Document er859MBQX90qQB7oq1ZMDKJ9

DOCUMENT BESUBZ CAM-167 06839 - [B2227260J Lack of Authority Hampers Attempts To Increase Cosmetic Safety. HRD-78-139; B-164031(2). August 8, 1578. 106 pp. + 7 appendices (30 pp.). Report to the Congress; by Eluer B. Staats, Ccoptrcller General. Issue Area: Consumer and Worker Protection: Identification of Uazardous Consumer Products (909). Contact: Human Resources Div. Budqet Function: .ealth: Prevention and Control of Health Problems (55- . Organization Concerned: Department of Beulth, Education, and Welfare; Food and Drug Administration. Congressional Relevance: House Committee on Interstate and Foreign Commerce; Senate ComMittee on Human Rescurces; Contress. Authority: Federal Food, Drug, and Cosmetic Act, as amended (21 U.S.C. 301). Fair Packaging and Labeling Act (15 U.S.C. 1451). Color Additive Amendments (E.L. 86-618). Federal Insecticide, Fungicide, and Rodenticide Act ot 1947 (7 U.S.C. 135). -16 C.F.R. 1500. -16 C.F.R. 1700. =21 C.F.R. 310. =21 C.F.R. 700. Alsay v. Califano, 569 F.2d 674 (D.C. Cir. 1977). Toilet Goods Association v. Finch, 419 F.2d 21 (1969). S. 2365 (95th Cong.). Cosmetics are regulated under the Federal Food, Drug, and Cosmetic Act which requires that a cosmetic be free cf injurious substances and be produced under sanitary conditions. nany ingredients available for cosaetic use are suspected of causing cancer or birth d .-ts or of having adverse effects on the nervous system. Fin.. e,/Conclusioas: In spite of the 3ignificant risk of injury to consumers, the Food and Dr'Jq Administration (FDA) does not have an effective program for regulating cosmetics. The act does not authorize BIA to require manufacturers to register their pl&ats or products, file data on ingredients, file reports of cos-etic-related injuries, or test their products for safety. Also, exemptions in the act doc not permit effective regulation of coal tar hair dyes. FEA has not effectively used its existing authority. For examfle: it has not inspected most manufacturers' planes or sampled products for compliance with the act; it has established regulations governing the use of only 11 ingredients used in cosmetics; the safety of about 25 color additives has not been established; and it has had difficulty developing appropriate tests to be used by manufacturers in eialuating safety. Recommendations: FDA should: require the listing of known allergens, help to develop product standards, define "adequate substantiation of sa'ety," insure childproof packaging of toxic cosmetics, evaluate data from literature on cosmetic product safety, evaluate restrict 4 nns of other countries, establish an information system on cosaetic-related injuries and complaints, establish rsFrtaeaeuDuvAgrrtihvueaohewldarialeitilziqroaoeufnnadcstycFeDeeoArleoaipnlturroaotgtghareroerdaderdmdiqii.teuttoyinivrTteescfh,oeorcssomaaCnsrfoedmeentgtigeycuerts,lisecastastceblmovnslnaahigltsnuoahuuiacnfoltadeisancmtgsaauemaortefrdieceernrsdtuyepgttfrshoofd,eedacsthuautaacibcsvtmsottee,ninttocmo:tdahaarelgktaeivt e to. FD repeal supporting exeaptions the effectiveness ef preservatives used, concerning coal tax hair dyes. It should and also authorize PDA to obtain access to cosaetic manufacturers' production violations and control of the act. records and (RT g) to assess civil penalties for BY THE COMPTROLLER GENERAL Report To The Congress OF THE UNITED STATES Lack Of Authority Hampers Attempts To Increase Cosmetic Safety eTuuDncfhraotuescug.tguCAhroBednreamgscuraeintutshosissoetprsriarhtoyttohivoueetnlodttaheaogefuefretnehsccqaotyufirveiizreteyedlyoctoehorsfesemtghFnueelooatiirotctedpmhrcoaaaonvdnsed--- metics, products are being marketed which may pose a hazard to consumers. About ingredients available for use in cosmetics suspected of causing cancer, and about 25 125 are are suspected of causing birth defects. Although mbeaennyvoefriftiheed,re3p0oortfedtheadivnegrrseedeiefnfetsctasrehakvneonwont to cause cancer tain impurities in humans known to or animals or cause cancer. conThe ability of these ingredients to fects through cosmetic use has cause toxic efnot been deter- mined. Manufacturers do not have to determine the safety of their tell the Food products they products before selling them or and Drug Administration what are selling and what ingredients anargoeet nuvcsoye.ludAnsitnaaritlhryeesmguiv.lte,MnaashnuayczhamrIdanonfouursfmaccaottusiormenrestticohctahavnee be marketed until istration obtains the Food and Drug Admininformation to prove that the product may be injurious to users. tCcOUI4 HRD-78-139 AUGUST 8, 1978 COMPTROLLER GENERAL OF THE UNITEO STATES WAIWH;NGTON, D.C. ]sAd 8-164031(2) To the President of the Speaker of the House of Senate and the Representatives bHtaceeeouatrmtltimhteneohrgrrT,chieitet.shnEyesduutrrcaoTeeachntteoeiirntovtFahnioeb,tolsidesheaaosnfawtdneshdtedyWitesDhFlceorofufuoasgdnrsceeeAoea,dsddndmmeiiifstnnoDirircsturhtgeairspdsapArdtoodiinrdmtoseuiipinconob,tnirlsasteltD.reiapnfltaoerirgiotinmnatsedelnmrattstiotinavoitefse- inq ing We Inade our review pursuant AAcctt,of19211950(31(31U.SU..CS..C.53)6,7).and to the Budget and Accountthe Accountin and Audit- We Office Health, are sending copies of this report to of Management and Budget, Education, and Welfare. and to the the Director, Secretary of Comptroler er al of the United States COMPTROLLER GENERAL'S REPORT TO THE CONGRESS LACK OF AUTHORITY HAMPERS ATTEMPTS TO INCREASE COSMETIC SAFETY DI GEST In 1975 Americans spent as much on cosmetics as they did on prescription drugs. In 1977 cosmetic sales were about $9 billion. Cosmetics, such as makeup, perfumes, baby lotions and powders, bubble baths, hair dyes, and toothpastes, may pose significant hazards to consumers. Toxic effects from cosmetic exposure can occur through --oral ingestion (i.e., toothpastes; mouthwashes), -- inhalation (i.e., hairsprays, deodorant sprays), or -- absorption through the skin or scalp (i.e., hair dyes, makeup, body lotions and powders). About 125 ingredients available for use in cosmetics are suspected of causing cancer, according to studies. In addition, about 25 are suspected of causing birth defects and 20 may cause adverse effects on the nervous system, including headaches, drowsiness, and convulsions. (See p. 9.) Many different routes of exposure and species of animals were used in the studies of the ingredients. Because the appropriateness and reliability of the tests have not been determined, no conclusion can be reached concerning the ability of most of the ingredients to cause the reported effects. Although many of the reported adverse effects have not been verified, 12 of the ingredients are known to cause cancer in humans or contain impurities known Taer Sht. Upon removal. the report cover date should be noted hereon. i HRD-78--139 to cause cancer in humans. Another 18 ingredients have been found to cause cancer in animals by the Food and Drug Administration, the National Cancer Institute, or an agency of the World Health Organization. Before the ability of the ingredients to cause toxic effects through cosmetic use can be determined, such factors as the amount of the ingredient used; the route, frequency, find length of administration; and the amount of absor -'ir through the skin must be evaluated. %Ai'itional injuries associated with cosmetic use are discussed in chapter 2. Although there is increasing evidence thet some cosmetic products and ingredients may carry a significant risk of injury to consumers, the Food and Drug Administration does not have an effective program for regulating cosmetics. Cosmetics are regulated under the Federal Food, Drug, and Cosmetic Act. The act requires that a cosmetic be free of substances that may make it injurious and be produced under sanitary conditions. It does NOi' authorize the Food and Drug Administration to require manufacturers to -- register their plants or products, -- file data on the ingredients in their products, -- file reports of cosmetic-related ?njuries, or -- test their products for safety. In addition, exemptions in the act do not permit the Food and Drug Administration to effectively regulate coal tar hair dyes, the dyes most widely used. ii While attempts by the Fcod and Drug Administration to regulate cosmetics are hampered by a lack of adequate legislative authority, the agency could make improvements under its present authority to regulate cosmetics. NEED FOR ADDITIONAL LEGISLATIVE AUT-ORITY Before 1972 the Food and Drug Administration did not have a formal program to regulate cosmetics. It took regulatory action on a case-by-case basis. Since then it has established several regulations to improve its control over cosmetics. However, the effectiveness of many of these regulatory efforts has been limited because it lacks adequate legislative authority. For example, in 1972 and 1973 the agency asked cosmetic manufacturers, packers, and distributors to register their plants and file information on the ingredients used in their products and the injuries reported from their use. As of December 1977, about 40 percent of the manufacturers and packers had registered their plants; less than 20 percent of the manufacturers, packers, and distributors had filed ingredient listings; and less than 4 percent had filed injury reports. A Food and Drug Administration regulation requires that labeling of cosmetics that have not been adequately tested for safety include a warning to that effect. This regulation cannot be effectively enforced because the agency is not authorized to require manufacturers to test their products for safety or to make their test results available to the agency. In addition, many manufacturers have refused Food and Drug Administration inspectors access to manufacturing records, such as iii qualitative and quantitative formulas, sales or shipping records, and consumer complaint files. The agency lacks authority to require that such records be made available. (See p. 100.) The Congress should amend the act to provide the Food and Drug Administration additional authority t' regulate cosmetics. (See pp. 48, 71, and 105.) BETTER USE OF EXISTING AUTHORITY The Food and Drug Administration is authorized to -- insper cosmetic plants and collect and test cosmetic samples, -- establish manufacturing standards, -- take regulatory action against violative manufacturers, -- restrict the use of hazardous cosmetic ingredient_ and require precautionary labeling on cosmetic products, -- require manufacturers to prove the safety of color additives used in cosmetics, and -- establish by regulation the appropriateness of the tests used in its market surveillance program for evaluating the safety of cosmetics. However, the agency has not effectively used this authority. Limited market surveillance and enforcement The Food and Drug Administration has not inspected most manufacturers' plants or sampled most of their products for compliance with the Federal Food, Drug, and iv and Cosmetic Act.. Only about half the cosmetic establishments were inspected between fiscal years 1969 and 1975. Since 1975 the agency identified about 1,000 additional manufacturers, which it had never inspected because they had been unknown to the agency. (See pp. 92 and 93.) The Food and Drug Administration alsc has not established criteria to determine whether adequate methods, facilities, and controls are used in all phases of manufacturing and distribution of cosmetics. According to an agency official, about 75 :percent of a sample of over 300 firms inspected since 1976 had deficiencies in their manufacturing practices. (See pp. 93 to 95.) Between 1974 and 1976 Food and Drug Administration inspectors and laboratories identified over 400 violations of the cosmetic provisions of the act which they believed warranted some form of regulatory action. Yet only 141 regulatory actions were taken; 54 involved 1 violative product. No prosecutions were started. (See pp. 95 to 100.) Product and ingredient restrictions Establishing regulations to prohibit or limit the use of an individual ingredient or requiring the use of a specific warning on the label is an effective way tc increase consumer safety with regard to a specific product or class of products. However, as of January 1, 1978t the Food and Drug Administration had established regulations governing the use of only 11 ingredients used in cosmetics and had required precautionary labeling only on feminine deodorant TrE Sheet v sprays, aerosols containing chlorofluorocarbon propellants, dnd aerosol cosmetics in self-pressurized containers. Although the Consumer Product Safety Commission has established regulations requiring that specific iarnings be placed on labels of products containing certain toy4 c ingre-dients, restrictions have not been established by the Food and Drug Ac'ministration for use of these ingredients in cosmetics. (See p. 34.) Drug ingredients are subject to cosmetic rather than drug regulation as long as the product is not "intended" or "understood" to have a drug effect. Because the intended effect of a product is not always clearly stated on the label, there is often no clear distinction between drug and cosmetic products. GAO identified about 90 drug ingredients available for use in cosmetics. The Food and Druq Adm;iistration has not, in some cases, required the same warnings on labels of cosmetic products containing drug ingredients that are required on drug products containing the ingredients. (See pp. 59 to 64.) Color additive safety The 1960 Color Additives Amendments to the Federal Food, Drug, and Cosmetic Act Lequire the Food and Drug Administration to establish regulations listing color additives that are safe for use in cosmetics. Although color additives are sometimes used at concentrations exceeding 50 percent, the safety of about 25 color additives available for use in cosmetics has not been established. (See pp. 65 and 66.) Definition of product safety Although the Food and Drug Administration cannot require cosmetic manufacturers vi to test the safety of their products, can establish regulations identifying it appropriate tests which should by manufacturers in evaluating be used safety. The agency said that development of appropriate tests ing. is both difficult and resource demand- Coal tar hair dyes Some coal tar hair dyes may pose a significant risk of cancer to consumers because they contain colors known to cause or suspected of causing cancer in humans or animals. aAhHndaodmiwirenCvioedrssy,tmeerstaeitxucienomdnApecrttifortnohpmserevgFrereenadgtneutrleaatdltheintFgooFoodohc,daoiarlDanrddutygare,Dsrug effectively. The exemptions bar the agency from banning or restricting the use of coal tar hair dyes containing cancer-causing colors, if their labels warn of irritation or blindness. possible skin The Congress should repeal these exemptions. (See pp. 90 and 91.) Although coal. tar hair dyes are subject to Food and Drug Administration labeling requirements, the agency has not used this authority to require a cancer warning on labels of coal tar hair dyes containing known human or animal carcinogens. The agency has warning on proposed to require such a labels of coal tar hair dyes containing two ingredients found to cause cancer. (See ch. 6.) GAO is making recommendations to the Secretary of Heulth, Education, and Welfare (HEW) to enable the Food and Drug tration to improve its regulation Adminisof cosmetics. (See pp. 44, 56, 69, 90, and 104.) hEW agreed in principle with many of GAO's recommendations, but said that it did not Ir sh2U vii necessarily agree that they could be implemented under the present statute. HEW does not believe that an extensive expenditure of resources toward the reguIation of cosmetics is a wise investment because of the Food and Drug Administration's limited statutory authority to regulate cosmetics. (See pp. 44, 57, 69, 91, and 104.) viii Contents DIGEST CHAPTER 1 2 3 INTRODUCTION What does the term "cosmetic" mean? Who regulates cosmetics? How does FDA enforce the FD&C Act? How does FDA regulate cosmetics? COSMETICS POSE HAZARDS TO CONSUMERS Toxicity Microbial contamination Flammability Effects of chlorofluorocarbons on the ozone layer Nitrosamines Estimates of cosmetic-related injuries Conclusions NEED TO STRENGTHEN COSMETICS REGULATION FDA's program Labels should identify certain fragrance and flavoring ingredients Need to define adequate substantiation of safety Need to establish ingredient and product class standards Need for childproof packaging Cosmetic Ingredient Review Pending legislation Conclusions Recommendations to the Secretary, HEW Agency comments and our evaluation Reicommendations to the Congress NEED TO MORE EFFECTIVELY OBTAIN AND USE DATA ON COSMETIC SAFETY Limited safety data Ingredients banned in other countries used in U.S. cosmetics Page i 1 1 1 2 3 5 6 17 19 19 20 21 24 25 25 30 31 34 38 40 42 43 44 44 48 49 49 50 CHAPTER Need to establish an adversereaction-reporting system Conclusions Recommendations to the Secretary, HEV Agency comments and our evaluation 5 INADEQUATE REGULATION OF DRUG INGREDIENTS, COLOR ADDITIVES, AND PRESERVATIVES IN COSMETICS Need for stricter regulation of drug ingredients Regulation of color additives Need for clear authority to regulate preservatives Conclusions Recommendations to the Secretary, HEW Agency comments and our evaluation Recommendation to the Congress 6 NEED TO REPEAL HAIR DYE EXEMPTIONS Background Possible cancer risk to consumers Exemptions hinder effective regulation Conclusions. Recommendation to the Secretary, HEW Agency c3omments Recommendation to the Congress 7 NEED TO ESTABLISH AN EFFECTIVE MARKET SURVEILLANCE AND ENFORCEMENT PROGRAM Limited market surveillance Need for GMP regulations Need for effective enforcement Lack of authority limits enforcement Pending legislation Conclusions Recommendations to the Secretary, HEW Agency comments and our evaluation Recommendations to the Congress Page 52 56 56 57 59 59 65 66 68 69 69 71 72 72 73 86 90 90 91 91 92 92 93 95 100 102 103 104 104 105 ChAPTER 8 SCOPE OF REVIEW APPENDIX I Reported toxic effects o. certain cosmetic ingredients II III IV V VI VII Listing by intended drug function of drug ingredients available for use in cosmetics Status of color additives used in cosmetics Comparison of restrictions on the use of cosmetic ingredients by the proposed EEC directive and by FDA regulations Comparison of manufacturing practices observed in FDA inspections of cosmetic plants with drug GMPs Letter, dated June 12, 1978, from the Inspector General, HEW Principal HEW officials responsible for administering activities discussed in this report Page 106 107 117 120 121 125 127 136 CIR CPSC CTFA EDF EEC EPA FDA FD&C Act FIFRA ABBREVIATIONS Cosmetic Ingredient Review Consumer Product Safety Commission Cosmetic, Toiletry and Fragrance Association Environmental Defense Fur.d European Economic Community Environmental Protection Agency Food and Drug Administration Federal Food, Drug, and Cosmetic Act Federal Act Insecticide, Fungicide, and Rodenticide FPLA FTC GAO GMP HEW IARC NCI NDELA Fair Packaging and Labeling Act Federal Trade Commission General Accounting Office good manufacturing practice Department of Health, Education, and Welfare International Agency for Refearch on Cancer National Cancer Institute N-nitrosodiethanolamine NEISS NIOSH National Electronic Injury Surveillance System National Health Institute for Occupational Safety and OTC over the counter PPPA Poison Prevention Packaging Act CHAPTER 1 INTRODUCTION In 1975 Americans spent as much on cosmetics as they did on prescription drugs. Cosmetic sales have doubled in the oast 10 years and are expected to increase at a rate estimated as high as 15 percent annually. Total sales of cosmetics were estimated to be $9 billion in 1977. WHAT DOES THE TERM "COSMETIC" MEAN? The Federal Food, Drug, and Cosmetic Act (eD&C Act), as amended (21 U.S.C. 301 et seq.), defines a "cosmetic" as an article (except soap) intended to be rubbed, poured, sprinkled, sprayed on, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance. Although the term "cosmetics" has frequently been in ,rpreted as referring to products such as makeup, nail poliL.les, and perfumes used primarily by women, the term actually applies broadly to products used by men, women, and children. For example, the baby powder, bubble bath, and toothpaste used by children are cosmetics. Similarly, products used by men, such as deodorants, shaving cream, hair tonics and sprays, hair dyes, toothpastes, coloqnes, suntan lotions, and mouthwashes, are cosmetics. Accoroing to the Food and Drug Administration (FDA) there are at least 25,000 different cosmetic formulations marketed under 50,000 or more brand names. FDA estimates that about 4,000 cosmetic and another 4,000 fragrance ingredients are used in cosmetics. WhO REGULATES COSMEIICS? Authority to regulate cosmetics in interstate commerce is derived from the FD&C Act and the Fair Packaging and Labeling Act (EPLA) (15 U.S.C. 1451 et seq.). FDA, Department of Health, Education, and Welfare (HEw), administers the two acts as they pertain to cosmetics. Within FDA, the principal organization identifiable with regulation of cosmetics is the Division of Cosmetics Technology , Bureau of Foods. The FD&C Act requires that a cosmetic be --free of substances that may make it injurious to users under normal use; -- packaged in a safe and nondeceptive container; -- produced under sanitary conditions; and -- labeled with information about turer, packer, or distributor of its contents. the and oroduct's manufacthe quantity FPLA home uasuetholriistzestheFDAingtoredrieeqnutisre onthatthe a cosmetic label. sold for martfieeothrsnqectuoiluFurossDSoereef&iCnpcairirnednAeedcgmictuJfatolourisaol(kvmdtyPeee,iuttob1indm2lcsrua,isuspcgtpl1sriLi9,osbas6ve0wta,opilrena8rgp6tmpco-hifro6ectos1otvmo8lCeeteo)oddhtrle.ionrcraafsvod.reFcAdDoidAsstdrmaiiUeefvtniqteseiduitsevicyrenroettdhAtbiayhnmtaegetusrFnhteeDdeahdAmroieeaerenbmsinteestztsfnaaesofdbd.ermlteeiontsthosHOW DOES FDA ENFORCE THE FD&C ACT? doalmasFcfenarDeuotdbeAnpsetotpmrhrofieiemarrnnttiittosihnnomFpcecserDeslopi&ctemeaeCwthgpctcshoealthterlAiait-ccftoaphothnnrare,acccoarneorthinslFeiiseetPlobwlhlLeniiaFseeActtdD,ycthswuAtoh'lifcaestcttvnonhoehedmtesrebprmaavaltaetsilsdyepteioaaespidclwl;twlcaeiiitoatntcitrnsoighaohdoanbnelmmlssasptiieenplostndeeaobtcarsrroeirelebadrfeagdtensibuuatdtfeclsrieeaolauinrutdtrbnnme.iremgdieoeqi.nvcnvuteioTisiitdhnm.ereeesmIiwednnpefmcereetteccgasnooteodttiodatsFodibooDnstlfAsiiosnh,tvhirooluagtWhiheonnthedFuDrADienplgairstcimonevsneptrescotfiaonnJuasodtruilctseea:rmpalteionanaolrysaism,isbirtancdainn,g -- Prosecute an individual who violates the act. -- Enjoin a producer or an laws and regulations. individual from violating -- Seize when any cosmetic that intr-'uced into, or is adulterated or misbranded while in, interstate commerce. Acrloetschmaloelut,gihcsFDtAhtehamtaFyDa&rCreeqAcuatelsltedaoeepdsrodntouotcevriasoultahttooerivzotehleunFtDacAatr.itloy require recall a 2 atethhcxeetplawmniehAaneendnucfaiancftocyrartitumieriopxnenrtar,oelsneuaocnarputrtiooninpcoogpetnoei.rdccteiiunrngcoisuftmysha,treaeantrchicernosognu,tgwehhmiipsclahartheeewqdaou.ruiilrndegdI,etlbiygtmioivtnehaeste a FDA is violator not if a would be served required violation to is by a written issue minor a citation and if the or prosecute public interest notice or warning. atbilthynieejrotuaentnsgeFcruDmItslAwani,ahnotiuDanocfiFd,hrarDdyceAitcdbttuuoliitoreosretnns,rtnoueotetrtsDtcoicwvirrioniteesusaagslaiktuudoeelinpnacprgatorooosrofrdcerbyaiceanRtucbgelattlegetiiyrutiovltoneaernt.ertosssoaurhcalyetnitaidnloGtnutiihnihn.eadffaaotnrcecAsmareecas,ictezioruoreofrndcfaeieiinlvvguoiirroneltgao- The FD&C Act provides for criminal aa3udtyuheloatrreisrzaetiinocnipvrioilrsopnmeinasanbldrt/aoinredsinagfo$r1p0r,vo0vi0io0sliaotfniison.nes visions. penalties of up to for violation of the The act does not of its cosmetic pro- ttathioreoenssedFiDeC&zeooCufmsremedAFecPttLito.AcrosabireniejnmutninroscotbtdiruoapcnnueddneiudsnihdnaetubronldeectrhoebmymtehFreDc&crCeiFmDi&AinCcnatl.vAcitpoelHnaoaatwnliedvtoeinarer,seofsvunuiFdboPejlLreaAc-t HOW DOES FDA REGULATE COSMETICS? gptiBohbCrurormfeeaeolasopncsgsanellsaiuctmcdleisuleoeeim.vsastBneeetmtiecgnheeAcfotedtsoonAseicsfreIcmdcoeoweoncessscfdoti,mtitcurinheahaosdcacaetbtsatlisyrilinlmrnecidoetyga1bssnths9ut.hriie7htmtmecnef2a(oeesgfCgtnoBTaoFactreFpzclnoDoAttraikoAn)wsoownnsa,efg.ecurdrer,emtiienarntatdiegmnnhhcrtusMerlt-hln,aeheaiegaoyeemnCottwodoocobhnuv1sdCoryhigs9omsosyac7tlen-mvt2hrtuameechayinrateocpcteanintarn,sauctsieodsrfruodfvyaaTminoiidcOoettrndecptrioomdoetrsrulanuooeralesbgtifsntoaaerornsafrbprraygocyocr:m,ctutaosi1thsgiia9eaasernt7nft-ad3iodhcbmuDt,oreoyshrnFm-teut,FrcrpcgsoDaoiraalA-nepesfear-sr-eaene.ostdg-ty-- Voluntary registration of cosmetic manufacturers. 3 -- Voluntary filing of cosmetic product ingredient and raw material composition statements. -- Voluntary filing of cosmetic product experiences (injury reports). in addition, FDA has issued regulations requiring ingredient labeling of cosmetic products subject to FPLA and precautionary labelina of certain products. Also the use of several ingredients in cosmetics has been restricted. In fiscal year 1977, funding for FDA's regulatory program for cosmetics budget of $250 was $2.8 million. million; As of about 1 percent July 1, 1977, the of FDA's overall Division of Cosmetics Technology had only 15 professional employees to regulate the $9 billion cosmetics industry. 4 CHAPTER 2 COSMETICS POSE HAZARDS TO CONSUMERS In February 1974 hearings before the Subcommittee on Health, Senate Committee on Labor and Public Welfare, the FDA Commissioner said that: "One thing to keep in mind when discussing cosmetic safety is that cosmetics, unlike food or drugs, are not essential to health and well-being, regardless of their esthetic or camouflage value. * * * "In the case of drugs, a benefit-risk judgment can apply in which the expected benefits may justify the assumption of substantial risk. But since there are few, if any, cosmetics or cosmetic ingredients which we could not do without, were we forced to, we should be much less tolerant of any potential for injury from these products." Although there is increasing evidence that some cosmetics and their ingredients pose a hazard to consumers, FDA does not have an effective program to identify and remove them from the market. Cosmetics are being marketed in the United States which contain: -- Ingredients which may cause cancer, birth defects, central nervous system disorders, and other chronic toxic effects. (See p. 8.) -- Ingredients which may cause skin or eye irritations, genitourinary infections, allergic reactions, and other acute toxic effects. (See p. 10.) -- Drugs which may affect normal body functions. (See p. 59.) -- Bacteria which may cause serious eye injury. (See p. 17.) -- Ingredients which are banned or restricted for use in cosmetics in other countries. (See p. 50.) -- Flammable ingredients. (See p. 19.) 5 -- Ingredients which could deplete the Earth's protective ozone layer. (See p. 19.) Also some cosmetics have been found to contain N-nitrosodiethanolamine (NDELA), a known animal carcinogen, as a contaminant. (See p. 20.) In addition, available data indicate that the colors used in some coal tar hair dyes, essentially exempt from cosrietic regulation, may cause cancer and/or mutations. (See ch. 6.) TOXICITY In this report the term "toxicity" refers to the shortterm or long-term capacity of a cosmetic to :-:ce personal injury or illness to man or experimental ani :..;. The term may be used to refer to the toxicity of an inuividual ingredient or to a formulated product. Acute versus chronic effects Toxic effects may occur after one use of a cosmetic or after repeated use. In this report effects which appear soon after use are referred to as acute toxic effects because of the short time before onset of the injury. The injury may be either temporary, stch as a skin rash, or permanent, such as loss of sight. Injuries or illnesses whose symptoms appear months, and possibly years, after use of a cosmetic are referred to in this report as chronic toxic effects. Such effects include cancer, birth defects, central nervous system disorders, and lead poisoning. The injuries or illnesses usually result from repeated use over a long time. Mode of use Toxicity may result from either oral ingestion, absorption through the skin, or inhalation of toxic ingredients. Lipsticks and all oral hygiene products, such as toothpastes, mouthwashes, and breath fresheners, may be ingested during normal usage. Cosmetics may also be accidentally ingested. Most cosmetics are applied to the skin-or hair. After application, however, ingredients may ,p absorbed into the bloodstream through the skin. 6 oofsctfvhoiheorcerwetmnahiirecnAambagler1C5sle-r9Todda7Fiawn0Aieyg.nnecCstdplotseusu.rfdmdireeyoodtdmiT1con/tia1anfoIlettnneogrcarthbeh4eea3dsmpioipeprscenlpkartitilccinseaoDntniaticblotosinifoosfortnpeotafdtthrhioeyositnenhea2pn/otpichflneofiemooerpr1dog9iua7undn7nsgodiersceeedatd,osiiteianctotshonessme- Compound Total absorption (as a percent of applied dose) Benzoic acid p-Aminobenzoic acid (PABA) Salicylic acid Diethyltoluamide Nicotinamide Urea Phenol hexachlorophene Thiourea 43 28 23 17 11 6 4 3 1 eot(tatwrhheeatrnhtoaiOilntiraghnmegirrdangeyeedes)nist,teusndt;tihisnerdsoeucitgnohehsartmvgheeteethniedtcfessoms;rocmmnaaulsayplnt.dartaiietnomecInudrnlecsatltsihuhefrseioieuoatrgnhbshes,oorfatphsbetussicouhosrrnkpfitaanisco.otfnatnrctioos-fal 1/R. Feldmann and H. Maibach, "Absorption pounds Through the Skin in Man," Journal of of Some Organic ComInvestigative Dermatology, vol. 54, 1970, p. 399. 2/mnds2FatTueouD,biushatsA6lopein,t0enpdsr0aliyritmdotf;yheoropiia,rdlcntypatgpbrirurb"sosoetoyIieevnhdmntniaaiocttcdretlbiheenyeuyestdsisonittwcu,ofohaonftenssioiarmfasnoecoonprfdtoorurrismsiecsmenwaphenagnsaotshroriiuioemennilcudedddndlineucgdecssobirnlnitsynetoabgrdmdtetynueiCusetieTtirnaubnoFrce,estnAyset..dhuofitiesnonnhrbeeydADcttI.sihothii"tecoennhtnpgcgeioDerobrotrieanenecacsdtddaottiiairsisieieymononnientsntnotsadsfiorawtceyhibdbasetoaevhdutiaiotnannidoe-glits-c- 7 Also cosmetic ingredients and aerosol propellants may be inhaled. According to a study by Dupont Laboratories, concentrations of the Freon aerosol propellant as high as 460 parts per million were found in a ventilated room following use of an aerosol hairspray or deodorant. In determining the extent cf consumer exposure to aerosol particles, factors other than the initial concentration of the aerosol must be considered, including the extent to which aerosol particles remai. suspended in the air after use of an aerosol product and tV 2 size of the particles and disposition after they are inhaled. Some particles may remain suspended for several hours. Inhalation of talc-containing products, such as baby, body, and foot powders, may result in the lodging of talc particles in lung tissue. Toxic ingredients used in cosmetics To obtain data on the general toxicity of cosmetic ingredients, we compared a list of about 2,750 cosmetic ingredients 1/ with the list of toxic substances in the 1976 Registry of Toxic Effects of Chemical Substances prepared by HEW's National Institute for Occupational Safety and Health (NIOSH). NIOSH defines a "toxic substance" to be one that demonstrates the potential to -- induce malignant tumors (cancer) or benign tumors in man or animals (suspect carcinogens); -- induce a permanent transmissible change in the characteristics of an offspring from those of its human or experimental animal parents (mutagens); -- cause birth defects in humans or experimental animals (teratogens); 1/Includes about 2,600 ingredients listed in the second edition of the CTFA dictionary and about 150 ingredients reported to FDA as being used in cosmetic products iunder the voluntary program for filing of cosmetic ingredient statements but not included in the dictionary. FDA estimates that there may be as many as 4,000 cosmetic and another 4,000 fragrance ingredients used in cosmetic products. 8 -- produce death in animals exposed via the respiratory tract, skin, eye, mouth, or other routes; -- diminish mental alertness, reduce motivation, or alter behavior of humans (nervous system effects); or adversely affect the health of an individual by proJucing reversible or irreversible bodily injury or by endangering life or causing death from exposure via the respiratory tract, skin, eye, mouth, or any other route. Although we relied primarily on the NIOSH registry in identifying reported toxic effects of ingredients, additional data on carcinogenic effects were obtained from reports by the National Cancer Institute (NCI), FDA, the World Health Organization, and the Environmental Protection Agency (EPA). We identified reported toxic effects of about 600 of the did approximately 2,750 ingredients not identify any reported toxic reviewed. Although we effects for the remaining ingredients, exclusion of an ingredient from the registry does -ot necessarily imply that the ingredient is nontoxic because (1) many ingredients have not been adequately tested for their toxic effects, (2) cosmetic ingredients included in the dictionary which are trade name products representing compounded or formulated proprietary mixtures are excluded from the registry, and (3) the lack of consistent nomenclature for cosmetic in:-edients made it difficult to trace individual ingredients to th9 registry. Most of the ingredier-s whose reported toxic effects we identified are listed in the registry because of lethal responses of test animals to single or short-term exposure. However, many were shown to have other toxic effects. Of the approximately 600 ingredients --125 are known to cause or suspected of causing cancer (12 are human carcinogens or contain contaminants known to cause cancer in humans), --26 are suspected of causing birth defects, -- 20 may cause nervous system disorders, -- 17 may cause irritation, --6 may cause eye damage, and --3 may cause mutations. 9 Other ingredients may damage the skin, the digestive system, the blood, or the respiratory system or affect blood pressure, mental activity, or the metabolic and excretory function of the liver and kidneys. Appendix I lists the cosmetic ingredients reported to cause these effects. Many different routes of administration and species of arimals were used in the studies showing the adverse effects. The applicability of the test methods and results to cosmetic exposure has not been evaluated. (See p. 40 for a discussion of an industry-sponsored program to evaluate the safety of cosmetic ingredients.) Allergens, irritants, and photosensitizers Most cosmetic injuries suffered by consumers are attributed to contact demnatitis (i.e., a redness and an inflammation of the skin caused by exposure to chemicals). Two main types of chemicals may cause contact dermatitis: irritants and allergens. If light is needed to induce a reaction, the chemical is classified as either a phototoxin or photosensitizer. In addition, many cosmetics irritate eyes oF mucous membranes, if they come in contact with the eyes or- lips, or may cause hair or fingernail breakage. Irritants are substances which cause inflammation or more severe reactions of normal skin. Cosmetics commonly associated with primary irritation reactions include hair straighteners, deodorants, depilatories, bleaches, and permanent wave preparations. Among the substances in these cosmetics causing such irritations are the ammonium, calcium, and potassium salts of thioglycolic acid; ammonia; alkali hydroxides; and peroxides. Ur.less adequate directions are given for use of cosmetics containing irritants, consumer injury may occur. Of course, failure to follow directions may also result in injury. Eye irritants are substances which cause inflammation, swillinq, or other injury to the eyes. Among the most commcn eye irritants are soap and several shampoo ingredients. These ingredients may cause eye irritation when the shampoo accidentally gets in the user's eye; in some cases irritation occurs even when the shampoo is promptly rinsed out of the eye. (See p. 13,) 10 Allergens are substances which produce an exaggerated or a pathological reaction (such as sneezing, itching, swelling, or skin rashes) in some individuals. The National Institute of Allergy and Infectious Diseases estimates that 31 million people in the United States may have some form of allergy. Although any cosmetic ingredient can cause an allergic reaction in some users, certain ingredients, particularly perfume ingredients, preservatives, and some coal tar hair dyes, are more likely to cause allergic reactions. An individ- ual may exhibit an allergic reaction to a cosmetic the first time the product is used or may suddenly exhibit an allergic reaction to the Product after without adverse effects. The presence oi years of use an allergen at essentially any concentration may trigger an allergic reaction in a sensitive individual. Photosensitizers are substances which abnormal reaction to sunlight characterized cause an by redness; itching; burning; and, in severe cases, blistering of the skin reactions at and beyond the are most commonly site of application. These associated with sunscreeninq and antimicrobial agents. Toxicity of cosmetics Although many potentially toxic ingredients are cosmetics, their ability to cause toxic effects when used used cosmetics depends on such factors as (1) the amount of the in in ingredient used, (2) the route and frequency of administra- tion, (3) the amount of absorption through the skin, (4) the presence of other ingredients which may heighten or lessen the toxic effects, and (5) the length of exposure. Many cosmetics, including some bubble baths, hairspravs, shampoos, and feminine deodorant sprays, may be hazardous. Bubble baths have gained wide popularity since their development in the 1940s; their sales totaled almost $32 million in 1972. Adverse reactions were noted by physicians as early as 1955. Reported in- juries have included rashes, skin irritations, and genital/urinary tract disorders. The severity of the rashes and skin irritations ranges from minor skin redness, itching, and discomfort to the Stevens-Johnson syndrome (an illness characterized by rashes, fever, joint pain, eye disorder, and prostration). In June FDA's Office of Planning and Evaluation prepared an 1975 analysis of bubble bath product complaints received by FDA between 1967 and 1974. 11 According to the report on the analysis, of the 165 adverse reactions to bubble baths reported to FDA by consumers during the 8-year period, 107 (65 percent) were severe enough that the consumers contacted physicians. The nature of the complaints is summarized in the following table. Nature of injury Number of complaints Complaints confirmed by physician as product related (note a) Rash/skin irritation Urinary tract/bladder/ kidney disorder Genital disorder Eye irritation/injury Respiratory disorder Stomach disorder 69 48 26 2 13 7 26 20 14 1 1 Total 165 62 a/These figures are based on the 107 cases attended by physicians. Physicians did not report whether the injuries were product related in 40 cases. In only five cases did the physicians state the injuries were not product related. According to an FDA Consumer Safety Officer, there are strong indications that FDA is receiving notification of only a fraction of the actual injuries being caused by bubble baths. About 59 percent of the adverse reactions reported involve one major manufacturer's products. FDA officials believe that the detergent ingredients used in the bubble baths remove the protective coatings from the body and allow infections and/or inflammations to occur. The Office of Planning and Evaluation report notes that although the manufacturer has reformulated the product at least twice to reduce or replace the detergent ingredients, the actions have "seemingly failed to eliminate consumers' complaints." Although FDA has not compiled statistics on bubble bath complaints received since 1974, the Deputy Director of the Division of Cosmetics Technology said they are still being received. 12 the Feminine deodorant sprays Un-te- Statees inT 166. In were 1972 first sales introduced in totaled about $40 million. Between 1969 and 1972 verse reaction complaints involving FDA received 174 these sprays. ad- According to FDA, the? 174 complaints may represent only a small percentage ot the actual number of injuries. Data from the Consumer Product Safety Commission's (CPSC's) National Electronic Injury Surveillance System (NEISS) indicates that about 1,300 persons were tLeated in hospital emergency rooms alone adverse reactions to genital area during 1976 due to products, including feminine deodorant sprays. The reactions reported to FDA in included itching; burning; a few cases, inflammation of rashes; infections; the lower urinary and, tract. FDA has been unable to identify the specific ingredient or ingredients which cause the adverse reactions. In an attewat to reduce the incidence of adverse reactions, FDA, in March 1975, issued a regulation requiring that warning labels be placed on feminine deodorant sprays. The regulation became fully effective in September 1977. Because of the actions to feminine controversy concerning adverse deodorant sprays, FDA's ban on rethe use of hexachlorophene in them and questions concerning 'heir usefulness, sales of these sprays have decreased since 1972. Shampoos may cause varying degrees of eye injury if they accidentally enter the eye, especially in the undiluted state. Painful, transitory, and sometimes incapacitating lesions requiring medical treatment may occur. If the lesions become infected or chemical burn caused by the shampoo penetrates if the the Bowman's membrane (a thin membrane covering the front of the cornea), scar tissue may form, resulting in a clouding of the cornea thus interfering with vision. Loss of the eye could occur if this type of damage occurred in the presence of certain pathogenic organisms which may be present in eye makeup or other cosmet;is coming in contact with the eye. Two 1969 FDA studies demonstrated the ability of marketed shampoo to cause eye damage in rabbits. 13 In the first study, 11 complaints were filed were shampoos tested for for which consumer eye irritancy. 1/ Ten of 5 were the 11i shampoos were found to irritants even if the shampoo be eye irritants; was washed out of the eye within 30 seconds after application. for anIenstthheetisceceofnfdecsttsudyw,ere11 of the found to 13 shampoos tested produce loss of ocfvoeeuerlldin7gmahkooerursst.heensaButyseiropnroudnluaacwsiatnrigengoafnfersoitmnhjeulsreiysastotthheatnhesh1aemyhpeo,ouorsitn-o cluding injury the shampoo. estimated that resulting from the irritant effects The Division of Cosmetics Technology, at least 90 percent of the marketed of FDA, shampoos would produce anesthetic effects. (See p. 32 for a discussion of FDA efforts to regulate shampoos.) 1r9e6a9dilAsytlutddheioteuesgrhmaimrnaeenycwuhroerftehntethrleytshbheeayimnpghoaovsmearikbneecetlneudd,erdefwoeirnmcuoFluDalAtd'esdnot since 1969 to eliminate their irritant or anesthetic effects. However, an plaints involving FDA summary of adverse reaction comshampoos received between January 1970 and plaints chemical Although November 1973 shows that 27 of the 117 cominvolved eye injuries, including irritations, burns, corneal abrasions, and epithelial damage. FDA has not compiled statistics on eye injuries cTtiaoenuccshlFeunDddoAeldobbegyty46wsehsecaunmompmmopaDolresaycienmostbfisenrcceoofs1m,19ee7yt139ei,7c3-i,rareralDinaitdtvaeitdsiDioeoncinsenmjboauefsrrsioCecos3i1sa,mrteeetp1di9oc7rs7t,ed with use of shamooo. erosol disease known symptoms are hairsprays have been shown to cause a lung as pulmonary thesaurosis. Among the nodules on the lungs, shortness of breath, opatnohnerdtpssuaylmmmhpoiatnlvoademrsycboeueotgnfhhte.epsnuabuldrSiioisssnhiacespedp.epianurbelA1dic9c5c8awo,htreidnoiatnngusolefetaosottfhtehhetaswfioeirrsosrptterhpaeoryrretpsor,re-t was discontinued. 1/Auttlhihladescnsheariaomarriptsois,dooliinfgwofrhaoutsfsoedbctuvholcienlrosiiucinmsods9reonrsneeowadfe,rlelntdiooonrpmgabianceliwtitahytnlehusoitfpcreaorrrnit)tjth,iuaeannltccitonirefivnlfvaeaeeamri.mstai(topoinrtoohnedorfucofed 14 In the March 3, 1975, Federal Register (40 FR 8912-8929), FDA analyzed available data on the hazards of aerosol products and corcluded that there were not sufficient scientific data demonstrating a degree of health hazard to justify a total ban on all aerosol products. With regard to hairsprays, FDA cited the conclusion of the authors of a 1972 article I/ that the diagnosis of thesaurosis in hairspray users has not been confirmed through experimental animal studies and human observation. Subsequently, in August 1975 NIOSH issued a report on a "Morbidity Survey of Respiratory Symptoms and Functions Among Utah Beauticians." In the survey, a probability sample of 262 student cosmetologists and 213 graduate cosmetologists were medically tested and compared with a nonoccupationally exposed control group of 569 people matched by age, smoking history, and region. The survey report concluded that female cosmetologists "* * * are at increased risk of developing chronic respiratory disease and atypical sputum cytology which may progress toward more severe changes suggestive of lung malignancy. The thesaurosis-sarcoidosis syndrome was demonstrated in 22.5% of the graduate cosmetologists whereas students and controls were not significantly different from each other (12% and 14% respectively)." Cosmetologists were shown to use significantly more hairsprays, beauty aerosols, and household aerosols than the control group. An increased prevalence of chronic respiratory disease was noted in small salons where adequate ventilation was often lacking. Toxicity from accidental in9estion During 1974 over 10,600 possible poisonings from cosmetics were reported to poison control centers, of which almost 9,300 involved children under 5 years of age. 1/J. M. Gowdy and M. J. Wagstaff, "Pulmonary Infiltration Due to Aeroso' Thesaurosis," Archives of Environmental Health, vol. 25, August 1972, pp. 101-108. 15 Three deaths were reported. According to the former Director of FDA's Division of Poison Control, most of the possible poisonings resulted from accidental ingestion of the products. As shown by the following table, the majority of the possible poisonings involving children under 5 were from accidenta. ingestion of perfumes, colognes, toilet waters, fingernal preparations, and cosmetic lotions and creams. Type of cosmetic Possible poisonings reported Poisoning Hospitali- symptoms zations present reported Lotions and creams 1,844 98 19 Fingernail preparations 1,632 106 22 Hair preparations, except shampoo Shampoo Perfume, cologne, and 679 57 6 667 37 7 toilet water Personal deodorants Miscellaneous 3,385 187 40 317 29 3 76' 43 7 Total 9,291 557 104 While most cosmetics are virtually nontoxic or only slightly toxic, some are moderately to highly tcxic upon oral ingestion. According to the draft poison control guidelines prepared by HEW's National Clearinghouse for Poison Control Centers, the cosmetics having the greatest acute toxicity are permanent wave neutralizing solutions containing sodium or potassium bromates. The clearinghouse notes that: "One to two teaspoonsful of this [permanent wave] can produce serious poisoning in children." ** *** "Ingestion may produce vomiting, diarrhea, abdominal pain, methemoglobinemia [a condition resulting from the presence of an abnormal hemoglobin compound in the blood which interferes with the absorption of oxygen by the tissue], hemolysis [breakdown of the red blood cells], cyanosis [a bluish discoloration of the skin and mucous membranes due to reduced hemoglobin in the blood]. Restlessness followed by central nervous depression with apathy, lethargy, hypotension, tachycardia [excessively rapid heart action], coma, convulsions. Oliguria 16 [reduced output of urine], anuria [no urine output], azotemia [an increase of nitrogenous compounds in the blood resulting from kidney disease] with death from renal failure." Among other cosmetics which the clearinghouse considers slightly or moderately toxic are colognes, perfumes, toilet waters, permanent wave lotions containing sodium perborate, hair bleaches, dandruff shampoo, hair tonics, hair dyes, mouthwash concentrates, depilatories, skin fresheners, and preshave lotions. In addition, the clearinghouse reports that accidental breathing of dusting and talcum powders may cause acute bronchitis (inflammation of bronchial tubes) and bronchiolitis (inflammation of small bronchi in the lungs), cardiopulmonary failure, and death in young children. The poison control guidelines note that several deaths have been reported involving massive talcum powder aspiration but that most cases of accidental breathing of such powders can now be successfully tree'ted. The need for childproof packaging of cosmetics to prevent accidental ingestion is discussed on pages 38 to 40. MICROBIAL CONTAMINATION FDA has received several reports cf substantial vision loss resulting from the use of microbially contaminated cosmetics. Pseudomonas aeruginosa, a pathogenic bacterium that may be found in cosmetics, poses a serious threat to vision iz it comes in contact with a scratched or an abraded eye. Although the healthy eye is relatively resistant to microbial infection, the cornea or outer eye could easily become infected if accidentally injured by a makeup applicator brush or contact lens. Total corneal destruction and irreversible vision loss may occur within 24 to 96 hours after Pseudomonas becomes established in the injured eye. Microbial contamination may be present in shampoos, lotions, creams, and eye makeup when they are sold or they may become contaminated during use. In a 1969 FDA survey 1/ of hand and body lotions and creams, about 20 percent of the products sampled contained microbial contamination. Over 11 percent contained gram negative organisms, including Pseudomonas and coliforms, which FDA believes may pose a moderate to serious health hazard. 1/A. P. Dunnigan and J. R. Evans, "Report of a Special Survey: Microbiological Contamination of Topical Drugs and Cosmetics," TGA Cosmetic Journal, Winter 1970, pp. 39-41. 17 scataroolenietvyaaaemlT.ihwneamyaastkgUienroulpeneprasetsseobesfynttthaeenyheaonzamaamprkpatdelkh,euiepcuaphhtuocomwdoraenunvtreaibrinrb,nguossdhyauaspneoap.rnedeatfrhMfsceeiacncttrhoioabveoncerdosgmtapernorarienfsssrmeftosrehmvrraor-uegdh tive system, the microorganisms may the makeup and multiply rapidly. become established in Results of Medical College sities between an of 1971 FDA-sponsored study by researchers Georgia and Emory and Georgia State and 1976 1/ demonstrated that: at the Univer- -- About 10 percent of when sold. eye cosmetics were contaminated -- Fungi were isolated from eye cosmetics tested. about 10 percent of all used -- Bacteria were isolated from about used eye cosmetics tested. 50 percent of all -- Some popular brands of mascara without preservative systems. have been marketed --About half the in-use studies eye had cosmetics yielding bacteria during a persistent, reproducing microbial population over a 30-day storage period. --Most preservative systems broken down during use of bacterial growth. used in mascaras were the product and support l/L. A. under Wilson and D. FDA contracts G. Ahearn, unpublished progress 71-74 and 223-2016, 1971-1976. reports L. A. Wilson, J. W. Kuehne, "Microbial Contamination in S. W. Hall, and D. Ocular Cosmetics," Journal of Ophthalmology, vol. pp. 1298-1302. 71, no. 6, June G. Ahearn, American 1971, Datna.dmiGnG.a.tAihAoejnaerlnlD,ou,riLn."gMAi.cUsreoW,bi"ilasloDne,GvreolAwo.tphmJe.nitnJsulEiyinean,CIonsdDmu.esttJir.cisaR:leiMnihCcaorrndo-t-, biology, vol. 15, 1974, pp. 21I-216. L. A. Wilson, A. J. Julian, and D. G. Ahearn, "The Survival and Growth of Microorganisms in Mascara American Journal of Ophthalmology, vol. 1975, pp. 596-601. During Use," 79, no. 4, April 18 -- Over half the cosmetics used for demonstrations at cosmetic display counters were contaminated; some contained pathogens. The need for product class standards for eye area cosmetics is discussed on pages 36 and 37. FLAMMABILITY Serious burns have been reported from use of flammable cosmetics. Among those most likely to ignite at the time of application are perfumes and colognes which usually contain a high concentration of alcohol and nail polish removers which contain flammable ingredients, such as acetone and ethyl acetate. Some hairsprays and nail polishes have proven flammable after application. Some of the injuries reported to FDA since 1970 are indicated below. Second and third degree burns on the head Victim used hairspray before going out to dinner. After returning home, victim struck a match and her hair ignited. Thermal burns on the neck Victim sprayed herself with cologne, then lit a match 12 to 14 inches from her throat. The cologne ignited, burning her throat. Thermal burns on the head Victim's hair ignited 6 to 8 hours after hairspray was applied. Thermal burns under the arm Victim used an aerosol underarm deodorant, then reached over a stove. The deodorant ignited. Death caused by burns on upper part of body Victim used a hairspray and then attempted to light a cigarette. Her hair and clothes immediately ignited. EFFECTS OF CHLOROFLUOROCARBONS ON THE OZONE LAYER In June 1974 two University of California scientists reported their theory that once released into the atmosphere, chlorofluorocarDons, the most widely used aerosol propellants 19 in the United States, ozone layer. Ozone, a on oxygen, shields the Depletion of the ozone could deplete the Earth's protective gas formed by the action of sunlight planet layer from harmful solar radiation. may lead to increased incidence of and skin cancer, changes in destruction the Earth's of certain forms of climatic conditions. plant life, AAiccdaaeddneetmmiAyyf'iSseeodfptreeSbmypcboieretrtnh,ece1sCc9oa7n6lctioifnrnofeuripenrodirmatedrebsylcteihaeeasnetppiaosnottefesln.tcihoalfloArctohchefaolzraduNrioadnrtsgoicoantfroaiblrostnhtes oeaifatncchra1eb9oa71us3-tepelre7icnveepnltetshrececdnoeiutncl.crdiedaesCrneaecnsecuielnrtofthsienspkeiocanznioanlcueialsntctliesamryaeetrwse,otuirlmaedadtu2eoc-ctpciteuohrrnac.teniwtnitohzone dcdcfca9Iae0taoesarocncnbdtslsphtoouuiaehnrrsmneraIsaeeecnnnrrdepbntssoneru1srteboa9nyhap7lra6aoeloevntflyeadehl,bsAeoatsmtruniwstehatomtwierbpai.tiorttcpccu4oechua0thdphimnlCeenpspoohdgl-erastltrlmohwaocfeafeffnepttrlrrtnieoouostmcmhofs.arauidacolwsureuhechissrsrlainapoiocrggsrnrhebooagoofolyfnvuaslsesatc.urehetcodoerourous3ospInecrconadtohbalsellirtdlaolib-dnrlpoodior3fnniofoaosrntdlyeiuoeurrcotaooaaotnrsrbes,sooosrh.lutcoymitsahscda.arokrnvMbloeuao--nnys opaFsMR1oafraferaef9nlmtdoyg7aueeedip6locrrusa,yr1hacteczo3FllteAfk,icDaosrpfanaArrReggron1ieceb9fopi(lgtdo7ltnut4iin7huiib2svs,eo1ctolten5eiriFe,aso.cpirdlnhPcoouoarle.1afmbtyd9mormlen7obeia2is9sofns4iti)tMntthsn5n.aaesset3srrdr6Ftico)DhnirhAdDtAenateuhe-epceccrnpf1reFFee7teiroieDd,MmqnohvdAabaupiee-teyllo1brdroira9saien7tle1ttrqop8e9doiu1unh7dnl5laR7eg,ai(stret4npehugp3et1wreltirde9aeohsoo7srFdetunp8s.uetpoiotRpcrutnras.utsion(tasbecdootoell1reuhfn.i1eom,ces3fcatfsNh0onsiFsoFe1mun.ceevDd)mifhndeA,sealtem,nrcoirbAiectwnraaeofdeuiollnrtrt-tehehoru2edns6te,hoer NITROSAMINES Research sponsored by the National Science Foundation hstoaosdiceaitudsheeanntoiclfaianemcdienret,wheheinnpremfseadennycteocoosrfmaettsai.cnsi.trosNaDEmLiAne,hasN-bneietnro-found The American researchers at a Chemical Society March 1977 meeting of the reported that NDELA was found 20 in 25 of 27 cosmetics tested at concentrations ranging from a trace (less than 10 parts per billion) to 48,000 parts per billion. The products tested included makeup, hand and body lotions, and shampoos. According to the researchers: 1/ "It is not possible at the present time to assess properly the potential hazard to man from NDE]A since the carcinogenicity of NDE1A has been studied only via ingestion and not via absorption through the skin. However, since triethanolamine is a wetting agent and is used industrially to increase the penetration of organic liquids into wood, it does not seem unreasonable to assume that a significant amount of NDE1A applied to the skin may be absorbed. NDE1A is a known liver carcinogen in rats and belongs to a group of compounds which have been demonstrated to be carcinogenic to all species which have been tested." FDA considers the presence of NDELA in cosmetics to be a potentially serious problem. To evaluate the extent of the human health hazard, FDA plans to: -- Perform studies on the absorption of NDELA through human skin. -- Develop metnods for identification and determination of amount of NDELA in cosmetics. FDA has purchased the equipment needed to detect NDELA in cosmetics and has begun to analyze products for NDELA. ESTIMATPS OF COSMETIC-RELATED INJURIES Adequate estimates of cosmetic-related injuries are not available. While the product or ingredient causing acute toxic effects, such as allergic reactions, accidental poisonings, and eye irritations, can often be identified, the cause of chronic toxic effects, such as cancer or birth defects, 1/T.Y. Fan, U. Goff, L. Song, D. H. Fine, G. P. Arsenault, and K. Biemann, "N-Nitrosodiethanolamine in Cosmetics, Lotions, and Shampoos," Food and Cosmetics Toxicology, vol. 15, October 1977, pp. 423-430. 21 ocoenfaslntynitohmteaatceubtsteoexoirfcteoaxcdsiiouclsbymseettfaifindeccec-entrtseia.lfnaidetdeodnsbeeitcnajuuosrfeietshoefgettnhoeexriactlilmeyeffeabccetctsow.uenetn Thufuosrse None of the three studies we reviewed attempted to ebaIenxsltsoeaewnds.tdsitotifhoena,ceuxtteeaecnhtinjosuftruidceyhsr.woansicThieniantdjheurqreuieaetsestfufrdooirmesecsotasirmmeeattidicinsgceuxsptsohesedure. National Commission on Product Safetyestimate ptp1ihonedescraulsyruoCednoIesomndrmtiaoisnsrtksnseuiuiqnnaourJlnieulreanyerser,uoepnmp1tae9osibd7oro0litnceessader,lrreiiptlsoaohokuttasstttsleoynfctotoofiasiosmntnhehj.atetuioirrcyP,sTrrhefeessristeonirvmjidieunecrrcjnteeoutnrsaiaoaulecnbmlstoeeiuprrtvrugiehitppl6coyir0rco,trd0fee0uoeda0rcxct--s, tions, burns, reported that bietacuhtiyng,aidasnd alloanceerartainkonss.econTdheamCoonmgmispsrioodnuctaslso reported in its survey of product liability insurance claims. tflttaoihalroarntgseCt,lrAtoyhenceawscthouonmimmrceoedhnsr.dttna.gtgAaofffrtaouoeninqrruaseea,cncfotcorirtddmpheeeerdnrotbCalbSoleepmmcemsacciuiossawsselimiteohtntAi'hscsecsyoisseidmtsnoeatgtnietinmsocattsittoeonarserwt.aeahuseisrkSbPehiarensehesodnirsoedptaeiecn-d-t NEISS estimate cmtrteohhedmeelimacuet4an8seClitdPtiScymCtoia'rnntseotjeauiuttgNrmsuEdieioIoenduSestesSs.weepSnmortreteaortggertiesanrnmcecdlayuuterdeseidrtnoigomiimannstcjeauhsolroreisneptdsihiatanratjtlurreyaiaebeeatomsreuedtrng1ob9e2ty7n17c,.0tryh0ee0qruHoiomocrwemoiedssnvimgeceiratn,lic- FDA survey In an attempt to qather more reliable ocifnosatm.beeotuit-s-urr3ve5el,ya5,t00edpupbeilrnisjosunhrsei'des,uinseFJDuoAfnescpo1os9nm7se5o,triecdkse.pat data on 3-month survey Participants a diary of cosmetic ceived. cians to injuries dmuTaeshytaeegserehmaivarneneedp,obrereteinsnporwctteohersedeimretaripnecryvoifearewdesevlsdeairtosebndeya.lraeatjceuatdmigomneonftt,hpehyyifsip-etrh-e 22 During the :'urvey period, about 1 of every 60 participants suffered an injury confirmed by a physician as probably or definitely cosmetic related; about 1 of every 450 participants suffered a severe or moderate injury. Because the survey was based on injuries perceived by consumers as being cosmetic related, injuries which consumers could not readily associate with use of a cosmetic product are not included in the estimates. The injury data and criteria used in assessing the severity of the injuries are summarized below. Number and severity of cosmetic-related injuries Severity Number of survey participants Number of confirmed Injuries (note a) Ratio of injuries/ participants Severe (note b) Moderate (note c) Mild (note d) Undetermined 35,490 35,490 35,490 35,490 13 1:2,730 63 1: 563 505 1: 70 8 1:4,436 Total 35,490 589 1: 60 a/Number of injuries confirmed by physicians as probably or definitely cosmetic related. b/Severe injuries were described as those whose symptoms (1) might have been of systemic nature and were painful to the patient, (2) would cause a loss of time from normal activities, (3) were of such a degree of severity that, in the opinion of the survey's consulting physician, the subject would have been well advised to see a physician, and (4) persisted for a prolonged period. c/Moderate injuries were described as those whose symptoms (1) would be considered rather annoying to the patient, (2) could have caused loss of time from normal activities, (3) might have led the patient to see a physician, and (4) persisted for a prolonged period. d/Mild injuries were described as those whose symptoms (1) were of minor irritant type, (2) could cause no loss of time from normal activities, (3) would not require medication or physician evaluation, and (4) were of a fleeting nature. 23 total using Although the survey results cannot be U.S. population because participants projected to the were not selected a probability sample, the sociodemographic characteris- tics of the participants total U.S. population. are highly representative of the CONCLUSIONS mianygrepdoCisoeesnmteastiscweshriicoahursemabhyeaizna(gr1d)mcatarouksetetheedcapnuicbnelrit,ch.ebiUrnStiohtmeeddecfSoetncatttasei,sn which toxic or other chronic toxic effects, (2) contain contaminants known cottaroenacltciaovucicsenuegroezscotatninhoecrneo,rulgahyiientrs.kaiinsnimBiaamelbpcssoa,orurtspaeortniteox(npt3oh)saauntddreeptlhieentthoeahltaahztteahisreoednsEaipranostgshre'wedsedlilepbnrytaoss- them be carefully assessed. accuraAtveaillyabrleefleescttimtahteesextoefntcostmoewthiicc-hrelcaotnesdumeirnsjurairees do not exposed to of toxic cosmetic products and ingredients. chronic toxic effects may not occur until BFecause symptoms months or years after acute exposure. injury estimates generally account for only toxic effects. Estimates of acute cosmetic-related injuries injuries are probably understated in that they include resulting from accidental ingestion, injuries only treated in hospital emergency rooms, or injuries perceived by consumers. Th3 following chapters discuss other hazards posed by cosmetics and -he effectiveness of Federal efforts to insure cosmetic safety. 24 CHAPTER 3 NEED TO STRENGTHEN COSMETICS REGULATION Before May 1972 FDA did not have a formal program to regulate cosmetics but took regulatory action on a case-bycase basis. Since then FDA has established several regulations Cisigned to improve its control over cosmetic safety. Because FDA lacks adequate legislative authority for requlating cosmetics, compliance with many provisions of the regulations is voluntary, thus minimizing FDA's effectiveness. Under existing legislative authority, however, FDA could: -- Require that labels of cosmetics containing fragrance or flavoring ingredients frequently associated with allergic reactions specifically list those ingredients. -- Provide guidance to manufacturers as to what constitutes adequate substantiation of safety. -- Establish product and ingredient standards identifying when a product or an ingredient can safely be used. -- Require childproof packaging on highly toxic cosmetics. However, because FDA cannot require manufacturers to provide FDA access to data on the safety of their products, FDA must develop data to demonstrate that (1) a product contains a harmful substance and (2) the substance renders the product dangerous to consumers under cltstno:ary conditions. of use before it can issue a regulation o control use of the substance in cosmetics. By providing FDA additional authority to regulate cosmetics, the Congress could place the burden oc proof for safely where it belongs--on manufacturers. FDA'S PROGRAM Since May 1972 FDA has established regulations which provide for: -- Voluntary registration of cosmetic manufacturers. -- Voluntary filing of product ingredient and raw material composition statements. -- Voluntary filing of cosmetic product experiences. 25 -- Ingredient labeling of some cosmetics subject to the Fair Packaging and Labeling Act. -- Restricting the use of certain cosmetic ingredients. -- Precautionary labeling of certain cosmetics. Although FDA also established a regulation term tion "hypoallergenic" and describing the type of needed to support the claim that a cosmetic allergenic, the regulation was revoked effective 1978, pursuant to a court order. defining the substantia- i3 hypoMarch 14, Voluntary registration and submission of data FDA is not authorized manufacturers or filing of adverse reactions (product to require registration of cosmetic data on cosmetic ingredients and experience reports). Therefore, sqrFeuuDmbeAomsvitreteedlitfehruisonsmdeorndtahtemtaah.menaurfvkaAoecglttueunnrtcaeaydrruysolftpfetirrocaoitgvaeroldalsmusonrtcaoensrmssiiiesldnbyetrriaraneldgtehidesttoedcraoitsdamaeenntdtriiec-ftsyo. and opAptSifrniesroopsodntpOoguerccrcmotiaoItdobfamnubetceriemtftroxaohnpren1e1u9ir97fpcnfi72aoeag3eclstrnltmietceuthdietretiioieoefcrnnpwrssteare1.-dso9p-g7oa-1rnrFfwdtauDTasmhrAts.ethrhweateawofirsiCmmropbaseeslettmxxgeeeppimrtaanepiinnnhacddtaal,eeesdddevc-Totoitol-onmoiuvplnooMetliisatannuiyrrccntyylltiuua1odd9rarnee7nye2dg.tsfurhitleFelaagrittiaIneosgfngmrtrieyralnaintn-csge; and Although developed the voluntary program was first proposed by in coordination with CTFA, manufacturers' participation has been limited. As of December 31, 1977, --896 (about 40 percent) of the approximately 2,200 manufacturers identified by FDA had registered; -- 768 of the estimated 4,000 to 5,000 manufacturers, packers, and distributors had filed ingredient statements; and -- 130 of the 4,000 to 5,000 manufacturers, packers, and distributors had filed product experience reports. The percentage of cosmetic statements have been filed could the total number being marketed products for which not be determined is unknown. CTFA ingredient because estimates 26 that FDA has formulation data on about 80 percent of the products. FDA believes, however, that the percentage is much lower, possibly as low as 40 to 50 percent. In addition, FDA does not know how many of the products for which it has ingredient data are still being marketed. For example, one hair dye manufacturer reported formulation data on 26 products to FDA in Anril 1973, but did not notify FDA when production of the products waL stopped in December 1973. Thus FDA was unaware until December 1977 that the products were no longer being produced. Ingredient labeling On October 17, 1973, FDA published in the Federal Register regulations requiring that cosmetic product labels subject to FPLA -- list product ingredients in descending order of predominance, -- indicate the presence of flavoring or fragrance ingredients, -- identify the presence of trade secret ingredients through use of the term "and other ingredients," and -- list active drug ingredients first if the cosmetic is also a drug. All cosmetics sold to consumers for home use are subject to these regulations. However, cosmetics sold to beauty salons for application in the salon are exempt, as are free samples. Implementation of the regulations, however, was delayed until April 1977 because of industry objections. Manufacturers claimed that ingredient labeling could prove cumbersome and could release trade secrets. The issue was not resolved until the U.S. Court of Appeals in Washington, D.C., ruled in April 1977 that FDP could legally enforce the regulations. All cosmetics subject to FPLA labele:d after April 1977 must comply. Hypoallergenic cosmetics On June 6, 1975, FDA published in the Federal Register regulations defining the term "hypoallergenic" and describing the type of substantiation a manufacturer must submit to FDA to support the claim. Under the regulation the term 27 "hypoallergenic" can be used on a cosmetic label only if it has been shown by scientific studies that the frequency of adverse reactions in humans is significantly less than the frequency of such reactions from each "reference" product. The "reference" product must consist of one or more similar products on the market which represent at least 10 percent of the industry's combined volume in that cosmetic category. However, implementation of the hypoallergenic cosmetics regulations was also delayed by a court challenge. A dis.rict court decided in favor of FDA, and the regulations became effective September 3, 1976. 1/ However, in December 1977 the U.S. Court of Appeals ruled in the case of Almay v. Califano, 569 F. 2d 674 (D.C. Cir. 1977), that FDA's action In establishing a definition of "hypoallergenic" was arbitrary and capricious and directed the district court to declare the regulation invalid. As a result, effective March 14, 1978, FDA repealed its rule requiring manufacturers to substantiate hypoallergenic label claims. Ingredient restrictions Before 1972 FDA had issued specific regulations governing the use of only two noncoloring ingredients in cosmetics. Since then regulations governing nine other ingredients have beer, issued. The regulations are summarized on the following page. 1/Manufacturers of hypoallergenic cosmetics in commercial distribution as of June 6, 1975, were given until June 6, 1977, to substantiate the hypoallergenic claim. 28 Date of regu l a t ion Ingredient Purpose of regulation 7/16/58 2/14/68 Egg Bithionol Standard for egg content in "egg shampoo." Banned as a cosmetic ingredient effective 3/16/68. 9/27/72 1/5/73 Hexachlorophene Mercury Banned as a cosmetic ingrediept effective 9/27/7;', except as a preservative at a level of less than 0.1 percent if no other preservative is effective. Banned as a cosmetic ingredient effective 1/5/73, except as a preservative for eye area cosmetics at a level of less than 65 parts per million where no safe and effective substitute is available. 8/26/74 10/30/75 Vinyl chloride Tribromsalan Dibromsalan Metabromsalan TCSA (note a) Banned as an ingredient in cosmetic aerosols effective 9/25/74. Banned as a cosmetic ingredient after 12/1/75. 6/29/76 Chloroform Banned as a cosmetic ingredient effective 7/29/76. 8/16/77 Zirconium Banned for use in ae .-cosmetics effective 9/15/77. a/3,3',4,5'-tetrachlorosalicylanilide. 29 Warning statements In March 1975 FDA established a regulation requiring that the label of a cosmetic product hear a warning statement whenever necessary or appropriate to prevent a health hazard. Since then FDA has established regulations requiring specific warnings to be placed on the labels of certain products. FDA regulations now require that warnings appear on the labels of feminine deodorant sprays, aerosols containing chlorofluorocarbon propellants, and cosmetics in selfpressurized containers. FDA has also proposed that ,earnings be placed on the labels of bubble baths but as of April 1978 had not issued a final regulation. In addition, labeling of cosmetic products for which safety has not been adequately substantiated for either the finished product or any ingredient in it must bear the statement: "Warning--The safety of this product has not been determined." LABELS SHOULD IDENTIFY CERTAIN FRAGRANCE AND FLAVORING INGREDIENTS One of the claimed benefits of ingredient labeling is that it enables persons with known allergies co specific ingredients to avoid purchase of cosmetic products containing them. However, FDA regulations reauire that the presence of fragrances or flavorings in a cosmetic be declared on the labeling, but do not require the identification of individual fragrance or flavoring ingredients because of the large number of such ingredients that may be present in any one product. Many fragrance and flavoring ingredients, such as oil of cinnamon, oil of jasmine, and Peruvian balsam, are among the cosmetic ingredients most likely to cause allergic reactions. In June 1975 testimony before the Subcommittee on Health, Senate Committee on Labor and Public Welfare, three members of the American Academy of Dermatology said that they believe that perfume allergy represents a significant proportion of adverse reactions. Hypoallergenic cosmetics are intended to exclude ingredients to which a significant number of persons are known to be allergic. The list of ingredients excluded from one hypoallergenic cosmetic manufacturer's products included 43 ingredients which, according to a February 1978 FDA printout of data reported to the agency by manufacturers under the voluntary program, were being used in other manufacturers' products. Of the 43 ingredients, 12 were reported by the manufacturers to be fragrances or flavorings. 30 sosc"stkukianohnpiellmeopnnleywltenhirbiyAiegunntnpcdetuogocnmroaosbtebtclr.eoehdcdl"raiaieteFsnarnDoiglgAftoFleisnrtentoaAsrionlegcosaneneFlsnfrDcrsisriAetoota,ohpsigeuombzrsrpeusaatlottlotnsyiiimicnscmeoetdtaonoenfomudymifabanrnstygoeuoetsruaftnhetcheabsdteetciiirhtttieoshauiinnnatrzrgtstehrarsatirteovtth'idnoeuaeosilstyneyei.bnbldnecteiglasesiciuntFnmostDiineoAaintcsrmceoiepssaldsdlaeumeiinsdcerdcudseoteafaidmidtfttmtcaieiohis-dvnan.etliys ntoeedtheBnmeoctacuabsen(neoltiisntdieiddveindotnuiaflylabpferrloasdg,urcatcnsocencsouanmntedrasifnliwanivgtohritnhkgenmo.winngarleldeiregnitess NEED TO DEFINE ADEQUATE SUBSTANTIATION OF SAFETY ohsittfeathensaastCntt.ontesdoiAlmtaaletAbtfticoehsiorclopcnoiuesrngscdghaoiTifffeneiFogctsDfchyaAanflptoeholbrtlayeoyosatd"grhduyeece,ftafsBiostrunwtareahbteredalhnaiaiustswcnahhogfeoashefdtmatevtytecFoaioocoonntrdfshoesattpg'tiarutolbucdeDaeoutfitescefrinmtseeoeccnatttod"ir,oearcrqde,aueqtnhaquetuiDeariiltivnayenigggsreiensodcun-yb- "* * * can stantiated distributor be considered to be if the manufacturer, has accumulated all adequately subpacker, or the appropriate toxicological to him at the and other test data available present state of science and otatroescshucusnureosarltnsoocgmeyau,rntdyheaartnudsett.hhw"eehicc1cho/onsdpmiretotivioicndseisohfinmoptrweiistnchjruirtbiheoedus wocfmsMefoouaarrnsrfemdtcemuuhtalcdynUdatiun1etsfd9otetae7fpedrrc5hritaambpuCriturromnphtoemaereedrpcoduslodaw.cilubhtaocoaisntgvtnciedeciottaorcdelaPestdrafteensooidt,rgneriiracttnimmhihgfieoarntnmGeae,iudnciimyadeot,hlahnroetnewai.cesrrevtteehurasdMnA,naiaecfenecesudoe6taera7yldcdo,hinpbnetegrnmoFfceaDoewnAstrnuouetofpirapnFdtcDoshiAtrpred'eutey-srctentoirhtoens 1/H. J. Eiermann, "Safe and' Truly and Cosmetic Industry, vol. 115, Labeled Cosmetics," November 1974, c. Druq 3-. 31 Even when tests are performed, they are not always appropriate to establish the safety of the cosmetic. For example, when a major bubble bath manufacturer reformulated its product in April 1973 in an attempt to reduce the frequency of injury complaints, it completed a "guinea pig immersion test" and a human use test to support the safety of the new formulation. However, an FDA official stated that on the basis of a cursory evaluation of the tests, he had concluded that they were not indicative of actual use conditions and could not be extrapolated to a large use population. FDA maintained that the guinea pig immersion test had not included a nonirritating reference product and that the human use study had not had enough participants to be of statistical significance. Although FDA determined that the tests by the manufacturer were not appropriate to support the safety of its product, FDA has not issued regulations establishing testing protocols and criteria for substantiating the safety of bubble baths. Nor has FDA required manufacturers to place the statement "Warning--the safety of this product has not been determined" on bubble bath labels. FDA, however, proposed in the Federal Register of January 28, 1977 (42 F.R. 5368-5370), that the following statement appear on labels of bubble baths? "Caution--Use only as directed. Excessive use or prolonged exposure may cause irritation to skin and urinary tract. Discontinue use if rash, redness or itching occur. Consult your physician if irritation persists. Keep out of reach of children." Furthermore, unless FDA establishes by regulation that a specific test is appropriate for evaluating the safety of a cosmetic, it may have difficulty in using the test for enforcement purposes. For example, FDA attempted to prosecute a shampoo manufacturer for marketing an adulterated product, but could not show that the test used by the agency to evaluate the safety of the shampoo was appropriate. After a young girl suffered an eye injury from a shampoo concentrate that accidentally squirted in her eye, FDA performed eye irritancy tests on the product using the "Draize rabbit eye test" developed by an agency employee. FDA found that the shampoo was an eye irritant under the Draize rabbit eye test and attempted to prosecute the 32 thamriunuenarymsneauJurnolfatstanhscuietaanrournfdrypeasrrh1t(ta9e2m7sf)4ptobosrteohctaaohmtonueansrecrtkhaoteebhuFtberDiitAnstmghaa1hrmae/akdpyneoertosuaf.ladecwiuaadl2lsnet/deibarnenatytofeeadmxvsoothrrropeawrpoodofthulhacaazttttah.eredd(om1utaH)snootuwhfeteavhacenr-, why In FDA a February 6, 1974, memorandum analyzing the lost the case, FDA's then Chief Counsel said reasons that: "In the future, we must ascertain that the product in question is potentially more dangerous than other competing products against which we are taking no action, and that there is some rational basis for concluding that the potential injury involved is limited to this type of product and is not appplicable to other cosmetics unless we also take concurrent action against those other products. We must, in short, have a clear and consistent policy which singles out truly dangerous products and distinguishes them from other products against which no action is warranted. *w" * - In the future, we must clearly have sound evidence, and a consistent medical and scientific rationale, for charging potential injury to health. (It would be far preferable, of course, to specify by regulation standards that will classify a product as unacceptable, but this approach is not an absolute necessity.)" 1/United States of America v. An article consisting of ap2rox. in part: 95 cases of 12 bottles each, more (bottle) "beacon Castile Shampoo or less, labeled with Lanolin, 16 Fl. oz. (1pt.)Distributed by Topco Associates, SkokLe, Ill. No. 71-53 (N.D. Ohio). Inc., 2/The court also ruled that FDA had failed to show that Dcaoss(uaonhuhs1tudetae)armrtpd'tt(osrohh2nooece)a,pespytetfeeehyhtu,deeahl.teluhntiodhnctsweehjhoIereuannvrmbceypoetutrotnshh,oteteewlrreearsbui.teqesnweucujoiaauunrlulrooTttsdyfheeeodrsnriuFohnestcDatsieAunmrurtpsolooodttlrouoioddcsnimittedgahnmderaiyrnsgfooiahrutsmtloscemyeorweng'aovdeufssfiitslhdetueisetinohhyoonceenfutetsoordwtohothticeefhnhwuneeamstuehhesneye-e. tation. 33 The Director of FDA's Division of Cosmetics Technology told us that FDA might have won the case if the agency had established regulations governing the use of eye irritants in cosmetics. As of April 1978, however, FDA had not formally adopted the Draize rabbit eye test or any other eye irritancy test as the appropriate test to be used in testing shampoos or other cosmetic products. The Consumer Product Safety Commission has issued a regulation establishing a modified Draize rabbit eye test as the appropriate eye irritancy test for determining the safety of products regulated under the Federal Hazardous Substances Act (15 U.S.C. 1261). The agency regularly uses the test in its enforcement program. Although FDA cannot require that cosmetic manufacturers test their products for safety, by establishing a soecific definition of adequate substantiation, including protocols for conducting tests and criteria for evaluating the results, FDA could provide guidance to manufacturers in determining what tests to perform. FDA could also establish a comprehensive market surveillance and enforcement program in which samples of products are tested using the protocols. Knowledge that FDA may test their products and take enforcement action against products not meeting safety criteria should provide an incentive to manufacturers to perform safety tests before marketing cosmetics. However, FDA told us that it needs authority to require the submission of test results before it can effectively enforce any safety substantiation requirements. NEED TO ESTABLISH INGREDIENT AND PRODUCT CLASS STANDARDS According to the Deputy Director of FDA's Division of Cosmetics Technology, FDA has found: "As a general rule * * * the most effective means to increase consumer safety with regard to a specific category of products is to Promulgate an appropriate regulation. The regulation may prohibit or limit the use of an individual ingredient or require the use of a specific warning statement on the label. For example, the frequency of complaints of eye irritation associated with the consumer use of shampoos may warrant a regulation calling for a reduction in the concentration 34 of certain ingredients in these products as well as label warning statements." 1/ However, except for the regulations discussed on pages 28 and 29, FDA has not set safety standards for cosmetic ingredients or Products. As discussed in chapter 2, about 22 percent of the ingredients listed in the 1977 edition of the CTFA Cosmetic Ingredient Dictionary as available for use in cosmetics are considered toxic substances by the National Institute for Occupational Safety and Health because of their acute toxicity or because they may cause toxic effects, such as cancer, birth defects, or central nervous system disorders. Finished cosmetic products may be hazardous if they contain unsafe levels of toxic ingredients or if the label does not contain adequate directions for use and precautionary statements. In addition, combinations of toxic substances, each at a level below which it could be considered "toxic," may be toxic. Ingredient and product class standards might be established to: -- Limit the concentration of an ingredient that can be used in cosmetics. -- Restrict the use of an ingredient to certain types of products, such as those used externally. -- Provide for special labeling requirements, including directions for use and precautionary labeling. By analyzing cosmetic samples for compliance with such standards, FDA could better insure the safety of cosmetics. The following examples illustrate the need for ingredient and product class standards. Example 1 CPSC has established regulations requiring that specific warnings be placed on the labels of products containing certain toxic ingredients. FDA's August 1977 printout of data submitted to the agency by cosmetic manufacturers under the voluntary program showed the use of six of the ingredients 1/J. A. Wenninger, "Cosmetic Legislation: Technical Consideration," Journal of the American Medical Women's Association, vol. 29, no. 7, July 1974, p. 320. 35 in cosmetics at concentrations exceeding the level requiring special labeling in other products. The CPSC regulations, however, do not apply to cosmetic products, and FDA has not established regulations requiring precautionary labeling on cosmetics containing the ingredients. The following table shows the required warnings for the six ingredients when used in products subject to CPSC regulation and their use in cosmetics. !omparjsonOf Warninqs Reouired on Labels of Products a yultheyePdS and on Cosmetic Products by DA Inlqre <H-o;usrolAd-od ucsts Concentration re3ulring Requir-,d .ent Wwarnings label Cosmetic uses (note a) Cosmetic products Maximum concentTration reported by manufacturer_ note a) Required waning! Ammonia 5A "Poison" Hair bleaches 5% to 10% None Ammonium hydroxide 5% "PoSqon" Permanent waves 10% to 25% None Mineral suirrtisO1 "pDanner" "Harmful or faral if swallowed " "If swallowed do not Induce vomitinq. Call phvsician Immedite lv." Eyeliner, mascara Over 50% None Toluene 10% "Danqgr" Nail polish and "Harmful or fatal If enamel, other swallowed." manicuring "If swallowed do not Induce vomiting. pieparations Call thysicIrA immediately." "Vapor Harmful." Over 50% None Xylene Turpentine 10I "Danqer" Manicurinq 'Harmful or fatal if preparations swallowed." "If swallowed do not induce vomiting. Call physician immediately." "Vapor Harltul." 10i "Danger" "Har,tful or fatal If swallowed." Ir% to 25% None Over 50% None a/Reported to FDA by cosmetLI manufacturers undel the voluntary oroqram for filina of cosmetic oroduct Ingredient statements as of Auqust 1q77. Example_2 Results of studies at Emory University have shown the presence of potentially harmful bacteria in about 50 percent of the used eye makeup tested. (See p. 18.) One researcher has recommended to FDA on several occasions that expiration dates be required on the labels of eye cosmetics because the preservative systems used to prevent the growth of bacteria in the products break down during use. 36 According to the Director of FDA's Division of Cosmetics Technology, cosmetics which become contaminated during use and injure consumers are adulterated and violate the Federal Food, Drug, and Cosmetic Act. Despite the findings of the university studies and the researcher's recommendations, FDA has not established a product class standard for eye cosmetics. Such a standard might: -- Establish safe levels, if any, of bacterial contamination. -- Establish protocols for testing the effectiveness of the preservative system. -- Require inclusion of statements on the labels of eye cosmetics to warn users (1) about the potential for bacterial contamination and (2) to discontinue use if the eye becomes irritated. -- Require inclusion of expiration dates on product labels. Examole 3 A December 1974 Bureau of Foods safety evaluation of a mouthwash concentrate revealed that the Product contained formaldehyde, a powerful germicide that may injure oral tissues. The Bureau of Foods reviewer concluded that: "Reputable scientific opinion that continued use of formaldehyde in mouthwash formulations at any dilution cannot be recommended may have no legal status in connection with this mouthwash concentrate which contains formaldehyde. We would concur in the ooinion that formaldehyde use'be discouraged in a mouthwash which might be ingested." Because FDA has not issued an ingredient standard limiting the use of formaldehyde to externally applied cosmetics, it can still be used in cosmetics which may be ingested. According to FDA's February 1978 printout of data reoorted to FDA under the voluntary program for filing of cosmetic product ingredient statements, manufacturers reported the use of formaldehyde in three mouthwashes. Because of limited participation in the voluntary program, the actual number of mouthwashes containing formaldehyde could not be determined. 37 In following up on an injury complaint, the Bureau of Foods' Division of Cosmetics Technology obtained the opinion of er official from the Bureau's Division of Toxicology concerninq tie safety of the use of mineral oil in a hairspray at a concentration of 16.7 percent. It was the opinion of the Division of Toxicology official that mineral oil should not be used in a hairspray even though available data did not show that mineral oil in a hairspray is a hazard. He said that he had recently informed the Bureau's Division of Regulatory Guidance that regulatory action against a hairspray containing 30 percent mineral oil could not be supported because there were insufficient data to show it was a hazard. However, regulations (16 C.F.R. 1500.14(b)(3)(ii)) established by CPSC under the Federal Hazardous Substances Act require that labels of products (excluding cosmetics) containing 10 percent or more by weight of mineral oil bear the warnings "Danger," "Harmful or fatal if swallowed," and "If swallowed, do not induce vomiting. Call physician immediately." The regulation states that mineral oil "may be aspirated into the lungs, with resulting chemical pneumonitis, pneumonia, and pulmonary edema.' By establishing a similar ingredient standard for cosmetics, FDA could require that appropriate warnings be included on the labels of hairsprays or other cosmetics containing more than 10 percent mineral oil and taKe regulatory action againsc manufacturers not complying with the standard. NEED FOR CHILOPROOF PACKAGING The Poison Prevention Packaging Act (PPPA) of 1970 (15 U.S.C. 1471 et seq.) authorizes CPSC to require special packaging on household substances, including cosmetics, when necessary to protect children fror. serious personal injury or illness resulting from handling, using, or ingesting them. FDA is responsible under the FD&C Act for insuring that cosmetics are marketed in compliance with regulations issued by CPSC under PPPA. Section 60.(f) of the FD&C Act states that a cosmetic shall be deemed misbranded if its packaging or labeling violates a regulation issued under PPPA. Neither CPSC nor FDA, however, has taken effective action to insure that cosmetics are marketed in compliance with CPSC packaging requirements or assessed the need for additional packaging requirements for toxic cosmetics not presently covered by regulations. 38 pasapcikraigCniPnSgCandhisasfruereqnsuititaruberldeisphfoeolrdisrcheeegrsut,laaitnainodknisnfdorsdepsorcfordipubrciotndsguctwcsho.enntasiusncoihencgiaasl macrouistfeetergtltuteealhidaianesnttiCctoooTinstFnshmAtgrehreteaCeeiopdcsapismogle.feeyntntiscttc,yhoFeDAusiI'niunnsdncggeghrrrAreeueddagdiistueiehsneneettnttstvhs1oyD-9llli7-euic7tnsntutetireaopdprnrgeylianynritctnypioornluotae.tgsh,reoaafpm1vSo9aet7divsa7alehstanosabweiledouedifsmuthittfb-ohohanret hydroxide, and sodium hydroxide--had been reoorted by manufacturers to be used in some cosmetic products at concentrations requiring special packaging. that Although CPSC manufacturers regulations (16 C.F.R. 1700.14(b)) require of substances requiring special packaging submit to CPSC a sample of each type of special oackaqing used, the Director of CPSC's Division of Poison Prevention Packaging told us special packaging btyhatthehecwoassmetuincaswariendoufstrayn.y submissions of He sail that CPSC has not taken any actions concerning childproof oackaging for cosmetics. Nor has FDA taken any actions concerning childproof packaging for cosmetics. For example, CPSC regulations require that household products, including cosmetics, con- taining more than 2 sodium or potassium percent free hydroxide be or chemically unneutralized marketed in CPSC-approved childproof packaging. alkali content between that 19 contained more hydroxide and thus were FDA analyzed 22 hair straighteners for June 1970 and October 1975 and found than 2 percent sodium or potassium subject to the CPSC packaging requla- tions. Although none of CPSC-approved childproof the 19 products were marketed in packaging and thus were misbranded under the Cosmetics FD&C Act, the Deputy Director of Technology said he was not aware PDA's Division of of any regulatory action against the manufacturers of the oroducts, Nor has FDA requested that CPSC establish additional special packaging requirements for other toxic cosmetic ingredients. Some toxic ingredients are used in cosmetics at concentrations high enough from ingestion. For example, to cause serious poisoning sodium and potassium bromates oafifnrroemy1.ou5us1ne0gdtotocih3ni2lg5pdreraprmeemsnracnee((nna1ttb-.o1u/wt2avSeet1oristoo3oulsy2uetpaitrooesinasssoponloidion)nngscfofuhnolacl)selnotbowfreieanntgaioLi2nen-sngpoeersrrttcaeiendongnting solution of potassium or sodium bromate. 39 Similarly toluene and xylene are used in manicuring preparations at concentrations of 10 'ercent to over 50 Dercent. Ingestion of these substances, when present in a product at concentrations exceeding 10 percent, may be harmful or fatal. During 1973, 1,670 accidental ingestions involving manicurinq preparations were reported to poison control centers. Over 90 percent of the ingestions involved children under 5 year of age, 30 of whom required hospitalization. The Director of CPSC's Division of Poison Prevention Packaging told us that FDA has never made any recommendations to CPSC concerning special packaging for cosmetics containing sodium or potassium bromate, toluene, xylene, or any other toxic ingredient. COSMETIC INGREDIENT REVIEW In September 1975 CTFA established the Cosmetic Ingredient Review (CIR), a panel of scientists to review the safety of all cosmetic ingredients presently used in commercially distributed cosmetic products. Priority lists of ingredients to be reviewed are developed on the basis of such factors as (1) the frequency of use of the ingredient in cosmetics, (2) the availability of chemical specifications or descriptions, (3) any known questions about the ingredient's safety, and (4) the availability of sufficient data for the panel to make an informed scientific judgment on safety. Public comment is invited during preparation of the priority lists. After an ingredient is selected for review, a literature search is performed in which a bibliography of the U.S. and foreign toxicoloqical or other scientific literature, together with a description of each literature reference and a summary of the information found, is prepared. Interested parties are given 90 days to submit additional data, information, and views relevant to the safety of the ingredient. The oanel then reviews the available data to determine whether the ingredient is safe or unsafe or whether additional data are needed before a decision can be made with regard to safety. The preliminary findings of the panel are made available for public comment. The panel, after reviewing the comments received, makes a final determination with respect to the ingredient's safety and publishes the results in a final report. 40 pAiprnrigiorlreidIit1ney9n7Ot8clsti.oshbtaedronfo1t91879c7omtiphnlegertepedadineelnittssestfraoebrvliierswehveiodefw,aintysbuotffirassttheof In an April 1977 article 1/ evaluating different approaches to cosmetic safety substantiation, a Georgetown University Law Center professor and students evaluated the CIR program. one of his According third-vear to the authors: -- No standards are set for determining the final priority list of ingredients to be reviewed. -- Consumer and FDA input into selection of ingredients to be reviewed would be more effective at the initial stage of priority planning. -- Manufacturers are not required to notify the CIR program of possible safety problems with cosmetic ingredients, thus the program may be unaware of the need to review certain products. -- Composition of the steering committee, 2/ which appoints members of the expert panel, does not furnish an impartial method of selecting panel members. -- Effectiveness of nonvoting liaison members of the expert panel questionable meetings of product are representing consumers and FDA is highly because they are excluded from closed the panel, where confidential data on a submitted by a manufacturer or discussed by the panel. procedures no (Since publication of longer exclude liaison the article, members from CIR closed meetings. However, the FDA representative, who serves as a liaison member, contact person rather than as a does not attend closed meetings.) 1/J. A. Page and Administrative, Cosmetic Safety K. A. Blackburn, Legislative, and Substantiation," "Behind the Looking Glass: Private Approaches to UCLA Law Review, vol. 24, April 1977, pp. 795-837. 2/Composed of the CTFA President, a dermatologist represent- ing the American Academy of Dermatology, a toxicologist representing the Society CTFA Scientific Advisory President for Science. of Toxicology, Committee, and the the Chairman of CTFA Vice the 41 -- The standard a consumer's used to measure safety is viewpoint in that the CIR deficient from program defines a cosmetic ingredient as safe when there is "no evidence in the available information that demons- trates or suggests reasonable grounds to suspect a hlsaauczfkafridocfie*nitn*f*too.r'majtuis(otTnihfeyabdoeauftdientiaentrimoiinnngaartelidsoionenstotfatshesasalfletthyna.ot"t)"Abe The authors conclude that: "The regulatory impact of the CIR Drogram will be and should be minimal. While the CTFA's program could be used to generate safety substantiation data through the pooling of scientific resources, CIR cannot become a substitute for badly-needed FDA intervention in the area of cosmetic safety. An evaluation of the CIR plan must include recognition of the lack of success thus far enjoyed by other voluntary programs sponsored by the industry. Skepticism about CIR is fortified by industry's lack of cooperation with the FDA's OTC Drug Review of ingredients found in both nonprescription drugs and cosmetics." According to the need for new ability to detect FDA, the CIR program will neither "alter statutory authority" nor affect "FDA's safety problems and to monitor industry substantiation of data." Although of CTFA, fewer facturers are many large cosmetic manufacturers are members than 225 of the 2,200 known cosmetic manu- members. The extent to which nonmembers will participate in and adhere to the decisions made program is questionable. Nor will CTFA members the monographs developed under the CIR program. in be the CIR bound by PENDING LEGISLATION sFtDahAfeetFayDL&ceClogefiasArclctaotsmimatoenontdiasctwtsear.sefnogirtnThhteercnoodbniutFlcrDleAo,d'lsliSinnepgnraottgcheroeasmmb9ei5tltflihocrsC2,o3a6ns5gms,rauekrsiwisnongugltdmotahengadimave-end tory the provisions of FDA's current voluntary programs. Senate bill 2365 would: -- Require registration of cosmetic manufacturers. -- Require them to submit formulas for cosmetic products to FDA. 42 -- Require them to periodically forward consumer complaints about adverse reactions to cosmetics to FDA. -- Give FDA specific authority to prohibit use of certain ingredients in cosmetics, require additional labeling, limit the amounts of certain ingredients that may be used in cosmetics, or ban a cosmetic if necessary to protect the public health. -- Require manufacturers to submit safety test data to FDA upon request. -- Authorize FDA to require specific testing when necessary to assure safe cosmetics. -- Require registration of new cosmetics unlike types previously marketed. -- Provide clear authority for FDA to require ingredient, cautionary, and information labeling of cosmetics under the FD&C Act. -- Provide a procedure for informal notice-and-comment rulemaking subject to direct review in a U.S. court of appeals. CONCLUSIONS Because FDA lacks adequate legislative authority, the success of its rE ulatory program depends largely on the cooperation of the cosmetics industry. However, many manufacturers have not participated in FDA's voluntary programs for registration of manufacturers and filing of product ingredient and experience reports. FDA is also hindered by the failure of many manufacturers to adequately substantiate the safety of.their products and FDA's lack of authority to require manufacturers to provide FDA access to their safety data. Although FDA has made a significant effort to improve its control over cosmetics since 1972, it could take additional steps under existing authority. FDA could (1) require that certain fragrances and flavorings be listed on product labels, (2) establish testing criteria to guide industry in substantiating the safety of its products, (3) establish ingredient and product class standards, and (4) insure that toxic cosmetics are packaged in childproof packages. 43 However, efforts to establish ingredient and product class standards and testing criteria would be hindered by FDA's lack of access to manufacturers' test data and complaint files. By providing FDA additional legislative authority, the Congress could place the burden of proof for cosmetic safety where it rightfully belongs, on the manufacturers. RECOMMENDATIONS TO THE SECRETARY, HEW We recommend that the Secretary direct the FDA Commissioner to strengthen FDA's program for insuring the safety of cosmetic products. Specifically, FDA should: -- Require the listing of fragrances and flavorings on cosmetic labels when they are known allergens. -- Hasten the development of ingredient and product class standards. -- Establish a specific definition of "adequate substantiation of safety," including specific testing criteria. -- Take steps, in coordination with CPSC, to insure that toxic cosmetics are packaqed in childproof containers. AGENCY COMMENTS AND OUR EVALUATION HEW commented (see app. VI) that although it agrees in principle with many of our recommendations, it does not necessarily agree that they can be implemented under the present statute. HEW pointed out that the FDA Commissioner had stated in testimony before the Subcommittee on Oversight and Investigations, House Interstate and Foreign Commerce Committee, that 'As the law stands, cosmetics are the only products for which the legal burden rests on the Fool and Drug Administration (FDA) to orove a hazard to the oublic, rather than on the industry to demonstrate that their product has been tested in accordance with currently accepted methodology and that it is safe." HEW said that it does not believe that, under the current statutory authority, an extensive expenditure of resources toward regulation of cosmetics is a wiqe investment. The Commissioner also testified tliat 44 "* * * it you have important public health responsibilities in three different areas, and if each of them lays compelling claims to statutory authority, and in the other two it is at least better, then a wise man is going to allocate [resources] more heavily to where he is going to get a return." HEW comments on specific recommendations and our evaluation of them are presented in the appropriate chapters of the report. Listing of fragrance and Rlavoring ingredients on labels HEW said that there is a lack of adequate scientific information to classify a fragrance or flavor ingredient as a known allergen. HEW explained that any ingredient can give rise to allergic contact dermatitis in some susceptible individuals. According to HEW, the question that remains to be answered iv the frequency of such reactions which would permit an unaml)iguous classification of the ingredient as a known allergen. The matter, HEW said, is further complicated by the fact that the rate of allergic responses is related to the exposure concentration and that some alle. -ns can be safely used in some products and not others. According to HEW, if a substance produces allergic reactions to a significant extent, FDA may take regulatory action to restrict its use as a cosmetic ingredient, as it has done in the case of bithionol and haloger-'ted salicylanilides. (See p. 29.) Moreover, HEW said that the listing of all ingredients in a fragrance or flavor would in many instances require declaration of over 100 chemical names on a product label and may raise trade secret issue_. Although it may not now be possible to classify all fragrance and flavoring ingredients as either allergens or nonallergens, we believe there are adequate data to classify certain ingredients as allergens. For example, a project manager in the Division of Cosmetics Technology's Registration and Product Experience Branch told us that some ingredients, "such as formaldehyde or orris root are commonly known to be allergens." Also FDA officials told us that oil of cinnamon, oil of jasmine, and Peruvian balsam are among the cosmetic ingredients most likely to cause allergic reactions. 45 There are also several published lists of common cosmetic allergens. For example, the Ar-Ex Products Company prepared a list of "Common Cosmetic Irritants and Allergens." The list identifies the substance, the tv-Ts of cosmetics it is used in, and the symptoms observed in persons allergic to it. Similar, but less extensive, lists were published by the American Medical Association's Committee on Cutaneous Health and Cosmetics and byAlmay, Incorporated. We believe that requiring identification of the limited number of fragrance and flavoring ingredients that are known allergens on product labels would enable consumers sensitive to those ingredients to avoid products containing them without requiring the listing of all fragrance and flavoring ingredients. Development of ingredient and product class standards HEW said that before FDA could issue regulations establishing standards, it must show that a cosmetic violating the standards may be injurious under the conditions of use or otherwise in conflict with the existing law. HEW said that FDA is -ot authorized to require industry to submit the data necessary for developing ingredient and product class standards and does not now have resources available to collect the data in-house. Although FDA's ability to establish product and incredient standards is hindered by the lack of adequate statutory authority, we believe establishing such standards is fundamental to developing a more effective cosmetics program. Once established, product and ingredient standards should enable FDA to more effectively use available resources to better ensure cosmetic safety. Therefore, the initial commitment of resources to establish such standards would appear to be cost effective, especially where substantial data are already available. For example, available data indicate that mineral oil and formaldehyde should not be used in hairsprays and mouthwashes, respectively. (See pp. 37 and 38.) Definition of adequate substantia-t'ion of safety According to HEW, FDA has already clarified the meaning of "adequate substantiation of safety" in relation to cosmetics by publishing in the Federal Register of March 3, 1975 (40 F.R. 8916), a notice: 46 "* * * that the safety of a product can be adequately substantiated through (a) reliance on already available toxicological test data on individual ingredients and on product formulations that are similar in composition to particular cosmetics, and (b) performance of any additional toxicological and other tests that are appropriate in the light of such existing data and information. Although satisfactory toxicological data may exist for each ingredient of a cosmetic, it will still be necessary to conduct some toxicological testing with the complete formulation to assure adequately the safety of the finished cosmetic," HEW also said that FDA is not authorized to (1) require that cosmetic manufacturers substantiate the safety of their products, (2) establish specific testing criteria, or (3) require the submission of data to support development of such criteria at this time. Although the notice tells manufacturers how they can substantiate the safety of their products (i.e., through new or existing toxicological test data), it does not offer them guidance in determining what tests, if any, should be performed. For example, the manufacturer of a cosmetic likely to come in contact with the eyes, such as shampoo, determines (1) whether eye irritancy tests are needed to substantiate the safety of its product and (2) the appropriateness of the tests. By establishing specific testing criteria for cosmetics, FDA could provide guidance to the cosmetics industry in determining (1) what tests to perform and (2) what tests are considered appropriate by FDA. Although FDA cannot require manufacturers to test their products according to the criteria, the criteria would serve as the basis for FDA's enforcement testing of cosmetics. As a result, manufacturers might test their products for compliance with the criteria before they were marketed. Moreover, testing criteria would seem especially important in view of the position taken by FDA's Chief Counsel. in February 1974 that before FDA can charge that a cosmetic may cause injury, FDA must have sound evidence and a consistent medical and scientific rationale for the charge. He stated that it would be preferable for FDA to establish standards by regulation that would classify a product unacceptable. (See p. 33.) 47 Childproof containers HEW agreed that requiring childproof packaging would be worthwhile for those cosmetics revealed to be the cause of poison ingestions leading to injury. HEW said that at present FDA is not aware of any hazard associated with cosmetic products that warrants such packaging but that FDA will continue to evaluate data from CPSC's National Electronic Injury Surveillance System and take appropriate action as the need arises. As our report points out, some cosmetics contain toxic ingredients, such as sodium and potassium bromates, toluene, and xylene, which have caused serious poisoning in young children who accidentaly ingested them. (See pp. 39 and 40.) On the basis of such information, FDA should consider the need for childproof packaging of cosmetics containing these ingredients. Also, in its continuing evaluation of the need for childproof packaging, FDA should consider data from poison control centers, as well as the NEISS program, since reports to poison control centers involve primarily accidental ingestions by children under 5 years old. RECOMMENDATIONS TO THE CONGRESS We recommend that the Congress amend the FD&C Act to give FDA adequate authority for regulating cosmetic products. Specifically, we recommend that the Congress authorize FDA to require: -- Registration of all cosmetic manufacturers. -- Registration of cosmetic products and filing of ingredient statements. -- Manufacturers to submit to FDA data to support the safety of their products and the ingredients in them. -- Premarket approval by FDA of certain classes of cosmetics or ingredients when the agency deems such approval necessary to protect the public health. -- Manufacturers to submit to FDA consumer complaints about adverse reactions to cosmetics. -- Manufacturers to perform specific testing FDA deems necessary to support the safety of a cosmetic or an ingredient. 48 CHAPTER 4 NEED TO MORE EFFECTIVELY OBTAIN AND USE DATA ON COSMETIC SAFETY Because FDA manufacturers to products and the lacks authority to require cosmetic submit data ingredients concerning the safety of in them, the agency must their sys- teiclically obtain information from other sources. concerning cosmetic safety FDA, however, has only limited data on the cosmetic ingredients and has not actively sought and use additional data. Specifically, FDA has safety of to obtain not: -- Obtained safety studies available from published literature. -- Analyzed restrictions on use of cosmetic ingredients in other countries. -- Established an effective adverse-reaction-reporting system to obtain and analyze data on cosmeticrelated injuries. atmEnaavkreeknanedtvw.heeerfnsfeecdtaritevaaectqiauocentsitoihnoavneitnogbereetnhmeovoebstaaftiheenteydp,roofdFuDacAtphraofsdruocmntotthceaaulswianygs LIMITED SAFETY DATA mcdtiuaonostsxtamiiecttooTh.inloacovIgen1ey0fi6aAfnpdegfrericiiglentluedgisairvteee1end9lfti7oyse5rdnaettws1vsaeaa/.lfoauernnatedtyveitedhfwaeotetuhdnaetdoostxnhatiehfcee1i4yttB8yyudrieoordaffaunndatoohotmefcloycsFiomonnesogttedrailseice'dn,citeensFdtaDsfAety Although FDA cannot supporting the safety of require manufacturers their products or the to submit data ingredients l/Although the 1973 the ingredients were randomly selected from CTFA Cosmetic Ingredient Dictionary before issuance of the 1977 the later edition. edition, they are also listed in 49 in them, it could obtain gredients from published data on the literature. toxicity of many inAs noted on page 9, mtifahneetgrireoenNndcIieOesSonHntfsort.rheegeiasrTctheherpyorritenaenggddirsetdotritoyehxneirtcconpeltiufasbfitleneicsdst.hsesdopfOefcsioafbutiohrcuectesl106i60ct0oenritcanaotgisurnmreeedtiiierncneft-osr- for are which no safety data were available listed in the NIOSH registry, along in FDA files, 28 with literature citations. In provide addition, additional several available computer data references on the toxicity of bases can cosmetic ingredients. For example, we obtained several printouts of literature mercury. citations on the toxicity of formaldehyde and According to officials in the Bureau of Foods' Division of Toxicology, the safety data in their files is generally limited to data accumulated in response to specific inquiries. INGREDIENTS BANNED IN OTHER COUNTRIES USED IN U.S. COSMETICS Many European countries have established "negative" otlifhinesstcresoessmotiferntigicirctnesigdorinseesodnlitdesonntaisrnuesetthhaeaovtfaUinlcciaeotbrseltmdeaeitniSftcoarsitnemugssar.eyedinweoiFnttDthAs,oi.unthcolwuAredevenseutrmro,briecrtlhiaiossontfs not requested data on the basis for the actions taken in other countries. Restrictions in the European Economic Community of The European countries for Economic economic Community (EEC), 1/ cooperation, proposed an association that its mbpqmttearuhreyoeiimedrbusueemns.cmrouetetdlsntcT,tibhioseepnu.mlnaictpuxcorsriisieoTmmdtehpueesyotmsiiednaocdifdcsrocoepndonctaiscsttrmeuiieenbavocttjentiredaicacilvsttdreiiedoclatntoanl,iwdnivsosrteate(nses2dtxoi)rinn(isdsi1ctipcn)tcieogiacnisrotignmeneagedslrtiiweienhdcnalyistsmaesebnmettttbloohwseeihrnitrgycwephhdceiuorscceumh-ena-yof l/The nine full members are: the United West Germany, Italy, Belgium, Denmark, lands, and Luxembourg. Kingdom, Ireland, France, the Nether- 50 ingredients were to be banned or restricted. The lists have been approved by several countries. According to an August 1977 printout of data submitted to FDA under the voluntary program for filing of cosmetic product ingredient statements, manufacturers had reported the use of eight ingredients which would be banned for use in cosmetics by the proposed EEC directive. 1/ Use of the eight ingredients was reported by manufacturers at concentrations ranging from 1 to 50 percent. Four other ingredients-2-naphthol, 2,5-dinitrophenol, stramonium, and vitamin D--which would be banned by the directive were listed in the 1977 CTFA dictionary as available for use in cosmetics in the United States. No manufacturers had reported the use of the four ingredients to FDA. FDA has not established restrictions or special labeling requirements for any of the 12 ingredients which would be banned by the directive, or requested data from EEC on the reason for banning use of the ingredients. Another 19 ingredients to be subject to restrictions under the proposed directive are listed in the 1977 edition of the CTFA dictionary as available for use in cosmetics or were reported by manufacturers as being used. Although the directive would establish maximum allowable concentrations for each of the 19 ingredients, FDA has not established similar restrictions for 16 of the 19 ingredients. Appendix IV compares the restrictions which would be placed on the use of toxic ingredients in cosmetics by the proposed EEC directive and the restrictions on those ingredients in the United States. FDA's August 1977 printout of data submitted to FDA by manufacturers under the voluntary program indicates that some of the ingredients are used in cosmetics in the United States at concentrations in excess of the maximum concentrations established by the proposed directive. For example, the directive would limit the use of lead acetate, a coloring agent used to gradually cover gray hair, to concentrations of up to 1.75 percent. Use of lead acetate was reported to FDA to be between 10 and 25 percent in one hair dye. 1/The eight ingredients are antimony potassium tartrate, barium sulfide, brucine, cantharides (Spanish Fly), iodine, phenol, tricresyl phosphate, and tetrachloroethylene. 51 Other restrictioin Individual countries have banned or restricted use of certain additional ingredients in cosmetics which can be used without restriction in the United States. For example: -- France requires that hair dressings containing thioglycolic acid be sold only by a qualified pharmacist. Thioglycolic acid is used without restriction in home permanents in the United States. -- Holland banned the use of p-phenylenediamine and quaternary ammonium compounds in cosmetics and restricts the amount of thioglycolic acid that can be used in home permanents. P-phenylenediamine is widely used in permanent coal tar hair dyes in the United States. Also at least 49 quaternary ammonium compounds are listed in the 1977 CTFA dictionary as available for use in cosmetics in the United States. Such use has not been restricted by FDA. -- Switzerland has banned the use of certain substances, including mercury, lead, and p-phenylenediamine, in cosmetics. Use of all three is permitted in the United States. we could not readily identify the basis for the restrictions placed by other countries. NEED TO ESIABLISH AN ADVERSE-REACTION-REPORTING SYSTEM FDA does not receive reports of most adverse reactions to cosmetics and does not adequately follow up on those it does receive. Systematic reporting of adverse reactions could alert FDA to severe reactions and identify reaction trends that may be associated with certain cosmetics, Because cosmetics are not subject to premarket clearance, adverse reaction reports may offer the first indication that a cosmetic produ-t or ingredient is hazardous. Limited report>ng FDA obtains data on cosmetic-related injuries from two major sources, the public and manufacturers. However, neither group reports more than a small fraction of injuries to 'DA. 52 Although CPSC's NEISS program for reporting productrelated injuries treated in hospital emergency rooms estimated that nearly 22,000 cosmetic-related injuries were treated in emergency rooms during calendar year 1977, FDA received reports from the public on only about 430 cosmetic-related injuries. Most reports came from consumers, either directly or through referral from the Federal Trade Commission, CPSC, or the President's Office of Consumer Affairs. In a sample of about 100 consumer complaints reported to FDA since late 1969, 55 percent of the consumers indicated that they had sought medical treatment. However, few reports of cosmeticrelated injuries were sent to FDA b% the medical community. Although the voluntary program for filing product experience reports by cosmetic manufacturers was established by FDA in October 1973, only about 3 percent of the manufacturers were participating as of December 31, 1977. Other sources of injury data FDA needs a system to obtain data on cosmetic-related injuries from other sources, such as the medical community, insurance companies, and lawyers who have filed claims on behalf of injured consumers. Such sources could be especially important because they would normally become involved in only the more serious or disabling injuries. According to FDA, some information from the medical community is available to FDA under contract arrangements. FDA currently has several dermatologists and an ophthalmologist under contract. The medical commu 'ty, including skin specialists and eye doctors, could offer valuable assistance to FDA by reporting unusual or serious injuries which the consumer might not associate with cosmetic usage. This iq true especially with respect to chronic injuries where it is difficult to identify the cause of the injury. Insurance companies should be encouraged to provide data to FDA on cosmetic-related injury claims, which, according to the National Commission on Product Safety's 1970 report, ranked second among products reported in the Commission's survey of product liability claims. In helping FDA identify and remove hazardous cosmetics from the market, the insurance companies would also be reducing the number of insurance claims resulting from use of auch products. Although FDA receives many letters of inquiry from lawyers suing cosmetic manufacturers because of alleged 53 cosmetic-related injuries suffered by their not attempt to obtain data on the nature of clients, FDA the injuries does or the outcome of the lawsuits. Because of the documentation necessary in preparing for such lawsuits and the serious nature of the in evaluating alleged injuries, such data could the hazards of the products. be useful Inadequate followup cploamipnltaTsiontdrsee,tceerwiemviendseelbyetchteFeDdAadeasiqnurcaaecnydo1m9o7f0s.aFmDpAl'Weshilofefollathobewouutpcomo1p0nl0aciocnonamsn-utmer was generally interviewed by FDA collected for chemical analysis, followuo. FDA did not always and a sample was there was little sometimes additional -- contact injuries the had manufacturer to been reported determine and whether whether similar adequate data existed to support the cosmetic's safety, -- contact the complainant's physician to verify that the injury was cosmetic related, --refer complaints involvinq cosmetics that are also subject to drug regulations to the Bureau of Druqs for followup, or -- utilize data to remove hazardous cosmetics trom the market. The following examples illustrate the lack of adequate followup. Example 1 A trial attorney with no history of mental disorder claimed that an aerosol depressive effect on. her antiperspirant 1 to 3 hours caused a after use. marked She stated that on some days she found herself thinking about suicide. FDA performed a chemical interviewed Che complainant. analysis of the The Division or product and Cosmetics Technology'. Medical Directcr concluded tnat: "Because of the unusual nature of this complaint I am inclined to consider it legitimate. Anal;sis might be helpful, but if such an effect is real, it is probably due to the propellant." 54 Because the product is an antiperspirant, it is subject to both the cosmetic and druq provisions of the FD&C Act. However, the Division did not seek access to the manufacturer's records or refer the complaint to the bureau of Drugs for further followup. Example 2 Our random sample of about 100 complaints included complaints from 3 individuals of excessive loss of hair following the use of the same brand of shampoo. FDA had received 35 complaints of hair loss following use of the product. The Division of Cosmetics Technology interviewed some of the complainants and performed a chemical analysis of the product, but made no attempt to contact the manufacturer to discuss the complaints or review its complaint and/or safety files. The Division concluded tnat no additional followup was needed, but that it would be on the lookout for other complaints about the shampoo. Example 3 The Division of Cosmetics Technology's complaint files contain numerous complaints involving lead-based hair dyes, including a 1971 complaint in which lead was discovered in the blood of the complainant during a routine physical examination. Another complainant claimed that the hair dye had caused a low blood count. A third claimed that use of a lead acetate hair dye had contributed to the death of her husband. FDA did not contact the complainants' physicians in these cases. Available evidence indicates that lead may be absorbed through the sKin. Adequate studies have not been performed, however, to determine the rate of absorption and possible buildup of lead in the body. Example 4 In reviewing a consumer complaint involving an aerosol cosmetic finish (a type of facial makeup), the Division of Cosmetics Technoloqy's Assistant Director for Medical Review noted that: "There is a serious question of the safety of these preparations. We believe their marketing should be discontinued until such time as all doubts are removed by appropriate testing." 55 To support his conclusion, he cited the following. -- The product cannot be used without directing the spray into the eyes, nose, and mouth. --In spite of closing the eyes, some of the product might be propelled into the eyes, where it would be expected to cause irritation. -- Inhalation of Freon, the propellant in the product, may cause cardiac irregularity and sudden death. -- Ingestion of one of the ingredients could increase myocardial irritability and increase the likelihood of cardiac arrhythmia from any toxic agent. -- Certain ingredients are toxic to the liver. FDA files we reviewed, however, contained no indication that the concerns of the Assistant Director had been expressed to the manufacturer or that any action had been taken to remove the product from the market. CONCLUSIONS FDA has not systematically obtained information concerning the safety of cosmetic products. Its regulation of cosmetics could be improved if the agency (1) obtained and evaluated data on the safety of cosmetics and ingredients from published literature, (2) evaluated the basis for restrictions on the use of toxic ingredients in cosmetics in other countries, and (3) established an effective adversereaction-reporting system. RECOMMENDATIONS TO THE SECRETARY, HEW We recommend that the Secretary direct the FDA Commissioner to: -- Obtain and evaluate data from published literature on the safety of cosmetic products and ingredients. -- Obtain and evaluate the basis for restrictions on the use of certain ingredients in cosmetics in other countries and, where appropriate, adopt similar restrictions on their use in cosmetics used in the United States. 56 -- Establis|h a system to (1) develop additional sources of information on cosmetic-related injuries and (2) ensure effective followup on consumer complaints. AGENCY COMMENTS AND OUR EVALUATION HEW concurred with our recommendations and explained now FDA was complying with them. Evaluate published literature HEW said FDA scientists continuously review new scientific information both from published literature and other sources. But officials in the the Bureau of Foods' Division of Toxicology advised us that the safety data in their files are generally limited to data accumulated in response to specific inquiries. Furthermore, we identified published studies for 28 ingredients for which no safety data were available in FDA files. Therefore, we believe FDA should expand its review of scientific literature. Evaluate ingredient restrictions in other countries HEW said that (1) it would be appropriate to evaluate the basis for the restrictions or the use of ingredients by other countries when the conditions of use of such ingredients in cosmetics marketed in the United States warrant such action and (2) FDA is already familiar with the restrictions imposed by many countries and continues to review the basis for new restrictions as the need arises. HEW said that because under current statutes use of cosmetic ingredients in the United States can be prohibited or restricted only if proven to be harmful to users under conditions of use, FDA cannot take action on the basis of foreian restrictions alone. Although HEW said that FDA is familiar with the restrictions on the use of cosmetic ingredients in many countries, BFA could not give us data on the basis for the restrictions discussed on pages 50 to 52. FDA should obtain such data to enable it to determine Lhe need for establishing similar restrictions. Adverse-reaction-reportinq system HEW said that monitoring adverse reactions to cosmetic products is an important activity that has resulted in the removal of unsafe cosmetics from the market. According to 57 HEW, FDA is using and has used a substantial portion nf its cosmetics resources for this type of activity, including (1) a program for evaluating adverse reactions reported directly to FDA, (2) monitoring reactions at selected hospital emergency rooms under the NEISS program, (3) evaluating voluntarily submitted product experience reports from the co metics industry, (4) conducting a comprehensive consumer survey, and (5) contracting with dermatolgistb to evaluate and report adverse reactions from patients. Further improvement in this area, HEW said, would require a change in the statute enabling FDA to require mandatory reporting by industry. We agree that FDA needs additional legislative authority to enable it to require manufacturers to report adverse reactions. However, a more effective system could and should be established under existing authority by using other sources of adverse reaction reports, such as the medical community, insurance companies, and lawyers. HEW also said that effective followup on consumer adverse reaction complaints is conducted when facts available to FDA indicate a possibility that a significant health hazard is involved and that such followup could lead to FDA action to improve the safety of a specific product or cosmetics in ganeral. FDA's ability to follow up in every instance is limited, according to HEW, by the lack of resources, cooperation of the complainant or the physician, lack of reliable information to relate the product to the alleged injury, and lack of authority to review complaint files of cosmetic firms and the safety data used to substantiate the safety of the product. HEW said that when consumer or physician information indicates serious injury, complaints are currently investigated to the fullest extent possible. However, our review indicated that FDA did not always adequately attempt to follow up on reports of serious cosmeticrelated injuries. For example, FDA often failed to contact the complainant's physician or the manufacturer to obtain further information about the alleged injury and any similar injuries reported to the manufacturer. Because the success of FDA's followup depends on the cooperation of physicians and manufacturers, FDA should make a greater effort to contact them. 58 CHAP'TER 5 INALEQUATE REGULATION OF DRUG INGREDIENTS, COLOR ADDITIVES, AND PRESERVATIVES IN COSMETICS The use of drug ingredients, color additives, and preservatives in cosmetics is not being effectively regulated. --About 90 drugs available for use i,. cosmetics are not subject to the restrictions on drugs. -- About 25 color additives have been provisionally approved for use in cosmetics since 1960 although their safety has not been determined. -- Preservatives are used to prevent the growth of bacteria and other microorganisms in cosmetics, although their safety and effectiveness has not been determined. NEED FOR STRICTER REGULATION OF DRUG INGREDIENTS Drug ingredients are subject to cosmetic rather than drug regulation as long as the product is not "intended" or understood to have a drug effect. r'DA, however, lacks adequate legislative authority to inisure the safety of drug ingredients used in cosmetics. Furthermore, because the intended effect of a product is not always clearly stated on the product's label, there is often no clear distinction between drug and cosmetic products. Although FDA has adequate authority under the cosmetic provisions of the FD&C Act to require inclusion of warning labels on cosmetic products containing drug ingredients, consistent with label warnings required on drug products, it has not always reauired such warnings. Drug or cosmetic? Under the 'D&C Act (21 U.S.C. 321 (q)(1)), the term "drug" means: -- Articles recognized in the official United States Pharmacopeia, official liomeopathic Pharmacopeia of the United States, or official National Formulary. 59 -- Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. -- Articles (other than food) intended to affect the structure or any function of the body. -- Articles intended for use as a component of any of the above articles. Although articles recognized in the Pharmacopeia or National Formulary are defined as druqs, products containing them are classified and regulated as drugs only if they meet one of the other criteria listed above. Before 1976 FDA judged the intended effect of a product primarily on the basis of labeling claims. For example, if a product was marketed as an antiperspirant deodorant, FDA considered it an OTC (over-the-counter) drug because its label indicated that it was intended to affect a normal body function, i.e., perspiration. However, if the product was marketed as a deodorant claiming only to mask or cover up odor, FDA considered it a cosmetic even if it contained the same drug ingredient and would have the same effect on body function as the antiperspirant. The following table lists examples of drug claims and similar or related cosmetic claims. Drug claim Cosmetic claim Antiperspirant deodorant Removes wrinkles Prevents sunburn Prevents splitting nails Antiseptic mouthwash Deodorant Softens wrinkles Promotes tanning Hardens nails Prevents bad breath According to an article by an FDA attorney in the Marcn 1977 issue of the Food Druq Cosmetic Law Journal, 1/ FDA reevaluated the distinction between drugs and cosmetics in 1976 and determined treat a product whose labeling contains only cosmetic claims, but which contains a drug intended or understood to have a drug effect, can be ~la.ssified as a drug product. FDA ruled that a product la-eled solely 1/M. Gilnooley, "Update," rood Drug Cosmetic Law Journal, vol. 22, biarcn 1977, pp. 121-128. 60 as a suntan lotion (a cosmetic claim) is a drug if it contains an effective sunscreen because it that sunscreens prevent sunburn. drug/cosmetic determinations may is intended According to be made on a and understood the article, case-by-case basis of the because each particular determination product and the is based on intention the attributes in marketing it. dertaifitefchneetcprstrFoDdAwwi.uhehciacatcnonhsuldudesbacerydlecaliras"iinrsiniungfitcyneegnsrduttenahrdteieangnoudrltipaysrtptuoieindsonduncecstrotsifstoionpdorcedobon"dentutticwatfteioyseni.ninhngagvdedrFrsuourugagnsdeacrxniruadneqmgeprcnleose-s,me- drugs on a case-by-case stating that all suntan basis, FDA could issue a regulation products containing effective sun- screens are drugs. containing effective labeling claims made Similarly FDA could declare products antiperspirants drugs regardless of for them. Drug ingredients available for use in cosmetics pevreonducWtthheonuigshansuthbiejnetcpetrnoddetudoctdcroucsgomnetteaificfnescrtaathiesdrrungot.thaniddernutgifireedg,ulatthieon, mAociFIrfinreponioennpsdlrpgtemucimor(anecnoure2tedtgsltAd)iiimaebiocxerdovelonstyuofni.imttsbIciItypfwsterreD9idooAlrmi0nmdiameacgusnontdi,tcdntuirenstghfoiuetantgtrhhhcasettieeehhltrsniereiukyglreirArivneuddesa(,errgrdsti1uusiuen)gseogdtparntsealuvtininiaindsdlcnin1,eteisogl9derstrr7atdt7arebhtedtodlteidrediehFgiumeeehPnPgentAafhntorvotatsrerfohpirsuelnrmndaufuiiacvenesannc1tasctsegto9iitatr7opoilr7rbeueinoayeodtinsnbiiyaC.slneTcop,egnlfFoortiArsosvdurfmgiosaeerNCrnetmwtaoaglaohimstvicmuiecssetofiehtinonrsiapscliuae-. wcdatiihiopspreesetpannmceltteariicteeoAudidnlsicstnets,dhodoorntuhuldocieggyetanhsphueesopcnrerroasdaonsosldddmdmlrueeryuctuotg.tnighocfusseafi,nfaTntdfhcmhgeeteirecogtestrhhdapissetibeneicgnlweirpstihxauersettcldo,hnyelidneyutncouastesfsuisetcfdohttihhnauewearsgihseneridesEcmdaeuihomiaxsputeeetenndecittardtsscnrii,uaominfgslisllueaaycretaxhrhefbtefsaepeorcaapcrndosiltbamnniselicgedlnerdy-ne-- through product and has the skin. %here as a drug if the no drug effect. is no need to regulate a cosmetic drug ingredient is not absorbed However, FDA lacks legislative 61 authority to require cosmetic manufacturers to prove that the drug ingredients used in their cosmetics do not cause drug effects on users. Drug versus cosmetic regulation The FD&C Act provides for far stricter regulation of drug products than for cosmetic products. The act requires a drug manufacturer to: -- Register its manufacturing establishments and products with FDA. -- File new drug applications with FDA and obtain FDA's approval of them before introducing new drugs into interstate commerce. Such applications must prove the drugs' safety and effectiveness. -- Report adverse reaction information to FDA on drugs for which it holds new drug applications. -- Conduct clinical tests to demonstrate the safety of the drugs before they are marketed. By contrast, the act does not require that cosmetic manufacturers register either themselves or their products, obtain FDA approval to market new cosmetics or cosmetics containing new ingredients, test their products or product ingredients for safety and effectiveness, or report adverse reaction information to FDA. When a drug is used in a drug product, the manufacturer has the burden of proof of the product's safety. When a drug is used in a cosmetic product, FDA has the burden to prove the product is not safe. Regulation of drug ingredients in cosmetics in other countries Some countries have stricter regulations governing use of drug ingredients in cosmetics. For example: -- Norway's drug regulations contain lists of substances which are meant for medical purposes and may be used in cosmetics in free sale only with the permission of the Government. For example, the active drugs used in deodorants, antiperspirants, dandruff shampooq; and medicated skin creams cannot be used in cosmetics without permission. 62 -- Austria is authorized to enforce restrictions on use of drugs in cosmetics, including restrictions on the maximum concentration of drugs allowed in the products and the purity of the drugs. The Government can authorize the use of active drug ingredients in cosmetics under certain conditions. -.-Swiss law has established an extensive list of active drug ingredients that may be used in cosmetics. Maximum for the Permitted concentrations druas in three different are established groups of cosmetic products: (1) products likely to come in contact with mucous membranes, such as toothpastes and mouth washes, (2) products for external application which will remain on the skin, such as face creams and hair lotions, and (3) products for which will normally be washed external application or rinsed off directly after application, such as shampoos. Swiss law also sets out in detail the specific advertising claims permitted in connection with the sale of cosmetic products without any risk of their being considered drugs. Warning labels not required FDA requires inclusion of adequate warnings on the labels of OTC drug products. left to the manufacturer, FDA While the actual wording has established suggested ings for labels of UTC drug products containing certain is warndrugs. Although many of the drugs are also used in co;wmetics through the same routes of administration, FDA has riot required similar warnings for cosmetic labels. In some cases the cosmetic use of the drug directly conflicts with the OTC drug label warning. For example, the drug products containing boric acid must warn label of U'rC against its use as a dusting powder, but data submitted to the agency FDA's August 1977 printout of by manufacturers shows that the reported cosmetic uses of boric acid include its use in dusting powders. The suggested following for O'C table identifies some of the drug labels and the cosmetic warnings uses of those drug ingredients identified in printout that require no warnings. FDA's August 1977 63 -0-, I I U V @Wr w > w-.- u *U0:) 0L ) -wI) o 0 V0 UI1 . .0 o @ 0) '0:1CC(V 0)Js 17 U10 C-(U 3 O..0 Oo. ._.n' 0) ' U5 v 0. CC u0 v u 0.o >- , @~ C Caa ' UW a, : VO w C -i C_ :(OV o V' C I 0, C - *E@S-300 0 -1 oL o.C 0) CL ' cO-'u. .'. 0 0 ec0' )0'- v.) U) '0 ) CJXC . ,.U0)00 @Ue -' Cv3 CD )U.. > (0 IO)-c (uf -1(0O C0-- fo0. . ' ca,. ese ') . V . U C0n U'0 .' U c 'o.o X V.c 0) 0 () C W 0@" u 'a C) OC U_ '0 X . I vE . C, 'U > @0 .( (40 IrWn . 0 - 'C 0 0O a . O' U CC X On0) a, dr : -v' 6,- 4V 01~~~ v 'a @0 l' a) x Olw:C . tr 0 a M 0 CO,_, O n @D-I*Ctol _- '0 @o CJ DE C0 : _ O, - O.C0-_'L00.u>- . c' .c-.. I c t 3o 0 MI04CU>V - cIc u o . 3cc0 V XiU'. z a Dr 0 vo0 w C0 0 @>O- I> VI E E r C @ >OO0 v,,,CU 0, _ C ^ W- V 0) c 3CL a o' O E r 3 OM Z OU a v Oz recl 3111 3 1C fC ra -rM~ce Pc 3W ~ 2 .C O O0 4v0 O C0) E 3) 00) *0 *W cj u C 00 U0 X.0 X 00 Ws @ 0 @t1 t 0 )4 t 0 Q :- cI~ 'J wa 0 .q.- C4O1) 3 -3r03 nC C, >u: X ,,) rvC _ X 3UO > a. x C.ts~~~nU (L I -6 QI CL Uc >U bl n a00U MD I --nO . 00 w 6 3 C2 0x _ .D - r or O;I w,~o iV i_ C ' c O ' Cs O c a REGULATION OF COLOR ADDITIVES Color additives are used in sometimes exceeding 50 percent. cosmetics at concentrations cccFoooDlss&oCmmreettAAiiclaccttdsshd,oiruthegaiqthsvhueeisnrtoeshteatfhFeaDb1ttAe9ye6n0taoorfeeCsoetlmssaoatabrnfaleybilAsicdfhsodoerlhidot.riruvseeeagsIdundliniaAsttmoiiefmvonoeenodssdm,ecnalutsdsiesressudtgitsnFoi,gDnAtahend permitted continued use of for over 15 years without their safety. color. dditives in submission of data cosmetics to support FDA submit a regulations petition to specify that FDA proposing any interested that a color person additive may be listed for use in a 1960 amendments, color food, drug, or additives which cosmetic. Under the were commercially ebsianscstiiaetsbnheltiifsfoFrhiDecAd"aribenergvfeueoalsrsateotinigaoaJbntulsileoyntspo1e2,rmniaeoke1ded9"e6d0p,poesfnoswrdeiirbneldgeetpectrrohommevipiinrlsieintougisnoeanltlhoenyoifrlanithssetaiefndetteyr.im octtesl2rhho6uxieelptsoppetorronmcetsordodanAvtleensiorduhfrsfaootsisarfhaw.ocehdntiidbAuaruelisplrAeeetrlepniisyrpvlamiesefeannesxln1dtitou9cyisvef7oa.xetna8svred,cmadetVeidutlT24r0lbhia2yeiecbtsroslycts.eepFosaDrJlAroaopfsvnrteoTiurhfrhseoaeftarirooduoycrsdpnomeeuiralsst3oloe1tiavir,avndibeidslnlsaiiic1idto9sos8cdintshh1oioaima,stnlnedmgiattevlihtblteecheioissufesscssnttsapiuhm.feaondpperssgirettmeoryasvbmoniefoaedfeontninfoetnntlghtyely Some additives used in cosmetics were pro'Tisionally listed for permanent was never listing in of gold in data. lsciuoSovsbeseptmrmtiieenttmgt1ibe5cedosrfyeaantf1droh9rse76F.Dbc1A6oelfooyfHrreoiseawn.reasvlpelerywtI,iinttthieoFoonDruneAmtsinpcaseawturseebemrdm,eiitstgftseohiidleloden,dpthreoosafveiepusskeseiiatonfignettaiylon was In not afinloetdheruntcialse,Febcrauraamreyl,197a6.col1o/r additive FDA will petition permit the 1/A single color additive petition for caramel and other colors was submitted rejected by FDA in January in December 1975, but 1976 because separate tions were required for each color. six was peti- 65 continued use of caramel as a color additive until January 1981, although the February 1976 petition did not contain the studies required to support its safety. The petition lacked data on eye area studies, short-term subchronic studies, and skin-painting studies. According to an FDA official, FDA initial'y told manufacturers of certain color additives that they did not have to file petitions because FDA had adequate data to catermine the safety of the olors, but subsequently required that petitions be submitted when new criteria and methods for determining the safety of additives were developed. NEED FOR CLEAR AUTHORITY TO REGULATE PRESERVATIVES Many cosmetic products, including eye makeup, shampoos, and hand and bocK creams and lotions, provide a good medium for the growth of microorganisms. Preservatives such as mercury and hexachlorophene can be used in some cosmetic products to prevent growth of microorganisms. Because microorganisms can pose a serious threat to vision in a scratched or an abraded eye (see p. 17), it is important that a safe and an effective preservative be used .n cosmetics where microorganisms are likely to flourish. FDA, however, lacks clear authority under the FD&C .ct tc require that manufacturers prove the safety and effectivenes; of preservatives in their products, or even to require th.:t mnanufacturers add preservatives to their products. A'though the Environmental Protection Agency could regilate cosmetic preservatives as esticides under the Federal Insecticide, Pungicide, and Rodenticide Act (FIFRA) of 1947, as amended (7 U.S.C. 135 et set.), EPA has not attempted to do so. Safety and eftecuiveness of preservatives Although they are used in small amounts, some preservatives, such as hexachloroohene and mercury, are absorbed through the sNin and bave been shown to cause toxic effects in animals or humans. Several preservatives, includinc boric acid, denydroacetic acid, captan, and formaldehyde, are suspected of causinq cancer in anin; Ls- Jthers, including captan, hexacnlorophene, EDTA (ethylenediaminetetra3cetic acid), and phen'i mercuric acetaie, nave been found to cause birth defects in animals. Hexachloronhene and boric acid also affect the central nervous system. 66 In addition, some Preservatives such as formaldehyde, propylparaben, and methylparaben, may be skin sensitizers. As stated on page 17, studies at Emory University showed that preservatives used in mascaras often broke down during use of the product and became ineffective. Other mascaras were marketed without preservatives. FDA authority to iegulate Preservatives FDA has the same authority to regulate cosmetic preservatives that it has to regulate other cosmetic ingredients; i.e., FDA can ban use of a preservative it proves is hazardous under conditions of use. FDA, however, cannot require a manufacturer to prove the safety of the preservatives it uses. Nor can FDA require a manufacturer to prove that its preservatives effectively prevent growth of microorganisms in its products and that the preservatives are not broken down by (1) other ingredients in the products or (2) microorganisms introduced into the products during use. In the Federal Register of October 11, 1977 (42 F.R. 54837-54838), FDA announced its intention to propose a regulation regarding preservation of cosmetics coming in contact with the eye. FDA said that the proposal will include not only a requirement for preservation sufficient to protect a cosmetic against likely contamination during manufacture, processing, packing, or holding, but also the requirement that a cosmetic be adequately preserved to withstand contamination under intended or customary conditions of use. The Federal Register notice also states that FDA considers inadequately preserved cosmetics to be in violation of the FD&C Act and that the agency will take whatever action is necessary to remove from the market any cosmetic that poses an unreasonable risk of injury because of inadequate preservation to withstand contamination under custonary conditions of use. EPA authority to regulate preservatives FIFRA defines the term "pesticide" to include substances intended for preventing, destroying, repelling, or mitigating any form of plant or animal life or virus, bacteria, or other microorganism that the EPA Administrator declares to be a pest (except viruses, bacteria, or other microorganisms on or in living man or other living animals). Because preservatives such as mercury, captan, and hexachlorophene are used in 67 cosmetic products to inhibit the growth of the product rather than on the human body, microorganisms in the EPA Adminis- trator pests could declare the microorganisms in cosmetics to and regulate cosmetic preservatives as pesticides. be FIFRA requires that registered ;ith EPA pesticides he sale and effective before they are marketed. and EPA, however, has not attempted preservatives as pesticides. In July to requlate cosmetic 1975 regulations (40 C.F.R. 162.14) declaring viruses ;and other microorganisms pests, the Administrator specifically excluded viruses ind microorqanisms in cosmetics from che declaration. Pccordinq to an other microorganisms EPA official, EPA excluded viruses and in cosmetics because it felt FDA had adequaze the FD&C istrator pesticide authority to regulate cosmetic preservatives under Act. Section 25(b) of FIFRA permits the EPA Adminto exempt from the requirements of the act any which he determines to be adequately regulated qbFuyDlAaatnhiaoodtnhsebreebneFfedogerirevaelntheaayngenowcepyrp.eortfuiTnhnieatlyiozfettdio,cicaoblmutmepnhotaidntoenndottohueotbjEePtcAhtaterde- to the exemption granted to cosmetic preservatives. Another there should EPA official be some kind told us thac while fie believes of precl'arance for all ingredients used in products for human contact, such as cosmetics, he also believes that one agency--FDA--should be requllating all the ingredients in tne products. Furtt _rmo:e, althouqh EPA could require a preservative manifacturer to prove that its preservative could be safely and effectively used to in cosmetics, EPA could prevent the not require grGwth of microorganisms a cosmetic manufacturer to use a preservative in its tiveness of tne oreservacive products as used. or to prove the effec- CONC USIONS The use of active Crug ingredients, co1oL additives, and preservatives in cosmetics is not being effectively regulated. Drugs can be used in a cosmetic without being subject to druq regulation iL the product is not intended oeurssetauobnfldiesdrhrseutdgosodLeingtuolcaohtasivmoeentsia.csdirducegonutliedfffyeibcentg.sdtrrueFgnDgA'tishnegnrceeodndtireionflts(o1vt)ehraFtDAthe are int&nded or understood to have a drug effect when used jr certain types of Froducts, (2) FDA required inclusion of warning labels or cosmetic products containing active 68 drug ingredients consistent with label warnings on similarly ata(ouSdetmehpiornroriivesetctyoemrtmehweedansddsaragtuifigveoetnnyproottfdooucFtithDnesAg,reCtdooainnegdrnreteq(ssu3si)ruesoaenddcdopi.stimnieo4tn8t.iah)cleirlmeagpnirusofldaauctctituvsre.ers The safety and effectiveness of prevent the growth of microorganisms ter be ensured if FDA were authorized preservatives used to in cosmetics could bet- to require manufacturers to submit data to FDA demonstrating the effectiveness of those preservatives. safety (see p. 48) and use used Although FDA has of color additives its authority to adequate authority to regulate the in cosmetics, require color it has not effectively manufacturers or persons submitting color additive petitions to evidence of the safety of their colors. have been available for use for over 15 safety being fully established. provide About years more timely 25 additives without their RECOMMENDATIONS TO THE SECRETARY, HEW We recommend sioner to: that the Secretary direct the FDA Commis- -- Establish regulations identifying are intended or understood to have when drug ingredients a drug effect. -- Establish produ-ts regulations requiring containing drugs bear that labels of cosmetic warnings consistent with same those required ingredients and on drug given products containing the through the same routes of administration. -- hasten the review of the safety of color provisionally listed for use in cosmetics the use in cosmetics of those colors not be safe unde. the conditions of uise. additives and prevent proven to AGFNCY COMMENTS AND OUR EVALUATION R~egulaticn on use of drug ingredients HEW said of whether a case basis. the facts to intended for that FDA would have to approach the problem particular ingredient is a According to HEW, it would drug have on to a case-bylook a ail11 determine if it can prove that the product was use as a drug or a cosmetic. 69 HEW pointed out that the FD&C Act defines the term "cosmetic" to mean "(1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles * * ." while that act 'fines the term "drug" to mean "(B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other arimals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals." HEW said that the distinction between a drug and a cosmetic therefore rests upon the intended use of the article. Contrary to HEW's statemerit that the drug/cosmetic determination must be made on a cas: -by-case basis, FDA has, in fac', made such a determinatio~n on a product class basis in at least one instance. FDA treated all toothpastes containing sodium or stannous flouride as drugs, regardless of whether the labels contained drug claims (21 C.F.R. 310.201(a)(10) and (15)). Similarly FDA has declared one suntan lotion a drug on the basis of the presence of a sunscreen which is understood have a dcug effect, without regard to its labeling claims. This would indicate that FDA could declare all suntan lotion containing the sunscreen drugs. to Warning labels HEW said that iL believes it is appropriate for FDA to examine the need for consistent warnings on drug and cosmetic products but that more study is needed to determine whether specific warnings should be required in each case. HEW also pointed out that under FDA regulations, the label of a cosme-tic is required to bear a warning whenever necessary or appropriate to prevent a health hazard. However, unless FDA establishes regulations identifying when specific warnings are necessary or appropriate, 70 the need for and wording of such warnings is determined by the manufacturer. Thus, before FDA could take regulatory action under its regulations, it must prove the need for a warning on a particular product. As stated by the Deputy Director of FDA's Division of Cosmetics Technology: "As a general rule * * * the most effective means to increase consumer safety with regard to a specific category of products is to promulgate an appropriate re-ulation. The regulation may * * * require the use of a specific warning statement on the label." Review of color additives HEW told us that FDA hds already accelerated the review of color additives provisionally listed for use in cosmetics and that the speed of the review is dictated by agency resources, the availability of data from petitioners, and the time required to make sound scientific judgments in the public interest. HEN also said that FDA is taking action to prohibit the use of colors that pose safety problems. RECOMMENDATION TO THE CONGRESS We recommend that the Congress amend the FD&C Act to authorize FDA to require cosmetic manufacturers to submit data to FDA supporting the effectiveness of preservatives used. 71 CHAPTER 6 NEED TO REPEAL HAIR DYE EXEMPTIONS Although coal tar hair dyes expose consumers to poten- tially serious hazards, FDA lacks adequate legislative authority to effectively regulate them. The FD&C Act requires cosmetics to be properly labeled and to be unadulterated. However, coal tar hair dyes whose labels contain a prescrited statutory warning concerning possible skin irritation and blindness are exempt from the aculteration provisions of the act. Because the labels of most such dyes bear this warning, they are the adulteration generally provisions, exempt even from FDA regulation if they pose hazards, under such as cancer, not covered by the warning. Matters discussed in this chapter were discussed in our December 6, 1977, report to the Chairman, Subcommittee on Oversight and Investigations, House Committee on Interstate and Foreign Commerce, entitled "Cancer and Coal Tar hair Dyes: An Unregulated Hazard to Consumers" (HRD-78-22). BACKGROUND According to a CTFA representative, about 33 million women their use hair dyes to temporarily or hair color. Most dyes marketed permanently change for use by women are known as coal tar hair dyes because initially coal tar was the only commercially practical source of material needed to synthesize the colors used in them. The remainder of the women's hair dye market is divided between metallic dyes, which are advertised to gradually cover gray nair, and the vegetable dye, henna. Although some men use coal tar hair dyes, the most popular dyes marketed for men are metallic dyes. Estimates on the number of men who use hair dyes were not readily available. The Deputy Director of FDA's Division of Cosmetics Technoloqy told us that most coal tar hair dyes contain colors derived from petroleum rather than coal tar. Because a color chemically identical to the petroleum-derived color could be derived from coal tar, FDA classifies petroleumaerived colors as coal tar colors and regulates hair dyes containing them accordingly. Throughout this report we refer to all nair dyes containing petroleum-derived and coaltar-derived colors as coal tar hair dyes. Coal tar hair dyes are divided into three groups-temporary, semipermanent, and permanent--dependinq on the permanence of the color. 72 Temporary and brightness hair, and blend hair dyes to natural unevenly tone bleached hair, add hiqhlights color, improve shades of gray colored hair. The first temporary cattdaCohopyoelpemsolstmirihhemseeariwdilcerairttraeitoplof.ipoibrbptnehotrtredaTor.huidoecnubdtcauBtsdcaeseyeucedgsas:oeguf,deiseannenrtetehor1etas9hdlh2~eeal2hoydpyaleoioa.rdsrcnoiodtnacentnwTuddoaeertirmtnoeapangroieernpanastaerhmctreyoiatamxnelbddstrleyuunyderreosfedtaphtceehoaaernfrrfeeottueostrfgreueahvsxteuteraialllleys. the hair, they are completely removable with one shampooing. dcobttyaohfleuefessnaedhdaadafSinrgteroerehmraiiycufgphoshetrehulrwmaaiomiilga2cr0lhnoa,yterlsntottatoprhtpoerh40laeaieicinmretmapdiitrsonuohdnuvrayitneameelpstsolaatoykhpseelbe.seibnfqlecoouptornilrlTeddaaohctreeehbbyiaaenisidgatrenurh.greoeiwfnhrhogiiwafScnhitehsiare.etpnideppiblseuuiorsthcuemaltadaiew.trnfei,teatonrontooB,rnepbsaloneerdmnaidrptyeheorfmhaacniosreleonvrtedryaedolsfy,eshcaosilderoomrispnaesotrtmodaosnoiebpgntentariimfndaiynceeatsnnhtetlgydehenaseiairrfrfaeeldcdylteyss.hctaohdneetL.aisiktnerucatteumr-e haSnoatgti$aelurxnhre3iwsbeisrerrosdiodmo.headuienuaqenbgoedtPiutlthnieresetaoarn.astnfrmatcedgeahsra1nesie"o/ddoeenvswyninreteltirwphiy,eyhPttenosiehrgcrraemo$,nhmersa4odmaohnfonpmaeposveeeirnrpxcenrretoehidthsednedatxutbmahpotcyhbaitsreeayicioeniraohntrmlnsyco,thdodhnhdtarlyarethymooeieheherpgsraalscoeicyoonnrtdao,liairynponteoelrpdrgunsyoiey.rs.sdrmeao.uoaoslfcxfrseiteTtaSedhqcplucTreeuoryhccflieehaoorvohsuctreritynhodcdodteloyurycooaessfolotrsiflogllmaoyeoeritrwtrnecslhaoseodsarralyrpkobeoehxtoi"drarhiuniioadt-nrtxi-.izdeed POCSIRLE CANCER RI3K TO CONSUMERS There is increasing evidence that some coal tar hair dyes may pose a significant risk of cancer to users because 1/The primary intermediates, such as para-phenylenediamine and para-aminophenol, or another oxidant, a coupler, such as 2 , are oxidized by hydrogen peroxide The resulting products react 4 -diaminoanisole, resorcinol, with meta- aminophenol, and 1, another unoxidized 5 -dihydroxynaphthalene, "para" dye to give the or with desired shade. 73 known or suspected cancer-causing colors in these dyes may be absorbed through the skin and scalp. Specifically: -- Temporary hair dyes may contain coal tar colors shown to cause cancer in laboratory animals and banned by FDA for use in other cosmetic products. -- Temporary and semipermanent hair dyes may contain azo colors 1/ derived from benzidine, a kno:n human carcinogen. Such colors contain ben;:idine as a contaminant, and the colors may break down in the body and release benzidine. -- Other coal tar colors available for use in temporary or semipermanent hair dyes have reportedly caused cancer in laboratory animals. -- Evidence from screening tests or animal studies indicates that several coal tar colors used in permanent hair dyes, including toluene-2,4-diamine and 2,4-diaminoanisole, 2/ may cause cancer. Existinq epidemioloqical studies provide limited and conflicting evidence about the incidence of cancer among coal tar hair dye users. Skin absorption In a study published in 1968 3/ three permanent hair dye ingredients--p-phenylenediamine, m-phenylenediamine, and toluene-2,5-diamine--were applied to the skin of dogs in gels and fluids, such as those used in hair dyes. The amount of dye absorbed through the skin was calculated l/Azo colors contain an "azo" group--two connected nitrogen atoms, each of which is usually linked to a carbon atom. 2/2,4-diaminoanisole is commonly referred to as 4-methoxym-phenylenediamine on hair dye labels. 3/M. Kiese, M. Rachor, and E. Rauscher, "The Absorption of Some Phenylenediamines Through the Skin of Dogs," Toxicology and Applied Pharmacology, vol. 12, 1968, pp. 495-507. 74 from the concentrations found in the blood or the urine. About 1 percent of the p-phenylenediamine applied was absorbed in 3 hours. The amount absorbed increased to about 7 percent if the gel was covered with aluminum foil immediately after application. Absorption decreased to about 0.1 percent if the dye was mixed with hydrogen peroxide before application. About 3 and 4 percent, respectively, were absorbed after applying toluene-2,5-diamine and m-phenylenediamine. A second study 1/ demonstrated the absorption of toluene-2,5-diamine Through human skin. The hair of five persons was dyed with a dye composed of toluene-2,5-diamine, resorcinol, and hydrogen peroxide. About 0.3 percent of the toluene-2,5-diamine was absorbed. In a 1975 study report 2/ University of California researchers noted that many aromatic amines and diamines, such as benzidine, are absorbed through human skin. They estimated that women could absorb as much as 1 percent of the hair dye chemicals applied to the scalp. Although we identified several reports stating that the colors in semipermanent hair dyes are absorbed, we could not find any studies identifying the extent to which they are absorbed. FDA has received several reports of consumers experiencing brown or otherwise discolored urine following use of hair dyes. Banned colors used in hair dyes Coal tar hair dyes are exempt from the color addi'ive provisions of the FD&C Act and, therefore, coal tar color additives banned from use in food, drugs, or other cosmetics may continue to be used in coal tar hair dyes. i/M. Kiese and E. Rauscher, "The Absorption of p-Toluenediamine [toluene-2,5-diamine] Through Human Skin in Hair Dyeing," Toxicology and Applied Pharmacology, vol. 13, 1968, pp. 325-331. 2/B. Ames, H.O. Kammen, and E. Yamasaki, "Hair Dyes Are Mutagenic: Identification of a Variety of Mutagenic Ingredients," Proceedings of the National Academy of Sciences of the United States of America, vol. 72, no. 6., June 1975, pp. 2423-2427. 75 Nine color additives banned for use in cosmetics are listed in the 1977 edition of the CTFA Cosmetic Ingredient Dictionary as "available for use" in coal tar hair dyes. According to FDA officials, such colors would generally be used in temporary hair dyes. We found evidence that four of the nine colors--FD&C Green No. 2, FD&C Red No. 2, FD&C Violet No. 1, and FD&C Red No. 1--cause cancer in laboratory animals. The dictionary refers to these colors as Acid Green 5, Acid Red 27, Acid Violet 49, and HC Red No. 6, respectively. The remaining five colors (and their CTFA references) are: External D&C Red No. 11 (Acid Red 1), External D&C Red No. 13 (Acid Red 73), External D&C Red No. 8 (Acid Red 88), External D&C Yellow No. 3 (Acid Yellow 11), and External D&C Blue No. 1 (Basic Blue 9). We did not identify the toxic effects associated with these colors. According to a November 1977 FDA printout of data submitted by manufacturers under the voluntary program for filing cosmetic product ingredient statements, manufacturers reported the use of FD&C Red No. 2 in three hair dyes, FD&C Red No. 1 in four hair dyes, and External D&C Blue No. 1 in thirteen hair dyes. A December 15, 1977, newspaper article on our report to the Subcommittee on Oversight and Investigations quoted an industry spokesperson as stating that no major hair dye manufacturer was currently using one of the banned colors shown to cause cancer in animals. The manufacturer of the four hair dyes reported to FDA as containing FD&C Red No.1 subsequently confirmed to us the use of the banned color in its products. However, the manufacturer that reported the use of FD&C Red No. 2 in hair dyes told us on December 21, 1977, that the banned color was no longer being used. Because of the limited participation in the voluntary program and failure of participating manufacturers to update their submissions, the total number of products containing the nine colors could not be determined. Benzidine-derived azo colors Among the coal tar colors that may be used in temporary and semipermanent hair dyes are several azo colors derived from benzidine. According to EPA, benzidine-derived azo colors may contain up to 20 parts per million of benzidine. More significant, however, are daa indicating that benzidine-derived azo colors may reconvert to benzidine in the body. 76 Benzidine was identified as a human carcinogen in the 1930s when factory workers exposed to benzidine developed an increased incidence of bladder cancer. Many scientists believe that cancer car result from ingestion, inhalation, or skin absorption of bnzidine. In animal studies benzidine caused liver tumors in ilice, rats, and hamsters and bladder cancer in dogs. In a study report published in July 1975, 1/ two researchers from the New York University MedicaT Center reported on the metabolic reduction of benzidine-derived azo colors in the rhesus monkey. Monkeys were fed by stomach tube a single dose of beneidine or a benzidine-derived azo color dissolved in dimethyl sulfoxide. Four benzidine-derived azo colors were included in the study. Control urine was collected from each monkey before the test was begun. The researchers analyzed urine collected from the monkeys over a 72-hour period and found benzidine and a benzidine metabolite (monoacetyl benzidine) in extracts of urine from both the monkeys fed benzidine and those fed benzidine-derived azo colors. They found that the metabolic reduction of the colors to benzidine was nearly total. The researchers stated that the results of their work support the implication of an earlier study (one made in 1973) that an increased incidence of bladder cancer found in .apanese silk kimono painters had resulted from benzidine metabolically derived from ingested azo colors. The earlier study had demonstrated the reduction of benzidine-derived azo colors to benzidine in the presence of certain bacteria. NIOSH began a study in 1977 to determine the degree of occupational risk to workers in the textile-dyeing and leather-tanning industries exposed to benzidine-derived colors. NIOSH notes that most dyestuffs are of a chemical class which offers the potential for rapid skin and lung absorption but that it is not known if the metabolites resulting from such occupational exposure differ from those reported in the New York University study. 1/E. Rinde and W. Troll, "Metabolic Reduction of Benzidine Azo Dyes to Benzidine in the Rhesus Monkey," Journal of the National Cancer Institute, vol. 55, no. 1, July 1975, pp. 181-182. 77 We could not locate any studies on the extent to which benzidine-derived azo colors are absorbed through the skin. The 1977 edition of the CTFA Cosmetic Ingredient Dictionary lists eight benzidine-derived azo colors (Direct Black 38 and 131, Direct Blue 6, and Direct Brown 1, 1:2,2,31, and 154) as "available for use" in coal tar hair dyes. By letter dated January 5, 1978, the National Cancer Institute's Associate Director for Carcinogentsis Testing Program notified the Chairman, Subcommittee on Oversight and Investigations, House Committee on Interstate and Foreign Commerce, that from inspection of preliminary test data on Direct Black 38 and Direct Blue 6, it appears that the colors are carcinogenic. NCI did not test the other benzidine-derived azo dyes. In an interim report on the animal tests for carcinogenicity of Direct Black 38 and Direct Blue 6, NCI noted that: "* * * Ninety-day tests have been completed by the National Cancer Institute * * *. "In the short-term feeding studies, [the two] dyes produced liver toxicity in both species. Cancerous and precancerous conditions were found in rats, similar to the damage produced by known liver carcinogens. "In addition, though the dyes were benzidine free when fed to the animals, benzidine was found in the urine of dosed rats and mice, an indication t'iat animal systems break down the dyes and release benzidine. "Because the effects were so striking in the brief trial period and in comparatively young animals, NCI scientists resolved that findings should be reported, in order to expedite investigation of human exposures and the possible risks involved." A December 15, 1977, newspaper article quoted CTFA as stating that no major hair dye manufacturers had used benzidir.e-derived azo colors in their products since 1973. 78 However, we subsequently purchased eight temporary hair dyes at Rockville, Maryland, drug stores containing one or more benzidine-derived azo colors. Because the manufacturer--a CTFA member--does not participate in FDA's voluntary program for filing cosmetic product ingredient statements, FDA wra unaware that the products contained benzidine-deriveo azo colors. FDA officials said benzidine-derived colors may also be used in semipermanent hair dyes. Another manufacturer reported to FDA in April 1973 the use of benzidine-derived colors in 26 hair dyes but failed to notify FDA until December 1977 that manufacture of the products had been discontinued in Dece;ber 1973. The failure of participating manufacturers to update their submissions, coupled with the limited participation in the voluntary program, prevented us from determining the total number of products containing benzidine derived azo colors. Two of the eight colors available for use in coal tar hair dyes were included in the New York University study, and one of them, Direct Black 38, also reportedly was used by the Japanese kimono painters who developed an increased incidence of cancer. The university researchers concluded that: "It is not our intent to imply that all azo dyes are biologicaly [sic] reduced to carcinogens, but those derived from carcinogenic aromatic amines should receive particular attention." The CTFA dictionary lists other azo colors derived from toluene-2,4-diamine, toluene-2,4-diamine sulfate, and o-tolidine, each of which is a known or a suspected animal carcinogen. Other suspected carcinogens in temporary and semipermanent hair dyes Eleven other colors listed as suspected carcinogens in the 1976 NIOSH Registry of Toxic Effects of Chemical Substances were listed in the 1977 edition of the CTFA dictionary as "available for use" in coal tar hair dyes. The 79 NIOSH registry lists the studies 'upon which the list is based. Neither we nor NIOSH, however, has reviewed the adequacy of the studies or the appropriateness of the studies as a basis for determining the safety of the colors for use in hair dyes. The table below lists the 11 colors, the animal species in which the studies were made, and the routes by which the colors were administered to the animals. Color Test animal route of administration Acid Blue 9 Acid Blue 9 ammonium salt Acid Blue 74 Acid Red 18 Acid Red 87 Acid Yellow 73 sodium salt Basic Orange 2 Batsic Violet 10 Disperse Yellow 3 (note a) Pigment Red 53 (note a) Pigment Red 53:1 (note a) Rat Rat Rat Rat Rat Rat Rat Rat Mouse Rat Not identified Not identified Not identified Subcutaneous Parenteral Subcutaneous Parenteral Subcutdneous Oral Subcutaneous Subcutaneous Oral Subcutaneous Not identified Not identified Not identified a/Reviewed by the World Health Organization's International Agency for Research on Cancer. Available data were indefinite with respect to carcinogenicity. Although'the CTFA dictionary indicates that these 11 colors are "available for use" in coal tar hair dyes, we could not readily identify individual products that contain them. Possible carcinogenicit of permanent hair dyes Screening tests and animal-feeding studies provide additional evidence that some widely used permanent hair dye ingredients may be carcinogenic or mutagenic. CTFA has questioned the appropriateness of such studies for 80 determining the safety of hair dyes and has cited certain animal-skin-painting studies to support their safety. However, some scientists have questioned the adequacy of these studies. We reviewed some of the more significant studies, which are briefly discussed below. Screening tests University of California researchers have developed a very sensitive and simple bacterial screening test for detecting chemical mutagens. The test is also believed to offer strong evidence of possible carcinogenicity. The researchers reported that 85 percent of the chemicals found carcinogenic in animal studies had been detected as mutagens in the bacterial test. By contrast, less than 10 percent of the chemicals classified as noncarcinogenic in animal studies showed mutagenic potential in the bacterial tests. The researchers tested 169 marketed permanent hair dyes. The dyes were tested both before and after mixing with hydrogen peroxide. Of the 169 dyes, 150 (89 percent) were found to be mutagenic. Most of the dyes retained their mutagenic activity after being mixed with hydrogen peroxide. The researchers also tested 25 semipermanent hair dyes and found most to be mutagenic. In addition, the researchers obtained from industry representatives 18 chemicals used in permanent hair dyes and tested them for mutagenic properties. Nine of the 18 showed various degrees of mutagenicity. 1/ Oxidation by hydrogen peroxide caused three of the chemicals to become strongly mutagenic. An official from FDA's Division of Cosmetics Technology told us that although screening tests offer strong indications of possible carcinogenicity and mutagenicity, they alone do not provide sufficient evidence to conclude that a substance is harmful to humans. The official stated that such tests need corroboration by tests on animals. l/The nine ingredients were 2,4-diaminoanisole, 4-nitroo-phenylenediamine, 2-nitro-p-phenylenediamine, 2,5-diaminoanisole, 2-amino-5-nitrophenol, m-phenylenediamine, o-phenylenediamine, 2-amino-4-nitrophenol, and toluene-2,5-diamine. 81 NCI studies NCI has contracted for animal studies on the carcinogenicity of 16 coal tar hair dye ingredients. The studies involve feeding the ingredients to rats and mice or applying the ingredients to the skin of rabbits and mice. Ab of October 1977 NCI nad not completed the analysis of any of Lhe studies. Because it is impossible to assign priorities to chemicals in different use categories and because chemicals (including hair dye ingredients) appear in more than one use category, NCI had elected to analyze and report the results of experiments in the order that was most expeditious (usually chronological). NCI's Associate Director for Carcinogenesis Testing Program said, however, that because of the structural similarity of the coal tar colors being tested to known carcinogens, he expects many o' them to be found carcinogenic. He said that analysis p:robably would not be completed before the spring of 1978. Cn September 2, 1977, the FDA Commissioner wrote to the NCI Director requesting that priority be given to completion of the evaluations of 2,4-diaminoanisole, toluene-2,4-diamine, and any other ingredients which show positive effects. The letter stated: "Possible positive results with respect to two of the compounds studied, in particular, 2 ,4-diaminoanisole (2,4 DAA) and toluene-2,4diamine (2,4 TDA) 1/ have attracted our attention. In addition, there is evidence that compounds such as these do penetrate intact skin. "In light of this and the extensive use of hair dyes x * * the need to confirm the conclusions suggested by preliminary reviews in an orderly scientific manner is obvious." By letter dated October 18, 1977, NCI's Associate Director for Carcinogenesis Testing Prog:amw advised the FDA Commissioner that NCI had found both 2,4-diaminoanisole and toluene-2,4-diamine carcinogenic in animals. The i/Most cosmetic manufacturers stopped using toluene2.4-diamine in hair dyes after it was found to cause cancer in laboratory animals. However, data submitted to FDA under its voluntary program for filing cosmetic product ingredient statements indicates that it is still used in at least seven permanent hair dyes. 82 Associate Director gave FDA a draft of a technical report on 2,4-diaminoanisole and advised FDA that results of the other study would be submitted to the Journal of the National Cancer Institute for publication. By letter dated October 21, 1977, the Acting Director of FDA's Bureau of Foods notified NCI that FDA was beginning an immediate evaluation of the draft technical report on 2,4-diaminoanisole. On October 17, 1977, the Environmental Defense Fund, Inc. (EDF), a private nonprofit national consumer organization, petitiorne FDA to require all hair dyes containing 2,4diaminoanisole or 2,4-diaminoanisole sulfate to bear a cancer warning label. EDF stated that its evaluation of the data on 2,4-diaminoanisole compiled, but not yet released, by NCI showed the dye to be carcinogenic in both rats and mice following oral ingestion. EDF noted that the dye caused a statistically significant increase in certain types of tumors in male and female rats and mice. 2,4-diaminoanisole is a basic component of most permanent hair dyes. We identified, from data submitted by manufacturers to FDA, 407 hair dyes containing 2,4-diaminoanisole or 2,4diaminoanisole sulfate. By letter dated January 5, 1978, NCI's Associate Director for Carcinogenesis Testing Program notified the Chairman, Subcommittee on Oversight and Investigations, House Committee on Interstate and Foreign Cdmmerce, that from inspection of preliminary test data on four other permanent hair dye ingredients (4-amino-2-nitrophenol, 2-nitro-p-phenylenediamine, o-anisidine, and o-phenylenedianmine), it appears that they also are carcinogenic in animals. Skin-painting studies These studies involve applying a chemical or a chemical mixture to the skin of the test animal. Because topical application more closely approximates the actual conditions of hair dye use and permits testing the actual mixture of compounds produced during oxidation, CTfA believes that only skin-painting studies can offer meaningful results on hair dye carcinogenicity. CTFA noted that 2,4-diaminoanisole and toluene-2,4-diamine had been included in five skin-painting studies in which no problems had been found. While some researchers recognize 83 the the are usefulness of skin-painting studies, adequacy of the studies performed. discussed below. they Two of hive questioned these studies wNatohtycoiihafeaoteiakrnhrrnpbtsoosoo.wpshdxtlTneiayhyuhrtevemeeiiecTneovdawvetfideroe-hinchd2yrgiwioc,lscrencro5tcoerolsn-nedegaetdtliselrirletnoaoouonu)lmlblntd(.isolsybneysggaererrc1(,voAokar/el)uungeldpdpeseislcoin)wfktrtrvoahiawhcorsetneeiolsrrrnveaooouenflstdsaioehunultdersSoathrevpnnahedidree(r;vgamiirqi.2tinouo6x,nwg.unet4i,mpe-u-caotrDednhneagrivteowearwehlmmowheseagiui2ie.yirnp-tcknooyhlleeauweyradnpaatristwa(ssuroapoanetplptcroflepereoti)lraeihcitaveacetertt2adedio-do.n The researchers reported: -- There was no evidence that the caused any adverse effects. hair dye ingredients -- Ttanhrdeeraettehedwasriantcnsoidedwniictfehferorefenscpteeucmtobrestt,oweelnifetshepanconortrotlhe and type -- rhere were no tumors site of application. or other skin reactions at the -- histopathological studies lungs provided no evidence functional disturbance. of of the liver, kidney, and degenerative change or the Hlowever, University of usefulness of the study dyes, used. because of the small They noted that tne chemical that increased the population by 5 percent. California researchers questioned in evaluating the safety of hair number of experiment animals could and not low dosages detect a incidence of cancer in the i/HPv(.oeOlrx.cJiud.ti1a1zK,niiennokgPueelsdrygeaTasmon)odxnicSiniP.tryeRHsaostal,snz,dm"a19nC7nFa-,or3,oc-di"nSpCotoqusdemyn6ei1tc-oTiifct4yL.oTnoofgx-itcHeaorilmrogyD,yeJ 84 The different second study 1/ involved applying one hair dye formulations 2/ to the skin of of three mice. Each formulation and a control formulation without a dye inter- mediate were administered, after mixing with hydrogen peroxide, to two groups of mice--one weekly and one every 2 weeks for 18 months. A positive control group and an untreated control group were also used. The researchers reported that no evidence of toxicity or carcinogenicity had been noted. They noted that one ingredient used, toluene-2,4-diamine, had previously been shown to cause liver cancer when fed to rats. The University of California researchers, however, believed that this study was also inadequate for evaluating safety for humans. They noted that, compared -ith the previous study, smaller doses had been used, the dyeings had been done weekly or every 2 weeks rather than twice a week, and the animals had been sacrificed after only 18 months. Epidemiological studies Epidemiology is a science that deals with the incidence, distribution, and control of disease in a given population. Epidemiological studies compare the incidence of a disease, such as bladder cancer, in a population exposed to a particular chemical with the incidence of the disease in an unexposed population in order to identify causes for the disease. The two populations should be closely matched according to such factors as age, sex, and smoking habits. Although extensive epidemiological studies have not been performed for users of coal tar hair dyes, two studies on breast cancer patients have been performed with conflicting results. However, deficiencies have been noted in both studies. 1/C. Burnett, B. Lanman, R. Giovacchini, G. Wolcott, R. Scala, and M. Keplinger, "Long-Term Toxicity Studies on Oxidation Hair Dyes," Food Cosmetic Toxicology, vol. 13, Pergamon Press, '975, pp. 353-357. 2/Each formulation contained oleic acid, isopropanol, sodium sulphite, ammonia, toluene-2,5-diamine sulphate, p-phenylenediamine, resorcinol, and deionized water. In addition, each formulation contained one of the following: toluene-2,4-diamine base, 2,4-diaminoanisole sulphate, or m-phenylenedjamine base. 85 In one study 1/ a New York physician compared the use of coal tar hair dyes among his women breast cancer patients with use of the dyes by women of the same age who did not have breast cancer. The study showed that 87 of 100 breast cancer patients had been longtime (over 5 years) users of coal tar hair dyes whereas only 26 percent of the women without breast cancer were longtime users. The women were apparently matched by age, but not by other factors which could affect the incidence of cancer, such as smoking habits. In the second study 2/ 191 women with breast cancer and 561 women without breast cancer were matched according to age, marital status, and social class. Although data on factors known to affect the incidence of breast cancer were obtained from the women, the women were not matched according to those factors. The study showed no relationship between breast cancer and use of hair dyes. According to the October 17, 1977, EDF petitiorn to FDA, the second study is inadequate because of the short followup period. EDF maintains that the iatent period for development of cancer after exposure to hair dye use will probably be over 15 years, but too few wormen iln the study had used hair dyes for mure than 14 or 15 years before cancer diagnosis to make the data useful. EXEMPTIONS HINDER EFFECTIVE REGULATION Ordinarily FDA could ban the use of an ingredient in a cosmetic under the adulteration provisions of the FD&C Act if the substance may cause cancer under the conditions of use of the cosmetic. However, the exemptions granted to coal tar hair dyes prevent FDA from effectively regulating the dyes. Section 601(a) of the act states that a cosmetic shall be deemed to be adulterated if it bears or contains any 1/N. Shafer and R. W. Shafer, "Potential of Carcinogenic Effects of Hair Dyes," New York State Journal of Medicine, March 1976, pp. 394-396. 2/L. J. Kinlen, R. Harris, A. Garrod, and K. Rodriguez, "Use of Hair Dyes by Patients with Breast Cancer: A Case Control Study," British Medical Journal, vol. 2, 1977, pp. 366-368. 86 pcisonous or deleterious substance that may render it injt rious to users under normal u:se. It further states, however, that: .".* this provision shall iiot apply to coaltar hair dye, the label of which bears the following legend conspicuously displayed thereon: 'Caution--T'his 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 eyebrows; to do so may cause blindness.', and the labeling of which bears adequate directions for such preliminary testing." According to the November 1974 issue of the FDA Consumer, an agency periodical, the coal tar hair dye exemption was granted because industry persuasively arq.ei that while the dyes could not meet safety standards crf -he FD&C Act, they should nonetheless be sold to meet popsar demand. Although the Color Additive Amendments to the FD&C Act have required establishment of regulations listing color additives that are safe for use in food, drugs, and cosmetics, coal tar hair dyes were exempted from these provisions. Under section 601(e), a cosmetic is considered adulterated: "If it is not a hair dye and it is, or it bears or contains, a color additive which is unsafe withir the meaning of section 706(a)." The U.S. Court of Appeals, Second Circuit, ruled in the 1969 case of Toilet Goods Association v. Finch (419 F. 2d 21 (1969)) that the exemption does not apply to coloring ingredients in hair dyes not derived from coal tar, such as the metallic and vegetable dyes. The court noted that the legislative history of the Color Additive Amendments contained no indication that the Congress intended to broaden the 601(a) exemption. Under section 602 a cosmetic is considered misbranded if its labeling is false or misleading in any particular. Coal tar hair dyes are nots exemot from the misbranding provisions. 87 been Many coal tar hair dyes contain shown to cause cancer in humans ingredients or animals. that have Because of the exemptions, cancer-causing coal however, tar hair tDA dye cannot even ban the use of if the evidence that the dye is a human carcinogen, such taining a benzidine-derived azo color. as a hair dye a suggests con- wbAgtyhciuioclncoathrhtedieIionxpnnocsgssltreuaedddttceoeuodftagiotnnrhhifiyeatrnziogmaworranedrgwtnuhhoieleftnanhgtaetitxthohei(nemsw2,ap8stpebFrxl.doenRbim.lfpeftameni6,yr4o3en9nFc,toDaaAplJpfulriniotneeamdr1.t292hh6,ao3isTre1hi9es6dcs3your)evee.sedgruelrdae-- "If the poisonous or deleterious substance in the 'hair dye' is one to which the caution is inapplicable and for which patchtesting provides no safeguard, the exemption 6ces not apply * *w. A patch elbow, test is or behind a test on the forearm, on the bend of the the ear to detect allergic sensitivity. However, in the 1969 case the U.S. Court of Appeals upheld a district court ing that portion of the found that: ruling (278 regulation. F. Supp. 786) The court of invalidatappeals "The Government's argument should indeed be appealing to a legislator--what good is the warning to make a patch test if the test will not disclose the danger? But a court must take the statute as it is, and Congress wrote with great specificity. Whether it relied solely on the patch test warning because it was unaware in 19:A8 that coal-tar dyes might. have damaging effects not detectable by such a test, as the Government asserts but the industry denies, or because it thought such instances so rare as not to warrant indenta- tion of the exemption, the clear for us to read it as language is too meaning something different from what it so plainly says, at least in the absence of persuasive legisla- tive history." (419 F. 2d 21, 29 (1969)) were which Thus the court found to cause would not be ruled that cancer or detected by even if a coal tar hair dye some other adverse effect a patch test, the dye could 88 not be removed from the market under the adulteration provisions of the FD&C Act if the label bore the statutory warning. In 1971 FDA revised the regulation to delete the objectionable statement (36 F.R. 16902, Aug. 26, 1971). In the opinion of an FDA attorney, FDA could probably require, under the misbranding provisions of the act, that an additional warning be placed on the label of coal tar hair dyes posing hazards under conditions of use, such as cancer not covered by the statutory warnings. However, because section 601(e) exempts coal tar hair dyes from the color additives provisions of the act; FDA cannot require manufacturers to prove the safety of their products under the color additive requirements and, therefore, FDA has the burden of proof for any additional label warnings it may require. By contrast, FDA can require the manufacturers of colors used in metallic and vegetable hair dyes to prove the safety of their colors because the law does not similarly exempt these products from the color additive requirements. In its October 17, 1477, petition to ItDA, EDF asked the agency to require the following warning on labels of coal tar hair dyes containing 2,4-diaminoanisole. "This product contains the chemical 2,4 DAA [2,4-diaminoanisole], which can enter your bloodstream through your scalp and has been shown to cause cancer in animals." In our report to the Subcommittee on Oversight and Investigations, we recommended that the Secretary, HEW, direct tne FDA Ci.'imissioner to a3luate safety data on coal tar hair dye ingredients and requ.re, where applicable, cancer or other appropriate warnings on product labels. On January 6, 1978, FDA published in the Federal Register a proposal to require that labels of hair dyes containing 2,4-diaminoanisole contain a cancer warning statement. FDA also proposed that hairdressers be required to post signs suggesting that their customers request to see the labeling of a hair dye before it is used. FDA is still considering the need for cancer warnings on labels of hair dyes containing other suspected carcinogens. Our report also recommended that the Congress repeal the coal tar hair dye exemptions. 89 Pending legislation Under Senate bill 2365, introduced during the 95th CsScsooeeelncncogtatrritieoeosnnasdb,id66li00lt11ti((hveae2))e3.6e5opxfreowmvoptiuthsleiidoonFnDnso&gtCrgarAnractenteptdeeawdlotuolttdohceoabcleoeaxletrmaerpptaetraihloaenihdar.ifLrdoymdeHysoewtsheuevneduren,rder Several other bills have 95th Congress to repeal both including House bill 10512. been introduced during the the 601(a) and 601(e) exemptions, CONCLUSIONS cbtttehhiaeeorncasibucsnsMoeooanigrndnbeyioentftdsihcoeocnaottslahhFlaOrto&otfCutaagrprhAuoscsheteaht.iahriepbraortdsdekyynieFentsDsiAaaclntfodhrnahottamaszicabmnaraaldypnks.nniconawbguneHscoeoaworuresvceeasrrnue,csstephtreertcyihtceuetmndiadeynexgremp- Although requirements, coal tar hair dyes FDA has not issued are subject to FDA labeling final regulations requiring aknocwanncehrumawnarnoringaniomnallabcealrscinoofgecnosa.l tar hair dyes containing Such regulations have botfroeireonn2st,hp4eri-isodrpiomasanmedeideendoadonirnefilsfsytiosclfueolrwtistuhhbalyifraFDttAhed,e.yesrfaaTtchchteoenrttiahsiatsnthuiaannntghceeth2eob,fu4rm-dasdenuinucafhmaoicfnrtoeuagprnrueoilroassf-o.le uafsdaedcdittuirIivenfersstt,hheewsoteuoelxddepymrehpesatmviaeorwnkoseuttoldweparrpbeoepvreorsvueabtplhjeeeaclbteys,da,fFeDLtAityhmeiflooarfcroltsohatreofetociytonhlgeorarrnesdd.iceomnlaotnrsu- Hstheuaaptlp:tohrI,tnedFSeebenralutiaemriynCaotm1im9oi7n4tteotefestothniemoLnaeybxoermbpetfainodornesP.utbheliFcDSAuWbectloefmsatmriieft,iteedeFDAon "coal tar hair dyes should not receiv: privileged treatment but should be subject to the same regulation and safety appraisal as other cosmetics." RECOMMENDATION TO THE SECRETARY, HEW We recommend that the Secretary direct the sioner to evaluate safety data on coal tar hair FDA dye Commisingredients 90 and require, where applicable, a cancer or other appropriate warning on product labeis. AGENCY COMMENTS HEW said that FDA saevaluating safety data on coal tar hair dyes. According to HEW, FDA intends to take Lction similar to that which it has proposed against hair dyes containing 2,4-diaminoanisole (see p. 89) against any other chemical used in coal tar hair dyes that poses a cancer risk on the basis of FDA's review of appropriate tests. FDA officials advised us that their evaluation of NCI's data on 2,4-diaminoanisole is continuing and that final reports on five other suspected carcinogens submitted to FDA by NCI are awaiting review. HEW pointed out, however, that the ability of FDA to protect the public from risks associated with long-term use of hair dyes will continue to be severely limited until the Congress repeals the coal tar hair aye exemption in the FD&C Act. RECOMMENDATION TO THE CONGRESS To permit FDA to better regulate coal tar hair dyes, we recommend that the Congress repeal exemptions in sections 601(a) and 601(e) of the FD&C Act concerning these dyes. 91 CHAPTER 7 NEED TO ESTABLISd AN EFFECTIVE MARKET SURVEILLANCE AND ENFORCEMENT PROGRAM Because FDA cannot test cosmetics for safety before they are marketed or require manufacturers to do so, its success in insuring cosmetics' safety depends laLgely upon the effectiveness of its market surveillance and enforcement efforts. However, such efforts have not been effective because: --FDA has not inspected most manufacturers' plants nor sampled most of their products for compliance with the FD&C Act. -- FDA has not established good manufacturing practice (GMP) regulations for cosmetics. -- FDA has not always taken effective enforcement actions when violations of the FD&C Act Were discovered. The lack of adequate legislative authority and interpretative regulations also limits the effectiveness of the market surveillance and enforcement program. LIMITED MARKET SURVEILLANCE FDA has the same basic authority to conduct inspections and collect samples to enforce the cosmetic provisions of the FD&C Act as it has to enforce the food, drug, and medical devices provisions of the act. FDA is authorized to visually inspect any factory, warehouse, or establishment in which cosmetics are manufactured, processed, packed, or held for introduction into interstate commerce and to collect product samples for analysis. However, most cosmetic plants have never been inspected and most products have never been sampled. FDA officials told us that an effective market surveillance program should provide for every firm to be inspected every 2 years but that under the current rate of inspection--about 500 inspections per year--that would be impossible. An FDA printout of inspection and sampling history of cosmetic plarts between fiscal years 1969 and 1975 listed about 2,200 plants operated by the approximately 1,200 cosmetic manufacturers known to FDA at that time. Although 92 FDA conducted about 3c800 inspections during the 7-year period, about half of the 2,200 plants were never inspected, while others were inspected several times. We were not able to readily determine how many of the 1,200 manufacturers had one or more of their plants inspected. Many other plants were not inspected because they were operating without FDA's knowledge. In 1976 FDA contracted with a market research consultant to identify cosmetic firms previously unknown to FDA. FDA simultaneously undertook an in-house project to .dentify new firms, As a result of these efforts, FDA identified about 1,000 additional ntanufacturers which it had never inspected because they had been unknown to the agency, increasing the total number of known cosmetic manufacturers from 1,200 to 2,200. FDA's testing of cosmetics is even more limited. FDA collected about 3,000 samples between 1968 and 1976. According to FDA, many of these were not analyzed because of lack of personnel and higher priority programs. Because more than one sample was often collected for an individual product, we could not determine the total number of products sampled during this period. However, it represents only a fraction of the more than 50,000 different brand name products. Testing of cosmetics was generally limited to chemical analysis to identify some of the ingredients in them. Tests to identify microbial contamination and tests to identify products that are skin and eye irritants were performed much less frequently. Almost three-fourths of the tests run were for chemical analysis. FDA has had to devote considerable resources to chemical analysis because manufacturers nave not registered their products or product formulations with FDA. Effective implementation of FDA's ingredient-labeling regulations, which became effective in April 1977, should decrease the need for chemical analyses and make resources available for other tests. However, because FDA has not established product and ingredient standards, it has no criteria for using the results of tests for eye and skin irritation or microbial contamination for regulatory purposes. (See p. 34.) NEED FOR GMP REGUK'A?'IONS Although FDA has established specific criteria, known as GMPs, for deternining whetter, 4dequate methods, facilities, 93 mafffenoaanrdccttt,uuccrrooiesnfnmtigernatoniildsrcshesecd.doiarsrdetaFsnrD,diAubsuuaeutndnsidfeosiinnnl,iassbuahcoliehlrtdathpcoamhrrsaaiytsteeenrsrcoiiotaanoltfesrsi,otnflaosbcoi.ldoninsstpahaneedicdnteidrorsnsuus,gchmmoafacnnruuie--tqeuriipa- coeirosfntdariibettlnUiidnhoseadrnhseeserddbewtethhinheenarjtuepFrbrDiey&ioptCuaisrtAiescdtmt,,uoanynphaeeahcacaclvkeoteesshdsm.,aberetycioorcCmofeouhirrestlcddtohdeneeteumacnGemidodiesrnviaeottrnoiensndmsbehaenanwtviiaettdahturolytfeilrtahted phtoraovveceonidtnihttaetiropnrasentyeodfprotmdhaeuncutftaecrwtmausr"eaicnotsruaanlislttyaorraycgoecnotnatdmhiiattniaotwneosdu".ld The courts to refer result, with reasonable possibility, in product contamination. troegmulaanGtuMifPoancrsteugrwueolualotdrionscsatuosrweeoulctdhoesmmiedtteionctsibefyidneseuamccehcdorcadodanundlciteteirowanitste.hd.GMFPailure ososttffpfhepoearoeticdccTaioielfmsfAocsirmaich,cenccnatuaoodtifllrrticaluodeocygsginttynmsu,agaGrenMpequPpftaruoflolrsiaitrpcchetmtaosfgheubuhiuenlragnltelehiaDlrstishirtfFe.oooeeDdnrcsAsttcompaTohrrbihsaaolcemssdireousotfgdnchbiruoticutitsasgdhs,l,eepelGesiMctcBtinePoiutaesnfrbtstiegrlacaeiemuadtsgnihtuhueenirelroaoidafatnnteligsiflFGoofyoMnneoPif,scdonustrssr'ieepsevsstergetaacuOnatwtlfteebihaflsoemitisnaciss-eohns dobf1ufa9art7cic5pinhlrgCieotsrameeitprcnelovsirapadetasncictvreieeaoncndaPsslrylosa.tngthreaamitmsAn:cvceuGosnuretiddodiranynigcnecottnohMtearinaourlaslpu,rmsomydFasuDrtcAyetmsii,nnasdpeaieqtncusdtaotmMreaasricnthtfoaoiunnd -- Less than 33 percent of the material specifications. establishments had raw -- Less than 50 percent kept adequate batch records. -- Less than 15 percent tested equipment for microbial contamination. -- Only 30 percent had established finished product specifications (chemical, microbial, physical, etc.). -- Only 20 percent systems. tested the effectiveness of preservative 94 -- Only 25 adequate percent maintained inventory to facilitate a recall. control systems Assfipipnpcecieceantldi,io1xn97sa6bVotuhoctaodmdrp7du5agerfepiseGcrMicPteehnnertceicgeoousfnldaitaintiiosonatnsmhs.peliernoAmtocaefcdnouorfvddeaiurcrntigun3rgt0io0ncgaofnsipmrremFsatDciAtciioncfsie-pnse-.cted ctdp1tbuho9ruoises7abn8mfldct.eatiiohtcesnsaAtidhgmtnceeBsdoteoGat,nicnMhtlacPietyunicostrorfiewtesnonhhhgomeseaedFueypnsDlteAFaicafecetctnronhdisidonfaeoomstornndwarassriFmclnutDieoghAffntdRo'oaresrGttgethMihisePcOeoestofnntasfffreabmiooerdlecrcrguitocecuilsueeflclthomaodseereoft,drfniabtcoGteGonteliMmhspanoPpmeuwenryer.rconparavptolhenerssaAgndoeduolC.vsalttoisahunstoonbaiitusoesoogefnnhlbarssMepeaepFgtnrolDfuocfoiAllhrdeadhtai1so,ns NEED FOR EFFECTIVE ENFORCEMENT oaaFifunDntc&dheCithocearbAFticyDettlA.yamwtahonaiwsunFifDtlhaAcnle'caoststbeucesroafesalrmotiwsefrlateuyiarswscteiesetrudhitsooiewudntisdehtufeihsoftrtescrmcoyitrsaniemuivptetmehethualaiomttycreidmctpuaosyrjnevoosivtreooiiqltsusaiveetoinnieonfcolnsoenafr.stocoirfeoccneoctsmuohleemdnptliomnowclrroieaatnnrbeot1ro2dr3,a3rnaBdtopipteneefeetodfrrwriccet1yeec0hesnn9ienop,tteme,,ner1fcos,irioo6osfeffn5cos8na7rtlemthlnphceeoeooytrfsefcsmao9eawer5urnm2tsanetpdirg,lcrus1ealad9sonpame7ftltp4fiaoalinnrentcaasygthinlesedynarazpnecci1elagitn9dalueis7.nylsop6tzane,setcwdothFi.reiinDdycnAhs1paa8Iiec8nntnc,tdhstiaepeodyoeidndrcnitbtwaoe21ine11rlodr8sine,ep,vea1er2n3dd-, srioenmgseupleacAfttoloortrmrhysouogfoahrctrieFlogDanuAbsloaritwadoeterroneyrtyifaticaptkeeiedronsnoo,ndvnueerralisn4gcs00hlotahwsdenseiffb3ii-eceylideoeawnrcaisoepnselwryairworh1d4ai.1nchtinigts Seizures attempted Injunctions obtained Regulatory letters issued Information letters issued Total 74 2 28 37 141 95 FDA did not issue any citations or refer any cases to the Department of Justice for prosecution. Furthermore, 54 (53 seizures and 1 injunction) of the 141 regulatory actions were taken in an effort to prevent the marketing of one violative product, a fingernail lengthener containing methyl methacrylate monomer. Thus regulatory action was actually taken for about 20 percent of the violations FDA determined warranted such action. In addition, FDA requested the recall of 52 products during the 3-year period. Although recall is a voluntary action on the part of the manufacturer, FDA has found it to be the most efficient means to remove a hazardous product from the market. As shown by the following examples, FDA has not always taken effective regulatory action even in cases of serious or repeated violations of the act. Nor has FDA always conducted timely followup inspections to assure that corrective action has been taken. Firm A manufactures hair care and bath products and has estimated annual sales of between $500,000 and $1 million. FDA made three compliance inspections of this firm's manufacturing practices between August 1970 and March 1973. In each case the inspector found what he believed were major deficiencies in the firm's manufacturing practices. FDA has not inspected the firm's manufacturing practices since March 1973. A summary of the August 1970 inspection stated that the firm was: "* * ~ operating under conditions which may cause bacterial contamination of the finished product (Egg Shampoo). Poor housekeeping conditions such as pools of stagnant water, dirt, and debris on the floor in the manufacturing area and paint peeling from the ceiling directly over the mixing tank were found during the inspection. In addition, open unscreened doors off the street to the manufacturing area could cause bacterial contaminateoLu of the finished product." Inspection observations were discussed with the president of the firm, but no enforcement action was taken by FDA. Although the president promised to correct the deficiencies, FDA did not make another inspection of the firm's manufacturing practices until January 1973. 96 During the January 197' inspection, the firm was again found to be operating under poor sanitary conditions. A 41-point list was given to management pointing out conditions which could lead firm's products, to bacterial or especially baby filth contamination of the shampoo. The list of con- ditions included: -- Rodent excreta at several locations in the plant. -- A dead mouse in a storage closet; a live mouse in the firm's office. -- A "filthy, inadequate toilet facility" adjacent to the men's lunchroom with no wash basin and inoperable plumbing. -- Waste on the floor rot confined to drain areas. --Foreign material ii the "window" of the pipe feeding baby shampoo to the filler. A postinspection letter was sent to the manufacturer, and reinspection was scheduled for March 1973. Management replied to the letter and promised that corrections would be made. was However, the followup inspection revealed that the firm still operating under unsanitary conditions. Many of the 59 deficiencies observed during this inspection were problems that had also been noted during the prior inspection. These conditions included: --A dead, decomposed mouse on the storage room floor (according to the inspection report, "the same mouse noted in the January 1973 inspection"). -- Rodent harborage areas throughout the plant. -- Potential pest entry ways throughout the plant. -- Sewers throughout the manufacturing areas left uncovered when not in use. --A large accumulation of wash water and product waste on the floor. --Equipment leaks allowing the product to seep out on the floor. 97 -- An accumulation of a jelly-like substance in a crack in the floor near the product storage area. All three inspections identified major deficiencies which the FDA inspector believed warranted regulatory action. Corrective action was again promised by the management after a discussion with FDA of the deficiencies. As of April 1978 no FDA followup had been made and no regulatory action taken. Firm B manufactures hair products and other cosmetics and has estimated annual sales of between $100,000 and $500,000. FDA made five inspections of this firm's manufacturing practices between February 1965 and December 1973. Four inspections revealed illegal use of coal tar color additives in the firm's cosmetics. In addition, all five inspections revealed that the firm had an inadequate quality control system for production and packaging. In the February 1965 inspection, FDA found the firm using a banned coal tar color additive, FD&C Yellow No. 4, in two products. Management stated that it did not know that use of FD&C Yellow No. 4 was illegal and voluntarily agreed to destroy the remaining supply of the color and stocks of the two products containing it. A followup inspection in March 1966 showed the firm had discontinued the use of FD&C Yellow No. 4. An April 1970 inspection showed that the firm was using three different color additives--Burnt Sienna, Umber, and D&C Brown No. 1--no longer approved for use. The inspection also revealed that the equipment used in cosmetic manufacture was not cleaned or sanitized between production runs. At management's request the inspector gave it a copy of FDA regulations listing the color additives that can legally be used in cosmetics. During a January '973 inspection, FDA found quantities of four color additives on hand, Burnt Sienna, Umber, D&C Brown No. 1, and External D&C Red No. 15, which were no longer approved for use. The firm had been notified during the April 1970 inspection that three of the colors were no longer approved for use in cosmetics. Management informed the inspector that Umb!r, Burnt Sienna, and External D&C Red No. 15 were being used in makeup products and that D&C Brown No. 1 had been used in a mascara which was no longer manufactured. On January 4, 1973, the firm notified FDA that it would remove all disapproved color additives from its plant and would not manufacture makeup products until it had substitute colors approved by FDA. 98 NNmofooa..nuthf11eaIcnintcnouoDlresloictorneongmcgbkew.eratrshehaMv1dpao9rnl7oau3adgnuetlFcmaeDtegrAaniltlcfyoonssudtantiadiasditpnutoishtsnehegaadtnfdiitori.fmtthawbstyaAtslilltihltaerwheahamrafdadeiirmndDD.ii&&nsCCgcoBBnrrsttooiowwncnnuked orpeecroartdiiSonengvses,rawletreesitnsls,apxeocrts-ioncncoedersneopwoewrrrtesittarevenavielasalpbeeldcei.ftihcaattimoannsu,facbtautrching oTnFlrohDete&tCtthepmerAreTconhtptetloioaxsoaFennDtddmAhaeenidFlutPieffhLstieaAttrrcremtirfucotorthncuienindtotgehffdefidriuomcrspb'eieeasvnrsegaiprtsuraistoleohopnefosaos.flesDldeeecrigeiliemolsdbeusegsuaravlnvic1ioe9col7ola3latootifrioionannsassdprdbeeiuocgttftuiilvoadteniths.doery mnnoa1ooilf9nlf7i4eirfngucegeregbFtd'ueDhslwcAeaha'vrteusrionseoreqelDyusaaiettovsaifpaitborcslnotiaisdiofsuonlohcnaratmcnoekdhfinasitdsoRisfuenaabgisnenunaueclsdfneapeefyteqieocuotcfrtaaiykiteieoenranntrGsieurtFavieahgiDdgnaadAautdienl.nncgascebutteeioeAdrdnseyecthlnoiiiomnlsfaenceddeetestrMf.enaitrirrfhcnmoehgriandndit1deMsh9eat7t8yer,ri-ct wFrdotfiasffeDanhfoeinpigr&enufsneneCtnciucihidaractsafnllAeeihfziFgcwgdeeoariteudunmryrsrlnc'rdematedasieoapalhtegnrureiCodsussobnsspr,loydriytauFoso1fitPcdFf9iniLotuDa6irgnaArs9Accnmrcb.y.tt'elenisclsdutaaooaanidwtnmdcdObeiemIipftunonneaowlirrtgnnn1eioisatuaa9rnan,thfl1dp$.engeo5laod5cr.oyciaeinrnttmt2,eoMd0iiuhkstieolrmnBennlims1aoood3,inatintw7roogmhcnu-nphiryfFnlaebvoaDcpieaedibAcornasrtoitsanshlamudeimcpealarnxptetetjiheatic$ioenrmcrticc1origieoi0ceononmmolsnsdeadpnatmpm.dielsbairtanfinomlawniiaorilcir2untcna7nOitcefgictanoievaeeotlrncescnryies.eaatbciqoawslmueieumine,prtsesitpdleewFsrhleverDui-eseemAsnsnnaewth.ajhoaierofvn-ri-ng otAlPcaifrimsrmoinoeepnbenuaotdusgdhrit.eottaIeaminntdnodoihtnnenaTassthls,opeaJdiencuecknbtfnitheaietnieccehocotdiifl1nesebu9rnaadt7icccrio0aiatnes.esegvcaiesreonniardisalrbTwetpleeheeifedeccrzictaecictuconiitsongoheoteenntnph,daecesimnipostieerladFidnseumeDoastpfAnteiliwisinoecninocnsinoneendtmonoecaatowcdoonlfesifluodelnfsspegateiacchcvneotttwetuhearuhtlodsaerhfdgleiiernpeanmtghrsoci'aopbocsvdeptjmeuchreppcieacortacctuoilotintdolniodiu-nymcniceeantsbgs.l.e 99 In October 1973 the firm voluntarily recalled a shampoo containing bacterial contamination. FDA conducted a limited inspection to obtain information pertaining to the recall but did not inspect the firm's manufacturing practices. However, during an October 1973 tour of the firm's plant, the Director and Deputy Director of the Division of Cosmetics Technology noticed what they considered deficiencies in the firm's manufacturing practices. They noted that: "Microbiological control facilities were essentially non-existant [sic] and demonstrated poor housekeeping. Control specifications were minimal at best. Based on remarks made by * * * [company officials] guidelines for proper preservation of products were inadequate, and microbiological testing appeared to be minimal." During a November 1975 inspection, many objectionable conditions were again noted in the manufacturing area. The inspection disclosed that not all Law materials were identified, some raw materials were stored under conditions whereby they may become contaminated, and manufacturing equipment was uncovered in an area having open unscreened windows. A list of 18 deficiencies was discussed with the manufacturer. Management promised corrections for most of the deficiencies, but in other cases when the deficiencies would result in the product being exposed to unsanitary conditions, management felt that the deficiencies were not significant and did not agree to take corrective action. No deficiencies were noted in manufacturing practices during a followup inspection in October 1976. However, when the inspector asked to review the firm's microbiological test data, the firm denied FDA access to the data until the request was considered by the firm's lawyers. Consent was never received and FDA made no further attempts to obtain the test data. As of March 1978 no further action had been taken by FDA. LACK OF AUTHORITY LIMITS ENFORCEMENT FDA's market surveillance and enforcement efforts are further limited because FDA lacks adequate legislative authority to (1) obtain access to a manufacturer's production and other records and (2) assess civil penalties for violations of the cosmetic provisions of the FD&C Act. 100 Access to manufacturers' records ospccrftfoloeaoumasccmrennotrpet;ruelrsedrsfaAc.tseuiali,rsnsttcsateho-lsTooms,hrupffaegiernhoFtlreuetDhmfqfshAaiouat,ettlechrlnteiooutnFscwrmlDsaFciiayApfDunnnee&rgguctrCirftyeneaofAtpsdrucacdlpsstbtaaeelutbnceraewtta,ietsFounrw,DsrtgeeAushfemooinmerarrttavecoimreccfuzdinoieloeezsrseaxsecdsstrasasiemFl.ofintDnuonotAsyteheeeAsdidasuartnrctthesshayaaeqp,pciueercirr1csre9eetse6sscihc8suoaoiolrnnpnmtddpstaa,snoiuno.dnmnufgeumftrmaha1ebnc9Ieu7-n6r-.s Type of refusal Number of refusals Access to qualitative or quantitative formulas Access to sales or shipping records Access to complaint files Permit photographing of plant Access to quality control records Access to plant except by appointment or other condition Access to plant Permit observation of manufacturing procedures Pert,.t collection of official srmples 464 75 61 33 32 19 5 4 4 In several cases, FDA inspectors were denied access complaint they were files, product formulation, conducting a followup to a and/or consumer safety data complaint. to when Civilpenalties The FD&C violations of Act its provides for criminal cosmetics provisions. penalties for However, it may be difficult for such violations. FDA FDA tohasasseesstsablcirsihmeindalinfpoernmaalltiecsritfeorriamantyo be for be muevstiedolbaeitfnioordneestpeorrfomsientciheuntgiFoDwn&hCetihsAectrc.ontosAimdpoernrogesdectuhaertee:caondmiatniuofancstutroer -- Prior warning must be given to the firm. --An individual officer(s) must be identified as responsible for the violation. 101 -- A responsible officer(s) must be given notice of the impending charges. -- The violation must be a continuing or flagrant violation, not a first offense. However, as shown earlier in this chapter, it is unlikely that FDA will inspect most manufacturers' plants or sample their products frequently enough to develop a case history supporting prosecution. One alternative that could help FDA enforce the act's provisions would be the authority to assess civil money penalties for viOlationn of the cosmetic provisions. In a 1972 recommendation, the Administrati'._ -nference of the United States--established to study the -.. ciency, adequacy, and fairness of Federal agencies' admln.strative procedures--expressed the desirability of regulatory agencies making greater use of civil money penalties. The conference stated that civil penalties are an important and useful tool that should enable agencies to (1) obtain quicker corrective action for violations and (2) demonstrate greater consistency in their judicial reviews. Criminal penalties would remain available for use when appropriate. The conference said that use of civil penalties would not reduce or eliminate the due process protection now provided under criminal penalty situations. Civil penalties would be assessed in accordance with the Administrative Procedure Act (5 U.S.C. 551 et seq.), which provides for review, on appeal, by the U.S. Court of Appeals (5 U.S.C. 701, et - .). Also the conference suggested that agencies be allowed to compromise or mitigate any civil penalty settlenent either before or after assessment. Subseq ently, the 1972 amendments to the Federal Insecticide, Fungicide, and Rodenticide Act authorized the Environmental Protection Agency to assess civil penalties for violations of its provisions. Since then EPA has used civil penalties extensively in enforcing the act. An EPA official said the agency often assesses civil penalties for pesticide violations rather than attempting to institute criminal action against first-time offenders. PENDING LEGISLATI(N Several provisions of Senate bill 2365 would provide FDA additional authority to enforce the cosmetics provisions of the FD&C Act. Specifically Senate bill 2365 would: 102 --BobrreoaamrdiiesnnbgraoFnnDdAe'wdsh.etihnesrpeacticoonsmeptoiwcermsaytobeincalduudleterraetceodrds --Give FDA clear authority compliance with GtPs. to establish and enforce -- Authorize FDA violations of to levy civil the FD&C Act. money penalties for CONCLUSIONS wmFwfialiheDonhtivenArsisantmuchiirhilisevaonanBsifmgbseeoilfpcslgGeiGteasahMrhMcuettPamPtsnfitssoetoorrbirnwpsaaeofsirslsfomloiuraalmsalnrttprtdkchhteneofaeoottsmitraimnalndenFsodehtaeuDuwnainfArvtcpefavpeisrfoceerf,ofrtifiidecualofeucerlreFdctmeasicD.tiernitAtvnscgyietebnvceioeioecfuanlafnoilcynfdcmtditoaiidhurnnoeepsectngnrene.tofcmeicvooteffoirhsnfyHndcemteioteeecwnamtltegamegiivcincumetntsuiicria.ndto,otleanpneedndrdsceioBsestgiyrsritaeaoanFsetmdnbDtoso,Aslatukiaresbcnh-e-s mtboaasdeeedstmIoaafnbnldtiahssetuhochrvyao,flamuconttrhtoeearrsydeaftafpaesrcotgpirrvaoemvsidmeaddriksecttuossFseDudArvesiinhlolucalhndacpeteenrapbrlo3egraarFmeDA -- past sampling and enforcement history of the firm, -- the type and volume of products it makes, -- the number and severity of reported for its products, adverse and reactions -- the degree of ingredients. potential hazard of the products and In addition, cosmetic samples tests for product contamination and fssrFkaoDifmAnetctyoae,nusdltdsseuycfsehohrifaitsrcrhieettmemaisptcthiasaolsnif.socromimnpiocsarinotabilioyanzlintgo caetroonvedracrlloeuerfcavdAotytsruie,mtvcuheiloaivarniatimclcitaltoynuinpudoefitnnandoaagclttfotauobsi,rrtheeaisrwvip'onipusoiwllnoadagucctlocdimeeropsnenlsaecsibno.alartnebdoclsee,mFDaAqwnitiuutafthlaotoicttmGyuMotPrraseekc.erosne'tqfruAfoieuplcctrkthoeiodrrvrueeicclttoyyridosn, 103 RECOMMENDATIONS TO THE SECRETARY, HEW We recommend that the Secretary direct the FDA Commissioner to: -- Devise a more effective program to insure that all cosmetic manufacturers are periodically inspected. -- Establish GMPs specifically applicable to cosmetics. -- Expand the collection and testing of cosmetic samples for such factors as microbial contamination and -ve and skin irritation. -- Insure that prompt and effective enforcement action is taken when violations are found in plant inspections or sample analyses. AGENCY COMMENTS AND OUR EVALUATION HEW said that during the past 2 years, FDA has instituted more effective (1) manufacturing establishment and product inspection evaluation programs, (2) information systems, of the compliance activities. HEW and (3) said that the lack of legal authority to require cosmetic firms to register their manufacturing sites, coupled with resources constraints, continues to restrict the inspection program for cosmetic manufacturers. about 500 per However, year, which the FDA rate of inspection officials agreed! continues at is insufficient for an effective market surveillance program. HEW agreed that GMP regulations are needed for ,osmetics and said that FDA is reviewing a draft of proposed '.MP regula- tions and industry. considering a GMP petition submitted hy che cosmetic HEW said that work on the GMP regulations will be done as expeditiously as possible, given the limited resources available and competing activities. With respect to product testing, HEW said that surveillance programs to determine if cosmetics are contaminated with harmful microorganisms were conducted during fiscal years 1975 and 1977. According to HEW, FDA ccncluded in both surveys that contamination with harmful microorganisms did not constitute a problem among either domestic or imported produces for sale in this country. HEW said tnat similar surveys will be conducted in the future, as resources permit and the need arises. 104 However, HEW pointed out that there is evidence that some mascara and other eye area products may not be adequ- ately preserved to prevent the growth of harmful microor- ganisras under conditions of use. HEW said that a notice of intent to propose rules designed had been nrinted in the October 11, to correct this problem 1977, Federal Register. At ling to HEW, collection and testing of cosmetic samples co determine eye and skin irritation potential wiiivl far exceed budgeted resources. Because additional data , e required to make safety determinations, e.g., product 7rmposition, ingredient purity, intended use, and toxicological data on individual ingredients, collectioz: and testiny of products for irritation are directed to those instances when adverse experience or other reliable data indicates that a particular product or an ingredient may be harmful under conditions of use. As FDA does not have enough data on cosmetic-related safety problems (see ch. 4), collection and testing of cosmetic samples remains an important source of information. HEW should b agreed taken that when prompt and violations effective are found enforcement action in plant inspections or sample an ';ses and said that FDA's present policy is consistent with our recommendations. HEW said that when viola- tions of the statute are found, FDA takes the most appropriate regulatory action. According to HEW, many of the conditions discussed in this report are not actiornable because of a lack of adequate evidence to prove that there was a violation of the FD&C Act. Taking prompt and effect-ve enforcement action depends on many factors, including development of adequate supporting evidence. identified As noted on pages 95 to 100, FDA inspectors have conditions at manufacturing plants which they con- sider to be major violations of the FD&C Act but apparently have not obtained sufficient supporting evidence. FDA should ensure that inspectors obtain adequate supporting evidence during inspections. RECOMMENDATIONS TO THE CONGRESS To improve FDA's ability to enforce the cosmetic provisions of the FD&C Act, we recommend that the Congress authorize FDA to: -- Obtain access to cosmetic manufacturers' production and control r*crd.. -- Assess civil penalties for violations of the FD&C Act. 105 CHAPTER 8 SCOPE OF REVIEW Our review incl siad: -- Reviewing FDA's headquarters in regulation Rockville, of cosmetic products at FDA Maryland, and Washington, D.C. -- Analyzing reports and publications prepared other experts and reviewing legislation and tions, policies, and procedures. by FDA and FDA regula- -- RppueabvrlieiedcwibnyagndFDcAmoasmnreuetfgiaiccontauclroimnpoglfafipincletasn.treipnosrptesctrieocneifvieldesfrporme-the -- Comparing the lists of ingredients in cosmetics with NIOSH's Registry available for use of Toxic Effects of Chemical Substances and NCI's list of substances under test. -- Interviewing officials EPA, CPSC, NCI, and the and reviewing Federal Trade records at FDA, Commission. -- Interviewing CTFA officials. 106 APPENDIX I APPENDIX I REPORTED TOXIC EFFECTS OF CERTAIN COSMETIC INGREDIENTS The toxic following list effect attributed to a substance in the is based primarily on test data reported in the 1976 NIOSH Registry of Toxic Effects of Chemical Sub- stances. Neither we nor NIOSH has reviewed the adequacy of the tests performed or the applicability of the results to exposure to the ingredients through use of cosmetics. The list also contains data obtained from FDA, EPA, the International Agency for Research on Cancer (IARC) of the WorlC Health Organization, and published articles. The listing was obtai;ned from the 1977 edition of the CTFA Cosmetic Ingredient Dictionary--a list of ingredients "available for use" in cosmetic products--and from ingredient lists voluntarily submitted to FDA by the industry. We did not determine whether all these ingredients are currently being used in cosmetics. Carcinogenic (note a) Ingredient Comments 1. Acacia 2. Acid Blue 9 3. Acid Blue 9 ammonium salt 4. Acid Blue 74 5. Acid Green 5 6. Acid Red 18 7. Acid Red 27 8. Acid Red 87 9. Acid Violet 49 10. Acid Yellow 73 sodium salt 11. Alcohol 12. 4-Amino-2-nitrophenol 13. o-Anisidine 14. Asbestos FDA determination: animal carcinogen; formerly FD&C Red No. 2 Formerly FD&C Violet No. 1 NCI determination: animal carcinogen NCI determination: animal carcinogen Contaminant of talc; NCI determination: human carcinogen 107 APPENDIX I APPENDIX I Ingred ient 15. Basic Orange 2 16. Basic Violet 1 17. Basic Violet 3 18. Basic Violet 10 19. Boric acid 20. Butyrolactone 21. Calcium carrageenan 22. Calcium saccharin 23. Captan 24. Carrageenan 25. Chloramine-T 26. Chloroacetic acid 27. Cholesterol 28. Chromium oxide greens 29. Coal tar 30. Coumarin 31. Creosote 32. 33. 34. 35. 36. 37. 38. 39. 40. 41. 42. D&C Blue No. 1 Aluminum Lake D&C Blue No. 2 Aluminum Lake D&C Blue No. 4 D&C Green No. 3 Aluminum Lake D&C Red No. 4 Aluminum Lake D&C Red No. 9 D&C Red No. 9 Barium Lake D&C Red No. 9 Barium/ Strontium Lake D&C Red No. 9 Zirconium Lake D&C Red No. 17 D&C Red No. 19 Comments IARC determination: animal carcinogen Also known as Gentian Violet Also known as Gentian Violet IARC determination: IARC determination: suspect indefinite animal FDA determination: animal carcinogen, suspect human carcinogen EPA determination: animal suspect IARC determination: animal suspect IARC determination: indefinite IARC determination: animal suspect NCI determination: human carcinogen IARC determination: animal carcinogen NCI determination: human carcinogen IARC determination: IARC determination: IARC determination: IARC determination: IARC determination: indefinite indefinite indefinite indefinite indefinite 108 APPENDIX I APPENDIX I Ingredient 43. 44. 45. 46. 47. 48. 49. 50. 51. D&C Red No. 19 Aluminum Lake D&C Red No. 19 Barium Lake D&C Red No. 19 Zirconium Lake D&C Red No. 22 D&C Yellow No. 6 Aluminum Lake D&C Yellow No. 8 Dehydroacetic acid Dimethoxane Dimethyl sulfate 52. Direct Black 38 53. Direct Black 131 54. Direct Blue 6 55. Direct Brown 1 56. Direct Brown 1:2 57. Direct Brown 2 58. Direct Brown 31 59. Direct Brown 154 60. Disperse Yellow 3 61. Estrone 62. Ethyl carbonate 63. Ethylene oxide 64. Ethylene urea 65. Ethynylestradiol 66. FD&C Blue No. 1 67. PD&C Blue No. 1 Aluminum Lake Comments IARC determination: human suspect NCI determination: animal carcinogen Contains benzidine, a human carcinogen May be converted to benzidine in the body Contains benzidine, a human carcinogen May be converted to benzidine in the body NCI determination: animal carcinogen Contains benzidine, a human carcinogen May be converted to benzidine in the body See comments under 53 See comments under 53 See comments under 53 See comments under 53 See comments under 53 IARC determination: indefinite NCI determination: human carcinogen IARC determination: indefinite IARC determination: animal carcinogen 109 APPENDIX I APPENDIX I Ingredient Comments 68. 69. 70. 71. 72. 73. 74. 75. 76. 77. 78. 79. 80. 81. 82. 83. 84. 85. 86. 87. 88. 89. 90. 91. 92. 93. 94. 95. 96. 97. 98. 99. FD&C Blue No. 2 FD&C Blue No. 2 Aluminum Lake FD&C Green No. 3 FD&C Red No. 4 IARC determination: negative FDA determination: animal suspect FD&C Red No. 40 FDA determination: animal suspect FD&C Yellow No. 6 FD&C Yellow No. 6 IARC determination: indefinite IARC determination: indefinite Aluminum Lake Formaldehyde HC Red No. 6 Formerly FD&C Red No. 1 IARC determination: animal carcinogen Hydroquinone Hydroxystearic acid Iron oxides IARC determination: indefinite Krameria extract Lactose Lead acetate IARC determination: animal carcinogen Maleic anhydride Methenamine 4-Methoxy-m-pheny- NCI determination: animal lenediamine carcinogen 4-Methoxy--m-pheny- NCI determination: animal lenediamine sulfate carcinogen Methyl hydroxystearate Methyl methacrylate Methyl oleate Methyl stearate 2-Nitro-p-phenylene- NCI determination: animal diamine carcinogen N-nitrosodiethano- FDA determination: animal lamine carcinogen Unintentional contaminant Nylon Oleic acid Oxyquinoline Oxyquinoline sulfate Paraffin PEG-8 Phenol EPA determination: animal suspe-ct 110 APPENDIX I APPENDIX I Ingredient 100. 101. Phenylalanine, Lo-Phenylenediamine 102. 103. 104. 105. 106. 107. 108. 109. Phenyl mercuric acetate Pigment Red 53:1 Pigment Red 53 Polyethylene Polysorbate 80 Polyvinyl alcohol Propyl alcohol Propylene oxide 110. PVP 111. Ricinoleic acid 112. Saccharin 113. Silver 114. Sodium saccharin 115. 116. 117. 118. Solvent Red 23 Sorbic acid Succinic anhydride Thiourea 119. Toluene 120. Toluene-2,4-diamine 121. Trichloroethylene 122. Tristearin 123. Ultramarine green 124. Zinc chloride 125. Zinc sulfate Comme lts IARC determination: suspect NCI determination: carcinogen human animal IARC determination: indefinite IARC determination: indefinite IARC determination: animal suspect FDA determination: animal carcinogen, human suspect FDA determination: animal carcinogen, human suspect IARC determination: indefinite IARC determination: animal carcinogen NCI determination: carcinogen IARC determination: suspect animal animal IARC determination: animal suspect 111 APPENDIX I APPENDIX I Teratogenic (note b) Ingredient Comments 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 1,. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. Acid Red 27 6 -Aminecaproic acid BHT Butyl methacrylate Captan Carbon dioxide Cetrimonium bromide Dibutyl phthalate Dimethyl phthalate Dioctyl phthalate EDTA Estrone Ethyl methacrylate Ethyl phthalate Hexachlorophene Lead acetate Lithium chloride MEK Nitrous oxide Phenyl mercuric acetate Retinol Retinyl palmitate Salicylamide Sodium chloride Sodium salicylate Theophylline Nervous systemeffects (note c) Ingredient Comments 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. Acetone Boric acid p-Cymene Dibutyl phthalate Ethylene dichloride Hexachlorophene MEK Methoxyethanol Methyl alcohol Methylene chloride Methyl methacrylate Phenacetin Sodium fluoride Based on human exposure Based on human exposure Pased on human exposure Based on human exposure Based on human exposure Based on human exposure Based on human exposure Based on human exposure Based on human exposure Based on human exposure Based on human exposure Based on human exposure Based on human exposure 112 APPENDIX I APPENDIX I Ingredient 14. Sodium Salicylate 15. Sodium Sulfite 16. Tetrachloroethylene 17. Theophylline 18. Toluene 19. Trichloroethane 20. Trichloroethylene Comments Based on human exposure Based on human exposure Based on human exposure Based on human exposure Based on human exposure Based on human exposure Based on human exposure Irritant effects (note d) Ingredient Comments 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. Acetaldehyde Acetic acid Ammonia Amyl acetate Butyl acetate n-Butyl alcohol Ether Ethyl acetate Fcrmaldehyde Isopropyl acetate Isopropyl alcohol MEK Methyl methacrylate Phosphoric acid Sodium salicylate Trichloroethylene Xylene Based on human exposure Based on human exposure Based on human exposure Based on human exposure Based on human exposure Based on human exposure Based on human exposure Based on human exposure Based on human exposure Based on human exposure Based on human exposure Based on human exposure Rased on human exposure Based on human exposure Based on human exposure Based on human exposure Based on human exposure Eye effects (note e) Ingredient Comments 1. Ammonium hydroxide 2. Boric acid 3. Furfural 4. Isopropyl acetate 5. Methyl alcohol 6. Tetrachloroethylene Based on human exposure Based on human exposure Based on human exposure Based on human exposure Based on human exposure Based on human exposure 113 APPENDIX I APPENDIX I Ingredient Skin effects (note f) Comments 1. Benzoic acid 2. Boric acid 3. N,N-Dimethyl-.p phenylenediamine 4. Silver Based on human exposure Based on human exposure Based on human exposure Based on human exposure Gastrointestinal tract effects (note g) Ingredient Comments 1. Alcohol 2. Dioctyl phthalate 3. Phenol Based on human exposure Based on human exposure Based on human exposure Blood effects (note h) Ingredient Comments i. Methylene chloride 2. Sodium thiosulfate 3. Thiourea Based on human exposure Based on human exposure Based on human exposure Mutagenic effects (note i) Ingredient Comments 1. Bis (2-Ethylhexyl) adipate 2. Ethylene oxide 3. Captan Pulmonary effects (note j) Ingredient Comments 1. Sulfur dioxide 2. Zinc chloride Based on human exposure Based on human exposure Psychotropic cffects (note k) Ingredient Comments 1. Toluene 2. Trichloroethane Based on human exposure Based on human exposure 114 APPENDIX I APPENDIX I Systemic effects (note 1) Ingredient Comments 1. Tetrachloroethylene Based on human exposure Ingredient Blood pressure effects (note m) Comments 1. Sodium chloride Based on human exposure a/Carcinogenic substances produce the nature of which is fatal or formation of secondary tumors. cancer, a cellular is associated with tumor, the b/Teratogenic substances produce birth defects or nontransmissible changes in the offspring. c/Nervous system effects include headaches, tremors, ness, convulsions, hypnosis, and anesthesia. drowsi- d/Irritant effects include any irritant effect on the skin, eye, or mucous membrane. e/Eye effects ground, and include irritation, blindness. diplopia, cataracts, eye f/Skin effects include erythema, rash, skin, and petechial hemorrhage. sensitization of the g/Gastrointestinal tract effects tion, and ulceration. include diarrhea, constipa- h/Blood effects trolytes, pH, include effects on all blood protein, and oxygen carrying elements, elecor releasing capacity. i/Mutagenic substances produce mutations or transmissible changes in the offspring. i/Pulmonary effects pathology. are effects on respiration and respiratory k/Psychotropic substances affect the mind and can modify mental activity. 115 APPENDIX I APPENDIX I 1/Systemic effects are effects on the metabolic and excretory function of the liver or kidneys. m/Blood pressure effects are those which increase or decrease blood pressure from normal. 116 APPENDIX II APPENDIX II LISTING BY INTENDED DRUG FUNCTION OF DRUG INGREDIENTS AVAILABLE FOR USE IN COSMETICS The following ingredients were either (1) listed in the second edition of the CTFA Cosmetic Ingredient Dictionary as available for use in cosmetic products or (2) reported by manufacturers as being used in cosmetics under FDA's voluntary program for filing cosmetic product ingredient statements. The intended effects of these ingredients were obtained from the U.S. Pharmacopeia, the National Formulary, or the Physician's Desk Reference. Diagnostic aids; vitamins; and pharmaceutic aids, such as colors, flavors, and solvents, are not included. We have not attempted to evaluate the potential of the ingredients to cause drug effects as they are used in cosmetics. Such a determination would depend on factors such as (1) the normal route of administration of the ingredient and the route of administration during cosmetic usage and (2) the extent to which the ingredient is absorbed through the skin. Druq function/ingredient: Abrasive (dental) (a substance used to polish, grind, or wear away the teeth): pumice. Acidifier (a substance used to cause acidity;: ammonium chloride, sodium ;iphosphate. Alkalizer (a substance that causes alkalinization): sodium acetate, sodium bicarbonate, tromethamine. Analgesic (an agent that alleviates pain): chlorobutanol, cl-ove il, eugenol, phenacetin, salicylamide, sodium salicylate. Androgenic (an agent which produces masculine characteristics): testosterone propionate. Anesthetic (an agent used to eliminate pain): benzocaine (local), ether (general), lidocaine (topical), nitrous oxide (general). Antacid (a substance that neutralizes acidity): alumina, aluminum hydroxide, bismuth subnitrate, calcium carbonate, magnesium carbonate, magnesium hydroxide, magnesium phosphate, magnesium trisilicate, sodium bicarbonate. 117 APPENDIX II APPENDIX II Drug function/ingredient: Antihelminitic (an agent that tetrachloroethylene. is destructive to worms): Antibacterial (a substance which destroys suppresses their growth): methenamine. bacteria or Anticonvulsant (an agent that prevents or relieves convulsions): magnesium sulfate. Antieczematic (an agent used to treat an inflammatory skin disease): coal tar, juniper tar. Antifungal of their (an agent growth,): destructive to fungi or suppressive sodium propionate, undecylenic acid, zinc undecylenate. Antiinfective benzalkorium (an agent that fights infection): alcohol, chloride, cetylpyridinium chloride, GbeenntzieatnhonViiuomletc,hlohryiddLeo,crnsilpveerroxindiet,ratiec,hthtahmimmoe]r,osamle.thyl- Antipruritic (an agent which relieves or prevents itching): camphor, menthol, phenol. Antischistosomal (an agent which destroys a type of blood parasite): antimony potassium tartrate. Antiseborrheic disturbance (an agent used of the sebaceous in treating seborrhea, a glands marked by greasy scales on the body): resorcinol monoacetate. Astringent (an agent which stops bodily discharges!: alum, aluminum acetate, aluminum chloride, hydroxide, zinc chloride, zinc oxide, zinc calcium sulfate. Cathartic (an evacuation agent which quickens and from the bowels): castor increases oil, magnesium hydroxide, magnesium sulfate, mineral oil, carboxymethylcellulose, sodium phosphate. sodium Caustic (an agent which destructive to living is burning or corrosive and tissue): silver nitrate. Contraceptive (an agent which prevents conception): nonoxynol-9, octoxynol. 118 APPENDIX II APPENDIX II Drug function/ingredient: Dental caries prophylactic (ar agent which prevents tooth decay): sodium fluoride, stannous fluoride. Depigmenting agent (a substance which removes piqmentation from the skin): hydroquinone. Diuretic (an agent which promotes the secretion of urine): mannitol, theophylline, urea. Emetic (an agent which causes vomiting): ipecac. Estrogens (compounds which produce estrus, the cycle of changes in the genital tract which are produced as a result of ovarian hormonal activity): estradiol benzoate, estrogen, estrone. Expectorant (an agent which promotes the clearing of mucus from the lungs, nose, and throat): potassium iodide. Irritant, local (an agent that produces irritation): camphor. Keratolytic (an agent which causes peeling of the outer ayver of the skin): resorcinol, resorcinol monoacetate, salicylic acid. Lipotropic (an agent which acts on fat metabolism to speed the removal of fat in the liver): methionine. Protectant (an agent that provides a defense against a harmful influence, such as a substance applied to the skin to avoid the effects of the sun's rays): benzoin, calamine, collodion, pectin, Peruvian balsam, petrolatum (white), titanium dioxide, zinc oxide. Relaxant (an agent that reduces tension): theophylline (smooth muscle relaxant). Rubefacient (an agent that reddens the skin by increasing the blood flow): isopropyl alcohol, Peruvian balsam. Scabicide (an agent used to destroy an itch mite which bo es beneath the skin): benzyl benzoate. 119 APPENDIX III APPENDIX III STATUS OF COLOR ADDITIVES USED I14 COSMETICS Permanently listed Provisionally listed 1. Aluminum powder 2. Annatto 3. Azulene 4. Bismuth oxychloride 5. Bronze powder 6. Carmine 7. Carotene 8. 9. 10. 11. 12. 13. 14. 15. Chromium hydroxide green Chromium Lxide greens Copper (metallic powder) D&C Blue No. 4 O&C Brown No. 1 D&C Green No. 8 D&C Orange Jo. 4 D&C Orange No. 10 16. D&C Orange No. 11 17. D&C Red No. 17 18. D&C Red No, 31 19. D&C Red '4o. 34 20. D&C Violet No. 2 21, D&C Yellow No. 7 22. D&C Ys'L';> No. 8 23. D&C Yellow No. 11 24. Dihydroxyacetone 25. Disodium EDTA - copper 26. External D&C Violet No. 2 27. External D&C Yellow No. 7 28. FD&C Red No. 10 29. Ferric ferrocyanide 30. Guanine (pearl essence) 31. Henna 32. Iron oxides 33. Manganese violet 34. Mica 35. Potassium sodium copper chlorophyllin 36. Pyrophyllite 37. Titanium dioxide 38. Ultramarine blue 39. Ultramarine green 40. Ultramarine pink 41. Ultramarine red 42. Zinc oxide 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. Caramel 'J&C Green No. 5 D&C Green No. 6 D&C Orange No. 17 D&C Red No. 6 D&C Red No. 7 D&C Red No. 8 D&C Red No. 9 D&C Red No. 19 D&C Red No. 21 D&C Red No. 22 D&C Red No. 27 D&C Red No. 28 D&C Red No. 30 D&C Red No. 33 D&C Red No. 36 D&C Red No. 37 D&C Yellow No. 10 D&C Orange No. 5 FD&C Blue No. 1 FD&C Blue No. 2 FD&C Green No. 3 FD&C Red No. 3 FD&C Yellow No. 5 FD&C Yellow No. 6 Lead acetate 120 APPENDIX IV APPENDIX IV o; e[.. el _.' 4I4, 4 fbi CI1 0o .o 04 -4 _. O 4 -M . A0 0O _ 0 0OO U _N -A 0.* o4 o 0- _0 =^ c 'aa A * > 4s 4 1 0 u- - -e 1aa 0 Cv C I 00 0 0 a oo * - a M C 4a 0 a 0 MC 4I 0 0 0 0 00 0 0 00 0 0 1 cc l lIaI , 1 I hI21 e 011m ~'cc 3I ~-.M.0 " e aG & 4 01 lI I Xal21 1 'nE I c .I C ~~4' .... CI 1c C t 41 o ~ U41i~ UN Il. - 41 uuj v0 Mm r~ c 121c m am 141. Mr 22I Cr0 40- U c444 ec X41, 0 41 - .C f. > 40 2 APPENDIX IV V 0::l BU1u 410Ul 0 9 CC H1O 0 0C1-~~~~ N V4 > 9 O, C4 _ oLat~ 4_ V1411 0 a .00 .o Vm I * ~e o. . ec . .z 00 CV 4 CL U b o e c1 CN 41 vo c c1' a.2 0 4 0I a, a., o 0 o.04 o la CL C ,.,C APPENDIX IV 4_1 .k= U e.1 0- _ev 1. 41 d .c * 0 04 S 0 O 04 V Cl v. 4I vr U411 2 U @-1 DZ 0o o a > U -V4 Z 0I a 0. u c~o wxs & 4 ._ 414 ~_ Z01 C 041414 ._O. 4..CO.'4 0s 041@..0C@ @V_V041 o0 9f OUIIY 1l.*L u C_ 0 O ll @ 41 u0 41 l1 C N.l@N J0>. 1 O, uvUg 41 e V 0e 0 Z U-. oc 0c 4 01 Z4 Wc 0: 0 C -o 0t W" I 0 x U C OC .- 41 v.4 0 40 C4 1CV O _ *1 41 V Oe141P1.4 v 4e1 1 _4* U4O O@V--n, 4t1 41OC4U1C1.a v41..410C401 0 4 u1 C 0 P ~U0 9 UI 0 Z 0 41. *I 0 0.C 00 V C o0 W~~2 V eC >C Ue I u. l o Vc CS u0o a C1 I Y4 410 0 o041 4u 1 C* 041 vl1 I'. eIa 1 ._ e -_C C0 122 APPENDIX IV APPENDIX IV ' o t01 U, C 4, U, C MPIC. l,,7 ut' @0 o c az ua 0 C za 3*-. lO~ i::= U 0 14014 0 e) Oc C C 0 0C1I --I 4)1 4' L0I C 4' 41 ' .. 4 C C CC C u 11411; 40u0 00.U 4,1' , 4 @e, 0 Oce e *).-, uo14I', cUo.cU UL: Y@ v o o e .U qu 41 (u W C v00, @ >O ^ U-e.C - C o' ml 1C4a- 441V4O0. N v_e<u1@m'ou.0o4me4z _V04'@C1 4 0U; iv o0 C t UC00eM.C,1.C, , Uv o 4 U 00 U X Ue C" M0 .,, . M , 0 4CC- 4te CO s 0 *4 rX4 '5 4 U UA.-S; -4u ., U. III V00 . 4.~1~~123 e ^@ . 0 V CW .CU C-O V aa C N ew cc e'DC c 0123WE4.O 3CW 4 o 'OU APPENDIX IV 'l 0ev PCl _ 201 0 N 0 ECI: G 0 UInOCO v DUO e oe ., U 0.G Ol g a*.- v D o01 Dcl . 1.1 G' vn-S cvC e C 0 - 00 U =e0 Un -0 : ce GD 0 -c Dl Uc gDU C'a. 0.0 APPENDIX IV U -C'I c K' eC - '' C ' CV 0 6t U C,a 3....; U .O C 'ai Vo 0 (0 . rren w i 40 @l GD0'1-UGD~ Pr ' G'0 . C _G CC 'C . C v.0e_ Wv 4 DI C01GvUc... D I c01 c C aa cw u mD WI C 0cG Clow 01 cD-G e _Cl *.0 (.Du, UC -c G _-l o.0 r U 0u Ca e n .U.G 0e U-' Ge DOC UCcGD 0o- C I. Dc~a O U" c UC 0O_o s1DGGD C W cD r C' GD KK rGr D C C CI o 1.1 Ut O-O GDo Uo a2, 2 GOu a -0. D..aC '-.1. - e -e 0 APPENDIX V APPENDIX V In~~~~~~~~4 0)04 0w C ~00) '> I5 0 C 0 .U009.) CO '- VU 0 4) ('- .CC' U0)) 0i 0 'CV0. ) 0) . 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L0 .0I.nm .a 1A LO ) r4'UO 0 U)-0U.L 44l.)aU.400-M451..140)'U4)) -4 a 43 )& Li )4U0 0LICi00W IM14n w-400 L) .-.4 0 0) .. 0m C0 40000 0. 0 EU04-0iC0Li0ti 3W5). (U U) w)(am 0.0)-4 0u(a %U M 10~~~~2 U Z 4 CL CL wm.0-r- w 0w <r 0 , mw 0a w- z A 0 U 4i U) Ai a>, 0 4m ,,U "'U J 0 ) IC 0 .4cN)fIUEE)nr..4 405 M cOcOI0n.q-4) WL 4LCi00 U - In 'Ul I 0~ 0)40 0) - 4i -4M CCI0) i Indi EnC040c0 *.-4i4'0A V0 0)0. 0aV)E)D '>Li IOS 0)14 0 0) > C4Ci C4C 40C4i.4. U) -40 )0 -(CED C.-CC_ '-- Ic- -0 44 0 t-4' 0 r0 Li -4- *w.j U 40 M.0l4JV'C44*Wn Li 0.-4C*-4la- 0.U0t'CC .t0.0.0 mwU 04-400:2) 40 '3> --40) 4iA' i 0 -0 3IIA93-4X,Qr 0) 0) 04-00 104 , 4.0 .4. 0 .LI U4J .~0L ' to 0t73 LEiw0 -4 U)Li0 EC Er 4126(A 4 - -4w09)N0 U -IJ C4-O i 0M.IE.D0tU'o00) -0.)4IU100(14a4-.lC c ACCI~ w IY M0I~) 0 -40 -- UI ro Q 126 APPENDIX VI APPENDIX VI (liit~ DEPARTMENT OF HEALTH, EDUCATION. OFFICE OF THE SECRE ARY WASHINGTON. DC 20201 AND WELFARE June 12, 1978 Mr. Gregory J. Ahart Director, Human Resources Division United States General Accounting Office Washington, D.C. 20548 Dear Mr. Ahart: TcHhoaemmmpeeSnretscsrEefotnfaorryytosuarskteoddraEfntthsautrreepIoCrortsemsepetonintcditltSeoadf,eytoyu".rL"acrkeTqhouefestAeuntcfhloroorsieoutdry comments represent the tentative and are subject to reevaluation this report is received. position when the of the Department final version of We appreciate report before the its opportunity to publication. comment on this draft Sincerely yours, Enclosure Thomas C. Morris Inspector General 127 APPENDIX VI APPENDIX VI COMMENfS OF THE DEPARTMENT OF HEALTH, EDUCATION AND WELFARE ON THE COMPTROLLER GENERAL'S DRAFT REPORT ENTITLED "LACK OF AUTHORITY HAMPERS EFFORTS TO ENSURE COSMETIC SAFETY" General Comments:As it; Commissioner of Food and Drugs stated in testimony before the Subcommittee on Ov-rsight and Investigations Committee on Interstate and Foreign Commerce of the House of Represthpahnaeredznoatdrautldhtceaitgtvateholsai,sbtthuerb"iedAseepsnunsbatflhrteieee.css",ttlseadrwaontsihtneatranhcedcst,ohFraodnocadonsocnmaeendttiwhcieDtsrhuignardceuuAsrdtrmtreihynnetilsotytonrlaydatceicmpoeornpnotsdetu(drcFtaDmstAee)tfhottoohrdaotwplrhooitgvchyeheira Although we report, we the present agree in principle with many do not necessarily agree that statute. Nor do we believe of the recommendations in this these steps can be taken under that, under current statutory authority, an extensive expenditure of resources toward the regulation of cosmetics also stated, is a wise investment of public funds. As ". . .if you have important public health the Commissioner responsibilities in three different areas, and your resources, and in one of if each of them those areas you lays have compelling manifestly claims to inadequate statutory authority, and in the other two wise man is going to allocate (resources) going to get a return." it is at least better, then a more heavily to where he is GAO Recommendation That the Secretary, HEWS, program for insuring the should: direct safety the FDA Commissioner to strengthen FDA's of cosmetic products. Snecifically FDA -- Require a listing of fragrance and flavoring ingredients on cosmetic labels when those ingredients are known allergens. Department Comment We do not concur. There is a lack of adequate classify a fragrance or flavor ingredient as a scientific information "known allergen." Any to ingredient can individuals. give rise to The question allergic contact that remains to be dermatitis resolved in some susceptible is the frequency of such reactions which would permit ingredient as a "known allergen." an unambiguous classification of the This matter is further complicated by the fact that the rate of allergic responses is related to the exposure concentra- oschatthsltiaielhgloenonarigdisfeenac.incngocaldrsataemnerdetFtdaithuteiarincttesothxanstelsierionnmciomgtfoyenr,rleeaaoda,nvilFiefeDllrnrAeiitarfdggmaeraeaasahsyn.nusscnutiedabctrksa(ehoe2ntd1raasnbrCcceefhFegldeRuaosmlnvapieaofr7ctre0oaol0dilr.wyuny1oc1uneutlashsadmeecaedntasdlicinlaoiseno7nnerm0ga0stnia.oooyc1fm5rpe.rebir)osinepdttsarurhtcociiaTtdtconhiutnceocoentllsssalibitesarsatltneondiqdunuasaginendroetomfay raise trade secret issues. 128 APPENDIX VI APPENDIX VI GAO Recommendation -- Hasten the development of ingredient and product-class standards. Department Comment We do not concur. The FDA does not data submissions from industry that have the would be authority to require required before such the standards could Le developed. For FDA to collect the data necessary for the development of ingredient and product-class standards would require resources that are Furthermore, FDA can issue not available to the program at this time. regulations establishing standards only if it can show that a cosmetic violating the standards may be injurious under the condition of use or otherwise in conflict with the existing law. GAO Recommendation -- Establish a specific definition of "adequate substantiation of safety" including specific testing criteria. Department Comment The FDA safety" 21 CFR has already clarified the meaning of "adequate substantiation of in relation to cosmetics with respect to the warning requirement 740.10. In the Federal Register of March 3, 1975 (40 FR 8916) the of Commissioner advised: ". . .that the safety of a product can be adequately substantiated through (a) reliance on already available toxicological test data on individual ingredients and on product formulations that are similar in composition to particular cosmetics, and (b) performance of any additional toxicological and other tests that are appropriate in the light of such existing data and information. Although satisfactory toxicological data may exist for each ingredient of a cosmetic, it will still be necessary to conduct some toxicological testing with the complete formulation to assure adequately the safety of the finished cosmetic." Furthermore, FDA does not have manufacturers substantiate the the authority to require safety of their products that cosmetic nor the authority to establish specific testing criteria. FDA the authority to require submission of data to support also does not have development of such criteria at this time. 129 APPENDIX VI APPENDIX VI GAO Recommendation -- Take steps, in coordination with CPSC, to ensure are packaged in child-proof containers. that toxic cosmetics Department Comment We agree that requiring child-proof packaging for those cosmetics that are revealed to be the cause of poison ingestions leading to injury is not would aware be of worthwhile. At the present time, however, the FDA any hazard associated with cosmetic products that would warrant such received from the Electronic Injury packaging. The FDA will continue to Consumer Product Safety Commission's Surveillance System (NEISS) and take evaluate data (CPSC) Naticnal appropriate action as the need arises. GAO Recommendation That the Secretary, HEW, direct the FDA Commissioner to: -- Obtain and evaluate data from the published literature on the safety of cosmetic products and ingredients. Department Comment We concu. with this recommendation. FDA scientists continuously review ne;w scientific information both from the published literature and other sources. GAO Recommendation -- Obtain and evaluate the basis for ingredients in cosmetics in other restrictions on countries, and, the use of certain where appropriate, adopt similar restrictions on the use of the ingredients in U.S. cosmetics. Department Comment We agree that evaluating ingredients in cosmetics the basis for restrictions placed on the use by other countries is appropriate when the of uUrfcsoneoerisnttdernoidfietcwitcoSiorntosesanmstseteotrsfiiiccwmttaphiroeirosnaengudnsrsteedbaiysosefunmctthahssneuycanhciectneoiidutonhnnget.rareriUidensiTsieehtsnee.tadsnFdHDoSAiwtcnaeoitvncseetosrisa,nmluerceetaunsaindcdbysetero mfacparurrmerokivrhelieitienbeawtidrttewhsidietntahbottaurhsettiehses, tttrohheeesistrhbroaiwsucistseet.hdaotfoTnhlftiyhosereiirifgennpqgruroiervrdeeeignmeuenlntatttooirbwnyeoquulhredaesrstmtpifrroueinlccltuiptdooosenesudstheaaerlsohnFaeDuz.AnadrefdrrIotmatswhoetuailkctdionnigdbsieutasicneotednic.seosnsoaofrny 130 APPENDIX VI APPENDIX VI GAO Recommendation -- Establish an adverse reaction reporting system to (1) develop additional sources of information on cosmetic-related injuries and (2) ensure effective follow up on consumer complaints. Department Comment Monitoring adverse reactions to cosmetic products is an important activity which has resulted in the removal of unsafe cosmetic products from the market. The FDA is using and has used a substantial portion of its cosmetic resources for this type of activity. This includes a program for evaluating adverse reactions reported directly to FDA, monitoring reactions at selected hospital emergency rooms under the NEISS program, evaluating voluntarily submitted product experience reports from the cosmetic industry, conducting a comprehensive consumer survey, and contracting with dermatologists to evaluate and report cosmetic adverse reactions from patients. To further improve efforts in this area, the statute would have to be changed to require mandatory reporting by industry. Effective follow ups on consumer adverse reaction complaints about cosmetics is conducted when facts available to the FDA indicate a possibility that a significant health hazard is involved and that such follow up could lead to an action on the part of the FDA which would improve the safety of a specific prod'uct or cosmetic products in _eneral. FDA's ability to follow up in every instance is limited by the lack of resources, cooperation of the complainant or the treating physician, lack of reliable information to relate the product to the alleged injury, and lack of authority to review complaint files of cosmetic firms and the safety data used to substantiate the safety of the product. Where consumer or physician information indicates serious injury, reports of adverse reactions are currently investigated to the fullest extent possible. GAO Recommendation That the Secretary, HEW, direct the FDA Commissioner to: -- Establish regulations indentifying the conditions of use of drug ingredients under which the ingredient is "intended or understood" to have a drug effect. Department Comment We do not concur. The Food, Drug and Cosmetic (FD&C) Act defines the term "cosmetic" to mean "(1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; .. ." (emphasis added) 131 APPENDIX VI APPENDIX VI Tofifhonertednitudsseeeerdmasietn"odrtinauhfegmf"aednciitasgorndtoheseofitishsn,eterrduccuaitrnneui,rmteahlemsio;rtFiDg&aaCannydtiAoc(fntCu,)ncatstairroet"nai(t8cmo)lefensatrt,ht(eiocotblrhoeedspryretiovhnfaetnnemtnaidfnoeondod) dwoorruulgodthahenadrveaanictmooaslmasep,tpirco"acr(heesmttpshheasuipprosonbaledtmdhneed)io.fntwcrhTdehetudsh,erusteaheopfadritsthiteciunlcaartrtiiocnilnegb.reetdwieWeeennt a is a drug on a case by case basis. In the facts to determine if we can prove use as a drug or a cosmetic. each that case we have to the product was look at all intended for GAO Recommendation -- Establish regulations requiring that labels of cosmetic products containing drug ingredients bear warning statements those required on and given through drug products containing the same the same route of administration. consistent ingredient with Department Comment We do not concur. We believe that it is need for consistent statements, but more appropriate for study is needed FDA to examine to determine the wubheneadtrehrear21wasrCpnFeiRcnigfSiecscttaiwtoaenrmnei7nn4tg0s.1w,hsehnoteuhveledrlabbeneelcreesoqfsuairrayedcoosrimneatpeipacrcohpprrcioaadsteue.ct health hazard that may be associated with the product. Furthermore, is required to prevent a to GAO Recommendation -- Hasten the review of the for use in cosmetics and the conditions of use. safety of color additives provisionally listed take appropriate regulatory action to prevent Department Comment ptfiWianhrrsedeoodmhTidaihtlroebpierievventtieapoiteusdtbwytilhcpoiieorencsnonecvgurdisauisneigrstceietdaootrannfhedtaaiseltnctdlot.yhltaebonhyrelsiatsicarmtcgeteeeehvdlnaitecreerywfqaoputrorsiesehrdescoeoouduslsrrdmaecfetveoetibstiee,mycwasfkoptuefhrarenotdbshtloaeheurveimnasdsias.lactasfcabcekeiitilTlenyehingerttaoyitfasfepcidoetccf.eiodoldjnoauroTtdfhtageoemFeDnAts 132 APPENDIX VI APPEtNDIX VI GAO Recommendation That the Secretary, HEW, direct the FDA Commissioner to evaluate safety data on coal tar hair dye ingredients and require, where applicable, a cancel or other appropriate warning on product labels. Department Comment The FDA is already evaluating safety data on coal tar hair dyes and published a notice in the Federal Register of January 6, 1978 (43 FR 1101-1106) proposing a warning statement o:;hair dye labels about the risk of cancer that may result from the use of hair dyes containing these ingredients. Also proposed is the placement of an information poster in beauty salons advising consumers to review the labels of the products intended for their hair to determine if they contain an ingredient found to cause cancer in animals. TheF_ proposals concern coil tar hair dyes containing 4-methoxy-m-phenylenediamine and its sulfate (also known as 2,4-diaminoanisole and its sulfate). On February 3, 1978, the FDA testified before Congress that it intends to take similar action in regard to any other chemical used in coal tar hair dyes that poses a cancer risk based on FDA's review of appropriate tests, A review of toxicological data on additional coal tar hair dye ingredients is presently underway. The ability of FDA to protect the public from risks associated with long-term use of hair dyes will continue to be severely limited until Congress repeals the coal tar hair dye exemption in the FD&C Act. GAO Recommendation That the Secretary, HEW, direct the FDA Commissioner to: -- Devise a more effective inspection program to ensure that all cosmetic manufacturers are periodically inspected. Department Comment During the past two years, the FDA has instituted more effective manufacturing establishment and product inspection programs, information systems, and evaluation of the compliance activities. FDA has also identified some 1,000 cosmetic manufacturing establishments that were previously unknown, bringing the total number identified to about 2,200. However, lack of legal authority to require cosmetic firms to register their manufacturing sites, coupled with the resource constraints previously discussed, continues to restrict the inspection program for cosmetic manufacturers. 133 APPENDIX VI APPENDIX VI GAO Reconmendation -- Lotabliah GMP's specifically applicable to cosmetic manufacture. Department Comment We concur with the need for Good Manufacturing Practices (GMP) regulations for cosmetics. Currently, the FDA is reviewing a draft of proposed GCP regulations and is concurrently considering a GMP petition submitted by the cosmetic industry. Work on the GMP regulations will be done as expeditiously as possible, given the limited resources available and competing activities. GAO Recommendation -- Expand the collection and testing of cosmetic samples for such factors as microbial contamination and eve and skin irritation. Department Comment Surveillarce programs to determine if cosmetic products are contaminated with harmful microorganisms were conducted during fiscal years 1975 and 1977. In both surveys it was concluded that contamination with harmful microorganisms did not constitute a problem among either domestic or imported products for sale in this country. Similar surveys will be conducted in the future, as resources permit and the need arises. However, there is evidence that some mascara and other eye atea products may not be adequately preserved to prevent the growth of harmful microorganisms under conditions of use. A notice of intent to propose rules, designed to correct this problem, was initiated in the October 11, 1977, Federal Register. Collection and testing of cosmetic samples to determine eye and skin irritation potential would far exceed budgeted resources. Furthermore, additional data are required to make safety determinations; e.g., product composition, ingredient purity, intended use, toxicological data on individual ingredients. Collection and testing of products for irritation are, therefore, directed to those instances where adverse experience, or other reliable data, indicate that a particular product or ingredient may be harmful under conditions of use. 134 APPENDIX VI APPENDIX VI GAO Recommendation -- Take appropriate steps to ensure that prompt and effective enforcement action is taken when violations are found in plant inspections or sample analyses. Department Comment We concur. The present policy of the FDA is consistent with this recommendation. In those situations where violations of the statute are found, FDA takes the most appropriate regulatory action. However, many of the conditions discussed in this report were not actionable because of a lack of adequate evidence to prove that there was a violation of the FD&C Act. Technical Commenvs GAO note: These technical comments have been incorporated into the final report and are not included here. 135 APPENDIX VII APPENDIX VII I>fNCIPAL HEW OFFICIALS RESPON'iBLE FOR ADMINIS ERING ACTIVITIES DISCUSSED IN THIS REPORT Tenure of office From To SECRETARY SF HEALTH, EDUCATION, AND WELFARE: JoGseph A. Califano, Jr. Pavid Mathews Caspar W. Weinberger Frank C. Carlucci (acting) Elliot L. Richardson Robert H. Finch Wilbur J. Cohen John W. Gardner Jan. 1977 Aug. 1975 Feb. 1973 Jan. 1973 June 1970 Jan. 1969 Mar. 1968 Aug. 1965 Present Jan. 1977 Auq. 1975 Feb. 1973 Jan. 1973 June 1970 Jan. 1969 Mar. 1968 ASSISTANT SECRETARY FOR HEALTH (note a)Julius Richmond James F. Dickson (acting) Theodore Cooper Theodore Cooper (acting) Charles C. Edwards Richard L. Seggel (acting) Merlin K. Duval, Jr. Roger O. Egeberg Phillip R. Lee July 1977 Jan. 1977 May 1975 Feb. 1975 Mar. 1973 Dec. 1972 July 1971 July 1969 Nov. 1965 Present July 1977 Jan. 1977 Apr. 1975 Jan. 1975 Mar. 1973 Dec. 1972 July 1971 Feb. 1969 COMMISSIONER, FOOD AND DRUG ADMINISTRATION: Donald Kennedy Sherwin Gardner (acting) Alexander M. Schmidt Sherwin Gardner (acting) Charles C. Edwards Herbert L. Ley, Jr. James L. Goddard Apr. 1977 Dec. 1976 July 1973 Mar. 1973 Feb. 1970 July 1968 Jan. 1966 Present APr. 1977 Dec. 1976 July 1973 Mar. 1973 Dec. 1969 June 1968 a/Until December 1972 the title of this position was Assistant Secretary (Health and Scientific Affairs). (10859) 136 ',".!. -I RNMIT PRINTING- (IFFI':CI: i,7H(:"- 0-199.'25 9