University of Southern California Dissertations and Theses

Regulating cosmeceuticals in the United States: a cosmetic industry view

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Regulating cosmeceuticals in the United States: a cosmetic industry view

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REGULATING!COSMECEUTICALS!IN!THE!UNITED!STATES:!
A!COSMETIC!INDUSTRY!VIEW!!
!
by!
!
Simone!E.!Turnbull!
!
!
!
!
A!Dissertation!Presented!to!the!
FACULTY!OF!THE!USC!SCHOOL!OF!PHARMACY!
UNIVERSITY!OF!SOUTHERN!CALIFORNIA!
In!Partial!Fulfillment!of!the!
Requirements!for!the!Degree!
DOCTOR!OF!REGULATORY!SCIENCE!
!
!
May!2016!
!
!
Copyright!2016! ! ! ! ! ! ! !!!Simone!E.!Turnbull!!
! 2!
DEDICATION)
! I!dedicate!this!dissertation!to!my!parents!Samuel!and!Esther!Turnbull,!who!
never!stopped!encouraging!me!to!finish,!even!when!I!sincerely!wished!they!would.!!I!
owe!you!both!my!life.!
! 3!
ACKNOWLEDGEMENTS)
“It$takes$an$entire$village$or$community$to$raise$a$child.”$–$Chinua$Achebe,$ Things$Fall$
Apart $
! First!and!foremost!I!would!like!to!thank!God!for!showing!me!the!way,!the!
truth!and!the!light!at!the!end!of!this!tunnel.!!Second,!I!would!like!to!thank!my!Aunt!
Marilyn!and!my!late!Uncle!Clem!for!giving!my!brothers!and!I!the!opportunity!for!a!
better!life,!and!my!parents!for!making!it!possible.!!I!would!also!like!to!thank!all!of!my!
family,!relatives!and!friends!who!kept!me!in!their!thoughts!and!prayers!during!this!
process.!!Third,!I!would!like!to!thank!everyone!at!the!USC!Regulatory!Science!
Program!for!the!great!work!they!do,!my!committee!members,!my!focus!group!
participants,!and!my!fellow!cohorts.!!I!am!proud!to!have!studied!and!worked!
alongside!all!of!you.!!Last!but!definitely!not!least,!I!would!like!to!say!a!heartfelt!thank!
you!to!Dr.!Frances!Richmond,!who!gave!so!selflessly!of!her!time!and!talent!
throughout!this!entire!process,!and!who!never!stopped!believing!in!me.!!You!are!a!
blessing!and!an!inspiration.!!Thank!you!all.!
! 4!
TABLE)OF)CONTENTS)
DEDICATION! 2!
ACKNOWLEDGEMENTS! 3!
LIST!OF!TABLES! 8!
LIST!OF!FIGURES! 10!
ABSTRACT! 12!
CHAPTER!1:!OVERVIEW!OF!THE!STUDY! 14!
1.1.! INTRODUCTION! 14!
1.2.! STATEMENT!OF!THE!PROBLEM! 15!
1.3.! PURPOSE!OF!THE!STUDY! 17!
1.4.! IMPORTANCE!OF!THE!STUDY! 18!
1.5.! LIMITATIONS,!DELIMITATIONS!AND!ASSUMPTIONS! 20!
1.6.! ORGANIZATION!OF!THE!STUDY! 21!
1.7.! DEFINITIONS! 22!
CHAPTER!2:!LITERATURE!REVIEW! 24!
2.1.! INTRODUCTION! 24!
2.2.! THE!HISTORY!OF!COSMETICS! 25!
! 5!
2.2.1.! COSMETICS!IN!THE!MIDDLE!EAST:!EARLY!CIVILIZATIONS! 26!
2.2.2.! COSMETICS!IN!EUROPE:!THE!MIDDLE!AGES!THRU!THE!NINETEENTH!CENTURY! 27!
2.2.3.! COSMETICS!IN!THE!UNITED!STATES:!THE!PAINTED!FACE! 28!
2.3.! THE!RISE!OF!THE!MASS!MARKET!COSMETIC!INDUSTRY! 30!
2.3.1.! THE!COSMECEUTICAL!ERA! 31!
2.3.2.! THE!MARKET!GROWTH!OF!COSMECEUTICALS! 33!
2.3.3.! INDUSTRY!OUTLOOK! 37!
2.4.! COSMETIC!REGULATIONS!IN!THE!UNITED!STATES! 39!
2.4.1.! COSMETIC!REGISTRATION!REQUIREMENTS! 42!
2.4.2.! REGULATION!OF!COSMETICS!MARKETED!WITH!DRUG!CLAIMS! 43!
2.4.3.! REGULATORY!ACTION!FOR!COSMETICS!MARKETED!WITH!DRUG!CLAIMS! 45!
2.5.! MODELS!FOR!REGULATING!COSMECEUTICALS!IN!THE!UNITED!STATES! 48!
2.5.1.! DRUGS!REQUIRING!FDA!APPROVAL! 49!
2.5.2.! OVER^THE^COUNTER!(OTC)!DRUGS! 52!
2.5.3.! DIFFERENCES!BETWEEN!NDA!APPROVAL!AND!OTC!DRUG!MONOGRAPH!PROCESSES! 55!
2.5.4.! SUMMARY!OF!CURRENT!MODELS!FOR!REGULATING!COSMECEUTICALS!IN!THE!U.S.! 58!
2.6.! ALTERNATIVE!MODELS!TO!INFORM!COSMECEUTICAL!REGULATION! 59!
2.6.1.! DIETARY!SUPPLEMENT!REGULATIONS!IN!THE!UNITED!STATES! 59!
2.6.2.! THE!COSMETICS!REGULATION!IN!EUROPE! 68!
2.6.3.! NATURAL!HEALTH!PRODUCT!REGULATIONS!IN!CANADA! 73!
2.6.4.! THE!QUASI^DRUG!SYSTEM!IN!JAPAN! 76!
2.6.5.! SUMMARY!OF!ALTERNATIVE!MODELS!IN!OTHER!CONSTITUENCIES! 78!
2.7.! FRAMING!THE!STUDY!OF!COSMECEUTICAL!REGULATIONS!IN!THE!UNITED!STATES! 79!
! 6!
2.8.! SUMMARY!AND!RESEARCH!DIRECTION! 83!
CHAPTER!3:!METHODOLOGY! 85!
3.1.! SURVEY!DEVELOPMENT! 85!
3.2.! SURVEY!DELIVERY! 86!
3.3.! SURVEY!ANALYSIS! 88!
CHAPTER!4:!RESULTS! 89!
4.1.! FOCUS!GROUP!RESULTS! 89!
4.2.! ANALYSIS!OF!SURVEY!RESULTS! 90!
4.3.! COMPANY!DEMOGRAPHICS! 92!
4.4.! RESPONDENT!DEMOGRAPHICS! 95!
4.5.! BUSINESS!STRATEGIES!FOR!MARKETING!COSMECEUTICALS! 99!
4.6.! CURRENT!VS.!FUTURE!APPROACHES!FOR!REGULATING!COSMECEUTICALS! 108!
4.7.! U.S.!MODELS!TO!INFORM!COSMECEUTICAL!REGULATION! 115!
4.8.! ALTERNATIVE!MODELS!TO!INFORM!COSMECEUTICAL!REGULATION! 123!
4.9.! INTERVIEWS! 127!
4.10.! CROSS!TABULATIONS! 127!
CHAPTER!5:!DISCUSSION!AND!CONCLUSION! 131!
5.1.! INTRODUCTION! 131!
5.2.! CONSIDERATIONS!OF!THE!RESEARCH!METHODOLOGY! 132!
5.3.! SELECTING!A!SURVEY!SAMPLE! 133!
! 7!
5.4.! OTHER!DELIMITATIONS,!LIMITATIONS!AND!ASSUMPTIONS! 135!
5.5.! CONVENING!A!FOCUS!GROUP! 138!
5.6.! DO!CURRENT!REGULATIONS!ENSURE!SAFETY,!QUALITY!AND!EFFECTIVENESS?! 139!
5.7.! DOES!THE!CURRENT!SYSTEM!LEVEL!THE!PLAYING!FIELD?! 144!
5.8.! DOES!THE!CURRENT!SYSTEM!PROTECT!THE!ECONOMIC!INTERESTS!OF!COMPANIES?! 147!
5.9.! FUTURE!DIRECTION!OF!COSMETICS/COSMECEUTICAL!LEGISLATION! 149!
5.10.! CONCLUSION! 151!
REFERENCES! 153!
APPENDIX!A:!DECISION!TREE!FOR!NDI!NOTIFICATIONS! 165!
APPENDIX!B:!DRAFT!SURVEY! 166!
APPENDIX!C:!FINAL!SURVEY! 180!
APPENDIX!D:!SURVEY!RESULTS! 192!
APPENDIX!E:!CROSS!TABULATIONS! 226!
!
!
! 8!
LIST)OF)TABLES)
Table!1:!Ten!Basic!Cosmeceutical!Mechanisms!of!Action! 33!
Table!2:!U.S.!Retail!Sales!of!Cosmeceuticals,!2007^2011! 36!
Table!3:!U.S.!Retail!Dollar!Sales!of!Cosmeceutical!Skin!Care!Products,!!
! !!!2007^2011! 36!
Table!4:!Projected!U.S.!Retail!Sales!of!Cosmeceuticals,!2011^2016! 37!
Table!5:!Warning!Letters!Addressing!Drug!Claims!Made!for!Products!!
! !!!Marketed!as!Cosmetics! 46!
Table!6:!Differences:!NDA!Approval!and!OTC!Drug!Monograph!Processes! 56!
Table!7:!Market!Size!of!Vitamins!and!Dietary!Supplements!in!the!U.S.! 60!
Table!8:!NDI!Definition,!Requirement!for!Notification!and!Applicability!of!!
! !!!Adulteration!Standard! 64!
Table!9:!Three^Tiered!Class!System!for!Natural!Health!Products! 75!
Table!10:!A!Side^by^Side!Comparison!of!the!Ramsey!and!Reddington!!
! !!!!!Regulatory!Frameworks! 83!
Table!11:!Company!Size! 94!
Table!12:!Primary!Job!Function!–!Other! 96!
Table!13:!Respondent!Experience!Level! 96!
Table!14:!Examples!of!Claims!Made!on!Cosmetic!Products!or!Ingredients! 101!
Table!15:!Other!Reasons!for!Not!Updating!Product!Packaging! 103!
Table!16:!Business!Activities!within!the!Cosmetic!Industry! 106!
! 9!
Table!17:!Benefits!of!being!a!Small!vs.!Medium!or!Large!Company! 108!
Table!18:!Cosmeceuticals!and!the!FD&C!Act! 110!
Table!19:!Industry!Recommendations!for!Regulating!Cosmeceuticals! 113!
Table!20:!U.S.!Marketing!Pathways!for!OTC!Drugs! 116!
Table!21:!FDA!Dept.!Best!Suited!to!Develop!Cosmeceutical!Monographs! 117!
Table!22:!New!Cosmeceutical!Ingredient!Notification!Review!Process! 119!
Table!23:!Reasons!against!a!New!Cosmeceutical!Ingredient!Notification!!
! !!!!!Requirement! 120!
Table!24:!Reasons!for/against!Qualified!Health!Claims!for!Cosmeceuticals! 122!
Table!25:!Most!Beneficial!Aspects!of!the!European!Cosmetics!Regulation! 124!
Table!26:!Cross!Tabulation!of!Responses!in!Table!14! 130!
!
! 10!
LIST)OF)FIGURES)
Figure!1:!Cosmeceuticals!–!The!Fast!Growing!Sector! 34!
Figure!2:!Number!of!adults!aged!50!and!older!and!Per!capita!disposable!!
! !!!!!income! 38!
Figure!3:!Current!Models!for!Regulating!Cosmeceuticals!in!the!U.S.! 58!
Figure!4:!The!Struggle:!Players!and!Issues! 61!
Figure!5:!Product!Information!File!(PIF)!Summary! 72!
Figure!6:!Review!Targets!for!Natural!Health!Products! 76!
Figure!7:!Classification!of!Examinations!for!the!Approval!of!Drugs,!!
! !!!!!Quasi^Drugs!and!Cosmetics! 78!
Figure!8:!Summary!of!Regulatory!Frameworks!in!Europe,!Canada!and!Japan! 79!
Figure!9:!The!Three!Objectives!of!Regulation! 81!
Figure!10:!Key!Areas!of!Survey!Research! 86!
Figure!11:!Response!Rates!to!Survey!Questions! 91!
Figure!12:!Industry!Representation! 93!
Figure!13:!Company!Product!Portfolios! 94!
Figure!14:!Primary!Job!Function! 95!
Figure!15:!Respondent!Familiarity!with!U.S.!Regulatory!Systems! 98!
Figure!16:!Respondent!Familiarity!with!International!Regulatory!Systems! 98!
Figure!17:!Color!vs.!Hair!or!Skin!care!Cosmetics! 108!
Figure!18:!Industry!Satisfaction!with!the!Current!System!for!Cosmeceuticals! 111!
! 11!
Figure!19:!New!Cosmeceutical!Ingredient!Notification!Requirement! 118!
Figure!20:!Class^Based!Risk/Benefit!System!for!Cosmeceuticals! 125!
Figure!21:!Premarket!Approval!of!Safety,!Efficacy!and!Stability!Data!for!!
! !!!!!!!Cosmeceutical!“Active”!Ingredients! 126!
Figure!22:!International!Regulatory!System!Most!Beneficial!to!Informing!U.S.!!
! !!!!!!!Cosmeceutical!Regulatory!Policy! 127!
!
! 12!
ABSTRACT)
! The!cosmetic!industry!has!changed!rapidly!due!to!the!introduction!of!
cosmeceutical!products!that!sit!at!the!interface!between!traditional!cosmetics!and!
drugs.!!This!research!study!sought!to!explore!the!views!of!regulatory!affairs,!legal!
affairs,!product!development!and!marketing!professionals!in!the!cosmetic!industry!
concerning!the!adequacy!of!current!pathways!for!regulating!cosmeceuticals!in!the!
United!States!in!light!of!this!change.!!A!survey!instrument!was!used!to!examine!the!
perceived!effectiveness!of!current!regulations!to!satisfy!three!principal!objectives!of!
regulation,!including!the!assurance!of!safety,!quality!and!effectiveness,!the!
preservation!of!market!efficiencies!and!the!assurance!of!a!level!playing!field!for!
different!market!participants.!!Results!showed!that!most!of!the!respondents!
believed!that!cosmetics!in!the!U.S.!were!relatively!safe,!but!that!cosmeceuticals!
should!be!held!to!a!higher!pre^market!standard!for!assessing!efficacy!and!safety.!!
Respondents!also!expressed!the!view!that!enforcement!actions!regarding!
cosmeceutical!claims!were!relatively!rare!and!inconsistently!applied!across!
companies!of!different!sizes!and!product!categories,!and!this!contributed!to!an!
uneven!playing!field!that!most!of!the!respondents!felt!currently!existed!in!the!
cosmetic!industry.!!Respondents!further!often!felt!that!other!approaches!to!
regulations!modeled!after!either!the!dietary!supplement!regulations!in!the!U.S.!or!
the!cosmetic!regulations!in!Europe!might!have!useful!lessons!for!policy!or!
regulatory!change.!!However,!the!results!here!also!suggest!that!whatever!is!
! 13!
proposed!for!such!regulation,!either!through!the!issuance!of!guidance!or!formal!
rulemaking,!will!face!a!mixed!audience!with!very!different!views!on!how!
cosmeceuticals!should!be!regulated!even!within!this!singular!stakeholder!group.!
! 14!
CHAPTER)1:)OVERVIEW)OF)THE)STUDY )
1.1. Introduction)
! The!word!“cosmetic”!is!derived!from!the!Greek!adjective!“kosmétikos”!or!the!
verb!“kosméo”,!which!can!be!translated!to!mean!“to!straighten!up”!or!“to!decorate”!
(Kerscher!&!Buntrock,!2011).!!The!origin!of!the!word!can!also!be!traced!back!to!the!
Greek!word!“kosmos”!meaning!order.!!In!this!instance,!it!refers!to!a!“well^ordered!
face!or!appearance”!(Goering,!2005).!!Throughout!history,!the!American!use!of!
cosmetics!has!been!influenced!by!many!cultures,!from!the!Native!Americans!to!the!
English!immigrants,!who!first!brought!cosmetic!formulations!to!the!colonies!in!the!
1600s.!!However,!the!Victorian!era!appears!to!have!had!the!most!influence!on!the!
American!beauty!culture,!both!in!terms!of!cosmetic!fashion!and!preparation!(Peiss,!
1998).!!!
! In!the!early!1900s,!cosmetic!production!moved!from!crude!in^home!
preparations!to!full^scale!contract!manufacturing!operations.!!As!mass!production!
and!commercialization!became!established,!the!risk!of!consumer!poisoning!or!harm!
from!cosmetics!increased!(Termini!&!Tressler,!2008).!!After!several!publicized!
incidents!of!consumer!injuries,!one!of!which!was!the!Lash!Lure!Eyelash!aniline!dye!
incident!of!the!1930s!in!which!16!people!were!blinded,!President!Franklin!D.!
Roosevelt!signed!the!(Copeland^Lea)!Federal!Food,!Drug!and!Cosmetic!Act!(FD&C!
! 15!
Act!or!“the!Act”)!into!law!(Newburger,!2009;!Termini!&!Tressler,!2008).!!Cosmetics!
were!introduced!into!the!Act,!and!along!with!food!and!drugs,!were!now!subject!to!
the!regulatory!authority!of!the!U.S.!Food!and!Drug!Administration!(FDA).! !!!
! Cosmetics!are!substances!applied!either!to!the!hair,!nails!or!skin!as!a!means!
of!altering!appearance!or!enhancing!beauty.!!Drugs!are!substances!that!claim!to!
treat!or!prevent!disease!or!affect!the!structure!and!function!of!the!human!body.!!
According!to!these!definitions,!what!distinguishes!a!cosmetic!from!a!drug!is!the!
intended!effect!on!the!body.!!If!that!effect!does!not!rely!on!a!metabolic!action!on!the!
targeted!tissue,!then!the!product!is!considered!to!be!a!cosmetic.!!However,!if!that!
effect!is!therapeutic!in!any!way,!then!the!product!is!considered!to!be!a!drug,!even!if!
the!end!result!of!the!action!is!to!beautify!(Hutt,!2000).!
1.2. Statement)of)the)Problem)
! Although!the!FD&C!Act!has!been!amended!many!times!since!1938,!the!
definitions!of!a!cosmetic!and!a!drug!remain!the!same!as!they!were!in!the!original!
Act,!even!though!at!that!time!knowledge!of!skin!physiology!was!still!in!its!infancy.!!
The!notion!that!a!cosmetic!product!would!enhance!beauty!by!using!a!drug^like!
mechanism!was!not!envisioned!by!the!Act.!!However,!the!introduction!of!the!
“cosmeceutical”!into!the!marketplace!began!to!challenge!this!dichotomy.!
! First!coined!by!Raymond!Reed!to!describe!“active”!and!science^based!
cosmetics!(Newburger,!2009),!the!term!“cosmeceutical”!was!later!redefined!by!Dr.!
Albert!Kligman,!to!describe!a!product!in!between!a!cosmetic!and!a!drug.!!“The!
! 16!
neologism”,!he!stated!at!that!time,!“would!be!timely!and!useful,!since!it!reconciled!
archaic!legal!statutes!with!modern!science”!(Kligman,!2000).!!Cosmeceuticals!are!
hybrids!between!cosmetics!and!pharmaceuticals!that!are!intended!to!enhance!the!
health!and!beauty!of!the!skin.!!They!represent!a!category!of!products!that!include!
such!preparations!as!cleansers,!exfoliants,!antioxidants,!skin^lightening!agents!and!
moisturizers!(Amer!&!Maged,!2009).!
! Even!though!cosmeceuticals!have!been!available!in!the!marketplace!for!
several!decades,!the!policies!and!procedures!for!regulating!these!hybrid!products!
have!not!been!reexamined!or!modified!in!light!of!the!changing!environment!and!
market!trends.!!The!FD&C!Act!still!does!not!recognize!cosmeceuticals!as!a!valid!
product!category.!!A!product!can!either!be!a!drug,!a!cosmetic,!or!a!combination!of!
the!two!e.g.,!an!anti^dandruff!shampoo,!but!the!term!"cosmeceutical"!has!no!
meaning!under!the!law!(U.S.!Food!and!Drug!Administration,!2002).!!If!a!cosmetic!
product!is!purported!to!have!therapeutic!or!drug!properties,!the!FDA!must!approve!
it!as!a!drug.!!Although!benefits!can!accrue!when!the!FDA!approves!such!a!product!as!
a!drug,!the!cost,!complexity!and!time!involved!in!the!approval!process!can!outweigh!
those!benefits.!!Thus,!the!current!regulatory!environment!would!appear!to!make!it!
difficult!for!companies!to!develop!and!gain!marketing!approval!for!cosmeceutical!
products,!because!the!costs!cannot!be!recouped!by!later!product!sales.!!However,!to!
date,!very!little!systematic!study!has!been!directed!at!understanding!the!views!of!
the!cosmetic!industry!with!regard!to!the!current!U.S.!regulatory!environment!for!
cosmeceuticals.!!It!is!not!clear!which!aspects!of!our!regulation!are!the!most!
! 17!
problematic!and!why.!!Further,!it!is!not!clear!whether!an!alternative!model!for!
regulatory!oversight!would!be!seen!by!industry!as!offering!a!better!balance!with!
respect!to!the!multiple!goals!of!regulation,!which!includes!protecting!consumers,!
minimizing!unnecessary!resource!expenditure,!and!maintaining!a!competitive!
marketplace.!
1.3. Purpose)of)the)Study)
! This!study!had!two!parts.!!First,!the!literature!was!reviewed!in!order!to!
examine!the!current!regulations!for!FDA^regulated!cosmetic!and!drug!products!in!
the!United!States.!!Then!certain!alternative!models!for!regulatory!oversight,!
including!the!relatively!newer!regulatory!paradigm!used!to!notify!new!dietary!
ingredients!in!dietary!supplements!in!the!U.S.,!and!the!non^harmonized!approaches!
used!in!Europe,!Canada!and!Japan!were!also!reviewed,!as!these!additional!regimes!
may!provide!advantageous!elements!that!could!be!considered!in!any!design!of!
cosmeceutical!regulatory!policy.!!!
! Second,!I!attempted!to!understand!how!the!current!regulations!in!different!
constituencies!and!product!sectors!were!seen!to!meet!the!common!goals!for!
regulation.!!To!this!end,!I!used!a!triadic!framework!that!described!the!principal!
regulatory!goals,!as!proposed!by!Ramsey!in!a!2013!study!on!the!Impact!of!
Incomplete!Monographs!on!the!OTC!Drug!Industry.!!The!three!key!aims!of!
regulatory!policy!included!in!her!framework!were:!1)!to!ensure!safety,!(quality)!and!
effectiveness,!2)!to!facilitate!efficiencies!in!research,!commercialization,!and!costs!
! 18!
and!3)!to!equalize!the!requirements!and!standards!for!industry!(Ramsey,!2013).!!
Using!these!aims!as!a!guide,!I!developed!a!survey!instrument!that!was!examined!
critically!by!a!focus!group!of!individuals!with!different!academic,!regulatory!and!
business!backgrounds.!!Once!most!of!their!recommended!changes!were!reviewed!
and!incorporated!into!the!survey,!the!survey!was!then!administered!to!individuals!
currently!or!previously!working!in!the!regulatory!affairs,!legal!affairs,!product!
development!and!marketing!functions!of!companies!that!formulate,!manufacture!or!
distribute!cosmetic!products!or!ingredients!marketed!with!drug!claims.!!To!
understand!further!if!alternative!approaches!might!be!preferable!to!that!currently!in!
place!in!the!U.S.,!I!also!used!the!survey!to!explore!how!industry!viewed!the!
advantages!and!weaknesses!of!previously!identified!alternatives!to!the!current!U.S.!
systems!in!comparison!to!the!system!currently!in!place.!!!
1.4. Importance)of)the)Study)
! Various!proposals!have!been!submitted!for!regulating!cosmeceuticals,!
including!revising!the!current!definitions!for!cosmetics!and!drugs,!adding!a!
cosmeceutical!category!to!the!regulations!or!requiring!premarket!testing!for!safety!
and!efficacy!(Farren,!2008;!Mason,!2008).!!However,!inspection!of!the!literature!
shows!that!no!one!has!attempted!to!investigate!the!current!views!of!the!cosmetic!
industry!with!regard!to!the!study!of!cosmeceutical!regulations!in!the!United!States.!!
Obtaining!industry!perspective!on!cosmeceuticals!is!important!because!it!is!the!
industry!that!is!impacted!most!directly,!both!because!1)!they!must!be!motivated!to!
! 19!
continue!to!develop!these!products!and!2)!their!commercial!success!is!key!to!
industry!growth.!!In!fact,!cosmeceuticals!represent!the!fastest!growing!sector!of!the!
cosmetic!industry.!!According!to!Packaged!Facts,!a!market!intelligence!research!
company,!U.S.!retail!sales!of!cosmeceuticals!were!projected!to!reach!$11.9!billion!by!
the!end!of!this!year,!up!from!$9.7!billion!in!2011!and!$9.3!billion!in!2010!(Brown!&!
Marigny!Research!Group,!2012).!
! Understanding!the!regulatory!environment!and!the!implications!of!
continuing!on!the!current!path!is!particularly!important!now,!as!many!novel!
products!continue!to!enter!the!market.!!So!far,!FDA’s!regulatory!enforcement!of!
noncompliance!by!industry!has!been!minimal,!suggesting!that!they!have!chosen!to!
exercise!discretion!in!pursuing!deviations!associated!with!these!seemingly!low^risk,!
innocuous!products.!!However,!not!all!of!these!new!cosmeceuticals!may!be!without!
risk.!!Proactive!assessment!of!regulations!for!cosmeceuticals!that!takes!industry!
input!into!consideration!can!help!to!assure!that!the!regulations!are!best!constructed!
to!balance!the!competing!aims!of!regulatory!policy.!!If!not,!then!the!FDA!risks!a!
“crisis^legislation^adaptation”!cycle!that!has!often!been!characteristic!of!policy!
development!in!the!earlier!years!of!the!FDA,!where!the!agency!only!implements!new!
law!after!being!mandated!by!Congress!in!response!to!a!crisis!(Borchers,!Hagie,!Keen,!
&!Gershwin,!2007).!!Also,!as!suggested!by!Stokey!and!Zeckhauser,!the!role!of!
government!is!justifiable!in!the!marketplace!based!on!two!key!factors:!1)!it!creates!
equity,!where!a!more!desirable!distribution!of!goods!and!services!among!the!
members!of!society!is!fostered,!and!2)!it!promotes!efficiency,!especially!in!situations!
! 20!
where!the!market!has!failed!(Stokey!&!Zeckhauser,!1978).!!Finally,!a!proactive!
approach!to!regulating!cosmeceuticals!and!some!of!the!potential!solutions!that!it!
generates!can!also!be!applied!to!newer!product!categories!that!blur!regulatory!lines,!
e.g.,!nutraceuticals,!which!are!functional!foods!that!provide!health!benefits.!!
1.5. Limitations,)Delimitations)and)Assumptions)
! This!research!was!delimited!to!the!study!of!cosmeceutical!regulations!in!the!
United!States!of!America.!!The!regulations!of!other!constituencies!were!introduced!
only!to!serve!as!models!that!might!be!considered!by!U.S.!regulators!as!alternatives!
for!informing!cosmeceutical!regulatory!policy.!!It!was!further!delimited!to!
individuals!currently!or!previously!working!in!the!regulatory!affairs,!legal!affairs,!
product!development!and!marketing!functions!in!companies!that!formulate,!
manufacture!or!distribute!cosmetic!products!or!ingredients!marketed!with!drug!
claims.!!These!particular!job!functions!were!chosen!because!these!individuals!were!
most!likely!to!understand!and!appreciate!the!challenges!of!cosmeceutical!promotion!
on!the!cosmetic!industry.!!Surveys!of!other!stakeholders,!such!as!consumers!or!
regulators,!could!have!provided!different!views,!but!these!views!were!not!explored!
in!this!research.!!The!scope!of!the!present!study!was!also!delimited!to!cosmetic!
products!or!cosmetic!ingredients!specifically!marketed!to!contain!therapeutic!or!
drug!properties,!as!these!products!blur!the!lines!between!cosmetics!and!drugs.!!
! Limitations!of!this!study!related!in!part!to!the!use!of!a!survey!instrument!to!
address!all!of!the!research!questions.!!It!was!also!limited!by!my!ability!to!develop!an!
! 21!
effective!survey!tool!that!lacked!bias.!!To!mitigate!this!potential!problem,!the!survey!
was!evaluated!by!a!focus!group!of!experts!to!ensure!that!it!was!as!effective!and!
unbiased!as!possible.!!However,!some!level!of!challenge!may!still!remain.!!Because!
only!a!sample!of!cosmeceutical!experts!was!surveyed,!the!validity!of!the!results!
depended!on!the!extent!to!which!these!individuals!represented!the!broader!
population!of!individuals!in!the!same!job!functions!across!the!U.S.!!Additionally,!the!
survey!was!also!limited!by!the!willingness!of!the!respondents!to!answer!the!survey!
questions!honestly.!!Because!the!topic!of!the!survey!was!directly!relevant!to!the!
success!of!the!businesses!that!employed!the!respondents,!their!responses!may!
reflect!a!desire!to!ensure!continued!company!success.!!The!usefulness!of!the!survey!
responses!was!also!limited!by!the!experience!and!regulatory!knowledge!of!the!
respondents.!!!
! The!assumption!was!made!that!all!survey!respondents!were!familiar!with!the!
definition!of!cosmetics!and!drugs!as!stated!in!the!FD&C!Act,!the!more!informal!
definition!of!cosmeceuticals,!and!the!regulatory!approaches!used!by!the!FDA!to!
regulate!all!of!the!aforementioned!products.!
1.6. Organization)of)the)Study)
! This!study!consists!of!five!chapters.!!Chapter!1!provides!a!brief!overview!of!
the!problem!posed!by!the!current!U.S.!regulatory!environment!for!cosmeceuticals,!
and!the!research!that!was!conducted!to!understand!the!views!of!industry!
stakeholders.!!Chapter!2!briefly!describes!the!history!of!cosmetics!and!
! 22!
cosmeceutical!development.!!It!outlines!cosmetic!and!drug!regulations!in!the!U.S.!
and!summarizes!the!proposed!alternative!models!for!regulating!cosmeceuticals.!!
Finally,!it!outlines!the!framework!that!was!used!as!the!basis!for!this!research.!!
Chapter!3!explains!the!methodology!used!to!conduct!the!research!study,!including!
the!development!and!use!of!a!survey!instrument.!!Chapter!4!examines!the!survey!
findings!in!detail.!!Finally,!Chapter!5!concludes!with!a!discussion!of!specific!survey!
findings!relative!to!the!underlying!framework!of!the!study,!and!the!possible!
regulatory!future!for!cosmetics!and!cosmeceuticals!in!the!United!States.!
1.7. Definitions)
Cosmetic)
! Any!substance!applied!to!the!human!body!or!any!part!thereof!for!cleansing,!
beautifying,!promoting!attractiveness,!or!altering!the!appearance.!
Prescription)(Rx))Drug)
! A!prescription!drug!is!a!drug!product!approved!for!marketing!that!can!only!
be!obtained!with!a!prescription!from!an!appropriate!health!care!practitioner.!
Over7the7Counter)(OTC))Drug)
! An!OTC!drug!is!a!drug!product!marketed!for!use!by!the!consumer!without!a!
prescription!from!a!health!care!practitioner.!
! 23!
Cosmetic7Drug)
! Any!substance!that!legally!meets!the!definitions!for!both!a!cosmetic!and!a!
drug!e.g.,!anti^dandruff!shampoo.!!These!products!are!a!subset!of!OTC!drugs!that!
must!meet!the!regulatory!requirements!for!both!cosmetics!and!drugs.!
Cosmeceutical)
! Any!substance!that!meets!the!definition!of!a!cosmetic!but!is!purported!or!
marketed!as!having!therapeutic!or!drug!properties.!
! 24!
CHAPTER)2:)LITERATURE)REVIEW)
2.1. Introduction)
! For!much!of!history,!cosmetics!were!relatively!simple!compounds!designed!
to!beautify!skin!without!affecting!the!structure!or!metabolism!of!the!underlying!
tissues.!!However,!more!recent!technological!developments!have!yielded!cosmetic!
products!that!not!only!improve!the!appearance!of!the!skin!but!also!affect!its!
structure!and!function.!!These!“cosmeceuticals”!blur!the!hard!line!that!regulators!
once!drew!between!cosmetics!and!drugs.!
! In!this!chapter,!I!briefly!describe!the!history!of!cosmetics!and!cosmeceuticals.!!
Then,!I!outline!the!current!models!for!FDA^regulated!consumer!products!in!the!
United!States,!and!compare/contrast!them!with!other!regulatory!frameworks!in!
Europe,!Canada!and!Japan.!!This!provides!a!comprehensive!overview!of!approaches!
that!may!guide!developers!of!regulatory!policy!for!cosmeceuticals.!!Finally,!I!discuss!
the!framework!upon!which!the!survey!was!based,!in!order!to!explore!the!current!
views!of!the!cosmetic!industry!with!regard!to!cosmeceutical!regulations!in!the!U.S.!!
This!survey!is!guided!by!a!framework!of!health!policy!objectives!previously!stated!
by!Ramsey!(2013),!which!suggests!that!successful!regulatory!approaches!must!
balance!three!objectives:!1)!they!must!ensure!the!safety,!(quality)!and!effectiveness!
of!products!relative!to!their!risks!2)!they!must!foster!efficiencies!in!their!
! 25!
management!of!research,!commercialization,!and!costs,!and!3)!they!must!equalize!
the!requirements!and!standards!for!all!competitors!in!the!marketplace.!!Using!this!
framework,!I!examine!how!current!regulatory!approaches!satisfy!these!various!
objectives!and!whether!approaches!of!other!countries!might!also!provide!
advantages.!
2.2. The)History)of)Cosmetics)
! Archaeologists!date!the!earliest!use!of!cosmetics!to!around!10,000!B.C.,!
(Corson,!1972).!!The!original!functions!of!cosmetics!were!far!removed!from!that!of!
enhancing!beauty,!so!prevalent!in!today’s!society.!!The!Neanderthals!used!body!
paint!as!a!way!to!camouflage!themselves!while!hunting!prey.!!The!tribesmen!of!
Africa!used!it!in!religious!ceremonies.!!The!North!American!Indians!used!it!to!
frighten!their!enemies!(Chaudhri!&!Jain,!2009;!Gunn,!1983).!!Color!also!played!an!
important!role!in!the!use!of!paints!because!of!its!linkage!to!human!emotions!and!
associations.!!Red,!the!color!of!blood,!was!associated!with!acts!of!aggression!and!as!
such,!was!frequently!used!in!preparation!for!battle!and!initiation!rites.!!Black,!a!
symbol!of!night!and!darkness,!was!often!employed!in!rituals!and!ceremonies!with!
sinister!connotations.!!White!was!associated!with!the!spiritual!realm!and!
transcendence!to!the!afterlife!(Gunn,!1983).!!However,!as!civilization!advanced,!
colored!cosmetics!became!more!common!and!valued!for!their!ability!to!enhance!
appearance!and!signal!good!health.!
! 26!
2.2.1. Cosmetics)in)the)Middle)East:)Early)Civilizations )
! Cosmetics!were!employed!extensively!for!cleansing,!perfuming!and!self^
decoration!in!the!early!Middle!Eastern!and!Mediterranean!civilizations!of!around!
10,000!B.C.,!(Chaudhri!&!Jain,!2009).!!The!Egyptian!fascination!with!the!eyes!
resulted!in!advanced!formulations!of!eye!makeup!or!“msdmt”,!made!from!malachite,!
which!is!a!green!ore!of!copper,!and!galena,!a!dark!grey!ore!of!lead.!!Materials!for!eye!
paint,!or!kohl,!included!carbonate!of!lead,!oxide!of!copper,!iron!and!manganese,!
among!other!ingredients!(Gunn,!1983;!Lucas,!1930).!!The!use!of!eye!paints!was!
widely!encouraged!among!men,!women!and!children!not!only!for!beautifying,!but!
also!because!of!its!potential!health^giving!effects,!perhaps!the!first!intimation!of!
cosmeceutical!function.!!Egyptians!believed!that!copper!helped!to!prevent!eye!
diseases!that!were!prevalent!during!that!time,!and!also!to!protect!the!eyes!against!
the!intense!glare!of!the!sun!(Gunn,!1983).!!The!use!of!traditional!preparations!of!
kohl!or!“kajal”,!as!it!is!called!in!the!Hindu!culture,!was!also!encouraged!on!children!
and!adults!for!their!health!benefits!(Chaudhri!&!Jain,!2009).!!
! The!Egyptians!were!also!well!known!for!their!frequent!baths!and!liberal!
applications!of!perfumes,!unguents!and!aromatic!oils.!!They!believed!that!perfumes,!
like!eye!paints,!had!magical!power!and!frequently!used!them!in!religious!
ceremonies!and!also!in!the!process!of!embalming!(Chaudhri!&!Jain,!2009;!Gunn,!
1983).!!Egyptian!scented!oils!and!unguents!were!comprised!of!natural!ingredients!
such!as!myrrh,!cinnamon,!cassia,!cardamom,!spikenard,!iris!root,!honey,!wine,!
aromatic!resins!and!scented!woods.!!Because!the!distillation!process!appears!not!yet!
! 27!
to!have!been!invented,!all!scents!were!extracted!in!fat!or!oil!to!ensure!fixation!on!the!
skin!(Gunn,!1983;!Lucas,!1930).!
! The!Egyptian!uses!of!cosmetics!and!aromatics!appeared!to!influence!other!
Middle!Eastern!societies,!such!as!that!of!the!Hebrews.!!The!bible!makes!several!
references!to!the!uses!of!cosmetics,!scented!oils!and!perfumes.!!One!of!the!most!
notable!references!to!fragrance!in!the!bible!is!found!in!Matthew!2:11,!which!
describes!the!Magi!bringing!gifts!of!gold,!incense!and!myrrh!after!the!birth!of!Jesus!
Christ.!!With!respect!to!the!use!of!cosmetics,!2!Kings!9:30!speaks!of!Jezebel,!one!of!
the!most!notorious!women!in!the!bible.!
Then!Jehu!went!to!Jezreel.!!When!Jezebel!heard!about!it,!she!painted!her!eyes,!
arranged!her!hair!and!looked!out!of!a!window!(International!Bible!Society).!
During!that!time,!the!Hebrew!prophets!and!puritans!denounced!the!use!of!cosmetics!
by!Hebrew!women.!!In!spite!of!this!these!conservative!admonitions,!the!Egyptians!
continued!to!exert!a!powerful!influence!on!the!fashion!and!beauty!regimen!of!the!
Hebrew!and!other!nearby!societies.!
2.2.2. Cosmetics)in)Europe:)The)Middle)Ages)thru)the)Nineteenth)Ce ntury)
! Both!Egyptian!and!Grecian!practices!influenced!cosmetic!use!in!Europe.!!The!
Romans!absorbed!the!Grecian!art!of!perfumery!and!hygiene!habits!that!they!in!turn!
shared!with!the!Celts!when!they!colonized!Britain.!!These!influences!persisted!after!
the!departure!of!the!Romans!in!AD!429,!and!became!stronger!during!the!Crusades!
! 28!
when!European!men!were!exposed!to!Middle!Eastern!luxuries!(Angeloglou,!1970).!!
They!brought!perfumes,!aromatics!and!cosmetic!preparations!back!to!their!home!
countries!when!they!returned!from!travel.!!The!use!of!powders!and!rouge!was!less!
common!in!England!than!in!France!prior!to!the!1600s,!probably!due!to!the!more!
puritanical!views!held!by!the!English!church!that!cosmetic!artifices!were!the!work!of!
the!devil!(Gunn,!1983).!
! The!crowning!of!Elizabeth!I!in!1559!appeared!to!mark!a!turning!point,!after!
which!Englishwomen!adopted!all!of!the!Continental!cosmetic!practices,!including!
the!use!of!lip!color!and!rouge,!which!was!often!formulated!with!ceruse!or!white!lead!
as!a!base.!!The!pale!face!of!the!queen!became!an!emulated!style!that!required!the!
heavy!use!of!white!powder,!also!made!with!ceruse!(Downing,!2012;!Gunn,!1983).!!
Unfortunately!the!drug^like,!toxic!effects!of!these!lead!compounds!were!not!yet!
understood!and!they!became!accepted!ingredients!in!cosmetics!for!many!centuries.!
2.2.3. Cosmetics)in)the)United)States:)The) Painted)Face)
! English!immigrants!first!brought!cosmetic!formulations!to!the!colonies!in!the!
1600s.!!These!formulations!blended!with!the!already!existing!American!Indian,!
French,!Spanish!and!African!traditions!of!skin!adornment.!!Much!later,!in!the!
seventeenth!and!eighteenth!centuries,!American!women!inherited!the!homemade!
cosmetic!preparations!or!“cosmetic!physic”!of!Englishwomen,!who!knew!how!to!
blend!housewifery,!therapeutics!and!aesthetics!(Peiss,!1998).!!Even!though!
American!women!inherited!these!homemade!concoctions,!they!mostly!looked!
! 29!
askance!at!the!Victorian!model!of!the!painted!face!and!insisted!on!differentiating!
between!skin^improving!and!skin^masking!substances.!
The!word!cosmetic!usually!referred!to!creams,!lotions,!and!other!substances!
that!acted!on!the!skin!to!protect!and!correct!it.!!Paints!and!enamels,!in!
contrast,!were!white!and!tinted!liquids,!mainly!produced!commercially,!that!
covered!the!skin.!!“Paints!must!not!be!confounded!with!Cosmetics,!which!
often!really!do!impart!whiteness,!freshness,!suppleness,!and!brilliancy!to!the!
skin,”!instructed!one!writer;!“these!consequently!assist!Nature,!and!make!
amends!for!her!defects.”!!Paints,!however,!masked!Nature’s!handiwork!to!
hide!expression!and!truth!behind!and!“encrusted!mould,”!a!“mummy!
surface.”!(Peiss,!1998)!
! In!spite!of!this!sentiment,!in!the!nineteenth!century!the!ideal!face!was!still!
that!of!pale!skin!and!blushing!cheeks.!!After!the!Civil!War,!medical!case!records!of!
women!who!used!dangerous!lead^based!whitening!lotions,!such!as!George!W.!
Laird’s!Bloom!of!Youth!started!to!appear.!!Purported!to!be!safe!and!effective,!this!
skin!lightener!contained!enough!lead!to!bring!on!lead!palsy!within!two!to!three!
years!of!use!(Downing,!2012).!!This!marketing!of!adulterated!compounds!with!
harmful!ingredients!can!now!be!recognized!as!early!examples!of!dangerous!
practices!that!were!later!seen!to!require!regulatory!oversight.!!Many!incidents!of!
cosmetic!injury!occurred!during!the!what!has!since!been!called!the!Progressive!Era,!
a!period!of!economic,!political,!and!social!reform!in!America,!which!lasted!from!the!
1890s!to!about!1914!(Gould,!2001).!!During!this!time,!the!public!became!sensitized!
to!linkages!between!health!problems!and!exposure!to!dangerous!foods,!drugs!and!
! 30!
cosmetics.!!A!political!movement!for!safer!food!and!drugs!gained!strength,!so!that!by!
1900,!the!use!of!paints!and!rouges!were!in!decline!as!the!public!became!aware!that!
cosmetics!often!contained!lead,!mercury!and!other!harmful!ingredients!(Peiss,!
1998).!!
2.3. The)Rise)of)the)Mass)Market)Cosmetic)Industry )
! The!early!stages!of!the!cosmetic!industry!in!the!United!States,!from!the!1890s!
to!the!1920s,!were!organized!as!what!was!termed!a!“beauty!culture”.!!This!system!of!
commerce!relied!on!the!social!patterns!and!customs!of!women!as!they!visited!and!
conversed!with!each!other.!!Because!women!were!restricted!from!mainstream!
business!practices,!they!seized!opportunities!to!become!entrepreneurs!by!
establishing!salons,!beauty!schools,!mail^order!and!direct^sales!marketing!
companies!(Peiss,!1998).!!Thus,!it!was!women!who!primarily!built!the!cosmetic!
industry.!!!
! However,!changes!in!business!development!practices!in!the!twentieth!
century!caused!cosmetic!products!to!evolve!from!a!cottage!to!a!mass^market!
industry!(Termini!&!Tressler,!2008).!!Between!1909!and!1929,!a!new!national!
system!of!mass!production,!distribution,!and!marketing!emerged,!and!cosmetics!
moved!from!in^home!compounding!to!full^scale!contract!manufacturing!
organizations.!!As!a!result,!the!number!of!cosmetic!and!perfume!manufacturers!
increased,!and!the!factory!value!of!their!products!rose!from!$14.2!million!to!nearly!
$141!million!over!a!20^year!period.!!In!1929,!sociologist!Robert!Lynd!estimated!that!
! 31!
Americans!were!spending!$700!million!annually!for!cosmetics!and!beauty!services,!
which!had!become!an!affordable!luxury!for!American!women,!regardless!of!their!
socioeconomic!status!(Peiss,!1998).!!
2.3.1. The)Cosmeceutical)Era)
! Prior!to!1950,!the!purposes!and!mechanisms!of!action!of!cosmetics!were!
quite!clear,!to!enhance!the!appearance!of!facial!features,!skin!and!hair.!!Toward!the!
latter!half!of!the!twentieth!century,!however,!technological!developments!yielded!a!
new!class!of!cosmetics!called!“cosmeceuticals”,!which!blurred!the!hard!line!between!
cosmetics!and!drugs.!!This!development!arose!out!of!consumer!demand!for!
cosmetics!that!could!go!beyond!simple!skin!adornment!to!the!more!functional!effect!
of!skin!improvement.!!“Cosmeceutical”!was!a!term!first!coined!by!Raymond!Reed,!
founding!member!of!the!U.S.!Society!of!Cosmetic!Chemists,!in!1962.!!His!definition!
was!based!on!four!principles:!!
1.! A!cosmeceutical!is!a!scientifically!designed!product!intended!for!external!
application!to!the!human!body.!!
2.! A!cosmeceutical!produces!a!useful,!desired!result.!!
3.! A!cosmeceutical!has!desirable!aesthetic!properties.!!
4.! A!cosmeceutical!meets!rigid!chemical,!physical!and!medical!standards.!
(Saint^Leger,!2012)!
! 32!
! Originally,!these!criteria!spoke!more!to!establishing!high^quality!standards!to!
cosmetics!similar!to!those!used!for!pharmaceuticals.!!However,!when!Kligman!
modified!the!use!of!the!term!at!the!National!Scientific!Meeting!of!the!Society!of!
Cosmetic!Chemists!in!1984,!to!define!a!product!at!the!interface!between!a!cosmetic!
and!a!drug,!industry!focus!shifted!to!the!unexplored!physiological!activities!of!some!
cosmetic!products.!!Initially,!the!cosmetic!industry!showed!some!resistance!to!this!
new!use!of!the!term,!but!gradually!industry!support!for!the!terminology!gained!
momentum!(Kligman,!2000).!!Currently,!there!are!different!definitions!and!
descriptions!for!cosmeceuticals!that!greatly!expand!upon!Kligman’s!revised!
meaning!of!the!term.!!Terms!such!as!“performance!cosmetics”,!“functional!
cosmetics”,!“dermoceuticals”!and!“active!cosmetics”!all!imply!benefits!beyond!
beauty!(Kligman,!2000).!!An!article!published!in!May!of!2010!described!a!current!
concept!of!cosmeceuticals!as!“a!category!of!cosmetic!products!with!biologically!
active!ingredients!that!offer!medicinal!benefits”.!!Sachdev!and!Friedman!further!
state!that:!!
As!one!of!the!hottest!and!fastest!growing!segments!of!the!natural,!personal!
care!industry,!Cosmeceuticals!are!employed!to!carry!out!numerous!functions,!
such!as!preventing!UV!damage,!reducing!free!radical!formation,!improving!
the!skin!lipid!barrier,!brightening!and!unifying!skin!tone,!smoothing!texture!
and!reducing!pore!size.!!Vitamins!and!botanicals!encompass!a!large!
component!of!this!cosmeceutical!market,!much!of!which!has!yet!to!be!clearly!
defined!or!regulated!(Sachdev!&!Friedman,!2010).!
! 33!
! Author!Zoe!Draelos!expresses!a!similar!view.!!She!lists!ten!basic!mechanisms!
of!action!for!cosmeceuticals,!listed!in!Table!1.!!She!states!that!the!ideal!
cosmeceutical!should!incorporate!as!many!of!these!functions!as!possible!into!a!
single!product.!!Some!of!these!activities!modify!the!stratum!corneum,!which!is!non^
living.!!Some!go!beyond!the!stratum!corneum!to!affect!the!underlying!tissues,!and!it!
is!one!of!the!reasons!why!cosmeceuticals!are!a!controversial!regulatory!topic!today!
(Draelos,!2007).!!!
Table)1:)Ten)Basic)Cosmeceutical)Mechanisms)of)Action)
!
!
Source:!Journal!of!Cosmetic!Dermatology,!4!(Draelos,!2005)!
2.3.2. The)Market)Growth)of)Cosmeceuticals)
! Since!its!inception,!the!term!“cosmeceutical”!has!been!embraced!fully!by!
marketers.!!As!a!result,!these!products!have!grown!in!popularity,!as!consumers!
continue!to!expect!more!benefits!from!their!health!and!beauty!products.!!In!a!
! 34!
November!2009!Special!Report!titled,!“Cosmetics:!Niche!markets!put!a!fresh!face!on!
the!industry”,!U.S.!industry!research!company,!IBISWorld,!Inc.,!stated!that!the!
cosmeceutical!sector!was!the!fastest!growing!area!of!the!cosmetic!industry.!!
Cosmeceuticals,!which!they!defined!as!“pharmaceutical^based!cosmetics,!which!
contain!active!ingredients!that!are!functional”,!rose!from!a!near^nothing!industry!to!
an!estimated!worth!of!$3.5!billion!by!year^end!2009.!!They!attributed!this!growth!to!
a!stronger!consumer!focus!on!wellness!and!a!more!holistic!approach!to!beauty.!!
Their!belief!was!that!wellness!will!play!a!large!role!in!driving!product!innovation!
that!in!turn!will!blur!the!boundaries!between!cosmetics!and!medicine!(IBISWorld,!
2009).!!IBISWorld!forecasted!that!the!cosmeceutical!market!will!grow!7.7%!to!
exceed!$4!billion!in!2011,!and!will!continue!to!grow!at!near!double^digit!rates!for!
quite!some!time!(IBISWorld,!2009).!
Figure)1:)Cosmeceuticals)–)The)Fast)Growing)Sector )
!
Source:!IBISWorld!Inc.!(2009)!
!
! 35!
! In!April!2012,!Packaged!Facts,!another!consumer!research!company,!
published!a!market!report!for!cosmeceuticals!sold!at!retail!in!the!U.S.!through!mass!
market!and!prestige!channels.!!In!the!report,!they!delimited!cosmeceuticals!as!
health!and!beauty!care!(HBC)!products!specifically!positioned!as!having!beautifying!
or!curative!effects!in!an!active!physiological!way.!!They!grouped!cosmeceuticals!into!
three!categories:!
• Skin!Care:!Including!face!and!body!moisturizers,!anti^aging!products,!and!
cleansers.!
• Hair!Care:!Including!shampoos,!conditioners,!and!hair!treatments.!
• Color:!Including!eye,!face,!lip!and!nail!care.!!
Excluded!from!the!scope!were!products!purely!cosmetic!in!nature,!as!well!as!
products!already!classified!as!drugs!or!that!provided!purely!health^related!benefits!
without!offering!cosmetic!benefits!as!well,!e.g.!sunscreens!and!hair!growth!products!
(Brown!&!Marigny!Research!Group,!2012).! !
! Packaged!Facts!estimated!that!the!U.S.!retail!sales!of!cosmeceuticals!were!
valued!at!$9.7!billion!in!2011,!up!from!$9.3!billion!in!2010.!!This!increase!marked!a!
return!to!market!growth!after!two!years!of!stagnant!sales!associated!with!the!
economic!recession!in!2008^2010,!as!depicted!in!Table!2.!!These!projections!are!
consonant!with!the!earlier!projections!from!IBISWorld.!!Skin!care!cosmeceuticals!
comprised!46%!or!$4.5!billion!of!the!retail!cosmeceutical!market!share,!compared!
! 36!
to!hair!care!cosmeceuticals!at!32%!and!color!cosmeceuticals!at!22%!(Brown!&!
Marigny!Research!Group,!2012).!
Table)2:)U.S.)Retail)Sales)of)Cosmeceuticals,)2007 [2011)
!
Source:!Cosmeceuticals!in!the!U.S,!6
th
!Edition,!Packaged!Facts!(2012)!
Table)3:)U.S.)Retail)Dollar)Sales)of)Cosmeceutical)Skin)Care)Products,)2007 [2011)
!
Source:!Cosmeceuticals!in!the!U.S,!6
th
!Edition,!Packaged!Facts!(2012)!
! 37!
2.3.3. Industry)Outlook)
! As!a!result!of!the!factors!and!trends!discussed!in!their!report,!Packaged!Facts!
estimated!that!U.S.!retail!sales!of!cosmeceuticals!will!reach!$11.9!billion!by!the!end!
of!this!year,!with!annual!growth!rates!edging!up!from!3.5%!in!2012!to!5.0%,!as!
shown!in!Table!4.!!This!forecast!is!based!largely!on!an!expected!economic!recovery,!
which!will!allow!consumers!to!spend!more!freely,!and!on!the!growing!number!of!
cosmeceutical!products!targeting!all!age!groups!(Brown!&!Marigny!Research!Group,!
2012).!!If!skincare!cosmeceuticals!continue!to!maintain!46%!of!the!overall!retail!
cosmeceutical!market,!then!sales!of!skincare!cosmeceuticals!will!reach!an!estimated!
$5.5!billion.!
Table)4:)Projected)U.S.)Retail)Sales)of)Cosmeceuticals,)20 11[2016)
!
Source:!Cosmeceuticals!in!the!U.S,!6
th
!Edition,!Packaged!Facts!(2012)!
!
! 38!
! In!a!new!2013!report!on!cosmeceutical!skincare!production!in!the!U.S.,!
IBISWorld!echoed!the!Packaged!Facts!estimates.!!It!predicted!that!industry!revenue!
would!increase!by!10.2%!to!$5.0!billion.!!They!expressed!the!view!that!external!
drivers!of!the!growth!would!include!the!following:!
• Increases!in!the!number!of!adults!aged!50!and!older,!a!key!target!
demographic!for!the!cosmeceutical!industry.!!!
• Increases!in!per!capita!disposable!income!i.e.,!the!amount!of!money!
available!to!spend!on!discretionary!products!such!as!cosmeceuticals,!is!
also!expected!to!increase!slowly!during!2013.!
• Increases!in!research!and!development!expenditure!on!new!products!and!
packaging.!!
• Increases!in!demand!from!the!mass!market,!as!warehouse!clubs!and!
supercenters!continue!to!promote!cosmeceutical!products!at!affordable!
prices.!!(Panteva,!2013)!
Figure)2:)Number)of)adults)aged)50)and)older)and)Per)capita)disposable)income )
!
Source:!IBISWorld!Inc.!(2013)!
! 39!
!
! On!the!other!hand,!the!trade^weighted!index,!i.e.,!the!value!of!the!US!dollar!
against!its!major!trading!partners’!currencies!such!as!the!euro!or!yen,!could!pose!a!
potential!threat!to!growth!in!the!cosmeceutical!industry.!!If!the!value!of!the!U.S.!
dollar!increases,!which!is!forecasted!to!happen,!then!the!prices!of!U.S.!made!
products!will!rise,!and!this!could!compromise!the!very!large!but!price!sensitive!
international!market.!!On!balance,!however,!revenue!growth!is!projected!to!remain!
strong!to!2018.!!IBISWorld!anticipates!revenue!to!rise!at!an!average!annual!rate!of!
7.5%!to!$7.2!billion!(Panteva,!2013).!
2.4. Cosmetic)Regulations)in)the)United)States )
! The!rapid!evolution!and!growth!of!the!cosmetics!industry!in!the!twentieth!
century!was!not!without!consequence.!!As!cosmetics!became!mass^produced,!the!
risk!of!distributing!harmful!products!to!a!wider!audience!greatly!increased!(Termini!
&!Tressler,!2008).!!In!the!early!1930s,!the!Food!and!Drug!Administration,!previously!
known!as!the!Bureau!of!Chemistry!(Junod,!2003),!sponsored!an!exhibit!called!“The!
American!Chamber!of!Horrors”,!where!they!utilized!before!and!after!makeovers!to!
unmask!the!dangers!of!cosmetic!products.!!The!strategy!worked.!!Women’s!groups!
obtained!support!from!First!Lady!Eleanor!Roosevelt!and!lobbied!for!the!passage!of!a!
federal!law!to!make!cosmetics!safer!to!use!(Peiss,!1998).!!!
! Signed!in!1938!by!President!Franklin!D.!Roosevelt,!the!Federal!Food,!Drug!
and!Cosmetic!Act!(“FD&C!Act”!or!“the!Act”)!prohibits!the!marketing!of!adulterated!
! 40!
or!misbranded!products!in!interstate!commerce.!!It!was!and!still!remains!the!
primary!law!governing!all!FDA^regulated!products.!!Cosmetics!were!called!out!in!the!
Act!and!distinguished!from!drugs.!!As!defined!in!the!Act!cosmetics!are,!
articles!intended!to!be!rubbed,!poured,!sprinkled,!or!sprayed!on,!introduced!
into,!or!otherwise!applied!to!the!human!body!or!any!part!thereof!for!
cleansing,!beautifying,!promoting!attractiveness,!or!altering!the!appearance!
(21!U.S.C.!§!321(i),!2010)!
Among!the!products!included!in!this!definition!were!skin!moisturizers,!perfumes,!
lipsticks,!fingernail!polishes,!eye!and!facial!makeup!preparations,!shampoos,!
permanent!waves,!hair!colors,!toothpastes,!and!deodorants,!as!well!as!any!material!
intended!for!use!as!a!component!of!a!cosmetic!product!(U.S.!Food!and!Drug!
Administration,!2002).!
! In!contrast,!the!FD&C!Act!defined!drugs!by!their!intended!use!as,!
articles!intended!for!use!in!the!diagnosis,!cure,!mitigation,!treatment,!or!
prevention!of!disease"!and!"articles!(other!than!food)!intended!to!affect!the!
structure!or!any!function!of!the!body!of!man!or!other!animals!(21!U.S.C.!§!
321(g)(1),!2010)!
! According!to!these!definitions,!the!legal!difference!between!a!cosmetic!and!a!
drug!is!determined!by!a!product's!intended!use.!!However,!there!are!cosmetic^drugs!
that!meet!the!definitions!for!both!a!cosmetic!and!a!drug.!!For!example,!an!anti^
dandruff!shampoo!is!a!cosmetic!because!its!intended!use!is!to!cleanse!the!hair.!!By!
incorporating!an!anti^dandruff!treatment,!the!shampoo!is!also!a!drug!because!its!
! 41!
intended!use!is!to!treat!dandruff.!!Other!examples!of!cosmetic^drugs!include!
toothpastes!that!contain!fluoride,!deodorants!that!are!also!antiperspirants,!and!
moisturizers!and!makeup!marketed!with!sun^protection!claims.!!These!cosmetic^
drugs!must!comply!with!the!requirements!for!both!cosmetics!and!drugs!(Hutt,!
2000).!
! In!the!FDA!guidance!“Is!It!a!Cosmetic,!a!Drug,!or!Both?!(Or!Is!It!Soap?)”,!a!
product’s!intended!use!can!be!established!in!a!number!of!ways.!!Some!examples!
include,!but!are!not!limited!to:!
• Claims'stated'on'the'product'labeling,'in'advertising,'on'the'Internet,'
or'in'other'promotional'materials.!!Such!claims!establish!the!product!
as!a!drug!because!the!intended!use!is!to!treat!or!prevent!disease!or!
otherwise!affect!the!structure!or!functions!of!the!human!body.!!Some!
examples!are!claims!that!products!will!restore!hair!growth,!reduce!
cellulite,!treat!varicose!veins,!increase!or!decrease!the!production!of!
melanin!(pigment)!in!the!skin,!or!regenerate!cells.!
• Consumer'perception,'which'may'be'established'through'the'
product's'reputation.!!This!means!asking!why!the!consumer!is!buying!it!
and!what!the!consumer!expects!it!to!do.!
• Ingredients'that'cause'a'product'to'be'considered'a'drug'because'
they'have'a'well;known'(to'the'public'and'industry)'therapeutic'use.!!
An!example!is!fluoride!in!toothpaste.!!(U.S.!Food!and!Drug!Administration,!
2002)!
! There!are!other!laws!that!affect!the!regulation!of!cosmetic!and!other!FDA^
regulated!products.!!The!Fair!Packaging!and!Labeling!Act!(FPLA)!of!1967!prevents!
! 42!
unfair!and!deceptive!packaging!and!labeling!practices!of!consumer!products.!!
Enforcement!of!this!law!falls!under!the!jurisdiction!of!the!Federal!Trade!
Commission!(FTC),!whose!dual!mission!is!to!protect!consumers!and!promote!
competition!(Federal!Trade!Commission,!2013).!!The!FTC!works!together!with!the!
FDA!to!oversee!the!protection!of!consumers!in!the!marketplace,!with!respect!to!the!
manufacture!and!distribution!of!consumer!products.!!Failure!to!comply!with!the!
FD&C!Act!and!the!FPLA!can!result!in!enforcement!action!by!either!or!both!agencies.!
2.4.1. Cosmetic)Registration)Requirements)
! The!U.S.!has!a!permissive!registration!system!for!cosmetics.!!Thus,!most!
cosmetic!products!and!their!ingredients!require!neither!notification!to!the!FDA!nor!
approval!by!the!FDA!prior!to!being!placed!on!the!market.!!Instead,!manufacturers,!
packers!and!distributors!of!cosmetic!products!have!the!option!to!register!their!
manufacturing!and/or!packaging!establishments,!as!well!as!their!cosmetic!product!
ingredient!statements!(CPIS)!with!the!FDA!via!the!Voluntary!Cosmetic!Registration!
Program!(VCRP).!!The!VCRP!assists!the!FDA!greatly!in!their!efforts!to!regulate!
cosmetics!because!from!it,!they!derive!the!best!information!available!about!the!
nature!of!U.S.!cosmetic!products!and!ingredients,!their!frequency!of!use,!and!the!
businesses!engaged!in!their!manufacture!and!distribution!(73!Fed.!Reg.!76360).!
! Under!the!U.S.!regulatory!system!for!cosmetics,!companies!that!market!
cosmetic!products!bear!the!responsibility!of!ensuring!that!their!products!are!safe!
for!consumers!under!labeled!or!customary!conditions!of!use.!!Cosmetic!companies!
! 43!
that!fail!to!provide!adequate!substantiation!of!safety!are!required!to!display!the!
statement!on!the!principal!display!panel!(PDP)!of!their!products,!“Warning^^The!
safety!of!this!product!has!not!been!determined”!(21!C.F.R.!§!740.10(a),!2013).!
! Typically!the!U.S.!regulatory!system!for!cosmetics!has!worked!well.!!
However,!in!the!last!decade!much!attention!has!been!paid!to!two!types!of!challenges!
to!this!system.!!The!first!relates!to!cosmetic!imports!that!violate!the!Act,!either!
through!the!illegal!use!of!prohibited!and!restricted!ingredients,!or!as!a!result!of!
microbial!contamination,!color!additive!and!labeling!violations.!!This!challenge!is!
largely!related!to!compliance!and!enforcement,!and!is!beyond!the!scope!of!this!
research.!!The!second!concern!challenges!the!fundamental!issue!of!regulatory!policy!
and!is!more!central!to!the!subject!of!this!study.!!It!directly!relates!to!cosmetic!
products!applied!to!the!human!body!that!are!marketed!as!having!the!ability!to!affect!
the!structure!or!metabolism!of!the!skin,!hair!or!the!underlying!tissues.!!These!
cosmeceuticals!add!a!new!dimension!to!the!regulations!that!was!not!taken!into!
consideration!at!the!time!the!FD&C!Act!was!signed!in!1938.!!!
2.4.2. Regulation)of)Cosmetics)Marketed)with)Drug)Claims )
! For!many!years,!the!FD&C!Act!relied!on!the!relatively!easy!differentiation!of!
cosmetics!and!drugs.!!However,!the!introduction!of!cosmeceuticals!began!to!
challenge!this!dichotomy.!!On!its!face,!cosmeceuticals!are!simply!cosmetic!products!
marketed!with!drug!claims.!!However,!based!on!the!Act,!cosmeceuticals!are!
! 44!
unapproved!new!drugs!because!their!primary!intent!is!to!affect!the!structure!and!
function!of!the!human!body.!!
! Considerations!of!cosmeceuticals!raise!two!fundamental!questions.!!First,!at!
what!point!do!they!become!“biologically!active”?!!Is!it!not!the!case!that!many!
traditional!cosmetic!products!have!some!type!of!an!effect!on!the!structure!and!
function!of!the!skin!or!the!underlying!tissues?!!According!to!Kligman,!it!is!impossible!
to!think!of!a!single!substance!that!cannot,!under!some!circumstances,!alter!the!
structure!and!function!of!the!skin.!!He!gives!the!example!of!water,!that!when!applied!
to!a!moistened!cotton!pad!and!sealed!to!human!skin!for!two!days,!causes!
interleukins!to!be!released!from!the!dead!stratum!corneum,!then!causing!cytotoxic!
changes!in!the!viable!epidermis!and!dermis!below.!!This!reaction!occurs!often!in!
people!such!as!bartenders!who!have!prolonged!exposure!to!water!(Kligman,!2000).!!
! Second,!how!should!cosmeceuticals!i.e.,!cosmetics!marketed!with!drug!
claims,!be!regulated!in!the!U.S.?!!Interpretation!of!the!legislation!requires!sensitivity!
to!the!challenges!facing!the!cosmetic!industry!concerning!the!marketing!of!
cosmeceuticals.!!These!challenges!are!exacerbated!by!the!nature!and!variability!of!
cosmeceuticals,!which!can!possibly!constrain!the!range!of!solutions!that!could!be!
provided.!!This!makes!it!difficult!to!propose!laws!to!regulate!these!products!in!ways!
that!are!acceptable!to!regulators,!industry!and!consumers.!!This!research!seeks!to!
understand!the!views!and!behavior!of!the!cosmetic!industry!in!light!of!the!current!
constraints!that!are!explained!more!fully!below.!
! 45!
2.4.3. Regulatory)Action)for)Cosmetics)Marketed)with)Drug)Claims )
! Unless!and!until!a!consensus!can!be!reached!regarding!cosmeceutical!
regulatory!oversight!in!the!U.S.,!the!FDA!has!the!authority!to!sanction!the!marketing!
of!cosmetic!products!with!drug!claims.!!As!an!initial!enforcement!action,!the!FDA!
issues!warning!letters!to!companies!making!drug!claims!on!their!cosmetic!products.!!
Failure!to!address!the!comments!stated!in!a!warning!letter!can!escalate!into!more!
serious!enforcement!actions!from!the!FDA,!or!even!court!actions!through!the!
Department!of!Justice.! !
! Table!5!shows!the!list!of!warning!letters!addressed!to!cosmetic!companies!
for!making!drug!claims!on!their!products!over!the!last!10+!years.!!According!to!the!
FDA,!some!of!the!common!drug!claims!made!are!those!for!acne!treatment,!cellulite!
and!stretch!mark!reduction,!wrinkle!removal,!dandruff!treatment,!hair!restoration!
and!eyelash!growth!(U.S.!Food!and!Drug!Administration,!2015c).!
! 46!
Table)5:)Warning)Letters)Addressing)Drug)Claims)Made)for)Products)Marketed)as)
Cosmetics)
!
Source:!U.S.!Food!and!Drug!Administration!(2015c)!
! 47!
! The!number!of!warning!letters!in!Table!5!is!relatively!low,!suggesting!that!
the!FDA!has!been!exercising!discretion!when!issuing!warning!letters!for!cosmetic!
products!marketed!with!drug!claims.!!Notably,!the!biggest!gap!in!warning!letters!
from!2007!to!2011!coincides!with!a!period!of!incremental!growth!in!the!U.S.!retail!
sales!of!cosmeceuticals,!despite!an!economic!downturn!that!depressed!sales!of!most!
other!consumer!products!(refer!to!Tables!2!and!3).!!In!spite!of!this!growth!trend,!
violative!cosmeceutical!claims!continue!to!attract!relatively!little!attention!from!the!
FDA.!!Even!though!nine!warning!letters!were!issued!in!2012,!no!letters!were!issued!
in!2013,!and!only!two!letters!were!issued!in!2014.!!!
Regulatory!scrutiny!increased!in!2015,!reflected!by!the!fact!that!the!FDA!
issued!nine!warning!letters.!!Two!notable!recipients!included!La!Roche^Posay!for!
redness!and!dark!spot!correction!claims,!two!claims!not!previously!addressed!in!
warning!letters,!and!Strivectin!Operating!Company!for!wrinkle!reducing!and!skin!
tightening/firming!claims.!!Interestingly,!La!Roche^Posay!is!owned!by!L’Oréal!USA,!
who!previously!received!a!warning!letter!in!September!2012!for!Lancôme!USA.!!This!
is!also!the!second!time!that!Strivectin!has!received!a!warning!letter!from!FDA!for!
their!drug!claims.!!Basic!Research,!LLC!received!a!warning!letter!in!2005!for!drug!
claims!on!Strivectin,!in!addition!to!some!of!their!other!sub^family!of!brands,!before!
they!divested!Strivectin!to!the!Strivectin!Operating!Company,!Inc.!in!2009.!!
! 48!
2.5. Models)for)Regulating)Cosmeceuticals)in)the)United)States )
! By!law,!cosmeceuticals!are!unapproved!new!drugs.!!Therefore,!the!current!
regulatory!environment!stipulates!that!they!must!have!FDA!approval!prior!to!being!
sold.!!This!is!not!a!surprise!considering!that!a!number!of!currently!marketed!
prescription!drug!products!also!provide!cosmetic!benefits.!!Prescription!drug!
cosmeceuticals!include!topical!retinoids!for!improving!dermal!collagen!production!
and!topical!minoxidil!for!enhanced!scalp!hair!growth,!for!example!(Draelos,!2007).!!
In!addition,!there!are!injectable!drug!products!such!as!Botox®!Cosmetic!
(onabotulinumtoxinA),!Juvéderm®!XC!and!Restylane®!that!beautify!through!
injection!or!implantation!under!the!supervision!of!a!physician.!!The!usefulness!of!
treating!such!products!as!drugs!is!not!typically!at!issue.!!What!is!at!issue!and!is!the!
topic!of!this!dissertation,!is!the!appropriateness!of!the!current!and!projected!
regulatory!approaches!that!govern!low^risk!cosmeceutical!products!that!are!applied!
to!the!surface!of!hair,!skin!and!nails,!and!are!made!available!through!multiple!
distribution!channels.!!!
! Drugs!have!stricter!regulatory!requirements!than!cosmetics!in!the!U.S.!!
Typically!they!enter!the!market!by!conformance!with!one!of!two!regulatory!paths,!
either!by!securing!FDA!approval!through!an!application!and!review!process,!or!by!
conformance!with!an!applicable!Over^the^Counter!(OTC)!drug!monograph.!!
Regardless!of!path,!all!drugs!must!be!manufactured!according!to!the!current!Good!
Manufacturing!Practices!(cGMPs)!for!drugs!and!finished!pharmaceuticals!as!set!
forth!in!Parts!210!and!211!in!Title!21!of!the!Code!of!Federal!Regulations!
! 49!
respectively.!!Also,!unlike!cosmetic!companies,!drug!companies!are!required!to!
register!their!establishments!and!list!their!drug!products!with!the!FDA!according!to!
§510!of!the!FD&C!Act!(21!U.S.C.!§!360(b),!2010).!
2.5.1. Drugs)Requiring)FDA)Approval)
! Drug!products!requiring!FDA!approval!can!be!divided!into!three!subtypes.!!
Some!are!new!products!that!have!never!been!on!the!market!previously,!so^called!
“innovator”!drugs!that!must!be!presented!to!regulators!using!a!lengthy!regulatory!
submission!called!a!New!Drug!Application!(NDA),!according!to!§!505(b)(1)!of!the!
FD&C!Act!(21!U.S.C.!§!355(b)(1),!2010).!!A!supplemental!NDA!is!also!required!if!an!
already!approved!or!marketed!drug!is!modified,!or!a!new!therapeutic!indication!for!
use!has!been!discovered!by!the!sponsor.!!Drugs!that!modify!the!kinetic!properties!of!
marketed!drugs,!and!which!are!not!being!developed!by!the!original!sponsor/patent^
holder,!must!also!be!submitted!via!a!somewhat!modified!NDA,!according!to!§!
505(b)(2)!of!the!Act!(21!U.S.C.!§!355(b)(2),!2010).!!Finally,!drugs!that!replicate!
innovator!drugs!and!are!marketed!after!the!patent!for!the!new!drug!has!expired!are!
classified!as!generic!drugs!and!must!be!submitted!for!approval!via!an!Abbreviated!
New!Drug!Application!(ANDA),!according!to!§!505(j)!of!the!Act!(21!U.S.C.!§!
355(j)(2)(A)(vii),!2010).!!
! 50!
2.5.1.1. New)Drug)Application)(NDA))
! When!a!drug!is!a!“new!drug”!under!Section!201(p)!of!the!FD&C!Act,!it!
requires!an!approved!New!Drug!Application!(NDA)!before!it!can!be!legally!marketed!
in!the!United!States!(21!U.S.C.!§!355(a),!2010).!!Since!1938,!every!new!drug!that!is!
currently!on!the!market!has!been!the!subject!of!a!NDA.!!The!purpose!of!a!NDA!is!
threefold.!!It!determines,!
• whether!the!drug!is!safe!and!effective!in!its!proposed!use(s),!and!whether!
the!benefits!of!the!drug!outweigh!the!risks.!
• whether!the!drug's!proposed!labeling!(package!insert)!is!appropriate,!and!
what!it!should!contain.!
• whether!the!methods!used!in!manufacturing!the!drug!and!the!controls!
used!to!maintain!the!drug's!quality!are!adequate!to!preserve!the!drug's!
identity,!strength,!quality,!and!purity.!!(U.S.!Food!and!Drug!
Administration,!2013c)!
! The!NDA!pathway!is!complex!with!two!main!stages.!!In!the!first,!preclinical!
stage,!results!from!laboratory!and!animal!tests!must!be!submitted!as!evidence!that!
the!drug!is!safe!for!use!in!humans.!!In!the!subsequent!clinical!stage,!clinical!studies!
determine!that!the!drug!has!an!acceptable!risk^benefit!profile!and!provides!a!real!
health!benefit.!!This!testing!strategy!is!lengthy!and!expensive.!!The!estimated!cost!of!
bringing!a!new!drug!to!market!is!over!$1.3!billion!USD,!and!the!time!required!can!be!
as!long!as!or!longer!than!15!years!(Kalorama!Information,!2012;!S.!Morgan,!
Grootendorst,!Lexchin,!Cunningham,!&!Greyson,!2011).!!In!part,!these!high!numbers!
! 51!
also!reflect!the!large!risk!associated!with!failed!compounds!that!might!also!be!under!
development.!!According!to!a!2004!FDA!Report,!a!new!medicinal!compound!
entering!a!Phase!I!clinical!trial!had!an!8%!chance!of!receiving!pre^market!approval.!!
This!reflected!a!decline!in!the!historical!success!rate!of!about!14%.!!To!put!this!into!
perspective,!a!new!drug!entering!Phase!I!clinical!trials!in!2000!had!an!equal!chance!
for!success!as!one!entering!Phase!I!trials!in!1985.!!This!was!in!spite!of!the!
breakthroughs!in!biomedical!research!(U.S.!Food!and!Drug!Administration,!2004).!!A!
more!recent!study!on!outsourcing!in!drug!development!conducted!by!the!conducted!
by!the!Tufts!Center!for!Drug!Development!concluded!that!75%!of!the!drugs!that!
enter!Phase!I!move!forward!to!Phase!II.!!However,!only!42%!of!those!drugs!progress!
to!Phase!III.!!Of!those!Phase!III!drugs,!only!64%!successfully!make!it!through!to!FDA!
approval!(Kalorama!Information,!2012).!
! In!the!case!of!OTC!drugs!that!require!FDA!approval!because!they!are!“new”!to!
the!OTC!marketplace,!the!sponsor!must!submit!a!NDA!to!the!newly!combined!
Division!of!Nonprescription!Drug!Products!(DNDP),!formerly!the!Division!of!
Nonprescription!Clinical!Evaluation!(DNCE)!and!the!Division!of!Nonprescription!
Regulation!Development!(DNRD)!in!the!Office!of!Drug!Evaluation!IV!of!the!FDA.!!The!
NDA!must!show!that!the!drug!product!is!safe!and!effective!for!use!by!consumers!
without!the!assistance!of!a!healthcare!professional.!!DNDP!reviews!and!approves!the!
NDA!before!that!drug!product!can!be!marketed!as!an!OTC!drug.!!They!also!approve!
the!labeling.!!Therefore,!any!changes!to!the!formulation!or!labeling!must!be!
submitted!to!them!for!approval!via!a!NDA!supplement.!
! 52!
2.5.1.2. Abbreviated)New)Drug)Application)(ANDA):)Generic)Drugs )
! A!generic!drug!product!is!one!that!is!comparable!to!an!innovator!drug!
product.!!In!order!to!market!the!drug,!the!sponsor!must!submit!an!Abbreviated!New!
Drug!Application!(ANDA)!to!the!Office!of!Generic!Drugs!in!the!Center!for!Drug!
Evaluation!(CDER)!at!the!FDA.!!It!is!called!an!abbreviated!application!because!
preclinical!(animal)!and!clinical!(human)!data!is!not!required!to!establish!safety!and!
effectiveness.!!The!sponsor!must!instead!demonstrate!that!the!generic!drug!product!
is!bioequivalent,!i.e.,!performs!in!the!same!manner!as!the!innovator!drug,!usually!by!
performing!a!small!study!of!24!to!36!healthy!volunteers.!!The!generic!drug!must!
exhibit!a!pharmacokinetic!profile!in!the!patients'!bloodstream!that!matches!the!
innovator!drug!(U.S.!Food!and!Drug!Administration,!2013a).!!The!cost!and!time!for!
submitting!an!ANDA!is!not!as!great!and!exhaustive!as!a!NDA!due!to!a!much!reduced!
drug!development!cycle,!but!its!use!is!clearly!restricted!to!products!that!already!
have!a!strong!market!presence!for!which!patent!protection!no!longer!exists.!
2.5.2. Over[the[Counter)(OTC))Drugs)
! Over^the^Counter!(OTC)!drugs!are!drug!products!for!which!a!doctor’s!
prescription!is!not!required.!!The!margin!of!risk!associated!with!using!an!OTC!drug!
is!relatively!low.!!Thus,!consumers!can!use!them!for!self^diagnosed!conditions.!!
According!to!the!FDA,!there!are!over!300,000!marketed!OTC!drug!products!and!over!
80!therapeutic!classes,!ranging!from!acne!to!weight!control!(U.S.!Food!and!Drug!
Administration,!2013e).!!Some!OTC!drugs,!such!as!anti^dandruff!shampoos,!fluoride!
! 53!
toothpastes!and!anti^perspirants,!also!have!cosmetic!functions.!!As!stated!
previously,!these!drugs!must!comply!with!the!requirements!for!both!cosmetics!and!
drugs.!
! The!numbers!of!OTC!drug!products!are!large,!and!would!provide!a!huge!
regulatory!burden!to!the!FDA!if!there!were!not!to!be!a!simpler!path!for!well^
understood!products.!!This!path!was!provided!by!a!monograph!process!that!relied!
on!already^acknowledged!evidence!of!safety!and!effectiveness!of!ingredients!
published!in!the!monograph.!!The!development!of!monographs!was!placed!in!the!
hands!of!OTC!Drug!Review!panels!that!were!established!to!evaluate!the!safety!and!
effectiveness!of!OTC!drug!products!marketed!in!the!United!States!before!May!11,!
1972!(U.S.!Food!and!Drug!Administration,!2013d).!!Members!of!each!panel!reviewed!
all!the!data!presented!to!support!the!safety!and!efficacy!of!different!active!
ingredients!in!a!particular!therapeutic!class!of!drugs.!!The!panels!then!developed!
monographs,!which!are!a!set!of!rules!or!standards!governing!the!active!ingredients!
and!labeling!within!each!therapeutic!class,!instead!of!individual!drugs.!!Establishing!
a!monograph!requires!a!three^phase!public!rulemaking!process,!as!described!
further!below.!
2.5.2.1. Advanced)Notice)of)Proposed)Rulemaking)(ANPR) )
! In!the!first!phase,!an!advisory!panel!meets!to!determine!whether!or!not!the!
active!ingredients!in!an!OTC!therapeutic!class!of!drugs!could!be!generally!
recognized!as!safe!and!effective!for!use!in!self^treatment.!!The!panel!classifies!the!
! 54!
ingredients!under!review!into!three!categories,!as!listed!below.!!Their!findings!are!
published!in!the!Federal!Register!as!what!is!known!as!an!“advanced!notice!of!
proposed!rulemaking!(ANPR)”.!
• Category!I:!generally!recognized!as!safe!and!effective!for!the!claimed!
therapeutic!indication;!
• Category!II:!not!generally!recognized!as!safe!and!effective!or!unacceptable!
indications;!
• Category!III:!insufficient!data!available!to!permit!final!classification!(U.S.!
Food!and!Drug!Administration,!2013d)!
2.5.2.2. Tentative)Final)Monograph)(TFM))
! After!a!period!of!time!is!allotted!for!public!comments!in!response!to!the!
ANPR,!the!panel!reviews!the!ingredients!in!each!class!of!drugs,!taking!into!account!
the!comments!from!the!public!and!any!new!data!that!becomes!available.!!They!then!
publish!their!findings!in!the!form!of!a!tentative!final!monograph!(TFM).!
2.5.2.3. Final)Monograph)(FM))
! After!another!period!of!time!for!public!comments,!the!panel!publishes!final!
regulations!in!the!form!of!a!monograph.!!Final!monographs!identify!safe!levels!of!
potency!and!combinations!of!active!ingredients!within!an!OTC!therapeutic!category.!!
They!also!specify!the!labeling!and!any!other!general!requirements.!!An!OTC!drug!
product!complying!with!these!standards!is!considered!to!be!“generally!recognized!
! 55!
as!safe!and!effective”!(GRASE)!and!not!misbranded!(U.S.!Food!and!Drug!
Administration,!2013d).!!Such!products!do!not!need!to!be!pre^reviewed!by!the!FDA!
prior!to!marketing.!
2.5.3. Differences)between)NDA)Approval)and)OTC)Drug)Monograph)Processes )
! The!submission!of!regulatory!drug!applications!is!daunting!for!
manufacturers,!not!only!because!of!the!complexity!and!risk!of!the!product!
development,!but!also!because!of!the!increasing!cost!of!the!submission!process.!!The!
application!or!user!fee!for!new!drug!applications!requiring!clinical!data!is!
$2,374,200!USD!for!fiscal!year!(FY)!2016.!!In!FY!2015,!that!same!application!fee!was!
$2,335,200.00!USD.!!For!new!drug!applications!not!requiring!clinical!data!or!
supplemental!applications,!the!cost!is!$1,187,100.00!USD!in!FY!2016,!compared!to!
$1,167,600.00!USD!in!FY!2015!(79!Fed.!Reg.!44807;!80!Fed.!Reg.!46028).!!These!
costs!are!perhaps!justifiable!for!a!new!blockbuster!drug!that!has!patent!protection!
for!several!years,!because!the!drug!can!be!sold!at!a!premium!to!recoup!the!
development!and!submission!costs.!!However,!cosmeceuticals!are!typically!not!
protected!by!patents!and!are!price^sensitive.!!Cosmeceutical!pricing!depends!on!the!
relatively!short!product!development!cycles,!the!absence!of!an!expensive!pre^
market!approval!system!and!the!relatively!inexpensive!manufacturing!costs!when!
compared!to!their!pharmaceutical!counterparts.!!The!financial!investment!that!is!
required!for!a!NDA!process!will!not!typically!be!recovered!because!of!the!relatively!
lower!sales!price!for!this!product!category.!!!!!
! 56!
! The!OTC!route!has!many!advantages!compared!to!a!NDA!route!for!products!
whose!risks!are!relatively!low!and!whose!prices!are!also!affordable!for!most!
consumers!(Table!6).!!Following!a!monograph!is!relatively!straightforward.!!The!
regulatory!requirements!related!to!marketing!are!the!registration!of!the!drug!
manufacturing!establishment!and!listing!of!the!drug!products.!!The!fees!associated!
with!these!simple!steps!are!minimal.!
Table)6:)Differences:)NDA)Approval)and)OTC)Drug)Monograph)Processes )
!
!
Source:!Small!Business!Assistance,!Center!for!Drug!Evaluation!and!Research!(U.S.!
Food!and!Drug!Administration,!2013b)!
!
! 57!
! However,!the!OTC!monograph!process!also!has!its!challenges.!!Although!the!
OTC!Drug!Review!panels!were!initiated!in!1972,!there!remain!several!monographs!
that!have!not!yet!been!finalized.!!Until!they!are!complete,!FDA!has!suggested!to!
industry!that!they!should!follow!the!tentative!final!monographs!but!they!are!not!
required!to!do!so.!!Reciprocally,!the!agency!will!exercise!“enforcement!discretion”,!
which!means!that!they!will!not!prosecute!companies!that!deviate!from!the!
monograph!unless!safety!issues!are!presented.!!This!instruction!appears!to!have!
created!an!uneven!playing!field!amongst!different!OTC!drug!companies.!!Ramsey!
(2013)!found!that!a!subset!of!companies!seem!to!accept!and!even!appreciate!the!
benefits!derived!from!incomplete!monographs,!which!permit!them!additional!
latitude!to!deviate!from!the!monograph!in!their!use!of!active!ingredients!or!product!
labeling.!!Other!companies,!however,!are!unwilling!to!deviate!so!greatly!and!would!
prefer!that!the!monographs!be!finalized.!!Because!many!monographs!deal!with!
products!that!could!be!loosely!considered!as!cosmeceuticals,!it!seems!safe!to!assume!
that!cosmeceutical!companies!specifically!have!to!make!decisions!about!whether!to!
adhere!to!the!tentative!final!monographs!or!take!advantage!of!the!flexibility!
currently!available!under!the!enforcement!discretion!policy.!!However,!it!is!unlikely!
that!this!permissive!approach!will!continue!for!much!longer!because!in!March!2014,!
the!FDA!held!a!public!hearing!to!obtain!feedback!on!the!strengths!and!weaknesses!
of!the!current!OTC!monograph!process,!and!to!discuss!ideas!about!modifications!or!
alternatives!in!the!future!(FDA$ A$OverAtheACounter$Drug$Monograph$System$Past,$
Present$and$Future$A$Public$Hearing$2014).!
! 58!
2.5.4. Summary)of)Current)Models)for)Regulating)Cosmeceuti cals)in)the)U.S.)
! In!summary,!there!are!three!established!regulatory!models!for!regulating!
cosmeceuticals!in!the!U.S.,!as!depicted!in!Figure!3.!!Each!of!these!models!has!
regulatory!advantages!and!disadvantages!in!terms!of!complexity/ease!of!the!FDA!
approval!process,!cost!and!time.!!!
Figure)3:)Current)Models)for)Regulating)Cosmeceuticals)in)the)U.S. )
!
!
!
! All!of!the!models!that!directly!impact!cosmeceutical!regulations!in!the!U.S.!
have!been!examined,!but!not!all!constituencies!use!this!type!of!regulatory!structure.!!!
It!would!be!useful!to!explore!different!regulatory!approaches!used!in!the!U.S.!and!
other!constituencies!to!regulate!different!types!of!products,!in!order!to!determine!
what!benefits!they!may!provide!regulators!when!developing!cosmeceutical!
regulatory!policy.!
! 59!
2.6. Alternative)Models)to)Inform)Cosmeceutical)Regulation )
! If!current!regulations!in!the!U.S.!appear!to!not!meet!the!needs!of!
cosmeceuticals!whose!existence!could!not!have!been!foreseen!when!the!FD&C!Act!
was!written,!it!may!be!important!to!explore!how!the!statutes!and!regulations!might!
be!altered,!in!order!to!achieve!a!more!satisfactory!approach!to!their!approval!and!
oversight.!!Two!approaches!were!used!to!identify!other!models!that!might!inform!
such!change.!!First,!dietary!supplement!regulations!developed!in!the!U.S.!in!the!early!
1990s!may!suggest!alternative!ways!to!regulate!lower^risk!cosmeceuticals!that!are!
the!subject!of!this!dissertation.!!Second,!regulatory!approaches!used!by!other!
countries!for!cosmetics!and!cosmetic^drugs!may!also!provide!illustrative!examples!
of!alternatives!that!might!be!considered.!
2.6.1. Dietary)Supplement)Regulations)in)the)United)States )
! At!first!glance,!dietary!supplements!should!not!be!the!subject!of!
cosmeceutical!regulatory!policy.!!However,!many!similarities!exist!between!the!
dietary!supplement!and!cosmetic!industries.!!Like!cosmetics,!dietary!supplements!
have!a!long!history!of!relatively!safe!use!in!the!United!States.!!Also,!like!the!evolution!
of!cosmeceuticals!in!the!cosmetic!market!segment,!today!most!consumers!recognize!
additional!categories!of!foods,!including!“functional!foods”!and!“nutraceuticals”,!
which!provide!more!health^related!benefits!than!conventional!foods!(Burdock,!
Carabin,!&!Griffiths,!2006).!!!
! 60!
! Dietary!supplements!comprise!a!large!and!growing!business.!!According!to!
the!Passport/Global!Market!Information!Database!(GMID)!by!Euromonitor,!sales!of!
Vitamins!and!Dietary!Supplements!(aggregating!Dietary!Supplements,!Vitamins,!
Pediatric!Vitamins!and!Dietary!Supplements,!and!Tonics!and!Bottled!Nutritive!
Drinks!categories)!have!increased!incrementally!from!U.S.!$16.8!billion!in!2007!to!
$22.9!billion!in!2012!as!shown!in!Table!7.!
Table)7:)Market)Size)of)Vitamins)and)Dietary)Supplements)in)the)U.S. )
!
!
Source:!©Euromonitor!International!(2014)!
!
! Similar!to!the!cosmetic!industry,!the!dietary!supplement!industry!has!a!range!
of!stakeholders!with!different!views!on!the!proper!oversight!of!such!products,!some!
of!whom!are!active!in!promoting!their!own!interests.!!Consumers!demand!greater!
access!to!products!for!which!they!see!added!health!benefits,!while!industry!often!
“pushes!the!envelope”!with!respect!to!product!claims!to!satisfy!that!demand.!!This!
poses!problems!for!regulators!who!are!mandated!by!law!to!facilitate!consumer!
access!to!dietary!supplements!and!also!to!protect!them!from!unsafe!products!and!
fraud!stemming!from!false!claims!(Levitt,!2002).!!This!can!lead!to!a!power!struggle,!
as!suggested!by!Figure!4!(Burdock!et!al.,!2006).!!As!a!way!to!find!a!middle!ground,!
! 61!
Congress!passed!a!new!law!that!gave!dietary!supplements!a!different!classification!
and!a!modified!set!of!rules!for!marketing!purposes.!
Figure)4:)The)Struggle:)Players)and)I ssues)
!
!
Source:!G.A.!Burdock!et!al.!/!Toxicology!221!(2006)!
2.6.1.1. Dietary)Supplement)Health)and)Edu cation)Act)of)1994)(DSHEA) )
! An!overview!of!the!regulations!for!dietary!supplements!is!instructive.!!Prior!
to!1994,!dietary!supplements!were!subject!to!the!same!regulations!as!foods.!!
However,!the!Dietary!Supplement!Health!and!Education!Act!(DSHEA)!amended!the!
FD&C!Act!to!create!a!new!regulatory!framework!that!assigned!dual!responsibilities!
to!the!suppliers!and!regulators!respectively:!
1.! Manufacturers!of!dietary!supplements!or!dietary!ingredients!were!
responsible!to!ensure!that!their!products!were!safe!before!being!marketed.!
2.! FDA!was!responsible!for!taking!action!against!any!unsafe!dietary!
supplement!product!after!it!reached!the!market!(Pub.!L.!103–417,!1994).!!
! 62!
! According!to!DSHEA,!dietary!supplements!are!products!intended!to!
supplement!the!diet!that!are!not!represented!for!use!as!a!conventional!food!or!as!the!
sole!item!of!a!meal!or!diet,!and!are!labeled!accordingly.!!They!may!contain!vitamins,!
minerals,!amino!acids,!extracts,!botanicals!or!other!constituents!as!dietary!
ingredients!(21!U.S.C.!§!321(ff),!2010).!!!
! FDA!attempted!to!base!its!decision^making!regarding!these!products!on!two!
activities;!1)!processes!for!prioritizing,!evaluating,!and!describing!available!
information!to!establish!risk!of!harm,!and!2)!evaluations!according!to!a!set!of!
science^based!principles!that!serve!as!guidelines!for!evaluating!risk!to!human!health!
(Committee!on!the!Framework!for!Evaluating!the!Safety!of!the!Dietary!Supplements,!
2005).!!As!part!of!these!new!regulations,!dietary!supplement!ingredients!that!were!
already!marketed!and!showed!a!history!of!safe!use!did!not!need!to!submit!further!
documentation!or!approval!dossiers!at!the!time!the!legislation!was!passed.!!
However,!manufacturers!and!distributors!of!“new”!dietary!ingredients,!defined!as!
ingredients!that!were!not!marketed!in!the!United!States!before!October!15,!1994!
(21!U.S.C.!§!350b(d),!2011),!were!required!to!submit!a!New!Dietary!Ingredient!(NDI)!
notification!to!the!FDA!at!least!75!days!before!introducing!the!new!ingredient!into!
interstate!commerce!(62!Fed.!Reg.!49886;!21!C.F.R.!§190.6).!!Although!DSHEA!did!
not!specify!the!type!or!amount!of!evidence!to!be!presented,!the!notification!was!
required!to!contain!information!on!which!the!sponsor!based!its!decision!that!a!
dietary!supplement!containing!the!new!dietary!ingredient!would!reasonably!be!
expected!to!be!safe.!!For!90!days!following!receipt,!the!FDA!was!required!to!keep!
! 63!
this!information!confidential!during!their!review.!!After!90!days,!if!the!FDA!had!no!
objections!to!the!notification,!the!non^proprietary!information!contained!in!the!
notification!would!be!placed!on!public!display.!!In!principle,!this!approach!greatly!
shortened!the!path!that!would!otherwise!be!required!if!a!dietary!supplement!
containing!a!new!dietary!ingredient!were!to!be!treated!as!a!new!drug.!!In!practice,!
however,!after!receiving!many!deficient!NDI!notifications!and!fielding!questions!
from!industry,!the!FDA!realized!that!the!process!for!notification!and!approval!was!
relatively!opaque!(U.S.!Food!and!Drug!Administration,!2011a).!!Further!legislation!
to!ensure!more!transparency!in!the!process!was!thus!developed.!!
2.6.1.2. New)Dietary)Ingredient)(NDI))Notification)Process )
! On!January!4,!2011,!President!Barack!Obama!signed!into!law!the!Food!Safety!
Modernization!Act!(FSMA).!!Section!113(b)!of!FSMA!required!the!FDA!to!publish!
guidance!to!clarify,!1)!when!a!dietary!supplement!ingredient!would!be!considered!to!
be!a!NDI,!2)!when!the!manufacturer!or!distributor!of!a!dietary!ingredient!or!dietary!
supplement!should!submit!a!NDI!notification!to!the!FDA!under!section!413(a)(2)!of!
the!FD&C!Act,!3)!what!level!of!evidence!would!be!needed!to!document!the!safety!of!a!
NDI,!and!4)!what!would!be!the!appropriate!methods!for!establishing!the!identity!of!
a!NDI!(U.S.!Food!and!Drug!Administration,!2011a).!
! On!July!5,!2011,!the!FDA!published!the!“Draft!Guidance!for!Industry:!Dietary!
Supplements:!New!Dietary!Ingredient!Notifications!and!Related!Issues”.!!The!
guidance!answered!frequently!asked!questions!about!NDI!notifications!and!related!
! 64!
issues.!!It!also!recommended!“best!practices”!for!preparing!better!NDI!notifications!
so!that!the!agency!would!be!able!to!review!them!more!efficiently.!!Table!8!illustrates!
when!a!NDI!notification!is!required!and!whether!the!supplement!is!governed!by!the!
NDI!adulteration!standard.!!The!FDA!also!created!a!decision!tree!for!when!an!NDI!
notification!should!be!submitted,!which!can!be!found!in!Appendix!A.!
Table)8:)NDI)Definition,)Requirement)for)Notification)and)Applicability)of)
Adulteration)Standard)
!
Source:!FDA.gov!(2011a)!
!
! When!the!decision!is!made!to!submit!a!NDI!notification,!a!dossier!is!
developed!that!is!expected!to!contain!the!name!of!the!NDI,!a!description!of!the!
dietary!supplement!containing!the!NDI,!recommended!conditions!of!use,!evidence!of!
! 65!
safety,!and!the!person(s)!responsible!for!submitting!the!application!(62!Fed.!Reg.!
49886;!21!C.F.R.!§190.6).!!
2.6.1.3. Advantages)and)Disadvantages)of)the)NDI)Notification)Process )
! The!abbreviated!approach!to!the!regulation!of!dietary!supplements!has!
several!advantages.!!First,!it!ensures!that!new!dietary!ingredients!have!undergone!
some!type!of!FDA!review!for!safety.!!It!“grandfathers”!ingredients!with!a!
documented!history!of!safe!use!in!the!United!States.!!As!a!result,!consumers!have!
some!assurance!that!the!dietary!ingredient!is!expected!to!be!relatively!safe.!!
! Second,!it!facilitates!advances!in!research!and!technology!in!a!way!that!
minimizes!regulatory!cost!and!maximizes!efficiency.!!The!current!dietary!
supplement!NDI!notification!process!is!free!and!the!FDA!is!required!to!come!to!a!
decision!within!75!days.!!!
! Third,!it!encourages!transparency!between!regulators!and!the!dietary!
supplement!industry!due!to!the!fact!that!all!of!the!non^proprietary!information!
contained!in!a!notification!is!placed!on!public!display!after!the!notification!period!
has!elapsed.!!The!information!is!shared!among!industry,!so!that!further!
development!can!take!place.!!
! Last,!it!levels!the!playing!field!for!all!manufacturers!and!distributors.!!If!
everyone!is!playing!by!the!same!rules!regarding!the!introduction!of!new!dietary!
ingredients,!then!smaller!companies!have!as!much!chance!for!success!as!larger!
companies!with!deeper!pockets!and!higher!profit!margins.!!This!aspect!of!the!
! 66!
regulation!is!important,!because!new!regulatory!requirements!are!often!
accompanied!by!economies!of!scale,!which!make!it!harder!for!smaller!firms!to!
compete!successfully!(Quirk,!1980).!
! The!DSHEA/NDIN!model!could!have!advantages!for!the!cosmetic!industry.!!
Further,!it!might!be!relatively!simple!to!implement!administratively!because!both!
cosmetics!and!dietary!supplement!products!are!under!the!oversight!of!the!same!
Center!of!the!FDA,!the!Center!for!Food!Safety!and!Applied!Nutrition!(CFSAN).!!The!
main!challenge!to!the!NDIN!process!is!that!it!is!only!effective!if!it!is!being!utilized.!!
According!to!the!FDA,!there!are!an!estimated!55,600!dietary!supplement!products!
on!the!market.!!However,!the!FDA!has!only!received!approximately!700!NDI!
notifications!since!they!began!reviewing!NDI!notifications!approximately!16!years!
ago.!!Additionally,!the!Institute!of!Medicine!has!estimated!that!1,000!new!dietary!
supplements!are!introduced!to!the!market!each!year!(U.S.!Food!and!Drug!
Administration,!2011a).!
2.6.1.4. Permitted)Claims)for)Dietary)Supplements )
! Dietary!supplement!regulations!also!permit!manufacturers!and!distributors!
to!make!three!types!of!claims!for!their!dietary!supplement!products;!1)!
structure/function!claims,!2)!nutrient!content!claims,!and!3)!health!claims.!!
Structure/function!claims!describe!the!intended!benefits!of!using!a!dietary!
supplement!product.!!Nutrient!content!claims!describe!the!amount!of!a!nutrient!
contained!in!a!dietary!supplement,!using!terms!such!as!“free”,!“high”,!and!“low”,!or!
! 67!
how!it!compares!the!level!of!a!nutrient!contained!in!another!dietary!supplement,!
using!terms!such!as!“more”,!“reduced”,!and!“lite”.!!Health!claims!describe!the!link!
between!a!dietary!supplement!and!its!ability!to!reduce!the!risk!of!a!disease!or!
health^related!condition.!!The!responsibility!for!ensuring!the!validity!of!these!claims!
rests!with!the!manufacturer!or!distributor!of!the!dietary!supplement,!but!can!be!
challenged!by!the!FDA,!or,!in!the!case!of!advertising,!with!the!FTC!(U.S.!Food!and!
Drug!Administration,!2003).!!Of!the!three,!health!claims!have!been!the!hardest!for!
industry!to!prove!to!the!FDA!and!it!was!very!difficult!obtain!permission!without!an!
exhaustive!dossier!of!evidence.!!However,!more!recent!judicial!decisions!have!led!to!
a!broadening!of!permissions!for!claims!language.!!The!Food!and!Drug!
Administration!Modernization!Act!of!1997!(FDAMA)!permits!certain!health!claims!
to!be!made!based!on!an!"authoritative!statement"!from!a!reputable!medical!or!
scientific!body.!!Also,!the!FDA's!2003!Consumer!Health!Information!for!Better!
Nutrition!Initiative!allows!for!the!use!of!“qualified!health!claims”,!which!shows!the!
relationship!between!a!dietary!supplement!and!the!reduced!risk!of!a!disease!or!
health^related!condition.!!In!this!instance,!scientific!evidence!by!a!reputable!body!is!
neither!available!nor!well!established.!!Therefore,!qualifying!language!is!included!as!
part!of!the!claim!(U.S.!Food!and!Drug!Administration,!2003).!
2.6.1.5. Summary)of)Dietary)Supplement)Regulations)in)the)U.S. )
! Dietary!supplement!regulations!provide!one!alternative!model!by!which!low!
risk!products!with!pharmacological!actions!might!be!regulated.!!Regulations!of!
! 68!
cosmetics!and!cosmeceuticals!in!other!countries!also!provide!additional!
alternatives.!!The!review!below!examines!the!regulatory!frameworks!in!three!
constituencies;!Europe,!Canada!and!Japan.!!These!constituencies!were!chosen!for!
two!main!reasons.!!First,!they!are!all!voluntary!members!of!the!International!
Cooperation!on!Cosmetics!Regulation!(ICCR).!!The!ICCR!is!comprised!of!regulatory!
authorities!from!each!country!and!their!focus!is!on!consumer!protection!and!
minimizing!barriers!to!international!trade!(Health!Canada,!2014).!!Second,!the!
regulations!for!cosmetics!and!cosmetic^drugs!in!these!countries!are!more!developed!
and!mature!than!countries!with!emerging!economies.!!In!less!developed!markets,!
the!regulations!may!either!be!absent!or!only!in!the!early!stages!of!development,!and!
regulators!may!lack!the!depth!of!experience!necessary!to!evaluate!policy!options.!
2.6.2. The)Cosmetics)Regulation)in)Europe)
! Europe,!like!the!U.S.,!defines!a!cosmetic!product!as,!“any!substance!or!
mixture!intended!for!use!on!the!body!for!purposes!of!cleansing,!beautifying!or!
perfuming”!(European!Parliament,!2009).!!Drugs!or!medicinal!products!are!defined!
as,!“any!substance!or!combination!of!substances!presented!as!having!properties!for!
treating!or!preventing!disease!in!human!beings”!(European!Parliament,!2001).!!This!
differentiation!is!similar!to!that!used!in!the!U.S.,!where!the!claims!of!the!product!
determine!whether!or!not!a!substance!is!classified!as!a!drug.!!However,!unlike!the!
U.S.,!there!are!no!over^the^counter!drugs.!!Products!like!sunscreens!and!toothpastes!
are!treated!as!cosmetics!in!the!EU.!!!
! 69!
! The!European!approach!to!regulating!cosmetics!is!different!from!that!of!the!
U.S.!!The!main!regulatory!framework!for!finished!cosmetic!products!in!Europe!was!
established!in!Council!Directive!76/768/EEC.!!Amended!seven!times!since!its!first!
iteration,!the!most!recent!recast!resulted!in!regulations!promulgated!in!November!
of!2009,!which!became!fully!enforceable!on!July!11,!2013.!!The!goal!of!this!new!
regulation!was!to!harmonize!the!rules!among!all!Member!States!and!strengthen!the!
safety!requirements!for!cosmetic!products,!while!taking!into!consideration!the!latest!
technological!developments.!
2.6.2.1. Notification)of)Cosmetic)Products)
! Cosmetics!must!undergo!a!compulsory!notification!procedure!with!
regulatory!authorities!in!the!EU.!!In!this!regard,!the!EU!process!resembles!the!
registration!and!listing!requirements!for!drugs!in!the!U.S.!!It!requires!the!
“responsible!person”,!a!person!or!business!entity!designated!by!the!manufacturer!or!
distributor,!to!submit!establishment!and!product!listing!information!through!the!
centralized!Cosmetic!Products!Notification!Portal!(CPNP).!!This!online!system!was!
specifically!created!for!the!implementation!of!Regulation!(EC)!No!1223/2009,!and!
provides!cosmetic!product!information!to!the!Competent!Authorities!of!all!member!
states!for!purposes!of!market!surveillance,!analysis!and!consumer!information.!!
! Article!13!of!the!Regulation!also!requires!the!submitted!information!to!
include!the!country!of!origin!of!the!product!in!the!case!of!imports,!and!the!Member!
States!in!which!the!product!will!be!marketed.!!It!further!requires!certain!significant!
! 70!
pieces!of!information!about!the!product!itself:!the!use!of!nanomaterials!in!the!
formulation,!a!copy!of!the!labeling,!and!even!the!“frame!formulation”!of!the!product,!
which!lists!the!category!or!function!of!ingredients!and!their!maximum!concentration!
in!the!cosmetic!product,!allowing!for!prompt!and!appropriate!medical!treatment!in!
the!event!of!difficulties!(European!Parliament,!2009).!!Thus,!the!EU!requires!much!
more!information!about!their!marketed!cosmetics!than!the!U.S.!!In!part,!this!may!
relate!to!the!added!challenge!of!ensuring!that!information!about!marketed!products!
is!shared!amongst!several!member!states!via!the!CPNP.!!
2.6.2.2. Cosmetic)Product)Safety)Report)(CPSR))
! The!new!Cosmetic!Regulation!also!requires!that!companies!create!a!Cosmetic!
Product!Safety!Report!(CPSR).!!It!is!divided!into!two!sections.!!Part!A!focuses!on!
gathering!the!data!necessary!to!identify!and!quantify!the!risks!that!a!cosmetic!
product!may!present!to!human!health.!!These!include!but!are!not!limited!to!the!
product!composition,!microbiological!quality,!and!physical/chemical!characteristics!
and!stability.!!Part!B!is!the!safety!assessment!leading!to!a!conclusion!about!the!
safety!of!the!cosmetic!product!conducted!by!a!qualified!EU!Safety!Assessor.!!The!
CPSR!forms!the!basis!of!the!Product!Information!File!(PIF).!!From!it,!one!can!easily!
derive!or!draw!conclusions!regarding!the!safety!of!a!cosmetic!product.!
! 71!
2.6.2.3. Product)Information)File)(PIF))
! The!Product!Information!File!(PIF)!is!the!most!vital!and!informative!report!
with!respect!to!any!cosmetic!product!being!placed!on!the!European!market.!!It!
houses!all!of!the!quality,!efficacy!and!safety!information!for!cosmetics!and!cosmetic!
ingredients!manufactured!in!or!imported!into!the!EU.!!Article!11!of!the!Cosmetics!
Regulation!requires!the!responsible!person!to!keep!the!PIF!on!file!for!10!years!from!
the!date!the!last!batch!of!cosmetic!products!is!placed!on!the!market.!!He!or!she!must!
make!the!PIF!readily!available!at!the!address!indicated!on!the!product!label!to!the!
competent!authority!of!the!Member!State!in!which!the!PIF!is!kept!(European!
Parliament,!2009).!
! Figure!5!summarizes!the!information!that!must!be!included!in!the!PIF.!!The!
items!listed!in!blue!are!new!requirements!from!the!Cosmetics!Regulation.!The!items!
in!black!were!carried!over!from!the!previous!Directive.!
! 72!
Figure)5:)Product)Information)File)(PIF))Summary )
!
Source:!COLIPA!Guidelines!on!the!Product!Information!File!(P.I.F.)!Requirement!
(2011)!
2.6.2.4. Communication)of)Serious)Undesirable)Effects )
! In!Europe,!it!is!mandatory!to!report!serious!undesirable!effects!in!cosmetic!
products,!which!result!in!temporary!or!permanent!functional!incapacity,!
hospitalization!or!death,!to!the!competent!authority!of!the!Member!State!where!the!
serious!undesirable!effect!occurred.!!This!information!must!include!the!nature!of!the!
effect,!the!affected!product!and!any!corrective!action!taken.!!This!system!is!different!
from!the!U.S.!in!that!adverse!event!reporting!is!only!required!for!drugs,!biologics,!
medical!devices!and!dietary!supplements.!
! 73!
2.6.3. Natural)Health)Product)Regulations)in)Canada )
! Like!the!United!States,!Canada!views!a!cosmetic!as!any!substance!used!to!
clean,!improve!or!alter!the!appearance!of!skin,!hair,!nails!or!teeth.!!There!is!a!
published!list!of!prohibited!and!restricted!cosmetic!ingredients,!more!
comprehensive!than!the!U.S.!!Manufacturers!and!importers!of!cosmetic!products!
must!notify!the!Minister!no!later!than!10!days!after!placing!the!product!on!the!
market!(Government!of!Canada,!2013).!!The!required!content!of!the!notification!is!
similar!to!the!EU;!however,!Canada!does!not!currently!utilize!an!electronic!
notification!system.!!Failure!to!notify!a!cosmetic!product!may!result!in!that!product!
being!refused!entry!into!Canada!or!removed!from!sale.!
! As!in!the!U.S.,!drugs!in!Canada!are!indicated!for!the!diagnosis!and!treatment!
of!disease.!!However,!based!on!the!definitions!of!cosmetics!and!drugs,!Canada!
acknowledges!the!existence!of!products!at!the!cosmetic^drug!interface!(PCDI),!
which!they!define!as,!
a!subset!of!personal!care!products,!which!are!not!easily!distinguished!as!
either!a!drug!or!cosmetic,!as!defined!in!the!Food!and!Drugs!Act!(Health!
Canada,!2008).!!!
Such!products!include!for!example,!acne!medications,!anti^perspirants,!anti^
dandruff!shampoos,!sunburn!protectants!and!fluoride^containing!anti^caries!
products.!!These!examples!would!be!classified!as!OTC!drugs!in!the!U.S.!!However,!
Canada!recognizes!a!third!category!of!product!called!Natural!Health!Products!
(NHPs).!!They!are!considered!as!a!subset!of!drugs,!which!treat!disease!or!modify!
! 74!
bodily!functions!in!a!manner!that!maintains!or!promotes!health.!!NHPs!can!be!
traditional!or!homeopathic!medicines!and!are!regulated!under!a!unique!set!of!
regulations,!called!the!Natural!Health!Products!Regulations,!which!came!into!force!
in!2004!(Health!Canada,!2008).!!The!regulation!aimed!to!protect!the!health!of!
consumers,!respect!their!access!to!products!and!guarantee!product!safety!and!
quality!(Joseph!Volpe,!1998).!
! In!their!November!2012!guidance!document,!“The!approach!to!natural!health!
products”,!the!Natural!Health!Product!Directorate!(NHPD)!outlined!a!three^class!
system!for!NHPs!based!on!their!known!risks!and!benefits,!as!shown!in!Table!9.!!This!
information!was!collected!from!over!70,000!NHPs!already!authorized!on!the!market!
(Health!Canada,!2012).!!A!monograph!system!was!introduced!for!the!least!risk!Class!
I!and!II!products.!
!
! 75!
Table)9:)Three[Tiered)Class)System)for)Natural)Health)Products )
!
Source:!Guidance!Document:!The!Approach!to!Natural!Health!Products!(2012)!
!
! Class!I!products!have!the!highest!level!of!certainty!of!the!three,!and!are!
subject!to!the!shortest!review!time!as!depicted!in!Figure!6.!!As!part!of!the!ongoing!
process!to!improve!efficiency,!the!NHPD!continues!to!update!and!expand!the!
monographs!for!Class!I!and!II,!which!will!allow!for!more!resources!to!be!reallocated!
to!the!timely!review!of!Class!III!products.!!
! 76!
Figure)6:)Review)Targets)for)Natural)Healt h)Products)
!
Source:!Guidance!Document:!The!Approach!to!Natural!Health!Products!(2012)!
2.6.4. The)Quasi[drug)System)in)Japan)
! Japanese!regulations!concerning!the!safety!of!cosmetics!and!cosmetic!
ingredients!are!the!strictest!of!the!three!ICCR!countries.!!In!the!past,!cosmetic!
registration!was!a!lengthy!and!complicated!process!in!Japan.!!However,!with!the!
revision!of!the!Pharmaceutical!Affairs!Act,!which!went!into!effect!as!of!June!1,!2009,!
cosmetics!notification!to!the!Ministry!of!Health,!Labor!and!Welfare!(MHLW)!is!
required!prior!to!manufacturing!or!importation!(Japan!External!Trade!Organization!
(JETRO),!2011).!!The!Japanese!Standards!for!Cosmetics!(Ministry!of!Health!and!
Welfare!Notification!No.331!of!2000)!provides!cosmetic!manufacturers!and!
distributors!with!positive!and!negative!ingredient!restrictions!for!cosmetics.!
! Similar!to!the!U.S.,!drugs!are!defined!as,!
1)!articles!recognized!in!the!official!Japanese!pharmacopoeia;!2)!articles!
(other!than!quasi!drugs)!that!are!intended!for!use!in!the!diagnosis,!cure,!or!
prevention!of!disease!in!humans!or!animals,!and!that!are!not!equipment!or!
! 77!
instruments!(including!dental!materials,!medical!supplies!and!sanitary!
materials);!and!3)!articles!(other!than!quasi!drugs!and!cosmetics)!that!are!
intended!to!affect!the!structure!or!any!function!of!the!body!of!humans!or!
animals,!and!that!are!not!equipments!or!instruments!(paragraph!1,!article!2!
of!the!law)!(Õba,!2000).!
! However,!Japan!has!a!sub^category!of!drugs,!known!as!quasi^drugs,!which!
are!defined!as,!!
articles!that!have!the!purposes!given!below!and!exert!mild!actions!on!the!
human!body,!or!similar!articles!designated!by!the!Minister!of!Health!and!
Welfare”!(Õba,!2000).!!!
Examples!of!quasi!drugs!include!hair!dyes,!agents!for!permanent!waving,!and!
products!that!prevent!acne,!and!disinfect!the!skin!and!mouth!(also!called!medicated!
cosmetics).!!Manufacturers!and!distributors!of!quasi^drugs!are!required!to!obtain!
approval!from!the!MHLW!prior!to!marketing.!!The!safety,!efficacy!and!stability!data!
submitted!for!approval!is!based!on!the!dose!level,!dosage!form!and!intended!
indication!or!effect!on!the!body!of!the!active!ingredient!and!not!the!quasi^drug!as!a!
whole.!!Figure!7!outlines!the!regulatory!approval!process!for!drugs,!quasi^drugs!and!
cosmetics!in!Japan.!
! 78!
Figure)7:)Classification)of)Examinations)for)the)Approval)of)Drugs,)Quas i[Drugs)
and)Cosmetics)
!
Source:!Ministry!of!Health,!Labour!and!Welfare!(2009)!
2.6.5. Summary)of)Alternative)Models)in)Other)Constituencies )
! The!regulatory!approaches!in!each!ICCR!country!provide!models!that!may!be!
helpful!in!reexamining!cosmeceutical!regulatory!policy!in!the!United!States.!!
Through!the!implementation!of!the!new!Cosmetics!Regulation,!Europe!increased!
market!efficiency!by!harmonizing!the!requirements!and!strengthening!safety!by!
tightening!in^market!controls.!!The!regulations!also!took!in!consideration!the!latest!
technological!developments!at!that!time,!when!sensitivity!was!heightened!to!the!
possible!effects!of!novel!products!such!as!nanomaterials.!!In!Canada,!the!Natural!
Health!Products!Regulations!were!created!to!provide!consumers!access!to!
therapeutic!products!that!were!not!only!safe,!but!also!of!high!quality.!!The!
regulations!were!similar!to!the!quasi^drug!requirements!in!Japan!and!took!into!
! 79!
account!the!unique!properties!of!these!products.!!Figure!8!outlines!the!regulatory!
frameworks!in!each!constituency!and!the!principles!that!were!identified!as!the!basis!
for!the!approach!in!developing!the!regulations.!
Figure)8:)Summary)of)Regulatory)Frameworks)in)Europe,)Canada)and)Ja pan)
!
2.7. Framing)the)Study)of)Cosmeceutical)Regulations)in)the)United)States )
! Although!countries!have!different!rules!to!govern!their!cosmetic!and!drug!
products,!they!develop!those!regulations!with!similar!aims!and!motivations.!!
Typically,!regulators!all!have!the!difficult!job!to!balance!consumer!access!to!desired!
! 80!
products!with!consumer!protection!from!risk.!!Thus,!when!judging!the!effectiveness!
of!a!regulation,!it!is!important!to!identify!why!the!regulation!was!developed!in!the!
first!place!and!to!use!this!as!a!framework!for!evaluating!its!success!or!failure.!!This!
study!aims!at!evaluating!whether!current!regulations!governing!cosmeceuticals!in!
the!U.S.!are!achieving!the!goals!by!which!regulations!should!be!judged,!or!whether!
other!models!have!different!attributes!that!might!better!accomplish!these!
objectives.!!To!do!this,!it!is!important!to!first!consider!what!the!aims!of!
cosmeceutical!regulation!should!be.!!
! Each!country!articulates!the!goals!of!medical!product!regulations!differently,!
though!there!are!many!commonalities!in!the!underlying!principles.!!In!the!U.S.,!the!
stated!goals!of!the!FDA!are!1)!to!ensure!the!safety,!efficacy!and!quality!of!all!FDA^
regulated!products,!2)!to!foster!innovation!to!make!medicines!effective,!safer!and!
more!affordable!and!3)!to!be!a!science^based!information!resource!to!consumers!
(U.S.!Food!and!Drug!Administration,!2013f).!!In!the!U.S.,!these!product!types!are!also!
governed!by!the!FTC,!which!aims!to!1)!protect!consumers!by!stopping!unfair,!
deceptive!or!fraudulent!practices!in!the!marketplace!and!2)!promote!competition!by!
enforcing!anti^trust!laws!(Federal!Trade!Commission,!2013).!!!
! In!comparison!to!the!U.S.!approach!to!regulation,!the!EU!model!is!similar!but!
has!more!granularity.!!The!EU!health!policy!objectives!for!pharmaceutical!products!
mandate!them!to!1)!protect!public!health,!2)!guarantee!patient!access!to!safe!and!
effective!medicines,!3)!improve!quality!of!care,!4)!minimize!expenditure,!5)!increase!
equity!and!efficiency!and!6)!meet!patient!need!(Mossialos,!Mrazek,!&!Walley,!2004).!!
! 81!
Unsurprisingly,!the!Canadian!goals!to!1)!protect!the!health!of!consumers!2)!respect!
consumers'!access!to!products!and!(3)!guarantee!product!safety!and!quality!(Joseph!
Volpe,!1998),!also!display!the!same!underlying!principles!as!the!U.S.!and!the!EU!.!!
! In!academic!literature,!these!goals!have!been!combined!to!try!to!capture!the!
intent!of!these!aims!into!a!small!number!of!elements!that!capture!their!essence.!!In!
Ramsey’s!study!on!the!Impact!of!Incomplete!Monographs!on!the!OTC!Drug!Industry,!
the!aims!were!condensed!into!a!triad!of!elements!that!she!argued!would!capture!the!
essential!objectives!of!OTC!drug!regulation!(Ramsey,!2013).!!Her!model!was!derived!
from!using!a!combination!of!the!FDA’s!and!FTC’s!mission!and!value!statements!and!
is!depicted!in!Figure!9.!
Figure)9:)The)Three)Objectives)of)Regulation )
!
Source:!The!Impact!of!Incomplete!Monographs!on!the!OTC!Drug!Industry:!A!Survey!
Investigation!of!Industry!Views!(Ramsey,!2013)!
!
! 82!
! In!Ramsey’s!model,!the!quality!aspect!in!the!first!FDA!mission!statement!is!
not!explicitly!stated.!!This!omission!is!not!troubling!because!quality!is!often!viewed!
as!an!important!aspect!of!safety.!!However,!for!the!purpose!of!clarity,!I!have!added!
quality!to!the!first!requirement!of!Ramsey’s!model.!!Also,!with!respect!to!the!FTC!
goal!of!equalizing!the!requirements!and!standards!of!industry,!her!aim!is!stated!
more!broadly!than!that!enunciated!by!the!FTC.!!Essentially,!when!the!agency!speaks!
about!preventing!unfair!business!and!competitive!practices,!the!motivation!behind!
it!is!consumer!protection.!!However,!by!suing!companies!and!individuals!that!violate!
the!law,!indirectly!it!helps!to!ensure!that!everyone!in!the!marketplace!is!playing!by!
the!same!rules,!thereby!leveling!the!playing!field.!!Thus,!Ramsey’s!focus!on!the!
enunciated!goals!of!the!U.S.!regulators!makes!this!an!attractive!model!on!which!to!
base!this!survey!of!industry!informants.!!Further,!it!appears!to!cover!the!more!
numerous!elements!of!the!EU!aims,!with!the!exception!of!improving!quality!of!
patient!care,!which!is!at!least!in!part!reliant!on!the!doctor^patient!relationship!and!
the!conduct!of!healthcare!facilities,!and!it!goes!beyond!the!scope!of!this!work.!!!
! Additionally,!the!Ramsey!model!is!not!dissimilar!to!Reddington’s!(2009)!
four^component!framework!which!includes!1)!economics!and!access,!2)!patient!
relief,!3)!rules!for!participation!and!4)!congressional!action.!!This!latter!model!was!
used!for!a!somewhat!different!purpose,!to!examine!proposed!Congressional!reforms!
to!the!Orphan!Drug!Act!(ODA)!in!the!1990s!(Reddington,!2009).!!However,!as!argued!
by!Ramsey,!each!component!of!Reddington’s!framework!covers!essentially!the!same!
goals!as!shown!in!Table!10.!!Even!though!the!Ramsey!model!is!more!simplified,!it!
! 83!
still!encompasses!all!of!Reddington’s!required!elements!for!securing!regulatory!
objectives.!!Therefore,!it!is!a!reasonable!model!of!aims!that!can!be!used!to!judge!the!
impact!of!cosmeceutical!regulations!on!the!cosmetic!industry.!!
Table)10:)A)Side[by[Side)Comparison)of)the)Ramsey)and)Reddington)Regulatory)
Frameworks)
!
!
2.8. Summary)and)Research)Direction)
! Inspection!of!the!literature!thus!far!reveals!a!paucity!of!literature!regarding!
the!current!views!of!the!cosmetic!industry!with!regard!to!the!regulation!of!
cosmeceuticals!in!the!United!States.!!As!a!first!step!to!better!understanding!these!
! 84!
views,!I!conducted!a!survey!investigating!how!well!current!regulations!are!meeting!
the!stated!objectives!of!regulations!using!Ramsey’s!model!as!a!framework!for!that!
exploration.!!Further,!the!survey!explored!whether!industry!feels!that!the!rules!
should!be!changed!and!which!elements!of!other!models!might!assist!such!change.!!
Respondents!included!individuals!currently!or!previously!working!in!the!regulatory!
affairs,!legal!affairs,!product!development!and!marketing!functions!in!companies!
that!formulate,!manufacture!or!distribute!cosmetic!products!or!ingredients!
marketed!with!drug!claims.!!
! 85!
CHAPTER)3:)METHODOLOGY)
3.1. Survey)Development)
! This!exploratory!study!utilized!a!web^based!survey!platform!to!explore!the!
views!of!industry!professionals!concerning!the!impact!of!cosmeceutical!regulations!
on!the!cosmetic!industry.!!After!the!initial!draft!survey!was!completed,!a!six^person!
focus!group!representing!different!backgrounds!in!academia,!industry!and!
government!was!convened!to!review!and!provide!feedback!on!the!first!survey!draft.!!
Notable!participants!included!S.!Valerie!Ramsey,!whose!model!is!the!underlying!
framework!for!this!research,!and!an!FDA!staff!member!from!the!Southern!California!
area.!!The!draft!survey!was!emailed!to!all!participants!a!few!days!in!advance!of!the!
session,!which!was!conducted!on!March!15,!2014!at!the!Health!Sciences!Campus!of!
the!University!of!Southern!California.!!Those!who!were!based!in!Southern!California!
attended!in!person.!!However,!for!those!unable!to!attend!in!person,!the!focus!group!
was!also!streamed!via!WebEx.!!The!session!lasted!exactly!two!hours!and!two!
minutes,!during!which!the!participants!recommended!several!changes!that!are!
discussed!in!Chapter!4.!!
! Once!most!of!the!recommended!changes!were!reviewed!and!incorporated,!
the!final!draft!survey!was!completed!and!sent!to!five!random!respondents,!including!
myself,!in!order!to!assure!the!integrity!of!the!emailed!document.!!After!a!few!minor!
! 86!
changes,!the!final!survey!titled,!“The!Impact!of!Cosmeceutical!Regulations!in!the!U.S.!
–!A!Survey!of!Industry!Views”!was!sent!to!a!list!of!70!respondents,!compiled!using!
past!and!present!industry!experience,!social!networking!sites!and!referrals.!!Survey!
questions!primarily!focused!on!three!key!areas!of!research!based!on!the!Ramsey!
framework:!
Figure)10:)Key)Areas)of)Surve y)Research)
!
!
3.2. Survey)Delivery)
! The!final!survey!was!emailed!to!participants!on!December!4,!2014!using!
Qualtrics.!!The!36^question!survey!consisted!of!a!combination!of!closed/open!
formats!such!as!“yes/no”,!“choose!one!or!multiple”,!“scaled”,!“rank^order”!and!
“open^ended”!questions.!!This!mixed!approach!was!used!in!order!to!capture!
! 87!
different!participant!views!on!the!study!of!cosmeceutical!regulations!on!the!
cosmetic!industry!in!the!U.S.!!The!survey!was!open!for!two!months!and!closed!on!
February!6,!2015.!
! The!original!target!population!for!this!survey!was!regulatory!affairs!and!
marketing!professionals!currently!or!previously!working!in!companies!that!
manufacture!or!distribute!cosmetic!products!or!ingredients!that!are!marketed!with!
drug!claims.!!However,!the!survey!population!was!expanded!to!include!the!legal!
affairs!and!product!development!job!functions.!!It!was!also!expanded!to!include!
companies!that!formulate!cosmetic!products!or!ingredients!marketed!with!drug!
claims.!!Initial!respondents!that!met!the!inclusion!criteria!were!identified!from!past!
and!current!industry!experience!and!also!from!social!network!sites!like!LinkedIn.!!
Once!they!indicated!their!willingness!to!participate!in!the!survey,!using!a!snowball!
technique,!they!were!also!asked!to!recommend!colleagues!with!similar!work!
experience!that!would!possibly!be!interested!in!participating.!!Survey!participation!
was!anonymous!and!respondents!were!not!recompensed!for!their!time.!!Toward!the!
end!of!the!survey,!each!respondent!was!asked!if!he/she!was!willing!to!undergo!a!15^
minute,!informal!phone!interview.!!Upon!completion!of!the!survey,!a!thank!you!
email!was!sent!automatically!using!Qualtrics.!!!
! In!total,!70!people!agreed!to!take!the!survey.!!Of!the!70!participants,!56!
started!the!survey,!and!53!completed!it.!!For!the!participants!who!did!not!complete!
the!survey!within!the!allotted!time!frame,!the!first!staged!reminder!was!sent!after!
two!weeks!via!Qualtrics.!!The!second!reminder!was!sent!after!one!month.!!In!spite!of!
! 88!
these!reminders,!some!respondents!still!did!not!complete!the!survey.!!A!final!
reminder!was!sent!after!an!additional!two!weeks!using!Qualtrics,!personal!emails!
and!phone!calls.!
3.3. Survey)Analysis)
! Results!of!the!survey!were!collected!and!stored!in!Qualtrics.!!Only!the!53!
respondents!who!completed!the!survey!are!included!in!the!final!survey!analysis.!!
Using!Qualtrics,!survey!data!was!cross!tabulated,!graphed!and!analyzed!to!measure!
beliefs!across!survey!sectors!concerning!the!study!of!cosmeceutical!regulations!on!
the!cosmetic!industry!in!America.!!It!was!also!used!to!explore!the!views!of!
respondents!with!regard!to!the!adequacy!of!the!current!regulatory!approaches.!!
Based!on!this!data,!recommendations!for!improvement!were!identified!with!respect!
to!the!three!domains!of!the!regulatory!goals!as!captured!in!the!underlying!
framework!for!this!study.!!
! 89!
CHAPTER)4:)RESULTS)
4.1. Focus)Group)Results)
! The!focus!group!began!with!an!introduction!to!the!topic!by!me,!followed!by!a!
sequential!review!of!questions!composing!the!survey.!!Participants!first!examined!
questions!related!to!“participant!experience”,!and!suggested!that!the!survey!
population!be!expanded!to!include!a!broader!range!of!job!functions!beyond!
marketing!and!regulatory!affairs.!!Simplifications!and!modifications!of!subsequent!
questions!were!also!suggested;!to!reduce!the!Likert!scale^type!questions!from!7^
point!to!5^point!because!it!was!considered!to!be!too!granular;!to!add!a!“cannot!
comment”!option!to!some!of!the!questions;!and!to!rearrange!the!order!of!the!
questions!to!improve!flow.!!New!ideas!included!adding!a!question!on!the!impact!of!
social!media!and!on!the!usefulness!of!requiring!good!manufacturing!practices!
(GMPs)!for!finished!cosmetic!products.!!However,!these!questions!were!not!included!
in!the!final!version!because!they!did!not!address!the!main!topic!of!the!36^question!
survey!that!was!already!considered!lengthy.!!None!of!the!participants!expressed!
concern!that!the!survey!exhibited!bias!or!failed!to!address!the!research!topic!in!
sufficient!detail.!!The!draft!and!final!surveys!are!shown!in!Appendices!B!and!C!
respectively.!
! 90!
! The!focus!group!also!shared!their!views!on!methods!to!ensure!sufficient!
participants!in!the!survey.!!I!was!encouraged!to!leverage!current!and!previous!work!
relationships!and!to!network!at!industry!social!events!and!seminars.!!Additionally,!I!
was!also!encouraged!to!reach!out!to!industry!trade!associations!and!to!find!possible!
speaking!engagements!to!share!the!research!initiative.!
4.2. Analysis)of)Survey)Results))
! Of!the!70!surveys!sent!to!participants,!53!responses!were!received,!equating!
to!a!response!rate!of!approximately!76%.!!Figure!11!shows!the!response!rates!for!
the!36!questions!answered!by!the!53!respondents.!!Their!more!detailed!responses!
to!the!survey!questions!can!be!found!in!Appendix!D.!
! 91!
Figure)11:)Response)Rates)to)Survey)Questions)
!
!
!
! Nineteen!of!the!36!survey!questions!were!answered!by!all!53!respondents!
(100%),!and!a!further!five!questions!were!answered!by!all!but!one!respondent!
(98%).!!Six!questions!were!answered!by!51!respondents!(96%)!and!one!question!
was!answered!by!50!respondents!(94%).!!Questions!11!and!12!had!lower!response!
! 92!
rates!of!58%!and!15%!respectively.!!These!lower!response!rates!were!related!to!the!
use!of!“display!logics”!for!these!two!questions,!because!they!were!only!displayed!to!
respondents!who!answered!question!10!either!in!the!affirmative!or!negative.!!Of!the!
31!respondents!who!responded!affirmatively,!all!31!answered!question!11,!a!100%!
response!rate.!!Of!the!nine!who!responded!negatively,!eight!of!them!answered!
question!12,!an!89%!response!rate.!!Similarly,!question!21!had!a!response!rate!of!
9.43%,!because!it!was!displayed!only!if!the!respondents!answered!“no”!to!question!
20.!!All!five!respondents!who!responded!with!a!“no”!to!question!20!answered!
question!21.!!!
! Questions!26!and!30!had!response!rates!of!68%!and!55%!respectively,!
Question!26!asked!respondents!to!rank!the!order!of!the!benefit!of!the!current!
regulatory!environment!to!small,!medium!and!large!companies!marketing!
cosmeceutical!products.!!Question!30!was!an!open^ended!question!asking!
respondents!about!the!changes!that!they!would!make!to!the!current!system!for!
regulating!cosmeceuticals,!in!order!to!improve!it.!!
4.3. Company)Demographics)
! Most!of!the!respondents!identified!their!current!or!most!recent!employer!as!a!
manufacturer!and/or!distributor!of!finished!cosmetic!products!(38/53!and!31/53!
respectively).!!Only!three!respondents!identified!their!current!or!most!recent!
employer!as!a!manufacturer!of!cosmetic!ingredients!(Figure!12).!!!
! 93!
Figure)12:)Industry)Representation)
Which$industry$describes$your$most$recent$employer$or$client?$$Check$all$that$apply.$
!
!
!
! Respondents!identified!specific!product!subgroups!in!the!product!portfolio!of!
their!most!recent!employer!or!client!in!order!of!frequency!as!skin!care!cosmetics!
(51/53),!hair!care!cosmetics!(25/53),!and!color!cosmetics!(8/53)!(Figure!13).!!The!
number!of!selections!greatly!exceeded!the!number!of!respondents!suggesting!that!
many!respondents!represented!companies!with!a!mixed!portfolio.!
! 94!
Figure)13:)Company)Product)Portfolios)
Which$category$describes$the$product$assortment$of$your$most$recent$employer$or$
client?$$Check$all$that$apply.$
!
!
! Respondents!came!from!companies!of!different!sizes,!from!large!(19)!and!
midsize!(22)!to!small!(8)!(n=53)!(Table!11).!
Table)11:)Company)Size)
How$many$people$currently$work$for$your$most$recent$employer$or$client?$
!
!
! 95!
4.4. Respondent)Demographics)
! Most!of!the!respondents!reported!that!they!worked!in!Regulatory!Affairs!
(19),!followed!by!Marketing!(11)!and!Product!Development!(10).!!Of!the!13!
remaining!respondents,!eight!identified!themselves!as!Other.!!Some!of!the!job!
functions!listed!under!this!category!included!Medical!Affairs,!Clinical!Research!and!
Product!Safety.!!The!all^inclusive!list!can!be!found!in!Table!12.!!Only!five!
respondents!identified!their!job!function!as!Legal!Affairs!(n=53)!(Figure!14).!
Figure)14:)Primary)Job)Function)
What$is$your$primary$job$function?$
!
!
!
! 96!
Table)12:)Primary)Job)Function)–)Other))
!
!
! Respondents!had!different!levels!of!experience,!from!less!than!a!year!(2/52)!
to!greater!than!20!years!of!experience!(9/52).!!However,!most!respondents!seemed!
to!fall!in!intermediate!parts!of!the!range,!including!1^5!years!(10/52),!6^10!years!
(16/52)!and!11^20!years!(15/52)!(Table!13).!
Table)13:)Respondent)Experience)Level)
Please$indicate$your$level$of$experience$within$the$cosmetic$industry.$
!
!
!
! 97!
! In!order!to!capture!industry!views!on!the!current!approaches!to!regulating!
cosmeceuticals!in!the!U.S.,!participants!were!asked!to!rate!their!level!of!familiarity!
or!knowledge!of!current!regulatory!systems!used!across!different!constituencies!
and!product!sectors.!!Concerning!the!U.S.!systems,!participants!appeared!most!
familiar!with!cosmetic!regulations!(51/53)!and!OTC!drug!monographs!(51/53),!
followed!by!the!New!Drug!Application!(NDA)!and!Abbreviated!New!Drug!
Application!(ANDA)!processes!for!prescription!drugs!(39/53!and!33/52!
respectively).!!Fewer!individuals!were!familiar!with!the!New!Dietary!Ingredient!
(NDI)!notification!requirement!for!dietary!supplements!(26/52)!(numerators!
represent!a!combination!of!“somewhat”!and!“very”!familiar)!(Figure!15).!!!
! The!levels!of!familiarity!dropped!when!respondents!were!asked!about!
international!requirements.!!Participants!seemed!more!commonly!familiar!with!the!
Natural!Health!Product!(NHP)!Regulations!in!Canada!(31/53)!than!the!European!
Cosmetics!Regulation!(EC)!No.!1223/2009!(26/52)!and!the!quasi^drug!registration!
process!in!Japan!(19/53)!(numerators!represent!a!combination!of!“somewhat”!and!
“very”!familiar)!(Figure!16).!!
! 98!
Figure)15:)Respondent)Familiarity)with)U.S.)Regulatory)Systems)
Please$indicate$your$level$of$familiarity$with$the$following$U.S.$regulatory$systems.$
)
!
Figure)16:)Respondent)Familiarity)with)International)Regulatory)Systems)
Please$indicate$your$level$of$familiarity$with$the$following$international$regulatory$
systems.$
!
!
!
! 99!
4.5. Business)Strategies)for)Marketing)Cosmeceuticals )
! Survey!participants!were!asked!numerous!questions!on!the!promotional!
activities!of!their!employer!or!client!when!marketing!cosmetic!products!with!
cosmeceutical!claims.!!When!asked!about!the!likelihood!that!their!company!would!
examine!the!claims!of!their!competitors!when!deciding!how!to!position!their!
cosmetic!product!or!ingredient!with!cosmeceutical!claims,!45!out!of!53!respondents!
stated!“Very!Likely”!and!five!stated!“Likely”.!!No!respondents!stated!“Unlikely”!and!
one!respondent!“Very!Unlikely”.!!Two!respondents!had!no!comment.!
Respondents!were!asked!to!think!of!one!cosmeceutical!product!marketed!by!
their!employer!or!client!where!claims!development!was!particularly!challenging.!!!
They!were!then!asked!if!the!claims!for!this!product!met!the!standards!set!by!the!
Federal!Trade!Commission!requiring!that!health^related!claims!be!supported!with!
"competent!and!reliable!scientific!evidence”.!!Most!respondents!stated!yes!(31/51),!
and!20!said!no.!!
! When!provided!with!examples!of!claims!that!have!been!used!to!promote!
cosmetic!products!or!ingredients,!participants!were!asked!to!identify!those!that!they!
believed!to!be!cosmeceutical!claims.!!Five!claims!were!taken!verbatim!from!different!
warning!letters,!where!FDA!identified!them!as!violative!drug!claims!for!products!
currently!being!marketed!as!cosmetics.!!
1) “Clinically!proven!to!reduce!breakouts!and!blemishes!by!84%”!(U.S.!Food!and!
Drug!Administration,!2012a)!(32/52),!!
! 100!
2) “See!significant!deep!wrinkle!reduction!in!UV!damaged!skin,!clinically!
proven”!(U.S.!Food!and!Drug!Administration,!2012b)!(32/52),!!
3) “Strengthens!and!lengthens!eyelashes!in!as!little!as!two!weeks”!(U.S.!Food!
and!Drug!Administration,!2011b)!(26/52),!!
4) “Boosts!the!activity!of!genes!and!stimulates!the!production!of!youth!proteins”!
(U.S.!Food!and!Drug!Administration,!2012b)!(35/52),!and!!
5) “The!first!Topical^Injectable!alternative!to!doctor^administered!anti^wrinkle!
injections:!proven!more!effective!than!Botox®!in!a!clinical!study”!(U.S.!Food!
and!Drug!Administration,!2007)!(34/52).!!!
In!addition!to!these!claims,!two!other!claims!were!not!from!warning!letters!but!were!
constructed!to!be!drug!claims!because!they!went!beyond!descriptions!of!effects!on!
appearance!to!descriptions!of!effects!on!the!structure!and!function!of!the!human!
body.!!
1) “Reverses!visible!signs!of!sun!damage”!(31/52),!and!!
2) “Restore!skin's!youth^boosting!trio!of!collagen,!hyaluronic!acid!and!elastin”!
(33/52).!!!
The!remaining!three!were!cosmetic!in!nature!since!they!only!spoke!about!the!look!
and!feel!of!hair!or!skin.!!However,!some!respondents!(numerator!in!brackets)!still!
identified!these!as!cosmeceutical!claims;!!
1) “Skin!looks!smoother,!firmer!and!more!resilient”!(14/52),!!
2) “Dramatically!reduces!the!look!of!multiple!signs!of!aging!including!fine!lines,!
wrinkles,!loss!of!firmness,!dullness!and!dehydrated!skin”!(13/52),!and!!
! 101!
3) “Hair!feels!twice!as!full,!twice!as!thick”!(11/52)!(Table!14).!!
Table)14:)Examples)of)Claims)Made)on)Cosmetic)Products)or)Ingredients )
The$following$is$a$list$of$examples$of$claims$made$on$cosmetic$products$or$ingredients$
by$the$cosmetic$industry.$$Please$check$all$those$that$you$think$are$cosmeceutical$
claims.$
!
!
!
! The!next!two!questions!asked!participants!if!their!most!recent!employer!or!
client!markets!cosmetic!products!or!ingredients!with!claims!similar!to!those!they!
! 102!
listed!above,!and!if!so,!how!many.!!Thirty^one!respondents!stated!yes,!and!20!said!no!
(n=51).!!Sixteen!respondents!said!that!greater!than!20!products!in!the!company!
portfolio!were!marketed!with!cosmeceutical!claims.!!Six!identified!11^20!products!
and!eight!stated!that!6^10!products!bore!such!claims.!!Six!respondents!identified!
only!1^5!products!as!having!such!claims.!!Seventeen!respondents!either!did!not!
know!how!many!products!or!ingredients!were!marketed!with!cosmeceutical!claims!
or!the!question!did!not!apply!to!them!(n=53).!!When!asked!if!their!companies!
changed!the!claims!language!on!these!cosmeceuticals!if!they!were!marketed!
overseas,!24!respondents!said!yes,!whereas!11!said!no.!!Seventeen!respondents!
either!did!not!know!or!the!question!did!not!apply!to!them!(n=52).!
! When!asked!if!they!would!immediately!change!cosmeceutical!claims!on!their!
packaging!in!response!to!a!top!competitor!receiving!an!FDA!warning!letter!for!
similar!claims,!48!out!of!the!53!respondents!stated!yes,!while!five!said!no.!!The!
respondents!who!said!no!were!asked!why!they!would!not!immediately!update!their!
packaging.!!Two!of!the!five!respondents!were!not!willing!to!lose!market!
competitiveness,!and!one!would!not!change!if!other!competitors!kept!their!claims!
the!same.!!No!respondents!indicated!cost,!time!or!lack!of!concern!of!regulatory!
action!from!FDA!as!a!reason!for!not!immediately!implementing!a!change.!!Instead,!
some!respondents!had!other!approaches;!for!example,!they!would!evaluate!on!a!
case^by^case!basis!or!they!would!try!to!negotiate!with!the!FDA.!!The!full!list!of!
reasons!can!be!found!in!Table!15.!!
! 103!
! When!respondents!were!asked!to!rank!the!reasons!why!they!thought!that!
cosmetic!companies!market!their!cosmetic!products!with!cosmeceutical!claims!in!
the!U.S.,!34!out!of!51!ranked!“drive!sales”!as!the!primary!reason,!followed!by!11!who!
thought!it!was!to!“increase!market!competitiveness”.!!Three!respondents!thought!
that!new!product!innovation!was!the!primary!reason;!two!thought!it!was!to!satisfy!
consumer!demand!and!one!thought!that!it!was!a!result!of!the!permissive!regulatory!
environment.!
Table)15:)Other)Reasons)for)Not)Updatin g)Product)Packaging)
!
! To!understand!the!business!impact!of!updating!a!product’s!packaging,!
respondents!were!asked!to!estimate!the!average!cost!for!this!change.!!Twelve!out!of!
53!respondents!estimated!that!it!would!cost!less!than!$10,000,!16!estimated!it!to!be!
$10,000^$49,999,!two!estimated!it!to!be!$50,000^$99,999!and!one!estimated!it!to!be!
equal!or!greater!than!$100,000.!!Twenty^two!respondents!either!did!not!know!or!
the!question!was!not!applicable!to!them.!!Respondents!were!also!asked!to!estimate!
the!average!time!per!product!to!implement!the!change.!!Answers!varied:!less!than!
six!months!(18/53),!6^12!months!(25/53),!1^2!years!(1/53)!and!over!2!years!
! 104!
(2/53).!!Seven!respondents!either!did!not!know!or!the!question!was!also!not!
applicable.!
Participants!were!also!provided!with!five!business!activities!and!were!asked!to!
rate!how!often!each!occurred!based!on!their!most!recent!or!current!experience.!!!
1) “Cosmetic!companies!register!their!cosmetic!product!ingredient!statements!
with!the!FDA!via!the!Voluntary!Cosmetic!Registration!Program!(VCRP).”!–!
The!most!common!response!of!those!who!could!answer!this!question!was!
that!VCRP!registration!happens!“occasionally”!(19/53).!!Seven!respondents!
said!“never”!and!seven!said!“very!often”.!!One!respondent!said!that!VCRP!
registration!always!occurred!based!on!their!experience.!!More!than!a!third!of!
the!respondents!could!not!comment!(19/53).!!
2) “Cosmetic!companies!test!their!finished!products!for!safe!use!in!humans.”!–!
Twenty^two!respondents!stated!that!this!activity!occurred!very!often,!
followed!by!15!who!agreed!this!always!occurred.!!Thirteen!respondents!
stated!this!occurred!occasionally.!!One!respondent!said!that!this!never!
occurred!in!their!business!environment!and!two!respondents!could!not!
comment!(n=53).!
3) “Cosmetic!companies!follow!the!good!manufacturing!practice!(GMP)!
guidelines/inspection!checklist!for!cosmetics.”!–!Most!respondents!agreed!
that!this!activity!happened!very!often!based!on!their!experience!(27/52),!
followed!by!19!who!said!that!it!always!occurred.!!Four!respondents!believed!
that!it!happened!occasionally!and!two!respondents!could!not!comment.!!!
! 105!
4) “The!FDA!exercises!discretion!when!deciding!to!issue!warning!letters!to!
companies!marketing!their!cosmetic!products!with!drug!claims.”!–!Nineteen!
respondents!agreed!that!this!happened!very!often,!followed!by!15!who!stated!
that!it!happened!occasionally.!!Four!respondents!said!that!it!either!never!or!
always!happened!based!on!their!experience.!!Eleven!respondents!could!not!
comment!(n=53).!
5) “A!lack!of!enforcement!action!by!the!FDA!is!creating!an!unequal!playing!field!
for!small,!medium!and!large!sized!cosmetic!companies.”!–!Seven!respondents!
felt!that!this!always!occurred!and!18!felt!that!this!occurred!very!often.!!
Fourteen!respondents!felt!that!it!happened!occasionally,!whereas!two!felt!
that!it!never!occurred.!!Twelve!respondents!could!not!comment!(n=53)!
(Table!16).!
! 106!
Table)16:)Business)Activities)within)the)Cosmetic)Industry )
Based$on$your$most$recent$experience,$please$indicate$how$often$do$you$think$the$
following$situations$occur.$
!
!
!
! Survey!participants!were!then!asked!which!product!category!they!thought!
best!matched!with!the!following!statements:!
! 107!
1) “Are!faced!with!the!biggest!challenge!of!cosmeceutical!claims!development.”!
–!Forty^five!respondents!chose!skin!care!cosmetics!to!be!the!best!match,!
followed!by!two!for!color!cosmetics.!!No!respondents!chose!hair!care!
cosmetics!and!six!could!not!comment!(n=53).!
2) “Have!the!biggest!share!of!the!retail!cosmeceutical!market.”!–!Forty^four!
respondents!chose!skin!care!cosmetics!as!the!best!match,!followed!by!three!
for!hair!care!cosmetics!and!two!for!color!cosmetics.!!Four!respondents!could!
not!comment!(n=53).!
3) “Are!most!likely!to!garner!the!attention!of!the!FDA!for!strong!cosmeceutical!
claims.”!–!Forty^nine!respondents!chose!skin!care!cosmetics!as!the!best!
match!and!one!chose!color!cosmetics.!!No!respondents!chose!hair!care!
cosmetics!and!three!could!not!comment!(n=53).!
4) “Are!marketed!with!the!strongest!cosmeceutical!claims.”!–!Forty^six!
respondents!chose!skin!care!cosmetics!as!the!best!match,!two!chose!color!
cosmetics!and!one!respondent!chose!hair!care!cosmetics.!!Four!respondents!
could!not!comment!(n=53)!(Figure!17).!
! Finally,!participants!were!asked!to!rank!the!order!in!which!different!sized!
companies!benefitted!from!the!current!regulatory!environment!for!cosmeceuticals.!!
In!overall!terms,!large!companies!appeared!to!be!seen!as!most!likely!to!benefit!
(17/36),!followed!by!small!companies!that!were!most!commonly!ranked!second!
(11/36).!!Medium^sized!companies!were!most!commonly!ranked!third!(8/36)!
(Table!17).!!
! 108!
Figure)17:)Color)vs.)Hair)or)Skin)care)Cosmetics )
Based$on$your$most$recent$experience,$please$choose$the$product$category$that$you$
think$best$matches$the$following$statements.$
!
!
!
Table)17:)Benefits)of)being)a)Small)vs.)Medium)or)Large)Company )
Please$rank$the$order$in$which$you$think$companies$of$different$sizes$benefit$from$the$
current$regulatory$environment$for$cosmeceuticals$in$the$U.S.$$Assign$numbers$1 A3,$
with$1$being$the$highest.$
!
!
4.6. Current)vs.)Future)Approaches)for)Regulating)Cosmeceuticals)
Some!questions!centered!on!the!nature!of!the!current!environment!and!
preferences!for!change!in!the!regulation!of!cosmeceuticals.!!Survey!participants!
! 109!
were!asked!whether!cosmeceutical!products!should!be!held!to!the!same!standards!
as!pharmaceuticals!that!require!clinical!evidence!of!efficacy!and!safety.!!Slightly!
more!than!half!of!the!respondents!disagreed!(28/53),!whereas!17!participants!
agreed.!!Seven!respondents!neither!agreed!nor!disagreed!with!the!statement!and!
one!could!not!comment.!!When!asked!further!if!the!current!environment!for!
regulating!cosmeceuticals!in!the!U.S.!encourages!product!innovation,!similar!
numbers!agreed!or!disagreed!(15!versus!13!respectively).!!However,!most!
respondents!had!a!neutral!view!(22/53)!and!three!could!not!comment.!!When!asked!
whether!the!FD&C!Act!should!be!revised!to!include!cosmeceuticals!as!a!specific!
product!category,!most!respondents!agreed!(29/53),!but!about!a!quarter!(14/53)!
disagreed.!!Eight!respondents!were!neutral!and!two!could!not!comment.!!When!
asked!if!the!definitions!of!a!cosmetic!and!a!drug!should!be!revised!in!the!FD&C!Act,!
17!respondents!agreed!with!revising!the!definition!of!a!cosmetic,!whereas!21!
disagreed.!!Thirteen!respondents!were!neutral!about!revising!the!cosmetic!
definition!and!two!could!not!comment!(n=53).!!In!contrast,!only!six!respondents!
agreed!with!revising!the!definition!of!a!drug!versus!32!respondents!who!disagreed,!
11!who!were!neutral!and!four!who!could!not!comment!(n=53)!(Table!18).!
! 110!
Table)18:)Cosmeceuticals)and)the)FD&C)Act )
The$Federal$Food,$Drug$and$Cosmetic$Act$("FD&C$Act"$or$“the$Act”)$does$not$recognize$
cosmeceuticals$as$a$valid$product$category.$$A$product$can$either$be$a$drug,$a$
cosmetic,$or$a$combination$of$the$two.$$Please$indicate$your$level$of$agreement$or$
disagreement$to$the$following$statements$based$on$the$FD&C$Act. $
!
!
!
When!asked!their!level!of!satisfaction!with!the!current!regulatory!system!for!
cosmeceuticals,!answers!were!distributed!on!both!sides!of!the!
satisfaction/dissatisfaction!spectrum;!one!respondent!was!very!satisfied!with!the!
current!system!and!21!were!satisfied,!whereas!19!respondents!were!dissatisfied!
and!two!respondents!were!very!dissatisfied.!!Ten!respondents!could!not!comment!
! 111!
(n=53)!(Figure!18).!!As!a!follow!up!to!that!question,!participants!were!asked!
whether!there!should!be!more!or!less!regulation!for!cosmeceuticals,!or!if!the!current!
system!was!sufficient.!!The!responses!varied!with!30!respondents!wanting!more!
regulation,!four!respondents!wanting!less!and!12!indicating!that!the!current!system!
was!sufficient.!!Six!respondents!could!not!comment!(n=52).!!!
Figure)18:)Industry)Satisfaction)with)the)Current)System)for)Cosmeceuticals )
How$satisfied$are$you$with$the$current$system$for$regulating$cosmeceuticals$in$the$
U.S.?$
!
!
!
! Twenty^nine!respondents!took!the!opportunity!to!suggest!changes!that!they!
would!make!to!the!current!system!for!regulating!cosmeceuticals!in!order!to!improve!
it.!!Responses!varied!from!having!more!clear^cut!regulations!for!cosmeceuticals,!to!
holding!companies!to!a!higher!standard,!or!to!regulating!them!more!like!health^food!
or!nutraceuticals!in!requiring!approved!claims!and!oversight!by!the!FDA.!!Additional!
recommendations!include!increasing!transparency,!improving!regulatory!
enforcement!action!of!a!currently!sufficient!system,!establishing!user!fees!that!
! 112!
would!be!fair!across!all!business!sizes,!and!creating!a!new!category!for!
cosmeceuticals!whose!requirements!were!between!drugs!and!cosmetics.!!The!full!
list!of!recommendations!can!be!found!in!Table!19.!
! 113!
Table)19:)Industry)Recommendations)for)Regulating)Cosmeceuticals )
What,$if$anything,$would$you$change$about$the$current$system$for$regulating$
cosmeceuticals$in$the$U.S.,$in$order$to$improve$it?$
!
Responses'
too!many!large!compaies!are!allowed!to!keep!products!with!improper!claims!on!the!
shelf!far!too!long!
There!should!be!clear!regulations/guidelines!around!what!is!a!cosmeceutical!and!how!
they!are!to!be!marketed.!!Right!now,!this!is!very!unclear.!
Current!FDA!approach!is!safety!focused!and!companies!have!to!consider!impact!on!
sales,!regulatory!enforcement!and!consumer!product!liability!claims!(amongst!others)!
while!making!claims.!!Regulation!of!cosmeceuticals!seems!adequate!because!if!a!
company!decides!to!make!a!claim!that!would!be!construed!to!be!a!drug!claim,!then!
that!cosmetic!product!could!be!subject!to!additional!federal!regulations!and!incur!
additional!liability.!If!a!company!chooses!to!use!an!approved!drug!as!an!ingredient,!
then!that!product!would!be!subject!to!meeting!additional!requirements,!as!well,!or!will!
be!considered!adulterated!by!the!FDA.!!Additionally,!patent!protection!adds!another!
layer!of!protection!for!consumers,!but!this!last!protection!may!not!really!protect!
against!small!manufacturers.!!It!would!be!a!good!policy!to!require!all!ingredients!to!be!
listed!in!a!cosmetic,!although!I!don’t!believe!companies!would!adulterate!their!product!
with!a!drug!ingredient!or!not!list!an!ingredient!because!it!allows!them!to!skirt!existing!
regulations.!
More!clarity!so!companies!understand!expectations!and!guardrails!from!FDA!
Make!cosmeceuticals!a!separate!category!with!requirements!less!stringent!than!OTC.!
Submission!and!FDA!review!based!process!needed!and!more!actual!scientific!
evaluation!of!ingredients!
Make!it!more!clear^cut.!
Establish!a!governing!body!
As!long!as!the!companies!do!not!make!drugs!claims,!there!is!no!need!for!changes!of!
regulation.!
At!a!minimum,!ensure!all!companies!are!testing!for!product!safety!but!ideally,!apply!
stricter!guidelines!for!validating!and!approving!claim!use.!
Dependent!upon!on!a!cosmeceutical's!ingredients!and!risk!to!benefit!ratio,!it!should!
either!be!approved!and!regulated!more!as!a!Rx!drug!or!OTC.!
Standardize!the!system!with!which!claims!have!to!be!substantiated,!make!certain!test!
protocols!mandatory!etc!
! 114!
I!do!believe!the!FDA!should!direct!more!attention!to!the!cosmetic!industry,!especially!
with!regards!to!safety!and!the!!claims!made.!!However,!I'm!not!sure!the!FDA!as!it!
stands!today!has!the!resources!to!direct!more!attention!to!cosmetics.!!I!think!it!would!
be!helpful!to!have!a!"cosmetic"!division,!so!the!FDA!would!have!more!time!to!focus!on!
cosmetic!products.!
Allow!companies!to!make!more!claims!to!better!inform!consumers!of!benefits!
Cosmeceuticals,!much!as!nutriceuicals,!should!be!held!to!a!higher!standard!than!they!
currently!are!and!to!accomplish!that!they!must!first!be!acknowledged!and!defined!by,!
perhaps,!a!new!division!within!our!regulatory!framework.!
Current!system!regulates!cosmeceuticals!as!either!cosmetics!or!drugs!depending!on!
the!claims!and!ingredients.!It!is!straight!forward!and!the!lines!are!clear!if!the!
appropriate!questions!are!asked.!
I!think!the!current!system!is!sufficient,!however,!I!think!it!would!be!better!if!we!had!
more!activity!to!enforce!the!regulations!that!are!in!place!to!keep!consumers!safe.!
less!areas!of!gray!in!interpreting!the!rules!
Make!it!more!like!the!health^food!or!neutriceutical!situations,!requiring!approved!
claims!and!oversight!by!FDA.!
As!proposed!earlier!^!Non^prescription!Drug!oversight!&!monographs.!
Allow!double!monograph,!e.g.!HQ!and!SPF!product!able!to!say!both!sun!protection!and!
skin!lightening.!
Allow!better!differentiation!between!drugs!and!cosmetics!to!permit!more!freedom!for!
cosmeceuticals!manufacturers!
First!and!foremost,!the!OTC!Monograph!system!needs!to!be!robust!to!accomodate!new!
API!for!cosmeceuticals!
Have!a!clear!category!for!cosmeceuticals!that!will!permit!companies!to!confidently!
make!claims!based!on!clinical!evidence!or!sound!literature!support,!without!having!to!
be!on!tenterhooks!of!receving!a!warning!letter!from!FDA!for!making!cosmetic^!drug!
claims.!
Evoke!stricter!regulation.!
More!transparency.!
Create!a!new!category!inbetween!drugs!and!cosmetics!for!cosmeseuticals!
The!current!system!for!regulating!cosmeceuticals!is!resulting!in!consumer!claims!that!
are!misleading!and!unsubstantiated.!Regulating!steps!should!be!put!in!place!so!that!
claims!better!disclose!formulation!results!and!set!consumer!expectations.!
Fees!to!play!in!the!arena!that!provide!fairness!across!all!business!sizes!
!
! 115!
4.7. U.S.)Models)to)Inform)Cosmeceutical)Regulation )
! Survey!participants!were!asked!whether!they!agreed!or!disagreed!with!
certain!statements!regarding!the!two!U.S.!marketing!pathways,!the!monograph!and!
NDA!pathways!for!OTC!drugs.!!Respondents!had!mixed!views!regarding!the!
appropriateness!and!effect!of!current!OTC!rules!on!cosmeceutical!management.!!
Approximately!equal!numbers!agreed!or!disagreed!that!many!cosmeceutical!claims!
were!a!direct!result!of!the!permissive!environment!created!by!non^finalized!OTC!
monographs!(15!agreed;!13!disagreed;!12!neutral;!and!12!could!not!comment,!
n=52).!!When!asked!if!the!existing!OTC!monographs!should!be!revised!to!include!
cosmeceutical!ingredients,!a!slightly!larger!number!of!respondents!disagreed!
(21/51)!than!agreed!(17/51);!ten!neither!agreed!nor!disagreed!with!suggestion!and!
three!could!not!comment.!!Instead,!most!of!the!respondents!agreed!that!a!new,!
separate!monograph!process!should!be!established!for!cosmeceuticals!(30/51).!!
Eleven!respondents!disagreed,!seven!were!neutral!and!three!could!not!comment.!!
When!asked!if!cosmeceutical!products!should!be!required!to!carry!a!Cosmeceutical!
Facts!box!similar!to!the!Drug!Facts!box!for!OTC!drugs,!24!respondents!agreed,!
whereas!18!disagreed.!!Seven!respondents!neither!agreed!nor!disagreed!and!four!
could!not!comment!(n=53)!(Table!20).!!!
! 116!
Table)20:)U.S.)Marketing)Pathways)for)OTC)D rugs)
In$the$U.S.,$OTC$drugs$are$marketed$either$via$monograph$or$under$an$approved$NDA.$$
The$newly$organized$Division$of$Nonprescription$Drug$Products$(DNDP)$is$responsible$
for$both$NDA$oversight$and$the$development$of$the$OTC$drug$monographs.$$Do$you$
agree$or$disagree$with$the$following$statements$regarding$these$processes?$
!
!
!
The!NDA!pathway!is!currently!an!alternative!way!to!bring!cosmeceutical!
products!to!market!but!was!less!favored!by!half!of!the!respondents.!!Sixteen!
respondents!agreed!with!the!idea!of!submitting!NDAs!in!order!to!market!
cosmeceutical!products!as!OTC!drugs.!!Eight!respondents!neither!agreed!nor!
disagreed!with!that!alternative!and!two!could!not!comment!(n=52)!(Table!20).!!
! 117!
When!asked!who!should!establish!monograph!rules!for!cosmeceutical!products!if!
they!were!to!be!marketed!as!OTC!drugs,!most!agreed!that!the!newly!combined!
Division!of!Nonprescription!Drug!Products!(DNDP)!was!best!suited!(22/53)!
compared!to!none!for!the!Center!for!Food!Safety!and!Applied!Nutrition,!under!
whose!authority!cosmetic!oversight!currently!resides.!!Fifteen!participants!
responded!that!a!new!division!should!be!established!in!the!FDA!in!order!to!develop!
these!monographs,!whereas!ten!respondents!did!not!agree!with!the!development!of!
a!new!monograph!process!(Table!21).!
Table)21:)FDA)Dept.)Best)Suited)to)Develop)Cosmeceutical) Monographs)
If$a$new$monograph$process$was$to$be$established$for$regulating$cosmeceuticals,$
which$department$in$the$FDA$should$be$responsible$for$developing$these$monographs? $
!
!
!
! Respondents!were!then!asked!about!whether!certain!aspects!of!dietary!
supplement!legislation!might!provide!a!useful!template!for!cosmeceutical!
! 118!
regulation.!!Currently,!manufacturers!and!distributors!of!"new!dietary!ingredients"!
are!required!to!submit!a!notification!to!FDA!prior!to!placing!their!supplement!on!the!
market.!!If!the!FDA!has!no!objections!to!the!notification!after!75!days,!the!ingredient!
can!be!marketed.!!Most!respondents!(31/53)!agreed!that!this!approach!would!also!
be!useful!for!manufacturers/distributors!of!"new!cosmeceutical!ingredients"!and!
nine!disagreed.!!Eight!respondents!were!neutral!and!five!could!not!comment!(Figure!
19).!
Figure)19:)New)Cosmeceutical)Ingredient)Notification)Requirement)
In$the$U.S.,$dietary$supplement$legislation$requires$manufacturers$and$distributors$of$
"new$dietary$ingredients"$to$submit$a$preAmarket$notification$to$FDA.$$If$the$FDA$has$
no$objections$to$the$notification$after$75$days,$the$ingredient$can$be$marketed.$$Would$
you$agree$to$a$similar$legislation$under$which$manufacturers/distributors$of$"new$
cosmeceutical$ingredients"$would$be$subject$to$this$same$requirement?$
!
!
!
! A!“display!logic”!method!was!used!to!provide!the!31!respondents!who!agreed!
with!a!similar!approach!for!new!cosmeceutical!ingredients!with!the!question,!“Who!
should!review!the!safety!notification?”!!Twelve!respondents!chose!the!Division!of!
Nonprescription!Drug!Products,!whereas!nine!respondents!thought!that!a!new!
division!should!be!established!within!the!FDA.!!Only!four!respondents!chose!the!
! 119!
Center!for!Food!Safety!and!Applied!Nutrition,!even!though!that!agency!has!an!
already!established!system!for!reviewing!safety!notifications!for!new!dietary!
ingredients!in!dietary!supplements.!!Three!respondents!liked!the!idea!that!a!
qualified!third!party!other!than!the!FDA!would!review!these!notifications!and!three!
respondents!could!not!comment!(n=31)!(Table!22).!
Table)22:)New)Cosmeceutical)Ingredient)Notification)Review )Process)
Who$should$review$this$safety$notification?$
!
!
!
! The!same!display!logic!method!was!used!to!explore!the!reason(s)!why!nine!
respondents!disagreed!with!the!notification!requirement!for!new!cosmeceutical!
ingredients.!!Some!responded!that!it!would!slow!market!access!to!a!cosmeceutical!
product,!create!an!additional!burden!on!industry!or!end!the!innovation!process.!!The!
full!list!of!reasons!can!be!found!in!Table!23!(n=8).!
! 120!
Table)23:)Reasons)against)a)New)Cosmeceutical)Ingredient)Notification)
Requirement)
Can$you$please$take$a$moment$to$explain$why$you$do$not$agree$to$a$similar$legislation?$
!
!
Dietary!supplement!legislation!also!permits!companies!to!make!"qualified!
health!claims"!regarding!the!role!of!a!dietary!supplement!in!reducing!the!risk!of!a!
disease!or!health^related!condition,!even!though!scientific!evidence!is!still!emerging.!!
When!asked!if!the!cosmetic!industry!should!be!allowed!to!make!qualified!health!
claims!on!cosmeceutical!products!similar!to!dietary!supplements,!most!participants!
responded!affirmatively!(31/51)!but!20!responded!negatively.!!In!either!instance,!
participants!were!asked!to!explain!the!reason!for!their!choice.!!Most!respondents!
who!supported!qualified!health!claims!for!cosmeceuticals!supported!it!only!if!the!
! 121!
claims!were!substantiated!with!solid,!scientific!evidence.!!For!those!who!opposed,!
the!reasons!were!less!uniform,!and!varied!from!suggestions!that!qualified!claims!
should!remain!with!foods!and!dietary!supplements!to!concerns!that!they!would!give!
consumers!a!false!sense!of!security.!!!One!respondent!gave!an!example!of!a!claim,!
“may!reduce!the!risk!of!heart!disease”,!which!could!be!interpreted!as!fact!by!
consumers,!when!that!may!not!necessarily!be!the!case!(Table!24).!
! 122!
Table)24:)Reasons)for/against)Qualified)Health)Claims)for)Cosmeceuticals )
!
! 123!
4.8. Alternative)Models)to)Inform)Cosmeceutical)Regulation )
Internationally,!three!constituencies,!Europe,!Canada!and!Japan,!were!chosen!
as!alternative!models!of!regulation,!in!order!to!gauge!the!level!of!preference!for!
different!approaches!to!regulating!cosmetics!and!cosmetic^drugs.!!When!asked!
which!aspects!of!the!European!Cosmetics!Regulation!would!be!most!beneficial!to!
informing!cosmeceutical!regulatory!policy!in!the!United!States,!twenty^six!
respondents!could!not!comment.!!Of!those!who!commented,!12!respondents!chose!
the!Cosmetic!Product!Safety!Report,!followed!by!nine!who!responded!that!all!
aspects!of!the!regulation!were!beneficial!to!informing!U.S.!cosmeceutical!regulatory!
policy.!!Eight!respondents!selected!the!Product!Information!File,!whereas!six!chose!
the!Serious!Undesirable!Effect!Reporting!requirement.!!Four!respondents!each!
selected!the!Safety!Assessor!and!the!Cosmetic!Product!Notification!Portal!and!two!
selected!Other.!!For!the!two!respondents!who!selected!Other,!the!first!stated!that!the!
European!Cosmetics!Regulation!was!not!beneficial!to!informing!cosmeceutical!
regulatory!policy!in!the!U.S.!!The!second!stated!that!the!European!regulation!
provided!greater!clarity!on!acceptable!versus!unacceptable!claims.!!The!number!of!
selections!exceeded!the!number!of!respondents,!which!suggests!that!several!
respondents!selected!more!than!one!aspect!(n=53)!(Table!25).!
! 124!
Table)25:)Most)Beneficial)Aspects)of)the)European) Cosmetics)Regulation)
In$your$opinion,$which$aspect(s)$of$the$European$regulation$would$be$the$most$
beneficial$to$informing$cosmeceutical$regulatory$policy$in$the$U.S.?$
!
!
!
!
! Respondents!were!then!asked!whether!or!not!the!FDA!should!establish!a!
class^based!system!for!cosmeceuticals!based!on!their!known!risks!and!benefits,!as!
the!Natural!Health!Product!Directorate!(NHPD)!did!in!Canada!for!NHPs.!!Of!the!50!
respondents!who!answered!that!question,!half!of!them!agreed!that!the!FDA!should!
establish!a!class^based!system,!compared!to!only!six!who!disagreed.!!Eight!
respondents!neither!agreed!nor!disagreed!with!the!question!and!11!could!not!
comment!(Figure!20).!
! 125!
Figure)20:)Class[Based)Risk/Benefit)System)for)Cosmeceuticals ))
In$2012,$the$Natural$Health$Product$Directorate$(NHPD)$outlined$a$threeAclass$system$
for$NHPs$based$on$their$known$risks$and$benefits.$$They$introduced$a$monograph$
system$for$the$less$risky$Class$I$and$II$products,$which$have$review$times$of$10$and$30$
days$respectively.$$However,$the$riskiest$class$III$products$are$subject$to$a$review$time$
of$180$days.$$Should$the$FDA$establish$a$similar$class Abased$system$for$cosmeceutical$
products$based$on$their$known$risks$and$benefits?$
!
!
!
! Respondents!were!also!asked!whether!or!not!companies!that!market!
cosmeceutical!products!should!be!required!to!submit!safety,!quality!and!efficacy!
data!for!their!cosmeceutical!“active”!ingredients!as!is!required!in!Japan!for!quasi^
drugs.!!Thirteen!participants!agreed!whereas!14!disagreed!with!this!approach.!!
Eight!respondents!neither!agreed!nor!disagreed!and!16!of!them!could!not!comment!
on!the!question!(n=51)!(Figure!21).!!!
! 126!
Figure)21:)Premarket)Approval)of)Safety,)Efficacy)and)Stability)Data)for)
Cosmeceutical)“Active”)Ingredients)
In$Japan,$the$safety,$efficacy$and$stability$data$submitted$for$approval$of$a$quasiAdrug$
is$based$on$the$dose$level,$dosage$form$and$intended$effect$on$the$body$of$the$active$
ingredient,$and$not$the$quasiAdrug$as$a$whole.$$Should$companies$that$market$
cosmeceutical$products$in$the$U.S.$be$required$to$do$the$same?$
!
!
!
! Finally,!respondents!were!asked!to!choose!which!regulatory!system!from!the!
three!constituencies!they!regarded!as!most!beneficial!to!informing!cosmeceutical!
regulatory!policy!in!the!United!Sates.!!Many!respondents!chose!the!European!
Cosmetics!Regulation!(EC)!No.!1223/2009!as!the!most!beneficial!(14/51),!whereas!
seven!chose!the!Natural!Health!Product!(NHP)!Regulations!in!Canada!and!three!
chose!the!quasi^drug!registration!process!in!Japan.!!Twenty^seven!respondents!
indicated!that!they!could!not!comment!on!the!question!(Figure!22).!
! 127!
Figure)22:)International)Regulatory)System)Most)Beneficial)to)Informing )U.S.)
Cosmeceutical)Regulatory)Policy)
Of$the$three$regulatory$systems,$please$choose$the$one$which$you$think$is$most$
beneficial$to$informing$cosmeceutical$regulatory$policy$in$the$U.S.$
!
!
!
4.9. Interviews)
The!last!survey!question!asked!respondents!if!they!were!willing!to!
participate!in!a!follow!up!phone!interview,!and!if!so,!to!provide!their!contact!
information.!!Only!a!minority!of!participants!responded!affirmatively!(11/52).!!
Given!the!low!response!number!and!the!consistency!of!the!survey!responses,!no!
interviews!were!conducted.!!
4.10. Cross)Tabulations)
! Demographic!information!gathered!from!the!respondents!to!this!survey!
showed!that!they!varied!in!their!job!functions!and!experience!levels.!!Because!these!
differences!might!be!anticipated!to!affect!the!responses!to!questions!in!which!some!
variation!in!opinion!appeared!to!be!present,!cross!tabulations!were!performed!to!
! 128!
stratify!their!views,!particularly!with!regard!to!the!adequacy!and!impact!of!the!
current!regulatory!approaches.!!These!cross!tabulations!can!be!found!in!Appendix!E.!
! One!area!of!interest!was!the!degree!to!which!job!function!affected!the!ability!
of!respondents!to!differentiate!between!cosmetic!and!drug!claims,!summarized!in!
Table!26.!!For!these!questions,!product!claims!were!misclassified!as!cosmeceutical!
by!individuals!in!all!job!categories!at!broadly!similar!rates!(Table!14).!!Of!the!14!of!
52!respondents!who!misidentified!the!claim,!“Skin!looks!smoother,!firmer!and!more!
resilient”!as!a!cosmeceutical!claim,!six!of!18!(33%)!professionals!who!responded!to!
this!question!worked!in!Regulatory!Affairs,!three!of!ten!(30%)!worked!in!Product!
Development,!three!of!eight!(38%)!identified!themselves!as!Other!and!one!each!of!
eleven!and!five!worked!in!Marketing!and!Legal!Affairs!respectively!(9%;!20%).!!
These!respondents!spanned!different!experience!levels,!from!1^5!years!(3/10,!30%),!
6^10!years!(5/16,!31%)!and!11^20!years!(6/14,!43%).!
! The!second!claim,!“Dramatically!reduces!the!look!of!multiple!signs!of!aging!
including!fine!lines,!wrinkles,!loss!of!firmness,!dullness!and!dehydrated!skin”!was!
misidentified!by!13!respondents!as!a!cosmeceutical!claim.!!Of!the!respondents,!four!
of!10!(40%)!worked!in!Product!Development,!4!of!8!(50%)!worked!in!an!“Other”!job!
function,!three!of!18!(17%)!worked!in!Regulatory!Affairs,!and!one!in!eleven!and!one!
in!five!worked!in!each!category!of!Marketing!and!Legal!functions!respectively!(9%;!
20%).!!Respondents!with!incorrect!answers!spanned!the!range!of!experience!level;!
six!respondents!had!11^20!years!of!experience!(6/14,!43%),!five!had!6^10!years!
! 129!
(5/16,!31%),!and!one!respondent!each!had!1^5!years!(1/10,!10%)!or!over!20!years!
(1/9,!11%)!of!experience.!
! Eleven!respondents!misidentified!“Hair!feels!twice!as!full,!twice!as!thick”!as!a!
cosmeceutical!claim.!!Four!of!18!(22%)!worked!in!Regulatory!Affairs,!two!of!10!
(20%)!worked!in!Product!Development!and!one!each!of!eleven!and!five!worked!in!
Marketing!and!Legal!Affairs!respectively!(9%;!20%).!!Three!of!eight!(38%)!worked!
in!one!of!the!“Other”!job!functions.!!Five!respondents!had!between!6^10!years!of!
experience!(5/16,!31%),!four!had!11^20!years!(4/14,!29%)!and!one!each!had!either!
1^5!years!(1/10,!10%)!or!over!20!years!(1/9,!11%)!of!experience.!!The!small!
numbers!precluded!effective!statistical!analysis.!
! 130!
Table)26:)Cross)Tabulation)of)Responses)in)Table)14 )
!
!
!
! 131!
CHAPTER)5:)DISCUSSION)AND)CONCLUSION )
5.1. Introduction)
Cosmeceuticals!blur!the!once!hard!line!that!distinguished!cosmetics!and!
drugs.!!The!separation!in!the!cosmetic!and!drug!definitions!of!the!1938!FD&C!Act!
did!not!foresee!that!cosmeceuticals,!products!that!fit!uneasily!under!either!
definition,!would!emerge!as!a!large!and!growing!market!segment!in!the!21
st
!century.!!
As!a!result,!regulators!are!faced!with!the!challenge!of!regulating!these!products!to!
ensure!that!they!are!safe!and!marketed!within!the!boundaries!set!forth!by!the!Act.!!
At!the!same!time,!the!cosmetic!industry!is!faced!with!the!challenge!of!satisfying!
increasing!consumer!demand!for!cosmeceuticals,!while!trying!not!to!attract!the!
attention!of!the!FDA!for!their!drug!claims.!!Additionally,!the!absence!of!set!
guidelines!and!perceived!enforcement!discretion!by!the!FDA!have!required!that!
cosmetic!companies!follow!their!own!regulatory!compass!with!regard!to!the!
promotion!and!management!of!these!products.!!For!many,!the!decreased!risk!of!
possible!FDA!enforcement!action!is!outweighed!by!the!benefit!of!market!
competitiveness!(Kawalek,!2005;!Mason,!2008).!!The!research!results!here!help!to!
show!how!these!tradeoffs!are!being!made.!!!
! 132!
5.2. Considerations)of)the)Research)Methodology )
! Key!to!exploring!the!research!question!in!this!study!was!the!use!of!the!survey!
methodology!to!gain!insight!into!the!views!of!industry!professionals!well!versed!in!
the!regulation!and!promotion!of!cosmeceutical!products.!!According!to!Punch!
(2003),!a!good!survey!should!begin!with!a!clearly!described!conceptual!framework,!
if!it!is!using!empirical!information!to!answer!questions!or!test!hypotheses!in!a!
systematic!way.!!This!view!of!research!has!four!main!features:!!
• framing!the!research!in!terms!of!research!questions!
• determining!what!data!are!necessary!to!answer!those!questions!
• designing!research!to!collect!and!analyze!those!data!and!!
• using!the!data!to!answer!the!questions!(Punch,!2003)!
! Thus,!in!order!to!probe!how!cosmeceutical!regulations!achieved!their!
objectives,!I!used!a!framework!previously!employed!by!Ramsey!(2013)!that!
identified!three!objectives!for!regulations:!1)!ensure!the!safety,!(quality)!and!
effectiveness!of!products,!2)!equalize!the!requirements!and!standards!for!industry,!
and!3)!facilitate!efficiencies!in!research,!commercialization!and!costs.!!The!survey!
also!explored!whether!the!cosmetic!industry!feels!that!the!rules!should!be!changed!
and!which!elements!of!other!regulatory!models!might!assist!such!change.!!Such!an!
approach!was!in!retrospect!valuable!because!the!survey!results!show!that!most!
respondents!are!divided!in!their!views!on!the!success!under!which!the!current!
! 133!
system!operates.!!However,!most!agreed!that!the!regulation!for!cosmeceuticals!
needs!to!be!changed.!
5.3. Selecting)a)Survey)Sample)
! Important!to!disseminating!a!survey!is!first!identifying!a!suitable!subset!of!
respondents!to!represent!the!general!population!of!interest!(Rea!&!Parker,!2014).!!
Because!the!general!population!for!this!research!are!those!in!the!U.S.!cosmetic!
industry!at!large,!and!no!list!of!such!individuals!exists,!I!had!to!find!an!identifiable!
population!that!corresponded!closely!enough!to!the!general!population!to!be!
considered!its!surrogate!(Rea!&!Parker,!2014).!!!
Additionally,!since!an!appropriately!constructed!survey!must!also!be!able!to!
provide!information!that!represents!a!snapshot!of!time,!it!must!be!capable!of!
delivering!results!within!a!reasonable!period!of!time.!!The!use!of!a!web^based!tool!
allowed!the!dissemination!of!the!survey!simultaneously!to!a!panel!of!recipients.!!
Compared!to!traditional!paper!approaches,!this!had!the!added!benefits!of!relatively!
low!cost!and!high!convenience!(Rea!&!Parker,!2014;!Shannon!&!Bradshaw,!2002).!!!
! Another!important!consideration!in!survey!research!is!assuring!a!sufficient!
sampling!of!the!population!of!interest.!!The!survey!had!a!response!rate!of!
approximately!76%.!!That!appears!quite!high!when!compared!with!other!work!in!
the!field!where!email!survey!rates!can!range!from!as!low!as!6%!to!a!high!of!75%!
(McMillan!&!Sheehan,!1999).!!The!high!response!rate!could!possibly!have!been!
assisted!by!three!contributing!factors:!1)!constraining!survey!length,!2)!assuring!
! 134!
respondent!pre^notification!and!3)!assuring!follow^up!contact!of!non^respondents.!!
Survey!length!was!of!particular!concern.!!Although!research!results!are!mixed!on!the!
influence!of!survey!length!on!response!rate!(Sheehan,!2001)!the!views!of!the!focus!
group!appeared!to!align!with!the!findings!of!Tomaskovic^Devey!et!al!(1994)!who!
concluded!that!survey!length!was!one!of!the!main!reasons!why!those!in!business!did!
not!respond!to!a!survey.!!Views!on!the!usefulness!of!pre^notification!emails!also!
vary.!!Survey!pre^notification!has!been!seen!to!increase!the!speed!of!recruiting!
respondents!(McMillan!&!Sheehan,!1999),!but!unless!the!respondent!already!knows!
the!researcher,!that!contact!might!be!regarded!as!an!unsolicited!and!unwelcomed!e^
mail.!!I!viewed!the!fact!that!survey!respondents!expressly!opted!to!join!the!
respondent!pool!as!evidence!that!the!topic!was!interesting!to!them,!and!as!a!signal!
that!respondents!might!welcome!reminders.!!Post^notification!emails!have!also!been!
seen!to!improve!survey!response!rate.!!For!example,!Sheehan!and!Hoy!(1997)!found!
that!a!reminder!message!in!an!e^mail!survey!increased!responses!by!25%![see!also!
(Sheehan,!2001)].!
! Views!vary!about!what!constitutes!an!adequate!response!rate.!!An!ideal!
response!rate!suggested!by!Rea!and!Parker!(2014)!is!at!least!80%,!to!assure!that!
observations!will!not!be!badly!biased,!even!if!the!non^respondents!tend!to!hold!
different!opinions!from!those!who!respond.!!However,!in!their!view,!any!survey!that!
exceeds!a!response!rate!of!50%!can!generally!be!considered!as!a!representative!
sample!(Rea!&!Parker,!2014).!!At!the!same!time,!others!believe!that!an!emphasis!on!
response!rate!or!even!sample!size!may!be!overemphasized!(Fosnacht,!Sarraf,!Howe,!
! 135!
&!Peck,!2013).!!With!this!background,!I!considered!that!the!76%!response!rate!was!
respectable,!and!that!a!further!increase!in!the!rate!would!be!unlikely!to!change!the!
results!in!a!significant!way.!!!
5.4. Other)Delimitations,)Limitations)and)Assumptions)
! The!extent!to!which!we!can!give!credence!to!the!research!results!presented!
here!depends!upon!recognizing!the!strengths!and!limitations!of!the!methods!that!
were!used!and!the!assumptions!made!prior!to!conducting!the!research.!!Every!study!
has!assumptions.!!In!this!study,!we!had!to!assume!that!the!survey!respondents!were!
familiar!with!the!definition!of!cosmetics!and!drugs!as!stated!in!the!FD&C!Act,!the!
more!informal!definition!of!cosmeceuticals,!and!the!regulatory!approaches!used!by!
the!FDA!to!regulate!all!of!these!products;!these!regulations!are!central!to!the!work!
that!they!would!do!in!their!professional!capacities.!!If!a!respondent!did!not!have!a!
good!understanding!of!these!basic!concepts,!it!could!cause!them!to!give!less!useful!
answers!or!to!fail!to!answer!some!questions!at!all.!!The!latter!would!have!been!
problematic!to!the!survey,!as!that!would!have!contributed!to!non^response!bias.!
Further,!some!later!questions!depended!on!a!respondent’s!broader!
knowledge!of!U.S.!dietary!supplement!and!international!cosmetic/cosmetic^drug!
regulations.!!It!is!likely!that!the!relatively!lower!familiarity!with!these!regulations!
accounted!for!the!higher!number!of!“Do!not!know”!or!“Cannot!comment”!responses!
for!questions!relying!on!this!knowledge.!!This!may!suggest!that!the!U.S.!cosmetic!
industry!may!not!be!as!familiar!with!the!regulations!for!other!consumer!products!
! 136!
both!internal!and!external!to!the!U.S.!!It!is!not!surprising!because!many!small!
companies!may!lack!the!resources!needed!for!international!expansion,!and!thus!may!
rely!on!forming!international!relationships!with!external!contractors!or!partners!
more!knowledgeable!in!their!own!regulations!(McDonald,!Tuselmann,!&!Wheeler,!
2002).!
Originally,!the!survey!respondent!pool!was!delimited!to!include!only!
regulatory!and!marketing!professionals!currently!or!previously!working!in!
companies!that!manufacture!or!distribute!cosmetic!products!or!ingredients!that!are!
marketed!with!drug!claims!in!the!United!States.!!These!job!functions!were!
considered!to!be!important!because!these!individuals!are!most!likely!to!understand!
and!appreciate!the!challenges!of!cosmeceutical!regulations!on!the!cosmetic!industry.!!
However,!the!survey!was!also!sent!to!other!individuals!in!roles!that!closely!interact!
with!Regulatory!Affairs!and!Marketing,!such!as!Legal!Affairs!and!Product!
Development.!!It!was!also!sent!to!individuals!currently!or!previously!working!in!all!
of!these!functions!in!companies!that!formulate!cosmetic!products!or!ingredients!
marketed!with!drug!claims!in!the!U.S.!!This!approach!ran!the!risk!of!smearing!the!
response!patterns!by!merging!subpopulations!with!different!viewpoints.!!However,!
to!ensure!that!the!views!of!individuals!in!different!job!functions!were!differentiated,!
cross^tabulations!were!carried!out!to!see!if!there!were!discernible!trends!in!the!
responses!to!questions!based!on!job!function.!!The!fact!that!the!responses!of!
individuals!in!different!job!functions!appeared!similar!suggests!that!including!these!
other!job!functions!did!not!confound!the!results!to!any!great!extent.!!Indeed,!it!
! 137!
appeared!likely!to!strengthen!the!survey!by!bringing!together!a!broader!
representation!of!views!from!affected!industry!professionals,!thereby!maximizing!
representativeness!and!minimizing!systematic!omissions!or!biases!(Rea!&!Parker,!
2014).!
! Although!delimiting!the!study!to!U.S.!respondents!decreased!the!number!of!
possible!participants!for!the!survey,!it!also!decreased!the!likelihood!that!results!
would!be!blurred!by!responses!from!individuals!outside!of!the!U.S.!who!might!be!
less!familiar!with!U.S.!systems.!!However,!this!delimitation!may!potentially!restrict!
the!external!validity!of!the!study.!!According!to!Steckler!and!McLeroy,!internal!
validity!is!often!viewed!as!priority!in!research,!but!in!an!applied!discipline!whose!
purpose!includes!working!to!improve!the!health!of!the!public,!it!is!also!important!
that!external!validity!be!emphasized!and!strengthened!(Steckler!&!McLeroy,!2008).!!
Thus,!a!future!direction!of!this!research!would!be!to!expand!the!sample!size!in!order!
to!gain!the!views!of!a!broader!population!of!individuals!in!the!same!job!functions!in!
other!countries!such!as!Europe!or!Japan.!!As!outsiders!looking!in,!these!individuals!
may!be!able!to!provide!valuable!insights!that!U.S.!centric!professionals!might!not!
have!considered.!!Additionally,!since!a!number!of!large!cosmetics!companies!are!
multinational,!future!research!would!also!be!needed!to!see!if!those!companies!
differed!in!their!views!from!companies!whose!primary!marketing!footprint!was!in!
the!United!States.!!!
! In!spite!of!these!efforts,!challenges!may!still!remain!with!the!study.!!Since!the!
topic!of!this!survey!was!directly!relevant!to!the!success!of!the!businesses!that!
! 138!
employed!the!respondents,!the!survey!could!potentially!be!limited!by!the!
willingness!of!those!respondents!to!answer!the!questions!honestly!and!without!bias.!!
It!was!clearly!not!possible!to!measure!the!extent!to!which!the!answers!that!the!
respondents!gave!came!from!their!own!personal!opinions,!or!whether!they!were!
expressed!on!behalf!of!the!company!whose!point!of!view!the!respondent!could!have!
felt!obliged!to!reflect.!!In!future!studies,!it!might!be!important!to!clarify!to!the!
employee!which!point!of!view!the!survey!would!like!to!capture!in!the!event!that!
those!positions!could!be!different.!!
5.5. Convening)a)Focus)Group)
! The!use!of!focus!groups!is!a!well^established!method!in!social!science!
research.!!Focus!groups!can!be!used!both!as!a!self^contained!research!method!and!as!
a!technique!that!can!be!used!in!conjunction!with!other!methods.!!For!this!research,!
the!goal!in!using!a!focus!group!was!to!help!guide!the!development!of!clear!and!
meaningful!research!questions!that!would!strengthen!the!face!validity!of!the!survey!
instrument.!!Knodel!et!al.!(1984)!suggested!that!such!groups!can!help!to!detect!
when!participants!fail!to!understand!a!question!as!the!researcher!had!intended!it.!!
Pretesting!with!focus!groups!cannot!only!help!to!identify!these!problems!but!also!
allow!an!immediate!exploration!of!how!to!correct!them!(The$SAGE$Handbook$of$
Interview$Research:$The$Complexity$of$the$Craft,!2012).!
! It!is!also!clear!from!my!research!that!the!ideal!number!of!participants!in!a!
focus!group!can!vary.!!The!size!of!the!focus!group!in!this!study!was!guided!by!the!
! 139!
findings!of!Stewart!et!al!(1994),!who!recommended!from!three!to!eight!participants,!
and!Krueger!and!Casey!(2009),!who!viewed!six!to!eight!participants!as!ideal.!!
Morgan!(1996)!reviewed!the!effects!of!varying!the!focus!group!size!on!its!
operational!outcomes.!!He!determined!that!smaller!groups!were!more!appropriate!
for!controversial!topics,!or!topics!that!will!generate!a!high!level!of!discussion,!
whereas!large!groups!are!appropriate!for!neutral!topics!that!will!not!generate!as!
much!discussion![see!also!(Jervis!&!Drake,!2014)].!!From!this!research,!I!considered!
the!six^person!size!of!the!focus!group!as!appropriate,!and!having!their!immediate!
feedback!I!believed!helped!to!strengthen!the!survey!instrument.!!
5.6. Do)Current)Regulations)Ensure)Safety,)Quality)and)Effectiveness? )
One!of!the!three!aims!of!regulation!as!identified!in!the!underlying!regulatory!
framework!for!this!study!is!to!ensure!the!safety,!quality!and!effectiveness!of!
marketed!products.!!Survey!participants!were!asked!specific!questions!to!probe!
their!views!about!whether!one!or!another!of!the!different!regulatory!approaches!
discussed!in!chapter!two!would!be!best!suited!to!accomplish!this!regulatory!
objective.!!It!is!evident!from!the!survey!results!that!most!respondents!think!that!
cosmeceuticals!should!be!held!to!some!type!of!enhanced!pre^market!standard!for!
efficacy!and!safety.!!For!example,!when!asked!if!cosmeceuticals!should!be!held!to!the!
same!standard!as!pharmaceuticals!with!respect!to!clinical!evidence!requirements!of!
efficacy!and!safety,!more!than!half!of!the!respondents!disagreed,!whereas!17!
participants!agreed.!!This!split!was!unanticipated.!!It!is!exceptionally!expensive!and!
! 140!
time!consuming!to!bring!a!pharmaceutical!product!to!market!even!when!it!is!
intended!for!a!cosmetic!application,!a!challenge!that!was!mentioned!several!times!
by!respondents!in!their!text!responses.!!Only!a!small!number!of!companies!are!
comfortable!making!the!billion^plus!dollar!investment!and!fifteen!year!time!
commitment!that!is!needed!for!the!development!of!a!single!pharmaceutical!agent!
(Kalorama!Information,!2012;!S.!Morgan!et!al.,!2011).!!It!is!not!clear!whether!
proponents!of!regulations!like!those!for!pharmaceutical!products!prefer!such!
approaches!because!they!offer!an!environment!in!which!regulations,!although!
onerous,!are!better!defined.!!As!suggested!by!Seiguer!&!Smith!(2005),!industry!likes!
the!black!and!white!of!rules!and!guidances!that!remove!the!vagaries!of!variable!
interpretations.!!In!future!research,!it!would!be!interesting!to!tease!out!the!aspects!
of!the!more!rigorous!pharmaceutical!submission!process!that!were!appealing!to!
those!responded!favorably.!!!
! It!was!also!interesting!that!many!respondents!saw!U.S.!systems!for!different!
types!of!products!as!offering!potential!useful!alternatives!for!cosmeceutical!
regulatory!policy.!!For!example,!most!respondents!responded!positively!to!the!
proposal!that!regulations!like!those!of!dietary!supplements,!where!pre^market!
notification!is!required!for!new!ingredients,!might!offer!a!way!forward!for!policy!
setters.!!Interestingly,!if!such!approaches!were!to!be!adopted!for!cosmeceuticals,!
only!a!few!of!the!respondents!thought!that!the!Center!for!Food!Safety!and!Applied!
Nutrition!(CFSAN)!should!review!them.!!The!responses!were!surprising!because!that!
Center!is!currently!responsible!for!oversight!of!both!cosmetics!and!dietary!
! 141!
supplements,!and!would!be!most!familiar!with!the!process!currently!in!place!for!
dietary!supplements!(U.S.!Food!and!Drug!Administration,!2015b).!!Respondents!
instead!preferred!that!either!the!Division!of!Nonprescription!Drug!Products!or!a!
new!division!be!established!within!the!FDA!to!review!these!notifications.!!It!is!not!
clear!why!most!of!the!respondents!responded!in!the!manner!in!which!they!did.!!It!
would!also!be!interesting!in!future!research!to!tease!this!aspect!out!further.!!It!could!
be!for!a!similar!reason!why!many!respondents!agreed!that!cosmeceuticals!should!be!
held!to!the!same!standard!as!pharmaceuticals!with!respect!to!clinical!evidence!
requirements!of!efficacy!and!safety.!!The!drug!approval!process!is!very!well!defined!
and!demands!rigorous!adherence!to!its!requirements.!!However,!the!same!cannot!be!
said!for!adherence!with!dietary!supplement!rules.!!At!the!Regulatory!Affairs!
Professional!Society!(RAPS)!Annual!Conference!on!October!27,!2015,!Cara!Welch,!
acting!deputy!director!of!the!Division!of!Dietary!Supplement!Programs!(DDSP),!
reported!significant!under^notification!of!new!dietary!ingredients!by!the!dietary!
supplement!industry!(Spicer,!2015).!!Previously!the!FDA!had!reported!receiving!
approximately!700!NDI!notifications!since!it!began!reviewing!such!notifications!
approximately!16!years!ago,!even!though!an!estimated!55,600!dietary!supplement!
products!are!presently!marketed!(U.S.!Food!and!Drug!Administration,!2011a).!!
Welch!suggested!that!the!lack!of!compliance!might!stem!from!the!absence!of!clear!
guidance!as!to!what!constitutes!a!strong!and!coherent!notification!package!to!the!
FDA!(Spicer,!2015).!!She!commented!that!the!agency!is!revising!the!draft!guidance!
that!was!initially!published!in!2011,!but!was!widely!criticized!by!the!dietary!
! 142!
supplement!industry.!!Their!goal,!she!stated,!was!to!have!a!revised!guidance!
published!by!the!end!of!2015,!to!increase!the!number!of!successful!acknowledgment!
letters!in!the!future!(Spicer,!2015).!!As!of!January!2016,!this!guidance!has!not!yet!
been!published.!!
! Another!possible!option!for!the!regulation!of!cosmeceuticals!is!through!the!
monograph!process,!a!process!that!is!currently!being!used!for!many!over^the^
counter!products!with!pharmaceutical!actions!of!low!risk!such!as!sunscreens.!!A!
clear!split!amongst!respondents!about!whether!such!a!move!to!add!cosmeceutical!
monographs!suggested!that!this!solution!might!not!be!optimal!for!many!
manufacturers.!!Although!it!is!easier!to!adhere!to!a!monograph!than!to!submit!a!new!
drug!application,!text!responses!suggested!concerns!regarding!the!slowness!with!
which!the!monographs!were!updated.!!In!the!words!of!one!respondent,!“OTC$
monograph$system$is$failing$to$keep$pace$with$technology$and$drug$innovation…”!!
Concerns!about!outdated!or!incomplete!monographs!were!not!surprising.!!Ramsey’s!
work!on!the!Impact!of!Incomplete!Monographs!on!the!OTC!Drug!Industry!has!
previously!drawn!attention!to!the!challenges!of!the!monograph!system!relative!to!
the!inclusion!of!“new”!active!ingredients!even!when!they!have!a!strong!safety!profile!
outside!of!the!United!States!(Ramsey,!2013).!!!
! Internationally,!most!respondents!chose!the!European!Cosmetics!Regulation!
(EC)!No.!1223/2009!as!being!the!most!beneficial!guide!for!changes!to!cosmeceutical!
regulatory!policy!in!the!United!States.!!Certain!aspects!of!the!European!regulation!
such!as!the!Cosmetic!Product!Safety!Report!(CPSR),!the!Product!Information!File,!
! 143!
which!includes!the!CPSR,!and!the!Serious!Undesirable!Effect!Reporting!requirement!
were!particularly!popular.!!Some!respondents!even!stated!that!all!aspects!of!the!
European!regulation!could!provide!a!beneficial!model!for!U.S.!cosmeceutical!
regulatory!policy.!!Some!of!these!requirements!are!not!greatly!different!from!those!
of!the!current!U.S.!system!because!U.S.!manufacturers!and!distributors!of!cosmetic!
products!are!also!required!to!have!safety!substantiation!on!file!prior!to!placing!their!
products!on!the!market.!!If!the!safety!of!a!cosmetic!product!has!not!been!
substantiated,!then!it!is!required!to!bear!the!statement,!“Warning^^The!safety!of!this!
product!has!not!been!determined”!on!its!principal!display!panel!(21!C.F.R.!§!
740.10(a),!2013).!!However,!the!Serious!Undesirable!Effect!Reporting!requirement!
contrasts!with!the!voluntary!adverse!event!reporting!system!in!the!U.S.!!From!these!
results,!one!might!gain!the!impression!that!the!cosmetic!industry!would!favor!
mandatory!serious!adverse!event!reporting!for!cosmetics.!!If!this!were!to!be!true!
and!if!consumer!safety!were!to!be!of!concern,!why!do!so!few!manufacturers!submit!
voluntary!reports!to!the!FDA?!!For!example,!in!a!keynote!address!on!March!3,!2015!
at!the!American!Conference!Institute’s!Legal,!Compliance!and!Regulatory!Forum!on!
Cosmetics,!Dr.!Linda!Katz,!Director!of!FDA’s!Office!of!Cosmetics!and!Colors!(OCAC),!
reported!that!FDA!received!491!adverse!event!reports!for!cosmetics!in!fiscal!year!
2014,!a!56%!increase!from!the!year!prior!(Nardella,!2015).!!She!stated!that!while!
that!number!seemed!high,!it!might!only!offer!a!partial!picture!of!AEs!in!the!
marketplace.!!!
! 144!
Another!voluntary!system!in!the!U.S.!that!is!also!not!well!subscribed!is!that!of!
the!Voluntary!Cosmetic!Registration!Program!(VCRP).!!In!the!same!keynote!address!
at!the!ACI!forum!on!cosmetics,!Dr.!Katz!estimated!that!only!about!30%!to!40%!of!
marketed!cosmetics!are!entered!into!the!VCRP,!which!sees!varying!levels!of!
participation!each!year!(Nardella,!2015).!!She!noted!that!while!useful,!the!VCRP!does!
not!necessarily!capture!everything!that!is!currently!being!sold!in!the!U.S.!market.!!
Similarly,!the!results!of!this!survey!identified!that!very!few!companies!register!their!
cosmetic!products!with!the!VCRP,!even!though!the!VCRP!assists!the!FDA!in!
regulating!cosmetics!(73!Fed.!Reg.!76360).!!Despite!the!low!participation!in!both!
programs,!survey!respondents!agreed!for!the!most!part!that!cosmetic!products!in!
the!United!States!were!relatively!safe,!as!evidenced!by!the!majority!who!agreed!with!
the!statement!that!cosmetic!companies!tested!their!cosmetic!products!for!safety,!
and!also!identified!that!their!companies!follow!the!GMP!guidelines/inspection!
checklist!for!cosmetics.!!!
5.7. Does)the)Current)System)Level)the)Playing)Field? ) )
The!second!objective!often!defined!for!regulations!is!to!establish!rules!that!
are!fair!and!transparent!to!all!players,!including!both!large!and!small!companies.!!It!
has!been!clear!that!FDA’s!regulatory!enforcement!of!promotional!overreach!by!the!
cosmetic!industry!has!been!minimal!but!not!absent.!!As!a!result,!one!might!question!
whether!the!enforcement!activities!and!expectations!of!companies!of!different!sizes!
and!product!types!are!being!applied!consistently.!!One!possible!impact!of!
! 145!
inconsistency!would!be!the!perception!that!the!playing!field!is!unequal!for!different!
cosmetic!companies.!!The!results!presented!here!suggest!that!this!may!in!fact!be!a!
problem.!!Most!respondents!agreed!that!the!lack!of!enforcement!action!by!FDA!has!
created!an!unequal!playing!field!for!small,!medium!and!large!sized!cosmetic!
companies.!Many,!though!not!all,!further!expressed!the!view!that!benefits!favored!
large!companies!most!and!favored!medium^sized!companies!least.!!This!may!
become!a!point!of!contention!for!policy!makers!to!take!note!seriously!because!a!
level!playing!field!is!of!paramount!concern!for!industry!(Seiguer!&!Smith,!2005).!
The!low!level!of!enforcement!action!by!the!FDA!also!creates!questions!about!
whether!the!uneven!playing!field!benefits!some!product!types!more!than!others.!!
Respondents!in!this!study!recognized!that!different!types!of!products!hold!
disproportionate!shares!of!the!cosmeceutical!retail!market,!as!confirmed!by!the!
estimates!from!Packaged!Facts.!!That!report!found!that!skin!care!cosmeceuticals!
comprised!46%!of!the!market!share,!compared!to!hair!care!cosmeceuticals!at!32%!
and!color!cosmeceuticals!at!22%!(Brown!&!Marigny!Research!Group,!2012).!!Most!of!
the!respondents!further!agreed!that!the!strong!success!of!skin!care!cosmeceuticals!
could!be!attributed!to!their!effectiveness!in!making!edgy!and!uncontested!strong!
cosmeceutical!claims.!!However!promotional!positioning,!so!important!for!the!
success!of!skin!care!cosmeceuticals,!also!presents!the!biggest!challenge!for!
cosmeceutical!claims!development.!!This!reliance!on!strong!cosmeceutical!claims!
was!seen!to!make!skin!care!companies!a!particularly!large!and!vulnerable!target!for!
! 146!
FDA!enforcement!actions!in!the!case!that!the!FDA!were!to!increase!those!
enforcement!efforts.!!!!
!That!skin!care!cosmeceuticals!position!themselves!in!a!way!that!can!invite!
FDA!scrutiny!is!reflected!in!the!list!of!warning!letters!that!the!FDA!addressed!to!
companies!for!making!drug!claims!on!their!cosmetic!products!in!Table!5.!!Of!the!
thirty^four!letters!issued!since!2002,!twenty^six!were!addressed!to!companies!for!
drug!claims!made!on!their!topical!skin!care!cosmetic!preparations!only,!compared!
to!two!for!eyelash!and!eyebrow!treatments!and!four!for!hair!care!preparations.!!Two!
letters!were!addressed!to!companies!for!both!hair!care!and!skin!care!cosmetic!
preparations!(U.S.!Food!and!Drug!Administration,!2015c).!!This!asymmetry!between!
skin!care!and!other!companies!may!suggest!that!the!playing!field!is!uneven;!
alternatively!it!could!reflect!a!greater!tolerance!for!riskier!behavior!regarding!
promotional!claims!by!skin!care!companies.!!!
The!inconsistent!and!low!rate!of!enforcement!action!may!also!represent!a!
missed!opportunity!by!the!FDA!to!regulate!the!industry!effectively!because!as!stated!
by!Seiguer!&!Smith!(2005),!industry!desires!consistency!in!terms!of!what!the!agency!
expects!from!them!and!their!competitors.!!Most!respondents!in!this!study!expressed!
the!view!that!companies!would!immediately!change!cosmeceutical!claims!on!their!
packaging!if!a!top!competitor!were!to!receive!a!warning!letter!from!the!FDA!for!
similar!claims.!!It!seems!clear!based!on!this!response!that!the!cosmetic!industry!
often!looks!to!its!competitors!instead!of!the!FDA!for!guidance!on!what!standards!to!
follow,!in!order!to!preserve!their!competitive!position.!!!
! 147!
5.8. Does)the)Current)System) Protect)the)Economic)Interests)of)
Companies?))
! As!cosmeceuticals!continue!to!be!a!growth!industry!of!the!21
st
!century,!the!
FDA!is!faced!with!the!challenge!of!regulating!cosmeceuticals!in!a!manner!that!
balances!safety!and!efficacy!with!market!efficiency.!!Compliance!with!regulations!
should!incur!as!little!cost!to!regulated!companies!as!possible.!!Regulatory!
requirements!must!also!avoid!standing!in!the!way!of!legitimate!sales!by!imposing!
unnecessary!restrictions.!!At!the!present!time,!the!uncertain!rules!around!cosmetic!
versus!drug!claims!have!created!an!environment!in!which!marketing!opportunities!
are!actually!more!permissive!than!what!otherwise!might!be!the!case!if!the!FDA!were!
to!enforce!its!own!rules!strictly.!!Strict!enforcement!regarding!the!approval!and!
promotion!of!cosmeceuticals!would!almost!certainly!reduce!the!scope!of!marketing!
claims!for!many!products,!and!this!in!turn!would!potentially!reduce!the!volume!of!
sales!for!those!products.!!It!is!clear!from!the!survey!results!that!respondents!see!the!
expansion!of!promotional!claims!as!risky,!but!that!the!risk!is!worth!taking!because!
the!probability!of!incurring!serious!penalties!is!low!(Kawalek,!2005;!Mason,!2008).!!!
! The!management!of!marketing!claims!is!further!complicated!by!the!fact!that!
many!in!the!industry!are!not!even!sure!about!what!constitutes!a!drug!claim.!!The!
surprising!observation!that!some!of!the!‘drug’!claims!presented!to!respondents!in!
this!survey!were!not!identified!correctly!by!a!substantial!proportion!of!respondents,!
and!that!certain!cosmetic!claims!were!identified!incorrectly!as!drug!clams!by!others,!
! 148!
further!suggests!that!the!promotional!line!is!grey,!and!commonly!misunderstood!by!
those!in!key!areas!of!the!company!such!as!marketing!and!regulatory!affairs,!where!
such!knowledge!might!have!been!anticipated.!
! Decisions!about!what!constitutes!acceptable!versus!non^acceptable!behavior!
is!probably!not!helped!by!the!relatively!low!level!of!feedback!from!FDA!through!its!
informal!guidance!activities.!!As!suggested!by!Seiguer!&!Smith!(2005)!and!Lewis!
(2011),!guidance!documents!may!offer!a!way!in!which!the!FDA!could!assist!the!
industry!in!circumstances!where!the!science!or!technology!may!be!evolving!rapidly,!
such!that!more!speed!and!flexibility!are!needed.!!This!approach!may!be!a!win^win!
for!both!industry!and!the!FDA!because!guidance!documents,!often!considered!as!
“soft!law”,!are!generally!considered!to!be!easier!to!put!into!place!compared!to!
rulemaking,!which!requires!an!extensive!public!comment!and!review!process!that!
provides!a!legally!binding!document!(Lewis,!2011).!!However!in!practice,!industry!
often!treats!guidance!no!differently!than!rules,!even!though!the!FDA!views!them!
differently!(Lewis,!2011;!Seiguer!&!Smith,!2005).!!!
! One!reason!why!the!FDA!may!not!have!issued!more!guidance!documents!for!
cosmetics!is!that!they!may!have!become!more!burdensome!to!develop!(Seiguer!&!
Smith,!2005).!!Ideally!guidance!documents!should!be!faster!and!more!flexible!to!
disseminate,!but!in!practice,!the!guidance!making!process!has!also!become!very!
rigid.!!As!a!result!of!the!Good!Guidance!Practices!(GCPs)!required!under!the!Food!
and!Drug!Modernization!Act!of!1997!(FDAMA),!guidance!documents!now!have!
increased!scrutiny!sometimes!approaching!that!of!rules!(Seiguer!&!Smith,!2005).!!
! 149!
Another!possible!reason!why!more!guidance!documents!are!not!written!is!the!
decision!of!whether!to!issue!a!rule!versus!guidance!can!be!even!more!important!
than!the!guidance!making!process!itself!because!of!the!signals!that!each!can!send.!!
Rulemaking!versus!guidance!will!define!the!scope!of!enforcement!authority!the!FDA!
has!going!forward!and!its!flexibility!to!adapt!to!technological!advancements!in!the!
field!(Lewis,!2011;!Seiguer!&!Smith,!2005).!
5.9. Future)Direction)of)Cosmetics/Cosmeceutical)Legislation )
! In!the!meantime!until!the!FDA!decides!how!to!regulate!cosmeceuticals!
differently,!increased!lobbying!by!consumer!advocacy!groups!is!undoubtedly!
influencing!potential!legislation.!!Additionally,!legislative!action!at!the!state!level!
may!have!the!potential!to!affect!how!FDA!regulations!are!promulgated!going!
forward!(Mason,!2008).!!Although!these!questions!were!not!specifically!addressed!
by!this!research!topic,!within!the!last!few!months,!a!new!regulatory!framework!for!
cosmetics!has!been!proposed!at!the!federal!level!by!Senators!Dianne!Feinstein!(D^
CA)!and!Susan!Collins!(R^ME)!in!the!form!of!the!newly!introduced!Personal!Care!
Products!Safety!Act,!a!bill!to!amend!the!FD&C!Act!to!ensure!the!safety!of!cosmetics.!!
The!bill!has!commonality!with!the!Safe!Cosmetics!and!Personal!Care!Products!Act!of!
2013,!previously!introduced!by!Rep.!Janice!D.!Schakowsky!(D^IL^9),!and!it!includes!
provisions!such!as!mandatory!cosmetics!registration,!user!fees!and!adverse!event!
reporting,!among!others!("Personal!Care!Products!Safety!Act,"!2015^2016;!"Safe!
Cosmetics!and!Personal!Care!Products!Act!of!2013,"!2013^2014).!!So!far!the!bill!has!
! 150!
the!support!of!the!Personal!Care!Products!Council!and!the!Environmental!Working!
Group!(EWG)!but!its!feasibility!is!still!being!debated!by!the!cosmetics!industry.!!In!
the!past,!initiatives!to!amend!cosmeceutical!regulations!have!been!unsuccessful!and!
it!is!unclear!whether!this!bill!will!gain!traction!after!the!presidential!elections!in!
2016.!!However,!any!ultimate!change!to!cosmetic!regulations!must!balance!the!
interests!of!multiple!stakeholders,!including!consumers.!!Although!this!research!
focused!on!the!views!of!the!cosmetic!industry!with!respect!to!cosmeceutical!
regulations,!it!is!easy!to!lose!sight!of!the!ultimate!goal!of!the!cosmetic!rules!–!to!
protect!the!health^related!and!economic!interests!of!consumers.!!As!stated!by!
Kawalek!in!2005,!!
It's!logical!that!the!FDA!is!choosing!to!focus!on!potentially!harmful!or!life^
altering!drugs!rather!than!anti^aging!creams.!But!by!doing!so,!it!is!ignoring!a!
primary!purpose!of!the!1938!act—to!protect!the!economic!interests!of!
consumers!(Kawalek,!2005).!!
! Consumers!often!take!for!granted!that!cosmeceuticals!are!subject!to!similar!
regulations!as!drugs.!!For!example,!according!to!a!2004!survey!conducted!by!the!
National!Consumers!League,!6!out!of!10!adults!think!that!the!FDA!tests!anti^aging!
products!for!safety!and!efficacy,!when!that!is!not!the!case!(Kawalek,!2005).!!As!also!
stated!by!Mason!in!2008,!!
By!inadequately!regulating!the!cosmetic!industry,!the!FDA,!whose!mission!
statement!is!to!protect!the!public!health!is!failing!the!American!public!by!its!
inadequate!regulation!of!the!cosmetic!industry!(Mason,!2008)!
! 151!
However,!according!to!the!FDA!Consumer!Updates!page,!the!FDA!has!stepped!up!its!
efforts!to!inform!consumers!about!what!constitutes!a!cosmetic!versus!a!drug!claim!
and!even!provides!examples.!!In!the!article,!“Are!Some!Cosmetics!Promising!Too!
Much”,!Dr.!Katz!explains!that!cosmeceutical!claims!are!not!pre^approved!by!the!FDA,!
and!that!the!agency!must!evaluate!any!cosmetic!product!making!claims!about!
changing!the!skin!or!treating!disease!as!drugs!prior!to!being!placed!on!the!market!
(U.S.!Food!and!Drug!Administration,!2015a).!
5.10. Conclusion)
! Surprisingly,!in!spite!of!the!lack!of!well^defined!regulatory!pathways!for!
cosmeceuticals,!the!results!of!this!survey!show!that!the!respondents!are!almost!
evenly!split!in!their!level!of!satisfaction/dissatisfaction!with!the!current!system!for!
regulating!them.!!However,!most!respondents!agreed!that!more!regulation!for!
cosmeceuticals!is!needed.!!What!that!is!going!to!resemble!in!the!future!still!needs!to!
be!decided!by!the!cosmetics!industry!and!the!FDA.!!Results!here!suggest!that!
whatever!is!proposed!as!a!policy!change!will!face!a!mixed!audience!with!very!
different!views.!!Options,!as!suggested!by!the!literature,!include!changing!the!
definitions!of!cosmetic!and!drugs,!adding!a!cosmeceutical!category!to!the!
regulations!or!implementing!new!regulations!specifically!to!address!cosmeceutical!
pre^market!testing!for!safety!and!efficacy!(Farren,!2008;!Mason,!2008).!!!
! On!the!legislative!front,!pending!cosmetics!legislation!proposes!new!
requirements!for!cosmetics!similar!to!that!of!drugs,!including!user!fees,!mandatory!
! 152!
establishment!registration!and!adverse!event!reporting!("Personal!Care!Products!
Safety!Act,"!2015^2016).!!However,!the!outcome!of!this!legislation!will!most!likely!
not!be!decided!until!after!the!2016!presidential!elections.!!Whatever!is!decided!will!
likely!have!two!distinct!outcomes:!1)!it!will!modernize!the!FDA’s!authority!on!
cosmetics!and!by!extension!cosmeceutical!products!going!forward,!which!I!see!as!a!
positive,!and!2)!as!with!other!highly!regulated!products,!it!may!shift!the!added!costs!
related!to!compliance!onto!the!consumer,!an!unfortunate!but!not!novel!
circumstance.!!
!
!
! 153!
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! 164!
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Drug!Claims!Made!for!Products!Marketed!as!Cosmetics.!Guidance,$Compliance$
&$Regulatory$Information:$Compliance$and$Enforcement.!!Retrieved!from!
http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation
/ComplianceEnforcement/WarningLetters/ucm081086.htm!
!
!
! 165!
Appendix)A:)Decision)Tree)for)NDI)Notifications )
!
! 166!
Appendix)B:)Draft)Survey)
The!following!survey!seeks!to!understand!the!views!of!the!cosmetic!industry!with!
regard!to!the!impact!of!cosmeceutical!regulations!in!the!United!States.!!It!is!a!part!of!
research!associated!with!the!Doctor!of!Regulatory!Science!degree!at!the!University!
of!Southern!California.!!Toward!the!end!of!the!survey,!there!will!be!an!option!to!
voluntary!participate!in!a!follow^up!phone!interview.!!Your!answers!are!important!
to!the!success!of!this!study.!!Survey!responses!are!completely!anonymous.!!Thank!
you!for!your!participation.!!
!
Q1!Which!occupational!category!best!describes!your!most!recent!employer?!
! Manufacturer!of!finished!cosmetic!products!
! Distributor!of!finished!cosmetic!products!
! Manufacturer!and!distributor!of!finished!cosmetic!products!!
! Manufacturer!of!cosmetic!ingredients!!
! Distributor!of!cosmetic!ingredients!!
! Manufacturer!and!distributor!of!cosmetic!ingredients!!
! Other!!____________________!
!
Q2!Which!category!best!represents!the!product!assortment!of!your!most!recent!
employer?!
! Skin!care!cosmetics:!including!face!and!body!moisturizers,!anti^aging!products,!
and!cleansers!!
! Hair!care!cosmetics:!including!shampoos,!conditioners,!and!hair!treatments!!
! Color!cosmetics:!including!eye,!face,!lip!and!nail!care!!
!
Q3!What!is!the!company!size!of!your!most!recent!employer!in!terms!of!number!of!
employees?!
! 1^49!!
! 50^499!!
! 500^999!!
! Over!1,000!!
! Do!not!know!!
!
! 167!
Q4!What!is!your!primary!occupation?!
! Marketing!or!Sales!!
! Regulatory!or!Legal!Affairs!!
! Other!!____________________!
!
Q5!Please!indicate!your!level!of!experience:!
! 1!year!or!less!!
! Over!1!year!but!less!than!5!years!!
! Over!5!years!but!less!than!10!years!!
! Over!10!years!but!less!than!20!years!!
! Over!20!years!!
!
Q6!Please!indicate!your!level!of!familiarity!with!the!following!U.S.!regulatory!
systems.!
! Very!
Familiar!!
Familiar!! Somewhat!
Familiar!!
Somewhat!
Unfamiliar!!
Unfamiliar!! Very!
Unfamiliar!!
New!Drug!
Application!
(NDA)!
Submissions!
in!the!U.S.!!
! ! ! ! ! ! ! ! ! ! ! !
OTC!Drug!
Monograph!
Process!in!
the!U.S.!!
! ! ! ! ! ! ! ! ! ! ! !
Dietary!
Supplement!
Regulations!
in!the!U.S.!!
! ! ! ! ! ! ! ! ! ! ! !
!
!
! 168!
Q7!The!Federal!Food,!Drug!and!Cosmetic!Act!("FD&C!Act"!or!“the!Act”)!does!not!
recognize!cosmeceuticals!as!a!valid!product!category.!!A!product!can!either!be!a!
drug,!a!cosmetic,!or!a!combination!of!the!two!e.g.,!an!anti^dandruff!shampoo,!but!the!
term!"cosmeceutical"!has!no!meaning!under!the!law!(U.S.!Food!and!Drug!
Administration,!2002).!!If!a!cosmetic!product!is!purported!to!have!therapeutic!or!
drug!properties,!the!FDA!must!approve!it!as!a!drug.!!Please!indicate!your!level!of!
agreement!or!disagreement!to!the!following!statements!based!on!the!FDA's!opinion.!
! Strongly!
Agree!!
Agree!! Neither!
Agree!nor!
Disagree!!
Disagree!! Strongly!
Disagree!!
Cannot!
Comment!!
Cosmeceuticals!
should!be!held!
to!the!same!
standards!as!
pharmaceuticals!
with!respect!to!
clinical!evidence!
requirements!of!
efficacy!and!
safety.!!
! ! ! ! ! ! ! ! ! ! ! !
The!current!
environment!for!
regulating!
cosmeceuticals!
in!the!U.S.!
encourages!
product!
innovation!and!
research!among!
the!cosmetic!
industry.!!
! ! ! ! ! ! ! ! ! ! ! !
The!FD&C!Act!
should!be!
amended!to!
include!
cosmeceuticals!
as!a!valid!
product!
category.!!
! ! ! ! ! ! ! ! ! ! ! !
The!definitions!
for!a!cosmetic!
and!a!drug!
should!be!
revised!in!the!
FD&C!Act.!!
! ! ! ! ! ! ! ! ! ! ! !
!
! 169!
!
Q8!In!the!U.S.,!OTC!drugs!are!developed!under!the!monograph!process!or!via!a!New!
Drug!Application!(NDA)!submission.!!The!Division!of!Nonprescription!Regulation!
Development!(DNRD)!in!the!Office!of!Drug!Evaluation!IV!is!responsible!for!
the!development!of!the!OTC!drug!monographs.!!On!the!other!hand,!a!company!
seeking!to!market!its!product!OTC,!either!directly!or!as!a!switch!from!prescription,!
must!submit!a!NDA!to!the!Division!of!Nonprescription!Clinical!Evaluation!(DNCE),!
also!in!the!Office!of!Drug!Evaluation!IV.!!Please!indicate!your!level!of!agreement!or!
disagreement!to!the!following!statements!based!on!the!OTC!drug!development!
process.!!!
! Strongly!
Agree!!
Agree!! Neither!
Agree!nor!
Disagree!!
Disagree!! Strongly!
Disagree!!
Cannot!
Comment!!
Many!
cosmeceutical!
claims!are!as!a!
direct!result!of!
the!OTC!
monographs!
that!have!not!yet!
been!finalized.!!
! ! ! ! ! ! ! ! ! ! ! !
The!current!OTC!
monograph!
process!is!
efficient,!allows!
for!product!
innovation!and!
is!designed!to!
respond!quickly!
to!newly!
emerging!
information.!!
! ! ! ! ! ! ! ! ! ! ! !
The!existing!OTC!
monographs,!
whether!
tentative!or!
final,!should!be!
revised!to!
include!
cosmeceutical!
ingredients.!!
! ! ! ! ! ! ! ! ! ! ! !
Cosmeceutical!
products!should!
be!required!to!
carry!a!
Cosmeceutical!
Facts!box!similar!
! ! ! ! ! ! ! ! ! ! ! !
! 170!
to!the!Drug!
Facts!box!for!
OTC!drugs.!!
Manufacturers!
and!distributors!
of!
cosmeceuticals!
should!be!
required!to!
submit!a!NDA!to!
the!DNCE!in!
order!to!market!
their!
cosmeceutical!
product!as!an!
OTC!drug.!!
! ! ! ! ! ! ! ! ! ! ! !
!
!
Q9!If!a!new!monograph!process!were!to!be!established!for!regulating!
cosmeceuticals,!which!Center!in!the!FDA!should!be!responsible!for!developing!these!
monographs?!
! Division!of!Nonprescription!Regulation!Development!(DNRD)!!
! Center!for!Drug!Evaluation!and!Research!(CDER)!!
! Center!for!Food!Safety!and!Applied!Nutrition!(CFSAN)!!
! A!new!center!should!be!established!!
! Do!not!agree!to!a!new!monograph!process!!
!
! 171!
Q10!In!the!U.S.,!dietary!supplement!legislation!requires!manufacturers!and!
distributors!of!"new!dietary!ingredients"!not!on!the!market!prior!to!October!15,!
1994!when!the!legislation!was!enacted,!to!submit!a!safety!notification!to!the!Center!
for!Food!Safety!and!Applied!Nutrition!(CFSAN)!in!the!FDA,!at!least!75!days!before!
introducing!the!new!ingredient!into!interstate!commerce.!!If!the!FDA!has!no!
objections!to!the!notification,!the!non^proprietary!information!contained!in!the!
notification!would!be!placed!on!public!display!after!the!time!period!has!elapsed.!
!Would!you!agree!to!a!similar!legislation!in!which!manufacturers/distributors!of!
"new!cosmeceutical!ingredients"!introduced!after!a!legislation!passes!to!be!subject!
to!this!requirement!before!being!able!to!sell!their!cosmeceutical!ingredient!for!use!
in!a!cosmetic!product?!
! Strongly!Agree!!
! Agree!!
! Neither!Agree!nor!Disagree!!
! Disagree!!
! Strongly!Disagree!!
! Cannot!Comment!!
!
Q11!If!you!agree!with!the!above!question,!who!should!review!this!safety!
notification?!!
! Center!for!Food!Safety!and!Applied!Nutrition!(CFSAN)!!
! Division!of!Nonprescription!Clinical!Evaluation!(DNCE)!!
! A!new!center!should!be!established!in!the!FDA!!
! The!safety!notification!should!be!sent!to!a!qualified!third!party!and!not!the!FDA!!
! Do!not!agree!to!a!similar!legislation!!
!
Q12!If!you!do!not!agree!with!question!19,!please!take!a!moment!to!explain!why!not.!
! ! ! ! ! ! ! ! ! ! ! ! !
!
Q13!Dietary!supplement!legislation!also!permits!manufacturers!and!distributors!of!
dietary!supplements!to!make!"qualified!health!claims",!which!show!the!relationship!
between!a!dietary!supplement!and!the!reduced!risk!of!a!disease!or!health^related!
condition.!!In!this!instance,!scientific!evidence!by!a!reputable!body!is!neither!
available!nor!well!established.!Therefore,!qualifying!language!is!included!as!part!of!
the!claim.!!Should!the!cosmetic!industry!be!allowed!to!make!qualified!health!claims!
on!their!cosmeceutical!products?!!In!either!response,!please!take!a!moment!to!
explain!the!reason(s)!for!your!answer.!
! Yes!!____________________!
! No!!____________________!
!
! 172!
Q14!The!FTC!requires!any!health^related!claims!to!be!supported!with!"competent!
and!reliable!scientific!evidence,"!defined!in!FTC!cases!as!"tests,!analyses,!research,!
studies,!or!other!evidence!based!on!the!expertise!of!professionals!in!the!relevant!
area,!that!have!been!conducted!and!evaluated!in!an!objective!manner!by!persons!
qualified!to!do!so,!using!procedures!generally!accepted!in!the!profession!to!yield!
accurate!and!reliable!results".!!Consider!one!such!cosmeceutical!product!marketed!
by!your!previous!employer,!where!claims!development!was!particularly!challenging.!
!Do!you!think!that!the!burden!of!proof,!as!defined!by!the!FTC,!was!met!for!this!
product?!
! Yes!!
! No!!
!
This!section!of!the!survey!focuses!on!the!cosmetic!industry's!response!to!the!
regulation!of!cosmeceuticals!in!the!United!States.!!For!purposes!of!this!survey,!a!
cosmeceutical!is!defined!as,!"any!substance!that!meets!the!definition!of!a!cosmetic!
but!is!purported!or!marketed!as!having!therapeutic!or!drug!properties".!
!
Q15!The!following!is!a!list!of!examples!of!claims!made!on!cosmetic!products!or!
ingredients!by!the!cosmetic!industry.!!Please!check!all!those!that!you!think!are!
cosmeceutical!claims.!!
" Skin!looks!smoother,!firmer!and!more!resilient!!
" Clinically!proven!to!reduce!breakouts!and!blemishes!by!84%!!
" Reverses!visible!signs!of!sun!damage!!
" Dramatically!reduces!the!look!of!multiple!signs!of!aging,!including!fine!lines,!
wrinkles,!loss!of!firmness,!dullness!and!dehydrated!skin!!
" See!significant!deep!wrinkle!reduction!in!UV!damaged!skin,!clinically!proven!!
" Restore!skin's!youth^boosting!trio!of!collagen,!hyaluronic!acid!and!elastin!!
" Hair!feels!twice!as!full,!twice!as!thick!!
" Strengthens!and!lengthens!eyelashes!in!as!little!as!two!weeks!!
" Boosts!the!activity!of!genes!and!stimulates!the!production!of!youth!proteins!!
" The!first!Topical^Injectable!alternative!to!doctor^administered!anti^wrinkle!
injections:!proven!more!effective!than!Botox®!in!a!clinical!study!!
!
Q16!Does!your!most!recent!employer!market!cosmetic!products!or!ingredients!with!
claims!similar!to!any!of!those!checked!above!in!the!U.S.?!
! Yes!!
! No!!
If!Yes!is!selected,!then!survey!skips!Q17.!!If!No!is!selected,!answer!Q17!then!continue!to!Q18.!
!
! 173!
Q17!Into!what!category(ies)!do/does!the!cosmetic!products!or!ingredients!of!your!
most!recent!employer!fall?!!Please!check!all!that!apply.!
" Anti^wrinkle/Wrinkle!Reduction!!
" Skin!Lightener!!
" Anti^oxidation!!
" Exfoliation!!
" Collagen!Improvement/Synthesis!!
" Pore!Size!Reduction!!
" Cellular!Regeneration!!
" Skin!Firming!!
" Cellulite!and!Stretch!Mark!Reduction!!
" Hair!Restoration!and!Regrowth!!
" Eyelash!Regrowth!!
" Other!!____________________!
!
Q18!Please!indicate!how!many!cosmetic!products!or!ingredients!in!total!your!most!
recent!employer!markets!with!cosmeceutical!claims!in!the!U.S.?!
! 1^5!!
! 5^10!!
! 10^20!!
! More!than!20!!
! Do!not!know!/!Not!applicable!!
!
Q19!If!your!most!recent!employer!also!markets!these!products!overseas,!do!they!
change!the!claims!language!used!on!the!packaging!or!advertising!materials?!
! Yes!!
! No!!
! Not!applicable!!
!
Q20!Based!on!your!most!recent!employer,!how!likely!is!a!company!to!view!the!
claims!of!their!competitors!when!deciding!how!to!position!their!cosmetic!product!or!
ingredients!with!cosmeceutical!claims!in!the!U.S.?!
! Very!Likely!!
! Likely!!
! Undecided!!
! Unlikely!!
! Very!Unlikely!!
! Cannot!Comment!!
!
! 174!
Q21!In!2012,!two!large!cosmetic!companies!Avon!Products!and!Lancôme!USA!
received!warning!letters!from!the!FDA!for!marketing!their!cosmetic!products!with!
drug!claims.!!In!response!to!this!regulatory!action,!did!your!most!recent!employer!
change!the!claims!language!used!on!their!product!packaging?!
! Yes!!
! No!!
If!Yes!is!selected,!then!survey!skips!Q22.!!If!No!is!selected,!answer!Q22!then!continue!to!Q23.!
!
Q22!Please!indicate!the!reason(s)!why!your!most!recent!employer!did!not!change!
the!claims!language!used!on!their!product!packaging?!!Please!check!all!that!apply.!
" Too!costly!to!implement!!
" Too!time^consuming!to!implement!!
" Not!concerned!about!regulatory!action!from!the!FDA!!
" Not!willing!to!lose!market!competitiveness!!
" Their!competitors!did!not!change!the!claims!language!on!their!product!
packaging!!
" All!of!the!above!!
" Other!!____________________!
!
Q23!How!long!did!it!take!your!most!recent!employer!to!implement!that!change!i.e.,!
updated!packaging!was!ready!to!ship?!
! Less!than!6!months!!
! 6^12!months!!
! 1^2!years!!
! Over!2!years!!
! Do!not!know!/!Not!applicable!!
!
Q24!What!was!the!estimated!cost!of!that!change?!
! Less!than!$10,000!!
! $10,001!to!$50,000!!
! $50,001!to!$100,000!!
! Over!$100,000!!
! Do!not!know!/!Not!applicable!!
!
! 175!
Q25!Based!on!your!most!recent!employer,!please!indicate!the!frequency!in!which!
you!think!the!following!situations!occur.!
! Always!! Very!Often!! Occasionally!! Never!! Cannot!
Comment!!
Cosmetic!companies!
register!their!cosmetic!
product!ingredient!
statements!with!the!FDA!
via!the!Voluntary!Cosmetic!
Registration!Program!
(VCRP).!!
! ! ! ! ! ! ! ! ! !
Cosmetic!companies!test!
their!finished!products!for!
safe!use!in!humans.!!
! ! ! ! ! ! ! ! ! !
The!FDA!exercises!
discretion!when!deciding!to!
issue!warning!letters!to!
companies!marketing!their!
cosmetic!products!with!
drug!claims.!!
! ! ! ! ! ! ! ! ! !
A!lack!of!enforcement!
action!by!the!FDA!is!
creating!an!unequal!playing!
field!for!small,!medium!and!
large!sized!cosmetic!
companies.!!
! ! ! ! ! ! ! ! ! !
!
!
! 176!
Q26!Based!on!your!most!recent!employer,!please!choose!the!product!category!that!
you!think!best!matches!the!following!statements.!
! Skin!care!
Cosmetics!!
Hair!care!
Cosmetics!!
Color!
Cosmetics!!
Cannot!
Comment!!
Faced!with!the!biggest!
challenge!of!
cosmeceutical!claims!
development.!!
! ! ! ! ! ! ! !
Has!the!biggest!share!of!
the!retail!cosmeceutical!
market.!!
! ! ! ! ! ! ! !
Most!likely!to!garner!
the!attention!of!the!FDA!
for!strong!
cosmeceutical!claims.!!
! ! ! ! ! ! ! !
Marketed!with!the!
strongest!cosmeceutical!
claims.!!
! ! ! ! ! ! ! !
!
!
Q27!Please!rank!the!order!in!which!you!think!different!sized!companies!benefit!from!
the!current!regulations!for!cosmeceuticals!in!the!U.S.,!with!1!benefiting!the!most!and!
3!benefiting!the!least.!!
______!Small!companies!!
______!Medium!companies!!
______!Large!companies!!
!
Q28!In!your!opinion,!why!do!you!think!cosmetic!companies!market!their!cosmetic!
products!or!ingredients!with!cosmeceutical!claims!in!the!U.S.?!
! ! ! ! ! ! ! ! ! ! ! ! !
!
Q29!How!satisfied!are!you!with!the!current!system!for!regulating!cosmeceuticals!in!
the!U.S.?!
! Very!Satisfied!!
! Satisfied!!
! Neutral!!
! Dissatisfied!!
! Very!Dissatisfied!!
! Cannot!Comment!!
!
Q30!What,!if!anything,!would!you!change!about!the!current!system!for!regulating!
cosmeceuticals!in!the!U.S.,!in!order!to!improve!it?!
! ! ! ! ! ! ! ! ! ! ! ! !
! 177!
!
Q31!Would!you!agree!to!participate!in!a!15^20!minute!phone!interview!to!further!
discuss!the!impact!of!cosmeceutical!regulations!on!the!cosmetic!industry!in!the!
United!States?!!If!so,!please!provide!your!contact!information.!
! Yes!!____________________!
! No!!
!
You!are!almost!to!the!end!of!the!survey.!!There!are!a!few!more!questions!on!
different!international!regulatory!models!that!may!provide!alternatives!to!the!
current!U.S.!systems.!!If!you!feel!comfortable!in!this!area,!I!appreciate!you!taking!the!
time!to!answer!these!questions.!
!
Q32!Please!indicate!your!level!of!familiarity!with!the!following!international!
regulatory!systems.!
! Very!
Familiar!!
Familiar!! Somewhat!
Familiar!!
Somewhat!
Unfamiliar!!
Unfamiliar!! Very!
Unfamiliar!!
Cosmetics!
Regulation!
(EC)!No.!
1223/2009!
in!Europe!!
! ! ! ! ! ! ! ! ! ! ! !
Natural!
Health!
Product!
(NHP)!
Regulations!
in!Canada!!
! ! ! ! ! ! ! ! ! ! ! !
Registration!
of!Quasi^
drugs!in!
Japan!!
! ! ! ! ! ! ! ! ! ! ! !
!
!
! 178!
Q33!In!your!opinion,!which!aspect(s)!of!the!European!regulation!would!be!the!most!
beneficial!to!informing!cosmeceutical!regulatory!policy!in!the!U.S.?!!Please!check!all!
that!apply.!
" Product!Information!File!!
" Cosmetic!Product!Safety!Report!!
" Cosmetic!Product!Notification!Portal!!
" Serious!Undesirable!Effect!Reporting!!
" Safety!Assessor!!
" Responsible!Person!!
" All!of!the!above!!
" Other!!____________________!
!
Q34!In!their!November!2012!guidance!document!“The!Approach!to!Natural!Health!
Products”,!the!Natural!Health!Product!Directorate!(NHPD)!outlined!a!three^class!
system!for!NHPs!based!on!their!known!risks!and!benefits.!!This!information!was!
collected!from!over!70,000!NHPs!already!authorized!on!the!market.!!A!monograph!
system!was!introduced!for!the!least!risk!Class!I!and!II!products,!which!have!review!
times!of!10!and!30!days!respectively.!!Whereas,!the!riskiest!class!III!products!are!
subject!to!the!longest!review!time!of!180!days.!!Should!the!FDA!establish!a!class^
based!system!for!cosmeceutical!products!based!on!their!known!risks!and!benefits?!
! Strongly!Agree!!
! Agree!!
! Neither!Agree!nor!Disagree!!
! Disagree!!
! Strongly!Disagree!!
! Cannot!Comment!!
!
Q35!In!Japan,!the!safety,!efficacy!and!stability!data!submitted!for!approval!of!a!
quasi^drug!is!based!on!the!dose!level,!dosage!form!and!intended!effect!on!the!body!
of!the!active!ingredient,!and!not!the!quasi^drug!as!a!whole.!!Should!manufacturers!
and!distributors!of!cosmetic!products!and!ingredients!marketed!with!cosmeceutical!
claims!be!required!to!submit!similar!data!for!their!"active"!cosmeceutical!
ingredient(s)!and!not!the!cosmeceutical!product!as!whole?!
! Strongly!Agree!!
! Agree!!
! Neither!Agree!nor!Disagree!!
! Disagree!!
! Strongly!Disagree!!
! Cannot!Comment!!
!
! 179!
Q36!Of!the!three!regulatory!systems,!please!rank!the!order!in!which!you!think!they!
are!beneficial!to!informing!cosmeceutical!regulatory!policy!in!the!U.S.,!with!1!being!
the!most!beneficial!and!3!being!the!least.!
______!Cosmetics!Regulation!(EC)!No.!1223/2009!in!Europe!!
______!Natural!Health!Product!(NHP)!Regulations!in!Canada!!
______!Registration!of!Quasi^drugs!in!Japan!!
!
!
! 180!
Appendix)C:)Final)Survey)
The!following!survey!seeks!to!understand!the!views!of!the!cosmetic!industry!with!
regard!to!cosmeceutical!regulations!in!the!United!States.!!It!is!part!of!research!
associated!with!the!Doctor!of!Regulatory!Science!degree!at!the!University!of!
Southern!California.!!Your!answers!are!important!to!the!success!of!this!study!and!
are!completely!anonymous.!!Toward!the!end!of!the!survey,!there!will!be!an!option!to!
voluntarily!participate!in!a!follow^up!phone!interview.!!Thank!you!in!advance!for!
your!participation.!
!
Q1!Which!industry!describes!your!most!recent!employer!or!client?!!Check!all!that!
apply.!
" Manufacturer!of!finished!cosmetic!products!
" Distributor!of!finished!cosmetic!products!
" Manufacturer!of!cosmetic!ingredients!
" Distributor!of!cosmetic!ingredients!
" Other!____________________!
!
Q2!Which!category!describes!the!product!assortment!of!your!most!recent!employer!
or!client?!!Check!all!that!apply.!
" Skin!care!cosmetics:!including!face!and!body!moisturizers,!anti^aging!products,!
and!cleansers!
" Hair!care!cosmetics:!including!shampoos,!conditioners,!and!hair!treatments!
" Color!cosmetics:!including!eye,!face,!lip!and!nail!care!
!
Q3!How!many!people!currently!work!for!your!most!recent!employer!or!client?!
! 1^49!
! 50^499!
! 500^999!
! ≥1,000!
! Do!not!know!
!
! 181!
Q4!What!is!your!primary!job!function?!
! Marketing!
! Product!Development!
! Regulatory!Affairs!
! Legal!
! Other!____________________!
!
Q5!Please!indicate!your!level!of!experience!within!the!cosmetic!industry:!
! <1!year!
! 1^5!years!
! 6^10!years!
! 11^20!years!
! >20!years!
!
Q6!Please!indicate!your!level!of!familiarity!with!the!following!U.S.!regulatory!
systems.!
! Very!Familiar!! Somewhat!Familiar!! Unfamiliar!
New!Drug!
Applications!(NDAs)!
! ! ! ! ! !
Abbreviated!New!Drug!
Applications!(ANDAs)!
! ! ! ! ! !
OTC!Drug!Monographs! ! ! ! ! ! !
Cosmetic!Regulations! ! ! ! ! ! !
New!Dietary!
Ingredient!
Notifications!
! ! ! ! ! !
!
!
! 182!
Q7!The!Federal!Food,!Drug!and!Cosmetic!Act!("FD&C!Act"!or!“the!Act”)!does!not!
recognize!cosmeceuticals!as!a!valid!product!category.!!A!product!can!either!be!a!
drug,!a!cosmetic,!or!a!combination!of!the!two.!!Please!indicate!your!level!of!
agreement!or!disagreement!to!the!following!statements!based!on!the!FD&C!Act.!
! Agree! Neither!Agree!
nor!Disagree!
Disagree! Cannot!Comment!
Cosmeceuticals!
should!be!held!to!
the!same!
standards!as!
pharmaceuticals!
with!respect!to!
clinical!evidence!
requirements!of!
efficacy!and!safety.!
! ! ! ! ! ! ! !
The!current!
environment!for!
regulating!
cosmeceuticals!in!
the!U.S.!
encourages!
product!
innovation!in!the!
cosmetic!industry.!
! ! ! ! ! ! ! !
The!FD&C!Act!
should!be!
amended!to!
include!
cosmeceuticals!as!
a!valid!product!
category.!
! ! ! ! ! ! ! !
The!definition!of!a!
cosmetic!should!
be!revised!in!the!
FD&C!Act.!
! ! ! ! ! ! ! !
The!definition!of!a!
drug!should!be!
revised!in!the!
FD&C!Act.!
! ! ! ! ! ! ! !
!
!
!
!
!
!
! 183!
Q8!In!the!U.S.,!OTC!drugs!are!marketed!either!via!monograph!or!under!an!approved!
NDA.!!The!newly!organized!Division!of!Nonprescription!Drug!Products!(DNDP)!is!
responsible!for!both!NDA!oversight!and!the!development!of!the!OTC!drug!
monographs.!!Do!you!agree!or!disagree!with!the!following!statements!regarding!
these!processes?!
! Agree! Neither!Agree!
nor!Disagree!
Disagree! Cannot!Comment!
Many!
cosmeceutical!
claims!are!as!a!
direct!result!of!the!
OTC!monographs!
that!have!not!yet!
been!finalized.!
! ! ! ! ! ! ! !
The!existing!OTC!
monographs!
should!be!revised!
to!include!
cosmeceutical!
ingredients.!
! ! ! ! ! ! ! !
A!monograph!
process!should!be!
established!
separately!for!
cosmeceuticals.!
! ! ! ! ! ! ! !
Cosmeceutical!
products!should!
be!required!to!
carry!a!
Cosmeceutical!
Facts!box!similar!
to!the!Drug!Facts!
box!for!OTC!drugs.!
! ! ! ! ! ! ! !
Manufacturers!
and!distributors!of!
cosmeceuticals!
should!be!
required!to!submit!
NDAs!to!DNDP!in!
order!to!market!
their!
cosmeceutical!
products!as!OTC!
drugs.!
! ! ! ! ! ! ! !
!
!
! 184!
Q9!If!a!new!monograph!process!was!to!be!established!for!regulating!cosmeceuticals,!
which!department!in!the!FDA!should!be!responsible!for!developing!these!
monographs?!
! Division!of!Nonprescription!Drug!Products!(DNDP)!
! Center!for!Food!Safety!and!Applied!Nutrition!(CFSAN)!
! A!new!center!should!be!established!
! Do!not!agree!to!a!new!monograph!process!
! Cannot!comment!
!
Q10!In!the!U.S.,!dietary!supplement!legislation!requires!manufacturers!and!
distributors!of!"new!dietary!ingredients"!to!submit!a!pre^market!notification!to!
FDA.!!If!the!FDA!has!no!objections!to!the!notification!after!75!days,!the!ingredient!
can!be!marketed.!!Would!you!agree!to!a!similar!legislation!under!
which!manufacturers/distributors!of!"new!cosmeceutical!ingredients"!would!be!
subject!to!this!same!requirement?!
! Agree!
! Neither!Agree!nor!Disagree!!
! Disagree!
! Cannot!Comment!
!
Q11!If!you!agree!with!the!above!question,!who!should!review!this!safety!
notification?!!
! Center!for!Food!Safety!and!Applied!Nutrition!(CFSAN)!
! A!new!center!should!be!established!in!the!FDA!
! The!safety!notification!should!be!sent!to!a!qualified!third!party!and!not!the!FDA!
! Do!not!agree!to!a!similar!legislation!
! Cannot!comment!
!
Q12!If!you!do!not!agree!with!question!19,!please!take!a!moment!to!explain!why!not.!
! ! ! ! ! ! ! ! ! ! ! ! !
!
Q13!Dietary!supplement!legislation!also!permits!companies!to!make!"qualified!
health!claims"!regarding!the!role!of!a!dietary!supplement!in!reducing!the!risk!of!a!
disease!or!health^related!condition,!even!though!scientific!evidence!is!still!
emerging.!!Should!the!cosmetic!industry!be!allowed!to!make!qualified!health!claims!
on!cosmeceutical!products?!!If!you!can,!please!take!a!moment!to!explain!your!
answer.!
! Yes!____________________!
! No!____________________!
!
! 185!
Q14!The!FTC!requires!any!health^related!claims!to!be!supported!with!"competent!
and!reliable!scientific!evidence,"!defined!as!"tests,!analyses,!research,!studies,!or!
other!evidence!based!on!the!expertise!of!professionals!in!the!relevant!area,!that!
have!been!conducted!and!evaluated!in!an!objective!manner!by!persons!qualified!to!
do!so,!using!procedures!generally!accepted!in!the!profession!to!yield!accurate!and!
reliable!results".!!Think!back!to!one!cosmeceutical!product!marketed!by!your!most!
recent!employer!or!client!where!claims!development!was!particularly!challenging.!
!Do!you!think!that!the!burden!of!proof,!as!defined!by!the!FTC,!was!met!for!this!
product?!
! Yes!
! No!
!
Q15!The!following!is!a!list!of!examples!of!claims!made!on!cosmetic!products!or!
ingredients!by!the!cosmetic!industry.!!Please!check!all!those!that!you!think!are!
cosmeceutical!claims.!!
" Skin!looks!smoother,!firmer!and!more!resilient!
" Clinically!proven!to!reduce!breakouts!and!blemishes!by!84%!
" Reverses!visible!signs!of!sun!damage!
" Dramatically!reduces!the!look!of!multiple!signs!of!aging,!including!fine!lines,!
wrinkles,!loss!of!firmness,!dullness!and!dehydrated!skin!
" See!significant!deep!wrinkle!reduction!in!UV!damaged!skin,!clinically!proven!
" Restore!skin's!youth^boosting!trio!of!collagen,!hyaluronic!acid!and!elastin!
" Hair!feels!twice!as!full,!twice!as!thick!
" Strengthens!and!lengthens!eyelashes!in!as!little!as!two!weeks!
" Boosts!the!activity!of!genes!and!stimulates!the!production!of!youth!proteins!
" The!first!Topical^Injectable!alternative!to!doctor^administered!anti^wrinkle!
injections:!proven!more!effective!than!Botox®!in!a!clinical!study!
!
Q16!Does!your!most!recent!employer!or!client!market!cosmetic!products!or!
ingredients!with!claims!similar!to!any!of!those!checked!above!in!the!U.S.?!
! Yes!
! No!
!
! 186!
Q17!How!many!cosmetic!products!or!ingredients!in!total!does!your!employer!or!
client!market!with!cosmeceutical!claims!in!the!U.S.?!
! 1^5!
! 6^10!
! 11^20!
! >20!
! Do!not!know!/!Not!applicable!
!
Q18!If!your!employer!or!client!also!markets!their!products!overseas,!do!they!change!
the!claims!language!used!on!the!packaging!or!advertising!materials?!
! Yes!!
! No!
! Do!not!know!/!Not!applicable!
!
Q19!Based!on!your!most!recent!experience,!how!likely!is!a!company!to!view!the!
claims!of!their!competitors!when!deciding!how!to!position!their!cosmetic!product!or!
ingredients!with!cosmeceutical!claims!in!the!U.S.?!
! Very!Likely!
! Likely!
! Unlikely!
! Very!Unlikely!
! Cannot!Comment!
!
Q20!If!any!of!your!employer's!or!client's!top!competitors!were!to!receive!a!warning!
letter!from!the!FDA!for!cosmeceutical!claims!similar!to!those!currently!marketed!on!
their!products,!would!you!recommend!that!they!immediately!update!their!product!
packaging!in!response!to!this!regulatory!action?!
! Yes!
! No!!
If!Yes!is!selected,!then!survey!skips!Q21.!!If!No!is!selected,!answer!Q21!then!continue!to!Q22.!
!
! 187!
Q21!Please!indicate!the!reason(s)!why!you!would!not!recommend!that!they!
immediately!update!their!product!packaging?!
" Too!costly!to!change!
" Too!time^consuming!to!change!
" Not!concerned!about!regulatory!action!from!the!FDA!
" Not!willing!to!lose!market!competitiveness!
" Other!competitors!did!not!change!the!claims!language!on!their!products!
" All!of!the!above!
" Other!____________________!
!
Q22!Generally!how!long!does!it!take!your!employer!or!client!to!update!a!product's!
packaging?!
! <6!months!
! 6^12!months!
! 1^2!years!
! >2!years!
! Do!not!know!/!Not!applicable!
!
Q23!How!much!on!average!does!it!cost!to!update!per!product?!
! <$10,000!
! $10,000!to!$49,999!
! $50,000!to!$99,999!
! ≥$100,000!
! Do!not!know!/!Not!applicable!
!
! 188!
Q24!Based!on!your!most!recent!experience,!please!indicate!how!often!do!you!think!
the!following!situations!occur.!
! Always! Very!Often! Occasionally! Never! Cannot!
Comment!
Cosmetic!companies!
register!their!
cosmetic!product!
ingredient!
statements!with!the!
FDA!via!the!
Voluntary!Cosmetic!
Registration!Program!
(VCRP).!
! ! ! ! ! ! ! ! ! !
They!test!their!
finished!products!for!
safe!use!in!humans.!
! ! ! ! ! ! ! ! ! !
They!follow!the!good!
manufacturing!
practice!(GMP)!
guidelines/inspection!
checklist!for!
cosmetics.!
! ! ! ! ! ! ! ! ! !
The!FDA!exercises!
discretion!when!
deciding!to!issue!
warning!letters!to!
companies!marketing!
their!cosmetic!
products!with!drug!
claims.!
! ! ! ! ! ! ! ! ! !
A!lack!of!enforcement!
action!by!the!FDA!is!
creating!an!unequal!
playing!field!for!
small,!medium!and!
large!sized!cosmetic!
companies.!
! ! ! ! ! ! ! ! ! !
!
!
! 189!
Q25!Based!on!your!most!recent!experience,!please!choose!the!product!category!that!
you!think!best!matches!the!following!statements.!
! Skin!care!
Cosmetics!
Hair!care!
Cosmetics!
Color!Cosmetics!! Cannot!
Comment!!
Are!faced!with!the!
biggest!challenge!
of!cosmeceutical!
claims!
development.!
! ! ! ! ! ! ! !
Have!the!biggest!
share!of!the!retail!
cosmeceutical!
market.!
! ! ! ! ! ! ! !
Are!most!likely!to!
garner!the!
attention!of!the!
FDA!for!strong!
cosmeceutical!
claims.!
! ! ! ! ! ! ! !
Are!marketed!
with!the!strongest!
cosmeceutical!
claims.!
! ! ! ! ! ! ! !
!
!
Q26!Please!rank!the!order!in!which!you!think!companies!of!different!sizes!benefit!
from!the!current!regulatory!environment!for!cosmeceuticals!in!the!U.S.!!Click!and!
drag!to!move.!
______!Small!companies!(<50!employees)!
______!Medium!companies!(>50!employees!but!<500)!!
______!Large!companies!(>500!employees)!
!
Q27!Please!rank!the!reasons!why!you!think!cosmetic!companies!market!their!
cosmetic!products!or!ingredients!with!cosmeceutical!claims!in!the!U.S.!!Click!and!
drag!to!move.!
______!Drive!sales!
______!Increase!market!competitiveness!
______!Permissive!regulatory!environment!
______!Satisfy!consumer!demand!
______!New!product!innovation!
!
! 190!
Q28!How!satisfied!are!you!with!the!current!system!for!regulating!cosmeceuticals!in!
the!U.S.?!
! Very!Satisfied!
! Satisfied!
! Dissatisfied!
! Very!Dissatisfied!
! Cannot!Comment!
!
Q29!In!your!opinion,!when!it!comes!to!cosmeceuticals,!should!there!be!more!
regulation,!less!regulation!or!is!the!current!system!sufficient?!
! More!regulation!
! Less!regulation!
! Current!system!is!sufficient!
! Cannot!Comment!
!
Q30!What,!if!anything,!would!you!change!about!the!current!system!for!regulating!
cosmeceuticals!in!the!U.S.,!in!order!to!improve!it?!
! ! ! ! ! ! ! ! ! ! ! ! !
!
Q31!Would!you!agree!to!participate!in!a!15^20!minute!phone!interview!to!further!
discuss!the!impact!of!cosmeceutical!regulations!on!the!cosmetic!industry!in!the!
United!States?!!If!so,!please!provide!your!contact!information.!
! Yes!____________________!
! No!
!
You!are!almost!to!the!end!of!the!survey.!!There!are!five!more!questions!on!different!
international!regulatory!models!that!may!provide!alternatives!to!the!current!U.S.!
system.!!I!appreciate!you!taking!the!time!to!answer!these!questions.!
!
Q32!Please!indicate!your!level!of!familiarity!with!the!following!international!
regulatory!systems.!
! Very!Familiar!! Somewhat!Familiar!! Unfamiliar!
Cosmetics!Regulation!
(EC)!No.!1223/2009!in!
Europe!!
! ! ! ! ! !
Natural!Health!
Product!(NHP)!
Regulations!in!Canada!
! ! ! ! ! !
Registration!of!Quasi^
drugs!in!Japan!!
! ! ! ! ! !
!
! 191!
!
Q33!In!your!opinion,!which!aspect(s)!of!the!European!regulation!would!be!the!most!
beneficial!to!informing!cosmeceutical!regulatory!policy!in!the!U.S.?!
" Product!Information!File!
" Cosmetic!Product!Safety!Report!
" Cosmetic!Product!Notification!Portal!
" Serious!Undesirable!Effect!Reporting!
" Safety!Assessor!
" Responsible!Person!
" All!of!the!above!
" Other!____________________!
" Cannot!Comment!!
!
Q34!In!2012,!the!Natural!Health!Product!Directorate!(NHPD)!outlined!a!three^class!
system!for!NHPs!based!on!their!known!risks!and!benefits.!!They!introduced!a!
monograph!system!for!the!less!risky!Class!I!and!II!products,!which!have!review!
times!of!10!and!30!days!respectively.!!However,!the!riskiest!class!III!products!are!
subject!to!a!review!time!of!180!days.!!Should!the!FDA!establish!a!similar!class^based!
system!for!cosmeceutical!products!based!on!their!known!risks!and!benefits?!
! Agree!
! Neither!Agree!nor!Disagree!
! Disagree!
! Cannot!Comment!
!
Q35!In!Japan,!the!safety,!efficacy!and!stability!data!submitted!for!approval!of!a!
quasi^drug!is!based!on!the!dose!level,!dosage!form!and!intended!effect!on!the!body!
of!the!active!ingredient,!and!not!the!quasi^drug!as!a!whole.!!Should!companies!that!
market!cosmeceutical!products!in!the!U.S.!be!required!to!do!the!same?!
! Agree!
! Neither!Agree!nor!Disagree!
! Disagree!
! Cannot!Comment!
!
Q36!Of!the!three!regulatory!systems,!please!rank!the!order!in!which!you!think!they!
are!beneficial!to!informing!cosmeceutical!regulatory!policy!in!the!U.S.!!Click!and!drag!
to!move.!
______!Cosmetics!Regulation!(EC)!No.!1223/2009!in!Europe!
______!Natural!Health!Product!(NHP)!Regulations!in!Canada!
______!Registration!of!Quasi^drugs!in!Japan!
!
! 192!
Appendix)D:)Survey)Results)
1.!!Which!industry!describes!your!most!recent!employer!or!client?!!Check!all!that!
apply.!
#! Answer! !!
!
Response! %!
1!
Manufacturer!of!
finished!
cosmetic!
products!
! !
!
38! 72%!
2!
Distributor!of!
finished!
cosmetic!
products!
! !
!
31! 58%!
3!
Manufacturer!of!
cosmetic!
ingredients!
! !
!
3! 6%!
4!
Distributor!of!
cosmetic!
ingredients!
!!
!
0! 0%!
5! Other! ! !
!
4! 8%!
!
Other!
Research!&!Development!
Retailer!
Attorney!to!companies!in!the!cosmetic!industry.!
Biotechnology!
!
Statistic! Value!
Min!Value! 1!
Max!Value! 5!
Total!Responses! 53!
!
!
! 193!
2.!!Which!category!describes!the!product!assortment!of!your!most!recent!employer!
or!client?!!Check!all!that!apply.!
#! Answer! !!
!
Response! %!
1!
Skin!care!
cosmetics:!
including!face!
and!body!
moisturizers,!
anti^aging!
products,!and!
cleansers!
! !
!
51! 96%!
2!
Hair!care!
cosmetics:!
including!
shampoos,!
conditioners,!
and!hair!
treatments!
! !
!
25! 47%!
3!
Color!
cosmetics:!
including!eye,!
face,!lip!and!nail!
care!
! !
!
8! 15%!
!
Statistic! Value!
Min!Value! 1!
Max!Value! 3!
Total!Responses! 53!
!
!
3.!!How!many!people!currently!work!for!your!most!recent!employer!or!client?!
#! Answer! !!
!
Response! %!
1! 1^49! ! !
!
8! 15%!
2! 50^499! ! !
!
22! 42%!
3! 500^999! ! !
!
11! 21%!
4! ≥1,000! ! !
!
8! 15%!
5! Do!not!know! ! !
!
4! 8%!
! Total! ! 53! 100%!
!
! 194!
Statistic! Value!
Min!Value! 1!
Max!Value! 5!
Mean! 2.58!
Variance! 1.32!
Standard!Deviation! 1.15!
Total!Responses! 53!
!
!
4.!!What!is!your!primary!job!function?!
#! Answer! !!
!
Response! %!
1! Marketing! ! !
!
11! 21%!
2!
Product!
Development!
! !
!
10! 19%!
3!
Regulatory!
Affairs!
! !
!
19! 36%!
4! Legal! ! !
!
5! 9%!
5! Other! ! !
!
8! 15%!
! Total! ! 53! 100%!
!
Other!
Management!
Clinical!Research!
Quaity!and!regulatory!affairs!
Management!
R&D!
Quality!Assurance!&!Regulatory!Compliance!
Product!Safety!
Medical!Affairs!
!
Statistic! Value!
Min!Value! 1!
Max!Value! 5!
Mean! 2.79!
Variance! 1.71!
Standard!Deviation! 1.31!
Total!Responses! 53!
!
!
! 195!
5.!!Please!indicate!your!level!of!experience!within!the!cosmetic!industry:!
#! Answer! !!
!
Response! %!
1! <1!year! !!
!
2! 4%!
2! 1^5!years! ! !
!
10! 19%!
3! 6^10!years! ! !
!
16! 31%!
4! 11^20!years! ! !
!
15! 29%!
5! >20!years! ! !
!
9! 17%!
! Total! ! 52! 100%!
!
Statistic! Value!
Min!Value! 1!
Max!Value! 5!
Mean! 3.37!
Variance! 1.22!
Standard!Deviation! 1.10!
Total!Responses! 52!
!
!
6.!!Please!indicate!your!level!of!familiarity!with!the!following!U.S.!regulatory!
systems.!
#! Question!
Very!
Familiar!
Somewhat!
Familiar!
Unfamiliar!
Total!
Responses!
Mean!
1!
New!Drug!
Applications!
(NDAs)!
14! 25! 14! 53! 2.00!
2!
Abbreviated!
New!Drug!
Applications!
(ANDAs)!
9! 24! 19! 52! 2.19!
3!
OTC!Drug!
Monographs!
33! 18! 2! 53! 1.42!
4!
Cosmetic!
Regulations!
32! 19! 2! 53! 1.43!
5!
New!Dietary!
Ingredient!
Notifications!
7! 19! 26! 52! 2.37!
!
! 196!
Statistic!
New!Drug!
Applications!
(NDAs)!
Abbreviated!
New!Drug!
Applications!
(ANDAs)!
OTC!Drug!
Monographs!
Cosmetic!
Regulations!
New!Dietary!
Ingredient!
Notifications!
Min!Value! 1! 1! 1! 1! 1!
Max!Value! 3! 3! 3! 3! 3!
Mean! 2.00! 2.19! 1.42! 1.43! 2.37!
Variance! 0.54! 0.51! 0.32! 0.33! 0.51!
Standard!
Deviation!
0.73! 0.72! 0.57! 0.57! 0.71!
Total!
Responses!
53! 52! 53! 53! 52!
!
!
! 197!
7.!!The!Federal!Food,!Drug!and!Cosmetic!Act!("FD&C!Act"!or!“the!Act”)!does!not!
recognize!cosmeceuticals!as!a!valid!product!category.!!A!product!can!either!be!a!
drug,!a!cosmetic,!or!a!combination!of!the!two.!!Please!indicate!your!level!of!
agreement!or!disagreement!to!the!following!statements!based!on!the!FD&C!Act.!
#! Question! Agree!
Neither!
Agree!
nor!
Disagree!
Disagree!
Cannot!
Comment!
Total!
Responses!
Mean!
1!
Cosmeceuticals!
should!be!held!
to!the!same!
standards!as!
pharmaceuticals!
with!respect!to!
clinical!evidence!
requirements!of!
efficacy!and!
safety.!
17! 7! 28! 1! 53! 2.25!
2!
The!current!
environment!for!
regulating!
cosmeceuticals!
in!the!U.S.!
encourages!
product!
innovation!in!
the!cosmetic!
industry.!
15! 22! 13! 3! 53! 2.08!
3!
The!FD&C!Act!
should!be!
amended!to!
include!
cosmeceuticals!
as!a!valid!
product!
category.!
29! 8! 14! 2! 53! 1.79!
4!
The!definition!
of!a!cosmetic!
should!be!
revised!in!the!
FD&C!Act.!
17! 13! 21! 2! 53! 2.15!
5!
The!definition!
of!a!drug!should!
be!revised!in!
the!FD&C!Act.!
6! 11! 32! 4! 53! 2.64!
!
! 198!
Statistic!
Cosmeceuticals!
should!be!held!
to!the!same!
standards!as!
pharmaceuticals!
with!respect!to!
clinical!evidence!
requirements!of!
efficacy!and!
safety.!
The!current!
environment!
for!regulating!
cosmeceuticals!
in!the!U.S.!
encourages!
product!
innovation!in!
the!cosmetic!
industry.!
The!FD&C!Act!
should!be!
amended!to!
include!
cosmeceuticals!
as!a!valid!
product!
category.!
The!
definition!
of!a!
cosmetic!
should!be!
revised!in!
the!FD&C!
Act.!
The!
definition!
of!a!drug!
should!be!
revised!in!
the!FD&C!
Act.!
Min!Value! 1! 1! 1! 1! 1!
Max!Value! 4! 4! 4! 4! 4!
Mean! 2.25! 2.08! 1.79! 2.15! 2.64!
Variance! 0.88! 0.76! 0.94! 0.86! 0.62!
Standard!
Deviation!
0.94! 0.87! 0.97! 0.93! 0.79!
Total!
Responses!
53! 53! 53! 53! 53!
!
!
! 199!
8.!!In!the!U.S.,!OTC!drugs!are!marketed!either!via!monograph!or!under!an!approved!
NDA.!!The!newly!organized!Division!of!Nonprescription!Drug!Products!(DNDP)!is!
responsible!for!both!NDA!oversight!and!the!development!of!the!OTC!drug!
monographs.!!Do!you!agree!or!disagree!with!the!following!statements!regarding!
these!processes?!
#! Question! Agree!
Neither!
Agree!
nor!
Disagree!
Disagree!
Cannot!
Comment!
Total!
Responses!
Mean!
1!
Many!
cosmeceutical!
claims!are!as!a!
direct!result!of!
the!OTC!
monographs!
that!have!not!
yet!been!
finalized.!
15! 12! 13! 12! 52! 2.42!
2!
The!existing!
OTC!
monographs!
should!be!
revised!to!
include!
cosmeceutical!
ingredients.!
17! 10! 21! 3! 51! 2.20!
3!
A!monograph!
process!should!
be!established!
separately!for!
cosmeceuticals.!
30! 7! 11! 3! 51! 1.75!
4!
Cosmeceutical!
products!
should!be!
required!to!
carry!a!
Cosmeceutical!
Facts!box!
similar!to!the!
Drug!Facts!box!
for!OTC!drugs.!
24! 7! 18! 4! 53! 2.04!
5!
Manufacturers!
and!
distributors!of!
cosmeceuticals!
should!be!
16! 8! 26! 2! 52! 2.27!
! 200!
required!to!
submit!NDAs!
to!DNDP!in!
order!to!
market!their!
cosmeceutical!
products!as!
OTC!drugs.!
!
Statistic!
Many!
cosmeceutical!
claims!are!as!
a!direct!result!
of!the!OTC!
monographs!
that!have!not!
yet!been!
finalized.!
The!existing!
OTC!
monographs!
should!be!
revised!to!
include!
cosmeceutical!
ingredients.!
A!monograph!
process!should!
be!established!
separately!for!
cosmeceuticals.!
Cosmeceutical!
products!
should!be!
required!to!
carry!a!
Cosmeceutical!
Facts!box!
similar!to!the!
Drug!Facts!
box!for!OTC!
drugs.!
Manufacturers!
and!
distributors!of!
cosmeceuticals!
should!be!
required!to!
submit!NDAs!
to!DNDP!in!
order!to!
market!their!
cosmeceutical!
products!as!
OTC!drugs.!
Min!Value! 1! 1! 1! 1! 1!
Max!Value! 4! 4! 4! 4! 4!
Mean! 2.42! 2.20! 1.75! 2.04! 2.27!
Variance! 1.31! 0.96! 0.99! 1.11! 0.91!
Standard!
Deviation!
1.14! 0.98! 1.00! 1.06! 0.95!
Total!
Responses!
52! 51! 51! 53! 52!
!
!
! 201!
9.!!If!a!new!monograph!process!was!to!be!established!for!regulating!cosmeceuticals,!
which!department!in!the!FDA!should!be!responsible!for!developing!these!
monographs?!
#! Answer! !!
!
Response! %!
1!
Division!of!
Nonprescription!
Drug!Products!
(DNDP)!
! !
!
22! 42%!
3!
Center!for!Food!
Safety!and!
Applied!
Nutrition!
(CFSAN)!
!!
!
0! 0%!
4!
A!new!divison!
should!be!
established!
! !
!
15! 28%!
5!
Do!not!agree!to!a!
new!monograph!
process!
! !
!
10! 19%!
6! Cannot!comment! ! !
!
6! 11%!
! Total! ! 53! 100%!
!
Statistic! Value!
Min!Value! 1!
Max!Value! 6!
Mean! 3.17!
Variance! 3.76!
Standard!Deviation! 1.94!
Total!Responses! 53!
!
!
! 202!
10.!!In!the!U.S.,!dietary!supplement!legislation!requires!manufacturers!and!
distributors!of!"new!dietary!ingredients"!to!submit!a!pre^market!notification!to!
FDA.!!If!the!FDA!has!no!objections!to!the!notification!after!75!days,!the!ingredient!
can!be!marketed.!!Would!you!agree!to!a!similar!legislation!under!
which!manufacturers/distributors!of!"new!cosmeceutical!ingredients"!would!be!
subject!to!this!same!requirement?!
#! Answer! !!
!
Response! %!
1! Agree! ! !
!
31! 58%!
2!
Neither!Agree!
nor!Disagree!
! !
!
8! 15%!
3! Disagree! ! !
!
9! 17%!
4!
Cannot!
Comment!
! !
!
5! 9%!
! Total! ! 53! 100%!
!
Statistic! Value!
Min!Value! 1!
Max!Value! 4!
Mean! 1.77!
Variance! 1.10!
Standard!Deviation! 1.05!
Total!Responses! 53!
!
!
! 203!
11.!!Who!should!review!this!safety!notification?!!
#! Answer! !!
!
Response! %!
1!
Center!for!Food!
Safety!and!
Applied!
Nutrition!
(CFSAN)!
! !
!
4! 13%!
2!
A!new!division!
should!be!
established!in!
the!FDA!
! !
!
9! 29%!
3!
The!safety!
notification!
should!be!sent!to!
a!qualified!third!
party!and!not!the!
FDA!
! !
!
3! 10%!
5! Cannot!comment! ! !
!
3! 10%!
6!
Division!of!
Nonprescription!
Drug!Products!
(DNDP)!
! !
!
12! 39%!
! Total! ! 31! 100%!
!
Statistic! Value!
Min!Value! 1!
Max!Value! 6!
Mean! 3.81!
Variance! 4.16!
Standard!Deviation! 2.04!
Total!Responses! 31!
!
!
! 204!
12.!!Can!you!please!take!a!moment!to!explain!why!you!do!not!agree!to!a!similar!
legislation?!
Text!Response!
Cosmeceuticals!are!typically!defined!by!claims,!not!new!ingredients.!NDI!type!legislation!
should!not!be!needed;!a!new!standard!for!safety!and!efficacy!should!be!developed!
instead.!
This!would!slow!the!speed!to!market!of!a!product.!
OTC!Monograph!system!is!failing!to!keep!pace!with!technology!and!drug!innovation,!so!I!
believe!that!any!type!of!"monograph"!system!for!other!categories!of!products!will!
ultimately!suffer!the!same!fate.!
This!type!of!legislation!is!would!create!a!burden!on!the!industry!and!end!the!innovation!
process.!!How!many!NDA's!have!been!submitted!for!sunscreens?!!The!reason!nobody!
submits!NDA's!for!sunscreens!isn't!that!there!isn't!new!innovation,!but!that!the!cost!is!
extremely!high.!
Potentially!too!restrictive.!Could!generate!more!gatekeeping.!Would!dramatically!restrict!
claims!creation!and!distance!the!consumer!from!the!product!
NO:!A!notification!process!is!a!fast!entry!point!into!the!market!place!and!works!well!for!
ingredients!with!established!safety!information!first!and!foremost.!!A!notification!process!
for!ingredients!without!established!safety!information!may!pose!risk!to!the!population.!
Consequently,!there!should!be!a!pre^market!review!by!the!FDA!to!ensure!both!safety!and!
efficacy!of!new!ingredient!(s)!for!cosmeceuticals.!
Because!a!cosmeceutical!might!have!potential!health!benefits.!!I!feel!the!same!way!about!
dietary!supplements!even!thought!it!is!not!necessary!to!provide!data!on!the!product!to!
support!the!claims!but!rather!data!in!the!literature!can!be!used!to!support!the!claims.!
I'm!not!sure!I!agree!with!the!current!policy;!as!such!wouldn't!want!to!continue!with!more!
ingredients.!
!
Statistic! Value!
Total!Responses! 8!
!
!
!
!
!
!
! 205!
13.!!Dietary!supplement!legislation!also!permits!companies!to!make!"qualified!
health!claims"!regarding!the!role!of!a!dietary!supplement!in!reducing!the!risk!of!a!
disease!or!health^related!condition,!even!though!scientific!evidence!is!still!
emerging.!!Should!the!cosmetic!industry!be!allowed!to!make!qualified!health!claims!
on!cosmeceutical!products?!!If!you!can,!please!take!a!moment!to!explain!your!
answer.!
#! Answer! !!
!
Response! %!
1! Yes! ! !
!
31! 61%!
2! No! ! !
!
20! 39%!
! Total! ! 51! 100%!
!
! 206!
Yes! No!
Yes,!provided!an!acceptable!standard!for!
safety!and!efficacy!exists!to!support!the!
claims.!
Qualified!claims!often!improve!perception!
of!the!product!and!the!FDA!review!process!
of!dietary!supplements!in!this!regard!
hasn't!protected!the!target!population!
adequately.!!I!am!still!torn!on!this.!
providing!that!there!is!some!evidence!to!
back!it!up!
This!could!be!a!slippery!slope!
Seems!logical!to!allow!this.!
The!average!consumer!does!not!
understand!the!"qualified"!meaning!in!
these!types!of!health!claims.!
Claims!are!already!being!made!that!can!be!
confusing!or!misleading.!!If!there!is!a!valid!
process!to!"qualify"!the!claims,!then!I!
would!support!this!move.!
Unless!a!clinical!study!substantiates!the!
claim.!
With!proper!qualifiers!and!substantiation!
I!don't!agree!the!DSHEA!should!promulgate!
qualified!health!claims!nor!should!
cosmeceutical!products!until!reliable!
scientific!evidence!is!provided.!
Because!a!cosmeceutical!includes!
ingredients!that!would!define!a!drug,!any!
health!claims!made!should!be!supported!by!
scientific!evidence.!
the!function!of!the!cosmeceutical!is!usually!
one!resulting!from!a!drug!active!ingredient.!
therefore,!clinicals!need!to!be!performed!
prior!to!use!to!assess!the!effectiveness!and!
safety.!
To!reduce!the!risk!of!health^related!
conditions!
Claims!should!be!proven!first!
if!efficacy!can!be!substantiated!
By!definition,!cosmetics!are!not!intended!to!
treat!or!reduce!risk!of!any!disease.!If!so,!
they!should!be!classified!as!drugs.!
I!think!they!should!be!allowed!if!the!
scientific!evidence!is!presented!to!back!up!
the!claims.!
qualified!health!claims!should!rest!with!
foods!and!dietary!supplements.!
If!the!evidence!is!there!
I!feel!that!this!information!is!too!loose^
ended!for!(most)!consumers.!A!claim!such!
as!"May!help!reduce!the!risk!of!heart!
disease",!it!can!be!understood!that!they!are!
in^fact!reducing!their!risk!of!heart!disease!
when!it!is!not!the!case.!
As!long!as!the!claim!remains!in!the!
"cosmetic"!realm!and!does!not!imply!
therapeutic!effect!
!
Some!cosmetics!can!give!health!benefits,!
but!the!attending!clims!need!careful!
review.!The!category!of!cosmetics!need!not!
be!changed.!
!
with!truthful!scienticfic!evidences! !
If!data!is!obtained!to!support!the!claims! !
! 207!
yes!when!there!is!consensus!about!the!
emerging!science!
!
Claims!supported!by!robust!empirical!data!
should!be!allowed.!
!
!
Statistic! Value!
Min!Value! 1!
Max!Value! 2!
Mean! 1.39!
Variance! 0.24!
Standard!Deviation! 0.49!
Total!Responses! 51!
!
!
14.!!The!FTC!requires!any!health^related!claims!to!be!supported!with!"competent!
and!reliable!scientific!evidence,"!defined!as!"tests,!analyses,!research,!studies,!or!
other!evidence!based!on!the!expertise!of!professionals!in!the!relevant!area,!that!
have!been!conducted!and!evaluated!in!an!objective!manner!by!persons!qualified!to!
do!so,!using!procedures!generally!accepted!in!the!profession!to!yield!accurate!and!
reliable!results".!!Think!back!to!one!cosmeceutical!product!marketed!by!your!most!
recent!employer!or!client!where!claims!development!was!particularly!challenging.!
!Do!you!think!that!the!burden!of!proof,!as!defined!by!the!FTC,!was!met!for!this!
product?!
#! Answer! !!
!
Response! %!
1! Yes! ! !
!
35! 69%!
2! No! ! !
!
16! 31%!
! Total! ! 51! 100%!
!
Statistic! Value!
Min!Value! 1!
Max!Value! 2!
Mean! 1.31!
Variance! 0.22!
Standard!Deviation! 0.47!
Total!Responses! 51!
!
!
! 208!
15.!!The!following!is!a!list!of!examples!of!claims!made!on!cosmetic!products!or!
ingredients!by!the!cosmetic!industry.!!Please!check!all!those!that!you!think!are!
cosmeceutical!claims.!!
#! Answer! !!
!
Response! %!
1!
Skin!looks!
smoother,!
firmer!and!
more!resilient!
! !
!
14! 27%!
2!
Clinically!
proven!to!
reduce!
breakouts!and!
blemishes!by!
84%!
! !
!
32! 62%!
3!
Reverses!visible!
signs!of!sun!
damage!
! !
!
31! 60%!
4!
Dramatically!
reduces!the!
look!of!multiple!
signs!of!aging,!
including!fine!
lines,!wrinkles,!
loss!of!firmness,!
dullness!and!
dehydrated!skin!
! !
!
13! 25%!
5!
See!significant!
deep!wrinkle!
reduction!in!UV!
damaged!skin,!
clinically!
proven!
! !
!
32! 62%!
6!
Restore!skin's!
youth^boosting!
trio!of!collagen,!
hyaluronic!acid!
and!elastin!
! !
!
33! 63%!
7!
Hair!feels!twice!
as!full,!twice!as!
thick!
! !
!
11! 21%!
8!
Strengthens!
and!lengthens!
eyelashes!in!as!
little!as!two!
weeks!
! !
!
26! 50%!
9! Boosts!the! ! !
!
35! 67%!
! 209!
activity!of!genes!
and!stimulates!
the!production!
of!youth!
proteins!
10!
The!first!
Topical^
Injectable!
alternative!to!
doctor^
administered!
anti^wrinkle!
injections:!
proven!more!
effective!than!
Botox®!in!a!
clinical!study!
! !
!
34! 65%!
!
Statistic! Value!
Min!Value! 1!
Max!Value! 10!
Total!Responses! 52!
!
!
16.!!Does!your!most!recent!employer!or!client!market!cosmetic!products!or!
ingredients!with!claims!similar!to!any!of!those!checked!above!in!the!U.S.?!
#! Answer! !!
!
Response! %!
1! Yes! ! !
!
31! 61%!
2! No! ! !
!
20! 39%!
! Total! ! 51! 100%!
!
Statistic! Value!
Min!Value! 1!
Max!Value! 2!
Mean! 1.39!
Variance! 0.24!
Standard!Deviation! 0.49!
Total!Responses! 51!
!
!
! 210!
17.!!How!many!cosmetic!products!or!ingredients!in!total!does!your!employer!or!
client!market!with!cosmeceutical!claims!in!the!U.S.?!
#! Answer! !!
!
Response! %!
1! 1^5! ! !
!
6! 11%!
2! 6^10! ! !
!
8! 15%!
3! 11^20! ! !
!
6! 11%!
4! >20! ! !
!
16! 30%!
5!
Do!not!know!
/!Not!
applicable!
! !
!
17! 32%!
! Total! ! 53! 100%!
!
Statistic! Value!
Min!Value! 1!
Max!Value! 5!
Mean! 3.57!
Variance! 1.90!
Standard!Deviation! 1.38!
Total!Responses! 53!
!
!
18.!!If!your!employer!or!client!also!markets!their!products!overseas,!do!they!change!
the!claims!language!used!on!the!packaging!or!advertising!materials?!
#! Answer! !!
!
Response! %!
1! Yes! ! !
!
24! 46%!
2! No! ! !
!
11! 21%!
3!
Do!not!know!
/!Not!
applicable!
! !
!
17! 33%!
! Total! ! 52! 100%!
!
Statistic! Value!
Min!Value! 1!
Max!Value! 3!
Mean! 1.87!
Variance! 0.79!
Standard!Deviation! 0.89!
Total!Responses! 52!
!
!
! 211!
19.!!Based!on!your!most!recent!experience,!how!likely!is!a!company!to!view!the!
claims!of!their!competitors!when!deciding!how!to!position!their!cosmetic!product!or!
ingredients!with!cosmeceutical!claims!in!the!U.S.?!
#! Answer! !!
!
Response! %!
1! Very!Likely! ! !
!
45! 85%!
2! Likely! ! !
!
5! 9%!
3! Unlikely! !!
!
0! 0%!
4!
Very!
Unlikely!
!!
!
1! 2%!
5!
Cannot!
Comment!
! !
!
2! 4%!
! Total! ! 53! 100%!
!
Statistic! Value!
Min!Value! 1!
Max!Value! 5!
Mean! 1.30!
Variance! 0.79!
Standard!Deviation! 0.89!
Total!Responses! 53!
!
!
20.!!If!any!of!your!employer's!or!client's!top!competitors!were!to!receive!a!warning!
letter!from!the!FDA!for!cosmeceutical!claims!similar!to!those!currently!marketed!on!
their!products,!would!you!recommend!that!they!immediately!update!their!product!
packaging!in!response!to!this!regulatory!action?!
#! Answer! !!
!
Response! %!
1! Yes! ! !
!
48! 91%!
2! No! ! !
!
5! 9%!
! Total! ! 53! 100%!
!
Statistic! Value!
Min!Value! 1!
Max!Value! 2!
Mean! 1.09!
Variance! 0.09!
Standard!Deviation! 0.30!
Total!Responses! 53!
!
!
! 212!
21.!!Please!indicate!the!reason(s)!why!you!would!not!recommend!that!they!
immediately!update!their!product!packaging?!
#! Answer! !!
!
Response! %!
1!
Too!costly!to!
change!
!!
!
0! 0%!
2!
Too!time^
consuming!to!
change!
!!
!
0! 0%!
3!
Not!concerned!
about!regulatory!
action!from!the!
FDA!
!!
!
0! 0%!
4!
Not!willing!to!
lose!market!
competitiveness!
! !
!
2! 40%!
5!
Other!
competitors!did!
not!change!the!
claims!language!
on!their!
products!
! !
!
1! 20%!
6! All!of!the!above! !!
!
0! 0%!
7! Other! ! !
!
5! 100%!
!
Other!
Case!by!case!basis!
Need!to!negotiate!with!FDA!
I!would!first!review!the!request!and!proceed!accordingly,!It!may!not!be!required!to!do!an!
immediate!change.!
Would!depend!on!reason!for!warning!
Deliberate!with!FDA!and!try!to!provide!reasoning!to!see!if!FDA!will!accept!it.!!If!not,!then!
packaging!will!be!updated.!
!
Statistic! Value!
Min!Value! 4!
Max!Value! 7!
Total!Responses! 5!
!
!
! 213!
22.!!Generally!how!long!does!it!take!your!employer!or!client!to!update!a!product's!
packaging?!
#! Answer! !!
!
Response! %!
1! <6!months! ! !
!
18! 34%!
2! 6^12!months! ! !
!
25! 47%!
3! 1^2!years! !!
!
1! 2%!
4! >2!years! !!
!
2! 4%!
5!
Do!not!know!/!
Not!applicable!
! !
!
7! 13%!
! Total! ! 53! 100%!
!
Statistic! Value!
Min!Value! 1!
Max!Value! 5!
Mean! 2.15!
Variance! 1.71!
Standard!Deviation! 1.31!
Total!Responses! 53!
!
!
23.!!How!much!on!average!does!it!cost!to!update!per!product?!
#! Answer! !!
!
Response! %!
1! <$10,000! ! !
!
12! 23%!
2!
$10,000!to!
$49,999!
! !
!
16! 30%!
3!
$50,000!to!
$99,999!
!!
!
2! 4%!
4! ≥$100,000! !!
!
1! 2%!
5!
Do!not!know!/!
Not!applicable!
! !
!
22! 42%!
! Total! ! 53! 100%!
!
Statistic! Value!
Min!Value! 1!
Max!Value! 5!
Mean! 3.09!
Variance! 2.93!
Standard!Deviation! 1.71!
Total!Responses! 53!
!
!
! 214!
24.!!Based!on!your!most!recent!experience,!please!indicate!how!often!do!you!think!
the!following!situations!occur.!
#! Question! Always!
Very!
Often!
Occasionally! Never!
Cannot!
Comment!
Total!
Responses!
Mean!
1!
Cosmetic!companies!
register!their!
cosmetic!product!
ingredient!statements!
with!the!FDA!via!the!
Voluntary!Cosmetic!
Registration!Program!
(VCRP).!
1! 7! 19! 7! 19! 53! 3.68!
2!
They!test!their!
finished!products!for!
safe!use!in!humans.!
15! 22! 13! 1! 2! 53! 2.11!
3!
They!follow!the!good!
manufacturing!
practice!(GMP)!
guidelines/inspection!
checklist!for!
cosmetics.!
19! 27! 4! 0! 2! 52! 1.83!
4!
The!FDA!exercises!
discretion!when!
deciding!to!issue!
warning!letters!to!
companies!marketing!
their!cosmetic!
products!with!drug!
claims.!
4! 19! 15! 4! 11! 53! 2.98!
5!
A!lack!of!enforcement!
action!by!the!FDA!is!
creating!an!unequal!
playing!field!for!small,!
medium!and!large!
sized!cosmetic!
companies.!
7! 18! 14! 2! 12! 53! 2.89!
!
! 215!
Statistic!
Cosmetic!
companies!
register!their!
cosmetic!
product!
ingredient!
statements!
with!the!FDA!
via!the!
Voluntary!
Cosmetic!
Registration!
Program!
(VCRP).!
They!test!
their!
finished!
products!for!
safe!use!in!
humans.!
They!follow!the!good!
manufacturing!
practice!(GMP)!
guidelines/inspection!
checklist!for!
cosmetics.!
The!FDA!
exercises!
discretion!
when!
deciding!to!
issue!warning!
letters!to!
companies!
marketing!
their!cosmetic!
products!with!
drug!claims.!
A!lack!of!
enforcement!
action!by!the!
FDA!is!creating!
an!unequal!
playing!field!
for!small,!
medium!and!
large!sized!
cosmetic!
companies.!
Min!Value! 1! 1! 1! 1! 1!
Max!Value! 5! 5! 5! 5! 5!
Mean! 3.68! 2.11! 1.83! 2.98! 2.89!
Variance! 1.34! 0.95! 0.77! 1.60! 1.83!
Standard!
Deviation!
1.16! 0.97! 0.88! 1.26! 1.35!
Total!
Responses!
53! 53! 52! 53! 53!
!
!
! 216!
25.!!Based!on!your!most!recent!experience,!please!choose!the!product!category!that!
you!think!best!matches!the!following!statements.!
#! Question!
Skin!care!
Cosmetics!
Hair!care!
Cosmetics!
Color!
Cosmetics!
Cannot!
Comment!
Total!
Responses!
Mean!
1!
Are!faced!
with!the!
biggest!
challenge!of!
cosmeceutical!
claims!
development.!
45! 0! 2! 6! 53! 1.42!
2!
Have!the!
biggest!share!
of!the!retail!
cosmeceutical!
market.!
44! 3! 2! 4! 53! 1.36!
3!
Are!most!
likely!to!
garner!the!
attention!of!
the!FDA!for!
strong!
cosmeceutical!
claims.!
49! 0! 1! 3! 53! 1.21!
4!
Are!marketed!
with!the!
strongest!
cosmeceutical!
claims.!
46! 1! 2! 4! 53! 1.32!
!
Statistic!
Are!faced!with!
the!biggest!
challenge!of!
cosmeceutical!
claims!
development.!
Have!the!
biggest!share!of!
the!retail!
cosmeceutical!
market.!
Are!most!likely!
to!garner!the!
attention!of!the!
FDA!for!strong!
cosmeceutical!
claims.!
Are!marketed!
with!the!
strongest!
cosmeceutical!
claims.!
Min!Value! 1! 1! 1! 1!
Max!Value! 4! 4! 4! 4!
Mean! 1.42! 1.36! 1.21! 1.32!
Variance! 1.02! 0.77! 0.55! 0.76!
Standard!
Deviation!
1.01! 0.88! 0.74! 0.87!
Total!
Responses!
53! 53! 53! 53!
!
!
! 217!
26.!!Please!rank!the!order!in!which!you!think!companies!of!different!sizes!benefit!
from!the!current!regulatory!environment!for!cosmeceuticals!in!the!U.S.!!Click!and!
drag!to!move.!
#! Answer! 1! 2! 3!
Total!
Responses!
1!
Small!
companies!
(<50!
employees)!
11! 6! 19! 36!
2!
Medium!
companies!
(>50!
employees!
but!<500)!
8! 23! 5! 36!
3!
Large!
companies!
(>500!
employees)!
17! 7! 12! 36!
! Total! 36! 36! 36! ^!
!
Statistic!
Small!companies!
(<50!employees)!
Medium!companies!
(>50!employees!but!
<500)!
Large!companies!
(>500!employees)!
Min!Value! 1! 1! 1!
Max!Value! 3! 3! 3!
Mean! 2.22! 1.92! 1.86!
Variance! 0.81! 0.36! 0.81!
Standard!Deviation! 0.90! 0.60! 0.90!
Total!Responses! 36! 36! 36!
!
!
! 218!
27.!!Please!rank!the!reasons!why!you!think!cosmetic!companies!market!their!
cosmetic!products!or!ingredients!with!cosmeceutical!claims!in!the!U.S.!!Click!and!
drag!to!move.!
#! Answer! 1! 2! 3! 4! 5!
Total!
Responses!
1! Drive!sales! 34! 8! 5! 4! 0! 51!
2!
Increase!market!
competitiveness!
11! 25! 11! 2! 2! 51!
3!
Permissive!
regulatory!
environment!
1! 2! 1! 17! 30! 51!
4!
Satisfy!
consumer!
demand!
2! 10! 16! 15! 8! 51!
5!
New!product!
innovation!
3! 6! 18! 13! 11! 51!
! Total! 51! 51! 51! 51! 51! ^!
!
Statistic!
Drive!
sales!
Increase!market!
competitiveness!
Permissive!
regulatory!
environment!
Satisfy!
consumer!
demand!
New!
product!
innovation!
Min!Value! 1! 1! 1! 1! 1!
Max!Value! 4! 5! 5! 5! 5!
Mean! 1.59! 2.20! 4.43! 3.33! 3.45!
Variance! 0.93! 0.92! 0.77! 1.19! 1.29!
Standard!
Deviation!
0.96! 0.96! 0.88! 1.09! 1.14!
Total!
Responses!
51! 51! 51! 51! 51!
!
!
28.!!How!satisfied!are!you!with!the!current!system!for!regulating!cosmeceuticals!in!
the!U.S.?!
#! Answer! !!
!
Response! %!
1! Very!Satisfied! !!
!
1! 2%!
2! Satisfied! ! !
!
21! 40%!
3! Dissatisfied! ! !
!
19! 36%!
4!
Very!
Dissatisfied!
! !
!
2! 4%!
5!
Cannot!
Comment!
! !
!
10! 19%!
! Total! ! 53! 100%!
!
! 219!
Statistic! Value!
Min!Value! 1!
Max!Value! 5!
Mean! 2.98!
Variance! 1.29!
Standard!Deviation! 1.13!
Total!Responses! 53!
!
!
29.!!In!your!opinion,!when!it!comes!to!cosmeceuticals,!should!there!be!more!
regulation,!less!regulation!or!is!the!current!system!sufficient?!
#! Answer! !!
!
Response! %!
1!
More!
regulation!
! !
!
30! 58%!
2!
Less!
regulation!
! !
!
4! 8%!
3!
Current!
system!is!
sufficient!
! !
!
12! 23%!
4!
Cannot!
Comment!
! !
!
6! 12%!
! Total! ! 52! 100%!
!
Statistic! Value!
Min!Value! 1!
Max!Value! 4!
Mean! 1.88!
Variance! 1.28!
Standard!Deviation! 1.13!
Total!Responses! 52!
!
!
! 220!
30.!!What,!if!anything,!would!you!change!about!the!current!system!for!regulating!
cosmeceuticals!in!the!U.S.,!in!order!to!improve!it?!
Text!Response!
too!many!large!compaies!are!allowed!to!keep!products!with!improper!claims!on!the!shelf!
far!too!long!
There!should!be!clear!regulations/guidelines!around!what!is!a!cosmeceutical!and!how!
they!are!to!be!marketed.!!Right!now,!this!is!very!unclear.!
Current!FDA!approach!is!safety!focused!and!companies!have!to!consider!impact!on!sales,!
regulatory!enforcement!and!consumer!product!liability!claims!(amongst!others)!while!
making!claims.!!Regulation!of!cosmeceuticals!seems!adequate!because!if!a!company!
decides!to!make!a!claim!that!would!be!construed!to!be!a!drug!claim,!then!that!cosmetic!
product!could!be!subject!to!additional!federal!regulations!and!incur!additional!liability.!If!
a!company!chooses!to!use!an!approved!drug!as!an!ingredient,!then!that!product!would!be!
subject!to!meeting!additional!requirements,!as!well,!or!will!be!considered!adulterated!by!
the!FDA.!!Additionally,!patent!protection!adds!another!layer!of!protection!for!consumers,!
but!this!last!protection!may!not!really!protect!against!small!manufacturers.!!It!would!be!a!
good!policy!to!require!all!ingredients!to!be!listed!in!a!cosmetic,!although!I!don’t!believe!
companies!would!adulterate!their!product!with!a!drug!ingredient!or!not!list!an!ingredient!
because!it!allows!them!to!skirt!existing!regulations.!
More!clarity!so!companies!understand!expectations!and!guardrails!from!FDA!
make!cosmeceuticals!a!seperate!category!with!requirements!less!stringent!than!OTC.!
Submission!and!FDA!review!based!process!needed!and!more!actual!scientific!evaluation!
of!ingredients!
Make!it!more!clear^cut.!
Establish!a!governing!body!
As!long!as!the!companies!do!not!make!drugs!claims,!there!is!no!need!for!changes!of!
regulation.!
At!a!minimum,!ensure!all!companies!are!testing!for!product!safety!but!ideally,!apply!
stricter!guidelines!for!validating!and!approving!claim!use.!
Dependent!upon!on!a!cosmeceutical's!ingredients!and!risk!to!benefit!ratio,!it!should!
either!be!approved!and!regulated!more!as!a!Rx!drug!or!OTC.!
Standardize!the!system!with!which!claims!have!to!be!substantiated,!make!certain!test!
protocols!mandatory!etc!
I!do!believe!the!FDA!should!direct!more!attention!to!the!cosmetic!industry,!especially!
with!regards!to!safety!and!the!!claims!made.!!However,!I'm!not!sure!the!FDA!as!it!stands!
today!has!the!resources!to!direct!more!attention!to!cosmetics.!!I!think!it!would!be!helpful!
to!have!a!"cosmetic"!division,!so!the!FDA!would!have!more!time!to!focus!on!cosmetic!
products.!
Allow!companies!to!make!more!claims!to!better!inform!consumers!of!benefits!
Cosmeceuticals,!much!as!nutriceuicals,!should!be!held!to!a!higher!standard!than!they!
currently!are!and!to!accomplish!that!they!must!first!be!acknowledged!and!defined!by,!
perhaps,!a!new!division!within!our!regulatory!framework.!
Current!system!regulates!cosmeceuticals!as!either!cosmetics!or!drugs!depending!on!the!
claims!and!ingredients.!It!is!straight!forward!and!the!lines!are!clear!if!the!appropriate!
questions!are!asked.!
I!think!the!current!system!is!sufficient,!however,!I!think!it!would!be!better!if!we!had!more!
! 221!
activity!to!enforce!the!regulations!that!are!in!place!to!keep!consumers!safe.!
less!areas!of!gray!in!interpreting!the!rules!
Make!it!more!like!the!health^food!or!neutriceutical!situations,!requiring!approved!claims!
and!oversight!by!FDA.!
As!proposed!earlier!^!Non^prescription!Drug!oversight!&!monographs.!
Allow!double!monograph,!e.g.!HQ!and!SPF!product!able!to!say!both!sun!protection!and!
skin!lightening.!
Allow!better!differentiation!between!drugs!and!cosmetics!to!permit!more!freedom!for!
cosmeceuticals!manufacturers!
First!and!foremost,!the!OTC!Monograph!system!needs!to!be!robust!to!accomodate!new!
API!for!cosmeceuticals!
Have!a!clear!category!for!cosmeceuticals!that!will!permit!companies!to!confidently!make!
claims!based!on!clinical!evidence!or!sound!literature!support,!without!having!to!be!on!
tenterhooks!of!receving!a!warning!letter!from!FDA!for!making!cosmetic^!drug!claims.!
Evoke!stricter!regulation.!
More!transparency.!
Create!a!new!category!inbetween!drugs!and!cosmetics!for!cosmeseuticals!
The!current!system!for!regulating!cosmeceuticals!is!resulting!in!consumer!claims!that!are!
misleading!and!unsubstantiated.!Regulating!steps!should!be!put!in!place!so!that!claims!
better!disclose!formulation!results!and!set!consumer!expectations.!
Fees!to!play!in!the!arena!that!provide!fairness!across!all!business!sizes!
!
Statistic! Value!
Total!Responses! 29!
!
!
31.!!Please!indicate!your!level!of!familiarity!with!the!following!international!
regulatory!systems.!
#! Question!
Very!
Familiar!
Somewhat!
Familiar!
Unfamiliar!
Total!
Responses!
Mean!
1!
Cosmetics!
Regulation!
(EC)!No.!
1223/2009!
in!Europe!
10! 16! 26! 52! 2.31!
2!
Natural!
Health!
Product!
(NHP)!
Regulations!
in!Canada!
10! 21! 22! 53! 2.23!
3!
Registration!
of!Quasi^
drugs!in!
Japan!
2! 17! 34! 53! 2.60!
!
! 222!
Statistic!
Cosmetics!
Regulation!(EC)!No.!
1223/2009!in!
Europe!
Natural!Health!
Product!(NHP)!
Regulations!in!
Canada!
Registration!of!
Quasi^drugs!in!
Japan!
Min!Value! 1! 1! 1!
Max!Value! 3! 3! 3!
Mean! 2.31! 2.23! 2.60!
Variance! 0.61! 0.56! 0.32!
Standard!Deviation! 0.78! 0.75! 0.57!
Total!Responses! 52! 53! 53!
!
!
32.!!In!your!opinion,!which!aspect(s)!of!the!European!regulation!would!be!the!most!
beneficial!to!informing!cosmeceutical!regulatory!policy!in!the!U.S.?!
#! Answer! !!
!
Response! %!
1!
Product!
Information!
File!
! !
!
8! 15%!
2!
Cosmetic!
Product!Safety!
Report!
! !
!
12! 23%!
3!
Cosmetic!
Product!
Notification!
Portal!
! !
!
4! 8%!
4!
Serious!
Undesirable!
Effect!
Reporting!
! !
!
6! 11%!
5! Safety!Assessor! ! !
!
4! 8%!
6!
Responsible!
Person!
!!
!
2! 4%!
7! All!of!the!above! ! !
!
9! 17%!
8! Other! !!
!
2! 4%!
9!
Cannot!
Comment!
! !
!
26! 49%!
!
Other!
Greater!clarity!on!acceptable!and!unacceptable!claims!
Based!on!the!definition!of!the!European!Cosmetic!Regulation,!it!would!not!be!beneficial!to!
informing!cosmeceutical!regulatory!policy!in!the!US.!
!
! 223!
Statistic! Value!
Min!Value! 1!
Max!Value! 9!
Total!Responses! 53!
!
!
33.!!In!2012,!the!Natural!Health!Product!Directorate!(NHPD)!outlined!a!three^class!
system!for!NHPs!based!on!their!known!risks!and!benefits.!!They!introduced!a!
monograph!system!for!the!less!risky!Class!I!and!II!products,!which!have!review!
times!of!10!and!30!days!respectively.!!However,!the!riskiest!class!III!products!are!
subject!to!a!review!time!of!180!days.!!Should!the!FDA!establish!a!similar!class^based!
system!for!cosmeceutical!products!based!on!their!known!risks!and!benefits?!
#! Answer! !!
!
Response! %!
1! Agree! ! !
!
25! 50%!
2!
Neither!
Agree!nor!
Disagree!
! !
!
8! 16%!
3! Disagree! ! !
!
6! 12%!
4!
Cannot!
Comment!
! !
!
11! 22%!
! Total! ! 50! 100%!
!
Statistic! Value!
Min!Value! 1!
Max!Value! 4!
Mean! 2.06!
Variance! 1.53!
Standard!Deviation! 1.24!
Total!Responses! 50!
!
!
! 224!
34.!!In!Japan,!the!safety,!efficacy!and!stability!data!submitted!for!approval!of!a!quasi^
drug!is!based!on!the!dose!level,!dosage!form!and!intended!effect!on!the!body!of!the!
active!ingredient,!and!not!the!quasi^drug!as!a!whole.!!Should!companies!that!market!
cosmeceutical!products!in!the!U.S.!be!required!to!do!the!same?!
#! Answer! !!
!
Response! %!
1! Agree! ! !
!
13! 25%!
2!
Neither!
Agree!nor!
Disagree!
! !
!
8! 16%!
3! Disagree! ! !
!
14! 27%!
4!
Cannot!
Comment!
! !
!
16! 31%!
! Total! ! 51! 100%!
!
Statistic! Value!
Min!Value! 1!
Max!Value! 4!
Mean! 2.65!
Variance! 1.39!
Standard!Deviation! 1.18!
Total!Responses! 51!
!
!
35.!!Of!the!three!regulatory!systems,!please!choose!the!one!which!you!think!is!most!
beneficial!to!informing!cosmeceutical!regulatory!policy!in!the!U.S.!!!
#! Answer! !!
!
Response! %!
1!
Cosmetics!
Regulation!
(EC)!No.!
1223/2009!in!
Europe!
! !
!
14! 27%!
2!
Natural!
Health!
Product!
(NHP)!
Regulations!in!
Canada!
! !
!
7! 14%!
3!
Registration!
of!Quasi^
drugs!in!Japan!
! !
!
3! 6%!
4!
Cannot!
Comment!
! !
!
27! 53%!
! Total! ! 51! 100%!
!
! 225!
Statistic! Value!
Min!Value! 1!
Max!Value! 4!
Mean! 2.84!
Variance! 1.77!
Standard!Deviation! 1.33!
Total!Responses! 51!
!
!
36.!!Would!you!agree!to!participate!in!a!15^20!minute!phone!interview!to!further!
discuss!the!impact!of!cosmeceutical!regulations!on!the!cosmetic!industry!in!the!
United!States?!!If!so,!please!provide!your!contact!information.!
#! Answer! !!
!
Response! %!
1! Yes! ! !
!
11! 21%!
2! No! ! !
!
41! 79%!
! Total! ! 52! 100%!
!
Statistic! Value!
Min!Value! 1!
Max!Value! 2!
Mean! 1.79!
Variance! 0.17!
Standard!Deviation! 0.41!
Total!Responses! 52!
!
!
!
! 226!
Appendix)E:)Cross)Tabulations)
!
!
! 227!
!
!
!
! 228!
!
!
!
! 229!
!
!
!
!

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Asset Metadata

Creator Turnbull, Simone E. (author)

Core Title Regulating cosmeceuticals in the United States: a cosmetic industry view

School School of Pharmacy

Degree Doctor of Regulatory Science

Degree Program Regulatory Science

Publication Date 02/22/2016

Defense Date 01/11/2016

Publisher University of Southern California (original), University of Southern California. Libraries (digital)

Tag cosmeceuticals,Cosmetics,OAI-PMH Harvest,regulations

Format application/pdf (imt)

Language English

Contributor Electronically uploaded by the author (provenance)

Advisor Richmond, Frances J. (committee chair), Pacifici, Eunjoo (committee member), Ramsey, Valerie (committee member), Rodgers, Kathleen (committee member)

Creator Email simonee.turnbull@gmail.com

Permanent Link (DOI) https://doi.org/10.25549/usctheses-c40-213494

Unique identifier UC11278132

Identifier etd-TurnbullSi-4143.pdf (filename),usctheses-c40-213494 (legacy record id)

Legacy Identifier etd-TurnbullSi-4143.pdf

Dmrecord 213494

Document Type Dissertation

Format application/pdf (imt)

Rights Turnbull, Simone E.

Type texts

Source University of Southern California (contributing entity), University of Southern California Dissertations and Theses (collection)

Access Conditions The author retains rights to his/her dissertation, thesis or other graduate work according to U.S. copyright law. Electronic access is being provided by the USC Libraries in agreement with the a...

Repository Name University of Southern California Digital Library

Repository Location USC Digital Library, University of Southern California, University Park Campus MC 2810, 3434 South Grand Avenue, 2nd Floor, Los Angeles, California 90089-2810, USA