COSMETICS Cosmetics & U.S.

Law Introduction Among the important differences between requirements for cosmetics in the United States and various other countries are the legal definitions of drugs and cosmetics restrictions on the use of color additives and other ingredients and registration requirements! Some products regulated as cosmetics in Europe for instance are regulated as drugs in the United States! Sunscreens are a case in point! There also are differences regarding prohibited and restricted ingredients particularl" color additives! Some countries ma" require cosmetic companies to register their establishments and list products and ingredients with the government# in the United States cosmetic registration is voluntar" but highl" recommended! $ow U!S! %aw &efines Cosmetics The 'ederal 'ood &rug ( Cosmetic Act )'&(C Act* defines cosmetics as +articles intended to be rubbed poured sprin,led or spra"ed on introduced into or otherwise applied to the human bod"!!!for cleansing beautif"ing promoting attractiveness or altering the appearance!+ Included in this definition are products such as s,in moisturi-ers perfumes lipstic,s fingernail polishes e"e and facial ma,eup preparations shampoos permanent waves hair colors toothpastes and deodorants as well as an" material intended for use as a component of a cosmetic product! $ow U!S! %aw &efines &rugs The '&(C Act defines drugs as +articles intended for use in the diagnosis cure mitigation treatment or prevention of disease!!!and articles )other than food* intended to affect the structure or an" function of the bod" of man or other animals!+ Over.the. counter )OTC* drugs are drugs that can be purchased without a doctor/s prescription! The agenc" is conducting a review of all OTC drugs to establish monographs )rules* under which the drugs are generall" recogni-ed as safe and effective and not misbranded! These rules are established on a class.b".class basis )for e0ample fluoride dentifrices cough suppressants and antihistamines*! OTC drugs must meet the requirements of the appropriate class once that rule is published as a final regulation! If an OTC drug does not meet the requirements of the appropriate final rule it is considered a misbranded drug and a +new drug!+ A +new drug+ must have an approved 1ew &rug Application )1&A* before it ma" be introduced into interstate commerce! In addition drug manufacturers must compl" with 2ood Manufacturing 3ractice regulations! Certain claims ma" cause a product to qualif" as a drug even if the product is mar,eted as if it were a cosmetic! Such claims establish the product as a drug because the intended use is to treat or prevent disease or otherwise affect the structure or functions of the human bod"! Some e0amples are claims that products will restore hair growth reduce

cellulite treat varicose veins or revitali-e cells! $ow a 3roduct Can 4e Considered 4oth a Cosmetic and a &rug OTC drugs are often mar,eted side b" side with cosmetics and some products qualif" both as cosmetics and as OTC drugs! This ma" happen when a product has two intended uses with ingredients intended to do two different things! 'or instance a shampoo is a cosmetic since its intended use is to cleanse the hair! An anti.dandruff treatment is a drug because its intended use is to treat dandruff! Consequentl" an antidandruff shampoo is both a cosmetic and a drug! Among other cosmetic5drug combinations are toothpastes that contain fluoride deodorants that are also antiperspirants and moisturi-ers and ma,eup mar,eted with sun.protection claims! Assuring Ingredient and 3roduct Safet" Cosmetics imported into the United States both ingredients and finished products must meet the same criteria for safet" and labeling as those manufactured domesticall"! '&A does not pre.approve cosmetic products or ingredients with the important e0ception of color additives! $owever cosmetic firms are responsible for mar,eting safe properl" labeled products# using no prohibited ingredients# and adhering to limits on restricted ingredients! It is also considered good practice to follow industr" safet" guidelines and recommendations! 4efore mar,eting a product containing a color additive in the United States it is essential to determine whether the additive is approved for its intended use! A number of color additives must be certified for purit" in '&A labs if the" are to be used legall" in a product mar,eted in the United States! Although U!S! regulations do not specif" an" particular testing regimens for cosmetic products or ingredients it is the cosmetic compan"/s responsibilit" to substantiate product and ingredient safet" prior to mar,eting! Cosmetic 6egistration Cosmetic companies ma" register in the United States through '&A/s 7oluntar" Cosmetic 6egistration 3rogram )7C63*! If a cosmetic manufacturer files a product formulation with the 7C63 '&A can advise the compan" if it is inadvertentl" using a non.permitted color additive or other prohibited or restricted ingredients! In that wa" manufacturers can correct their formulations before attempting to mar,et them in the United States thus avoiding the ris, of having their products detained and denied entr" into the United States because of a prohibited ingredient! 8e" %egal Concepts9 Interstate Commerce Adulterated and Misbranded The 'ederal 'ood &rug and Cosmetic Act prohibits the distribution of cosmetics that are adulterated or misbranded in interstate commerce! $ere is an introduction to what those terms mean!

Introduction The 'ederal 'ood &rug and Cosmetic Act )'&(C Act* prohibits among other things : +The introduction or deliver" for introduction into interstate commerce of an" food drug device or cosmetic that is adulterated or misbranded+ ;'&(C Act sec! <=>)a*# ?> U!S!C! <<>)a*@! : +The adulteration or misbranding of an" food drug device or cosmetic in interstate commerce+ ;'&(C Act sec! <=>)b*# ?> U!S!C! <<>)b*@! : +The receipt in interstate commerce of an" food drug device or cosmetic that is adulterated or misbranded and the deliver" or proffered deliver" thereof for pa" or otherwise+;'&(C Act sec! <=>)c*# ?> U!S!C! <<>)c*@! : +The alteration mutilation destruction obliteration or removal of the whole or an" part of the labeling of or the doing of an" other act with respect to a food drug device or cosmetic if such act is done while such article is held for sale )whether or not the first sale* after shipment in interstate commerce and results in such article being adulterated or misbranded+ ;'&(C Act sec! <=>),*# ?> U!S!C! <<>),*@! This means that nearl" ever"one involved in cosmetics in interstate commerce such as manufacturers pac,ers distributors and retailers is responsible for assuring that he or she is not dealing in products that are adulterated or misbranded even if someone else caused the adulteration or misbranding in the first place! If "ou introduce it into interstate commerce or receive it in interstate commerce "ou are responsible! The law applies to components and pac,aging as well as to finished products! The '&(C Act describes what constitutes interstate commerce adulteration and misbranding! It also authori-es '&A to ta,e legal action if cosmetics are adulterated or misbranded! In addition the 'air 3ac,aging and %abeling Act )'3%A* requires specific label information! 7iolations of the '3%A result in misbranding! Ahat the '&(C Act Means b" +Interstate Commerce+ Section ?=>)b* of the '&(C Act ;?> U!S!C! <?>)b*@ tells what circumstances place a product in interstate commerce9 +)>* commerce between an" State or Territor" and an" place outside thereof and )?* commerce within the &istrict of Columbia or within an" other Territor" not organi-ed with a legislative bod"!+ +Interstate commerce+ applies to all steps in a product/s manufacture pac,aging and distribution! It is ver" rare that a cosmetic product on the mar,et is not in +interstate commerce+ under the law! 'or e0ample at least some of "our ingredients or pac,aging most li,el" originate from out of state or even out of the countr"! %i,ewise it is foreseeable that "our products will leave the state! Although there are certain e0emptions ;?> C'6 B=>!C@ factors such as these generall" cause the requirements of the '&(C Act to appl" to "our products!

Ahat Ma,es a Cosmetic Adulterated Section D=> of the '&(C Act ;?> U!S!C! <D>@ describes what causes a cosmetic to be considered adulterated9 +A cosmetic shall be deemed to be adulterated.. : )a* If it bears or contains an" poisonous or deleterious substance which ma" render it inEurious to users under the conditions of use prescribed in the labeling thereof or under such conditions of use that are customar" or usual e0cept that this provision shall not appl" to coal.tar hair d"e the label of which bears the following legend conspicuousl" displa"ed thereon9 +Caution.This product contains ingredients which ma" cause s,in irritation on certain individuals and a preliminar" test according to accompan"ing directions should first be made! This product must not be used for d"eing the e"elashes or e"ebrows# to do so ma" cause blindness!+ and the labeling of which bears adequate directions for such preliminar" testing! 'or the purposes of this paragraph and paragraph )e* the term +hair d"e+ shall not include e"elash d"es or e"ebrow d"es! : )b* If it consists in whole or in part of an" filth" putrid or decomposed substance! : )c* If it has been prepared pac,ed or held under insanitar" conditions whereb" it ma" have become contaminated with filth or whereb" it ma" have been rendered inEurious to health! : )d* If its container is composed in whole or in part of an" poisonous or deleterious substance which ma" render the contents inEurious to health! : )e* If it is not a hair d"e and it is or it bears or contains a color additive which is unsafe within the meaning of section B?>)a*!+ )Section B?>)a* of the '&(C Act ;?> U!S!C! <BC)a*@ states the circumstances under which color additives are deemed unsafe!* 1ote that the law addresses.. : the composition of the product itself : the conditions under which the product is manufactured shipped and stored : the product/s container and : an e0ception for coal.tar hair d"es! bac, to top Ahat Ma,es a Cosmetic Misbranded Section D=? of the '&(C Act ;?> U!S!C! <D?@ describes what causes a cosmetic to be considered misbranded9 +A cosmetic shall be deemed to be misbranded..

)a* If its labeling is false or misleading in an" particular!

: )b* If in pac,age form unless it bears a label containing )>* the name and place of business of the manufacturer pac,er or distributor# and )?* an accurate statement of the quantit" of the contents in terms of weight measure or numerical count9 3rovided That under clause )?* of this paragraph reasonable variations shall be permitted and e0emptions as to small pac,ages shall be established b" regulations prescribed b" the Secretar"! : )c* If an" word statement or other information required b" or under authorit" of this Act to appear on the label or labeling is not prominentl" placed thereon with such conspicuousness )as compared with other words statements designs or devices in the labeling* and in such terms as to render it li,el" to be read and understood b" the ordinar" individual under customar" conditions of purchase and use! : )d* If its container is so made formed or filled as to be misleading! : )e* If it is a color additive unless its pac,aging and labeling are in conformit" with such pac,aging and labeling requirements applicable to such color additive as ma" be contained in regulations issued under section B?>! This paragraph shall not appl" to pac,ages of color additives which with respect to their use for cosmetics are mar,eted and intended for use onl" in or on hair d"es )as defined in the last sentence of section D=>)a**! : )f* If its pac,aging or labeling is in violation of an applicable regulation issued pursuant to section < or F of the 3oison 3revention 3ac,aging Act of >CB=! 1ote that under the '&(C Act the term +misbranding+ applies to.. : 'alse or misleading information G : %ac, of required information : Conspicuousness and readabilit" of required information : Misleading pac,aging : Improper pac,aging and labeling of color additives and : &eficiencies where the 3oison 3revention 3ac,aging Act requires special pac,aging! G1ote9 According to the '&(C Act a determination that labeling is +misleading+ includes considering both what the label sa"s and what it fails to reveal9 +If an article is alleged to be misbranded because the labeling or advertising is misleading then in determining whether the labeling or advertising is misleading there shall be ta,en into account )among other things* not onl" representations made or suggested b" statement word design device or an" combination thereof but also the e0tent to which the labeling or advertising fails to reveal facts material in the light of such representations or material with respect to consequences which ma" result from the use of the article to which the labeling or advertising relates

under the conditions of use prescribed in the labeling or advertising thereof or under such conditions of use as are customar" or usual+ )'&(C Act sec! ?=>)n*# ?> U!S!C! <?>)n*@! In addition a cosmetic mar,eted in violation of the '3%A or an" regulations issued under its authorit" is considered misbranded within the meaning of the '&(C Act ;>H U!S!C!>FHD)a*@! 'or cosmetics offered for sale as consumer commodities the '3%A.. : requires further label information such as the product/s identit" ;>H U!S!C!>FH<@ and : authori-es the implementation of regulations to specif" the proper presentation of required label information require an ingredient declaration and prevent deceptive pac,aging ;>H U!S!C!>FHF )c*@ The '3%A defines a consumer commodit" as it applies to '&A.regulated products as9 +an" food drug device or cosmetic )as those terms are defined b" the 'ederal 'ood &rug and Cosmetic Act !!! and an" other article product or commodit" of an" ,ind or class which is customaril" produced or distributed for sale through retail sales agencies or instrumentalities for consumption b" individuals or use b" individuals for purposes of personal care or in the performance of services ordinaril" rendered within the household and which usuall" is consumed or e0pended in the course of such consumption or use!+ ;>H U!S!C!>FHC)a*@ 1ote that the '3%A defines a consumer commodit" b" the wa" it is mar,eted not the wa" it is labeled! %abeling a product with words such as +'or 3rofessional Use Onl"+ does not ,eep "our product from being considered a consumer commodit" under the '3%A! %abeling regulations are ver" comple0! &etailed information on cosmetic labeling is available in '&A/s Cosmetic %abeling Manual and the labeling regulations themselves ;?> C'6 B=>@!

Is It a Cosmetic a &rug or 4othI )Or Is It SoapI* 4ac, to Cosmetics ( U!S! %aw Ahether a product is a cosmetic or a drug under the law is determined b" a product/s intended use! &ifferent laws and regulations appl" to each t"pe of product! 'irms sometimes violate the law b" mar,eting a cosmetic with a drug claim or b" mar,eting a drug as if it were a cosmetic without adhering to requirements for drugs! $ow does the law define a cosmeticI

The 'ederal 'ood &rug and Cosmetic Act )'&(C Act* defines cosmetics b" their intended use as +articles intended to be rubbed poured sprin,led or spra"ed on introduced into or otherwise applied to the human bod"!!!for cleansing beautif"ing promoting attractiveness or altering the appearance+ ;'&(C Act sec! ?=>)i*@! Among the products included in this definition are s,in moisturi-ers perfumes lipstic,s fingernail polishes e"e and facial ma,eup preparations cleansing shampoos permanent waves hair colors and deodorants as well as an" substance intended for use as a component of a cosmetic product! $ow does the law define a drugI The '&(C Act defines drugs in part b" their intended use as +articles intended for use in the diagnosis cure mitigation treatment or prevention of disease+ and +articles )other than food* intended to affect the structure or an" function of the bod" of man or other animals+ ;'&(C Act sec! ?=>)g*)>*@! bac, to top $ow can a product be both a cosmetic and a drugI Some products meet the definitions of both cosmetics and drugs! This ma" happen when a product has two intended uses! 'or e0ample a shampoo is a cosmetic because its intended use is to cleanse the hair! An antidandruff treatment is a drug because its intended use is to treat dandruff! Consequentl" an antidandruff shampoo is both a cosmetic and a drug! Among other cosmetic5drug combinations are toothpastes that contain fluoride deodorants that are also antiperspirants and moisturi-ers and ma,eup mar,eted with sun.protection claims! Such products must compl" with the requirements for both cosmetics and drugs! Ahat about +cosmeceuticals+I The '&(C Act does not recogni-e an" such categor" as +cosmeceuticals!+ A product can be a drug a cosmetic or a combination of both but the term +cosmeceutical+ has no meaning under the law! $ow is a product/s intended use establishedI Intended use ma" be established in a number of wa"s! The following are some e0amples9 : Claims stated on the product labeling in advertising on the Internet or in other promotional materials! Certain claims ma" cause a product to be considered a drug even if the product is mar,eted as if it were a cosmetic! Such claims establish the product as a drug because the intended use is to treat or prevent disease or otherwise affect the structure or functions of the human bod"! Some e0amples are claims that products will restore hair growth reduce cellulite treat varicose veins increase or decrease the production of melanin )pigment* in the s,in or regenerate cells! : Consumer perception which ma" be established through the product/s reputation!

This means as,ing wh" the consumer is bu"ing it and what the consumer e0pects it to do! : Ingredients that cause a product to be considered a drug because the" have a well. ,nown )to the public and industr"* therapeutic use! An e0ample is fluoride in toothpaste! This principle also holds true for +essential oils!+ 'or e0ample a fragrance mar,eted for promoting attractiveness is a cosmetic! 4ut a fragrance mar,eted with certain +aromatherap"+ claims such as assertions that the scent will help the consumer sleep or quit smo,ing meets the definition of a drug because of its intended use! Similarl" a massage oil that is simpl" intended to lubricate the s,in and impart fragrance is a cosmetic but if the product is intended for a therapeutic use such as relieving muscle pain it/s a drug! bac, to top $ow are the laws and regulations different for cosmetics and drugsI The following information is not a complete treatment of cosmetic or drug laws and regulations! It is intended onl" to alert "ou to some important differences between the laws and regulations for cosmetics and drugs in the areas of approval good manufacturing practice registration and labeling! Juestions regarding laws and regulations for drugs should be directed to '&A/s Center for &rug Evaluation and 6esearch )C&E6*! $ow approval requirements are different Under the '&(C Act cosmetic products and ingredients with the e0ception of color additives do not require '&A approval before the" go on the mar,et! &rugs however must generall" either receive premar,et approval b" '&A through the 1ew &rug Application )1&A* process or conform to a +monograph+ for a particular drug categor" as established b" '&A/s Over.the.Counter )OTC* &rug 6eview! These monographs specif" conditions whereb" OTC drug ingredients are generall" recogni-ed as safe and effective and not misbranded! Certain OTC drugs ma" remain on the mar,et without an 1&A approval until a monograph for its class of drugs is finali-ed as a regulation! $owever once '&A has made a final determination on the status of an OTC drug categor" such products must either be the subEect of an approved 1&A ;'&(C Act sec! H=H)a* and )b*@ or compl" with the appropriate monograph for an OTC drug! )A note on the term +new drug+9 &espite the word +new + a +new drug+ ma" have been in use for man" "ears! If a product is intended for use as a drug it must compl" with the requirements outlined above!* Ahat do these terms meanI : An 1&A is the vehicle through which drug sponsors formall" propose that '&A approve a pharmaceutical for sale and mar,eting in the United States! '&A onl"

approves an 1&A after determining for e0ample that the data is adequate to show the drug/s safet" and effectiveness for its proposed use and that its benefits outweigh the ris,s! The 1&A s"stem is also used for new ingredients and for new indications entering the OTC mar,etplace for the first time! 'or e0ample the newer OTC products )previousl" available onl" b" prescription* are first approved through the 1&A s"stem and their +switch+ to OTC status is then approved also through the 1&A s"stem! : '&A has published monographs or rules for a number of OTC drug categories! These monographs which are published in the 'ederal 6egister state requirements for categories of nonprescription drugs such as what ingredients ma" be used and for what intended use! Among the man" nonprescription drug categories covered b" OTC monographs are o acne medications o o treatments for dandruff seborrheic dermatitis and psoriasis sunscreens

Kou can find information on '&A/s website under +&evelopment and Approval 3rocess )&rugs* + especiall" +$ow &rugs Are &eveloped and Approved!+ If "ou still have questions about 1&As and OTC monographs or an" other aspect of drug regulation please contact C&E6! Kou can contact C&E6/s &ivision of &rug Information Small 4usiness Assistance at C&E6Small4usinessLfda!hhs!gov or for general drug.related inquiries C&E6/s &ivision of &rug Information at druginfoLfda!hhs!gov! $ow good manufacturing practice requirements are different 2ood manufacturing practice )2M3* is an important factor in helping to assure that "our cosmetic products are neither adulterated nor misbranded! $owever while '&A has provided guidelines for cosmetic 2M3 )see +2ood Manufacturing 3ractice )2M3* 2uidelines5Inspection Chec,list+* no regulations set forth specific 2M3 requirements for cosmetics! In contrast the law requires strict adherence to 2M3 requirements for drugs and there are regulations specif"ing minimum current 2M3 requirements for drugs ;Title ?> of the Code of 'ederal 6egulations )C'6* parts ?>= and ?>>@! 'ailure to follow 2M3 requirements causes a drug to be adulterated ;'&(C Act sec! H=>)a*)?*)4*@! $ow registration requirements are different '&A maintains the 7oluntar" Cosmetic 6egistration 3rogram or 7C63 for cosmetic establishments and formulations ;?> C'6 B>= and B?=@! As its name indicates this program is voluntar"! The '&(C Act does not require cosmetic firms to register their establishments or list their product formulations with '&A! In contrast it is mandator" for drug firms to register their establishments and list their drug products with '&A ;'&(C Act sec! H>=# ?> C'6 ?=B@! See &rug %isting and 6egistration S"stem )&6%S and e&6%S*! $ow labeling requirements are different

A cosmetic product must be labeled according to cosmetic labeling regulations! See the Cosmetic %abeling Manual for guidance on cosmetic labeling and lin,s to the regulations related to cosmetic labeling! OTC drugs must be labeled according to OTC drug regulations including the +&rug 'acts+ labeling as described in ?> C'6 ?=>!DD Combination OTC drug5cosmetic products must have combination OTC drug5cosmetic labeling! 'or e0ample the drug ingredients must be listed alphabeticall" as +Active Ingredients + followed b" cosmetic ingredients listed in descending order of predominance as +Inactive Ingredients!+ bac, to top And what if it/s +soap+I Soap is a categor" that needs special e0planation! That/s because the regulator" definition of +soap+ is different from the wa" in which people commonl" use the word! 3roducts that meet the definition of +soap+ are e0empt from the provisions of the '&(C Act becauseMeven though Section ?=>)i*)>* of the act includes +articles!!!for cleansing+ in the definition of a cosmeticMSection ?=>)i*)?* e0cludes soap from the definition of a cosmetic! $ow '&A defines +soap+ 1ot ever" product mar,eted as soap meets '&A/s definition of the term! '&A interprets the term +soap+ to appl" onl" when : the bul, of the nonvolatile matter in the product consists of an al,ali salt of fatt" acids and the product/s detergent properties are due to the al,ali.fatt" acid compounds and : the product is labeled sold and represented solel" as soap ;?> C'6 B=>!?=@! 3roducts that meet this definition of soap are regulated b" the Consumer 3roduct Safet" Commission )C3SC* not b" '&A! 3lease direct questions about these products such as safet" and labeling requirements to C3SC! If a cleanser does not meet all of these criteria!!! If a product intended to cleanse the human bod" does not meet all the criteria for soap as listed above it is either a cosmetic or a drug! 'or e0ample9 If a product : consists of detergents or : primaril" of al,ali salts of fatt" acids and : is intended not onl" for cleansing but also for other cosmetic uses it is regulated as a cosmetic! E0amples of cosmetic uses include ma,ing the user more

attractive b" acting as a deodorant imparting fragrance to the user or moisturi-ing the s,in! If a product : consists of detergents or : primaril" of al,ali salts of fatt" acids and : is intended not onl" for cleansing but also to cure treat or prevent disease or to affect the structure or an" function of the human bod" it is regulated as a drug or possibl" both a drug and a cosmetic! E0amples include antibacterial cleansers and cleansers that are also intended to treat acne! If a product : is intended solel" for cleansing the human bod" : has the characteristics consumers generall" associate with soap and : does not consist primaril" of al,ali salts of fatt" acids it ma" be identified in labeling as soap but it is regulated as a cosmetic! +Cosmeceutical+ Consumers and manufacturers sometimes have questions about the term +cosmeceutical!+ Ahile the 'ederal 'ood &rug and Cosmetic Act )'&(C Act* does not recogni-e the term +cosmeceutical + the cosmetic industr" uses this word to refer to cosmetic products that have medicinal or drug.li,e benefits! The '&(C Act defines drugs as those products that cure treat mitigate or prevent disease or that affect the structure or function of the human bod"! Ahile drugs are subEect to a review and approval process b" '&A cosmetics are not approved b" '&A prior to sale! If a product has drug properties it must be approved as a drug! $ow does '&A regulate cosmeticsI Are the" '&A approvedI '&A/s legal authorit" over cosmetics is different from other products we regulate such as drugs biologics and medical devices! '&A does not have the legal authorit" to approve cosmetics before the" go on the mar,et although we do approve color additives used in them )e0cept coal tar hair d"es*! $owever under the law cosmetics must not be +adulterated+ or +misbranded!+ 'or e0ample the" must be safe for consumers when used as directed in their labeling or under customar" conditions of use and the" must be properl" labeled! Companies and individuals who mar,et cosmetics have a legal responsibilit" for the safet" and labeling of their products! '&A can ta,e action against a cosmetic on the mar,et if we have reliable information

showing that it is adulterated or misbranded! '&A ta,es action within our legal authorit" based on public health priorities and available resources! Overview of %abeling 6equirements The following information is a brief introduction to labeling requirements! 'or a more thorough e0planation of cosmetic labeling regulations refer to '&A/s Cosmetic %abeling 2uide and the cosmetic labeling regulationsthemselves )?> C'6 parts B=> and BF=*! 'irms also ma" wish to discuss their labeling needs with a consultant! 3roper labeling is an important aspect of putting a cosmetic product on the mar,et! '&A regulates cosmetic labeling under the authorit" of both the 'ederal 'ood &rug and Cosmetic Act )'&(C Act* and the 'air 3ac,aging and %abeling Act )'3%A*! These laws and their related regulations are intended to protect consumers from health ha-ards and deceptive practices and to help consumers ma,e informed decisions regarding product purchase! bac, to top It is illegal to introduce a misbranded cosmetic into interstate commerce and such products are subEect to regulator" action! Some of the wa"s a cosmetic can become misbranded are9 : its labeling is false or misleading : its label fails to provide required information : its required label information is not properl" displa"ed and : its labeling violates requirements of the 3oison 3revention 3ac,aging Act of >CB= ;'&(C Act sec! D=?# ?> U!S!C! <D?@! &oes '&A pre.approve cosmetic product labelingI 1o! '&A does not have the resources or authorit" under the law for pre.mar,et approval of cosmetic product labeling! It is the manufacturer/s and5or distributor/s responsibilit" to ensure that products are labeled properl"! 'ailure to compl" with labeling requirements ma" result in a misbranded product! Some labeling terms to ,now 4efore proceeding with a discussion of labeling requirements it is helpful to ,now what some labeling terms mean9 : %abeling! This term refers to all labels and other written printed or graphic matter on or accompan"ing a product ;'&(C Act sec! ?=>)m*# ?> U!S!C! <?>)m*@! : 3rincipal &ispla" 3anel )3&3*! This is the part of the label most li,el" displa"ed or e0amined under customar" conditions of displa" for sale ;?> C'6 B=>!>=@! : Information 3anel! 2enerall" this term refers to a panel other than the 3&3 that

can accommodate label information where the consumer is li,el" to see it! Since the information must be prominent and conspicuous ;?> C'6 B=>!?)a*)?*@ the bottom of the pac,age is generall" not acceptable for placement of required information such as the cosmetic ingredient declaration! bac, to top Is it permitted to label cosmetics +'&A Approved+I 1o! As part of the prohibition against false or misleading information no cosmetic ma" be labeled or advertised with statements suggesting that '&A has approved the product! This applies even if the establishment is registered or the product is on file with '&A/s 7oluntar" Cosmetic 6egistration 3rogram )7C63* )see ?> C'6 B>=!N and B?=!C which prohibit the use of participation in the 7C63 to suggest official approval*! 'alse or misleading statements on labeling ma,e a cosmetic misbranded ;'&(C Act sec! D=?# ?> U!S!C! <D?@! Ahat about therapeutic claimsI 4e aware that promoting a product with claims that it treats or prevents disease or otherwise affects the structure or an" function of the bod" ma" cause the product to be considered a drug! '&A has an Import Alert in effect for cosmetics labeled with drug claims! 'or more information on drug claims refer to Is It a &rug a Cosmetic or 4othI )Or Is It SoapI*! $ow should products be labeled if the" are both drugs and cosmeticsI If a product is an over.the.counter )OTC* drug as well as a cosmetic its labeling must compl" with the regulations for both OTC drug and cosmetic ingredient labeling ;?> C'6 B=>!<)d*@! The drug ingredients must appear according to the OTC drug labeling requirements ;?> C'6 ?=>!DD)c*)?* and )d*@ and the cosmetic ingredients must appear separatel" in order of decreasing predominance ;?> C'6 ?=>!DD)c*)N* and )d*@! Contact the Center for &rug Evaluation and 6esearch )C&E6* for further information on drug labeling! bac, to top Ahat languages are acceptableI All labeling information that is required b" law or regulation must be in English! The onl" e0ception to this rule is for products distributed solel" in a U!S! territor" where a different language is predominant such as 3uerto 6ico! If the label or labeling contains an" representation in a foreign language all label information required under the '&(C Act must also appear in that language ;?> C'6 B=>!?)b*@! 'or information on dual declaration of ingredients see Ingredient 1ames! Ahat labeling information is requiredI

The following information must appear on the principal displa" panel9 : An identit" statement indicating the nature and use of the product b" means of either the common or usual name a descriptive name a fanciful name understood b" the public or an illustration ;?> C'6 B=>!>>@! : An accurate statement of the net quantit" of contents in terms of weight measure numerical count or a combination of numerical count and weight or measure ;?> C'6 B=>!><@! The following information must appear on an information panel9 : 1ame and place of business! This ma" be the manufacturer pac,er or distributor! ;?> C'6 B=>!>?@! : &istributor statement! If the name and address are not those of the manufacturer the label must sa" +Manufactured for!!!+ or +&istributed b"!!!+ ;?> C'6 B=>!>?@! : Material facts! 'ailure to reveal material facts is one form of misleading labeling and therefore ma,es a product misbranded ;?> C'6 >!?>@! An e0ample is directions for safe use if a product could be unsafe if used incorrectl"! : Aarning and caution statements! These must be prominent and conspicuous! The '&(C Act and related regulations specif" warning and caution statements related to specific products ;?> C'6 part B==@! In addition cosmetics that ma" be ha-ardous to consumers must bear appropriate label warnings ;?> C'6 BF=!>@! An e0ample of such ha-ardous products is flammable cosmetics! : Ingredients! If the product is sold on a retail basis to consumers even it it is labeled +'or professional use onl"+ or words to that effect the ingredients must appear on an information panel in descending order of predominance! ;?> C'6 B=>!<@! 6emember if the product is also a drug its labeling must compl" with the regulations for both OTC drug and cosmetic ingredient labeling as stated above!