Cosmeceuticals: Drugs vs. Cosmetics (Cosmetic Science and Technology)

385 Pages·2000·4.13 MB·English

by  Peter Elsner

Cosmeceuticals
Drugs vs. Cosmetics
edited by
Peter Elsner
Friedrich Schiller University,Jena,Germany
Howard I. Maibach
University of California,San Francisco,California

Marcel Dekker, Inc. New York Basel
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AbouttheSeries
TheCosmeticScienceandTechnologyserieswasconceivedtopermitdiscussionofabroad
rangeofcurrentknowledgeandtheoriesofcosmeticscienceandtechnology.Theseriesis
composedofbothbookswrittenbyasingleauthorandeditedvolumeswithanumberof
contributors.Authoritiesfromindustry,academia,andthegovernmentparticipateinwriting
thesebooks.
Theaimoftheseriesistocoverthemanyfacetsofcosmeticscienceandtechnology.Topicsare
drawnfromawidespectrumofdisciplinesrangingfromchemistry,physics,biochemistry,and
analyticalandconsumerevaluationstosafety,efficacy,toxicity,andregulatoryquestions.
Organic,inorganic,physicalandpolymerchemistry,emulsionandlipidtechnology,
microbiology,dermatology,andtoxicologyallplayimportantrolesincosmeticscience.
Thereislittlecommonalityinthescientificmethods,processes,andformulationsrequiredfor

thewidevarietyofcosmeticsandtoiletriesinthemarket.Productsrangefrompreparationsfor
hair,oral,andskincaretolipsticks,nailpolishesandextenders,deodorants,bodypowdersand
aerosols,toquasi-pharmaceuticalover-the-counterproductssuchasantiperspirants,dandruff
shampoos,antimicrobialsoaps,andacneandsunscreenproducts.
Cosmeticsandtoiletriesrepresentahighlydiversifiedfieldinvolvingmanysubsectionsof
scienceand“art.”Eveninthesedaysofhightechnology,artandintuitioncontinuetoplayan
importantpartinthedevelopmentofformulations,theirevaluation,selectionofrawmaterials,
and,perhapsmostimportantly,thesuccessfulmarketingofnewproducts.Theapplicationof
moresophisticatedscientificmethodologiesthatgainedsteaminthe1980shasincreasedinsuch
areasasclaimsubstantiation,safetytesting,producttesting,andchemicalanalysisandhasledto
abetterunderstandingofthepropertiesofskinandhair.Molecularmodelingtechniquesare
beginningtobeappliedtodataobtainedinskinsensorystudies.
EmphasisintheCosmeticScienceandTechnologyseriesisplacedonreportingthecurrent
statusofcosmetictechnologyandscienceandchangingregulatoryclimatesandpresenting
historicalreviews.Theserieshasnowgrownto26booksdealingwiththeconstantlychanging
technologiesandtrendsinthecosmeticindustry,includingglobalization.Severalofthevolumes
havebeentranslatedintoJapaneseandChinese.Contributionsrangefromhighlysophisticated
andscientifictreatisestoprimersandpresentationsofpracticalapplications.Authorsare
encouragedtopresenttheirownconceptsaswellasestablishedtheories.Contributorshavebeen
askednottoshyawayfromfieldsthatareinastateoftransition,nortohesitatetopresent
detaileddiscussionsoftheirownwork.Altogether,weintendtodevelopinthisseriesa

collectionofcriticalsurveysandideascoveringdiversephasesofthecosmeticindustry.
The13chaptersinMultifunctionalCosmeticscovermultifunctionalproductsforhair,nail,oral,
andskincare,aswellasproductswithenhancedsunscreenandantimicrobialpropertiesSeveral
chaptersdealwiththedevelopmentofclaimsupportdata,theroleofpackaging,andconsumer
researchontheperceptionofmultifunctionalcosmeticproducts.Theauthorskeepinmindthat
inthecaseofcosmetics,itisnotonlythephysicaleffectsthatcanbemeasuredontheskinor
hair,butalsothesensoryeffectsthathavetobetakenintoaccount.Cosmeticscanhavea
psychologicalandsocialimpactthatcannotbeunderestimated.
Iwanttothankallthecontributorsforparticipatinginthisprojectandparticularlytheeditors,
PerryRomanowskiandRandySchueller,forconceiving,organizing,andcoordinatingthisbook.
Itisthesecondbookthattheyhavecontributedtothisseriesandweappreciatetheirefforts.
SpecialthanksareduetoSandraBebermanandErinNihilloftheeditorialandproductionstaff
atMarcelDekker,Inc.Finally,Iwouldliketothankmywife,Eva,withoutwhoseconstant
supportandeditorialhelpIwouldnothaveundertakenthisproject.
EricJungermann,Ph.D.
COSMETICSCIENCEANDTECHNOLOGY
SeriesEditor
ERICJUNGERMANN
JungermannAssociates,Inc.
Phoenix,Arizona
1. Cosmetic and Drug Preservation: Principles and Practice, editedby
JonJ.Kabara
2. The Cosmetic Industry: Scientific and Regulatory Foundations, edited
byNormanF.Estrin
3. Cosmetic Product Testing: A Modern Psychophysical Approach,
HowardR.Moskowitz
4. Cosmetic Analysis: Selective Methods and Techniques, editedbyP.
Bor(cid:31)
5. CosmeticSafety:APrimerforCosmeticScientists,editedbyJamesH.
Whittam
6. OralHygieneProductsandPractice,MortonPader
7. Antiperspirants and Deodorants, edited by Karl Laden and Carl B.
Felger
8. Clinical Safety and Efficacy Testing of Cosmetics,editedbyWilliamC.
Waggoner
9. Methods for Cutaneous Investigation, editedbyRobertL.Rietschel
andThomasS.Spencer
10. Sunscreens:Development,Evaluation,andRegulatoryAspects,edited
byNicholasJ.LoweandNadimA.Shaath
11. Glycerine: A Key Cosmetic Ingredient,editedbyEricJungermannand
NormanO.V.Sonntag
12. HandbookofCosmeticMicrobiology,DonaldS.Orth
13. Rheological Properties of Cosmetics and Toiletries, editedbyDennis
Laba
14. Consumer Testing and Evaluation of Personal Care Products,Howard
R.Moskowitz
15. Sunscreens: Development, Evaluation, and Regulatory Aspects. Sec-
ond Edition, Revised and Expanded, editedbyNicholasJ.Lowe,Na-
dimA.Shaath,andMadhuA.Pathak
16. Preservative-Free and Self-Preserving Cosmetics and Drugs:
PrinciplesandPractice,editedbyJonJ.KabaraandDonaldS.Orth
17. HairandHairCare,editedbyDaleH.Johnson
18. CosmeticClaimsSubstantiation,editedbyLouiseB.Aust
19. Novel Cosmetic Delivery Systems, editedbyShlomoMagdassiand
ElkaTouitou
20. Antiperspirants and Deodorants: Second Edition, Revised and Ex-
panded,editedbyKarlLaden
21. Conditioning Agents for Hair and Skin,editedbyRandySchuellerand
PerryRomanowski
22. Principles of Polymer Science and Technology in Cosmetics and Per-
sonalCare,editedbyE.DesmondGoddardandJamesV.Gruber
23. Cosmeceuticals: Drugs vs. Cosmetics, edited by Peter Elsner and
HowardI.Maibach
24. CosmeticLipidsandtheSkinBarrier,editedbyThomasF(cid:31)rster
25. Skin Moisturization, editedbyJamesJ.LeydenandAnthonyV.Raw-
lings
26. MultifunctionalCosmetics,editedbyRandySchuellerandPerryRoma-
nowski
ADDITIONALVOLUMESINPREPARATION
Preface
Theterm‘‘cosmeceuticals,’’coinedbyAlbertKligman20 yearsago,hasright-
fullyprovokedthoughtanddiscussionamongscientists,industry,andregulating
authorities. Basically, the controversy revolves around the question of whether
there areany substances applied tothe skin thatdo not modify itsstructure and
function. Since scientific evidence shows that even purportedly ‘‘inert’’ sub-
stances such as water may profoundly change the structure and function of the
skin,thisdoes notseemhelpfulindistinguishingcosmeticsfromdrugs.Indeed,
thereisalegalproblemwiththedefinitionofcosmeticsintheUnitedStates,but
not in other major countries such as Europe and Japan.
InEurope,theCouncilDirective76/768/EECof27July1976,asamended
by six Directives, defines cosmetic products in Article 1:
Acosmeticproductmeansanysubstanceorpreparationintendedforplacing
intocontactwiththevariouspartsofthehumanbody(epidermis,hairsystem,
nails,lipsand externalgenitalorgans)orwiththe teethandmucousmem-
branesoftheoralcavitywithaviewexclusivelyorprincipallytocleaning
them, perfuming them or protecting them, in order to keep them in good
condition,changetheirappearanceorcorrectbodyodours.

Thus,acosmeticisdefinedbyitsmode ofapplicationandbytheintention with
whichitisused.Whilecosmeticsareusedonnormalornearlynormalskin,drugs
are defined as preparations to be used for the treatment of diseased skin. Obvi-
ously, there remains a gray zone between what is considered ‘‘normal’’ as op-
posedto‘‘diseased’’skin.Thismayvarydependingontheindividual,thesociety,
and over time. In this situation, Article 2 of the Council Directive is helpful.
AcosmeticproductputonthemarketwithintheCommunitymustnotcause
damagetohumanhealthwhenappliedundernormalorreasonablyforesee-
ableconditions ofuse.
Therefore,consumersafetyisofutmostimportanceincosmetics,whileitisarela-
tiveissueindrugs,whereabalancedbenefit–riskassessmenthastobemadede-
v
vi Preface
pending on the severity of the disease. This is reflected by a recent decision of
theScientificCommitteeonCosmeticsandNon-FoodProducts(SCCNFP)ofthe
European Commission regarding the use of the antifungal ketoconazole in cos-
metics. Following a thorough review of the safety profile of the substance, the
SCCNFPdecidedthattherewerenosafetyconcernsinusingupto2%ketocona-
zoleincosmeticproducts.Obviously,thisonlyreferstothecosmeticuseofketa-
conazole-containingproducts(e.g.,asantidandruffpreparations);whenusedtotreat
fungalskindisease,theywouldbeconsidereddrugsfromaregulatorypointofview.
TheCouncilofEuropeisanintergovernmentalinstitutionthatfosterscoop-
erationbetween Europeancountries.Membersarenot onlytheEuropeanUnion
memberstates,butalsonearlyallothercountriesontheEuropeanContinent.Its
PublicHealth Committee/Committee of Expertson CosmeticProducts statesin
a recent document (Comparative Study on Borderline Products and Borderline
Situations,RD4-1/32/1999)thatacosmeticproducthastofulfillthefourcriteria
offunction(Art.1asabove);presentation(i.e.,theclaimsmadefortheproduct);
mode of application (i.e., externally or on the mucous membranes of the oral
cavity);andcomposition(i.e.,notcontainingaprohibitedsubstanceortoomuch
ofaregulatedsubstance).TheCommitteehasanalyzedthesecriteriaforanumber
of cosmetic designations and substances and found that remarkable differences
existintheregulatoryapproachbetweencountries.Forexample,inSwitzerland,
productscontainingupto10%αhydroxyacidsareconsideredcosmetics,whereas
concentrationsabove10%leadtotheclassificationofpharmaceutical.InAustria,
theconcentrationlimitis30%,whilethereisnolimitinBelgium,Finland,Ger-
many,theNetherlands,andtheU.K.(RD4-1/32/1999).Sincedifferentclassifi-
cationofthesameproductshindersfreemovementofgoodsandhasanegative
effectontheestablishmentandfunctioningofacommonmarket,theCommittee
rightfully proposes to start a harmonization process regarding these borderline
products, and states
Such a harmonisation process may come to the benefit of all parties in-
volved—includin gtheconsumer.
We hope that this book will contribute to a sincere discussion of the status of
‘‘cosmeceuticals,’’productsthatareintendedforcosmeticusebutcontainactive
substances. Since people worldwide are getting older, becoming more aware of
their skin health and appearance, and more committed to use safe and effective
products to achieve this goal, this debate is a timely one.
Finally,wewouldliketo taketheopportunitytothankthecontributorsto
thisbook,allexpertsintheirfields,whodevotedtimeandefforttotheirchapters.
We are also indebtedto SandraBeberman and ElyceMisher ofMarcel Dekker,
Publishers, who were more than helpful in the editorial process.
Peter Elsner
Howard I. Maibach