Consumer Choice and FDARegulation of Sunlamp Products

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Citation Faina Shaltz, Consumer Choice and FDA Regulation of SunlampProducts (2011).

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ConsumerChoiceandFDARegulationofSunlampProducts

Abstract

ThispaperexploresthehistoryofFDAregulationofsunlampssince1974,identifiesand

critiquestheoverridingrationaleofconsumerchoiceasthebackgroundforrelativelylax

FDAregulations,anddiscussesthepossiblewaysinwhichFDAregulationofsunlampscan

changetobettersuittheFDA’sroleinprotectingconsumersfromdangerousproducts.

Proposalsforsunlampregulationareidentifiedandanalyzed,leadingtotheconclusion

thatmoreeffectiveregulationofsunlampuserequiresatleastsomeabandonmentofthe

consumerchoicerationaleinsunlampregulation.

Introduction

“TheUnitedStatesDepartmentofHealthandHumanServicesandtheWorldHealth

Organization’sInternationalAgencyforResearchonCancerhaveclassifiedUVradiation

fromtanningdevicesascarcinogenictohumans,inthesamecategoryastobaccoand

tobaccosmoking.Areviewofsevenstudiesfounda75percentincreaseinmelanomain

thosewhohadbeenexposedtoUVradiationfromindoortanningbeforetheageof35.”1

“Youmightbesurprisedatthenumberofbenefitsoftanningbeds.Obviously,themost

obviousbenefitisdevelopingawonderfultan.Typically,assummerapproaches,people

willbegintovisitthelocaltanningsalontoestablishabasetansowhentheydogo

outdoorsinthesuntheydonotburn,ortodeveloparichtanthatlooksasiftheyjustcame

1AmericanAcademyofDermatologyandAADAssociation.PositionStatementonIndoorTanning,November14,2009.Available:www.aad.org/.../Position%20statements/PS‐indoor‐tanning.pdf.

backfromvacationinHawaii.Then,thereareotherindividualswhohaveaspecialfunction

toattendwherebytheywantahealthyglow.”2

“Whileindoortanningisacosmeticservice,awell‐knownsideeffectofexposingtheskin

toultraviolet(UV)lightistheproductionofvitaminD.Emergingevidencesuggeststhat

theremaybeanepidemicofvitaminDdeficiencyinNorthAmerica.Researchalsosuggests

thatvitaminDplaysanimportantroleinmaintaininggoodhealth.”3

“[A]commonmisperceptionisthatindoortanningprotectsyoufromsundamageby

providingabasetan,andcanbeasafesourceofvitaminD.Botharefalse.”4

“[T]heagencybelievesthatsunlampsperformafunctiondesiredbytheconsumerand,

consequently,hasnotpenalizedtheprudentindividualbyremovingthispotentially

hazardousproductfromthemarketplace.”5

“Ifyou’reconfusedaboutthehealtheffectsofindoortanning,restassured:You’renot

alone.Fordecades,theAmericanAcademyofDermatology,theSkinCancerFoundation,

andothermedicalgroupshavepoundedhomethemessagethatit’sadangerouspractice

andshouldbeavoided.Manydermatologistssuggestthatthetanningindustry,likethe2TanningInfoCenter.TheBenefitsofTanningBeds.Available:http://www.tanninginfocenter.com/benefits‐of‐tanning‐beds.html.3TheIndoorTanningAssociation.“PositiveEffectsofUVLight.”Available:http://www.theita.com/?page=Positive_Effects_UV.4McCook,Alison.“Manyignoreindoortanningrisks.”Reuters,2010.Available:http://www.reuters.com/article/2010/12/21/us‐indoor‐tanning‐idUSTRE6BK44L20101221.521CFR§1002(1985).

tobaccoindustrybeforeit,ismanipulatinganddistortingscientificevidencetoprotecta

dangerousproduct.”6

ThereislittlequestionthatUVexposureiscarcinogenic.Sunlampsemitultraviolet

radiationinselectedwavelengths.Thoughalsousedtherapeutically,sunlampsare

associatedwithindoortanningandthecosmeticeffectofdarkerskinthatUVexposure

causes.SincetheadventofsunlampsandtheirgrowingpopularityintheUnitedStates,the

risksposedbyUVradiationcanbeaccessedviaindoortanningfacilities.Thispaper

exploresFDAregulationofsunlampsusedforcosmeticpurposes,andquestionsthe

validityofconsumerchoiceasarationaleforallowingtheircontinuedexistenceonthe

market.PartIpresentsahistoryofFDAregulationofsunlampsfrom1974tothepresent

day,andconcludesthatlittleabouttheirregulationhaschangedsincesunlampsentered

themarket.FDAregulationhascontinuedtofocusonlabelingrequirementswiththegoal

ofinformingconsumersaboutthedangersofsunlampstoenablethemtomakeinformed

choicesabouttheiruse.PartIIdiscussesthescientificevidencepertainingtothedangersof

sunlampuse.SunlampsemitUVradiation,whichdamagesskinandcausesDNAmutation

ofsubcutaneouscells.Thesemutationsinturnleadtothedevelopmentofcancerouscells.

PartIIIintroducesstateregulationspertainingtosunlampuse,showingthatstates’

emphasisisontheappropriateagetobegintanning.States’responsestothedangersof

tanningshowthatthereisastillanimportantrolefortheFDAtoplayinprotecting

consumersfromdangerousproducts.Thoughage‐basedrestrictionsareanimportantstep

6Voiland,Adam.“TheIndoorTanningIndustryWantsYou.”USNewsHealth,2008.Available:http://health.usnews.com/health‐news/family‐health/articles/2008/06/25/the‐indoor‐tanning‐industry‐wants‐you.

inensuringthatconsumersofsunlampshavethematuritynecessarytobalancetherisks

andbenefitsofindoortanning,consumerconfusionstillaboundsandFDAactionissorely

needed.PartIVdiscussesthetaxonindoortanningleviedby§10907ofthePatient

ProtectionandAffordableCareAct(PPACA).Thetax’seffectremainstobeseen,butit

appearsastepinthedirectionofincentivizingconsumerstoreconsiderthedesirabilityof

indoortanning.PPACA’smentionofindoortanningindicatesanacknowledgmentbyour

federalgovernmentofthedangersposedbyindoortanning,andsuggeststhatavenues

outsideoftheFDAarealsoavailableforprotectingconsumersfromthedangersofsunlamp

use.PartVdiscussespotentialavenuesforfutureFDAregulationofsunlamps,concluding

thatreclassificationofsunlampsasClassIIMedicalDeviceswouldconstituteanimportant

movebytheFDAinreducingconsumeruseofsunlamps.PartVIweighsconcernsabout

governmentalpaternalismwiththevalueofconsumerchoice,concludingthattheFDA’s

roleinbalancingthesevaluesrequiresmoreweightinfavorofprotectionofconsumers.

PartVIIsurveysseveralrecentcourtcasespertainingtoinjuriesfromsunlampuse,and

considerslessonsthesecasesmayprovideforadvocatesofconsumerchoice.Ultimately,

thedangersofsunlampsareserious,andthispaperconcludesthatmorestringent

regulationoftheindoortanningindustrybytheFDAisnecessary.

I.HistoryofSunlampRegulationbytheFDA

Despitecontinuingrecognitionofthedangersofindoortanning,theFDAhaschosen

toallowtheuseofsunlampsforcosmeticpurposes,citingtheimportanceofconsumer

choice.SincetheFDAbeganitsregulationofsunlamps,ithasfocuseduponensuringthat

thesedevicesareaccompaniedbyinformationthatshouldpermitthereasonableconsumer

tomakeadecisionregardingtherisksandbenefitsofsunlampuse.Sunlampsfirstmade

theirappearanceinEuropeinthe1970saswinter‐wearyindividualssoughtanalternative

tonaturalsunlight7.Inthe1970s,indoortanningmadeitswaytotheUnitedStatesand

gainedpopularity.8

TheFDAfirstbegantotackleregulationof“sunlamps”in1974,atwhichtimeitwas

alreadyknownthatindoortanningcarriedriskstoskinhealth.In1974,sunlampmakers

wererequiredtoreportinjuriescausedbytheuseofsunlamps9,buttheFDArequested

moreinformationabouttherisksthattheyposedtotheconsumer.10Acknowledgingthe

“potentialhazard”posedbysunlamps,theFDAopenedthetopicofsunlampregulationto

noticeandcomment.Whilethecarcinogenicnatureoftanningwasasyetunknownin

1974,seriousinjuriesfromtheuseofsunlampshadalreadybeenreported,suchassevere

burnsandretinaldamage.In1975,theFDAinvitedcommentsonawiderrangeof

questionsrelatedtosunlamps.Consideringrulemakingonsunlamps,theFDAinquiredas

towhatclassofproductssunlampsshouldfallinto,thesortofperformancestandardthat

shouldbeinstitutedforsunlamps,whethersunlampsshouldbeusableinhousehold

sockets,thehealthrisksposed,theconstitutionoffuturewarninglabels,andthe

environmentaleffectsofsunlamps.Alsoin1975,theFDAdistinguishedsunlampsusedin

thehealthcaresetting,definingitsregulationasapplyingonlytothosesunlampsused

withouttheaidofaphysicianorphysicaltherapist.11

7Drummond,Katie.“IndoorTanningGetsaMomentintheSun.March29,2010.Available:http://www.aolnews.com/2010/03/29/indoor‐tanning‐getting‐unwanted‐moment‐in‐the‐sun/ 8Id.921C.F.R.§1002(1974).10Id.1121C.F.R.§1020(1975).

ThefirstcomprehensiveregulationofsunlampsbytheFDAwasproposedin1977

andwas“intendedtoreducethepossibilityofsunlamp‐relatedinjurybyreducing

unnecessaryexposureandoverexposuretosunlampradiation.”12Intheyearsintervening

sincetheFDAfirstrecognizedtheneedtoregulatesunlampexposure,theNational

ElectronicInjurySurveillanceSystem,runbytheConsumerProductSafetyCommission,

hadestimatedthatsunlampscausedthousandsofinjuriesperyearresultinginvisitstothe

emergencyroom.13Thefirsttestsonlaboratoryanimalsexposedtosunlampshadalso

yieldedresultssuggestingthatsunlampsmaycauseskincancer.14Thoughtestson

laboratoryanimalsarenotconclusiveevidenceofadevice’seffectsonhumans,inthecase

ofsunlampsethicalconsiderationsdictatetheimpossibilityofconductinghumantrials.

Nevertheless,giventhescientificcommunity’sunderstandingofUVradiation’seffecton

skinandtheresultsofsuchanimalstudies,itissafetoconcludethatthecurrentstateof

scientificunderstandingleaveslittledoubtthatUVradiationfromsunlampsposesserious

dangertotheskinofconsumers.

Inrespondingtotheconcernsraisedbysuchreports,theFDACommissionercould

havetakenoneofanumberofcoursesofaction.Asdescribedinthe1977proposedrule,

theCommissionercouldhaveusedthedefectprovisionsofthePublicHealthServiceAct,

setforthvoluntaryrecommendationsforsunlampmakers,orcreatedaproduct

performancestandard.Examiningtheseoptions,theCommissionerfoundthatusingdefect

provisionswouldbeproblematicbecausetheyarenotprospective,andvoluntary

1221C.F.R.§1040(1977).13Id.14Id.

recommendationslacktheenforcementabilityofperformancestandards.15Thedefect

provisionsofthePublicHealthServiceActwouldessentiallyhaveallowedthe

Commissionertoclaimthatsunlampspossessadefectthatmakesthemineligibleforsale

intheUnitedStates.Conceivablythatdefectcouldbecarcinogenicityorgeneralimpacton

skinhealth.VoluntaryrecommendationswouldpermittheFDAtogivethetanning

industryflexibilityinmeetingthesuggestionsbytheFDA,butsinceenforceabilityis

importantwhenprotectingthesafetyofconsumerproductstheadvantageofvoluntary

recommendationsoverproductperformancestandardsisslim.Settlingontheuseof

“mandatoryproductperformancestandards,”theCommissioneracknowledgedthatthis

routewouldnotmitigateallrisksfromsunlamps,andthattheFDAwasopentothe

possibilityofstrongerconsumerprotection,morecomprehensiveuserestrictions,and

evenbanningtheuseofsunlampsoutsidetheprescriptionsetting.16

Thefirstfinalruleregardingsunlampswaspromulgatedin1979.Inadditionto

settingforthaperformancestandardfortheuseofsunlampsintheUnitedStates,inthe

FederalRegistertheFDAconsideredandrespondedtocommentsmaderegardingthe

proposedrule.Ultimately,thoughtheFDAacknowledgedtherisksposedbysunlampuse,it

concludedthat“sunlampsperformafunctiondesiredbytheconsumer,andconsequently,

hasnotpenalizedtheprudentindividualbyremovingthispotentiallyhazardousproduct

fromthemarketplace.”17Essentially,theFDA’sregulationofsunlampsappearstohave

startedfromthepremiseofguardingconsumerchoice.The1979regulationsdefined

sunlampsasamedicaldevice,becausetheFDAbelievedthetherapeuticfunctionof

15Id.16Id.1721C.F.R.§1002(1979).

sunlampsforuseintreatingdisorderslikepsoriasiscouldnotbereadilyseparatedfrom

thecosmeticuseoftheproduct.18Inordertoprotectconsumersinboththerapeuticand

cosmeticcontexts,theFDAdecidedtopromulgateperformancestandardsforsunlamps

generallyasamedicaldevice.Thequestionofdistinguishingbetweentherapeuticandnon‐

therapeuticusesofsunlampspresentedanissueofcontention,andtheFDAalsoindicated

in1979thatitsregulationsweremeanttoapplyonlytosunlampsmeantforcosmeticuse,

presumablyundertheassumptionthattherapeuticusesofsunlampswouldinclude

physiciansupervisionandthereforethatconsumersinthatsettingdonotneedthesame

protections.However,in1979theFDAalsoacknowledged,“theremaybenosafethreshold

levelforexposuretoultravioletradiation.”19TheFDAinitiallygotinvolvedtoensurethe

safetyofsunlampsusedintheUnitedStates,butfromtheinceptionoftheFDA’sregulation

ofsunlampstheemphasishasbeenonconsumerchoice.Whilerecognizingtheknown

dangersofsunlampuse,theFDA’sfocuswasalmostexclusivelyonlabelingrequirements

designedtoinformtheconsumer.Someregulationsoftheactualuseofsunlampswere

alsopromulgatedin1979,suchasaten‐minutemaximumforexposure,andrequirements

fortheuseofprotectiveeyewear.Thebulkofthe1979ruleswerededicated,however,to

ensuringthatadequatelabelinginformedtheconsumerofthedangersofsunlampuse.The

tanningindustrybalkedatthelabelingregulations,arguinginacommentthattheFDA

doesnotrequirelabelsascomprehensiveoncigarettes,whichareknowntobedangerous

tohumanhealth.Sidesteppingthecomparison,theFDAsimplyindicatedthatcigarettes

werenotthesubjectoftheparticularregulationatissue.

18Id.19Id.

Sincethe1979regulations,sunlampperformancestandardshavechanged

minimallytoaccommodatechangesinsunlamptechnologyandthedevelopmentofnew

sunlampproducts.Thewavelengthrangeoflightforwhichthesunlampregulationsapply

hasbeenchanged,from180‐320nmto200‐400nm,inkeepingwiththechanging

wavelengthcoverageofnewsunlamps.20TheFDAalsochangedtheapplicabilityofits

regulationstosunlampsthatemitUVA(asopposedtoUVAandUVB)radiation.21

Additionally,theFDAalteredthewarninglabels,requiringastatementthatindividualsthat

donottaneasilyinnaturalsunlightareunlikelytoachievethedesiredcosmetictanning

effectfromtheuseofsunlamps.22

ThecurrentFDAstanceonsunlampsintendedforcosmeticpurposesdefines

sunlampsasaClassIMedicalDevice,theleastregulatedcategoryformedicaldevices.In

March2010,theFDAconveneditsAdvisoryCommitteetoconsiderchangestoitsrules

regardingsunlamps.WhiletheoptionofreclassifyingsunlampsasClassIImedicaldevices,

thusstrengtheningtherestrictionsontheirmarketinganduse,wasonthetable,theFDA

concludedinMay2010thattheywouldremainClassIdevicesbutthatwarninglabels

shouldbestrengthened.TheFDAfiledareportwithCongressinresponsetoamandate

from2007,elucidatingtheneedforclearerwarninglabelsandbetterpositioningforthe

labels.TheFDAconsultedfocusgroupstodeterminethemosteffectivewayto

communicaterisksofindoortanningtoconsumers.Throughanumberofrulemakings,

however,theFDA’sclassificationsandrequirementsforsunlampshaveessentially

2021C.F.R.§1040(1985).21Id.22Id.

remainedunchanged:withadequatelabelingandafewotherrestrictions,theFDAallows

consumerstousesunlampsatwill.

II.DangersofSunlampUse

TherisksposedbyUVlightarewell‐documented,andlinkshavebeenmade

betweensunlampuseandthelikelihoodofdevelopingmelanomaandotherskin

diseases.23Since1974,moreandmoreinformationhasbeengatheredindicatingtherisks

associatedwithuseofsunlamps,andseveraladvocacyorganizationshaverequestedthat

theFDAchangeitspermissivestancetowardsunlamps.In1992,theInternationalAgency

forResearchonCancerreleaseditsreviewofevidenceregardingthedangersofsunlamp

use.Itconcludedthatradiationfromsunlampsisstronglylinkedtoskincancer,

particularlymelanoma.24ArecentstudyinPediatricsprovidesanoverviewofthe

scientificallyknownrisksofsunlampusetodate,andtheresultsaregrim.Notonlydo

animalstudiesshowthatUVlightpossessescarcinogenicproperties25,butUVlightisalso

knowntocausesunburn,skindamage,skinaging,andphotosensitivity.26ExposuretoUV

lighthasbeenlinkedtomanyseriousskinproblems,fromphotoagingtoagespotsto

23AmericanAcademyofDermatology.“IndoorTanning.”Available:www.aad.org/media‐resources/stats‐and‐facts/prevention‐and‐care/indoor‐tanning.24InternationalAgencyforResearchonCancer.IARCMonographsontheEvaluationofCarcinogenicRiskstoHumans.Volume55:SolarandUltravioletRadiation.SummaryofDataeReportedandEvaluation.Geneva,Switzerland:WorldHealthOrganization;1997.Availableat:http://monographs.iarc.fr/ENG/Monographs/vol55/volume55.pdf.AccessedApril20,2011.25Balk,SophieandtheCouncilonEnvironmentalHealthandSectiononDermatology.“TechnicalReportUltravioletRadiation:AHazardtoChildrenandAdolescents.”Pediatrics,Feb.28,2011,pg.e794.26Idat793‐794

multipleformsofskincancer.27UVradiationhasspecificallybeenshowntocausecancer

throughitseffectsonskin’scellularDNA.AbsorptionofUVAandUVBlightbytheskin’s

layersleadstogeneticmutationsthatareknowntocausecancer.28UVBlightabsorbsinto

fewerlayersofhumanskin,andisthuslesslikelytobecarcinogenicthanUVAlight.

Unfortunately,sunlampsaremanufacturedtoprimarilyemitthemoredangerousUVA

radiation.29

Figure1:AbsorptionofUVAandUVBlightbytheskin.30

Thecosmeticeffectoftanningactuallysignalsthattheskinhasexperienceddamageasa

resultofUVradiation.SkinbecomesdarkerinresponsetoUVexposureinanattemptto

protectitsDNAfromfurtherinjury.Essentially,DNAintheskinmutatesinordertoprotect

27“UVSkinDamageinaDifferentLight.NIH,1998.Available:www.nih.gov/news/pr/aug98/nigms‐31.htm.28“UVInformation.”www.skincancer.org/understanding‐uva‐and‐uvb.html.29Id.30Id.

itself,andthesemutationsareknowntocausevariousformsofskincancer.31Tumors

eventuallygrowontheskinasaresultandcommonlyknownsymptomssuchasmolesor

discolorationsoccurontheskin.

Figure2:Growthoftumorcellsontheskin.32

TheeffectsofUVlightonskincanbemitigatedthroughtheuseofsunscreen

productsandbyavoidingdirectexposuretothesun;however,theuseofsunlamps

increasesindividuals’normalexposuretoUVradiationandthustheriskofdevelopingskin

cancer.Thecosmeticeffectspromisedbythetanningindustry,darkerskinasaresultof

usingsunlamps,appearstobedirectlyrelatedtothedevelopmentofcancerousskincells.

Giventhewealthofscientificevidenceregardingthedangersofsunlampuse,it

seemsantitheticaltotheFDA’sroleinourgovernmentthatregulationofsunlampsissolax.

UVlight,uponcontactwithskin,essentiallysetsoffacarcinogenicprocessthatleadsto

31Id.32Id.

dangerousskindisorders.GivensuchastrongcausallinkbetweenexposuretoUVlightand

cancer,itissurprisingthattheFDAhasnottakenamoreactiveroleinmitigatingor

removingthisdangerfromthemarket.Sunlampshavebeenlikenedtocigarettesintheir

carcinogenicquality,butonekeydistinctionmayservetoexplaintheFDA’sreticencein

restrictingaccesstosunlamps:unlikecigaretteuse,eventhosewhodonotuseindoor

tanningfacilitiesareexposedtodamagingUVlight.Sunlamps,aspertheirname,aremeant

inmanyrespectstomimictheeffectsofthesun.Thoughratesofskincancerhave

increaseddramaticallysincesunlampsenteredthemarket,exposuretothecarcinogenic

UVlighttheyemitoccursnaturallyaswell.Nevertheless,giventhecontrollednatureand

increasedintensityofUVlightemittedbysunlamps,dataontheeffectsofUVexposureon

skinisveryrelevanttodeterminingthesafetyofsunlampsandindoortanning.Thosewho

areexposedtoUVlightthroughnaturecantakestepstoprotectthemselves:sunblock,

hats,andshadearecommonoptions.However,thosewhoconsumeindoortanning

servicesareseekingoutexposuretotheharmfulraysthatsciencehasshownarelikelyto

causecancer.

III.StateRegulationofSunlamps

ManystateshavetakenstepsinadditiontothosetakenbytheFDAtoensure

consumersafetyintherealmofsunlampuse.Theseregulationsrestrictorbanuseof

sunlampsbyminors,thoughnostatehasenactedanoutrightbanonsunlampuse,norhave

restrictionsbasedonskinsensitivity,etc.beenintroduced.Oneinterestingsteptakenby

severalstateshasbeentobanindoortanningbyminorswithoutaphysician’sprescription.

Takingthedecisionoutofminors’handsisnotaparticularlynewidea‐wedothiswith

othersubstancessuchasalcoholandtobacco;however,requiringaphysician’sapproval

forindoortanningessentiallyremovestheoptionoftanningforcosmeticpurposesby

minors.ThisadditionalsteptowardprotectingminorsfromunnecessaryUVexposure

couldpotentiallyformabasisforfutureregulationbytheFDAforallconsumers.Requiring

aphysician’sprescriptionconstitutesapaternalisticpolicyinthisarea,andwouldbeoutof

keepingwiththeFDA’scurrentpermissivestanceonsunlampuse,butcouldbeapolicy

considerediftheFDAreconsidersitsregulationofsunlamps.

Figure3:CurrentandPendingStateRegulationsofSunlampUsebyMinors33Arkansas Parentalsignaturerequiredunder18.Arizona Writtenparentalpermissionrequiredunder18.California Notanningforchildrenunder14,andunder18aparentalsignatureisrequired.Pending

statelegislationwouldbantanningforallminors.Connecticut Writtenpermissionfromaparentrequiredundertheageof18.Pendinglegislationwould

requirethatparentaccompanythechildforeachtanningsession.Delaware Notanningforchildrenunder14,andparentalsignatureaswellaspresencerequiredfor

thoseunder18.Florida Nottanningforchildrenunder14,andwrittenparentalpermissionrequiredunder18.Georgia Notanningforchildrenundertheageof14,andwrittenparentalpermissionrequiredfor

thoseunder18.Illinois Notanningforchildrenundertheageof14,parentalconsentrequiredundertheageof17.

Pendinglegislationwouldextendthetanningbantoanyoneunder18.Iowa Pendinglegislationwouldrequirephysician’sprescriptionforthoseunder18.Indiana Childrenunder16mustbeaccompaniedatfacilitybyaparent.Parentalsignatureof

waiverattanningfacilityrequiredundertheageof18.Kentucky Childrenunder16mustbeaccompaniedbyaparent,andparentalwaivermustbesigned

forthoseunder18(waiverisvalidforoneyearaftersignature).Pendinglegislationwouldprohibitthoseunder14fromtanning.

Louisiana Childrenunder14mustbeaccompaniedbyaparent,andwrittenparentalconsentisrequiredforthoseunder18.

Maine Notanningforchildrenunder14,andthosefrom14‐15mustbeaccompaniedbyaparent.Parentalconsentrequiredforthoseunder18(consentvalidforoneyear).Statuteexplicitlyrequirespresentingparentswithmaterialsthatwarnabouttherisksofindoortanning.

Maryland Parentalconsent,givenattanningfacility,requiredforthoseunder18.Pendinglegislationwouldbanminorsfromusingindoortanningfacilities.

Massachusetts Parentalconsentrequiredbetweentheagesof14to17.Notanningforthoseunder14.Pendinglegislationwouldbanindoortanningforthosewhoareundertheageof16.

Michigan Parentalconsentandacknowledgementofdangersoftanningrequiredforthoseunder18.Minnesota Parentalsignatureonwarningstatementrequiredforthoseunder16.Pendinglegislation

33“TanningRestrictionsforMinors‐AState‐by‐StateComparison.”AimatMelanoma.Available:http://www.aimatmelanoma.org/aim‐for‐a‐cure/legislative‐accomplishments‐in‐melanoma/tanning‐restrictions‐for‐minors.html.

wouldbantanningundertheageof18withoutphysician’sprescription.Mississippi Writtenparentalconsentrequiredforthoseunder18.Consentvalidforayear,butmust

indicatethenumberofsessionsitisvalidfor.Missouri Severalpendingpiecesoflegislationwouldprohibittanningundertheageof16and

requireparentalpresenceatthetanningfacilityforthoseundertheageof18.Nevada Pendinglegislationwouldrequirewrittenparentalconsentforthoseunder18.NewHampshire

Physicianapprovalrequiredundertheageof14,andparentalconsentandaccompanimentrequiredundertheageof18.

NewJersey Notanningforchildrenundertheageof14.Parentalconsentrequiredforthoseunder18.Pendinglegislationprohibitstanningforthoseunder18altogether.

NewMexico Pendinglegislationbansthoseunder18fromindoortanning.NewYork Notanningforchildrenunder14.Parentalconsent,giveninwritingandinpresenceof

tanningfacilityoperator,requiredforthoseunder18.Consentvalidforoneyearfromdateofsignature.Severalpiecesofpendinglegislationwouldeitherprohibittanningforthoseunder16orthoseunder18.

NorthCarolina Notanningundertheageof13withoutphysician’sprescription.Pendinglegislationwouldraisetheageforindoortanningto18.

NorthDakota Notanningwithoutphysician’sprescriptionforthoseunder14.Signedparentalconsentrequiredforthoseunder18,validforoneyear.

Ohio Parentalconsentbeforeeverytanningsessionrequiredforthoseunder18.Pendinglegislationrequiresphysician’sprescriptionforuseofatanningbedbythoseunder18.

Oregon Parentalconsentrequiredundertheageof18,signedinthepresenceoftanningfacilityoperator.

Pennsylvania Twopiecesofpendinglegislation.Onewouldrequireaphysician’sprescriptionforthoseunder18,andtheotherwouldprohibittanningforthoseunder14withoutadoctor’sprescriptionandwouldrequireparentalaccompanimentforthoseunder18.

RhodeIsland Parentalconsentformrequiredforthoseunder18.Pendinglegislationwouldrequirephysician’sprescriptionforthoseunder18.

SouthCarolina Writtenparentalpermissionrequired,giveninthepresenceofatanningfacilityoperator.SouthDakota Pendinglegislationwouldrequireparentalconsentundertheageof18.Tennessee Parentalconsentrequiredforthoseunder18.Mustbenotarized.Texas Parentalconsentrequiredforthoseunder18.Utah Parentalconsentandpresenceatfirsttanningsessionandonceevery12months

thereafterrequiredforthoseunder18.Vermont Pendinglegislationwouldbanuseofindoortanningundertheageof18.Virginia Writtenparentalconsentrequiredundertheageof15.Parentsmustalsoindicatetheir

child’sskintype.Validfor6months.Washington Twopiecesofpendinglegislationwouldrequireaphysician’sprescriptionforthoseeither

undertheageof16ortheageof18.WestVirginia Pendinglegislationwouldrequireparentalaccompanimentforthoseunder14andwritten

parentalconsentforthoseunder18.Wisconsin Notanningforthoseundertheageof16.Wyoming Parentalconsent,signedinpresenceoftanningfacilityoperator,requiredforthoseunder

18.Consentvalidforoneyear.Childrenunder15mustbeaccompaniedbyaparentduringeveryvisit.

IV.PPACATanningTax

ThePatientProtectionandAffordableCareAct(PPACA),Section10907,imposesa

10%excisetaxontheuseoftanningbeds34.Thetaxmustbepaidbyconsumersofindoor

tanningservices,andisexpectedtoreduceprofitsforthetanningindustry.Thejointgoals

ofthetaxaretoencouragepeopletomakesaferdecisionsabouttanningandtohelppay

forothermeasuresintheAct.SincethetaxbecamelawinJuly2010,indoortanning

facilitiesmustchargeanadditional10%oftheirregularratestoclients.Fromaneconomic

perspective,itseemsthatanincentiveisbeingputinplacetomoveconsumersinthe

directionoflesstanning.Theeffectofthistanningtaxonconsumptionofindoortanning

servicesremainstobeseen.Tenpercentmaynotbehighenoughtodeterthosewhowish

tosecurethecosmeticeffectsprovidedbyindoortanning,butitseemsastepinthe

directionofmoreaggressiveconsumerprotection.Consumersarestillallowedchoicein

thetaxscenario,butthetanningtaxmakesamoveawayfromtheFDA’semphasison

consumerchoice.Thoughnotcoerciveinthesensethatthetaxdoesnotbanaccessto

tanningservices,itisatleastslightlypaternalisticgiventhatPPACA’sdraftershave

identifiedaconsumeractivitytheybelieveisunhealthyandhaveaimedtaxationatthat

activityinthehopesofincentivizingsaferchoices.

V.FDAOptionsforRegulationofSunlamps

Regulationbystatesandthefederalgovernmentthroughlegislationoutsidethe

scopeoftheFDAmayservetoenhanceconsumersafetyinsunlampuse,buttheFDAstill

hasacontinuingobligationtoensurethesafetyofconsumerproductsthatfallwithinits34U.S.DepartmentoftheTreasury,InternalRevenueService,“IndoorTanningServices;CosmeticServices;ExciseTaxes,”75FederalRegister33740,June15,2010.

purview.Theseotheroptionsforregulatinganddiscouragingsunlampusebyconsumers

mayormaynotbeeffective,butthequestionremainsastotheproperrolethattheFDA

shouldplayintheirregulation.RecentreportsonFDA’sactivityintheareaofsunlamp

regulationshowwillingnesstoconsidermoreintrusiveregulations,butrecentregulations

havefallenonthesideoffavoringconsumerchoiceoverconsumerprotection.The

majorityofFDAregulationthroughoutthehistoryofsunlampuseintheUnitedStateshas

focusedonthepromulgationoflabelingrequirementsthatdisclosethedangersoftanning,

andsuggesteddurationandfrequencyofexposure.Inseekingtoprotectconsumer

autonomy,itseemsthattheFDAhasforsakenthepossibilityofmoreaggressivemeasures.

Giventhepopularityofindoortanning,itseemslikelythatwarningsalonewillnotdeter

thosewhowishtosecurethecosmeticeffectsofsunlampuse.

Whendecidinghowtoclassifysunlamps,theFDACommissionerfacesanumberof

options.Banningsunlampsoutrighthasalwaysbeenanoption,butonetheFDAhasshied

awayfromonconsumerchoicegrounds.Giventheirdangerousnature,theFDAcouldalso

haveclassifiedsunlampsasClassIIorClassIIImedicaldevices.Thestandardforclassifying

adeviceasClassIIorIIIisbasedonthedangerousnessofthedeviceatissueandtheextent

ofscientificknowledgeastothedangerthatthedeviceposestotheconsumer.Since

sunlampscannotdirectlybetestedonhumansduetoresearchethicsconcerns,the

knowledgeregardingtheireffectsiseitheranecdotalorbasedonanimalstudies.Animal

studieshaveshownlinksbetweenexposuretoUVradiationandskincancer,andthough

theFDAhasrecognizedcausallinksbetweensunlampuseandmelanoma,ithaspersisted

intakingarelativelyhands‐offapproachtoregulationinthisarea.

IftheFDAweretoentertainstricterregulationsonsunlamps,anumberof

importantrevisionsincurrentlawseeminkeepingwiththeneedtoprotectAmerican

consumers.First,federalagelimitsonsunlampusewouldrespecttheconsumerchoice

rationaletheFDAhasespousedinthisareawhileensuringthatyoungusersdonot

endangertheirhealth.Asasociety,wehaveacceptedthatindividualsundertheageof

eighteenhavenotmaturedenoughtomakedecisionssuchaswhotovotefor,whetherto

smokecigarettes,andwhethertodrink.Byextension,itseemswehavedeterminedthat

thebalancingofrisksandbenefitsexpectedofadultscannotalsobeexpectedofminors;

therefore,theconsumerchoicerationaledoesnotapplytothem.Attheleast,requiring

parentalconsentforuseofsunlampswouldensurethattheriskshavebeenadequately

takenintoaccountbyandindividualresponsiblefortheminor.Second,reclassificationof

sunlampsasClassIIorClassIIImedicaldeviceswouldputthetanningindustryonnotice

thatmorethanlabelingandnonintrusiveusagerequirementswouldemergefromfuture

FDAregulation.Whileindividualswhousetanningboothsarerequiredtocovertheireyes

andtherearetimelimitsonsunlampuse,theyareotherwiselefttotheirowndevices

regardingsunlampuse.Itis,ofcourse,questionableastowhetherabalancebetweenmore

regulationandconsumerchoicecanbestruck.Ifsunlampuseiscarcinogenic,afterall,itis

possiblethattheFDAshouldoutlawtheirusealtogether.Itwouldnotbefeasibleto

maintainrecordsofconsumers’sunlampusetoensurethattheydonotexceedacertain

numberofusesinaweek,butperhapsindividualtanningestablishmentscouldberequired

toestablishlimitsontheuseoftheirpatrons.Third,requiringaphysician’sprescription

mayprovideanavenueforregulationofsunlampsthatdoesnotcompletelyoutlawtheir

use.Whileanacceptedmethodusedbystatesforrestrictingminors’useofsunlamps,a

prescriptionrequirementwouldlikelydestroytheindoortanningindustry.Giventhe

dangersofUVlight,itisunlikelythatphysicianswouldbeeagertohelptheirpatientsgain

accesstosuchservices.Ifprescriptionrequirementswouldeffectivelyconstitutean

outrightban,theFDAmaynotbewillingtogothatfar.

VI.PaternalismandConsumerChoice

Thelinebetweenpaternalismandtheprotectionofconsumersisrarelyclear,butin

thecaseofsunlampsitdoesnotseemthattheFDAhasevencomeclosetotoeingthatline.

Inits1985regulationsettingaperformancestandardforsunlamps,theFDAidentifiedthe

needto“protecttheconsumerfromsunburns…andfromexposuretohazardousradiation

thatisunnecessaryforskintanning,”butconcluded,“FDAbelievesthattheuserofa

sunlampcantakeappropriateactionwheninformedofthepossibleadverseeffectstothe

bodyfromexposuretoultravioletradiation,iftheproductisequippedwithnecessary

safetyperformancefeatures.”Despiteacknowledgingthedangersposedtousersof

sunlampsforcosmeticpurposes,theFDA’s1985regulationdealtminimallywithsafety

featuresofsunlampuse(focusingoneyeprotectionandtimelimitsfortanning),and

focusedonthelabelingrequirementsforsunlampproducts.35TheFDA’soriginalrolein

governmentfocusedonidentifyingadulteratedorinaccuratelylabeledproducts.Inthat

role,analysisofrisksandbenefitsplaysonlyaminorpart;however,withtheexpansionof

theFDA’spurviewtoavarietyofdrugsanddevicesthe“agencyincreasinglyisrequiredto

determinethelevelofriskacceptableinproductsthatareproperlymanufacturedandused

35SunlampProducts;PerformanceStandard.50Fed.Reg.36548(September6,1985).

asintended.”36TheexpandedroleoftheFDAsince1938requirestheagency’sprioritiesto

shift,andcost‐benefitanalysesofproductsenteringthemarketarelikelytoincreasein

importance.Inthecaseofsunlamps,thereislittlequestionthattheiruseposesdangersto

theconsumer.Cosmeticbenefitintheformofdarkerskinseemstopaleincomparisonto

melanoma,prematureaging,andskindiscoloration.Whilethetanningindustryinsiststhat

itsproductsaresafeforconsumption,theFDA’sroleshouldbetolookatsuchclaims

skepticallyandconsiderwhethertheaverageconsumercanmakeappropriatechoices

regardingthehealthoftheirskin.Giventhecontinuingpopularityofindoortanningaswell

astheepidemicproportionsofskincancerdiagnoses,itseemsthatanewbalanceshould

bestruck.

HowstrongistheapparentreasoningfortheFDA’sdecisiontoleavesunlamps

accessibletoconsumers?Ifnosafelevelofsunlampexposureexists,thenwoulda

reasonableandinformedconsumereverchoosetousesunlamps?Consumerchoiceisan

importantvalue,aswewouldallliketofeelthatwehavecontroloverwhatproductswe

use,aswellasovertheriskswedecidetotake.Ifindoortanningcanbeconstruedasan

informedchoicebytheconsumertoacceptrisksinfavorofcosmeticbenefits,astheFDA

hastreatedit,thenitdoesnotseemparticularlyproblematictokeepsunlampsminimally

regulated.If,however,itcouldbearguedthatconsumersdonothaveallthefactsabout

sunlamps’dangers,thenmorestringentFDAregulationswouldbeinorder.The

carcinogeniceffectsofUVexposurearenowwellknown,soitisconceivablethattheFDA’s

positiononsunlampregulationreflectsabeliefthatconsumershaveweighedtheprosand

consofindoortanningandthosethatchoosetousesunlampsdosowiththeireyesopen36RichardA.Merrill,Risk­BenefitDecisionmakingbytheFoodandDrugAdministration.45GeorgeWashingtonLawReview994(1977).

(figurativelyspeaking).Nevertheless,itcouldalsobearguedthatifthecarcinogeniceffects

ofexposuretoUVradiationaretrulysowell‐known,thenitisantitheticaltotheFDA’srole

asagatekeeperfordecidingwhichsubstancesaretoodangerousforhumanconsumption

toallowsunlampstocontinuetopermeatethemarketwithsolittleregulation.Justasthe

FDAmaysetlimitsonmercurylevelsinfishorantibioticlevelsinmeat,itseemsinkeeping

withitsroletoexpectthattheFDAwouldimposestricterregulationsonsunlamps.

VII.CaselawonConsumerUseofSunlamps

Severalrecentcourtcasesindicatethattheconsumerchoicerationalemaybe

flawed.Twopredominanttypesofcaseshaveappearedinrecentyears:caseswherethe

plaintiffarguesthatadvertisingofindoortanningismisleading,andcasesinwhicha

plaintiffsufferedharmfromsunlampuse.Thoughtheclaimsandlegalargumentsdiffer,

theresultsindicatethesameconclusion:consumersarenotfullyinformedofthedangers

sunlampsposetotheirhealth,andthetanningindustry’seffortsatconsumersafetyand

informationleavesomethingtobedesired.

Severalcasesinthepastseveralyearshaveexploredthepossibilitythatthetanning

industrydistortstherisksandbenefitsoftanning,leavingconsumerswithaninadequate

understandingoftheeffectsofindoortanning.InNafarv.HollywoodTanning,339

Fed.Appx.216,2009WL2386666(C.A.(N.J.)),theplaintiffconsumerclaimedthat

defendantHollywoodTanningfailedtoadequatelyrepresentthedangersofindoortanning

toherandotherslikeher.ThoughHollywoodTanningcompliedwithFDAlabeling

regulations,Nafarclaimedthatthecompany’semployeesinformedherthatthedangersof

indoortanningwereminimal.Partsofthecasewereeventuallydismissedduetochoiceof

lawandclasscertificationissues,buttheclaimsmadebyNafardeservecloseranalysis.The

defendanthereallegedlydistortedthebenefitsofindoortanning,promisingabetter

complexionandpossibletreatmentofskindisorderssuchasacneandpsoriasis.Outsideof

theFDA‐requiredwarnings,Nafarclaimsthedefendantdidnotprovideanyinformation

aboutthecarcinogenicnatureofsunlampuse,andthatshewouldnothaveusedHollywood

Tanning’sservicesifshehadbeenapprisedofthesedangers.ThoughtheFDAexpectsits

regulationstoleadtosaferdecisionsbyconsumers,itseemsthatinNafar’scasethe

requiredlabelsdidnotleadinthedirectionofaninformedchoice.Protectionofconsumer

choiceispremisedontheconceptionoftheconsumerasreasonablepersonfacedwithall

relevantinformationinmakingadecision;here,Nafarclaimsthatshewasdeprivedofthe

abilitytomakesuchachoice.

InInreToshibaAmericaHDDVDMarketingandSalesPracticeLitigation,2009WL

2940081,thecourtadmitted,“theaverageconsumer’sknowledgeoftheharmfuleffectsof

indoortanningisadisputedissue.”WhiletheFDA’srequiredwarningsaremeantto

apprisetheconsumeroftherisksofindoortanning,itseemsthatthereissomethingofa

chasmbetweenconsumerknowledgeandtheknowledgeoftheFDA.Ifconsumersarenot

equippedwiththeappropriateinformationtomakeaninformedchoice,shouldtheFDA

changelabelingrequirements,ordoesthesolutionlieinmorerestrictiveusage

requirements?

Thebalancebetweenpaternalismandfreedommaybedifficulttostrike,butifcourt

casesregardingparticularlyegregiousinjuriestoconsumersareanyindication,itmaybe

timefortheFDAtomoveinthedirectionofpaternalismwhenitcomestosunlamps.In

Swindlev.BodyBlastersGym,Inc,La.App.2Cir.1999,theplaintiff’sskinturnedpurple

afterusingdefendant’sindoortanningfacilities.Theplaintiffhadbeentakingmedication

thatmadeherskinmoresensitivetoUVlight,andsheblamedtheextremeresultsshe

experiencedonthedefendant’scompany’snegligentfailuretowarnherofthepossibility

thatcertainmedicationsintensifytheeffectsofindoortanning.Thecourtfoundthatthe

FDA‐requiredwarninglabelshadbeenpresentatthegymduringheruseofthefacilities,

anddismissedhercase.OfnoteintheSwindlecaseisthecourt’sequationofreasonable

carewithmeetingtheFDA’srequirements.Vendorsofsunlampservicesarenot

responsibleforprovidinganymorewarningthatthatrequiredbytheFDA,andthusthe

FDA’sregulationstakeonagreatdealofimportanceforconsumersafety.TheFDA’srolein

essentiallydefiningthenegligencestandardforsunlampoperatorsmeansthatitsrequired

labelsaretheonlyprotectionconsumerscanexpect.

InFaransov.CassLakeBeachClub,Inc.,Mich.App.1998WL1991226,theplaintiff

sustainedseveresunburnswhenshefellasleepinatanningbedandawokeoveranhour

later.ShesueddefendantCassLakeBeachClubfornegligenceinoperatingtheirfacilities,

butlostthecasebecauseshesignedawaiverofliabilitythatthecourtfoundvalid.Ms.

Faransoreadandsignedasheetofpaperindicatingthatshewouldnotholdthedefendant

liableforanydamagesfromusingtheirtanningbeds.ThecourtfoundthatsinceMs.

Faransowasnotincapacitatedinanywaywhenshesignedthewaiver,itwasvalidand

CassLakeBeachClubwasnotliableforherinjuries.TheFaransocaseshowsthatcourts

expectconsumerstoinformthemselvesofthedangersofsunlampuseandinadditionto

makingthedecisionwhethertousesunlampscourtsexpectthatconsumerscanreasonably

decidewhethertosignaliabilitywaiver.Liabilitywaiversarecommoninmanyindustries,

andgiventhatsunlampsposehealthdangerstotheirusers,itmakessensethatoperators

ofindoortanningfacilitieswouldpursuethisavenuetoprotectthemselvesfromliability.In

fact,therelativedearthofcasesregardingindoortanninginjuriesdespitethestatisticson

actualinjuriessustainedintheUnitedStatesasaresultoftheirusemayberelatedtothe

useofsuchwaiversbyoperatorsoftanningfacilities.

Claimsofmisinformation,negligence,andmistakeappearintheabovecases,and

theydemonstratesomeseriousproblemswiththeconsumerchoicejustificationofferedby

theFDAinitsregulationofsunlamps.Itcouldbearguedthatdespiteadequatewarnings,

someconsumerswillmakethechoicetousesunlampsforcosmeticpurposes.Bethatasit

may,thequestionthenariseswhethertheFDA’sroleshouldbelimitedtosharing

informationaboutthedangersandprovidingforminimalsafetystandards,orwhetheritis

timeformoreaggressivemeasures.

Conclusion

FDAregulationofsunlampssince1974hasleftthecost‐benefitanalysisregarding

theirusetotheconsumer.Asidefromafewnonintrusiveusagerequirements,theFDAhas

focusedalmostexclusivelyoninformingtheconsumeraboutthedangersofindoortanning

andleavingthedecisiontoconsumerdiscretion.Giventheincreasingpopularityof

sunlampuse,theskyrocketingratesofskincancerintheUnitedStates,andexpressionsof

consumerdismaywhentheyareinfactinjuredbysunlampuse,itissafetosaythatthe

FDA’seffortstoinformconsumershavenotbeensuccessfultodate.Stateeffortstoprotect

minorsappeartowork,buttheseeffortshavebeenbasedonapaternalisticrationaleit

wouldbedifficulttoextendtoadultconsumers.PPACA’stanningtaxmaybean

intermediatesolutiontothedifficultyofregulatingsunlampusewhileensuringconsumer

choice.Bynudgingconsumersintheproperdirection,thetaxmayreducesomeconsumers’

usageofsunlampswhileultimatelyleavingthecost‐benefitanalysisinthehandsof

consumers.Asarelativelynewtax,theeffectsofPPACA’stanningtaxarenotyetknown,

butitdoesseemtobeastepintherightdirection.

Despitetheexistenceofseveraloptionsforregulatingsunlampuse,injuriesfrom

sunlampuseandthedangersofUVexposuredictatethattheFDAshouldreconsiderits

supportofconsumerchoiceandgetmoreinvolvedinprotectingconsumersfromthe

dangersofsunlampuse.Attheveryleast,reclassificationofsunlampsasaClassIIMedical

Device,subjectingthemtomorerigorousexaminationandregulationbytheFDA,appears

tobecalledfor.Reclassificationwouldcontinuetoprovideconsumerswiththechoiceof

whethertoengageinindoortanningwhilehopefullyservingtoexplorewhetherthereis

anywaytoreducetherisksthatconsumersface.SuchactionbytheFDAwouldrespectthe

autonomyofconsumerswhileenablingregulatorstogetmoreinvolvedindemandingmore

fromthetanningindustry.