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Bilberry Extract Laboratory Guidance Published by ABC-AHP-NCNPR Botanical Adulterants Program

BilberryExtractLaboratoryGuidancePublishedbyABC-AHP-NCNPRBotanicalAdulterantsProgram

QualityconsortiumssecondLabGuidanceDocumentreviews39laboratorymethodsfortheanalysisofbilberryextracttoensureproperidentityanddetectionofpossibleadulterants

(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.”1

TheProgram’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,theBotanicalAdulterantsMonitor,thathighlightsnewscientificpublicationsrelatedtobotanicalauthenticityandanalysistodetectpossibleadulteration,recentregulatoryactions,andProgramnews.

Reference

1.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.