Cosmeceuticals Drugs vs. Cosmetics.pdf - ANME

378 Pages·2002·3.49 MB·English

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
The CosmeticScienceand Technology series was conceived to permit discussion ofabroad
rangeof current knowledge and theories of cosmeticscience and technology.Theseries is
composed of both books written by asingleauthor and edited volumes with anumber of
contributors.Authorities fromindustry,academia, and thegovernment participatein writing
thesebooks.
The aimof theseries is to cover the many facets of cosmeticscience and technology.Topics are
drawn from a wide spectrumof disciplines ranging from chemistry,physics,biochemistry, and
analytical and consumer evaluations to safety, efficacy,toxicity,and regulatory questions.
Organic,inorganic,physical and polymer chemistry,emulsion and lipidtechnology,
microbiology,dermatology,and toxicology all play important roles in cosmeticscience.
Thereis littlecommonality in thescientific methods, processes, and formulations required for
thewidevariety of cosmetics and toiletries in the market.Products range frompreparations for
hair,oral, and skin careto lipsticks,nail polishes and extenders,deodorants,bodypowders and
aerosols,to quasi-pharmaceutical over-the-counter products such as antiperspirants,dandruff
shampoos,antimicrobial soaps,and acne and sun screen products.
Cosmetics and toiletries represent ahighlydiversified field involving many subsections of
scienceand “art.”Even in these days of high technology,art and intuitioncontinueto play an
important part in thedevelopment of formulations,their evaluation,selection of raw materials,
and,perhaps most importantly,thesuccessful marketing of new products.The application of
more sophisticated scientific methodologies that gained steam in the1980s has increased in such
areas as claimsubstantiation,safety testing,product testing,and chemical analysisand has led to
abetter understanding of theproperties ofskin and hair.Molecular modeling techniques are
beginning to beapplied to data obtained in skin sensory studies.
Emphasis in theCosmetic Science and Technology series is placed on reporting thecurrent
status of cosmetictechnology and scienceand changing regulatory climates and presenting
historical reviews. Theseries has now grown to 26 books dealing with theconstantly changing
technologies and trends in thecosmeticindustry,including globalization.Several of thevolumes
havebeen translated into Japanese and Chinese.Contributionsrangefrom highly sophisticated
and scientifictreatises to primers and presentations of practical applications.Authors are
encouraged to present their own concepts as well as established theories.Contributors havebeen
asked not to shy away fromfields that are in astate of transition,nor to hesitateto present
detailed discussionsof their own work. Altogether,weintend to develop in this series a
collection of critical surveys and ideas covering diversephases of thecosmeticindustry.
The13 chapters in Multifunctional Cosmetics cover multifunctional products forhair,nail, oral,
and skin care, as well as products with enhanced sunscreen and antimicrobial properties Several
chapters deal with thedevelopment of claimsupport data,the roleof packaging,and consumer
research on theperception of multifunctional cosmeticproducts.The authors keep in mind that
in thecase of cosmetics,it is not only thephysical effects that can be measured on theskin or
hair,but also thesensory effects that have to betaken into account.Cosmetics can have a
psychological and social impact that cannot beunderestimated.
I want to thank all thecontributors for participating in this project and particularly theeditors,
Perry Romanowski and Randy Schueller, for conceiving,organizing,and coordinating this book.
It is thesecond bookthat they havecontributed to this series and we appreciate their efforts.
Special thanks aredueto SandraBeberman and Erin Nihill oftheeditorial and production staff
at Marcel Dekker,Inc.Finally, I would liketo thank my wife, Eva, without whoseconstant
support and editorial help I would not haveundertaken this project.
EricJungermann,Ph.D.
COSMETICSCIENCEANDTECHNOLOGY
SeriesEditor
ERICJUNGERMANN
JungermannAssociates,Inc.
Phoenix,Arizona
1. Cosmetic and Drug Preservation: Principles and Practice, edited by
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, edited by P.
Boré
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, edited by William C.
Waggoner
9. Methods for Cutaneous Investigation, edited by Robert L. Rietschel
andThomasS.Spencer
10. Sunscreens:Development,Evaluation,andRegulatoryAspects,edited
byNicholasJ.LoweandNadimA.Shaath
11. Glycerine: A Key Cosmetic Ingredient, edited by Eric Jungermann and
NormanO.V.Sonntag
12. HandbookofCosmeticMicrobiology,DonaldS.Orth
13. Rheological Properties of Cosmetics and Toiletries, edited by Dennis
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, edited by Nicholas J. 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, edited by Shlomo Magdassi and
ElkaTouitou
20. Antiperspirants and Deodorants: Second Edition, Revised and Ex-
panded,editedbyKarlLaden
21. Conditioning Agents for Hair and Skin, edited by Randy Schueller and
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,editedbyThomasFörster
25. Skin Moisturization, edited by James J. Leyden and Anthony V. 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,changetheirappearanceorcorrectbody odours.
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—includingtheconsumer.
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