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ABC Says New York Attorney General Misused DNA Testing for Herbal Supplements, Should Also Have Used Other Test Methods as Controls

MediacoveragedoesnotmentionknownlimitationsofDNAtestingprotocols

(AUSTIN,Texas,Feb.3,2015)TheNewYorkStateAttorneyGeneral(AG)EricT.Schneidermanhasissuedapressrelease[1]statingthathisofficehassentcease-and-desistletterstofourmajorUSretailchainsinformingthemthattheymuststopsellingstorebrandsofherbaldietarysupplementsthatwerefoundproblematicinDNAbarcodingtestsconductedfortheAG'soffice.Schneiderman’sofficecommissionedtestingofstore-brandsupplementsfromGNC,Target,Walgreens,andWalmart,includingtheherbalsupplementslabeledasechinacea,garlic,ginkgo,ginseng,sawpalmetto,St.John’swort,andvalerian.Accordingtothepressrelease,allegedlyonly21%ofthestore-brandherbalsupplementscontainedDNAfromtheplantslistedontheproducts’labels.Theretailerwiththeleastamount(4%)oftestedproductsshowingDNAfromthelabeledplantswasWalmart.[1]Inaddition,manyproductsapparentlydidnotcontainanyDNAfromabotanicalsource.TheAG’sofficecontractedwithProf.JamesA.SchulteII,PhD,ofClarksonUniversityinPotsdam,NewYork,whoemployedDNAbarcodetechnologytotestthesupplements.Dr.Schultehasabackgroundinevolutionarybiologyandreptilianzoology,butisnotconsideredanexpertinbotany,pharmacognosy,ornaturalproductchemistry—threekeyscientificareasrelatedtoherbandmedicinalplantresearch.TheAmericanBotanicalCouncil(ABC)wascontactedbyNewYorkTimeswriterAnahadO’ConnoronMondayafternoonrequestingacommentontheAttorneyGeneral’s(then-embargoed)pressrelease.ChiefScienceOfficerofABCandTechnicalDirectoroftheABC-AHP-NCNPRBotanicalAdulterantsProgramStefanGafner,PhD,andABCFounderandExecutiveDirectorMarkBlumenthalsentthefollowingstatementtoMr.O’Connor,whichwasnotincludedintheTimes’articles[2,3]thatappearedonlineandonthefrontpageoftheNewYorkTimesthismorning(abovethefold):



TheAG’sstudyisnotbasedonadequatescienceanditsactionsarethuspremature.TheuseofDNAbarcodingtechnologyfortestingoftheidentityofbotanicaldietarysupplementsisausefulbutlimitedtechnology.DNAtestingseldomisabletoproperlyidentifychemicallycomplexherbalextractsaslittleornoDNAisextractedinmanycommercialextractionprocesses.Basingitsactionsonthebasisofonlyonetestingtechnologyfromonlyonelaboratory,theNYAGresultsarepreliminaryandrequirefurthersubstantiation.AdditionaltestingusingmicroscopicanalysisandvalidatedchemicalmethodsshouldbeconductedtoconfirmtheinitialresultsuponwhichtheAGisacting.

ABCalsoaddedthefollowingstatementbasedonrecentlypublishedDNAstudiesoncommercialginkgoextractsconductedattheNewYorkBotanicalGarden[4]andthehighlyrespectedUniversityofMississippi’sNationalCenterforNaturalProductResearch[5]:“TheAG’stestresultsdonotcomportwithotherrecentlypublishedresearchonherbaldietarysupplements.Tworecenttestsfromreputablelaboratoriesoncommercialginkgoextractshavefoundginkgoinalloralmostallofthesamplestested.”TheWashingtonPostalsopostedastory[6]thismorning,andothermediaoutletsareexpectedtofollowsuit.AccordingtoBlumenthal,“Fromascientificperspective,itappearsthattheNYAGiswayoutinfrontoftheavailablescientificevidencetosupportandsubstantiatehisposition.Wecannotknowthisforcertainuntilweknowmoreaboutthetestingprotocols,butingeneral,aswetoldtheNewYorkTimes,DNAbarcodetestingoftencannotdeterminetheidentityofabotanicalmaterialifit’sbeenextracted,orifthematerialhasbeensubmittedtoaprolongedheattreatment,”hecontinued,“so,ifanyoftheproductstestedwereextracts—e.g.,ginkgo,andpossiblytheSt.John’swortproducts—thenit’sunderstandablewhytheygotanegativefinding.Thisalsomaybetrueforotherproductstested,i.e.,iftheywereextracts.”“Further,”saidDr.Gafner,“itseemsasiftherewasn’tanyverificationoftheresults.AswenotedinthestatementtotheNewYorkTimes,microscopyandvalidatedchemicaltestmethods,likethosefoundinofficialpharmacopeiasforthesesevenherbs,shouldhavebeenconductedtoconfirmtheDNAfindings.Thebestwaytodeterminetheidentityofbotanicalmaterialsandingredientsinfinishedsupplementsistousearangeofappropriatemethodswheneverpossible.”“TheactionbytheNewYorkAttorneyGeneralishighlyproblematic,”addedBlumenthal.“WehereatABCaresympatheticwiththeAG’sobviousconcernaboutthereportedproblemsassociatedwithadulterationofherbalingredientsindietarysupplements.Afterall,ABCistheinternationalleaderineducatingtheindustry,researchers,andhealthprofessionalsabouttheproblemsassociatedwithadulteratedbotanicalingredientsthroughourleadershipoftheABC-AHP-NCNPRBotanicalAdulterantsProgram.However,everythingwearedoinginourProgramisbasedonscientificresearch,includingevaluationofappropriatetestingmethods,andfullpeerreview.Werespectfullymustquestionwhetheranappropriatelevelofscientificrigorhasbeenappliedinthiscase.”“TheNewYorkAGshouldtakeeveryprecautiontoapproachpotentialwaystodealwiththisproblembyusingappropriateprotocols,includinganextensivereviewbycompetentscientistswhoarefamiliarwiththeanalysisofbotanicaldietarysupplements,”addedDr.Gafner.“ConductingDNAtestswithlittleornoapparentverificationbyothertestmethods,andwithoutemployingasecondorevenathirdanalyticallaboratorytoconfirmthefindingsofthefirstlabresults,andthenproceedingtoengageinregulatoryactivityisprematurebasedontheevidencetheyhavecollectedanddisclosedthusfar.AdditionaltestinginanotherqualifiedDNAlabaswellasbyotherappropriateandvalidatedtestingmethodsisrequired.”Dr.GafneremphasizedthatalthoughsomeextractsmaycontainDNA,itisoftenoflowqualityordegradedtoapointthatmakesitimpossibletoperformproperauthentication.Otherprocesses,suchasextensiveheattreatmentorsubmissionofplantmaterialtoUVlightalsoimpactthequalityandmayleadtoerroneousresultsusingDNAmethods.“If,whenthedustsettlesonthisissueandallappropriateanalyticalmethodsandprotocolsareusedtotesttheseproducts,andtheystillconfirmtheNYAG’sinitialtests,onlythenshouldtheNewYorkAG(andtheFoodandDrugAdministration)pursueappropriatelegalandregulatoryenforcementoptions,”saidBlumenthal.“However,”hecontinued,“thatcanhappenonlywhenallappropriatetestsarerunbypeoplewhoareexpertinthetestingofplantmaterials.Basedonwhatwecandetermine,thathasn’toccurredhere.”

References

1.A.G.SchneidermanAsksMajorRetailerstoHaltSalesofCertainHerbalSupplementsasDNATestsFailtoDetectPlantMaterialsListedonMajorityofProductsTested[pressrelease].Albany,NY:NewYorkAttorneyGeneral’sOffice;February3,2015.Availableat:www.ag.ny.gov/press-release/ag-schneiderman-asks-major-retailers-halt-sales-certain-herbal-supplements-dna-tests.

2.O’ConnorA.NewYorkAttorneyGeneralTargetsSupplementsatMajorRetailers.NewYorkTimes.February3,2015.Availableat:http://well.blogs.nytimes.com/2015/02/03/new-york-attorney-general-targets-supplements-at-major-retailers/?_r=0.

3.O’ConnorA.What’sinThoseSupplements?NewYorkTimes.February3,2015.Availableat:http://well.blogs.nytimes.com/2015/02/03/sidebar-whats-in-those-supplements/.

4.LittleDP.AuthenticationofGinkgobilobaherbaldietarysupplementsusingDNAbarcoding.Genome.2014Sep;57(9):513-516.Availableat:www.nrcresearchpress.com/doi/pdf/10.1139/gen-2014-0130.

5.WangM,ZhaoJ,AvulaB,etal.High-Resolutiongaschromatography/massspectrometrymethodforcharacterizationandquantitativeanalysisofginkgolicacidsinGinkgobilobaplants,extracts,anddietarysupplements.JAgricFoodChem.2014Dec17;62(50):12103-12111.Availableat:http://pubs.acs.org/doi/abs/10.1021/jf503980f.

6.KaplanS.GNC,Target,Wal-Mart,Walgreensaccusedofsellingadulterated‘herbals’.WashingtonPost.February3,2015.Availableat:www.washingtonpost.com/news/morning-mix/wp/2015/02/03/gnc-target-wal-mart-walgreens-accused-of-selling-fake-herbals/.