsProgramQualityconsortium’ssecondLabGuidanceDocumentreviews39laboratorymethodsfortheanalysisofbilberryextracttoensureproperidentityanddetectionofpossibleadulterants(Austin,Texas,August12,2015)TheABC-AHP-NCNPRBotanicalAdulterantsProgramannouncesthepublicationofitsnewLaboratoryGuidanceDocument(LGD)onBilberry(Vacciniummyrtillus)fruitextract.ThisispartoftheProgram’snewseriesofcomprehensive,authoritative,extensivelypeer-reviewed,andup-to-datesummariesandassessmentsoflaboratoryanalyticalmethodsforauthenticationoftheidentityofbotanicalingredientsanddetectionofthepotentialpresenceofknownadulterants.TheProgram’sbilberryLGDisthesecondpublicationinitsLaboratoryGuidanceDocumentseriesforbotanicalingredients.ItfollowsJanuary’sinauguralLGDpublicationonskullcap(Scutellarialateriflora)herb.ThereisampleevidencefrompublishedandunpublishedlaboratoryreportsthatbothoftheseherbsaresubjecttoadulterationintheUSandinternationalmarkets.TheLGDsareintendedforusebyqualitycontrolpersonnelandlabtechniciansintheherbalmedicine,botanicalingredient,anddietarysupplementsectorsofindustrytohelpthemchoosethemostappropriatetechniquesandmethodsfortheirspecificanalyticalneeds.TheLGDsareavailabletomembersofindustry,researchers,healthprofessionals,andthegeneralpublicatnocostaspartoftheBotanicalAdulterantsProgram’spolicyofproducingfreelyavailableeducationaldocumentsonadulteration,madepossiblethroughfundingbytheProgram’sunderwritersandsupporters.TheAmericanBotanicalCouncil(ABC)-AmericanHerbalPharmacopoeia(AHP)-NationalCenterforNaturalProductsResearch(NCNPR)BotanicalAdulterantsProgram(BAP)isaninternationalconsortiumofnonprofitorganizations,analyticallaboratories,professionalscientists,industrymembers,professionalandtradeorganizations,andothersthatadvisesindustry,researchers,healthprofessionals,andthepublicaboutthevariouschallengesrelatedtoadulteratedherbandbotanicalingredientssoldincommerce.Todate,morethan165AmericanandinternationalpartieshavefinanciallysupportedorotherwiseendorsedtheProgram.“ForthefirstseveralyearsofourProgram,wepublishedarticlesalertingmembersoftheherbindustryaboutadulterationofspecificherbs,”saidMarkBlumenthal,founderandexecutivedirectoroftheAmericanBotanicalCouncilanddirectoroftheBAP.“Now,inadditiontooursoon-to-be-enhancedseriesofpublicationsonadulteratedherbs,weareofferingtechnicalresourcestoassistindustryandthird-partylaboratoriestodetectadulterationandhelppreventadulteratedbotanicalingredientsandextractsfrombeingprocessedintofinishedconsumerproducts.”TheABC-AHP-NCNPRLaboratoryGuidanceDocumentsareintendedtoprovidereliable,expertguidanceonsuitablemethodstocomplywiththemandatedrequirementsoftestingforidentity,purity,strength,andcompositionoutlinedintheUSFoodandDrugAdministration’scurrentGoodManufacturingPractices(cGMPs)fordietarysupplements,aswellasgovernment-mandatedGMPsinothercountries.PertheUScGMPs,itistheresponsibilityofthedietarysupplementmanufacturersto“conductatleastoneappropriatetestorexaminationtoverifytheidentityofanycomponentthatisadietaryingredient.”1TheProgram’sLGDsprovideinformationaboutthemostsuitableanalyticalmethodsfordetectionofcertainadulterantsandauthenticationofspecificbotanicalmaterialsintheformofwhole,cut,orpowderedrawmaterials,extracts,andessentialoils.Conclusionsarebasedonathoroughreviewofavailableanalyticalmethods(e.g.,fromofficialandunofficialcompendia,aswellasthepeer-reviewedliterature)andinputfrompeerreviewersfromacademia,government,andindustryinmultiplecountries.TheBilberryFruitExtractLGDwaspeer-reviewedby16suchexperts.Theprimaryassessmentofeachmethodisbasedonitsperformancecharacteristics(i.e.,suitabilityindetectingknownadulterants,iftheyarepresentinatestedmaterial);laborandanalysistimecomprisethesecondaryevaluationcriteria.StefanGafner,PhD,ABCchiefscienceofficerandBAPtechnicaldirector,emphasizedtheimportanceofhavingasolidanalyticalmethodtoevaluatebilberryrawmaterialsandfinishedproducts:“Basedoncommentsfromdietarysupplementingredientsuppliersandmanufacturers,theadulterationofbilberryextractsisabigconcernintheherbalindustry.Bilberriesarearichsourceofanthocyanins—naturallyoccurringblue-purplepigmentswithantioxidantandotherbeneficialpropertiesfoundinmanyfruitsandberries—butmanufacturingahigh-qualitybilberryextractisveryexpensiveduetothehighcostofbilberries.Peoplewhointendtocheathaveanumberofcheaperanthocyaninsourcesavailable,makingthediscoveryofadulterationsometimeschallenging.Therefore,itisimportanttouseananalyticalmethodthatisspecificenoughtodetectthepotentialadulterants.”TheBAP’sLGDsbeginwithastatementofpurposeandscopeinregardtotheparticularplantspeciescovered,followedbyashortoverviewofthebotanicalnomenclatureofthespeciesanditsknownadulterants.Alsoincludedaresectionsonanalyticaltechniques(generallyincludingmacroscopic,microscopic,chemical,andgeneticassays)andaphytochemicalcompositionoverviewofthespeciesandknownadulterants.TheLGDsconcludewithaconcisetableofstrengthsandlimitationsofthevariousassays.Completereferencesareprovidedwithlinkstooriginalsourcedocuments.ThenextLGDscheduledtobereleasedbytheABC-AHP-NCNPRBotanicalAdulterantsProgramisonthedetectionofblackcohosh(Actaearacemosa)adulteration.ForthebilberryextractLGD,39analyticalmethodswereevaluated,includingmacroscopicanalysis,botanicalmicroscopy,HPTLC,HPLC/UHPLC,andUV/Visspectrophotometry.“Thereviewisaccurateanditisavaluableguidanceonanalyticalmethodstoauthenticatebilberryextractsandtodetectadulteration,”commentedRobertoPace,PhD,directorofqualitycontrolatIndenaS.p.A.inMilan,Italy,afterreviewingthebilberryLGD.“Ideemitwillbeoneofthemainreferencesontheanalyticsofbilberry.”Todate,theABC-AHP-NCNPRBotanicalAdulterantsProgramhaspublishedfiveextensivelypeer-reviewedandreferencedarticlesonthehistoryofadulteration,adulterationoftheherbsblackcohoshandskullcap,andadulterationofbilberryfruitextractandso-called“grapefruitseedextract.”Theseopen-accessarticlesareavailableontheProgram’swebpage.TheProgramalsopublishesaquarterlye-newsletter,the“BotanicalAdulterantsMonitor,”thathighlightsnewscientificpublicationsrelatedtobotanicalauthenticityandanalysistodetectpossibleadulteration,recentregulatoryactions,andProgramnews.Reference1.USFoodandDrugAdministration.CodeofFederalRegulationsTitle21,Volume2,Part111(21CFR111):CurrentGoodManufacturingPracticeinManufacturing,Packaging,Labeling,orHoldingOperationsforDietarySupplements.Availableat:www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=111.RevisedApril1,2014.AccessedJuly22,2015.
