apragmaticanalysisoftheregulation … articles/007.pdf · 2015. 10. 13. · 2!...

Journal of Law and the Biosciences 1ndash28doi101093jlblsv039Original Article

A pragmatic analysis of the regulationof consumer transcranial direct current

stimulation (TDCS) devicesin the United States

AnnaWexlerlowast

Department of Science Technology and Society E51-070 Massachusetts Institute of Technology77Massachusetts Ave Cambridge MA 02141 USACorresponding author E-mail annawmitedu

ABSTRACTSeveral recent articles have called for the regulation of consumer tran-

scranial direct current stimulation (tDCS) devices which provide low lev-els of electrical current to the brainHowevermost of the discussion to-datehas focusedonethical or normative considerations there has been anotableabsence of scholarship regarding the actual legal framework in the UnitedStatesThis article aims to fill that gap by providing a pragmatic analysis ofthe consumer tDCS market and relevant laws and regulations In the fivemain sections of this manuscript I take into account (a) the history of thedo-it-yourself tDCSmovement and the subsequent emergence of direct-to-consumerdevices (b) the statutory languageof theFederal FoodDrug andCosmetic Act and how the definition of a medical devicemdashwhich focuseson the intended use of the device rather than its mechanism of actionmdashisof paramount importance for discussions of consumer tDCS device regu-lation (c) how both the Food and Drug Administration (FDA) and courtshave understood the FDArsquos jurisdiction overmedical devices in caseswherethe meaning of lsquointended usersquo has been challenged (d) an analysis of con-sumer tDCS regulatory enforcement action to-date and (e) the multi-ple US authorities other than the FDA that can regulate consumer brain

lowast Anna Wexler is a PhD candidate in the Department of Science Technology and Society at MIT She holdsdual BS degrees fromMIT in Brain and Cognitive Sciences and in Humanities and Science with a Focus inWriting and Neuroscience Her current research focuses on the ethical legal and social issues surroundingemerging neuroscience technology with a particular focus on non-invasive electrical brain stimulation

C⃝ The Author 2015 Published by Oxford University Press on behalf of Duke University School of LawHarvard Law School Oxford University Press and Stanford Law School This is an Open Access arti-cle distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence(httpcreativecommonsorglicensesby-nc-nd40) which permits non-commercial reproduction and distri-bution of the work in any medium provided the original work is not altered or transformed in any way and thatthe work is properly cited For commercial re-use please contact journalspermissionsoupcom

at Beth Israel Deaconess M

edical Center on October 13 2015

httpjlboxfordjournalsorgD

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2 A pragmatic analysis of the regulation of consumer TDCS devices

stimulation devices Taken together this paper demonstrates that ratherthan a lsquoregulatory gaprsquo there are multiple distinct pathways by which con-sumer tDCS can be regulated in the United States

KEYWORDS food and drug law human enhancement medical devicesneuroscience regulation transcranial direct current stimulation (tDCS)

INTRODUCTIONTranscranial direct current stimulation (tDCS) is a non-invasive form of brain stimu-lation that is thought to provide a constant low level of electrical current to the brainApproximately 1000 scientific studies have been published in peer-reviewed journalsin the last decade1 many of which suggest the beneficial effects of tDCS in both clin-ical populations for treating a variety of conditions and psychiatric disorders and inhealthy individuals for enhancing everything from creative problem solving to theacquisitionofmotor skills2 Because a tDCSdevice is relatively easy tomake (and cheapto acquire) there has arisen amovementwherein individuals stimulate their ownbrainswith tDCS outside of research or medical settings for self-improvement purposesThemovement has been colloquially referred to as do-it-yourself (DIY) tDCS as it beganwith individuals constructing tDCS devices themselves Since today many individualswho identify with the DIY tDCSmovement purchase ready-made direct-to-consumer(DTC) devices3 the border between DIY and DTC has become muddled In this pa-per I refer to those who use tDCS devices outside of professional research andmedicalsettings as lsquohomeusersrsquoThus there currently exists twogroupsmdashresearchers andhomeusersmdashwho utilize a single technology (sometimes even the exact same device) in verydifferentwaysWhereas researchers apply tDCS to subjectswithin the controlled realmof the laboratory home users apply tDCS on themselves mostly in private settings forcognitive enhancement or self-treatment

Unsurprisingly the use of tDCS outside of research settings has not been well re-ceived by scientists many of whom believe that home users may lsquoruin itrsquo for the entire

1 Pubmed title search for lsquotranscranial direct current stimulationrsquo or lsquotDCSrsquo httpwwwncbinlmnihgovpubmedterm=(22transcranial+direct+current+stimulation225BTitle5D)+OR+tdcs5BTitle5D

2 For a review of clinical tDCS studies see Min-Fang Kuo Walter Paulus amp Michael A Nitsche Thera-peutic Effects of Non-Invasive Brain Stimulation with Direct Currents (tDCS) in Neuropsychiatric Diseases85NEUROIMAGE 948 (2014) for tDCS in healthy populations see Brian A Coffman Vincent P ClarkampRajaParasuramanBattery PoweredThought Enhancement of Attention Learning andMemory in Healthy Adults Us-ing Transcranial Direct Current Stimulation 85 NEUROIMAGE 895 (2014) Note however that a few recentstudies have questionedwhether tDCS has any effect in healthy subjects see eg JaredCooneyHorvath JasonD Forte ampOlivia Carter EvidenceThat Transcranial Direct Current Stimulation (tDCS) Generates Little-to-NoReliable Neurophysiologic Effect Beyond MEP Amplitude Modulation in Healthy Human Subjects A SystematicReview 66 NEUROPSYCHOLOGIA 213 (2015)

3 Anita Jwa Early Adopters of the MagicalThinking Cap A Study On Do-It-Yourself (DIY) Transcranial DirectCurrent Stimulation (tDCS) User Community 2 J L BIOSCI 292 307 (2015)




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A pragmatic analysis of the regulation of consumer TDCS devices 3

academic field4 Researchers have publicly voiced their concerns a 2013Nature edito-rial stated that lsquoto try toboost cognitiveperformance in thiswaymight be a verybad ideaindeedrsquo5 One tDCS researcher published a letter inNature titled lsquoTranscranial devicesare not playthingsrsquo writing lsquoUnorthodox technologies and applications must not be al-lowed to distort the long-term validation of tDCSrsquo6 In addition scientists have urgedcaution regarding the uncontrolled use of tDCS although no serious adverse eventshave been reported among the 10000 subjects studied to date7 at least one study hasfound that tDCS can impair cognitive function in some individuals8

Currently tDCS is not approved in the United States by the Food and DrugAdministration (FDA) as a medical treatment for any indication Researchers (butnot the general public) may obtain tDCS devices for investigational use from eitherSoterix or Neuroconn the two US companies whose devices have an lsquoinvestigationaldevice exemptionrsquo from theFDA9 However as theSoterix andNeuroconnmodels costthousands of dollars some researchers have opted to repurpose cheaper iontophoresisdevices (current-providingmachines used to treat various conditions such as excessivesweating) for tDCSuse By contrast consumer tDCSdevicesmdashwhich are not regulatedas medical or investigational devicesmdashare available to the public there are currently atleast a half dozen devices on the market ranging in price from $49 to $299

Several scientists and neuroethicists have argued that there is a need for addi-tional regulation to cover consumer tDCS devices10 One paper proposed extendingmedical device regulation in Europe to include not just tDCS devices but also con-sumer electroencephalography (EEG) devices which passively record electrical brain-waves and display them to users11 (I focus here only on non-invasive electrical brainstimulation devices because as has been previously pointed out EEG devices in them-selves are measuring tools akin to heart-rate monitors)12 Some scholars have writtenextensively about the moral and ethical considerations related to non-invasive brain

4 According to the results of a questionnaire distributed at the 2015 New York City NeuromodulationConference researchers believe that one of the main issues facing the field over the next 15 yearsis the lsquoDIY community ruining it for the rest of usrsquo Conference Questionnaire Results Presentedon Jan 11 2015 at the New York City Neuromodulation Conference New York Jan 9ndash11 2015httpneuromodeccomeventsnyc-neuromodulation-conference-2015 (accessed Aug 25 2015)

5 Editorial Brain Blast 498 NATURE 271 272 (2013)6 MaromBikson Sven BestmannampDylan EdwardsNeuroscience Transcranial Devices Are Not Playthings 501

NATURE 167 (2013)7 Felipe Fregni et al Regulatory Considerations for the Clinical and Research Use of Transcranial Direct Current

Stimulation (tDCS) Review and Recommendations from an Expert Panel 32 CLIN RES REGUL AFF 22 pub-lished online first Dec 2 2014

8 Amar Sarkar AnnDowker ampRoi Cohen KadoshCognitive Enhancement or Cognitive Cost Trait-Specific Out-comes of Brain Stimulation in the Case of Mathematics Anxiety 34 J NEUROSCI 16605 (2014)

9 Fregni et al supra note 7 at 10 See also Soterix Medical httpsoterixmedicalcomtdcs and Jali Medical(US distributor for Neuroconn) httpwwwjalimedicalcomneuroconn dc stimulator mchtml (accessedSep 22 2015)

10 See eg Veljko Dubljevic Neurostimulation Devices for Cognitive Enhancement Toward a Comprehensive Reg-ulatory Framework 8 NEUROETHICS 115 (2015) Hannah Maslen et al Do-it-Yourself Brain Stimulation ARegulatory Model 41 J MED ETHICS 413 (2015)

11 Hannah Maslen et alThe Regulation of Cognitive Enhancement Devices Extending the Medical Model 1 J LBIOSCI 68 (2014)

12 Andreas Kuersten amp Roy H HamiltonThe Brain Cognitive Enhancement Devices and European Regulation 1J L BIOSCI 340 (2014)




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stimulation13 Others have argued that there is a need for greater engagement with theDIY brain stimulation community14 Collectively existing scholarship has contributedimportant normative and ethical perspectives on the regulation of such devices

Missing from this literature however are accounts that consider the practicalities ofthe law and how it applies to existing and foreseeable consumer brain stimulation de-vices For example as I will show in Part I below an examination of the current tDCSconsumer device market reveals that the recommended extension of medical deviceregulation in Europe would apply to only a small sliver of devices rendering it largelyineffective15 Furthermoremanyproposals neglect to consider the practical differencesbetween regulation and regulatory enforcementThough an ideal model of the law en-visions all regulations as being consistently and equally enforced a more realistic viewtakes into account the resource-constrained nature of government bodies who mustformally and sometimes informally prioritize regulatory enforcement and often do soin unclear or unsystematic waysThus before calling for additional regulation or con-cluding that there is a lsquoregulatory gaprsquo16 it must first be determined that the problem isthe lack of regulation not the lack of enforcement

It is also crucial to consider the precise statutory language of existing regulation Forexample in theUnited States the FDAmakes its determination of whether a product isamedical device based on the intended useof the device as stated by themanufacturermdashnotbasedon themechanismof actionof thedevice itselfOne recent paper co-authoredby tDCS experts failed to take into account the intricacies of the statute stating that itwould be lsquological to include tDCS devicesrsquo as medical devices according to the FDAregardless of lsquowhether indicated for medical treatments diagnostic purposes wellnessaids entertainment devices or any other purpose rsquo17 However legal authority carvesup jurisdictionmuchmore finely than this logic suggestsWithin current statutory defi-nitions productsmarketed for entertainment orwellness purposeswould not fall underthe scope of the FDA (as long as theymake nomedical-related claims aboutmodifyingthe structure or function of the body as will be discussed in Part II below) whereasa device intended for medical treatment or diagnosis would indeed be regulated as amedical device

This paper contributes to the literature on the regulation of consumer brain stim-ulation devices in the USA by providing a fact-based analysis of the consumer tDCSmarket and relevant laws and regulations In the first section I present a short his-tory of the DIY tDCS movement and the subsequent emergence of DTC devices Inthe second and third sections I outline the basics of FDA medical device regulationand discuss how the definition of a medical devicemdashwhich focuses on the intended useof the device rather than its mechanism of actionmdashis of paramount importance for

13 See eg Roy Hamilton Samuel Messing amp Anjan Chatterjee Rethinking the Thinking Cap Ethics of NeuralEnhancement Using Noninvasive Brain Stimulation 76 NEUROLOGY 187 (2011) Roi Cohen Kadosh et alTheNeuroethics of Non-Invasive Brain Stimulation 22 CURR BIOL R108 (2012)

14 Nicholas S Fitz amp Peter B Reiner The Challenge of Crafting Policy for Do-It-Yourself Brain Stimulation 41J MED ETHICS 410 (2015)

15 AnnaWexlerThe Practices of the Do-It-Yourself Brain Stimulation Community Implications for Regulatory Pro-posals and Ethical Discussions J MED ETHICS DOI101136medethics-2015-102704

16 Veljko Dubljevic Victoria Saigle amp Eric RacineThe Rising Tide of tDCS in the Media and Academic Literature82 NEURON 731 736 (2014)

17 Fregni et al supra note 7 at 2




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discussions of consumer tDCS device regulation I then discuss how both the FDA andthe courts have understood the FDArsquos jurisdiction over medical devices in cases wherethe meaning of lsquointended usersquo has been challenged In the fourth section I analyse theonly instance of tDCS regulatory action to date in which the California Departmentof Public Health (CDPH) forced a firm to recall several hundred consumer tDCS de-vices Although there exists a common perception that the FDA has not been involvedwith the regulation of consumer tDCS devices the California case demonstrates thatthe CDPHrsquos actions were instigated by an FDA engineer Finally I discuss the multi-ple US authorities other than the FDA that can regulate consumer brain stimulationdevices

In sum this paper dispels the notion of a lsquoregulatory gaprsquo with regard to consumernon-invasive brain stimulation (in theUnitedStates) Several papersmdashmostly those fo-cusing on the appropriate lsquolevelrsquo of regulationmdashseem to have assumed that additionalregulation is the de facto appropriate response to the existence of consumer tDCS de-vices I argue however that there already exists a comprehensive regulatory frameworkfor both consumer and medical tDCS devices in the United StatesThus rather thancalling for additional regulation I suggest the need for a practical approach to consumerbrain stimulation devices one that outlines relevant issues of concern and considersmultiple ways of addressing them

I FromDIY toDTCmdasha short history of the consumer tDCS devicemarketThe earliest mentions of DIY brain stimulation date back to 2007 in an online forumposting on Longecityorg18 and in an articleThe Phoenix which described how one in-dividual tried to treat his depression using a tDCS device he constructed by modifyinga Radio Shack Electronics Learning Lab19 Home use of tDCS seems to have remainedisolated until mid-2011 when a Yahoo group20 and a Reddit forum (called a lsquosubred-ditrsquo) dedicated to DIY tDCS were formed21 By early 2012 there were a number ofblogs and sites dedicated exclusively to the topic indicating that individuals were uti-lizing tDCS for both self-treatment and cognitive enhancement purposes

What factors contributed to the rise ofDIY tDCSThe appearance of themovementcorresponds to the increase in popularity of tDCS in scientific journals in 2011 therewere over 130 peer-reviewed articles about tDCS more than double that of the pre-vious year22 The following year 2012 saw the greatest quantitative increase in men-tions of tDCS in the popular press23 In addition DIY tDCS shares characteristicswith related movements that were well established by 2010 such as DIY biology and

18 Attaching a battery to your headLONGECITY 2007 httpwwwlongecityorgforumtopic19346-attaching-a-battery-to-your-head (accessed Sep 22 2015)

19 PaganKennedyBrain-O-Matic BOSTONPHOENIX Feb 7 2007 httpthephoenixcombostonlife33313-brain-o-matic (accessed Sep 22 2015)

20 Yahoo Transcranial Direct Current Stimulation group httpsgroupsyahoocomneogroupstDCStiminfo (accessed Sep 22 2015)

21 Reddit rtDCS (httpwwwredditcomrtDCS) began inApril 2011 E-mail frommoderator of rtDCSto AnnaWexler (Feb 17 2015) on file with author

22 Supra note 123 According to one study there were roughly three-dozen print media articles about tDCS in 2011 and nearly

70 in 2012 See Dubljevic et al supra note 16 at 732




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quantified self24 Finally and perhapsmost importantly although there are othermeth-ods of stimulating the brain with electricity or magnetism tDCS is unique in that thestimulation device is both non-invasive (ie no surgical implantation is required) andrelatively inexpensive to acquire or create25

During the early days of the DIY tDCS most individuals built their devices fromscratch with the help of diagrams posted online and electronics assistance from otherDIYers At its core a tDCS device contains a current-providing component (such asa 9 V battery) wires that plug into the current source and electrodes that interfacebetween the wire and the skin When both electrodes are connected to the scalp theelectrical circuit closes and current is thought to flow through the brain26 This sim-ple constructionmdashbattery wires and electrodesmdashforms the essence of a tDCS deviceCompared to other techniques that stimulate the brain with electricity such as elec-troconvulsive therapy (ECT) the level of current used in tDCS is relatively low mosttDCS studies use 05ndash2 mA whereas ECT utilizes 500ndash900 mA27

The notion of a ready-to-wear consumer tDCS headset first hit the media in thespring of 2012 when two undergraduates from the University ofMichiganMatt Sorn-son and Nick Woodhams built a prototype of a tDCS device called the GoFlow (lsquotheworldrsquos first tDCS kitrsquo) and promised to sell it for $9928 Various press outlets pickedup on the story enthusiastically describing the initiative with headlines such as lsquoBuy aDIY Brain Supercharger for $100rsquo and lsquoTranscranial direct current stimulation worksand you can try it at homersquo29 Twomonths later inMay 2012 the company announcedthat theywere being delayed due to FDA concerns30 and in early 2013 the co-foundersmade the decision to abandon plans for the headset31 Rumors swirled online that theGoFlow team lsquoran into some problemsrsquo with the FDA32 But Sornson had not been

24 Both DIY Biology andDIY tDCS embody what has become known as the maker culture which places a highvalue on tinkering engineering and creating things from scratch For DIY Biology see eg httpdiybioorgand ALESSANDRO DELFANTI BIOHACKERS THE POLITICS OF OPEN SCIENCE (2013) Both DIY tDCS and thequantified self-movement share the same underlying goal of self-improvement and self-optimization see egMelanie SwanThe Quantified Self Fundamental Disruption in Big Data Science and Biological Discovery 1 BIGDATA 85 87 (2013)

25 By comparison deep brain stimulation a treatment for Parkinsonrsquos disease that provides electrical stimula-tion to the brain requires neurosurgery Transcranial magnetic stimulation an FDA-approved treatment fordepression is non-invasive but the stimulation device is not easy to replicate

26 For a view that current is not entering the cortex and only affecting cranial nerves see William J Tyleret al Suppression of Human Psychophysiological and Biochemical Stress Responses Using High-Frequency Pulse-Modulated Transdermal Electrical Neurosignaling BIOXRIV preprint first published online Feb 8 2015doiorg101101015032

27 American Psychiatric AssociationThe Practice of ElectroconvulsiveTherapy Recommendations for Treat-ment Training and Privileging 147 (2d ed 2000)

28 GoFlow httpwwwflowstateengagedcom (accessed Mar 2012) httpwebarchiveorgweb20120314201106httpflowstateengagedcom

29 Ashlee Vance Buy a DIY Brain Supercharger for $100 BLOOMBERG BUSINESSWEEK Mar 21 2012httpwwwbusinessweekcomarticles2012-03-21buy-a-diy-brain-super-charger-for-100 (accessedSep 22 2015) Christopher Mims DIY Kit Overclocks Your Brain With Direct Current MIT TECHNOLOGY

REVIEWMar 8 2012httpwwwtechnologyreviewcomview427177diy-kit-overclocks-your-brain-with-direct-current (accessed Sep 22 2015)

30 Go Flow Kickstarter Campaign Denied DIYTDCS httpwwwdiytdcscom201205goflow-kickstarter-campaign-denied (accessed Dec 14 2013)

31 Interview withMatt Sornson co-developer of GoFlow Feb 14 201432 Longecity Forum httpwwwlongecityorgforumtopic57869-increased-cognition-with-9v-battery




ownloaded from


contacted by the FDA rather he andWoodhams abandoned the GoFlow for personalreasons though potential future complications with the FDAwere also a factor in theirdecision33The companyquietly sold theirmailing list anddomainname to afirmbuild-ing a consumer tDCS device called the Focus34 and in June 2013 announced that theywould not be moving forward with the project35

In the year between Sornsonrsquos and Woodhamrsquos start up and shut-down announce-ments a number of other consumer tDCS devices appeared on the market HongKong-based Trans Cranial Technologies36 began selling a $379 device and at leastthree other websites offered more affordable tDCS device lsquokitsrsquo37 The kits varied inboth price and level of sophistication but usually consisted of a 9 V battery enclo-sure (or a snap connector that the battery attached to) wires electrodes and a head-band to facilitate electrode placementThey were seemingly geared to those who hadknowledge of tDCS but lacked the necessary soldering skills to build their own devicefrom scratch Some home users like scientists began purchasing and repurposing ion-tophoresis devices which legally require a prescription but in practice are widely avail-able online38

The Focus device which was released in the summer of 2013 was arguably the firsttrue DTC tDCS device39 With its sleek ready-to-wear headset design it looked morelike Google Glass than a cobbled-together DIY device The companyrsquos website ad-vertising campaign (featuring photos of an attractive woman wearing the device) andpromised smartphone integrationmade it clear that the product was a step up from thekits sold by small-scale vendorsThough the Focus device was ostensibly marketed togamers its release thrust the DIY tDCS movement into the spotlight and brought thedebate over the regulation of cognitive enhancement devices to public attention40

Since 2013 thousands of Focus devices have been sold41 and the company has re-leased a second generation of products it currently has a headset specially designedfor exercise42 New consumer tDCS devices are constantly appearing on the market

33 E-mail fromMatt Sornson co-developer of GoFlow to AnnaWexler (Dec 15 2013) on file with author34 Supra note 3135 Id andNews from GoFlow Good and Bad DIYTDCS httpwwwdiytdcscom201306news-from-goflow-

good-and-bad (accessed Dec 14 2013)36 Trans Cranial Technologies httpwwwtrans-cranialcom (accessed July 1 2014) note that the company

is currently conducting business as TCT Research Limited37 See wwwbiocurrentkitcom wwwtdcs-kitcom and wwwtDCSdevicekitcom accessed between Dec 2012

and Apr 2013 archived versions at httpwebarchiveorg38 See eg httpwwwamazoncomDSS-Chattanooga-IontodpB00FC2SRMY and httpwww

isokineticsinccom (accessed Sep 22 2015)39 FOCUS Transcranial Direct Current Stimulation for Gamers httpwwwfocus (accessed July 8 2013)

httpwebarchiveorgweb20130708144009httpwwwfocus40 See eg Kate Murphy Jump-Starter Kits for the Mind THE NEW YORK TIMES Oct 28 2013

httpwwwnytimescom20131029sciencejump-starter-kits-for-the-mindhtml (accessed Sep22 2015) Nick StattWhenWearable Tech Makes You Smartermdashby Zapping Your Brain CNET Aug 9 2013httpnewscnetcom8301-11386 3-57597116-76when-wearable-tech-makes-you-smarter-by-zapping-your-brain (accessed Sep 22 2015)

41 Although sales data for the Focus device are not public the company sold out its first production run of 3000within a month (Murphy supra note 40) and has since had several production runs

42 Focus edge tDCS headset httpwwwfocusedge-tdcs-headset (accessed Jan 25 2015)




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most often manufactured in small runs by individuals interested in or involved withthe DIY tDCS movementThough the prospect of regulation looms large for many ofthese manufacturers the only legal action to date has come at a state level from theCDPH which effectively halted sales from tdcsdevicekitcom inMay 2013 (the case isdiscussed in detail in Part IV below)

In 2014 two Silicon Valley start-ups announced that they were entering the con-sumer brain stimulation device market One company Halo Neuroscience issued apress release in May 2014 noting that it had received $15 million in venture capitalfunding and was developing lsquowearable technology that boosts brain functionrsquo43 Thecompanyrsquos board includes well-known names such as Reed Hundt former chairmanof the Federal Communications Commission (FCC)44 In October 2014 a companynamed Thync announced that it had raised $13 million in venture capital funding45In June 2015 the company released its device ($299) which is controlled via smart-phone and provides a form of non-invasive brain stimulation for mood alteration pur-poses (either a lsquocalm vibersquo or an lsquoenergy vibersquo)46 The company has reportedly testedthousands of subjects both on its own and in collaboration with tDCS researchersand has posted some of its results online47 Given that both Halo Neuroscience andThync are well funded and highly connected consumer non-invasive electrical brainstimulation is certain to hit the mainstream public in the near futureThus what beganas DIY brain stimulation is likely to be superseded bymdashor at least dwarfed bymdashDTCbrain stimulation

At present however the border between DIY and DTC remains muddled Quali-tative research has shown that while some individuals from the DIY tDCS movementbuild their owndevices others acquire awide rangeof devices fromdevice lsquokitsrsquo (whichrequire assembly) and iontophoresis devices (which require repurposing) to theFocusheadset48 Given the variation in existing consumer tDCS devices the consumer non-invasive brain stimulation market does not lend itself easily to regulation Indeed theproposed extension of medical device regulation in Europe would apply only to trueDTC headsets it would not encompass self-built devices and iontophoresis devicesand it is unclear whether it would cover lsquokitsrsquo49 Furthermore if the devices fromThyncandHalo Neuroscience are sold at competitive price points it is possible that the mar-ket may take care of itself That is absent a material price difference consumers willopt for the safest andmost effective product As companies such asThync have already

43 Halo NeurosciencemdashPress Release (May 28 2014) httphaloneurocompress (accessed Jan 25 2015)44 Halo Neuroscience httphaloneurocom (accessed Jan 25 2015)45 Brad Stone Thync Lets You Give Your Mind a Jolt BLOOMBERG BUSINESS Oct 8 2014

httpwwwbloombergcombwarticles2014-10-08thync-raises-13-million-for-its-brain-stimulating-electrodes (accessed Sep 22 2015)

46 Id andThynccom (accessed Sep 22 2015)47 The safety section of Thyncrsquos website states lsquoThync Vibes were safely tested on several thousand in-

dividuals under a variety of conditions to optimize their performance and comfortrsquo ThyncmdashSafetyhttpwwwthynccomscience-and-technology (accessed June 25 2015) See also Tyler et al supra note26

48 Jwa supra note 3 Wexler supra note 1549 Wexler supra note 15




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been in dialog with the FDA50 it is unclear how additional regulationmdashwhich couldtake years to implementmdashmight fit into the overall picture

IIThe importance of lsquointended usersquo for FDAmedical device regulationPrior to 1976 medical devices were not required to secure FDA approval before beingmarketed51 But after a series of tragedies related to the implantation of pacemakers andintra-uterine devices52 Congress passed the Medical Device Amendments in 197653which set up a new regulatory scheme for devices classifying thembased on risk level54Class I devices are low-risk devices such as band-aids and examination gloves whichare subject to lsquogeneral controlsrsquo (eg registration of facilities device labeling compli-ance with good manufacturing practices)55 Class II devices are moderate risk devicessuch as surgical drapes and breast pump kits and are subject to additional lsquospecial con-trolsrsquo that vary by product (eg performance standards special labeling and post-marketsurveillance)56 To date most devices that provide a low level of electrical stimulationto the body for medical purposes such as transcutaneous electrical nerve stimulation(TENS) devices and powered muscle stimulation devices are considered Class II de-vices57 Class III devices are those that pose a high risk of illness or injury58 The onlyClass III non-invasive electrical stimulation devices are cranial electrotherapy stimula-tion (CES) devices and some iontophoresis devices though in 2014 the FDA indicatedthat it planned to recategorize both as Class II59 Prior to being marketed a new classIII device must submit a premarket application (PMA) demonstrating safety and ef-ficacy for a specific indication60 The PMA process which is similar to the new drugapproval process is often a multi-year multi-million dollar endeavorThus most med-ical device manufacturers take a faster and cheaper path to market by filing a 510(k)application to demonstrate lsquosubstantial equivalencersquo to a lsquopredicatersquo device61 In 2011nearly 99 per cent of newmedical devices were cleared by the FDA through the 510(k)

50 Infra notes 84 and 8551 PETER BARTONHUTT ET AL FOOD AND DRUG LAW 1201 (4d ed 2014)52 Id at 1202 120553 Medical Device Amendments of 1976 PubL No 94ndash295 90 Stat 53954 21 USC sect 360c(a)(1) (2012)55 Id and US Food and Drug Administration Regulatory Controls (Medical Devices) httpwwwfdagov

MedicalDevicesDeviceRegulationandGuidanceOverviewGeneralandSpecialControlsucm2005378htm(accessed Sep 22 2015)

56 Id57 See Fregni et al supra note 7 at 2 and eg 21 CFR sect8825890 sect8825891 and sect8825810 (2015)58 21 USC sect 360c(a)(1) (2012)59 For CES devices see Food and Drug Administration 79 Fed Reg 33712 (June 12 2014) (codified at 21

CFR 882) httpswwwfederalregistergovarticles201406122014ndash13756neurological-devices-withdrawal-of-proposed-effective-date-of-requirement-for-premarket-approval-for (accessedSep 22 2015)See also infra notes 63 and 128 For iontophoresis devices see Food and Drug Administration 79 FedReg 56532 (proposed Sept 22 2014) (to be codified at 21 CFR pt 890) httpswwwfederalregistergovarticles201409222014ndash22453reclassification-of-iontophoresis-devices-intended-for-any-other-purposes

60 21 USC sect 360c(a)(1) and US Food and Drug Administration Premarket ApprovalhttpwwwfdagovMedicalDevicesDeviceRegulationandGuidanceHowtoMarketYourDevicePremarketSubmissionsPremarketApprovalPMAucm2007514htm (accessed Jan 25 2015)

61 Section 510(k) of the Federal Food Drug and Cosmetic Act (FFDCA) (21USC sect 360(k)) (2012) and 21CFR sect 80792(a)(3) (2015)




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process62 Note however that most new Class III devices (which require PMAs) can-not be cleared via the 510(k) process63

While the level of risk determines the regulatory process for medical devices aproduct must first meet the definition of a medical device to fall within theregulatory jurisdiction of the FDA According to Section 201(h) of the FoodDrug amp Cosmetic (FDampC) Act a medical device is

an instrument apparatus implement machine contrivance implant invitro reagent or other similar or related article including a componentpart or accessory which is recognized in the official National Formulary or theUnited States Pharma-copoeia or any supplement to them intended for use in the diagnosis of disease or other conditions or inthe cure mitigation treatment or prevention of disease in man or otheranimals or intended to affect the structure or any function of the body of man or otheranimals andwhich does not achieve its primary intended purposes throughchemical action within or on the body of man or other animals and whichis not dependent upon being metabolized for the achievement of any of itsprimary intended purposes64

Importantly the definition of amedical device is not based on themechanism of actionof the device but rather on its intended use a product is amedical device if it is intendedfor use in diagnosis or treatment or intended to affect the structure or function of thebody Similar wording appears in the definition of a drug and lsquointended usersquo languagedates all the way back to the Federal Food and Drugs Act of 190665

How does the FDA establish intended use According to the code of federal reg-ulations Title 21 part 801 subpart A Section 8014 (lsquomeaning of intended usesrsquo) itfocuses on lsquothe objective intent of the persons legally responsible for the labeling of

62 Hutt et al supra note 51 at 1219 (lsquoIn 2011 FDA cleared 3072 premarket notifications while approving only37 PMAs In other words approximately 988 percent of new devices cleared for marketing by FDA that yearwere cleared under section 510(k) rather than by PMArsquo)

63 The only case wherein new Class III devices can be cleared via the 510(k) process is if the devices aresubstantially equivalent to certain lsquopreamendmentrsquo (ie introduced to the market before May 28 1976) ClassIII devices When the new regulatory scheme for medical devices took effect in the late 1970s the FDAtemporarily classified over 100 devices as Class III devices Such devices were never required to submitPMAs showing safety or efficacy It has taken the FDA several decades to lsquoreclassifyrsquo these devicesmdasheitherinto Class I or Class II or sustain the Class III classification but require a PMAmdashand currently there areless than 20 such devices awaiting FDA action Thus if a new (lsquopostamendmentrsquo) device can demonstratesubstantial equivalence to one of the few devices that were temporarily classified as Class III devices andhave yet to be reclassified the device can be cleared via the 510(k) process See infra note 128 and relatedtext for the discussion of one example a CES device US Food And Drug Administration 515 Program Ini-tiative httpwwwfdagovAboutFDACentersOfficesOfficeofMedicalProductsandTobaccoCDRHCDRHTransparencyucm240310htm (accessed Sep 22 2015)

64 Section 201(h) of the FFDCA (21 USC sect 321(h)) (2012) guidance to industry httpwwwfdagovMedicalDevicesDeviceRegulationandGuidanceOverviewClassifyYourDeviceucm051512htm(accessed Sep 22 2015)

65 Section 6 34 Stat 768 769 (1906)




ownloaded from


devicesrsquo as shown on both the productrsquos labels and advertising66 That is the product isclassified according to the manufacturerrsquos representation of itThus to a large extentmanufacturers canmaintain control over how their products are regulated Indeed thiswas the legislative intent a 1935Senate report noted that the lsquomanufacturer of a laxativewhich is amedicated candy or chewing gum can bring his product within the definitionof drug and escape that of food by representing the article fairly and unequivocally as adrug productrsquo67

A productrsquos classification as a drug or device can have far-reaching consequences asmentioned above new drugs (and many new devices if they cannot demonstrate sub-stantial equivalence to a predicate device)must undergo costly clinical trials to demon-strate safety and efficacy and it often takes several years to obtain FDA approval Insome industries such as cosmetics which have lenient regulatory requirements as com-pared todrugsmanufacturers take great pains to ensure that their advertising andprod-uct labels do not make disease or structurefunction claims It is no exaggeration tosay that a manufacturerrsquos fate may hinge on specific word choices In the classic exam-ple a cream that claims to lsquoreduce wrinklesrsquo will be classified as a drug (and subject tostringent regulatory requirements) because the wording makes a specific struc-turefunction claim but a cream that claims to lsquoreduce the appearance of wrinklesrsquowill be classified as a cosmetic because the language makes a beautification claim not astructurefunction one68

Given the importance of intended use claims for the classification of drugs and de-vices it is worthwhile to examine how manufacturers of consumer tDCS devices haverepresented their products As can be seen in Table 1 the overall intended use impliedby most manufacturers (based on their websites) is related enhancement or optimiza-tion of brain function Two manufacturers (TCT Research Limited69 and PriorMindboth based in Hong Kong) make explicit disease claims about their products Severalother manufacturers mention or link to studies on the therapeutic use of tDCS whileothers refrain from referring to any such research One manufacturer Super SpecificDevices makes no claims at all

66 The text of 21 CFR sect 8014 reads as followslsquoThe words intended uses refer to the objective intent of the persons legally responsible for the labeling ofdevicesThe intent is determined by such personsrsquo expressions or may be shown by the circumstances sur-rounding the distribution of the articleThis objective intent may for example be shown by labeling claimsadvertising matter or oral or written statements by such persons or their representatives It may be shown bythe circumstances that the article is with the knowledge of such persons or their representatives offered andused for a purpose for which it is neither labeled nor advertisedThe intended uses of an article may changeafter it has been introduced into interstate commerce by its manufacturer If for example a packer distribu-tor or seller intends an article for different uses than those intended by the person from whom he receivedthe devices such packer distributor or seller is required to supply adequate labeling in accordance with thenew intended uses But if a manufacturer knows or has knowledge of facts that would give him notice that adevice introduced into interstate commerce by him is to be used for conditions purposes or uses other thanthe ones for which he offers it he is required to provide adequate labeling for such a device which accordswith such other uses to which the article is to be putrsquo

67 This Senate report accompanied one of precursor bills to the FDampC SRep No 493 73dCong 2d Sess 2ndash3(1934) reprinted in 2 Legislative History 721 722ndash23

68 For comprehensive discussion see Peter BartonHuttThe Legal Distinction in the United States Between a Cos-metic and a Drug in COSMECEUTICALS 223 240 (Peter Elsner ampHoward I Maibach eds 2000)

69 TCT Research Limited previously conducted business as TCTTechnologies see supra note 36 but its web-site (wwwtrans-cranialcom) remained the same




ownloaded from


Table 1Marketing language from thewebsites of consumer tDCS devices availablefor purchase as of June 2015

CONSUMER TDCS DEVICE MARKETING LANGUAGE

Brain Stimulatorlowasthttpsthebrainstimulatornetwhat-is-tdcs

lsquotDCS allows you to unlock yourbrainrsquos true potentialrsquo

Cognitive Kitlowasthttpwwwcognitivekitcom

lsquoCharge your mindrsquo

tdcs-kithttpwwwtdcs-kitcom

lsquoPower your mindrsquo

ApeX Type Alowast

httpwwwapexdevicenetlsquoBe happier Be focused Be smarterrsquo

Focuslowasthttpwwwfocus

lsquomake your synapses fire fasterrsquolsquooverclock your brainrsquo lsquotake chargersquo

Thynclowasthttpwwwthynccom

lsquoquiet your mindrsquo lsquoboost your workoutrsquo

PriorMindhttpwwwpriormindcom

lsquoincrease your attention spanrsquolsquotDCS has been widely used to treatdepression rsquo

TCTlowast

httpwwwtrans-cranialcomlsquowhen only the best in tDCStherapy will dorsquo

Super Specific Deviceslowasthttpwwwsuperspecificdevicescom

lsquopersonal tDCS devicersquo

lowastWebsite contains some form of a medical or health-related disclaimer

Furthermore it seems that at least some manufacturers have attempted to writearound the provisions of the FDA Seven of the nine manufacturers display some formof health or medical-related disclaimer on their websites noting either that their prod-uct is not a medical device or that it is not intended to cure treat or diagnose diseasesTo date at least two manufacturers of tDCS devices have used the term lsquokitrsquo in hopesthat it would put distance between their product and the FDArsquos definition of a medicaldevice70

While products that make explicit or implied disease claims would be classified asmedical devices it is less clear whether those that mention or link to tDCS researchcould be consideredmedical devices For example while a link to a study describing thebenefits of tDCS for depression may be considered an implied medical claim notingthat scientists are studying the use of tDCS for various indications may not be Eachmanufacturerrsquos claim and product would have to be reviewed in their own contexts70 Richard OrsquoRourke of wwwtDCSdevicekitcom (which does not appear in Table 1 because it shut down in

2013) stated this to a California Department of Health investigator see Part IV andMedical Device Investiga-tive Report infra note 116 A manufacturer of one of the device kits in Table 1 stated lsquoI came up with theidea of a kit skirting the line a little bit itrsquos a kit itrsquos not a TDCS devicersquo Interview with manufacturer(Mar 27 2014)




ownloaded from


Although such individual reviews are outside the scope of this paper the issue of im-plied therapeutic claims is considered again in Part IV in the discussion of the regu-latory enforcement action taken by the CDPH against a small-scale consumer tDCSmanufacturer

The more complex question however is whether language such as lsquopower yourmindrsquo and lsquoincrease your attention spanrsquo implies an intended structurefunction claimThe FDA and courts have struggled to interpret the meaning of lsquointended to affect thestructure or any function of the body rsquo as a large number of productsmdashfrom high-heeled shoes to chairs to treadmillsmdashcan be said to be intended to affect the bodyrsquosstructure or function In general both the FDA and courts have recognized that inter-preting the statute literally would lead to a large number of consumer products com-ing under FDA regulation For example in one case the DC Circuit court noted thatCongress surely did not mean for there to be a broad reading of lsquointended to affectthe structure or function rsquo because otherwise amultitude of productsmdashanything thatlsquostimulates the sensesrsquomdashcould be considered a medical device or drug71

Instead courts have leaned toward a narrow interpretation of the statute in which astructurefunction claim must have a medical or therapeutic connotationThree casesin particular related to seizures of wrinkle remover creams in the 1960s have servedto clarify this interpretation In United States v An Article Sudden Change an appealscourt ruled that the question of whether a product is to lsquointended to affect the struc-ture or function of the bodyrsquo hinged on whether the claim may be said lsquoto constitutea representation that the product will affect the structure of the body in some medi-cal or drug-type fashionrsquo72 In United States v An Article of Drug Helene Curtis MagicSecret a district court also upheld that a lsquodrug connotationrsquo was necessary for a claimto be considered a structurefunction one73 In United States v An Article of Drug Line Away an appeals court ruled that the Line Away product was a drug becauseits structurefunction claims had therapeutic implications74 Though the latter threecases relate to drugs the lsquointended to affect rsquo clause is identical for drugs andmedicaldevices

Indeed in a 2002 letter FDAChiefCounselDanielTroy stated that theFoodDrugandCosmetic Act regulates only those devices whose claims havemedical or therapeu-tic connotations75 In the letter which can be said to reflect the FDArsquos most recent ex-plication of its position on intended use and structurefunction claims the FDA deter-mined that an implantable radio-frequency identification chip intended for health ap-plicationswas considered amedical devicewhereas the samechip intended for useonlyin security and personal identification applications was notThus even an implantabledevicemdashone that clearly affects the structure or functionof the body in somemannermdashwas considered a medical device by the FDA only when its intended use was medicallyrelated

With regard to consumer tDCS devices would lsquobrain optimizationrsquo or lsquocognitiveenhancementrsquo claims be considered to have medical or therapeutic connotations

71 Action on Smoking and Health v Harris 655 F2d 236 240 (DC Circuit 1980)72 United States v An Article Sudden Change 409 F2d 734 (2d Cir 1969)73 United States v An Article of Drug Helene Curtis Magic Secret 331 F Supp 912 (D Md 1971)74 United States v An Article of Drug Line Away 415 F2d 369 (3d Cir 1969)75 Letter from FDAChief Counsel Daniel E Troy to Jeffrey N Gibbs (Oct 17 2002)




ownloaded from


Indeed the issue of what sorts of lsquooptimizationrsquo claims are permissible for consumerdevices has become a pressing one in recent years due to the increase in wearable tech-nology devices and smartphone-based health applications In at least some industries itis thought that lsquowellnessrsquo claims (eg lsquosupports sleeprsquo) as opposed to therapeutic ones (eglsquoreduces insomniarsquo) will place a product outside the definition of a medical device Forexample at the 2014 Neurogaming conference a panel of neurotechnology investorsemphasized the importance of distinguishing between wellness and therapy claims foravoiding FDA regulation76 Indeed many consumer EEG devicesmdashwhich as men-tioned in the introduction monitor rather than stimulate the brainrsquos activitymdashseem tohave strategically marketed their devices for lsquoimprovingmental fitnessrsquo and lsquooptimizingbrain performancersquo77 However it should be noted that the lack of formal enforcementaction on the part of the FDA in the consumer neurotechnology arena (ie with regardto both tDCS and EEG devices) does not necessarily indicate that the FDA shares thisview

To address the regulatory status of health-related wearable technology devices theFDA published a draft guidance on January 20 2015 titled lsquoGeneral Wellness Pol-icy for Low Risk Devicesrsquo78 Although guidances are non-binding the FDA has in re-cent years increasingly used them to reflect its latest thinking to industry The draftguidancemdashwhich it should be emphasized is not the final version of the guidance norwill it bebindingor enforceablewhen it isfinalizedmdashindicates that theFDAdoesnot in-tend to enforce device provisions for lsquogeneral wellness productsrsquo presenting a low riskto safety The draft guidance defines a general wellness product in terms of intendeduse claims a general wellness product is one that makes claims related to lsquomaintain-ing or encouraging a general state of healthrsquo without references to diseases or condi-tions Among the examples of acceptable wellness claims provided are those relating tolsquomental acuityrsquo lsquoconcentrationrsquo lsquoproblem-solvingrsquo and lsquorelaxation and stress manage-mentrsquo79 Furthermore the draft guidance indicates that even certain structurefunctionclaims are permitted under the umbrella of lsquowellness claimsrsquo examples of acceptableclaims include those related to improving muscle size toning the body enhancing car-diac function and improving sexual performance among others80Thus at first glancethe draft guidance seems to indicate that the FDA does not intend to enforce regula-tions for tDCS devices marketed for wellness purposes

However the draft guidance also provides a second criterion the product must bea low-risk device According to the draft guidance a product is not a low-risk device iflsquoit involves an intervention or technology that may pose a risk to a userrsquos safety if devicecontrols are not appliedrsquo81 The draft guidance also states that in determining whether76 Neurogaming 2014 Investing in Neurogaming Panel Discussion May 7 2014 video recording at

httpswwwyoutubecomwatchv=fz95kEx3zx477 See eg Muse httpwwwchoosemusecom Emotiv Insight httpsemotivcominsightphp Neu-

rosky httpneuroskycom Melon httpwwwthinkmeloncom and FocusBand httpwwwifocusbandcom (accessedMarch 2015)

78 US Food And Drug AdministrationGeneral Wellness Policy for Low Risk Devices Draft Guidance for Industryand Food and Drug Administration Staff Jan 20 2015 httpswwwfederalregistergovarticles201501202015-00756general-wellness-policy-for-low-risk-devices-draft-guidance-for-industry-and-food-and-drug (accessedMar 1 2015)

79 Id at 380 Id at 481 Id at 5




ownloaded from


a device is low risk the manufacturer should consider whether a similar device is lsquoac-tively regulatedrsquo by the FDAThough the guidance provides a number of examples oflow-risk devices (mobile apps wearable heart-ratemonitors) and non-low-risk devices(cosmetic implants laser technology products) electrical brain stimulation devices arenot mentioned Would consumer tDCS products be classified as low-risk devices Onthe one hand tDCS has been consistently shown to have relatively mild side effects(eg surface skin burns headaches and dizziness)82 On the other hand no serious orchronic adverse events have been reported in the literature83

The recent letter from theFDAtoThync regarding the classificationof its device sup-ports the notion that the FDA does not view consumer neurotechnology devices thathave intended uses related to wellness or recreation as medical devices Prior to goingto marketThync submitted a 513(g) requesting information from the FDA regardinghow it would classify its product84 According to the company the FDA exempted theproduct frommedical device requirements such as pre-market approval and clearanceas the product was intended for recreational purposes85 It should be noted howeverthat the same decision might not hold true for manufacturers who do not limit theirclaims to recreational use Furthermore it is worth pointing out that the communica-tion between the FDA andThync has not been made public all information regardingthe FDArsquos letter has come from the company itself

Still one question remains if the definition of a medical device is based on its in-tended usemdashand neither on risk level nor mechanism of actionmdashcould a consumerdevice making only wellness or recreational claims (and not disease or medical-relatedstructurefunction ones) fall under the scope of FDA regulation Furthermore howcan the draft guidance pose risk level as a criterion for regulation if risk level only de-fines the regulatory process once a device is considered to be within the jurisdiction ofthe FDA Answering these questions requires an examination of how courts have con-strued the FDArsquos statutory authority with regard to medical devices which is the topicof the next section

III Judicial interpretation of lsquointended usersquo andmedical devicesWhen determining the intended use of a product the FDA has historically relied al-most exclusively onmanufacturersrsquo claims as represented on the productrsquos labeling and

82 AndreRBrunoni et alASystematic Review on Reporting andAssessment of Adverse Effects Associated with Tran-scranial Direct Current Stimulation 14 INT J NEUROPSYCHOPHARMACOL 1133 (2011)

83 Fregni et al supra note 784 Interview with Jamie Tyler CEO of Thync (Feb 12 2015) The company submitted a 513(g) lsquoRequest

for Informationrsquo to the FDA which is a lsquomeans of obtaining the agencyrsquos views about the classifica-tion and the regulatory requirementsrsquo applicable to a particular device See US Food and Drug Admin-istration Guidance for Industry and Food and Drug Administration Staff - FDA and Industry Proceduresfor Section 513(g) Requests for Information under the Federal Food Drug and Cosmetic Act Apr 6 2012httpwwwfdagovRegulatoryInformationGuidancesucm209841htm (accessed Feb 26 2015)

85 TheThync press release accompanying the launch of its device included the following statement lsquoBased onits intended use in lifestyle applications the FDA exempted theThync System from medical device regula-tions requiring pre-market notification (clearance) or approvalrsquo Thync Press Release Thync Launches FirstWearable to Shift Your State of Mind Consumer Product Delivers Calm and Energy withinMinutes June 2 2015httpwwwthynccomresourcespress-releasethync-launches-first-wearable-to-shift-your-state-of-mind(accessed June 12 2015)




ownloaded from


advertising86 For example in two cases from the 1950s district courts upheld the focusonmarketing claims finding that cigarettesmaking disease prevention87 or weight-lossclaims88 came under the FDArsquos jurisdiction whereas cigarettes that lacked such claimsfell outside it (Both of these cases came prior to the Medical Device Amendments of1976 and the courts in each case considered the cigarettes to be drugs not devices)Indeed today there are many lsquodual usersquo products that are identical in technology butregulated differently based on intended use as represented by the manufacturerrsquos in-tent For example exercise equipment marketed for medical purposes is regulated bythe FDA89 but exercise equipment for recreational use is regulated by the ConsumerProduct Safety Commission (CPSC)90 Other dual use products include bed rails91razors and binoculars92

Though the FDA has focused almost exclusively on marketing language to estab-lish intended use a close read of 21 CFR Section 8014 (lsquomeaning of intended usesrsquo)shows that the FDA can consider a variety of factors intent may be shown by the lsquocir-cumstances surrounding the distribution of the articlersquo or lsquooral and written statementsrsquoby the manufacturers and their representatives93 Indeed the courts have affirmed theFDArsquos extensive powers in this regard in one case the Seventh Circuit upheld theFDArsquos reliance on instruction booklets financial arrangements and individualsrsquo tes-timonies in determining the intended use of a product94 In another a district courtagreed that theFDAcould rely upon the lsquocircumstances surrounding the distributionofthe articlersquo to determine that a product was a drug even in the absence of explicit label-ing95 Furthermore according to 21 CFR Section 8014 if the FDA can demonstratethat the lsquoarticle is with the knowledge of such persons or their representatives offeredand used for a purpose for which it is neither labeled nor advertisedrsquo it can deem thedevicemisbranded96 With these broad criteria the FDAwould likely be well within itsauthority to take action against many small-scale tDCSmanufacturers

86 For a comprehensiveoverviewof intendeduse as it relates tomedical devices seeGaryEGamerman IntendedUse and Medical Devices Distinguishing Nonmedical Devices from Medical Devices under 21 USC 321(h) 61GEO WASH L REV 806 (1993) See also Hutt et al supra note 51 at 92 97

87 United States v 46 Cartons More or Less Containing Fairfax Cigarettes 113 F Supp 336 (DNJ 1953)88 United States v 354 Bulk Cartons Trim Reducing-Aid Cigarettes 178 F Supp 847 (DNJ 1959)89 See eg 21 CFR sectsect 8905350ndash5410 (2015) defining various kinds of FDA-regulated exercise equipment as

those lsquointended for medical purposesrsquo90 See Part V for further discussion of the Consumer Product Safety Commission91 US Food and Drug Administration Bed Rail Safety FDA and CPSC Activities httpwwwfdagov

MedicalDevicesProductsandMedicalProceduresHomeHealthandConsumerConsumerProductsBedRailSafetyucm362867htm (accessedMar 20 2015)

92 Gamerman supra note 86 at 833 835 and n18293 See supra note 66 for full text of 21 CFR sect 801494 United States v An Article of Device Toftness Radiation Detector 731 F2d 1253 1257 (7th Cir 1984)95 The product was a unlabeled balloon filled with nitrous oxide and the lsquocircumstances surrounding the distri-

butionrsquowere that thedefendantswere sellingballoonsoutside a rock concertThe court found this informationsufficient to establish intended use andnitrous oxidewas therefore considered a drugUnited States v Travia180 F Supp 2d 115 (DDC 2001)

96 See supra note 66 for full text of 21CFR sect 8014This particular line hasmost notably applied to the off-labeluse of drugs it is legal for physicians to prescribe a drug (or device) for an indication other than that for whichit has been approved by the FDA but a manufacturer cannot advertise label or otherwise represent the drug(or device) for a purpose other than approved by the FDA (21 CFR sect 8014)This rule has been recentlychallengedonFirstAmendment grounds for review see StephanieMGreeneampLarsNoahDebateOff-LabelDrug Promotion and the First Amendment 62 U PA L REV 239 267 (2014)




ownloaded from


Even if a consumer tDCSdevicemakesnoexplicit or impliedmedical-related claimscan the way that consumers actually use the product be sufficient to imply an intendeduseThis question has previously been raised in cases regarding cigarette regulation97In the late 1970s a citizen action group Action on Smoking and Health (ASH) at-tempted to compel the FDA to regulate cigarettes arguing that the way in which con-sumers actually used cigarettes demonstrated that the productrsquos lsquointended usersquo wasto lsquoaffect the structure or function of the bodyrsquo98 The FDA refused to regulate cit-ing the absence of manufacturersrsquo health claims99 In 1980rsquos Action on Smoking andHealth (ASH) v Harris the DC Circuit ruled that while it may be possible to demon-strate intention by showing actual consumer use the standard was high as it had to beshown that consumerswere using a product lsquonearly exclusivelyrsquo for a given intention100The court noted that lsquoASH did not establish and arguably cannot establish the near-exclusivity of consumer use of cigarettes with the intent ldquoto affect the structure or anyfunction of the body of man rdquorsquo101 However even if ASH had been able to demon-strate that consumers were indeed using cigarettes exclusively to affect the structure orfunction of the body the court would have had to confront the question of whether thestructurefunction use hadmedical or therapeutic connotations Exercisemachines forrecreational purposes for example are used by consumers lsquonearly exclusivelyrsquo to affectthe structure or function of the body yet they are not regulated as medical devices

The question of whether the lsquoactual and foreseeable usersquo of cigarettes could be suf-ficient to demonstrate an intended structurefunction use was raised again in 1995when the FDA under Commissioner David Kessler attempted to regulate tobacco102The tobacco industry challenged the FDA and the case ultimatelywent to the SupremeCourt103 InFood andDrugAdministration v BrownampWilliamson (2000) theCourt re-jected the FDArsquos assertion of jurisdiction over cigarettes but did not address the ques-tion of lsquoactual and foreseeable usersquo vs lsquointended usersquo and the matter has never beensubsequently resolved in court104 However it should be noted that in the 2002 letterfrom the FDAChief Counsel mentioned in the previous section the FDA took the po-sition that lsquo[f]oreseeability by the manufacturer does not suffice to establish intendedusersquo105

Thus intended use has most often been determined with relation to marketingclaims (although the FDA is fully within its power to consider a broad range of factors)and lsquoactual or foreseeable usersquo has not been sufficient to determine intended useWhilethe FDA and courts have favored a narrow interpretation of lsquointended usersquo recognizingthat a literal reading of the structurefunction definition would open up the door for97 For overview seeMargaret A Boyd ButtOutWhy the FDA Lacks Jurisdiction to Curb Smoking of Adolescents

and Children 13 J CONTEMP HEALTH LAW POLrsquoY 169 (1997) See also Hutt et al supra note 51 at 139 145(on struggles over tobacco regulation)

98 Hutt et al supra note 51 at 140 and infra note 9999 See history as set out in Action on Smoking And Health v Harris 655 F2d 236 (DC Cir 1980)100 Id at 237101 Id102 Food and Drug Administration 60 Fed Reg 41314 (Aug 11 1995)103 Hutt et al supra note 51 140 141104 Food andDrug Administration v BrownampWilliamson Tobacco Corp 529 US 120 (2000) It was not until

Congress passed the 2009 Family Smoking Prevention and Tobacco Control Act (FSPTCA Pub L No111ndash131) that tobacco came under the jurisdiction of the FDA

105 Troy supra note 75 at 5




ownloaded from


a large number of consumer products to come under its jurisdiction it is important tonote that courts are often willing to give deference to the FDArsquos statutory interpreta-tions For example in United States v An Article of Drug Bacto-Unidisk (1969) theSupreme Court upheld the FDArsquos decision to classify an antibiotic sensitivity disc as adrug rather than a device because doing so would subject the product to more strin-gent requirements106 The Court reasoned that Congress had not meant for the statuteto be read narrowly rather the FDampC Act lsquois to be given a liberal construction con-sistent with the Actrsquos overriding purpose to protect the public healthrsquo107 Subsequentopinions such as the dissent in Brown amp Williamson have quoted this line when rea-soning in favor of a liberal interpretation of the FDampC Act108 However it is unlikelythat a similar lsquopublic healthrsquo argument could be made with regard to consumer tDCSas it would have to be demonstrated that tDCS posed a significant public health riskmdashand according to one recent empirical study the home use of tDCS lsquodoes not seem topose an imminent risk or danger to the publicrsquo109

Importantly when attempting to both understand and predict the actions of theFDA it should be emphasized that the agency does not act consistently over time in-stead there is variation across different leaderships and agency actionsThus it is im-possible to draw a single coherent picture of how the FDA (and courts) has acted Forexample in at least one instance the FDA seemed to contradict its stance that struc-turefunction claims must be medically related in July 2000 it sent a warning letter toa companymarketing a battery-powered facial mask called Rejuvenique which appliedelectrical stimulation to the face In the warning lettermdashwhich it should be noted isnot final agency actionmdashthe FDA wrote that regardless of the manufacturersrsquo claimslsquobecause the Rejuvenique is intended to affect the structure or function of the body byproviding electrical current to various facial muscles to repeatedly contract them it is adevice rsquo110 The companyrsquos lawyers responded with a 15-page letter arguing that theproduct was not amedical device because the FDA classifies devices based on intendeduse not mechanism of action111 Evidently however the company decided it was intheir best interest to work with the FDA rather than litigating because one year laterthe Rejuvenique was cleared via the 510(k) process112

106 United States v An Article of Drug Bacto-Unidisk 394 US 784 (1969)The case took place prior to thepassage of theMedical Device Amendments when devices unlike drugs did not have to undergo pre-marketapproval

107 Id at 798108 In his dissent Justice Breyer argued that cigarettes should indeed be regulated by the FDA because (a) the

purpose of the FDampCAct is to protect public health and (b) cigarettes are certainly are intended to affectedthe structure or function of the body Food andDrug Administration v BrownampWilliamson Tobacco Corp529 US 120 (2000) (Breyer J dissenting)

109 See Jwa supra note 3 at 25110 Larry D Spears for Steven D Niedelman Acting Director Office of Compliance Food and Drug

Administration Warning Letter to Salton Inc July 12 2000 httpwwwcasewatchorgfdawarningprod2000saltonshtml (accessedMar 15 2015)

111 GeorgiaC Ravitz Counsel for Salton IncReRejuvenique Facial Toning System toMrWilliamFDefibaughCompliance Offer Center for Devices and Radiological Health Aug 11 2000 httpmediacorporate-irnetmedia filesnyssfpsalton rejuvpdf (accessedMar 15 2015)

112 510(k) Summary mdash Rejuvenique R⃝ Facial Toning System Aug 8 2001 httpwwwaccessdatafdagovcdrh docspdfk011935pdf (accessed Feb 25 2015) Note however that this pathway was some-what unusual because a 510(k) is granted when the device is similar in both lsquointended usersquo and lsquotechnologicalcharacteristicsrsquo Here the intended use was cosmetic not therapeutic




ownloaded from


TheRejuvenique case is particularly informative as it exemplifies the typical negotia-tions between government agency and manufacturer following a warning letter Whilethe Rejuvenique manufacturer could have challenged the FDA in court it chose thefaster and cheaper option of working with the agency Indeed practical business con-siderations may be the best predictor of how a company will engage with the FDAMany companies that have a product of unclear regulatory statusmdashespecially if theyare investor backed or are looking for fundingmdashwill open a dialog with the FDA earlyin the development process so as not to risk later regulatory action Indeed it is hard toimagine that venture capital-backed companies such asThync and Halo Neurosciencewould have been able to raise millions of dollars without a solid regulatory plan (Asnoted in the previous sectionThyncwas in contact with the FDAprior to going tomar-ket113 press mentions of Halo Neuroscience have indicated that the company intendsto work with the agency)114 By contrast a small-scale tDCS consumer device manu-facturer without the funds for legal counsel would probably attempt to place its deviceoutside of the scope of FDA regulation A manufacturer of this kind who received awarning letter or notice of violation from the FDA could in theory litigate (assumingthat its product does not have an medical or disease-related intended use according toall the factors set out in 21 CFR Section 8014) but in practice it would not likelybe worth the time or money The section below illustrates what happened when thestate of Californiamdashacting on an email from an engineer at the FDAmdashsent a notice ofviolation to a small-scale consumer tDCSmanufacturer

IV Regulatory action to datemdashtheCDPHandTDCSDevice Kit IncThus far the only instance of regulatory enforcement against a consumer tDCS de-vice has come at a state level from the CDPH which in May 2013 took action againsta company called TDCS Device Kit Inc for violating Californiarsquos Sherman FoodDrug andCosmetic Law115 According toCalifornia state lawmedical devices that arenot federally approved for market in the United States can be considered misbrandedandor adulterated under the Sherman Law116 Furthermore the Sherman Law re-quires anyonemanufacturing amedical device inCalifornia to obtain a license from theCDPH117

According to the CDPH report the investigation of TDCS Device Kit was initi-ated following receipt of an email and five-page analysis from a biomedical engineerat the FDArsquos Center for Devices and Radiological Health118 The company which

113 Interview withWilliam (Jamie) Tyler co-founder and chief scientific officer (CSO) ofThync Feb 12 2015114 Ben PopperTheHaloNeuroscienceHeadbandWants toMake You Smarter by Shocking Your BrainTHEVERGE

April 30 2014 httpwwwthevergecom20144305668086halo-neuroscience-brain-stimulation-funding-andreessen (accessed Feb 25 2015) John Biggs Halo the Brain-Improving Wearable Raises $15Million TECH CRUNCH May 1 2014 httptechcrunchcom20140501halo-the-brain-improving-wearable-raises-1-5-million (accessed Feb 25 2015)

115 State ofCaliforniaDepartment of PublicHealth Food andDrugBranchMedicalDevice SafetyUnitMedicalDevice Investigative Report TDCS Device Kit Inc inspection date May 7 2013

116 Cal HSC Code sect 109875 et seq See also infra 143 and 144 and related text for a discussion of the overlapbetween federal and state medical device laws

117 Cal HSC Code sect 111615118 The engineer was in the Office of Device EvaluationDivision of Neurological and Physical Medicine De-

vicesPhysical Medicine and Neurotherapeutic Devices Branch (CDRHODEDNPMDPNDB) supranote 115




ownloaded from


was based in California had been selling a lsquoHome TDCS Device Kitrsquo via its website(wwwtdcsdevicekitcom) The FDA engineer had concluded that the lsquoHome TDCSDevice Kitrsquo was a Class III medical device and would require 510(k) clearance to belegallymarketed in theUSA as the companyrsquos website implied that the device could beused to treat a variety of disorders Although the company never explicitly claimed thatits own device had medical benefits its website did contain several paragraphs abouttDCS with sentences such as lsquoClinical therapy using TDCSmay be the most promis-ing application of this technique There have been therapeutic effects shown in clini-cal trials involving Parkinsonrsquos disease tinnitus fibromyalgia and post-stroke motordeficitsrsquo

InMay 2013 an investigator from theCDPHcontacted the president of TDCSDe-viceKit RichardOrsquoRourke who believed that his product did not requireCDPHclear-ance since the product was a kit that was assembled by the user A few days later thesame investigator met OrsquoRourke and inspected the manufacturing facility the com-pany was issued a notice of violation that day for non-compliance with CaliforniarsquosSherman Food Drug and Cosmetic Law for manufacturing medical devices withouta license from the CDPH119 Two weeks later the CDPH issued TDCS Device Kita second notice of violation this time with 11 items related to lsquoselling and deliver-ing misbranded adulterated and unapproved medical devicesrsquo According to the no-tice of violation the device was unapproved by the FDA it was adulterated in that itdid not comply with good manufacturing practices and performance standards and itwas misbranded in that the manufacturing establishment was not licensed by the FDAor the CDPH and the label failed to bear adequate warnings directions and otherinformation120

The company subsequently stopped selling the devices and a sentencewas added toits website noting that the kits were lsquounavailable at this timersquo OrsquoRourke however wasreluctant to issue a recall and evidently did not take action to meet with the FDA ormedical device regulatory counsel to negotiate a plan to secure approval for the deviceTherefore the CDPH moved forward issuing a press release on June 28 2103 titledlsquoCDPHWarns Consumers Not to Use TDCS Home Device Kitrsquo121 The next monthTDCS Device Kit sent out a recall email to over 200 customersThe investigation wasofficially closed inOctober 2013 following aCDPHdetermination that thefirmrsquos recallefforts were adequate122

There are several contextual points of interest in this case First it remains an openquestion why the FDA engineer conducted his or her own analysis yet forwarded theissue to the CDPH One possibility is that the FDA engineer did not have evidence ofthe product being sold across state lines the FDArsquos jurisdiction lies only in interstatecommerce not in intrastate commerce123 Another possibility is that it was simpler tohand the case off to the state and not engender complex federal regulatory processes

119 Supra note 117120 Supra note 115121 California Department of Public Health CDPH Warns Consumers Not to Use TDCS Home Device Kit June

28 2013 httpwwwcdphcagovPagesNR13-029aspx (accessed Feb 1 2015)122 State ofCaliforniaDepartment of PublicHealth Food andDrugBranchMedicalDevice SafetyUnitMedical

Device Investigative Report TDCS Device Kit Inc inspection date Oct 7 2013123 Infra note 144




ownloaded from


In response to a query regarding the frequency of FDA referrals for medical device in-vestigations the CDPH noted that such referrals occur lsquooccasionallyrsquo124

Second all items in the 11-item notice of violation referred to the device as a lsquopre-scription medical devicersquo (emphasis added) The fifth item on the notice of violationwas based entirely on this characterization stating that the device was misbranded be-cause the label failed to bear the statement lsquoCaution federal law prohibits dispensingwithout a prescription rsquo or similar language However there is no clinical use of tDCSthat is FDA approved either for prescription or over-the-counter use When queriedabout the use of the term the CDPH noted that when lsquoadditional information was ob-tained it was determined the product was an unapproved new medical device as op-posed to a prescription medical devicersquo125 Indeed the second shorter CDPH reportdoes not mention the word lsquoprescriptionrsquo but it also does not make note of the initialerror

Third even though TDCS Device Kit never made a specific disease or struc-turefunction claim for its product the report states that treatment claims were lsquoim-pliedrsquo by the websiteThus if statements about the clinical effects of tDCS appear on awebsite that sells a consumer tDCS device representatives from the FDA and the stateof California have inferred that the product is a medical device Furthermore design-ing and marketing a consumer tDCS device as a lsquokitrsquo made no meaningful differenceThus severalmanufacturers that currently sell consumer tDCS devicesmay be liable toreceive notices of violation (at the state or federal level) for unapproved adulteratedor misbranded medical devices As noted in Part II several manufacturers link to ormention research regarding the therapeutic effects of tDCS

Fourth according to the CDPH report the FDA engineerrsquos five-page analysis con-cluded that the device was a Class III device that would require a 510(k) clearancebefore marketingThis implies that the FDA engineer had characterized the device assubstantially equivalent to an existing pre-amendment Class III device which as men-tioned in Part II is a device that poses the highest risk of injury and illness The ex-isting Class III device most similar to tDCS is a CES device which according to theFDArsquos definition lsquoapplies electrical current to a patientrsquos head to treat insomnia de-pression or anxietyrsquo126 The main difference between the two is that while tDCS usesdirect current CES uses alternating current127 The assumption of substantial equiv-alence to CES would explain the CDPH reportrsquos (incorrect) observation that tDCSlsquois typically used to treat depression and other mood disordersrsquo It would also explainthe use of the term lsquoprescriptionrsquo in the CDPHrsquos violation notice as CES is currently aprescription-only device

124 E-mail from Ronald Owens Office of Public Affairs California Department of Health to AnnaWexler (Feb13 2015) on file with author


126 21 CFR sect 8825800 (2015)127 Although the FDArsquos definition of CES is broad the agency has elsewhere described the specific charateristics

of CES and has distinguished it from tDCS See eg Section 12 in US Food and Drug AdministrationFDA Executive Summary Prepared for the February 10 2012 meeting of the Neurologic Devices PanelhttpwwwfdagovdownloadsAdvisoryCommitteesCommitteesMeetingMaterialsMedicalDevicesMedicalDevicesAdvisoryCommitteeNeurologicalDevicesPanelUCM290787pdf (accessed Sep 222015)




ownloaded from


The comparison of tDCS to CES is especially interesting in light of the ongoing bat-tles about whether CES should be categorized as a Class II or Class III device As men-tioned earlier the vast majority of non-invasive electrical stimulation devices for med-ical purposes are categorized as Class II devices and CES manufacturers have long at-tempted to have the CES device reclassified from aClass III to Class II In recent yearshowever the FDA has tried unsuccessfully and against heavy resistance to increase theburden on CES manufacturers128 In June 2014 in response to a flood of public com-ments the FDA stated that it planned to reclassify the device as Class II although ithas yet to follow through with this reclassification129 It is likely that the particular CEStroubles are a consequence of being grandfathered in under the 1976 Medical DeviceAmendments and automatically categorized as a Class III device CES was thereforenever required to submit a PMAdemonstrating safety and efficacyThe lack of PMA forCES also explains the FDA engineerrsquos surprising determination that the lsquoHome TDCSDevice Kitrsquo was substantially equivalent to an existing Class III device and would re-quire 510(k) clearance as most new Class III devices cannot be cleared via the 510(k)processThe engineer likely had CES in mind because the only instance where a newClass III device can be cleared via the 510(k) process is if it can demonstrate substantialequivalence to a lsquopreamendmentrsquo device that was automatically classified as Class IIIsuch as CES130

In sum the CDPH case shows that contrary to common perception the FDA hasbeen involved in the regulation of consumer tDCS devices however it should beemphasized that the FDA engineerrsquos email and analysis does not represent the formalposition of the FDA131 Though there was initial uncertainty on the part of the CDPHregarding the status of consumer tDCS devices state and federal regulators still con-sidered the product to be a medical device based on manufacturerrsquos statements aboutthe therapeutic effects of tDCS Importantly the use of the term lsquokitrsquo did not offer anyprotection Finally the only documented case to date of the FDArsquos involvement intDCS indicates that at least one engineer in its offices has viewed tDCS formedical pur-poses as a Class III device While this will likely be surprising for researchers who have

128 In 2011 the FDA issued a proposed rule to require the filing of a PMA (or a notice of completion of a productdevelopment protocol PDP) for CES devices In response three petitions were filed by CESmanufacturersrequesting reclassificationofCESdevices intoClass IIThe petitionswere referred to a 2012NeurologicalDe-vice Panel which agreed that the devices should require PMAs and remain in Class III In April 2013 (aroundthe time the FDA emailed theCDPH) the FDA issued an order to require additional pre-market approval forCESdevices See Background sectionUSFood andDrugAdministrationNeurologicalDevicesWithdrawalof Proposed Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Devices79 Fed Reg 33712 (June 12 2014) to be codified at 21 CFR 882

129 Id130 See infra note 63131 Under 21 CFR 1085(k) a statement by an FDA employee represents only the best personal judg-

ment of that individual and lsquodoes not necessarily represent the formal position of FDA and doesnot bind or otherwise obligate or commit the agency to the views expressedrsquo 21 CFR 1085(k)httpwwwaccessdatafdagovscriptscdrhcfdocscfcfrCFRSearchcfmfr=1085 (accessed Jan 252015)




ownloaded from


assumed that tDCS for medical use would be a Class II device the report should betaken with a grain of salt as the FDA engineerrsquos analysis is not representative of theagencyrsquos formal position Indeed another device similar to tDCSmdashone that provideselectrical stimulation to the head for headache treatmentmdashwas recently classified bythe FDA as a Class II device132

V Safety and advertising regulations for consumer productsIf the FDA does not recognize consumer tDCS devices as medical devices (or opts notto enforce existing regulations) such products would still be subject to a multitude ofconsumer product safety and advertising laws For example the Federal Trade Com-mission (FTC) has the authority to take relevant administrative action for lsquounfair ordeceptiversquo business practices133 The FTC interprets the term lsquodeceptiversquo broadlymdashtoinclude lsquosales of hazardous products without adequate disclosuresrsquomdashand thereforeissues related to the sale of consumer tDCSproducts could fall under its scope134 Whilethe FTC regulates the advertising of consumer products as well as over-the-counterdrugs and medical devices the FDA maintains regulatory authority over the advertis-ing of restricted (ie prescription) drugs and medical devices and for the labeling ofall products under its jurisdiction135 Thus if the FDA classifies consumer tDCS prod-ucts as unrestrictedmedical devices oversight of their advertising would fall under theFTC and labeling under the FDA if such devices are considered consumer productsoversight of both advertising and labeling would fall under the broad brush of the FTCTwo recent FDA guidancesmdashthe wellness device draft guidance mentioned in PartII and a 2015 guidance regarding health-related mobile applicationsmdashseem to shift aregulatory burden to the FTC by placing a large class of wellness products outside thescope of FDA regulation136 Indeed the FTC recently filed a complaint against a com-pany marketing a computer game that claimed to improve cognition in children137 It

132 US Food and Drug AdministrationMedical Devices Neurological Devices Classification of the TranscutaneousElectrical Nerve Stimulator to Treat Headache 79 Fed Reg 37946 (July 3 2014) to be codified at 21 CFR882httpswwwfederalregistergovarticles201407032014-15625medical-devices-neurological-devices-classification-of-the-transcutaneous-electrical-nerve (accessed Feb 22 2015)

133 15 USC sect 45(a)(1) (2012)134 Federal Trade Commission FTC Policy Statement on Deception httpwwwftcgovpublic-statements

198310ftc-policy-statement-deception (accessed Jan 25 2015)135 Although the FDA and FTC have overlapping jurisdiction since 1954 they have operated under a

Memorandum of Understanding However it should be noted that the Memorandum is only an in-formal division of authority Working Agreement Between Federal Trade Commission and Foodand Drug Administration 36 Fed Reg 18539 (Sept 16 1971) httpwwwfdagovAboutFDAPartnershipsCollaborationsMemorandaofUnderstandingMOUsDomesticMOUsucm115791htm (ac-cessed Jan 20 2015) See also discussion in James SerafinoDeveloping Standards for Health Claims-The FDAand the FTC 47 FOOD ampDRUG LJ 335 335ndash337 (1992)

136 US Food and Drug Administration Mobile Medical Applications Guidance for Industry and Food and DrugAdministration Staff (Feb 9 2015) httpwwwfdagovdownloadsMedicalDevices UCM263366pdf(accessed Feb 22 2015)

137 Federal Trade Commission Press Release Makers of Jungle Rangers Computer Game for Kids Set-tle FTC Charges that They Deceived Consumers with Baseless lsquoBrain Trainingrsquo Claims Jan 20 2015httpwwwftcgovnews-eventspress-releases201501makers-jungle-rangers-computer-game-kids-settle-ftc-charges-they (accessed Feb 26 2015)




ownloaded from


also has pursued action against variousmobilemedical health apps in recent years suchas ones that have claimed to treat acne and diagnose melanoma138

With regard to safety the CPSC is tasked with protecting the public from lsquounrea-sonable risks of injury associated with consumer productsrsquo139 and regulates productssuch as table saws cribs and carbon monoxide detectorsThe CPSC has the author-ity to ban products develop safety standards and facilitate product recalls All med-ical devices (and other products regulated by the FDA) fall outside the scope of theCPSC140 It should be noted however that as a matter of practice some authori-ties may be reluctant to take enforcement action over a product that may fall un-der the primary jurisdiction of another agency For example if a product has the ap-pearance of a medical device an agency such as the CPSC may be hesitant to assertjurisdiction

Another federal agency the FCC regulates the radio frequency output of variouswireless technology devices ensuring that they meet certain standards While mosttDCS devices from small-scale vendors do not incorporate wireless technology boththe Focus and the Thync devices have FCC certification as they can be controlledwirelessly from a smartphone141 The FCC and the FDA in some cases have over-lapping jurisdiction as they both regulate radiation-emitting products For examplethe FCC certifies cell phones and ensures that they meet certain radio frequencystandards whereas the FDA is responsible for potential cell phone-related healthissues142

In addition to federal regulations individual states also have health safety andmed-ical device laws According to section 521 of the FDampC Act the FDArsquos medical de-vice regulations preempt (ie supersede) state laws143Though the overlap between fed-eral and state regulations is complex in general a state law cannot interfere with FDAregulations (eg it cannot set lesser criteria for what constitutes amedical device) How-ever in some cases a state can apply additional rules or more stringent requirementsFor example the first notice of violation issued to TDCS Device Kit was related to astate requirement (lack of licensing from the CDPH) not a federal one Furthermore

138 Federal Trade Commission Press Release lsquoAcne Curersquo Mobile App Marketers Will Drop BaselessClaims Under FTC Settlements Sept 8 2011 httpswwwftcgovnews-eventspress-releases201109acne-cure-mobile-app-marketers-will-drop-baseless-claims-under (accessed Jan 8 2015) and FederalTrade Commission Press Release FTC Cracks Down on Marketers of lsquoMelanoma Detectionrsquo Apps Feb 232015 httpswwwftcgovnews-eventspress-releases201502ftc-cracks-down-marketers-melanoma-detection-apps (accessedMar 1 2015)

139 Consumer Product Safety Act (Codified at 15 USC sectsect 2051minus2089)140 US Consumer Product Safety Commission Products Under the Jurisdiction of Other Federal Agencies

httpwwwcpscgovenRegulations-LawsndashStandardsProducts-Outside-CPSCs-Jurisdiction (accessedJan 25 2015)

141 The application for FCC certification for the Focus devices (submitted by European Engineers Lim-ited FCC ID 2AAH6DLIG1) and for the Thync device (FCC ID 2AELZ-1000) are publicly viewablevia an lsquoEquipment Authorization Searchrsquo on the FCC website httpsappsfccgovoetcfeasreportsGenericSearchcfm (accessed Jan 8 2015)

142 USFood andDrugAdministrationRadiation-Emitting Products - Cell Phones httpwwwfdagovradiation-emittingproductsradiationemittingproductsandprocedureshomebusinessandentertainmentcellphonesdefaulthtm (accessed Jan 25 2015)

143 Section 521(a) of FDampC act as codified in 21 CFR sect 808 For discussion see Hutt et al supra note 51 at1280 1282




ownloaded from


the FDA has jurisdiction only over interstate commerce not intrastate commerce144Currently all US-based consumer tDCS device manufacturers are selling their prod-ucts on an interstate level but if every part of a device were to be manufactured andsold entirely within a single statemdashwhich of course is highly unlikelymdashthe productwould fall under state and not FDA jurisdiction States also have their own consumerprotection laws (often for unfair or deceptive business practices) that would be appli-cable in the realm of consumer tDCS

With regard to the importation of foreign tDCS devices into theUSA (such as thosefrom theHongKong-based companies TCTResearch Limited and PriorMind both ofwhichmake explicit medical claims) the FDA imposes identical requirements on bothforeign and domestic devices145 The FDA works with the Department of HomelandSecurity to inspect food drugs cosmetics and medical devices and the governmenthas broad powers to detain or seize imports146 However the FDA recognizes that it isnot practical to inspect every item imported into theUSA and the agency has thereforebeen permissivewith small quantities of drugs or devices imported for personal use Ac-cording to theFDArsquosRegulatoryProceduresManual the agency exercises enforcementdiscretion even for items that are in clear violation of FDA regulations However themanual notes that although the FDA lsquomay use discretion to allow admission of certainviolative items this should not be interpreted as a license to individuals to bring in suchshipmentsrsquo147 The FDA is more likely to take enforcement action when the productpresents a health risk if it is being actively promoted to US customers or if it is beingshipped repeatedly andor in large quantities

Finally the Better Business Bureau (BBB) a non-profit non-governmental organi-zation plays amajor role inwhat it is referred to as industry lsquoself-regulationrsquo148TheBBBinterfaces between companies and consumers to settle complaints outside of court ithas already helpedone consumerwith a complaint about theFocus device149TheBBBalso has aNationalAdvertisingDivisionwhichmonitors companiesrsquo advertising claimsand attempts to resolve matters through settlements150 Thus even if consumer tDCSdevices are not regulated as medical devices by the FDA they would still be subject tonumerous federal and state consumer product laws

144 Section 301 of the FDampCAct145 Section 801(a) of the FDampCAct146 See Hutt et al supra note 51 at 1450 for discussion of different outcomes for seizure as compared to refusal

of admission147 US Food and Drug Administration Regulatory Procedures Manual 9ndash2 Coverage of Personal Impor-

tations httpwwwfdagovICECIComplianceManualsRegulatoryProceduresManualucm179266htm(accessed Jan 10 2015)

148 Council ofBetterBusinessBureausMissionandVision httpwwwbbborgcouncilaboutvision-mission-and-values (accessed Jan 15 2015) FTC Commissioner Maureen K Ohlhausen has defined self-regulation as a lsquobroad concept that includes any attempt by an industry to moderate its conductwith the intent of improving marketplace behavior for the ultimate benefit of consumersrsquo Maureen KOhlhausen Remarks at the BBB Self-Regulation Conference June 24 2014 at 2 httpwwwftcgovsystemfilesdocumentspublic statements410391140624bbbself-regulationpdf (accessed Jan10 2015)

149 BBB Business Review European Engineers Limited (see lsquoComplaint Resolution Logrsquo) httpwwwbbborggreater-san-franciscobusiness-reviewshome-electronicseuropean-engineers-limited-in-redwood-city-ca-459140complaints (accessed Jan 25 2015)

150 National Advertising Division httpwwwbbborgcouncilthe-national-partner-programnational-advertising-review-servicesnational-advertising-division (accessed Jan 25 2015)




ownloaded from


CONCLUSIONIn sum this paper has offered an in-depth fact-based perspective on the regulation ofconsumer tDCS devices in the United States Rather than a lsquoregulatory gaprsquo there aremultiple distinct pathways by which consumer tDCS devices can be regulated in theUnited States An examination of the existing consumer device market illustrated thecomplex array of various tDCS devices and the shift fromDIY devices to DTC ones Areview of the statutory language of the FDampCAct as well as related judicial and agencyinterpretations demonstrated the importanceof considering theprecise languageof thelaw (and the intended use claimsmade for each consumer tDCS device) as well as howthe courts have construed the FDArsquos authority Although it is unclear whether the FDAor states will attempt to assert jurisdiction over small-scale consumer tDCS manufac-turers if regulatory action is initiated such small-scale manufacturers may be able tochallenge the FDA in limited circumstances151 though in practice this is unlikely to bea successful or worthwhile endeavor In addition an analysis of the state regulatory ac-tion taken against TDCSDevice Kit revealed one FDA engineerrsquos interpretation that aconsumer tDCSproductwas aClass III device it alsoprovidedan indicationof the levelof scrutiny that states and federal bodies might adopt in determining what constitutesan lsquoimpliedrsquo therapeutic use claim Finally I have shown that if the FDA does not regu-late consumer tDCS products as medical devices such products would still be subjectto a multitude of consumer safety and advertising regulations although enforcementmay not be vigorous

Taken together existing authorities provide diverse regulatory options For exam-ple products such as the Focus and tDCS device kits could be regulated as consumerdevices and thereforewouldbe subject to the consumer safety andadvertising lawsout-lined in the previous section Foreign device manufacturers who ship consumer tDCSdevices to the USA (such as TCT Research Limited and PriorMind) might not en-counter regulatory issues if they ship in limited quantities to individuals for personaluse Companies with greater resources such as Thync and Halo Neuroscience maybe more likely to work with the FDA as mentioned above according toThyncrsquos pressrelease the FDA exempted the company from obtaining approval or clearance for itsdevice

Separate from consumer tDCS devices medical and investigational devices havetheir own regulatory pathways Neuroconn could continue to provide its tDCS de-vice to clinicians and researchers for investigational purposes only under the FDArsquosinvestigational device exemption Scientists could continue to repurpose iontophore-sis devices for use in research studies as long as such devices are deemed to be non-significant risk devices by their local Institutional Review Board With regard to treat-ment psychiatrists and other medical professionals could continue to repurpose ion-tophoresis devices for lsquooff-labelrsquo use for either cognitive enhancement or treatmentsuch a practice is legal in the United States152 In the future a company could demon-strate the safety and efficacy of its device for a specific clinical use (eg depression) and

151 Since 21 CFR Section 8014 allows the FDA to consider a broad range of factors in determining intendeduse I use lsquolimited circumstancesrsquo here to refer to a situation wherein a disease claim or medical-related struc-turefunction claim could not be construed based on all the factors set out in that section

152 See supra note 96




ownloaded from


see it approved or cleared as a prescription-only medical deviceThus while all of theabove-mentioned examples involve some form of tDCS each is subject to differentforms of oversight

Given the multitude of regulation covering various forms of tDCS devices it isunclear how additional regulation might fit into the picture Indeed as I mentionedat the outset many scholars have conflated the lack of enforcement with the lackof regulation Furthermore much of the existing literature has neglected to con-sider current legal frameworks and factors such as the practical feasibility of imple-mentation (ie the procedures costs and length of time required to modify regula-tion) the precise targets of regulation (exactly which devices additional regulationwould affect and how) and possible social implications (such as the possibility thathome users might go further lsquoundergroundrsquo in response to a regulatory push) In-deed modifying a regulatory framework to questionably encompass a small sliver ofdevices that have yet to cause any serious adverse effects seems both impractical andunrealistic

Rather than focusing on the enforcement of existing regulation153mdashwhich wouldnot affect the use of home-built devices theThync device and iontophoresis devicesmdasha more productive method might be to begin with a review of existing devices and thepopulations who use them outlining the relevant issues of concern surrounding con-sumer non-invasive brain stimulation While there has been a large body of literatureon the ethics of cognitive enhancement drugs (eg inequalitywith regard to distributioncompelled use) the bulk of the conversation surrounding consumer tDCS devices hasfocused on issues of safety and risk However further clarification is necessary whenusing these terms as even a device that complies with regulatory standards may not belsquosafersquo under certain usage practices (eg long-term use of the Thync device) whereasa device that does not meet technical output standards may be safe when used in aspecific manner (eg a lsquoDIYerrsquo using a home-built device) In other words who is usingthe device is just as important as what device they are using Furthermore it is crucialto differentiate between short-term safety issues (eg side effects such as skin irritationand headaches) and long-term unknowns (eg the possibility of deleterious cognitiveeffects)

Importantly the review could focus on establishing guidelines that address usagepractices rather than devices themselves Such guidelines which would be along thelines of the engagement approach that has been previously suggested in the litera-ture154 could target home users the general public and physicians who currently ad-minister tDCS for off-label use Guidelines could reflect best usage practices as wellas current unknowns in the literature and leave it to the users to make informed de-cisions Such an approach could be quickly implemented flexible and would reacha global audience rather than being limited to a specific country Indeed qualitative

153 In most cases a federal or state agency cannot be compelled to enforce existing regulation However com-plaints may be filed with the various regulatory authorities

154 See Fitz amp Reiner supra note 14 and Nicholas S Fitz amp Peter B Reiner Buttressing Regulation of CognitiveEnhancement Devices with Principles of Harm Reduction 1 J L BIOSCI 322 (2014)




ownloaded from


studies have shown that tDCS home users look to the scientific community for guid-ance155 and would be open to guidelines from researchers156

Though an engagement approach to the regulatory issues surrounding DIY tDCSwas first proposed two years ago as of yet no initiative has come to fruition Indeedthere are a number of practical barriers that should be acknowledged First as homeusers are perceived as lsquofringersquo or lsquounorthodoxrsquo by much of the scientific communitythere is likely a stigma attached to engagingwith themdirectly Second given that tDCSis still verymuch in research and investigational stages most scientists are probably un-willing to make proclamations about what is safe and what is not and would likely notwant to take steps thatmaybeperceived as encouraging unsupervised useThird guide-lines could lead to liability issues (eg if a home user injured himself despite followingthe guidelines) Fourth given the lack of consensuswithin the tDCS field itself (egwithregard to optimal dosage andpotential long-termdeleterious effects) itmay be difficultfor researchers to agree on a single set of guidelines

Given these obstacles it may be beneficial for such guidelines to be developed un-der the umbrella of a reputable third party such as the National Academy of Medicine(formerly known as the Institute of Medicine) or a neuroethics committee A third-party might alleviate some of the stigma of interacting directly with the home usersand protections could be put into place to shield individual researchers from liabilityissues Rather than reflecting a single consensus guidelines could summarize the lat-est research regarding the short- and long-term issues regarding tDCS with a focus onminimizing side effects and encouraging safe usage practices Importantly the com-mittee could be an avenue not just for one-way communication from researchers tohome users and the general public but a venue for representatives of various groupsto interact Qualitative and quantitative work should continue to track tDCS homeuse and its potential uptake by the general public in order to provide ongoing in-formation regarding the use of non-invasive brain stimulation outside of academicsettings

Looking ahead it is clear that electrical brain stimulationwill soon become availableto a larger audience than it ever has before IfThyncrsquos initial results are borne outmdashandits device does have the same effect as a glass of wine or a cup of coffeemdashthen the tech-nology could be profoundly transformative in ways that we cannot yet grasp Ratherthan adopting an alarmist approach to the new reality of consumer brain stimulationwe must navigate this unfamiliar terrain with practical grounded assessments of socialand regulatory issues Establishing a forum for the continued interaction among man-ufacturers home users and regulators would represent an important first step in thisdirection

ACKNOWLEDGEMENTSThank you to Peter BartonHutt for providing invaluable guidance and assistancewith the preparationof this manuscript

155 SeeWexler supra note 15156 See Jwa supra note 3




ownloaded from


stimulation devices Taken together this paper demonstrates that ratherthan a lsquoregulatory gaprsquo there are multiple distinct pathways by which con-sumer tDCS can be regulated in the United States

KEYWORDS food and drug law human enhancement medical devicesneuroscience regulation transcranial direct current stimulation (tDCS)

INTRODUCTIONTranscranial direct current stimulation (tDCS) is a non-invasive form of brain stimu-lation that is thought to provide a constant low level of electrical current to the brainApproximately 1000 scientific studies have been published in peer-reviewed journalsin the last decade1 many of which suggest the beneficial effects of tDCS in both clin-ical populations for treating a variety of conditions and psychiatric disorders and inhealthy individuals for enhancing everything from creative problem solving to theacquisitionofmotor skills2 Because a tDCSdevice is relatively easy tomake (and cheapto acquire) there has arisen amovementwherein individuals stimulate their ownbrainswith tDCS outside of research or medical settings for self-improvement purposesThemovement has been colloquially referred to as do-it-yourself (DIY) tDCS as it beganwith individuals constructing tDCS devices themselves Since today many individualswho identify with the DIY tDCSmovement purchase ready-made direct-to-consumer(DTC) devices3 the border between DIY and DTC has become muddled In this pa-per I refer to those who use tDCS devices outside of professional research andmedicalsettings as lsquohomeusersrsquoThus there currently exists twogroupsmdashresearchers andhomeusersmdashwho utilize a single technology (sometimes even the exact same device) in verydifferentwaysWhereas researchers apply tDCS to subjectswithin the controlled realmof the laboratory home users apply tDCS on themselves mostly in private settings forcognitive enhancement or self-treatment

Unsurprisingly the use of tDCS outside of research settings has not been well re-ceived by scientists many of whom believe that home users may lsquoruin itrsquo for the entire

1 Pubmed title search for lsquotranscranial direct current stimulationrsquo or lsquotDCSrsquo httpwwwncbinlmnihgovpubmedterm=(22transcranial+direct+current+stimulation225BTitle5D)+OR+tdcs5BTitle5D

2 For a review of clinical tDCS studies see Min-Fang Kuo Walter Paulus amp Michael A Nitsche Thera-peutic Effects of Non-Invasive Brain Stimulation with Direct Currents (tDCS) in Neuropsychiatric Diseases85NEUROIMAGE 948 (2014) for tDCS in healthy populations see Brian A Coffman Vincent P ClarkampRajaParasuramanBattery PoweredThought Enhancement of Attention Learning andMemory in Healthy Adults Us-ing Transcranial Direct Current Stimulation 85 NEUROIMAGE 895 (2014) Note however that a few recentstudies have questionedwhether tDCS has any effect in healthy subjects see eg JaredCooneyHorvath JasonD Forte ampOlivia Carter EvidenceThat Transcranial Direct Current Stimulation (tDCS) Generates Little-to-NoReliable Neurophysiologic Effect Beyond MEP Amplitude Modulation in Healthy Human Subjects A SystematicReview 66 NEUROPSYCHOLOGIA 213 (2015)

3 Anita Jwa Early Adopters of the MagicalThinking Cap A Study On Do-It-Yourself (DIY) Transcranial DirectCurrent Stimulation (tDCS) User Community 2 J L BIOSCI 292 307 (2015)




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65 Section 6 34 Stat 768 769 (1906)




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ApeX Type Alowast








TCTlowast











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65 Section 6 34 Stat 768 769 (1906)




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ApeX Type Alowast








TCTlowast











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65 Section 6 34 Stat 768 769 (1906)




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ApeX Type Alowast








TCTlowast











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