Executive Offices 1012 14th Street, NW 10903 New Hampshire Ave · 2020-04-13 · Executive Offices 1012 14th Street, NW Suite 205 Washington, D.C. 20005 April 08, 2020 Food and Drug

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Washington,D.C.20005April08,2020FoodandDrugAdministration10903NewHampshireAveSilverSpring,MD20993-0002Re:DrugProductsLabeledasHomeopathic;DraftGuidanceforFoodandDrugAdministrationStaffandIndustry(DocketNo.FDA-2017-D-6580)DearMembersoftheAdministration,TheCenterforInquiry(CFI)appreciatesthisopportunitytocommentontheproposedfinalenforcementguidancefordrugproductslabeledashomeopathic.CFIIsaCharitableNonprofitOrganizationDedicatedtoAdvancingEvidence-BasedPolicyCFIisaneducationalandadvocacyorganizationthatpromotesreasonandscientificintegrityinpublicaffairs.CFI’svisionisaworldwherepeoplevalueevidenceandcriticalthinking,wheresuperstitionandprejudicesubside,andwherescienceandcompassionguidepublicpolicy.Ourcommentsaresubmittednotonlyonbehalfofourorganization,itsemployees,anditsmembersbutalsoonbehalfofdozensofdoctorsandscientistsassociatedwithCFIanditsaffiliateprogramtheCommitteeforSkepticalInquiry(CSI)1andCFI’sdivision,theRichardDawkinsFoundationforReason&Science,2withwhomweworkonthesematters.Sinceitsinception,CFIhasbeenaprominentadvocateofevidence-andscience-basedpolicyinallbranchesofgovernment.In2016,CFIsubmittedanamicusbrieftotheSupremeCourtarguingthataTexaslawthatrestrictedaccesstowomen’sreproductivehealthcarewasbasedonunscientificinformationgatheredbyanindividualwithnomedicalqualifications.TheCourtruledinfavorofCFI’sposition.Inaddition,CFIengagesinciviceducationtoimprovescientificliteracyintheUnitedStates.Forexample,in2015asaresultofCFIandCSI’sefforts,theAssociatedPressannouncedthatit

1https://www.csicop.org/2https://www.richarddawkins.net/

wouldnolongerusethetermskeptictodescribeindividualswhorejectthemainstreamscienceofclimatechange.AprimaryfocusofCFI’sworkispreventingpublicharmfrompolicies,initiatives,orinstitutionsthatfailtoadheretoknownscientificfactsorprinciples.The“alternativemedicine”industryissuchaninstitution.Oneofthemostegregiousexamplesofharmful“alternativemedicine”ishomeopathy,acategoryofproductsbasedonthedisproveneighteenth-centurytheorythatwhendilutedtovirtuallynonexistentconcentrations,3otherwisetoxicsubstancestransferunidentifiedhealingpropertiestowatermolecules.Notonlyisthistheoryunsupportedbyevidence,itviolatesknownpropertiesofphysicsandchemistry.InApril2015,CFItestifiedtotheFoodandDrugAdministration(FDA)abouthomeopathy’spotentialharmandtheneedtoholdhomeopathicdrugstothesamestandardsofsafetyandefficacyasconventionalmedicine.InNovember2015,followingtheFederalTradeCommission’s(FTC)HomeopathicMedicine&AdvertisingWorkshop,CFIfiledcommentsurgingtheFTCtostopmanufacturersfromfalselyadvertisinghomeopathy’ssafetyorefficacyuntilsuchclaimscanbescientificallyproven.InNovember2016,theFTCissuedastaffreportontheHomeopathicMedicine&AdvertisingWorkshopthatcitedCFI’scomments.Concurrentwiththereport,theFTCissuednewenforcementguidanceforhomeopathicproducts,whichdeclaredthathomeopathicproductscannotincludeclaimsofeffectivenesswithout“competentandreliablescientificevidence.”Ifnosuchevidenceexists,homeopathicproductsmuststatethisfactclearlyontheirlabelingandthattheproduct’sclaimsarebasedonlyoneighteenth-centurytheoriesthathavebeendiscardedbymodernscience.InJuly2018,CFIfiledsuitagainstCVSHealth,thelargestretailpharmacychainintheUnitedStates,forfraudulentlymarketinghomeopathicproductsintheDistrictofColumbia.InMay2019,CFIfiledsuitagainstWalmart,thelargestretailchainintheworld,forthesameviolation.Bothcasesarecurrentlyprogressing.FDA’sFinalDraftEnforcementGuidanceDoesNotIncorporateConcernsExpressedbyCFIinOurPublicCommentonFDA’sInitialDraftEnforcementGuidanceIn2017,CFIsubmittedapubliccommentinresponsetotheFDA’sissuanceofdraftenforcementguidancetoreplaceCPG400.400.Inthatcomment,CFIexpressedconcernthat

3Indeed,thelevelofdilutionisoftensohighthatitisimpossibleaccordingtothelawsofsciencethatasinglemoleculeoftheoriginalingredientremains.

thedraftguidancewouldmakecompliancemoredifficultandwouldjeopardizeconsumerhealthandsafety.Thepresentfinalguidanceisextremelysimilarinsubstancetothe2017initialdraftguidance.Therefore,inadditiontoourpresentcomment,CFIdirectsFDA’sattentiontoour2017draftenforcementguidancecomment,4inwhichwestated:

CFIbelievesthatthesuggestedguidancedoesnotadequatelyaddressthemajorissuesposedbythemarketingandsaleofhomeopathicproducts intheUnitedStates, and leaves patients vulnerable to significant harm caused by theinappropriateuseandsaleofhomeopathicproducts.CFIhassignificantconcernsthatthedraftguidanceissuedbytheFDArepresentsastepbackfromtheFDA’sresponsibilitytoensurethatAmericanconsumersareprotectedfromtheharmscausedby ineffectively labeledand inadequatelytestedhomeopathicproducts.While the FDA has a responsibility to protect consumers from the dangersreferenced in the proposed guidance, this alone is insufficient. CFI thereforerequests that the FDA broaden its proposed enforcement priorities to includeregulationofthetestingandlabelingofallhomeopathicproducts.

TheFDA itself, importantly,hasalso recognized thathomeopathy isnoteffective. Forexample,theFDAhasissuednumerouswarningstoconsumersaboutthehealthrisksofrelyingonhomeopathicproductstotreatseriousmedicalconditions.Theseinclude,forexample,theFDA’sMarch2015warningagainstusinghomeopathicproductsthatclaimtotreatasthma,anoftenlife-threateningcondition.5Init,theFDAstates“TheU.S.FoodandDrugAdministration iswarningconsumersnottorelyonasthmaproductslabeledas homeopathic that are sold over-the-counter (OTC). These products have not beenevaluatedby the FDA for safety and effectiveness.”6More recently, the FDA issued awarning to parents regarding the use of homeopathic baby teething products thatcontainedbelladonna,commonlyknownasDeadlyNightshade,describingthemas“anunnecessary risk to infants and children,” and “urg[ing] consumers not to use theseproducts.”7InSeptember2019,CFICommissionedaScientificSurveyThatFoundHomeopathicProductsMisleadPatients

4ID:FDA-2017-D-6580-3876TrackingNumber:1k2-923w-pdsv.PostedonMarch29,2018.Availableathttps://www.regulations.gov/document?D=FDA-2017-D-6580-3876.5“FDAwarnsconsumersaboutthepotentialhealthrisksofover-the-counterasthmaproductslabeledashomeopathic.”FDA.https://www.fda.gov/Drugs/DrugSafety/ucm438976.htm.6Id.7“FDAwarnsconsumersabouthomeopathicteethingproducts.”FDA.https://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm523936.htm.

InSeptember2019,CFIpublishedtheresultsofasurveythatitcommissionedtomeasuretheextenttowhichconsumersaremisledbyhomeopathicdrugproductmarketing.8Thesurveydrewfromanationallyrepresentativesampleof1,000adults,alongwithanoversampleof200adultswhoresideinWashington,D.C.,whereCFIhasfiledsuitagainstWalmartandCVSforfraudulentlymarketinghomeopathicproducts.CFI’ssurveydemonstratesthatthesaleandmarketingofhomeopathicdrugsforself-limitingconditionsunderminesdrugregulatorysafetybyblurringthelinebetweenFDA-approvedOTCdrugs,non-FDAapprovedhomeopathicproducts,anddietarysupplements.Asaresult,confusedconsumersunknowinglypurchaseineffectiveandpotentiallyunsafehomeopathicproducts.Oneintensurveyrespondentsreportedhavingaccidentallypurchasedahomeopathicdrugproduct,havingmistakenitforanFDA-approved,science-baseddrug.Asaresult,patients’sufferingisneedlesslyextendedandaggravatedbecausetheyunknowinglypurchasehomeopathicdrugsinsteadofFDA-approveddrugsthataresafeandeffective.CFI’sresearchfoundthatrespondentsweregenerallyunfamiliarwiththepseudoscientificprinciplesofhomeopathy.Afterhavingtheseprinciplesexplainedtothem,respondents’trustinhomeopathicproductssharplydeclined.Only1percentofrespondentscorrectlyidentifiedAnasbarbariae,the“active”ingredientinthewidelymarketedhomeopathicdrugOscillococcinum,astheheartandliverofaMuscovyduck.Twenty-twopercentofrespondentsthoughtthatAnasbarbariaewasamedicine.Another13percentthoughtitwasavitamin,whichwouldmeanthatAnasbarbariaewereregulatedintheUnitedStatesasadietarysupplementundertheDietarySupplementHealthandEducationAct(DSHEA).Fifty-ninepercentofrespondentswereunsure.Oncerespondentswereinformedofthe“active”ingredient,almosthalf(46percent)viewedOscillococcinumlessfavorably.AmongrespondentswhowerenotfamiliarwiththetheoryofhomeopathyorthecontentsofOscillococcinum,whenaskedtoevaluatethesafetyandefficacyofOscillococcinumbasedonlyontheproductlabel,50percentbelievedtheproducttobeeffective.Another34percentofrespondentswereunsureofitsefficacy.Similarly,57percentofrespondentsbelievedOscillococcinumtobesafe,withanother29percentunsure.Fifty-onepercentofrespondentsbelievedthatOscillococcinumshouldbesoldinthe“Cough,Cold,andFlu”sectionofthepharmacy.YetwhenrespondentsweregiveninformationaboutthetheoryofhomeopathyandthecontentsofOscillococcinum,15percentshiftedtheirviewoftheproductfrom“effective”to8Dixon,Tim,andGotoff,Daniel.LakeResearchPartners.August2019.Findingsfromanationwideonlinesurveyofadultsonattitudestowardhomeopathicproducts,includinganoversampleofWashington,D.C.residents.PDFavailableathttps://centerforinquiry.org/wp-content/uploads/2019/09/LRP-Report-Center-for-Inquiry-Homeopathy.pdf.

“noteffective,”bringingthetotalpercentageofrespondentswhobelievedinitsefficacydownfrom50to35percent.Inaddition,thisinformationconsiderablyreducedrespondents’uncertaintyabouttheefficacyofOscillococcinum.ThepercentageofrespondentswhowereunsureaboutOscillococcinum’sefficacydroppedfrommorethanonethird(34percent)tojustoveronefifth(21percent).ThepercentageofrespondentswhobelievedthatOscillococcinumissafedeclinedfrom57percentto51percent.Overall,morethantwiceasmanyrespondentsshiftedtheirviewofOscillococcinumtoward“lesssafe”(21percent)thanthosewhoseviewshiftedtoward“moresafe”(10percent)onafour-pointscale.AskedwhethertheywouldbelikelytopurchaseOscillococcinumforuseonthemselves,24percentofrespondentsshiftedtheirviewtoward“notlikely”onafour-pointscale.ThepercentageofrespondentswhobelievethatOscillococcinumshouldnotbesoldalongsidenon-homeopathicdrugsincreasedtenpoints,from22percentto32percent.Allmajorsubgroupsidentifiedbythesurveyinthecategoriesofgender,race,age,collegeeducation,andregionregisteredadecline.Apluralityofrespondents(31percent)agreedwiththestatement“Itismisleading,andevendeceptive,tosellhomeopathicOTCdrugsonashelfnexttonon-homeopathicOTCdrugsintheCough,Cold&Flusectionwithoutawarning.”RespondentsexpressedagreaterdegreeoftrustinlargeretailpharmaciesthanintheFoodandDrugAdministration.Askedwhethertheytrustvariousinstitutions,anet49percentofrespondentsdeclaredtrustinWalmart,thenation’slargestconsumerretailchain.Similarly,anet54percentofrespondentsdeclaredtrustinCVS,whichoperatesthelargestpharmacyretailchain.Incontrast,anet36percentofrespondentsagreedthattheytrusttheFDA.ThisfragiletrustiscrucialtotheeffectivenessofFDA’sOTCdrugregulatoryregime.Itisunderminedwhennon-FDAapprovedhomeopathicproductsaremarketedasdrugsalongsideFDA-approveddrugs.Onlythemostdiscerningpatientsarelikelytodistinguishbetweenapproveddrugsandnon-approvedhomeopathicproducts.Apluralityofrespondents(46percent)chooseacoldandfluremedybyselectingaproductfrom“theappropriateaisle”ofapharmacywithoutconsultingapharmacistordoctor.Therefore,peoplearelikelytoviewtheinclusionofhomeopathicproductsindrugaislesasanimplicitendorsementoftheproduct’ssafetyandefficacy.Indeed,10percentofrespondentsreportedthattheyhaveaccidentallypurchasedahomeopathicdrugwhentheyintendedtopurchaseanon-homeopathicdrug.Another20percentofrespondentswereunsure,suggestingthathomeopathicproductlabelingandplacementissovagueanddeceptivethattheycouldnotreliablyrecallwhethertheyhavepurchasedahomeopathicproduct.ToUpholdtheProvisionsoftheFood,Drug,andCosmeticActof1938,FDA’sEnforcementGuidanceMustAssumeThatHomeopathicProductsAreUnsafeandIneffective

FDA’senforcementguidanceforhomeopathicproductsassumesthatmanufacturersareactingingoodfaithtocomplywithfederallawsincludingtheFood,Drug,andCosmeticActof1938(FD&CAct).This“benefitofthedoubt”formanufacturersisunjustifiedandplacespatientsatrisk.Homeopathyisaninherentlypredatoryindustrythatdeceptivelymarketsplainwaterandsugarpillsasa“natural”alternativetoFDA-approveddrugsthathavesuccessfullywithstoodscientificscrutinyinpremarketclinicaltrials.Thetheoryofhomeopathyissoscientificallyimplausiblethatmanufacturersoftheseproductscannotbeassumedtoactingoodfaithinaccordancewithdrugsafetyandefficacyandconsumerprotectionlaws.Inproofofpoint,thetheorycombinesthesepseudoscientificconcepts:

• The“lawofsimilar”or“letlikesbecuredbylikes.”Thisisthebeliefthatamedicalconditioncaninfactbetreatedbyadministeringadilutedsubstanceobservedtocauseitorsimilarsymptoms.Forthisreason,homeopathicproductsoftenconsistofdilutedsolutionsoftoxicsubstances(suchastheuseofDeadlyNightshadeinbabyteethingproductsasnotedsupra).

• The“lawofinfinitesimaldoses.”Thisisabeliefthatthemoreonedilutesaningredient,themorepowerfulitbecomes.Asaresult,manyhomeopathicproductsaredilutedbeyondAvogadro’sNumber,thepointatwhichthefinalproduct,howeverlargethedosetaken,likelynolongercontainsevenamoleculeofthesupposedactiveingredient.9

• “Essence”and“watermemory.”Thebeliefsthatsubstancesaddedtowaterimparttheir“essence”ontothewatermoleculesthemselves,andthatwaterretainsa“memory”ofthingsthathavebeeninpreviouscontactwithit.Thisentirelyunsubstantiatedsuppositionistheinventionofhomeopathswhorecognizetheimpossibilityofreconcilingthetechniqueofextremedilutionwiththelawsofchemistry.So,althoughafinishedhomeopathicsolutionmaynolongercontainanymoleculesoftheactualsupposedremedy,homeopathscontendthatthewatermaintainsitspower.

• “Miasmtheory”and“vitalforce/vitalprincipletheory.”Thehypothesesthatalldiseasesarecausedbyoneofthreeoffending“miasms”—psora,syphilis,andsycosis—whichdisruptthe“vitalforce”atthecoreofahumanbeing.Asasystemofvitalism,homeopathicproductsaremeanttoaddressthesemiasms.

• “Thelawofsusceptibility.”Thehypothesisthatnegativethinkingcanattractsaidmiasmsandleadtoillness.

CFInotesthattheNationalCenterforComplementaryandIntegrativeHealth(NCCIH)attheNationalInstitutesofHealth(NIH)hasrejectedtheefficacyofhomeopathy,stating,“There’s

9Forexample,Oscillococcinum,ahomeopathicpreparationthatisclaimedtotreatinfluenza,consistsoftheliverandheartofaparticularkindofduck,dilutedtoalevelof200C,leavingonepartduckoffalto10400partswater.Bywayofcomparison,currentestimatessuggestthattheknownuniversecontainsupto1082atoms.

littleevidencetosupporthomeopathyasaneffectivetreatmentforanyspecifichealthcondition.”10Thesaleofhomeopathicproductswillthereforecauseunknowingpatientstodelayorrejectevidence-basedtreatmentswithFDA-approveddrugs,causingthemunnecessarysufferingandpossiblyexacerbatingtheseriousnessoftheirdiseaseandmakingitmoredifficulttotreat.AsFDAnotesinitsfinalenforcementguidance,homeopathicproductsarenotgenerallyrecognizedassafeandeffective“byqualifiedexpertsforuseundertheconditionsprescribed,recommended,orsuggestedinthelabeling(GRAS/E).”Therefore,inaccordancewithSection201(p)oftheFD&CAct,allhomeopathicproductsareclassifiedas“NewDrugs.”FDAmakesGRAS/EdeterminationsforOTCdrugsmarketedundertheOTCDrugReviewbuttheagencydeferredreviewofhomeopathicproductsin1972andhasnotreviewedanyhomeopathicpreparationthatiscurrentlymarketedasadrug.11CFIbelievesthatacomprehensiveFDAreviewofthehomeopathicpreparationsdescribedintheHomeopathicPharmacoepiaoftheUnitedStates(HPUS)isvitallynecessarytoprotectpatientsfromunsafeand/orineffectivenewdrugs.FDAshouldconductthisdecades-overduereviewbeforemakingfurtherrevisionstopolicyorguidanceinthisarea.Nevertheless,intheabsenceofsuchreviewandinlightofthefactsdescribedabove,FDAshouldassume,initsenforcementguidanceandinallotherconsiderations,thathomeopathicpreparationsareneithersafenoreffectiveattreatinganydisease.Inaddition,inrecentyearsgovernmentsinseveralcountrieshavebannedthesaleofhomeopathicproducts,severelyrestrictedtheirpermitteduses,repealedgovernmentfundingfortheuseorpurchaseoftheseproducts,orproposeddoingso,explicitlyinresponsetotheabundantscientificevidencethattheseproductsdonotandcannotsafelyandeffectivelytreatanyknownhealthcondition.ThesecountriesincludeCanada,12France,13Australia,14theUnitedKingdom,15andSpain.16FDA’sFinalEnforcementGuidanceShouldIncludeRequirementsThatExplicitlyReferencetheRelevantProvisionsoftheFD&CAct

10https://nccih.nih.gov/health/homeopathy#hed111FederalRegister.May11,1972.Volume37,Number92.12https://www.cbc.ca/news/health/government-funding-homeopaths-honduras-1.504605613https://www.theguardian.com/world/2019/jul/10/france-to-stop-reimbursing-patients-for-homeopathic-treatment14https://www.health.gov.au/internet/main/publishing.nsf/content/7E5846EB2D7BA299CA257F5C007C0E21/$File/review-of-pharmacy-remuneration-and-regulation-final-report.pdf15https://www.theguardian.com/lifeandstyle/2017/jul/21/a-misuse-of-scarce-funds-nhs-to-end-prescription-of-homeopathic-remedies16https://elpais.com/elpais/2018/11/14/inenglish/1542203925_514487.html

ThedraftguidanceeliminatesthedetailedreferencestorelevantprovisionsoftheFD&CActthatwereincludedinCPG400.400.HomeopathicdrugmanufacturerswilllikelyinterpretthisomissionasFDA’stacitpermissiontounlawfullymarketunapprovedhomeopathicpreparationsasdrugssolongasmanufacturersavoidonlythemostegregiousviolations.ThisinturnwillunderminetheperceivedlegitimacyoftheFDAapprovalprocessandtheimportanceofpremarketscientificresearchonthesafetyandefficacyofnewdrugs.AnyenforcementguidanceissuedbyFDAshouldincludespecificinstructionsforhomeopathicmanufacturerstocomplywiththerequirementsoftheFD&CActwithreferencestospecificprovisions.Forexample,injustifyingitsrequirementtotranslateproductingredientnamesfromLatintoEnglish,CPG400.400referredtomultipleprovisionsoftheFD&CActandcorrespondingfederalregulations:Section502(e)(3)oftheActand21CFR201.10requirethatdrugproductsbearanestablishedname.Section502(c)oftheActand21CFR201.15(c)(1)requirethatalldrugproductlabelingbeinEnglish.TheRequirementEstablishedinCPG400.400toListIngredientNamesinEnglishIsCriticaltoEliminatingUnnecessaryRisksPosedbyUnapprovedNewDrugsandShouldNotBeRepealedCPG400.400,firstissuedinMay1988,requiredhomeopathicdrugmanufacturerstotranslateactiveingredientsfromLatintotheircommonEnglishnamesonproductlabeling“byJune11,1990,orascurrentlabelingstocksaredepleted,whicheveroccursfirst.”Sincethen,homeopathyhasgrowntoanindustryofmorethan$1billionannually.Today,nearlythirtyyearslater,manyhomeopathicdrugmanufacturersarestillinviolationofthiscommonsenserequirement.Intheencloseddocuments,Figure1isaphotographofahomeopathicdrugproduct,Sinusalia,takenbyCFIonNovember27,2018.SinusaliaismanufacturedbyBoiron,oneofthelargestmanufacturersofhomeopathicdrugproductsinboththeUnitedStatesandintheworld.Morethantwenty-eightyearsafterthedeadlineimposedbyFDA,BoironcontinuestomarkethomeopathicdrugproductswithingredientnameslistedonlyinLatin.Figure2isaphotographofthesamehomeopathicdrugproduct,Sinusalia,takenbyCFIonNovember27,2018,withCFI’stranslationofthetoxicactiveingredientsfromLatintoEnglishsuperimposedontheproductingredientlabel.Figure3isaphotographofahomeopathicdrugproduct,SinusCalm,purchasedbyCFIonSeptember16,2019.SinusCalmisalsomanufacturedbyBoiron.SinusCalmcontainsthesameingredientsasSinusaliaandisapparentlyanidenticalproductmarketedunderanewname.Despitehavingobviouslychangeditslabelingstockstoaccommodatethenewproductname,BoironcontinuestolisttheactiveingredientsexclusivelyinLatin.

Theseflagrantviolationsdeceiveconsumersbymakingitappearthatthecommontoxins,whichcomprisehomeopathy’s“active”ingredients,wereevaluatedbymedicalspecialistseducatedinprofessionaljargon.DespiteFDA’sclaimthatCPG400.400isoutdated,therequirementtotranslateingredientnamesfromLatintoEnglishismorerelevantthanever.ToremovethisrequirementeffectivelycondonesthisdeceptivepracticeandtacitlyencourageshomeopathicmanufacturerstoviolateotherFDAregulations.FDAshouldretainthisrequirementandrenewitscommitmenttoenforcementofit.Clearly,therequirementtolistactiveingredientsinthelanguageoffluencyofmostAmericansisanecessarycomponentofFDA’sguidance.Ifyouhaveanyquestionsaboutourcomments,pleasecontactJasonLemieuxatjlemieux@centerforinquiry.org.Sincerely,

RobynBlumnerPresidentandCEOCenterforInquiry

NicholasLittleVicePresidentandGeneralCounsel,LegalDirectorCenterforInquiry

JasonLemieuxDirectorofGovernmentAffairsCenterforInquiry

Enclosures:Figure1–BoironHomeopathicDrugSinusaliainviolationofFDA’srequirementtotranslateactiveingredientsfromLatintoEnglish.ObservedonNovember27,2018.Figure2–BoironHomeopathicDrugSinusaliawithCFI’stranslationoftoxicactiveingredientsfromLatintoEnglish.ObservedonNovember27,2018.Figure3–BoironHomeopathicDrugSinusCalm,withingredientsidenticaltoBoiron’sdiscontinuedproductSinusalia,inviolationofFDA’srequirementtotranslateactiveingredientsfromLatintoEnglish.PurchasedonSeptember16,2019.

Figure1–BoironHomeopathicDrugSinusaliainviolationofFDA’srequirementtotranslateactiveingredientsfromLatintoEnglish.ObservedonNovember27,2018.

Figure2-HomeopathicDrugSinusaliawithCFI’stranslationoftoxicactiveingredientsfromLatintoEnglish.ObservedonNovember27,2018.

Figure3–BoironHomeopathicDrugSinusCalm,withingredientsidenticaltoBoiron’sdiscontinuedproductSinusalia,inviolationofFDA’srequirementtotranslateactiveingredientsfromLatintoEnglish.PurchasedonSeptember16,2019.