Dangerous Cosmetic and Skin Care Ingredients Sodium Laurel Sulfate DANGEROUS BEAUTY: Scientists Warn of Harmful n!

redients n Our S"am#oos and $osmetics% &' Da(id Lo)ell *ern Ne) "ealt" concerns are &ein! raised o(er some common in!redients in "air s"am#oos% s+in creams% toot"#astes% and ot"er #ersonal care items, Researc"ers in t"e U, S,% German'% S)it-erland% .a#an% found t"ese in!redients ma' &e lin+ed to #remature &aldness% cataracts% en(ironmental cancers% contact dermatitis% and #ossi&le e'e dama!e in 'oun! c"ildren, SLS and Eye Damage in Young Children T"e !reatest concern of man' scientists is sodium laur'l sulfate /SLS0% a deter!ent found in a&out 12 #ercent of commercial s"am#oos, Also +no)n as sodium dodec'l% sodium lauret" sulfate /SL3S0 t"is c"emical "as &een s"o)n to dama!e #rotein formation in e'e tissue in 'oun! animals% raisin! serious concerns a&out t"e #ossi&ilit' of ocular tissue malformation% &lindness in infants and 'oun! c"ildren, n animal studies% SLS #enetration and u#ta+e is muc" !reater in neonatal and 'oun! animal e'e tissue% com#ared to adult animals% s"o)in! 4#enetration into t"e e'e% as )ell as s'stemic tissues /&rain% "eart% li(er% etc,04 SLS also s"o)ed lon!5term retention in tissues% u# to 6 da's after a sin!le dro#,7 Researc"er *eit" Green% 8",D,% D, Sc,% of t"e 9edical $olle!e of Geor!ia% also re#orts t"at SLS e:tends t"e "ealin! of corneal tissue &' a factor of 6% from ; da's /normal0 to more t"an 72 da's, He also "as concerns a&out cataract formation from SLS, Writin! for Researc" to 8re(ent Blindness% nc,% Dr, Green states in #art: T"ere is an immediate concern relatin! to t"e #enetration of t"ese c"emicals into t"e e'e and ot"er tissues, T"is is es#eciall' im#ortant in infants,,,e:#osure to SLS results in accumulation in e'e tissues% a #rocess t"at could retard "ealin! and #ossi&l' "a(e lon!5term effects, Dr, Green concludes t"at e:#osure to SLS sulfate causes im#ro#er e'e de(elo#ment in c"ildren and t"at since SLS is a&sor&ed s'stemicall' t"rou!" t"e s+in% it doesn<t "a(e to enter t"e e'e directl', Our o)n researc" found t"at SLS is #resent as a main in!redient in most commercial s"am#oos for adults or c"ildren, SLS Toxicity and Cancer Anot"er serious "ealt" concern )it" SLS is its tendenc' to react )it" ot"er in!redients to form NDELA% a nitrosamine and #otent carcino!en, Accordin! to a 71=> 3DA re#ort% s"am#ooin! t"e "air )it" a #roduct contaminated )it" t"is nitrosamine can lead to its a&sor#tion into t"e &od' at le(els muc" "i!"er t"an eatin! nitrate5 contaminated foods, /Researc"ers estimate t"e nitrate a&sor#tion from one s"am#oo is e?ual to eatin! a #ound of &acon,0 T"e 3DA "as recentl' )arned s"am#oo manufacturers of unacce#ta&le le(els of dio:in formation in #roducts containin! SL3S /dio:ins are also dan!erous carcino!enic com#ounds0, Onl' la&orator' testin! can determine if a s"am#oo is contaminated )it" t"ese #o)erful carcino!enic com#ounds,

Damage To Your Skin Researc"ers "a(e +no)n for 'ears t"at SLS is a s+in irritant, SLS is used as a la&orator' standard for irritatin! s+in and inducin! contact dermatitis,;%@%A SLS is useful to la& testin! &ecause of its a&ilit' to #enetrate and im#air t"e s+in &arrier, 6 SLS dama!es t"e s+in &arrier functions%B en"ances aller!ic res#onse to ot"er to:ins and aller!ens%= dama!es and alters s+in cells% > causes su&stantial rou!"ness to t"e s+in% 1 results in se(ere modification of s+in recom&inant structure,72 SLS is listed as to:ic to s+in in man' studies,77%7;%7@ n #atients )it" se&orr"ea and ec-ema% SLS increases irritant reactions and susce#ti&ilit',7A SLS is indicated in mi!ration of Lan!er"ans cells to re!ional l'm#" sites in contact dermatitis% e:#lainin! l'm#" node inflammation in some cases, /A s'stemic res#onse is clearl' indicated,0 Researc" also found t"at fair s+in is more susce#ti&le to SLS irritations% as is s+in )it" e:istin! ec-ema e(en )"ere t"e ec-ema is not local to t"e SLS contact,76 SLS and Premature Hair Loss SLS is im#licated in #remature "air loss in men and )omen% and ma' &e one reason for )ide5s#read incidence of t"innin! "air, Because SLS is suc" a caustic cleanser% it actuall' corrodes t"e "air follicle and im#airs its a&ilit' to !ro) "air, SLES /sodium laur'l et"er sulfate0 causes dramatic decline in t"e "air !ro)t" c'cle% and #rolon!s t"e "air loss #"ase /normall' @ mont"s0 &' a factor of ei!"t, Sim#l' remo(in! t"is in!redient% and its corrosi(e and irritatin! effects% &e!ins to restore t"e natural% "ealt"' function of t"e follicle, SLS is also im#licated in scal# irritation% ec-ema% dandruff% and ot"er scal# conditions, 9an' s"am#oos desi!ned to alle(iate dandruff% itc"in!% and ot"er scal# disorders ma' actuall' &e causin! t"e to:icit' of SLS5containin! formulas to t"e s+in and scal#, A(oidin! contact )it" t"is c'toto:ic /cell5 +illin!0 c"emical is all t"at man' #eo#le re?uire to com#letel' alle(iate scal# disorders, Natural Brands O er No Protection n!redient re(ie)s of s"am#oos sold in "ealt" food stores under natural &rands and la&els "a(e turned u# man' formulas containin! SLS, T"e cost% re#utation% or mar+et #osition of a s"am#oo a##arentl' "as little to do )it" its contents, Some of t"e most re#uta&le and e:clusi(e &rands contain SLS, Don<t &e fooled &' "i!" #rices or mar+etin! "'#e, You must c"ec+ t"e in!redients on eac" #roduct if 'ou )ant to a(oid t"e "armful effects of SLS, !hat You Should Do C $"ec+ 'our s"am#oos% toot"#aste% li?uid soa#s% &od' !els% and ot"er s+in #roducts for sodium laur'l sulfate, We recommend t"at 'ou a(oid an' furt"er s+in contact )it" #roducts containin! t"is in!redient, C f 'ou "a(e c"ildren% ma+e sure t"e' are not usin! s"am#oos and toot"#astes containin! sodium laur'l sulfate, $"ildren under B are es#eciall' (ulnera&le to im#ro#er e'e de(elo#ment, Also c"ec+ sun&loc+ #roducts, /We found one t"at contains SLS and aluminum% a #otentiall' dan!erous com&ination for &rain cell deterioration,0 C Re#lace #roducts containin! SLS )it" safe alternati(es /formulas )it"out SLS0, C $"ec+ all 'our cosmetic #roducts for #ro#'lene !l'col% and !et t"em off 'our s+in, f 'ou "a(e infants% c"ec+ 'our &a&' )i#es and &a&' lotions% and find alternati(e #roducts t"at are safe for c"ildren /some &a&' )i#es are a(aila&le )it" aloe instead ;

of #ro#'lene !l'col0, 3rom: ))),#ronature,com Al+'l#"enol Et"o:'lates Ben-eneDBen-oic AcidDBen-'l Ben-oate $oal Tar 3ound to reduce s#erm count $onsidered a carcino!en% is an endocrine disru#tor% and is sus#ected to cause &irt" defects *no)n "uman carcino!en, 8ro"i&ited for us in cosmetics in t"e Euro#ean Union, 9a' contian "armful im#urities or &rea+do)n #roducts, 3ound in dandruff s"am#oos% anti5itc" creams and "air d'es, Used as in"i&itors of micro&ial !ro)t" and to e:tend s"elf life of #roducts, Ha(e caused man' aller!ic reactions and s+in ras"es, Studies "a(e s"o)n t"at t"e' are )ea+l' estro!enic and can &e a&sor&ed &' t"e &od' t"rou!" t"e s+in, Widel' used e(en t"ou!" t"e' are +no)n to &e to:ic, 8ro"i&ited for us in cosmetics in t"e Euro#ean Union, 8osso&le "uman re#roducti(e or de(elo#mental to:in, Endocrine disru#tor, 3ound in some nail #olis"% #erfume and "air s#ra', Often used in cosmetics as emulsifiers andDor foamin! a!ents, T"e' can cause aller!ic reactions% e'e irritation and dr'ness of "air and s+in, DEA and TEA are 4amines4 /ammonia com#ounds0 and can form cancer5causin! nitrosamines )"en t"e' come in contact )it" nitrates, To:ic if a&sor&ed into t"e &od' o(er a lon! #eriod of time, T"is c"emical interferes )it" t"e &od'<s a&ilit' to a&sor& c"oline )"ic" is needed for #ro#er fetal &rain de(elo#ment, T"ese are )idel' used #reser(ati(es, T"e American Academ' of Dermatolo!' "as found t"em to &e a #rimar' cause of contact dermatitis, T)o trade names for t"ese c"emicals are Germall and Germall 776, Neit"er of t"e Germall c"emicals contains a !ood antifun!al a!ent% and t"e' must &e com&ined )it" ot"er #reser(ati(es, Bot" t"ese c"emicals release formalde"'de% )"ic" can &e to:ic, T"is is an e:treme irritant to t"e mucous mem&ranes )it" often destructi(e effects, t is also considered to &e a neuroto:in and carcino!en, T"e la&el of 43ra!rances4 can mas+ a multitude of to:ic% s'nt"etic c"emicals% man' of )"ic" su##ress t"e immune s'stem% are endocrine disru#tors% and cause cancer, W"en loo+in! for scented #roducts% ma+e sure it<s scented &' essential oils 55 )"ic" are e:#ensi(eE t"erefore% com#anies usuall' list )"at essential oils are contained in t"e #roduct )it"out re(ertin! to t"e !eneric term 43ra!rances4, T"is is a s+in irritant t"at causes flus"in!% #ulse rate fluctuations% di--iness% "eadac"es% and nausea, *no)n "uman re#roducti(e and de(elo#mental to:in, 8ro"i&ited for use in cosmetics in t"e Euro#ean Union, 3ound in some "air d'es and cleanser, 8ossi&le "uman carcino!en, 8osso&le "uman re#roducti(e or de(elo#mental to:in, 3ound in some e'e dro#s and ointment,

9et"'l% 8ro#'l% But'l and Et"'l 8ara&en

Di&ut'l 8"t"alate

Diet"anolamine /DEA0% Triet"anolamine /TEA0

Dia-olidin'l Urea% mida-olidin'l Urea

3ormalde"'de

3ra!rances

so#ro#anolD so#ro#'l Alco"ol Lead Acetate 9ercur'

9et"'lisot"ia-oline% or 9 T T"is can cause s+in and e'e irritation and is +no)n to cause neurolo!ical dama!e, 8ara&ens / so&ut'l#ara&en% But'l#ara&en% 9et"'l#ara&en% 8ro#'l#ara&en0 8etrolatum ncreases a #erson<s ris+ of &reast cancer, T"ese class of c"emicals are also endocrine disru#tors and "a(e &een lin+ed to fertilit' #ro&lems, Also +no)n as #etroleum Fell'% t"is mineral oil deri(ati(e is used for its emollient #ro#erties in cosmetics, t "as no nutrient (alue for t"e s+in and can interfere )it" t"e @

&od'<s o)n natural moisturi-in! mec"anism% leadin! to dr'ness and c"a##in!, t often creates t"e (er' conditions it claims to alle(iate, 9anufacturers use #etrolatum &ecause it is un&elie(a&l' c"ea#, 8etroleum Distillates 8"t"alates 8ossi&le "uman carcino!en, 9a' contain "armful im#urities or &rea+do)n #roducts, 8ro"i&ited for use in cosmetics in t"e Euro#ean Union, 3ound in some mascara% #erfume% foundation% li#stic+ and li# &alm, T"is "as &een lin+ed to dama!e of t"e or!ans 55 +idne's% lun!s% and li(er 55 as )ell as t"e re#roducti(e s'stem, deall' t"is is a (e!eta&le !l'cerin mi:ed )it" !rain alco"ol% &ot" of )"ic" are natural, Usuall' it is a s'nt"etic #etroc"emical mi: used as a "umectant, t "as &een +no)n to cause aller!ic reactions% "i(es and ec-ema, W"en 'ou see 8EG /#ol'et"'lene !l'col0 or 88G /#ol'#ro#'lene !l'col0 on la&els% &e)areGt"ese are related s'nt"etics, Alt"ou!" e:#osure to "i!" le(els of 8ro#'lene Gl'col is +no)n to cause serious and #otentiall' irre(ersi&le "ealt" conditions% t"e c"emical industr' tell us t"at 4small4 ?uantities or lo) le(el e:#osure of 8ro#'lene Gl'col is 4safe4 to use on t"e s+in and in food, Accordin! to t"e safet' data s"eets of industrial c"emical manufacturers% c"emicals suc" as Et"'lene Gl'col and 8ro#'lene Gl'col )ill cause serious "ealt" conditions% includin! li(er and "eart dama!e and dama!e to t"e central ner(ous s'stem if sufficient is a&sor&ed &' t"e &od', A #etroleum5deri(ed c"emical used in "airs#ra's% st'lin! aids and ot"er cosmetics, t can &e considered to:ic% since in"aled #articles can dama!e t"e lun!s of sensiti(e #ersons, A c"ea#% "ars" deter!ent used in s"am#oos for its cleansin! and foam5&uildin! #ro#erties, Often deri(ed from #etroleum% it is fre?uentl' dis!uised in #seudo5natural cosmetics )it" t"e #"rase 4comes from coconuts,4 t causes e'e irritation% scal# scurf similar to dandruff% s+in ras"es and ot"er aller!ic reactions, A ?uaternar' ammonium com#ound used in "air conditioners and creams, De(elo#ed &' t"e fa&ric industr' as a fa&ric softener% it is a lot c"ea#er and easier to use in "air conditionin! formulas t"an #roteins or "er&als% )"ic" are &eneficial to t"e "air, $auses aller!ic reactions, To:ic, Used to ma+e cosmetics 4#rett'%4 s'nt"etic colors% alon! )it" s'nt"etic "air d'es% s"ould &e a(oided at all costs, T"e' )ill &e la&eled as 3DI$ or DI$% follo)ed &' a color and a num&er, E:am#le: 3DI$ Red No, B D DI$ Green No, B, 9an' s'nt"etic colors can &e carcino!enic, f a cosmetic contains t"em% don<t use it, T"e s'nt"etic fra!rances used in cosmetics can "a(e as man' as ;22 in!redients, T"ere is no )a' to +no) )"at t"e c"emicals are% since on t"e la&el it )ill sim#l' read 4fra!rance,4 Some #ro&lems caused &' t"ese c"emicals include "eadac"es% di--iness% ras"% "'#er#i!mentation% (iolent cou!"in!% (omitin!% s+in irritationGt"e list !oes on, Ad(ice: Don<t &u' a cosmetic t"at "as t"e )ord 4fra!rance4 on t"e in!redients la&el,

8ro#'lene Gl'col

8H8DHA $o#ol'mer

Sodium Laur'lDLauret" Sulfate

Stearal+onium $"loride

S'nt"etic $olors

S'nt"etic 3ra!rances

Alpha Hydroxy Acids

Why are AHAs used in some cosmetics? How do AHAs work? What about products that contain AHAs and are marketed with therapeutic claims? Has FDA received reports of adverse events related to AHAs? Has FDA conducted research on the safety of AHAs? How can AHAs be used safely? How can I know if a product contains AHAs?

The following information is intended to answer uestions about alpha hydro!y acids" also known as AHAs" which are often used as ingredients in cosmetic and drug products applied to the skin# Why are AHAs used in some cosmetics? $roducts containing AHAs are marketed for a variety of purposes" such as smoothing fine lines and surface wrinkles" improving skin te!ture and tone" unblocking and cleansing pores" and improving skin condition in general# %ometimes AHAs are used in cosmetics for other purposes" such as to ad&ust the pH 'the degree of acidity or alkalinity(# How do AHAs work? AHA)containing products cause e!foliation" or shedding of the surface skin# The e!tent of e!foliation depends on the type and concentration of the AHA" its pH" and other ingredients in the product# What about products that contain AHAs and are marketed with therapeutic claims? %ome products containing AHAs have been marketed for uses such as treating acne" removing scars" and lightening discolorations# Among these are some products marketed as *skin peelers"* which may contain relatively high concentrations of AHAs or other acids and are designed to remove the outer layer of the skin# $roducts that are intended for use in the diagnosis" cure" mitigation" treatment" or prevention of disease" or to affect the structure or any function of the body are drugs under the law 'Federal Food" Drug" and +osmetic Act" %ec# ,-.'g((# For e!ample" products intended for use as acne treatments or skin lighteners are considered drugs# For more on this sub&ect" see Is It a +osmetic" a Drug" or /oth? 'or Is It %oap?( and the Warning 0etter issued to 1lobal 2sthetics 'available in $DF ',3-4/((# Has FDA recei ed reports o! ad erse e ents related to AHAs? FDA received a total of ..5 adverse dermatologic e!perience reports for AHA)containing skin care products between .66, and February ,--5" with the ma!imum number in .665# The reported adverse e!periences included burning '57(" dermatitis or rash '37(" swelling ',6(" pigmentary changes '.7(" blisters or welts '.5(" skin peeling '.3(" itching '.,(" irritation or tenderness '8(" chemical burns '9(" and increased sunburn '3(# The fre uency of such reports for skin e!foliating products that contain AHAs has been considerably lower in subse uent years# The more serious adverse reactions appear to occur most often with products that cause the greatest degree of e!foliation" such as *skin peelers#* Has FDA conducted research on the sa!ety o! AHAs? 6

:es# These studies '.( compared the effect of AHAs" topically applied in a cream" on the sensitivity of human skin to ultraviolet ';<( radiation with the effect of the same cream containing no AHAs" ',( measured how fast the skin returns to normal after use of the AHA)containing cream is discontinued" and '3( investigated whether AHAs enhance ;<)induced damage to D=A in the skin '4ays 4aidbey" /etsy %utherland" $aula /ennett" Wayne 1# Wamer" +urtis /arton" Donna Dennis" and Andri&a 4ornhauser" Topical glycolic acid enhances photodamage by ultraviolet light" Photodermatology, Photoimmunology and Photomedicine " vol# .6 ',--3(" issue ." pages ,.),>(# These studies confirmed previous industry studies indicating that applying AHAs to the skin results in increased ;< sensitivity# After four weeks of AHA application" volunteers? sensitivity to skin reddening produced by ;< increased by .8 percent# %imilarly" the volunteers? sensitivity to ;<) induced cellular damage doubled" on average" with considerable differences among individuals# However" the studies also indicated that this increase in sensitivity is reversible and does not last long after discontinuing use of the AHA cream# @ne week after the treatments were halted" researchers found no significant differences in ;< sensitivity among the various skin sites# The studies did not identify e!actly how AHAs bring about the increased ;< sensitivity" although the effects did not appear to involve dramatic increases in ;<)induced damage to D=A in the skin# $revious FDA studies have indicated that a cosmetic)type cream base caused an AHA to penetrate more deeply into the skin when compared to an AHA solution without the usual cosmetic ingredients# However" further studies will be needed to learn how much" if at all" those cosmetic) type ingredients influence the AHA)related effects on ;< sensitivity# FDA also has collaborated with the =ational To!icology $rogram '=T$( to assess the safety of the long)term use of AHAs# This study determined that glycolic acid did not affect photocarcinogenesis 'the development of cancer cells associated with e!posure to light( in mice" and that salicyclic acid had a photoprotective effect 'protected against the effects of light( in mice# The complete results of this study are available in the =T$ Technical Aeport on the $hotocarcinogenesis %tudy of 1lycolic Acid and %alicylic Acid '+A% =@%# >6).5). and 96)>,)>( in %4H). Bice 'available in $DF'.#6B/((# FDA continues to review available data on AHAs to address the potential for this increased skin sensitivity to the sun# How can AHAs be used sa!ely? It is important to follow directions carefully and heed any warning statements on the label when using any cosmetic product# If you are using AHAs" it is advisable to use sun protection# In Canuary ,--7" FDA issued 1uidance for IndustryD 0abeling of +osmetics +ontaining Alpha Hydro!y Acids as Ingredients# The purpose of this guidance is to educate consumers about the potential for increased skin sensitivity to the sun from the topical use of cosmetics containing AHAs and to educate manufacturers to help ensure that their labeling for these products is not false or misleading# FDA recommends that the labeling of a cosmetic product that contains an AHA as an ingredient and that is topically applied to the skin or mucous membrane" such as the lips" bear a statement that conveys the following informationD %unburn AlertD This product contains an alpha hydro!y acid 'AHA( that may increase your skin?s sensitivity to the sun and particularly the possibility of sunburn# ;se a sunscreen" wear protective clothing" and limit sun e!posure while using this product and for a week afterwards# /ased on industry)sponsored studies" the +osmetic Ingredient Aeview '+IA( 2!pert $anel E the industry?s self)regulatory body for reviewing the safety of cosmetic ingredients E concluded that products containing the AHAs glycolic and lactic acid are safe for use by consumers ifD The AHA concentration is .- percent or less# The final product has a pH of 3#7 or greater# The final product is formulated in such a way that it protects the skin from increased sun sensitivity or its package directions tell consumers to use daily protection from the sun# B

How can I know i! a cosmetic product contains AHAs? ;nder the authority of the Fair $ackaging and 0abeling Act 'F$0A(" FDA re uires an ingredient declaration on cosmetic products sold at the retail level to consumers# However" because the F$0A does not apply to products used e!clusively by professionals E for e!ample" in salons E the re uirement for an ingredient declaration does not apply to these products# The most common AHAs in cosmetic products are glycolic acid and lactic acid# Among others are citric acid" hydro!ycaprylic acid" and hydro!ycapric acid# "eta Hydroxy Acids in Cosmetics Throughout the last decade" alpha hydro!y acids 'AHAs( have increasingly appeared as ingredients in cosmetics intended to reduce the signs of aging in the skin# Bore recently" beta hydro!y acids '/HAs(" or a combination of AHAs and /HAs" have appeared as ingredients in these skin care products# While both AHAs and /HAs act as e!foliants" it has been claimed that /HAs are effective in reducing the appearance of fine lines and wrinkles" and improving overall skin te!ture" without the occasional irritation associated with the use of AHAs# /HA ingredients may be listed as ) salicylic acid 'or related substances" such as salicylate" sodium salicylate" and willow e!tract( F beta hydro!ybutanoic acid tropic acid trethocanic acid +urrently" the /HA most commonly used in cosmetics is salicylic acid# @n rare occasions" citric acid is also cited as a /HA in cosmetic formulations# Bore commonly" citric acid is referred to as an AHA# The safety of salicylic acid used as a cosmetic ingredient has been evaluated by both the cosmetic industry and FDA# At a meeting in February ,---" the +osmetic Ingredient Aeview '+IA( 2!pert $anel" the cosmetic industry?s independent body for reviewing the safety of cosmetic ingredients" reached the tentative conclusion that the use of salicylic acid related substances in cosmetics is *safe as used when formulated to avoid irritation and when formulated to avoid increased sun sensitivity#* +IA added that *when sun sensitivity would be e!pected" directions for use GshouldH include the daily use of sun protection#* In other words" according to +IA Director Alan Andersen" products containing salicylic acid should either contain a sunscreen or bear directions advising consumers to use other sun protection# In order to comply with the +IA recommendations" cosmetic manufacturers should test their products to determine whether or not they cause an increase in sensitivity to the harmful ultraviolet radiation in sunlight# The long)term safety of salicylic acid in cosmetics also is being evaluated in studies initiated by FDA and sponsored by the =ational To!icology $rogram# These government)sponsored studies are e!amining the long)term effects of both glycolic acid 'an AHA( and salicylic acid on the skin?s response to ultraviolet ';<( light# These studies have determined that applying glycolic acid to the skin can make people more susceptible to the damaging effects of the sun" including sunburn# ;ntil these safety assessments are completed" FDA advises that similar precautions be taken for the use of cosmetics containing AHAs and /HAs# These precautions areD Test any product that contains a /HA on a small area of skin before applying it to a large area# If you use cosmetics with /HAs and e!perience skin irritation or prolonged stinging" stop using the product and consult your physician# Follow the use instructions on the label# Do not e!ceed the recommended applications# =

Avoid using /HA)containing products on infants and children# ;se sun protection if you use a /HA product#

+onsumers should report any adverse reactions" such as irritation or sun sensitivity" associated with the use of /HAs to their local FDA office" listed in the /lue $ages of the phone book" or to FDA?s @ffice of +onsumer Affairs at .)8--)73,)555-#I If you have purchased a product whose outer packaging has become separated from the product and you are unsure whether it contains /HAs" call the manufacturer" whose phone number may be listed on the inner packaging#
F

From a chemist?s perspective" salicylic acid is not a true /HA# However" cosmetic companies often refer to it as a /HA and" conse uently" many consumers think of it as one# %ee alsoD Information About %untan $roducts" %unscreens" and Tanning

Color Additi es and Cosmetics

Bore information on ) +olor Additives ) +olor Additives and +osmetics +olor additives are sub&ect to a strict system of approval under ;#%# law GFDJ+ Act" sec# >,.K ,. ;#%#+# 3>6eH# 2!cept in the case of coal)tar hair dyes" failure to meet ;#%# color additive re uirements causes a cosmetic to be adulterated GFDJ+ Act" sec# 9-.'e(K ,. ;#%# +ode 39.'e(H# +olor additive violations are a common reason for detaining imported cosmetic products offered for entry into this country# Some "asic #e$uirements If your product 'e!cept coal)tar hair dyes( contains a color additive" by law GFDJ+ Act" %ec# >,.K ,. ;#%#+# 3>6eK ,. +FA $arts >- and 8-H you must adhere to re uirements forD Appro al% All color additives used in cosmetics 'or any other FDA)regulated product( must be approved by FDA# There must be a regulation specifically addressing a substance?s use as a color additive" specifications" and restrictions# Certi!ication% In addition to approval" a number of color additives must be batch certified by FDA if they are to be used in cosmetics 'or any other FDA)regulated product( marketed in the ;#%# Identity and speci!ications% All color additives must meet the re uirements for identity and specifications stated in the +ode of Federal Aegulations '+FA(# &se and restrictions% +olor additives may be used only for the intended uses stated in the regulations that pertain to them# The regulations also specify other restrictions for certain colors" such as the ma!imum permissible concentration in the finished product# How are color additi es categori'ed? The FDJ+ Act %ection >,.'c( G,. ;#%# +# 3>6e'c(H and color additive regulations G,. +FA $arts >and 8-H separate approved color additives into two main categoriesD those sub&ect to certification 'sometimes called *certifiable*( and those e!empt from certification# In addition" the regulations refer to other classifications" such as straight colors and lakes# >

Colors sub(ect to certi!ication% These color additives are derived primarily from petroleum and are sometimes known as *coal)tar dyes* or *synthetic)organic* colors# ' )*+,- +oal)tar colors are materials consisting of one or more substances that either are made from coal)tar or can be derived from intermediates of the same identity as coal)tar intermediates# They may also include diluents or substrata# '%ee Federal Register" Bay 6" .636" page .6,,#( Today" most are made from petroleum#( o 2!cept in the case of coal)tar hair dyes" these colors must not be used unless FDA has certified that the batch in uestion has passed analysis of its composition and purity in FDA?s own labs# If the batch is not FDA)certified" don?t use it# o These certified colors generally have three)part names# The names include a prefi! FDJ+" DJ+" or 2!ternal DJ+K a colorK and a number# An e!ample is *FDJ+ :ellow =o# 7#* +ertified colors also may be identified in cosmetic ingredient declarations by color and number alone" without a prefi! 'such as *:ellow 7*(# Colors exempt !rom certi!ication% These color additives are obtained primarily from mineral" plant" or animal sources# They are not sub&ect to batch certification re uirements# However" they still are considered artificial colors" and when used in cosmetics or other FDA)regulated products" they must comply with the identity" specifications" uses" restrictions" and labeling re uirements stated in the regulations G,. +FA >3H# Straight color% *%traight color* refers to any color additive listed in ,. +FA >3" >5" and 8. G,. +FA >-#3'&(H# .ake% A lake is a straight color e!tended on a substratum by adsorption" coprecipitation" or chemical combination that does not include any combination of ingredients made by a simple mi!ing process G,. +FA >-#3'l(H# /ecause lakes are not soluble in water" they often are used when it is important to keep a color from *bleeding"* as in lipstick# In some cases" special restrictions apply to their use# As with any color additive" it is important to check the %ummary of +olor Additives and the regulations themselves G,. +FA 8," %ubparts / and +H to be sure you are using lakes only for their approved uses#

How can I guard against color additi e iolations? %everal precautions can help you avoid color additive violations that will cause your cosmetic to be adulteratedD Do not con!use certi!ied colors with their uncerti!ied counterparts% For e!ample" FDJ+ :ellow =o# 7 is the certified form of tartraLine" and is approved for use in cosmetics generally# /ut tartraLine" which has not undergone FDA analysis and received FDA certification" must not be substituted for or identified in an ingredient declaration as FDJ+ :ellow =o# 7# Do not con!use certi!ied colors with colors identi!ied only by a Colour Index /CI0 number1 or by the , number sometimes used in ,uropean color identi!ication% :ou must not use a color sub&ect to certification unless FDA has certified the batch in uestion GFDJ+ Act" sec# >,.'a('.('A(# A +I or 2 number does not indicate FDA certification# When purchasing color additi es sub(ect to certi!ication1 check the label% If the lot is certified" the color?s label must state the legal name for the color 'such as *FDJ+ :ellow =o# 7*(" or" if it is a mi!ture" the name of each ingredientK the FDA lot certification numberK and the color?s uses and restrictions as stated in the +FA G,. +FA >-#,7(# Check the Summary o! Color Additi es on FDA2s Web site% Although this table is not a substitute for the regulations" it is an easy)to)use reference that introduces you to FDA) approved color additives and directs you to the regulations addressing specific color additives# "ecome !amiliar with the regulations themsel es% The color additive regulations are in ,. +FA $arts >- through 8,# %pecific color additives are addressed in $arts >3" >5" and 8,# 1

The color additive regulations are posted on FDA?s Web site at httpDMMwww#cfsan#fda#govMNdmsMcol)cfr#html# To purchase printed copies of the +FA by credit card" call the 1overnment $rinting @ffice at ',-,( 7.,).8--" Bonday through Friday" from 8D-- a#m# to 5D-- p#m#" 2astern %tandard Time# To pay by check" write to the %uperintendent of Documents" AttnD =ew @rders" $#@# /o! 3>.675" $ittsburgh" $A .7,7-) >675# +ontact the 1overnment $rinting @ffice directly for current costs# Con!irm the status o! color additi es be!ore use% There may be changes in color additive approvals and changes in the uses and restrictions that apply to a color additive# %uch changes may affect colors sub&ect to certification as well as colors e!empt from certification# To stay current with the regulations" you can check the latest edition of the +FA and FDA Dockets# :ou also may contact FDA at +olor#+ertOfda#hhs#gov# When purchasing colors sub(ect to certi!ication1 con!irm that the manu!acturer has re$uested certi!ication% For e!ample" you can choose a manufacturer from FDA?s list of companies that have re uested color certification within the past two years# This list is posted on FDA?s Web site at httpDMMwww#cfsan#fda#govMNdmsMcol)comp#html and is available as Document P>.- by mail or fa! through the +enter for Food %afety and Applied =utrition @utreach and Information +enter?s toll)free phone number" .)888)%AF2F@@D# If the company that appears on the color additive label is not on this list" you may contact FDA at +olor#+ertOfda#hhs#gov to determine whether the company has in fact re uested certification of its color additives#

3ust I match colors with intended use? :es# =o matter whether a particular color is sub&ect to certification or e!empt from certification" ;#%# law prohibits its use in cosmetics 'or any other FDA)regulated product( unless it is approved specifically for the intended use GFDJ+ Act" sec# >,.'a('.('A(K ,. ;#%#+# 3>6e'a('.('A(H# The regulations also restrict intended use as followsD ,ye4area use- :ou may not use a color additive in the area of the eye unless the regulation for that additive specifically permits such use G,. +FA >-#7'a(H# The *area of the eye* includes *the area enclosed within the circumference of the supra)orbital ridge and the infra) orbital ridge" including the eyebrow" the skin below the eyebrow" the eyelids and the eyelashes" and con&unctival sac of the eye" the eyeball" and the soft areolar tissue that lies within the perimeter of the infra)orbital ridge* G,. +FA >-#3's(H# Although there are color additives approved for use in products such as mascara and eyebrow pencils" none is approved for dyeing the eyebrows or eyelashes# ,xternally applied cosmetics- This term does not apply to the lips or any body surface covered by mucous membrane# For instance" if a color additive is approved for use in e!ternally applied cosmetics" you may not use it in products such as lipsticks unless the regulation specifically permits this use G,. +FA >-#3 'v(H# In(ection- =o color additive may be used in in&ections unless its listing in the regulations specifically provides for such use# This includes in&ection into the skin for tattooing or permanent makeup# The fact that a color additive is listed for any other use does not mean that it may be used for in&ections G,. +FA >-#7'b(H# There are no color additives listed in the regulations as approved for in&ections# What about special e!!ects and no elty use? =o matter how e!otic or novel the color additive or its intended use" it is sub&ect to the same regulations as the more everyday colors and products# The following items are a sampling of some out)of)the)ordinary color additives# This list is not e!haustive# Aather" it is intended to show how the regulations apply to such colorsD 72

Color4changing pigments- +olors that change in response to such factors as change in pH or e!posure to o!ygen or temperature are sub&ect to the same regulations as all other color additives# Composite pigments- +olor additives used in combination to achieve variable effects" such as those found in pearlescent products" are sub&ect to the same regulations as all other color additives# %ome color additives" when used in combination" may form new pigments" which may not be approved for the intended use# An e!ample is a *holographic* glitter" consisting of aluminum an approved color additive bonded to an etched plastic film# Fluorescent colors- @nly the following fluorescent colors are approved for use in cosmetics" and there are limits on their intended usesD DJ+ @range =o# 7" =o# .-" and =o# ..K and DJ+ Aed =o# ,." =o# ,," =o# ,>" and =o# ,8 G,. +FA >5#,,75" >5#,,9-" >5#,,9." >5#,3,." >5#,3,," >5#,3,>" and >5#,3,8H# 5low4in4the4dark colors- 0uminescent Linc sulfide is the only approved glow)in)the)dark color additive G,. +FA >3#,667H# Halloween makeup- These products are considered cosmetics GFDJ+ Act" sec# ,-.'i(K ,. ;#%#+# 3,.'i(H and are therefore sub&ect to the same regulations as other cosmetics" including the same restrictions on color additives# .i$uid crystal colors- These additives" which produce color motifs in a product through diffraction" are unapproved color additives# Their use in cosmetics is therefore illegal GFDJ+ Act" sec# 9-.'e(K ,. ;#%#+# 39.'e(H# +attoo pigments- As noted above" no color additives are approved for in&ection into the skin" as in tattoos and permanent makeup# +heatrical makeup- 0ike Halloween makeup" these products are considered cosmetics GFDJ+ Act" sec# ,-.'i(K ,. ;#%#+# 3,.'i(H and are therefore sub&ect to the same regulations as other cosmetics" including the same restrictions on color additives#

Diethanolamine and Cosmetic 6roducts

The =ational To!icology $rogram '=T$( completed a study in .668 that found an association between the topical application of diethanolamine 'D2A( and certain D2A)related ingredients and cancer in laboratory animals# For the D2A)related ingredients" the =T$ study suggests that the carcinogenic response is linked to possible residual levels of D2A# The =T$ study did not establish a link between D2A and the risk of cancer in humans# D2A and D2A)related ingredients function as emulsifiers or foaming agents in cosmetics" or to ad&ust a product?s pH 'acidity(# /ased on information filed with FDA?s <oluntary +osmetic Aegistration $rogram" it appears that D2A and D2A)related ingredients are used much less fre uently in cosmetic products than they were when the =T$ completed its study# 1enerally speaking" e!cept for most color additives and those ingredients that are prohibited or restricted by regulation from use in cosmetics" a manufacturer may use any ingredient in the formulation of a cosmetic product provided that the ingredient and the finished cosmetic are safe" the product is properly labled" and the use of the specific substance does nototherwise cause the cosmetic to be adulterated or misbranded under the laws that FDA enforces# FDA believes that at the present time there is no reason for consumers to be alarmed based on the use of these substances in cosmetics# However" consumers wishing to avoid cosmetics containing D2A or D2A)related ingredients may do so by reviewing the ingredient statement that is re uired to appear on the outer container label of cosmetics offered for retail sale to consumers# The following are some of the most commonly used ingredients that may contain D2AD +ocamide D2A +ocamide B2A 77

D2A)+etyl $hosphate D2A @leth)3 $hosphate 0auramide D2A 0inoleamide B2A Byristamide D2A @leamide D2A %tearamide B2A T2A)0auryl %ulfate Triethanolamine

If FDA determines that a health haLard e!ists" the agency will advise the industry and the public and will consider its legal options under the authority of the Food" Drug and +osmetic Act in protecting the health and welfare of consumers#

7184Dioxane
What is ."5)dio!ane? Is ."5)dio!ane in cosmetic products harmful? What is FDA doing to assure that cosmetics do not contain unsafe levels of ."5)dio!ane? FDA has received uestions on the sub&ect of ."5)dio!ane" a contaminant that may occur in trace amounts in certain cosmetics# The following information has been compiled from responses to those uestions" from the published scientific literature" and other public sources# What is 7184dioxane? The compound ."5)dio!ane is a contaminant that may be present in e!tremely small amounts in some cosmetics# It forms as a byproduct during the manufacturing process of certain cosmetic ingredients# These ingredients include certain detergents" foaming agents" emulsifiers and solvents identifiable by the prefi!" word" or syllables *$21"* *$olyethylene"* *$olyethylene glycol"* *$olyo!yethylene"* *)eth)"* or *)o!ynol)#* However" ."5)dio!ane itself is not used as a cosmetic ingredient# Is 7184dioxane in cosmetic products harm!ul? The levels at which a chemical compound would be considered harmful in a cosmetic depend on the conditions of use 'FDJ+ Act" section 9-.'a((# The ."5)dio!ane levels we have seen in our monitoring of cosmetics do not present a haLard to consumers# +oncerns initially were raised in the .6>-s" when studies at the =ational +ancer Institute found an association between."5)dio!ane and cancer in animals when ."5)dio!ane was administered in high levels in the animal feed# However" the levels in cosmetic products are far lower than those found to be harmful in feeding studies and" for the most part" the types of products in which it is found are only in contact with the skin for a short time# As a precaution" FDA followed up with skin absorption studies" which showed that ."5)dio!ane can penetrate animal and human skin when applied in certain preparations" such as lotions# However" further research by FDA determined that ."5)dio!ane evaporates readily" further diminishing the already small amount available for skin absorption" even in products that remain on the skin for hours# 'Aobert 0# /ronaugh" *$ercutaneous Absorption of +osmetic Ingredients"* in $rinciples of +osmetics for the Dermatologist" $hilip Frost" B#D#" and %teven HorwitL" B#D#" 2ds# %t# 0ouisD The +#<# Bosby +ompany" .68,( 7;

What is FDA doing to assure that cosmetics do not contain unsa!e le els o! 7184dioxane? FDA has been monitoring this issue since the late .6>-s# We periodically monitor the levels of ."5) dio!ane in cosmetic products" and have observed that the changes made in the manufacturing process have resulted in a significant decline in the levels of this contaminant# 'Aoderick 2# /lack" Fred C# Hurley and Donald +# Havery" *@ccurrence of ."5)Dio!ane in +osmetic Aaw Baterials and Finished +osmetic $roducts"* Cournal of A@A+ International" 85 '3(" ,--." pp# 999)99>( FDA has not established or recommended a specific limit on the level of ."5)dio!ane in cosmetics# We have provided guidance to manufacturers alerting them to the health concerns and how to minimiLe ."5)dio!ane by means of a process called *vacuum stripping* at the end of the polymeriLation process# This information has been posted on our website in the +osmetic Handbook for IndustryD +osmetic $roduct)Aelated Aegulatory Ae uirements and Health HaLard Issues# We also provide FDA inspectors with information on this procedure in our 1uide to Inspections of +osmetic $roduct Banufacturers so that when they conduct inspections they will know what to look for and what uestions to ask# If FDA were to determine that a health haLard e!ists" it would advise the industry and the public" and would consider its legal options for protecting the health and welfare of consumers# For more on the sub&ect of cosmetic safety and the law" see FDA Authority @ver +osmetics" 4ey 0egal +onceptsD *Interstate +ommerce"* *Adulterated"* and *Bisbranded*" and the cosmetics provisions of the Federal Food" Drug" and +osmetic Act#

,ye Cosmetic Sa!ety

'This document in Arabic 'August ." ,--.(( 2ye cosmetics are intended to make eyes more attractive" or in some cases to cleanse the eye area# @ne thing they shouldn?t do is cause harm# Bost are safe when used properly# However" there are some things to be careful about when using these products" such as the risk of infection" the risk of in&ury from the applicator" and the use of unapproved color additives# The following information provides an introduction to some safety concerns and legal issues related to eye cosmetics# 9eep it clean: 2ye cosmetics are usually safe when you buy them" but misusing them can allow dangerous bacteria or fungi to grow in them# Then" when applied to the eye area" a cosmetic can cause an infection# In rare cases" women have been temporarily or permanently blinded by an infection from an eye cosmetic# %ee the %afety +hecklist below for tips on keeping your eye cosmetics clean and protecting against infections# @ccasionally" contamination can be a problem for some eye cosmetics even when they are new# FDA has an Import Alert in effect for cosmetics )) including eye cosmetics )) contaminated with harmful microorganisms# Don2t share: Don2t swap: Don?t share or swap eye cosmetics )) not even with your best friend# Another person?s germs may be haLardous to you# The risk of contamination may be even greater with *testers* at retail stores" where a number of people are using the same sample product# If you feel you must sample cosmetics at a store" make sure they are applied with single)use applicators" such as clean cotton swabs# 7@

Hold still: It may seem like efficient use of your time to apply makeup in the car or on the bus" but resist that temptation" even if you?re not in the driver?s seat# If you hit a bump" come to a sudden stop" or are hit by another vehicle" you risk in&uring your eye 'scratching your cornea" for e!ample( with a mascara wand or other applicator# 2ven a slight scratch can result in a serious infection# What2s in it? As with any cosmetic product sold on a retail basis to consumers" eye cosmetics are re uired to have an ingredient declaration on the label" according to regulations implemented under the Fair $ackaging and 0abeling Act" or F$0A )) an important consumer protection law# If you wish to avoid certain ingredients or compare the ingredients in different brands" you can check the ingredient declaration# If a cosmetic sold on a retail basis to consumers does not have an ingredient declaration" it is considered misbranded and is illegal in interstate commerce# <ery small packages in tightly compartmented display racks may have copies of the ingredient declaration available on tear)off sheets accompanying the display# If neither the package nor the display rack provides the ingredient declaration" you aren?t getting the information you?re entitled to# Don?t hesitate to ask the store manager or the manufacturer why not# What2s that shade you2re wearing? In the ;nited %tates" the use of color additives is strictly regulated# A number of color additives approved for cosmetic use in general are not approved for use in the area of the eye# An import alert for cosmetics containing illegal colors lists several eye cosmetics# 9eep away !rom kohl 44 and keep kohl away !rom kids: @ne color additive of particular concern is kohl# Also known as al)kahl" ka&al" or surma" kohl is used in some parts of the world to enhance the appearance of the eyes" but is unapproved for cosmetic use in the ;nited %tates# 4ohl consists of salts of heavy metals" such as antimony and lead# It may be tempting to think that because kohl has been used traditionally as an eye cosmetic in some parts of the world" it must be safe# However" there have been reports linking the use of kohl to lead poisoning in children#F An FDA Import Alert cites three main reasons for detaining imports of kohlD .# For containing an unsafe color additive" which makes the product adulterated# ,# For labeling that describes the product falsely as *FDA Approved#* 3# For lack of an ingredient declaration# %ome eye cosmetics may be labeled with the word *kohl* only to indicate the shade" not because they contain true kohl# If the product is properly labeled" you can check to see whether the color additives declared on the label are in FDA?s list of color additives approved for use in cosmetics" then make sure they are listed as approved for use in the area of the eye# Dying to dye your eyelashes? $ermanent eyelash and eyebrow tints and dyes have been known to cause serious eye in&uries" including blindness# There are no color additives approved by FDA for permanent dyeing or tinting of eyelashes and eyebrows# FDA has an Import Alert in effect for eyelash and eyebrow dyes containing coal tar colors# 7A

+hinking o! !alse eyelashes or extensions? FDA considers false eyelashes" eyelash e!tensions" and their adhesives to be cosmetic products" and as such they must adhere to the safety and labeling re uirements for cosmetics# False eyelashes and eyelash e!tensions re uire adhesives to hold them in place# Aemember that the eyelids are delicate" and an allergic reaction" irritation" or other in&ury in the eye area can be particularly troublesome# +heck the ingredients before using these adhesives# "ad #eaction? If you have a bad reaction to eye cosmetics" first contact your healthcare provider# FDA also encourages consumers to report any adverse reactions to cosmetics either to their nearest FDA district office or to FDA?s +enter for Food %afety and Applied =utrition '+F%A=( Adverse 2vent Aeporting %ystem '+A2A%(# Here?s howD To contact your nearest FDA district office" you can find their phone numbers on FDA?s Web site# These phone numbers also are included in the ;#%# 1overnment listings in the /lue $ages of the phone book under ;nited %tates 1overnmentMHealth and Human %ervices# To contact FDA?s +enter for Food %afety and Applied =utrition '+F%A=( Adverse 2vent Aeporting %ystem '+A2A%(" call '3-.( 539),5-7 or email +A2A%Ocfsan#fda#gov# Sa!ety Checklist If you use eye cosmetics" FDA urges you to follow these safety tipsD If any eye cosmetic causes irritation" stop using it immediately# If irritation persists" see a doctor# Avoid using eye cosmetics if you have an eye infection or the skin around the eye is inflamed# Wait until the area is healed# Discard any eye cosmetics you were using when you got the infection# /e aware that there are bacteria on your hands that" if placed in the eye" could cause infections# Wash your hands before applying eye cosmetics# Bake sure that any instrument you place in the eye area is clean# Don?t share your cosmetics# Another person?s bacteria may be haLardous to you# Don?t allow cosmetics to become covered with dust or contaminated with dirt or soil# 4eep containers clean# Don?t use old containers of eye cosmetics# Banufacturers usually recommend discarding mascara two to four months after purchase# Discard dried)up mascara# Don?t add saliva or water to moisten it# The bacteria from your mouth may grow in the mascara and cause infection# Adding water may introduce bacteria and will dilute the preservative that is intended to protect against microbial growth# Don?t store cosmetics at temperatures above 87 degrees F# +osmetics held for long periods in hot cars" for e!ample" are more susceptible to deterioration of the preservative# When applying or removing eye cosmetics" be careful not to scratch the eyeball or other sensitive area# =ever apply or remove eye cosmetics in a moving vehicle# Don?t use any cosmetics near your eyes unless they are intended specifically for that use# For instance" don?t use a lip liner as an eye liner# :ou may be e!posing your eyes to contamination from your mouth" or to color additives that are not approved for use in the area of the eye# Avoid color additives that are not approved for use in the area of the eye" such as *permanent* eyelash tints and kohl# /e especially careful to keep kohl away from children" since reports have linked it to lead poisoning 76

9ohl1 9a(al1 Al49ahl1 or Surma"y Any )ame1 "eware o! .ead 6oisoning Bany people are aware of some of the most common and best known sources of lead poisoning" such as lead paint and fumes from leaded gasoline# /ut many may be unaware of the risk of lead poisoning" in both adults and children" from an easily avoidable sourceD the traditional eye cosmetic known variously as kohl" ka&al" al)kahl" or surma# The following information is intended to answer uestions people may ask about kohl and its dangersD What is kohl made o!? %amples tested often contain significant amounts of lead# 0ead sometimes accounts for more than half the weight of a sample of kohl" usually in the form of lead sulfide# 4ohl may also contain a variety of other materials" such as aluminum" antimony" carbon" iron" and Linc compounds" as well as camphor and menthol#." ," 9" >" 8" 6" .-" .. What are the e!!ects o! lead poisoning? The risks associated with e!posure to lead are especially serious for children" who are particularly susceptible to absorbing lead from the environment# Among the effects associated with high levels of e!posure are anemia" kidney problems" and neurological damage that may include seiLures" coma and death# 2ven at relatively low levels" chronic e!posure to lead may lead to learning and behavior problems 'see Dangers of 0ead %till 0inger"* FDA Consumer" Canuary)February .668(# Is kohl directly linked to increased le els o! lead in children? :es# FDA has learned of recent instances of kohl)related lead poisoning in children in the ;#%# A number of studies have shown that children e!posed to kohl have increased levels of lead in their blood#3" 5" 6" .. This e!posure puts them at increased risk for the serious conse uences of lead poisoning# How are children exposed to kohl? In some cultures" it is common for parents to apply kohl to the eyes of infants and children# Infants of mothers who use kohl sometimes have elevated levels of lead in their blood# 6" .. Also" some people traditionally paint a newborn?s umbilical stump with kohl" supposedly for medicinal reasons#
3" 5

;nlike some sources of e!posure to lead" this one is easily avoidable by not using kohl on your children or yourself" and keeping it out of your home# I! someone in my !amily has been exposed to kohl1 what should I do? %top all use of kohl immediately and be especially careful to protect children from further e!posure# $lace unused kohl in a sealable container or plastic bag and contact your local sanitation or waste department regarding appropriate methods for disposal# Thoroughly wash hands and any other body parts that may have come in contact with kohl# Wash e!posed household surfaces with soap and hot water# Ask a health care provider to test children as well as pregnant or nursing women for lead poisoning if they have used kohl# Is kohl legal in the &%S%? =o# 4ohl is a color additive as that term is defined in the Federal Food" Drug and +osmetic Act 'FDJ+ Act(" and there is no regulation permitting its use in a cosmetic or in any other FDA) regulated product# +olor additives 'other than coal)tar hair dyes( that are not permitted by regulation are considered unsafe under the law# 'For more information on color additives and the law" see the FDJ+ Act" sections ,-.'t( and >,. as well as FDA?s +olor Additives Web site# 7B

FDA has an Import Alert in effect for cosmetics containing kohl" not only because it is an unsafe color additive" but also because of labeling violations# For e!ample" some samples have been labeled with the false statement" *FDA Approved#* %uch products are sub&ect to detention and refusal of admission at ;#%# ports of entry# =@T2D %ome manufacturers may label eye cosmetics with the term *kohl* simply to indicate the shade" not because the product actually contains kohl# If the product is properly labeled" consumers can check the ingredient declaration to determine whether it contains only color additives that are approved for cosmetic use in the area of the eye# If no color additives are declared" it would be wise to stay on the safe side and assume that the product is" in fact" kohl# Where does kohl come !rom? $opular in much of the world since ancient times" particularly in parts of Africa" the Biddle 2ast" Iran" $akistan" and India" kohl now sometimes appears in 2urope and =orth America" especially in some Biddle 2astern and Asian specialty markets# Despite its illegal status in the ;#%#" it may be imported surreptitiously" for e!ample" in personal luggage# It also has been advertised for mail order on some Web sites# Where can I learn more about lead poisoning? The following are some useful resourcesD FDA

*Dangers of 0ead %till 0inger"* FDA +onsumer" Canuary)February .668

Centers !or Disease Control and 6re ention 0ead $oisoning $revention $rogram ,n ironmental 6rotection Agency Traditional remedies reported to contain lead ;se 2ye +osmetics %afely $rinter)friendly $DF '35, 4/( The Food and Drug Administration 'FDA(regulates all cosmetics marketed in the ;nited %tates" including mascara" eye shadows" eye liner" concealers" and eyebrow pencils# %afety e!perts within the @ffice of +osmetics and +olors in FDA?s +enter for Food %afety and Applied =utrition '+F%A=( offer consumers the following adviceD 9eep e erything clean% Dangerous bacteria or fungi can grow in some cosmetic products" as well as their containers# +leanliness can help prevent eye infections# Always wash your hands before applying eye cosmetics" and be sure that any instrument you place near your eyes is clean# /e especially careful not to contaminate cosmetics by introducing microorganisms# For e!ample" don?t lay an eyelash wand on a countertop where it can pick up bacteria# 4eep containers clean" since these may also be a source of contamination# Don2t moisten cosmetic products% Don?t add saliva or water to moisten eye cosmetics# Doing so can introduce bacteria# $roblems can arise if you overpower a product?s preservative capability# Don2t share or swap% $eople can be harmed by others? germs when they share eye makeup# 4eep this in mind when you come across *testers* at retail stores# If you do sample cosmetics at a store" be sure to use single)use applicators" such as clean cotton swabs# Don2t apply or remo e eye makeup in a mo ing ehicle% Any bump or sudden stop can cause in&ury to your eye with a mascara wand or other applicator# 7=

Check ingredients1 including color additi es% As with any cosmetic product sold to consumers" eye cosmetics are re uired to have an ingredient declaration on the label# If they don?t" they are considered misbranded and illegal# In the ;nited %tates" the use of color additives is strictly regulated# %ome color additives approved for cosmetic use in general are not approved for areas near the eyes# If the product is properly labeled" you can check to see whether the color additives declared on the label are in FDA?s 0ist of +olor Additives Approved for ;se in +osmetics# ';nder *For Bore Information* below" see *+olor Additives Approved for ;se in +osmetics* and *FDA?s Import Alert for +osmetics +ontaining Illegal +olors#*( &se only cosmetics intended !or the eyes on the eyes% Don?t use a lip liner as an eye liner" for e!ample# :ou may e!pose eyes either to contamination from your mouth or to color additives that are not approved for use near the eyes# Say ;no; to kohl: Also known as al)kahl" ka&al" or surma" kohl is used in some parts of the world for enhancing the appearance of the eyes# /ut kohl is unapproved for cosmetic use in the ;nited %tates# 4ohl contains salts of heavy metals such as antimony and lead# Aeports have linked the use of kohl to lead poisoning in children# %ome eye cosmetics may be labeled with the word *kohl* only to indicate the shade" not because they contain true kohl# A product?s *ingredient statement* should not list kohlEthis is not an FDA)approved color additive# +heck the ingredient statement to make sure that kohl is not present# Don2t dye eyelashes and eyebrows% =o color additives are approved by FDA for permanent dyeing or tinting of eyelashes and eyebrows# $ermanent eyelash and eyebrow tints and dyes have been known to cause serious eye in&uries# &se care with !alse eyelashes or extensions% False eyelashes and e!tensions" as well as their adhesives" must meet the safety and labeling re uirements for cosmetics# %ince the eyelids are delicate" an allergic reaction" irritation" or in&ury in the eye area can occur# +heck the ingredients to make sure you are not allergic to the adhesives# Don2t use eye cosmetics that cause irritation% %top using a product immediately if irritation occurs# %ee a doctor if irritation persists# A oid using eye cosmetics i! you ha e an eye in!ection% Discard any eye cosmetics you were using when you got the infection# Also" don?t use eye cosmetics if the skin around the eye is inflamed# Don2t use old eye cosmetics% Banufacturers usually recommend discarding mascara two to four months after purchase# Discard dried)up mascara# Don2t store cosmetics at temperatures abo e <=> F% $reservatives that keep bacteria or fungi from growing can lose their effectiveness" for e!ample" in cosmetics kept for long periods in hot cars

Hair #emo al
The following is excerpted from FDA Consumer, March-April !!"# $arnings for Ma%ers of Compounded Pain ProductsD #emo ing Hair Sa!ely The FDA?s +enter for Devices and Aadiological Health regulates electrolysis e uipment and lasers# +hemical depilatories" wa!es" and shaving creams and gels fall under the &urisdiction of the FDA?s @ffice of +osmetics and +olors in the +enter for Food %afety and Applied =utrition# The practice of professional hair removal is generally regulated by state and local authorities# Here are some tips related to common methods of hair removal# 7>

.aser Hair #emo al In this method" a laser destroys hair follicles with heat# 0asers are prescription devices that should be used only under the direction of a licensed practitioner# If a topical anesthetic product is recommended before a laser hair removal procedure to minimiLe pain" the FDA recommends that consumers discuss the circumstances under which the cream should be used with a medical professional" and whether the use is appropriate# Those who decide to use a skin)numbing product should follow the directions of a health care provider and consider using a product that contains the lowest amount of anesthetic drugs possible# The FDA?s +enter for Drug 2valuation and Aesearch has received reports of serious and life)threatening side effects after use of large amounts of skin) numbing products for laser hair removal# %ide effects of laser hair removal can include blistering" discoloration after treatment" swelling" redness" and scarring# %unlight should be avoided during healing after the procedure# ,pilators- )eedle1 ,lectrolysis1 and +wee'er =eedle epilators introduce a fine wire close to the hair shaft" under the skin" and into the hair follicle# An electric current travels down the wire and destroys the hair root at the bottom of the follicle" and the loosened hair is removed with tweeLers# Bedical electrolysis devices destroy hair growth with a shortwave radio fre uency after a thin probe is placed in the hair follicle# Aisks from these methods include infection from an unsterile needle and scarring from improper techni ue# 2lectrolysis is considered a permanent hair removal method" since it destroys the hair follicle# It re uires a series of appointments over a period of time# TweeLer epilators also use electric current to remove hair# The tweeLers grasp the hair close to the skin" and energy is applied at the tip of the tweeLer# There is no body of significant information establishing the effectiveness of the tweeLer epilator to permanently remove hair# Depilatories Available in gel" cream" lotion" aerosol" and roll)on forms" depilatories are highly alkaline 'or" in some cases" acidic( formulations that affect the protein structure of the hair" causing it to dissolve into a &ellylike mass that the user can easily wipe from the skin# +onsumers should carefully follow instructions and heed all warnings on the product label# For e!ample" manufacturers typically recommend conducting a preliminary skin test for allergic reaction and irritation# Depilatories should not be used for eyebrows or around eyes or on inflamed or broken skin# The FDA?s @ffice of +osmetics and +olors has received reports of burns" blisters" stinging" itchy rashes" and skin peeling associated with depilatories and other types of cosmetic hair removers# Waxing1 Sugaring1 and +hreading ;nlike chemical depilatories that remove hair at the skin?s surface" these methods pluck hairs out of the follicle" below the surface# With wa!ing" a layer of melted wa! is applied to the skin and allowed to harden# '+old wa!es" which are soft at room temperature" allow the user to skip the steps of melting and hardening#( It is then pulled off uickly in the opposite direction of the hair growth" taking the uprooted hair with it# 0abeling of wa!es may caution that these products should not be used by people with diabetes and circulatory problems# Wa!es should not be used over varicose veins" moles" or warts# Wa!es also shouldn?t be used on eyelashes" the nose" ears" or on nipples" genital areas" or on irritated" chapped" or sunburned skin# As with chemical depilatories" it can be a good idea to do a preliminary test on a small area for allergic reaction or irritation# %ugaring is similar to wa!ing# A heated sugar mi!ture is spread on the skin" sometimes covered with a strip of fabric" and then lifted off to remove hair# Threading is an ancient techni ue in which a loop of thread is rotated across the skin to pluck the hair# All of these techni ues may cause skin irritation and infection#

71

Sha ing %having hair only when it?s wet" and shaving in the direction in which the hairs lie" can help lessen skin irritation and cuts# It?s important to use a clean raLor with a sharp blade# +ontrary to popular belief" shaving does not change the te!ture" color" or growth rate of hair# AaLors and electric shavers are under the &urisdiction of the +onsumer $roduct %afety +ommission#

Hair Dye 6roducts

Hair dye products may be divided into three categories" i#e#" permanent" semi)permanent and temporary hair colors# $ermanent hair colors are the most popular hair dye products# They may be further divided into o!idation hair dyes and progressive hair dyes# @!idation hair dye products consist of '.( a solution of dye intermediates" e#g#" p)phenylenediamine" which form hair dyes on chemical reaction" and preformed dyes" e#g#" ,)nitro)p)phenylenediamine" which already are dyes and are added to achieve the intended shades" in an a ueous" ammoniacal vehicle containing soap" detergents and conditioning agentsK and" ',( a solution of hydrogen pero!ide" usually 9Q" in water or a cream lotion# The ammoniacal dye solution and the hydrogen pero!ide solution" often called the developer" are mi!ed shortly before application to the hair# The applied mi!ture causes the hair to swell and the dye intermediates 'and preformed dyes( penetrate the hair shaft to some e!tent before they have fully reacted with each other and the hydrogen pero!ide and formed the hair dye# $rogressive hair dye products contain lead acetate as the active ingredient# 0ead acetate is approved as a color additive for coloring hair on the scalp at concentrations not e!ceeding -#9Q wMv" calculated as metallic lead ',. +FA >3#,369(# /ismuth citrate" the other approved color additive ',. +FA >3#,..-(" is used to a much lesser e!tent# $rogressive hair dyes change the color of hair gradually from light straw color to almost black by reacting with the sulfur of hair keratin as well as o!idiLing on the hair surface# %emi)permanent and temporary hair coloring products are solutions 'on rare occasions dry powders( of various coal)tar" i#e# synthetic organic" dyes which deposit and adhere to the hair shaft to a greater or lesser e!tent# Temporary hair colors must be reapplied after each shampooing# The vehicle may consist of water" organic solvents" gums" surfactants and conditioning agents# The coal)tar dyes are either listed and certified colors additives or dyes for which approval has not been sought# The dyes may not be non)permitted metallic salts or vegetable substances# A hair dye product containing a non)approved coal)tar color 'but not a non)approved metallic or vegetable dye( which is known to cause adverse reactions under conditions of use cannot be considered adulterated if the label bears the caution statement provided in section 9-.'a( of the FDJ+ Act and offers ade uate directions for preliminary patch testing by consumers for skin sensitivity# The caution statement reads as followsD +aution ) This product contains ingredients which may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made# This product must not be used for dyeing the eyelashes or eyebrowsK to do may cause blindness# If the label of a coal)tar color)containing hair dye product does not bear the caution statement of section 9-.'a( and the patch testing directions" it may be sub&ect to regulatory action if it is determined to be harmful under customary conditions of use# %everal coal)tar hair dye ingredients have been found to cause cancer in laboratory animals# In the case of 5)metho!y)m)phenylenediamine '5)BB$D" ,"5)diaminoanisole( which had also been demonstrated in human and animal studies to penetrate the skin" the agency considered the risk associated with its use in hair dyes a *material fact* which should be made known to consumers# The regulation re uiring a label warning on hair dye products containing 5)BB$D published in ;2

@ctober .6>6 was to become effective April .9" .68-# The regulation re uired that hair dyes containing 5)BB$D bear the following warningD Warning ) +ontains an ingredient that can penetrate your skin and has been determined to cause cancer in laboratory animals# %ome hair dyes manufacturers held that the potential risk was too small to be considered *material* and challenged the validity of the regulation in court# The agency decided to reconsider its earlier position" entered into a consent agreement with hair dye manufacturers" and stayed the effectiveness of the regulation until completion of an assessment of the carcinogenic risk of 5) BB$D in accordance with scientifically accepted procedures# In addition to 5)BB$D" the following other hair dye ingredients have been reported to cause cancer in at least one animal species in lifetime feeding studiesD 5)chloro)m)phenylenediamine" ,"5)toluenediamine" ,)nitro)p)phenylenediamine and 5)amino),)nitrophenol# They were also found to penetrate human and animal skin#

Heading *!! Hair4Care Disasters&se Caution With #elaxers and Dyes

&y Michelle Meadows It?s never a good sign when the hairdresser panics# That?s what happened to /arbara +abrera) Avila" 38" when she returned to the salon about si! weeks after having her hair straightened a couple of years ago# The cause for alarmD several bald spots in the back of her head# The Adelphi" Bd#" resident began having her curls straightened at the age of si! so her hair would be easier to comb and style# %he says over)processed hair likely played a role in her hair loss" and stress could have been a factor# What?s certain is that three dermatologists advised her to take a break from hair straighteners" also known as rela!ers# /arbara says giving up the straight hair she had grown comfortable with wasn?t easy# After all" people?s personal preferences about how they want to look tie into self)esteem))a fact that makes for good sales in the hair business# In addition to paying for trims and cuts to achieve a certain look" consumers spend millions of dollars each year to get hair that?s different from what nature intended))whether it?s to tame tight curls" give flat hair a boost" or get rid of the gray# According to the Food and Drug Administration?s @ffice of +osmetics and +olors" hair straighteners and hair dyes are among its top consumer complaint areas# +omplaints range from hair breakage to symptoms warranting an emergency room visit# Aeporting such complaints is voluntary" and the reported problem is often due to incorrect use of a product rather than the product itself# FDA encourages consumers to understand the risks that come with using hair chemicals" and to take a proactive approach in ensuring their proper use# The agency doesn?t have authority under the Federal Food" Drug" and +osmetic Act to re uire premarket approval for cosmetics" but it can take action when safety issues surface# When the 6roduct Is the 6roblem When consumers notify FDA of problems with cosmetics" the agency evaluates evidence on a case)by)case basis and determines if follow)up is needed" says Allen Halper" an FDA consumer safety officer# FDA looks for patterns of complaints or unusual or severe reactions# The agency may conduct an investigation" and if the evidence supports regulatory action" FDA may re uest removal of a cosmetic from the market# Take the e!ample of two popular hair rela!er products by World Aio +orp#))the Aio =aturaliLer %ystem '=eutral Formula( and the Aio =aturaliLer %ystem with +olor 2nhancer '/lackM0icorice(# After receiving complaints about these products in =ovember and December of .665" FDA warned the public against using them# +onsumers complained of hair loss" scalp irritation" and discolored hair# ;7

In December .665" the World Aio +orp#" Inc# of 0os Angeles" +alif#" announced that it stopped sales and shipments of the product# /ut reports indicated that the company continued to take orders" and the +alifornia Department of Health also stepped in to stop sales# In Canuary of .667" the ;#%# Attorney?s @ffice in 0os Angeles filed a seiLure action against these products on behalf of FDA# /y then" the agency had received more than 3"--- complaints about the Aio products# Although most rela!ers are alkaline" this product was formulated to be acidic# In the resulting consent decree of condemnation and permanent in&unction" FDA alleged that the products were potentially harmful or in&urious when used as intended" that they were more acidic than declared in the labeling" and that the labeling described the products as *chemical free* when *allegedly they contained ingredients commonly understood to be ?chemicals#?* Sa!er Straightening FDA has received complaints about scalp irritation and hair breakage related to both lye and *no lye* rela!ers# %ome consumers falsely assume that compared to lye rela!ers" *no lye* rela!ers take all the worry out of straightening# *$eople may think because it says ?no lye? that it?s not caustic"* says FDA biologist 0ark 0ambert# /ut both types of rela!ers contain ingredients that work by breaking chemical bonds of the hair" and both can burn the scalp if used incorrectly# 0ye rela!ers contain sodium hydro!ide as the active ingredient# With *no lye* rela!ers" calcium hydro!ide and guanidine carbonate are mi!ed to produce guanidine hydro!ide# Aesearch has shown that this combination in *no lye* rela!ers results in less scalp irritation than lye rela!ers" but the same safety rules apply for both# They should be used properly" left on no longer than the prescribed time" carefully washed out with neutraliLing shampoo" and followed up with regular conditioning# For those who opt to straighten their own hair" it?s wise to enlist help simply because not being able to see and reach the top and back of the head makes proper application of the chemical and thorough rinsing more of a challenge# %ome stylists recommend applying a layer of petroleum &elly on the scalp before applying a rela!er because it creates a protective barrier between the chemical and the skin# %cratching" brushing" and combing can make the scalp more susceptible to chemical damage and should be avoided right before using a rela!er# $arents should be especially cautious when applying chemicals to children?s hair and should keep rela!ers out of children?s reach# There have been reports of small children ingesting straightening chemicals and suffering in&uries that include burns to the face" tongue" and esophagus# How often to rela! hair is a personal decision# According to $earl Freier" an instructor at the International Academy of Hair Design in %outh Daytona" Fla#" rela!ing at intervals of si! to eight weeks is common" and the fre uency depends on the rate of a person?s hair growth# 0eslie F# %afer" BD" a dermatologist in Albany" 1a#" who has treated women with scalp irritation from rela!ers" says straightening every si! weeks is too fre uent" in his opinion# Aela!ers can cause hair breakage in the long term" he says" and blow drying and curling can do more damage# +onsumers should be aware that applying more than one type of chemical treatment" such as coloring hair one week and then rela!ing it the ne!t" can increase the risk of hair damage# *The only color we recommend for rela!ed hair is semi)permanent because it has no ammonia and less pero!ide"* compared with permanent color" Freier says# Hair Dye #eactions As with hair rela!ers" some consumers have reported hair loss" burning" redness" and irritation from hair dyes# Allergic reactions to dyes include itching" swelling of the face" and even difficulty breathing# +oal tar hair dye ingredients are known to cause allergic reactions in some people" FDA?s 0ambert says# %ynthetic organic chemicals" including hair dyes and other color additives" were originally manufactured from coal tar" but today manufacturers primarily use materials derived from ;;

petroleum# The use of the term *coal tar* continues because historically that language has been incorporated into the law and regulations# The law does not re uire that coal tar hair dyes be approved by FDA" as is re uired for other uses of color additives# In addition" the law does not allow FDA to take action against coal tar hair dyes that are shown to be harmful" if the product is labeled with the prescribed caution statement indicating that the product may cause irritation in certain individuals" that a patch test for skin sensitivity should be done" and that the product must not be used for dyeing the eyelashes or eyebrows# The patch test involves putting a dab of hair dye behind the ear or inside the elbow" leaving it there for two days" and looking for itching" burning" redness" or other reactions# *The problem is that people can become sensitiLed))that is" develop an allergy))to these ingredients"* 0ambert says# *They may do the patch test once" and then use the product for .years* before having an allergic reaction# */ut you?re supposed to do the patch test every time"* he says" even in salons# And what about ending up with something other than the e!act shade of strawberry blonde on the shelf? *Don?t think the color on the bo! is the color you?ll get"* says Freier" the cosmetology instructor# *There are so many variables" like what chemicals are already in your hair and what your natural color is" that go into how your hair will turn out#* When using all hair chemicals" it?s critical to keep them away from children to prevent ingestion and other accidents" and to follow product directions carefully# It sounds basic" but some people don?t do it" says FDA?s Halper# *If it says leave on hair for five minutes" seven minutes doesn?t make it better"* he says# *In fact" it could do damage#* Michelle Meadows is a staff writer for FDA Consumer' FDA encourages voluntary reporting of adverse reactions to hair products toD FDA" +enter for Food %afety and Applied =utrition" @ffice of +osmetics and +olors" ,-- + %t# %#W#" Washington" D+ ,-,-5" ,-,),-7)5>-9# F .ook *ut For ?our ,yes Whether applying hair chemicals at home or in a hair salon" consumers and beauticians should be careful to keep them away from the eyes# FDA has received reports of in&uries from hair rela!ers and hair dye accidentally getting into eyes# And while it may be tempting to match a new hair color to eyebrows and eyelashes" consumers should resist the urge# The use of permanent eyelash and eyebrow tinting and dyeing has been known to cause serious eye in&uries and even blindness# There are no color additives approved by FDA for dyeing or tinting eyelashes and eyebrows# The law does not re uire that coal tar hair dyes be approved by FDA" as is re uired for other uses of color additives# In addition" the law does not allow FDA to take action against coal tar hair dyes that are shown to be harmful" if the product is labeled with the following caution statementD ;Caution4+his product contains ingredients which may cause skin irritation on certain indi iduals and a preliminary test according to accompanying directions should !irst be made% +his product must not be used !or dyeing the eyelashes or eyebrows@ to do so may cause blindness%; ))B#B# Hair Color and Cancer @ver the years" some studies have indicated a possible link between hair dye use and cancer" while others have not# In February .665" FDA and the American +ancer %ociety released an epidemiologic study involving 7>3"--- women# Aesearchers found that women who had ever used permanent hair dyes showed decreased risk of all fatal cancers combined and also of urinary system cancers# The study also revealed that women who had ever used permanent hair dyes ;@

showed no increased risk of any type of hematopoietic cancer 'cancer of the body?s blood)forming systems(# This research" published in the Cournal of the =ational +ancer Institute" did suggest that prolonged use ',- years or more of constant use( of black hair dye may slightly increase the occurrence of non)Hodgkin?s lymphoma and multiple myeloma" but these cases represented a small fraction of hair dye users# This study followed previous =+I studies that raised concern about the use of hair dyes and higher rates of non)Hodgkin?s lymphoma# In another study" published in the @ctober 7" .665" issue of the Cournal of the =ational +ancer Institute" researchers from /righam and Women?s Hospital in /oston followed 66"--- women and found no greater risk of cancers of the blood or lymph systems among women who had ever used permanent hair dyes# Then in .668" scientists at the ;niversity of +alifornia at %an Francisco uestioned ,"755 people about their use of hair)color products# After integrating the results of this study with those of animal and other epidemiologic studies" they concluded that there was little convincing evidence linking non)Hodgkin?s lymphoma with normal use of hair)color products in humans# The study was published in the December .668 issue of the American (ournal of Pu)lic *ealth# FDA continues to follow research in this field# ))B#B#

Ingredients 6rohibited and #estricted by FDA #egulations With the important e!ception of color additives that are not coal)tar hair dyes" cosmetic ingredients are not sub&ect to FDA premarket approval authority# However" regulations prohibit the use of some substances and restrict the use of others because of safety concerns or environmental factors# <iolating the restrictions on the use of these substances may cause FDA to pursue regulatory action# What ingredients are prohibited by regulation? Aegulations specifically prohibit or restrict the use of the following ingredients in cosmetics# For complete details" refer to the regulations ',. +FA" $arts ,7-#,7- and >--#.. through >--#37(# "ithionol% The use of bithionol is prohibited because it may cause photo)contact sensitiLation ',. +FA >--#..(# Chloro!luorocarbon propellants% The use of chlorofluorocarbon propellants 'fully halogenated chlorofluoroalkanes( in cosmetic aerosol products intended for domestic consumption is prohibited ',. +FA >--#,3(# Chloro!orm% The use of chloroform in cosmetic products is prohibited because of its animal carcinogenicity and likely haLard to human health# The regulation makes an e!ception for residual amounts from its use as a processing solvent during manufacture" or as a byproduct from the synthesis of an ingredient ',. +FA >--#.8(# Halogenated salicylanilides /di41 tri41 metabromsalan and tetrachlorosalicylanilide0% These are prohibited in cosmetic products because they may cause photocontact sensitiLation ',. +FA >--#.7(# 3ethylene chloride% The use of this substance in cosmetic products is prohibited because of its animal carcinogenicity and likely haLard to human health ',. +FA >--#.6(# ;A

Ainyl chloride% The use of vinyl chloride is prohibited as an ingredient of aerosol products" because of its carcinogenicity G,. +FA >--#.5H# Birconium4containing complexes% The use of Lirconium)containing comple!es in aerosol cosmetic products is prohibited because of their to!ic effect on lungs" including the formation of granulomas G,. +FA >--#.9H# 6rohibited cattle materials% To protect against bovine spongiform encephalopathy '/%2(" also known as *mad cow disease"* cosmetics may not be manufactured from" processed with" or otherwise contain" prohibited cattle materials# These materials include specified risk materialsF" material from nonambulatory cattle" material from cattle not inspected and passed" or mechanically separated beef# $rohibited cattle materials do not include tallow that contains no more than -#.7 percent insoluble impurities" tallow derivatives" and hides and hide)derived products" and milk and milk products#FF G,. +FA >--#,>" as amendedH#

What cosmetic ingredients are restricted by regulation? %ome ingredients may be used in cosmetics" but only under the restrictions stated in the regulationsD Hexachlorophene% /ecause of its to!ic effect and ability to penetrate human skin" he!achlorophene 'H+$( may be used only when an alternative preservative has not been shown to be as effective# The H+$ concentration of the cosmetic may not e!ceed -#. percent# H+$ may not be used in cosmetics that in normal use may be applied to mucous membranes" such as the lips G,. +FA ,7-#,7-H# 3ercury compounds% Bercury compounds are readily absorbed through the skin on topical application and tend to accumulate in the body# They may cause allergic reactions" skin irritation" or neuroto!ic manifestations# The use of mercury compounds as cosmetic ingredients is limited to eye area cosmetics at concentrations not e!ceeding 97 parts per million '-#--97 percent( of mercury calculated as the metal 'about .-- ppm or -#-. percent phenylmercuric acetate or nitrate( and is permitted only if no other effective and safe preservative is available for use# All other cosmetics containing mercury are adulterated and sub&ect to regulatory action unless it occurs in a trace amount of less than . part per million '-#---. percent( calculated as the metal and its presence is unavoidable under conditions of good manufacturing practice G,. +FA >--#.3H# Sunscreens in cosmetics% ;se of the term *sunscreen* or similar sun protection terminology in a product?s labeling generally causes the product to be sub&ect to regulation as a drug# However" sunscreen ingredients may also be used in some products for nontherapeutic" nonphysiologic uses 'for e!ample" as a color additive or to protect the color of the product(# To avoid consumer misunderstanding" if a cosmetic product contains a sunscreen ingredient and uses the term *sunscreen* or similar sun protection terminology anywhere in its labeling" the term must be ualified" in accordance with ,. +FA >--#37'b(" by describing the benefit to the cosmetic product provided by the sunscreen ingredient 'for e!ample" *+ontains a sunscreen to protect product color#*(# @therwise" the product may be sub&ect to regulation as a drug G,. +FA >--#37H# For further information on sunscreens" refer to Information About %untan $roducts" %unscreens" and Tanning# Are these the only ingredients that can cause a product to become iolati e? =o# A product may become adulterated or misbranded in a number of ways# Among these are improperly used color additives or any ingredient" other than a coal)tar hair dye" that causes a cosmetic to be harmful under customary or usual conditions of use" or cause a cosmetic to become misbranded" as stated in the Federal Food" Drug" and +osmetic Act" %ections 9-. and 9-,# ;6

Additionally" an ingredient having a history of use in or as a cosmetic may at any time have its safety brought into uestion by new information# For related information" see 4ey 0egal +onceptsD Interstate +ommerce" Adulteration" and Bisbranding and FDA Authority @ver +osmetics# F *%pecified risk material* means the brain" skull" eyes" trigeminal ganglia" spinal cord" vertebral column 'e!cluding the vertebrae of the tail" the transverse processes of the thoracic and lumbar vertebrae" and the wings of the sacrum(" and dorsal root ganglia of cattle 3- months and older and the tonsils and distal ileum of the small intestine of all cattle# FF Tallow must be produced from tissues that are not prohibited cattle materials or must contain not more than -#.7 percent insoluble impurities as determined by the method entitled *Insoluble Impurities* 'A@+% @fficial Bethod +a 3a)59(" American @il +hemists? %ociety 'A@+%(" 7th 2dition" .66>" incorporated by reference in accordance with 7 ;#%#+# 77,'a( and . +FA part 7." or another method e uivalent in accuracy" precision" and sensitivity to A@+% @fficial Bethod +a 3a)59# :ou may obtain copies of the method from A@+%" ,,.. W# /radley Ave# +hampaign" I0 9.8,.

.ipstick and .eadCuestions and Answers

What is FDA?s legal authority over cosmetics? Has FDA been aware of concerns about lead in lipstick ? Has FDA published tolerance levels for lead in lipstick ? It?s been reported that levels of lead in certain lipstick e!ceed those for candy# Is this a fair comparison? Is FDA following up on the latest reports? Does FDA intend to take enforcement action" given the latest report ?

The Food and Drug Administration 'FDA( has received a number of in uiries regarding reports of levels of lead in lipstick# The following information is drawn from responses to those in uiries# What is FDA2s legal authority o er cosmetics? FDA regulates cosmetics under the authority of the Federal Food" Drug" and +osmetic Act 'FDJ+ Act(# The Act does not sub&ect cosmetics to pre)market approval by FDA" with the e!ception of most color additives# It does" however" re uire that cosmetics marketed in interstate commerce be safe when used as directed in the labeling or under customary conditions of use# The FDJ+ Act sub&ects all color additives 'other than coal)tar hair dyes( used in FDA)regulated products" including those used in lipstick" to pre)market approval# The listing regulation for each approved color additive includes limits for trace levels of heavy metal contaminants" if appropriate# FDA can and does take action against firms and individuals who violate the law" as determined by public ;B

health priorities and resources# To learn more on this sub&ect" please refer to FDA Authority @ver +osmetics# Has FDA been aware o! concerns about lead in lipstick? Aeports about lead in lipstick are not new# In the .66-s" reports of analytical results from a commercial testing laboratory suggested that traces of lead in lipstick might be of concern# %ubse uent evaluation by FDA of that laboratory?s test results determined that an unvalidated and inappropriate testing method had been used# FDA?s analyses did not detect levels of lead that would be considered harmful# The levels found did not e!ceed trace amounts that would be unavoidable even under conditions of good manufacturing practice" given background levels in the environment# Has FDA published tolerance le els !or lead in lipstick? FDA has not published tolerance levels for contaminants" such as lead" in cosmetics# However" FDA does set specifications for impurities" such as lead" for color additives used in cosmetics# In addition" as noted above" cosmetics must by law be safe when used as directed in the labeling or under customary conditions of use# It2s been reported that le els o! lead in certain lipstick exceed those !or candy% Is this a !air comparison? FDA has yet to confirm the latest reports# However" it is not valid to compare the FDA) recommended level for lead in candy" a product intended for ingestion and which may be consumed on a regular basis" with lead levels in lipstick" a product intended for topical use and which is ingested in much smaller uantities than candy# Is FDA !ollowing up on the latest reports? /ecause allegations regarding lead in lipstick surface periodically" and because of the amount of time since FDA last surveyed lipsticks in the marketplace" FDA has decided to allocate the resources necessary to conduct independent testing of a selection of lipstick on the market# FDA has obtained commercial samples of the same lipstick brands cited in the recent report# FDA laboratories have been adapting a previously validated" state)of)the)art method to do the analyses# Does FDA intend to take en!orcement action1 gi en the latest report? As a science)based public health agency" FDA bases its actions upon authoritative scientific evidence and the agency?s authority under the law# FDA takes seriously its commitment to develop and implement policies that will promote consumer safety and enhance public health# If FDA determines that a health haLard e!ists" the agency will advise the industry and the public" and will consider its options under the authority of the FDJ+ Act in protecting the health and welfare of consumers#

&sing )ail 6roducts

How =ail $roducts Are Aegulated =ail $roduct Ingredient %afety ;=

%ome +ommon =ail $roduct Ingredients Acetonitrile Formaldehyde Bethacrylate Bonomers Bethacrylic Acid Aeporting Adverse =ail $roduct Aeactions There are many nail products on the market# It is important to know how to use them safely# As with any cosmetic product" follow the labeled directions carefully and pay careful attention to any warning statements# The following information will answer commonly asked uestions about some nail products and ingredients# How )ail 6roducts Are #egulated =ail products for both home and salon use are regulated by the Food and Drug Administration# ;nder the Federal Food" Drug" and +osmetic Act 'FDJ+ Act(" these products are cosmetics GFDJ+ Act" section ,-.'i(H# /y law" nail products sold in the ;nited %tates must be free of poisonous or deleterious 'harmful( substances that might in&ure users when used as labeled or under the usual or customary conditions of use 'see 4ey 0egal +onceptsD Interstate +ommerce" Adulteration and Bisbranding(# Bany nail products contain potentially harmful ingredients" but are allowed on the market because they are safe when used as directed# For e!ample" some nail ingredients are harmful only when ingested" which is not their intended use# The labels of all cosmetics" whether marketed to consumers or salons" must include a warning statement whenever necessary or appropriate to prevent a health haLard that may occur with use of the product ',. +FA >5-#.(# +osmetics sold on a retail basis to consumers also must bear an ingredient declaration" with the names of the ingredients listed in descending order of predominance# The re uirement for an ingredient declaration does not apply" for e!ample" to products used at professional establishments or samples distributed free of charge# However" the re uirement does apply if these products are also sold at retail" even if they are labeled *For professional use only* 'see +osmetic 0abelingD An @verview(# ;nder the law" cosmetic products and ingredients" including nail products" are not sub&ect to FDA premarket approval authority" with the e!ception of most color additives# However" FDA may pursue enforcement action against violative products" or against firms or individuals who violate the law '%ee FDA Authority @ver +osmetics(# While FDA regulates the nail products intended for use at home and in salons" the operation of nail salons and the licensing of their technicians are regulated by state and local authorities# Also" the @ccupational %afety and Health Administration has addressed the safety of employees in nail salons# )ail 6roduct Ingredient Sa!ety Infections and allergic reactions can occur with some nail products# As mentioned previously" some ingredients in nail products may be harmful if ingested# %ome can easily catch fire if e!posed to the flame of the pilot light of a stove" a lit cigarette" or other heat source" such as the heating element of a curling iron# =ail products also can be dangerous if they get in the eyes# +onsumers should read labels of nail products carefully and heed any warnings# Some Common )ail 6roduct Ingredients

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Acetonitrile in Arti!icial )ail #emo ers Artificial nail removers consist primarily of acetonitrile# +hild)resistant packaging is re uired for all household glue removers in li uid form containing more than 7-- milligrams of acetonitrile in a single container G.9 +FA .>--#.5 '.8(H# The +onsumer $roduct %afety +ommission '+$%+( enforces this re uirement under authority of the $oison $revention $ackaging Act G.7 ;#%#+# .5>.) .5>9H# However" the fact that a product is in *child)resistant* packaging does not mean that a child could not open it# 0ike any cosmetic product that may be haLardous if misused" it is important for these artificial nail removers to carry an appropriate warning on the label" along with directions for safe use# Formaldehyde in )ail Hardeners =ail hardeners that contain formaldehyde may cause an irritation or allergic reaction to those sensitiLed to this compound# There is also some evidence that certain individuals may become allergic to toluene sulfonamideRformaldehyde resin" a common ingredient in nail preparations# In .685" the +osmetic Ingredient Aeview '+IA( 2!pert $anel F reported that available to!icological data and other information were insufficient to conclude that cosmetics containing formaldehyde in e!cess of -#,Q are safe# However" the +IA was referring to cosmetic products applied to the skin" not nail products# The concentration of formaldehyde needed for nail hardening is higher than -#,Q" but formaldehyde is less likely to cause skin sensitiLation when shields are used to keep the hardener away from the skin# If you are allergic to formaldehyde" have previously e!perienced an allergic reaction to nail preparations or for any other reason wish to avoid this ingredient" be sure to read the product ingredient statement on the label to determine if formaldehyde and toluene sulfonamide)formaldehyde resin are present# 3ethacrylate 3onomers in Arti!icial )ails /;Acrylics;0 Artificial nails are composed primarily of acrylic polymers and are made by reacting together acrylic monomers" such as ethyl methacrylate monomer" with acrylic polymers" such as polymethylmethacrylate# When the reaction is completed" traces of the monomer are likely to remain in the polymer# For e!ample" traces of methacrylate monomers remain after artificail nails are formed# The polymers themselves are typically uite safe" but traces of the reactive monomers could result in an adverse reaction" such as redness" swelling" and pain in the nail bed" among people who have become sensitive 'allergic( to methacrylates# 2thyl methacrylate monomer is commonly used today in acrylic nails" although methyl methacrylate monomer may still be found in some artificial nail products# In the early .6>-s" FDA received a number of complaints of in&ury associated with the use of artificial nails containing methyl methacrylate monomer# Among these in&uries were reports of fingernail damage and deformity" as well as contact dermatitis# ;nlike methyl methacrylate monomer" methyl methacrylate polymers were not associated with these in&uries# /ased on its investigations of the in&uries and discussions with medical e!perts in the field of dermatology" the agency chose to remove from the market products containing .-- percent methyl methacrylate monomer through court proceedings" which resulted in a preliminary in&unction against one firm as well as several seiLure actions and voluntary recalls# =o regulation specifically prohibits the use of methyl methacrylate monomer in cosmetic products# The +IA 2!pert $anel determined in ,--, that ethyl methacrylate is safe as used when application is accompanied by directions to avoid skin contact because of its sensitiLing potential 'that is" the possibility that a person might develop an allergy to this material(# 3ethacrylic Acid in )ail 6rimers Despite the similar names" methacrylic acid is different from methacrylate monomers# It also is used differently and raises different safety concerns# Bethacrylic acid 'BAA( has been used in nail primers to help acrylic nails adhere to the nail surfaces# In response to cases of poisoning and ;1

in&ury" the +$%+ issued a regulation G.9 +FA .>--#.5 ',6(H re uiring child)resistant packaging for household products containing BAA# A number of serious in&uries have occurred to children who ingested such products or spilled them" receiving burns to their skin# =ail primers that contain BAA are most commonly distributed through wholesale suppliers to nail salons and retail beauty supply stores" and they usually are labeled *For $rofessional ;se @nly#* However" some of these retail stores sell to both professionals and consumers# The +$%+ regulation" established in accordance with the $oison $revention $ackaging Act" re uires child) resistant packaging for li uid household products containing more than 7 percent BAA" weight to volume" in a single retail package# That means that it applies" for e!ample" to a product containing more than 7 grams of BAA per .-- milliliters# BAA products applied by means of absorbent material in a dispenser" such as a pen)like marker" are e!empt from this re uirement if there is no free li uid in the device and if" under any reasonably foreseeable conditions of use" the methacrylic acid will emerge only through the tip of the device# For more information regarding the child)resistant packaging re uirements for BAA" contact the @ffice of +ompliance" +$%+" at '3-.( 7-5)-9-8# +oluene in )ail 6olishes and *ther 6roducts Toluene is used as a solvent in a variety of nail products" such as nail polish" nail hardeners" and polish removers# Toluene was reviewed by the +IA 2!pert $anel in .68>" when the $anel determined that it was safe for cosmetic use in nail products when limited to concentrations no greater than 7- percent# The $anel re)evaluated the safety of toluene in ,--7 and confirmed its original conclusion# #eporting Ad erse )ail 6roduct #eactions +onsumers" nail technicians" and healthcare providers can report adverse reactions from nail products to the nearest FDA office" listed in the blue section of the telephone book# @r" contact FDA?s +enter for Food %afety and Applied =utrition" Adverse 2vents Aeporting %ystem '+A2A%( by phone at '3-.( 539),5-7 or by e)mail at +A2A%Ofda#hhs#gov#

FDA )anotechnology +ask Force #eport *utlines Scienti!ic1 #egulatory Challenges Fact Sheet
=anotechnology is changing the way that many FDA)regulated products will be made# To further its mission of promoting and protecting the public health" FDA will work to clarify what information will be needed in its efforts to oversee products that contain nanoscale materials Rthose created at siLes as small as .M.--"---th of a human hair% The Food and Drug AdministrationSs =anotechnology Task Force report released in Culy ,--> addresses the science and regulatory needs to regulate drugs" medical devices and other products built on the nanoscale# =anotechnology may provide new drugs that are able to reach specific areas of the body more effectively and at safer doses# T=anomedicineU includes development of tiny sensors that detect disease markers in the body far earlier than e!isting diagnostic methods" and incredibly small pumps capable of delivering medications precisely to the cells and tissues that need them# @ther e!amples of nano)products in development include disease imaging tools and food packaging that further e!tends shelf life# FDA +ommissioner" Dr# Andrew +# von 2schenbach says *=anotechnology holds enormous potential for use in a vast array of products# AecogniLing the emerging nature of this technology @2

and its potential for rapid development" this report fosters the continued development of innovative" safe and effective FDA)regulated products that use nanotechnology materials#U The Task Force reported that the potential use of nanoscale materials includes most product types regulated by FDA and that those materials present regulatory challenges similar to other emerging technologies# The Task Force recogniLes" however" that product safety and effectiveness can change as siLe goes up or down within the nanoscale" adding additional comple!ity to the product review# The emerging and uncertain nature of nanotechnology and the potential for rapid development of FDA)regulated products using this particular technology make it all the more important that in regulating nanotechnology FDA follow its transparent" consistent" and predictable process# The report recommendsD +onsideration of guidance that would clarify what information manufacturers should give FDA about products" and also when the use of nanoscale materials may change the regulatory status of particular products# That manufacturers contact the FDA early in the product development process# In addition" the report recommends that the agency should assess data needs for regulated nanotechnology products" including biological effects and interactions of nano)particles# That FDA develop in)house e!pertise and ensure the consideration of new information on nanotechnology as it becomes available# FDA also should evaluate current testing approaches to assess the safety" effectiveness" and uality of nanoscale materials# FDA and ,, other federal agencies are part of the =ational =anotechnology Initiative" a federal research and development program established to coordinate the multi)agency efforts in nanoscale science" engineering" and technology# For more informationD =ational =anotechnology Initiative httpDMMwww#nano#govM

Sunless +anners and "ron'ers

A number of cosmetic products are marketed for consumers to achieve a tanned appearance without having to go out in the sun or use artificial sources of ultraviolet radiation# FDA has received uestions about some of these products# The following information is provided in response to these uestions# What are ;sunless tanners;? =either the laws nor the regulations enforced by FDA define the term *sunless tanner#* It typically refers to products that provide a tanned appearance without e!posure to the sun or other sources of ultraviolet radiation# @ne commonly used ingredient in these products is dihydro!yacetone 'DHA(" a color additive that darkens the skin by reacting with amino acids in the skin?s surface# What are ;bron'ers;? 0ike the term *sunless tanner"* *bronLer* is not defined in either the laws or the regulations enforced by FDA# It is often used to describe a variety of products intended to achieve a temporary tanned appearance# For e!ample" among the products marketed as bronLers are tinted moisturiLers and brush)on powders# These produce a temporary effect" similar to other types of makeup" and wash off over time# %ome products are marketed with other ingredients in addition to DHA in order to provide a tanned appearance# @7

What does the law say about color additi es1 and DHA in particular? The Federal Food" Drug" and +osmetic Act 'FDJ+ Act(" %ection >,. authoriLes the regulation of color additives 'other than coal)tar hair dyes(" including their uses and restrictions# These regulations are found in Title ,." +ode of Federal Aegulations ',. +FA(" beginning at $art >-# If a color additive is not permitted by regulation or is used in a way that does not comply with the specific regulation's( authoriLing its use" it is considered unsafe under the law# %uch misuse of color additives causes a cosmetic to be adulterated# DHA is listed in the regulations as a color additive for use in imparting color to the human body# However" its use in cosmetics))including sunless *tanning* products))is restricted to e!ternal application ',. +FA >3#,.7-(# According to the +FA" *e!ternally applied* cosmetics are those *applied only to e!ternal parts of the body and not to the lips or any body surface covered by mucous membrane* ',. +FA >-#3v(# The industry has not provided safety data to FDA in order for the agency to consider approving it for use on these e!posure routes" including *misting* from tanning booths# In addition" no color additive may be used in cosmetics intended for use in the area of the eye unless the color additive is permitted specifically for such use ',. +FA >-#7a( DHA is not permitted for use in the area of the eye# The +FA defines *area of the eye* as followsD *the area enclosed within the circumference of the supra)orbital ridge" including the eyebrow" the skin below the eyebrow" the eyelids and the eyelashes" and con&unctival sac of the eye" the eyeball" and the soft areolar tissue that lies within the perimeter of the infra)orbital ridge#* ',. +FA >-#3s( As with the lips and other areas covered by mucous membrane" the industry has not provided safety data to FDA in order for the agency to consider approving it for use in the area of the eye# The regulations listing DHA as a color additive also re uire it to meet tight specifications" with strict limitations on impurities# For e!ample" volatile matter must not e!ceed -#7 percent when measured at 35#9 degrees centigrade for three hours at a pressure of not more than 3- mm# mercury# '$lease note that the reference to *millimeters of mercury* is a measure of atmospheric pressure" not an indication that DHA contains mercury#( +ertain minerals are restricted to miniscule amounts" measured in parts per million ',. +FA >3#..7- and >3#,.7-(# What does this mean !or DHA spray ;tanning; booths? As noted above" the use of DHA in *tanning* booths as an all)over spray has not been approved by the FDA" since safety data to support this use has not been submitted to the Agency for review and evaluation" When using DHA)containing products as an all)over spray or mist in a commercial spray *tanning* booth" it may be difficult to avoid e!posure in a manner for which DHA is not approved" including the area of the eyes" lips" or mucous membrane" or even internally# +onse uently" FDA advises asking the following uestions when considering commercial facilities where DHA is applied by spraying or mistingD Are consumers protected from e!posure in the entire area of the eyes" in addition to the eyes themselves? Are consumers protected from e!posure on the lips and all parts of the body covered by mucous membrane? Are consumers protected from internal e!posure caused by inhaling or ingesting the product? If the answer to any of these uestions is *no"* the consumer is not protected from the unapproved use of this color additive# +onsumers should re uest measures to protect their eyes and mucous membranes and prevent inhalation# @;

What about sunless tanning products sold in retail stores1 such as creams and lotions? DHA is approved for e!ternal application to the human body" which is the way these products are intended to be used# +onsumers can easily avoid inhaling them or applying them to the area of the eye or mucous membrane# Who is responsible !or the sa!ety o! spray tanning booths? The FDJ+ Act does not authoriLe FDA to approve cosmetic products or ingredients" with the e!ception of color additives that are not coal)tar hair dyes# Firms and individuals who market cosmetics are responsible for assuring that the products they market are safe when used under labeled or customary conditions of use and properly labeled# FDA can take action against firms and individuals who violate the law# The practice of administering such products by professionals" such as in salons" is generally the responsibility of local and state health authorities# For more information about the regulation of cosmetic products and ingredients" see FDA Authority @ver +osmetics# Do sunless tanners and bron'ers pro ide protection !rom the sun? %unless tanners and bronLers may or may not provide protection from the sun# @nly those sunless tanners that contain sunscreen ingredients and are labeled with sun protection factor '*%$F*( numbers may provide protection# +onsumers are advised to read the labeling carefully to determine whether or not these products provide protection from the sun# All suntanning preparations that do not contain sunscreen ingredients are re uired to carry the following warning statement on the labelD *Warning))This product does not contain a sunscreen and does not protect against sunburn# Aepeated e!posure of unprotected skin while tanning may increase the risk of skin aging" skin cancer" and other harmful effects to the skin even if you do not burn#* ',. +FA >5-#.6( %unscreens are regulated as over)the)counter drugs unless they are used in the product for reasons other than protecting the consumer from the sun" such as protecting the product itself from fading# +osmetic products that are marketed with sun)protection claims" such as makeup labeled with %$F numbers" are regulated as both drugs and cosmetics# '%ee *Is It a +osmetic" a Drug" or /oth '@r Is It %oap?*( Has FDA recei ed reports o! ad erse reactions associated with sunless tanners? FDA has received reports from consumers stating that they have e!perienced adverse events associated with sunless tanning" including rashes and" primarily in the case of spray tanning booths" coughing" diLLiness" and fainting# It is uncertain what" if any" ingredient or combination of ingredients in the sunless tanning products might have caused these adverse events" whether an individual?s allergic reaction might have played a part" or whether factors unrelated to the sunless tanning products may have been involved" such as pre)e!isting medical conditions# ;nder the authority of the Fair $ackaging and 0abeling Act 'F$0A(" FDA re uires ingredient declarations on cosmetics sold on a retail basis to consumers# In this way" consumers can know what ingredients are contained in the products they purchase and avoid ingredients to which they may be sensitive# However" the F$0A does not apply to products used e!clusively by professionals" such as those used in spray tanning booths# How can I report an ad erse reaction to sunless tanners or other cosmetics?

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+onsumers and healthcare providers can report adverse reactions from cosmetic products" including sunless tanners" to the nearest FDA office" listed in the blue section of the telephone book# @r" contact FDA?s +enter for Food %afety and Applied =utrition" Adverse 2vents Aeporting %ystem '+A2A%( by phone at '3-.( 539),5-7 or by e)mail at +A2A%Ofda#hhs#gov# #e$uired Warning Statement !or +anning 6roducts Without Sunscreen 2ffective Bay ,," ,---" all suntanning preparations that do not contain sunscreen ingredients are re uired to carry the following warning statement on the labelD ;Warning44+his product does not contain a sunscreen and does not protect against sunburn% #epeated exposure o! unprotected skin while tanning may increase the risk o! skin aging1 skin cancer1 and other harm!ul e!!ects to the skin e en i! you do not burn%; 'Title ,. of the +ode of Federal Aegulations" %ection >5-#.6( FDA is re uiring this warning statement so that consumers are fully informed that such products do not provide protection from the sun# The term *suntanning preparations* includes gels" creams" li uids" and other topical products that are intended to provide cosmetic effects on the skin while tanning through e!posure to ultraviolet ';<( radiation 'such as moisturiLing or conditioning products( or to give the appearance of a tan by imparting color to the skin through the application of approved color additives" such as dihydro!yacetone" without the need for e!posure to ;< radiation# /ecause such products include those sold for use at the beach or for use in tanning salons" consumers are strongly encouraged to read carefully the labeling of all tanning products to determine whether or not they provide protection against the harmful effects of ;< radiation# This re uired warning was published in the rulemaking for over)the)counter sunscreen drug products in the Federal Aegister Bay ,." .666# For more information" see Tanning $roducts#

+HI5H C#,A3S
<arious products have been promoted in the skin care market as thigh and stomach slimmers# %ome advertising claims also promise the reduction of *cellulite*" waffly looking or orange)peel type skin caused by fatty deposits# Aminophylline" an approved prescription drug used in the treatment of asthma" is an ingredient used in many of these thigh cream products that marketers claim will dissolve the fat and smooth the skin# %ince some individuals suffer from allergic reactions to ethylenediamine" a component of aminophylline" the FDA is concerned about the use of this ingredient in cosmetics# +onsumers need to be aware of this potential for developing an allergic reaction and carefully read product labels and follow directions# $ersons who suffer from asthma may wish to avoid these products so that they don?t develop a sensitiLation 'become allergic( to aminophylline# Drugs" unlike cosmetics" alter the structure or function of the body and are sub&ect to an intensive review and approval process by FDA before their release to the public# Thigh creams may more appropriately be classified as drugs under the Food" Drug" and +osmetic Act since removal or reduction of cellulite affects the *structure or function* of the body#

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