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Casey Mee Lee Daum

Class of 2006

May 2006

Food & Drug Law:

This paper is submitted in satisfaction of the

course requirement and the third year written work requirement.


The 1938 Food, Drug, and Cosmetic Act brought the cosmetic industry under the regulatory jurisdiction of the FDA. However, the confluence of federal administrative budgetary constraints, historical conditions of the cosmetic industry’s development, and pragmatic policy considerations has fostered a unique regulatory regime. The FDA has come to rely heavily on the cosmetic industry to regulate itself in order to ensure consumer safety. Recent criticisms allege that this system of self-regulation is ineffective, inefficient, and/or inappropriate. This paper will situate these criticisms within their various contexts – the historical, social, and administrative realities which define and constrain potential regulatory approaches – in order to assess the propriety of the current schema of cosmetic industry self-regulation. I. INTRODUCTION

“But our desire for beauty is likely to outlast its object because, as Kant once observed, unlike all other pleasures, the pleasure we take in beauty is inexhaustible.”[1]

The pursuit of beauty as achieved through cosmetics is a virtually timeless and universally enduring endeavor. For centuries women have utilized cosmetics to enhance or alter physical appearance, negotiate conceptions of femininity, combat external manifestations of aging, challenge societal gender norms, assert social status, and so on. For, “the urge to decorate ourselves is one of the most fundamental instincts in human nature,” and the act of acceding to such an urge can entail profound symbolic messages and societal consequences according to social context.[2] The long history of cosmetics usage can be demonstrated by the fact that earliest archaelogical indications of cosmetics date back to 10,000 B.C.[3] Now, centuries later, we inhabit a societal context which has fostered and maintained the ascendency of the cosmetic industry – a context of increasing globalization, rampant consumerism, technological sophistication, lengthened life expectancy, and societal preoccupation with aesthetics and youthful image. The president of the Cosmetic, Toiletry, and Fragrance Association (CTFA) notes the wide reach of the industry and its potential for seemingly limitless expansion: “In an era of globalization, we are truly one of the world’s most global industries. Our products and our innovation know no boundaries. Whether it’s Bangkok or Beijing, Baton Rouge or Bagdad, the products that we make are the products that women and families use every single day.”[4] The cosmetic industry today is a $29 billion business whose aggressive marketing and advertising efforts have forged a powerful trajectory of continued growth.[5]

While the 1938 Food, Drug, and Cosmetic Act provisions granted the FDA de jure regulatory authority in the cosmetic arena, industry developments and FDA budgetary limitations since the 1960s or so have resulted in a de facto regulatory regime of fairly minimal FDA regulation of the cosmetic industry and extensive industry efforts at voluntary self-regulation. This regime of voluntary self-regulation has recently been criticized by groups such as the Environmental Working Group as ineffective and inadequate for the protection of consumer safety. This paper will examine the current framework of limited FDA regulation and extensive efforts at industry self-regulation in order to determine whether such framework is a necessary and effective reality or only an illusory form of regulation in need of replacement or change. This debate must be contextualized in order to be properly addressed, taking into account: the societal context of cosmetic usage, industry realities, pragmatic limitations on regulatory possibilities, and theoretical bases for administrative regimes.


“In regulating cosmetics, the agency functions like a highway patrolman.... FDA regulation of cosmetics is entirely ex post.”[6]

Most citizens likely believe, probably vaguely but with conviction, that the FDA engages in expansive direct regulation of the detailed workings of the cosmetic industry. In fact, the first Food and Drug Act in 1906 did not even include cosmetics within its purview – it was not until the 1938 Act that cosmetics came under FDA regulatory authority. Contrary to popular belief, FDA regulation under the 1938 Act has primarily been limited to regulation of cosmetic products after their release into the marketplace; in other words, despite popular understanding of “the mighty FDA [as] a powerful organisation,” “neither products or ingredients are reviewed or approved before they are sold to the public.”[7] This ex post regulation of cosmetics involves a process by which the FDA “functions like a highway patrolman” – “its inspectors look out for products that are dangerous to health, about which it can, like a highway patrol man, do something.... manufacturers routinely do [pre-market] testing, but that is not because FDA demands it.”[8] In place of extensive pre-marketplace regulation, the FDA has a long history of reliance on the cosmetic industry’s engagement in voluntary self-regulation.

The Federal Food and Drugs Act of 1906

The Federal Food and Drugs Act of 1906, “the progenitor of today’s regulatory system,” did not include cosmetics within its regulatory scope. This exclusion created a federal regulatory gap in the area of cosmetics; this gap was at the time filled by the U.S. Post Office’s enforcement of the postal fraud statutes and the Federal Trade Commission’s enforcement of the Federal Trade Commission Act.[9] The exclusion of cosmetics from the 1906 Act likely occurred because of politics: “in 1906 the beauty industry was considered so inconsequential that its inclusion would have lowered the tone of the legislation. Also, the beauty industry affected only women. And women couldn’t vote.”[10] In fact, as a general matter, “because ‘only’ women used beauty aids, cosmetics and their impact on the economy have been almost wholly ignored in historical analyses about consumption.”[11] While the undeniable reality of women’s political impotence in 1906 surely constituted a major factor in the exclusion of cosmetics from the 1906Act, the mere fact of market size also played a role. For, “according to manufacturing census data on toilet items, with which cosmetics were included... sales of cosmetics in 1900 stood at about $100,000.”[12] However, beginning around 1900, the cosmetic industry emerged and rapidly expanded, as “women’s growing interest in beauty products coincided with their new sense of identity as consumers.”[13] By around the mid-1920s, retail cosmetics sales were estimated at about $125,000,000 per year[14] and about $150,000,000 in 1940.[15]

The federal regulatory gap created by the 1906 Act’s exclusion of cosmetics grew in significance as the industry grew in size during the early 20th century. This gap was quickly felt by “the very agency charged with enforcement” of the Act, the Bureau of Chemistry: “In annual reports as early as 1918, the bureau bemoaned both a lack of funding and a lack of true protection for consumers. Many consumers assumed protection where none existed, unconsciously expanding the power of the law and the enforcement ability of the bureau to protect them.”[16] The disparity between consumers’ assumptions and regulatory reality became dangerous when cosmetic products began harming consumers, and “by the 1930s, the industry was getting away with murder”:

A fifty-two-year-old woman was fatally poisoned by Lash-Lure, a mascara substitute. Koremlu, a depilatory made with rat poison, crippled scores of women. Cuticle removers removed fingernails and fingertips along with cuticles. Acetone, carbolic acid, coal-tar dyes, formaldehyde, and mercury were common ingredients.... In 1933, the FDA put together its ‘Chamber of Horrors,’ an exhibit intended to pump up support for the Tugwell Bill, an amendment to the 1906 act that would have given FDA jurisdiction over the beauty industry.... The shock tactics got publicity, but didn’t get the bill passed.... The beauty industry had lobbied aggressively against the bill, arguing that factory inspection would reveal trade secrets and ingredient names would only confuse women...[17]

Many point out that a historical pattern of tragedy and its attendant publicity provided the political impetus and momentum for legislative change in the form of increased federal regulation of cosmetic products. For example, one writer argues that “some well-publicized incidents caused by unregulated products, particularly cosmetics, spurred consumer activism in the years from 1900 to 1945.... It was grassroots political activism, combined with the power of personal tragic stories, I argue, that ultimately challenged, and changed, national law culminating in the 1938 Food, Drug, and Cosmetic Act.”[18] A notable player in this consumer activism was M.C. Phillips and her 1934 report Skin Deep – an “expose of the beauty industry that did much to whip up the demand for cosmetics regulation”; through this expose, Phillips “denounced the ‘cosmetics racket’ for selling illusions, and she claimed women’s right, as voters and taxpayers, to safe, honest cosmetics.”[19]

The 1938 Food, Drug, and Cosmetic Act

The 1938 Food, Drug, and Cosmetic Act provided the first authority for the FDA to regulate the cosmetic industry. In fact, a major purpose of this Act was the regulation of cosmetics in response to some early twentieth century tragedies involving unsafe cosmetic products.[20] The major provisions of the 1938 Act regarding FDA regulation of cosmetics involve adulteration and misbranding of cosmetics. These provisions are as follows:

§ 361.  Adulterated cosmetics. A cosmetic shall be deemed to be adulterated--
(a) If it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual, except that this provision shall not apply to coal-tar hair dye, the label of which bears the following legend conspicuously displayed thereon: "Caution--This product contains ingredients which may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows; to do so may cause blindness", and the labeling of which bears adequate directions for such preliminary testing. For the purposes of this paragraph and paragraph (e) the term "hair dye" shall not include eyelash dyes or eyebrow dyes.
(b) If it consists in whole or in part of any filthy, putrid, or decomposed substance.
(c) If it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
(d) If its container is composed in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health.
(e) If it is not a hair dye and it is, or it bears or contains, a color additive which is unsafe within the meaning of section 721(a).[21]

§ 362.  Misbranded cosmetics. A cosmetic shall be deemed to be misbranded--
(a) If its labeling is false or misleading in any particular.
(b) If in package form unless it bears a label containing (1) the name and place of business of the manufacturer, packer, or distributor; and (2) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count: Provided, That under clause (2) of this paragraph reasonable variations shall be permitted, and exemptions as to small packages shall be established, by regulations prescribed by the Secretary.
(c) If any word, statement, or other information required by or under authority of this Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
(d) If its container is so made, formed, or filled as to be misleading.
(e) If it is a color additive, unless its packaging and labeling are in conformity with such packaging and labeling requirements, applicable to such color additive, as may be contained in regulations issued under section 721. This paragraph shall not apply to packages of color additives which, with respect to their use for cosmetics, are marketed and intended for use only in or on hair dyes (as defined in the last sentence of section 601(a).
(f) If its packaging or labeling is in violation of an applicable regulation issued pursuant to section 3 or 4 of the Poison Prevention Packaging Act of 1970.[22]

§ 363.  Regulations making exemptions. The Secretary shall promulgate regulations exempting from any labeling requirement of this Act cosmetics which are, in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantities at establishments other than those where originally processed or packed, on condition that such cosmetics are not adulterated or misbranded under the provisions of this Act upon removal from such processing, labeling, or repacking establishment.[23]

Cosmetic products are also considered misbranded under the 1938 Act if they fail to comply with the ingredient declaration provisions of the Fair Packaging and Labeling Act, for “the ingredient list on a cosmetic container is the only place where a consumer can readily find out the truth about what he or she is buying.”[24] Thus, retail sale cosmetic labeling must contain a conspicuous ingredient declaration which lists ingredients in descending order of predominance, according to 21 CFR 701.3. The FDA has promulgated specific regulations regarding adulteration, misbranding, and voluntary registration. The legislative history for the 1938 Act does not indicate any legislative intent to require “premarket testing, premarket notification, premarket approval, or any other form of listing or registration” for cosmetic ingredients or final products.[25]

History of FDA Reliance on Industry Self-Regulation

The early years of 1938 Act enforcement manifested a spirit of collaboration among the FDA and various industry organizations which would endure and come to characterize the current regulatory framework: “What emerged in the first years of enforcement was a loose collaboration between physicians, manufacturers, and the FDA.... problems continued to crop up, but the FDA and manufacturers responded much more quickly than previously.... The cooperation of the [Toilet Goods Association] and other food, drug, and cosmetic associations was, some felt, indicative of the broad support the new law enjoyed.”[26] In fact, despite earlier (and possibly more recent or enduring) indications of potential industry aversion to regulation, it seemed that at least some major cosmetic industry players and organizations were in support of the 1938 Act at its time of enactment; although this support perhaps was based upon the Act’s minimal pre-market safety regulation requirements. The early regulatory regime in a way bifurcated industry attitudes towards cooperation with the FDA: in general, more prominent cosmetic empires with more established reputations were more cooperative as compared to smaller, less reputable operations. FDA Chief Walter Campbell wrote in January 1940:

‘Really, the big cosmetic houses aren’t sorry that the regulation has come.... One spokesman for the industry said that they realized for some time that they were being driven too far by the ‘lunatic fringe.’ When some fly-by-night put out a paste and promised that one application would make a hag into a candidate for the front row of the chorus, more reputable houses felt pushed into making some assertions or suggestions which were on the inflated side.’[27]

The 1938 Act, and particularly the early era of its enforcement, was aimed at improving consumer safety across the industry by limiting the assertions and actions of both larger and smaller cosmetic firms. In these early years of regulation, the pervasive spirit of collaboration between the FDA and the industry also encompassed consumers and their physicians: “The FDA... relied in no small measure on the American public and physicians to alert the agency about possible problem products.” Theodore Klumpp, Chief of the FDA Drug Division, addressed consumers and physicians in 1940: “‘Congress had not provided us with facilities nor the personnel to make clinical tests of drugs, devices or cosmetics, ourselves.... We are dependent upon the reports of your experiences.’”[28] This early history of across-the-board and comprehensive collaboration paved the way for the modern regime of voluntary industry self-regulation and cooperation with the FDA.

The 1938 Act does not grant the FDA authorization to require registration of cosmetic manufacturers, ingredient listing submission, or submission of pre-market information or safety substantiation for cosmetic products. The FDA website explicitly defines the limits of FDA authority over cosmetics and affirms the important role of the industry in assuming responsibility for safety in the face of these limitations. The website section entitled “FDA Authority Over Cosmetics” prominently features two subsections which plainly declare the respective roles of the FDA and the industry:

Does FDA approve cosmetics before they go on the market? FDA’s legal authority over cosmetics is different from other products regulated by the agency.... Cosmetic products and ingredients are not subject to FDA premarket approval authority, with the exception of color additives. However, FDA may pursue enforcement action against violative products, or against firms or individuals who violate the law.

Who is Responsible for substantiating the safety of cosmetics? Cosmetic firms are responsible for substantiating the safety of their products and ingredients before marketing. Failure to adequately substantiate the safety of a cosmetic product or its ingredients prior to marketing causes the product to be misbranded unless the following warning statement appears...[29]

The FDA’s establishment in 1971 and 1972 via regulations of a three-part voluntary program for the submission by manufacturers of establishment and ingredient information occurred at the request of the CTFA. This voluntary program initially included: 1) registration of cosmetic establishments (21 C.F.R. Part 710), 2) voluntary filing of cosmetic product ingredient statements (21 C.F.R. Part 720), and 3) voluntary filing of adverse reaction reports (21 C.F.R. Part 730). The third part of the program was withdrawn in 1997. Shortly after the voluntary program began, former FDA Commissioner Alexander Schmidt commented on the industry’s successful participation: “‘I know of no other industry which has a better record of voluntary accomplishment.’”[30] When in 1998 the FDA suspended the establishment registration and ingredient listing programs because of severe budgetary constraints, the CTFA helped to rescue the programs by successfully lobbying Congress to “restore adequate funds for a credible cosmetic regulatory program.”[31]

The FDA website provides information and instructions about the voluntary program in a straightforward style which signals to the industry both the “do it yourself” nature of the regulatory regime and the mutually beneficial (to both FDA and the industry) importance of industry participation in the program:

The Voluntary Cosmetic Registration Program is an FDA post-market reporting system for use by manufacturers, packers, and distributors of cosmetic products that are in commercial distribution in the United States.... The VCRP helps FDA in its mission to protect consumers, while also helping cosmetic manufacturers and distributors make informed decisions. The greater the participation by the cosmetic industry, the better this program works.[32]

The “How to Participate” section of the webpage employs clear and accessible, non-legal, non-statutory style of language to delineate the two simple voluntary steps for cosmetic manufacturers:

1) Registering cosmetic manufacturing establishments. Cosmetic manufacturers or packers whose products are in commercial distribution in the United States should register their establishments, using a separate Form FDA 2511 for each manufacturing location. Only manufacturers and packers should register, not distributors. FDA assigns a registration number to each manufacturing establishment registered and sends you a receipt.

2) Filing Cosmetic Product Ingredient Statements (CPIS). A cosmetic manufacturer, packer, or distributor should file a statement for each product the firm has entered into commercial distribution in the United States. With the distributor’s permission, a private labeler or packer also may file these forms. Use a separate Form FDA 2512 for each formulation.[33]

The website then goes on to explicitly point out the benefits to all – industry participants, FDA, and consumers – of industry participation in the program: VCRP participation enables FDA to easily and quickly provide manufacturers with important information about cosmetic ingredients, and the VCRP program enables safety evaluation of cosmetic ingredients by the CIR.[34] FDA utilizes this website to emphasize the voluntary nature of this program, the need for ensuring consumer safety, and the cosmetic industry’s important responsibility to self-regulate and self-police in the face of minimal FDA regulatory authority and capacity: “The VCRP is not a cosmetic approval program. Cosmetics are not subject to FDA premarket approval or mandatory establishment registration or ingredient reporting. It is the firm’s responsibility to assure that its cosmetic products and ingredients are safe and properly labeled, in full compliance with the law.”[35] The VCRP provides a nexus for informational flow between the FDA and the industry, and thus its effectiveness depends upon the percentage of industry participation. Currently only about 35% of eligible companies in the industry participate in the program; the FDA would prefer a higher participation rate.[36]

A recurring safety issue in cosmetic regulation history is the distinction between drugs

and cosmetics. The Drug Amendments of 1962 strengthened the new drug provisions of the 1938 Act, making the distinction between a drug and a cosmetic very important.[37] The diverse outcomes of 1960s cases regarding “wrinkle remover” products claims established what would be an enduring difficulty in differentiating between drug and cosmetic claims in cosmetic labeling.[38] Further difficulties in this area arose in the 1980s with the emergence of new, more technologically advanced skin care products. FDA regulatory letters alleging that the advanced claims made by these skin care products were in fact illegal new drugs were ultimately resolved through industry adjustments of marketing claims. The blurry distinction between cosmetics and drugs resurfaced in the 1990s with the popularity of alpha hydroxy acids products.[39] Thus, it appears that inevitably “this will remain an area of contention for years to come.”[40]

The Color Additive Amendments of 1960 constitute the only legislative amendments to the cosmetic provisions of the 1938 Act. Congressional consideration of additional legislation has never resulted in new legislative authority for cosmetic regulation, as “there has been no credible evidence that existing cosmetic ingredients and products pose a significant health hazard to consumers.”[41] For example, 1988 House hearings conducted by Representative Ron Wyden regarding the safety of cosmetic ingredients and products did not result in additional legislation; the proposed legislation included a pre-market testing requirement, increased FDA access to industry data regarding safety, mandatory registration of establishments, products, and ingredients, and mandatory ingredient listing for professional products. CTFA’s vigorous defense of the industry’s safety record constituted a critical focal point of these hearings. CTFA responded to allegations of toxic chemicals in cosmetics by the National Institute of Occupational Safety and Health with a statement that these chemicals are not in fact toxic as used in cosmetics and in fact are commonly used in various other consumer products.[42] Overall, CTFA’s response to criticisms made of the industry during the hearings focused on “three major points: (1) cosmetics are safe; (2) the industry's voluntary programs work; and (3) FDA has existing and adequate authority to act if deemed necessary.”[43] The strong defense of the industry by CTFA in these hearings is emblematic of the prevailing regulatory regime founded upon industry safety assurance via voluntary self-regulation. This regime will likely endure, for “as long as the combined efforts of FDA and CTFA do in fact protect consumers from significant health hazards and assure the public of adequate information about cosmetic products in the marketplace, there will be no justification for new cosmetic legislation in the future.”[44]


“Cosmetics are among the safest of all consumer products. Their continued safety is ensured by ongoing industry voluntary programs, as well as by ample FDA authority to regulate.”[45]

The Cosmetic, Toiletry, and Fragrance Association maintains a website entitled “Cosmetics Are Safe”[46] which emphasizes both FDA regulatory authority and industry self-regulation in order to diffuse any consumer concerns about the safety of cosmetic products, particularly in light of recent criticisms. The website states: “The FDA has the legal authority to regulate the safety of cosmetic products; however, it has comparatively little need to use its authority because cosmetics are composed of safe ingredients and because, when necessary, the cosmetic industry has acted voluntarily to prevent safety problems.”[47] Glossing over the details of precisely what forms of legal regulatory authority the FDA specifically wields, this CTFA-sponsored website statement instead emphasizes voluntary industry efforts to ensure safety. In so doing, this statement aptly encapsulates the essence of the current regime of extensive industry self-regulation. This spirit of industry self-sufficiency perhaps grew out of the historical conditions of the industry’s emergence. The beauty industry began as a consumer empire built by women for women – an industry whose foundational forerunners embraced a spirit of determined self-sufficient entrepreneurship and a fiercely consumer-oriented retail ethic.

Industry Emergence

While “nineteenth-century American women inherited a tradition of cosmetic preparation, which freely borrowed from a variety of sources and reached back through the centuries,”[48] traces of the modern cosmetic industry as we know it today began to emerge around the end of the nineteenth century. The commercial manufacture of cosmetic products at this time occurred in diverse forms, but primarily on a fairly local or regional level: the “more commonplace were the hundreds of local druggists and hairdressers who compounded their own powders and creams.... in the late nineteenth century, cosmetics manufactured solely for a local or regional market far outnumbered those that achieved national distribution.”[49] Focused predominantly on limited regional markets, cosmetic manufacturing “remained a small-scale business, highly entrepreneurial and without a distinctive identity.... until the years immediately before and after World War I... [when] the industry experienced substantial growth.”[50] The localized, entrepreneurial self-sufficiency of this nascent phase of cosmetic production can perhaps be viewed as foreshadowing the self-sufficiency of the cosmetic industry in the modern regulatory arena.

Around 1900, as “women’s growing interest in beauty products coincided with their new sense of identity as consumers,” “a new, self-conscious notion of the woman consumer emerged”[51] and the cosmetic industry evolved in tandem with this new woman consumer – a female consumer who was beginning to find herself freed from the constraints of Victorian era anti-cosmetics attitudes. Department of Commerce statistics indicate an extraordinary increase in the number of firms manufacturing perfume and toilet goods around 1900: from 67 firms in 1880 to 262 firms in 1900.[52] Naturally, women’s societal context has intimately influenced the evolution of the cosmetic industry over time, as the industry has continued to respond to women’s needs and desires by creating the appropriate products and marketing strategies. At this important juncture, some of the most influential and enduring industry players emerged and were critical in shaping the future of the industry: “At least five enduring companies got their American start in the first fifteen years of the twentieth century. Each company took advantage of women’s (and society’s) changing perceptions and conceptions about beauty. These companies effectively parlayed a standardized, homogenized perception of beauty into a multimillion dollar business.”[53]

Many of the pioneers of this stage of industry formation were women who were able to create new opportunities both for the industry and for their gender:

...this business for women was largely built by women. In the early stages of the developing cosmetics industry, from the 1890s to the 1920s, women formulated and organized ‘beauty culture’ to a remarkable extent. The very notion of femininity... opened opportunities in this business, even as it restricted them elsewhere. And women seized their chances, becoming entrepreneurs, inventors, manufacturers, distributors, and promoters.[54]

Early female entrepreneurs in the industry such as Elizabeth Arden, Madam C.J. Walker, Annie Turbo Malone, etc. worked for the betterment of women’s opportunities in a way that challenges many feminist critiques of the beauty industry as oppressing all women; for these women “consciously created job opportunities for women, addressed the politics of appearance, and committed their profits to their community. Indeed, the history of these businesswomen flatly contradicts the view that the beauty industry worked only against women’s interests.”[55] In utilizing the cosmetic industry to provide both products and opportunities for women just like themselves, female pioneers in the industry fostered a spirit of self-sufficiency – an idea of a group creating something for itself and by itself. [56] This form of proprietary independence perhaps established some organic roots of for the modern industry’s regime of self-regulation and industry independence; the emergence of an industry via the efforts of the natural users and consumers of its products lays important thematic groundwork for an enduring history of industry self-sufficiency in the context of regulation.

In addition to progressively challenging prevailing limitations on women’s career opportunities by creating new roles for women in business, early female cosmetics entrepreneurs contributed in positive and progressive ways to American social democracy through example and through ideological imagery. For, “strikingly, many of the most successful entrepreneurs were immigrant, working-class, or black women. Coming from poor, socially marginal backgrounds, they played a surprisingly central role in redefining mainstream ideals of beauty and femininity in the twentieth century.... they made the pursuit of beauty visible and respectable.”[57] By means of their own success, these women carved out the possibility in American society for the similar advancement of other socially marginalized women. They also worked – albeit with profit-based incentives – to de-stigmatize and socially legitimize the consumerist pursuit of beauty, thus democratically expanding the array of physical self-improvement options available to all women: “By promoting the idea of improving nature, women entrepreneurs validated beauty culture for a broad range of women.... In the female democracy of manufactured beauty, all could improve their looks – and those who did not had only themselves to blame! These ideas, of course, circulated in the service of profit.”[58]

As societal acceptance and consumer enthusiasm for the cosmetic industry grew during the early twentieth century, the mass market for cosmetics emerged, flourished, and continued to grow at a remarkably rapid rate. “Between 1909 and 1929 the number of American perfume and cosmetics manufacturers nearly doubled, and the factory value of their products rose tenfold,” and in 1929, Americans spent an estimated $700 million per year on cosmetics and related services; thus, “in a very short time, cosmetics had become an affordable indulgence for American women across the socioeconomic spectrum.”[59] This growth continued, and in the 1930s, “makeup had become an aesthetic expression woven deeply into women’s daily life, a life increasingly entwined with commodities, advertising, and mass media that promoted, in Charles Revson’s famous phrase, ‘hope in a jar.’”[60] By the 1940s “manufactured beauty formed a major sector of the economy and informed the everyday practices of women,” and “in the decades that followed, mass media tied cosmetics ever more closely to notions of feminine identity and self-fulfillment.”[61]

The early twentieth century explosion of industry growth and its attendant culture of consumerist marketing eventually provoked some critical reactions of skepticism and concern. While some were simply not ready to entirely buy into the industry’s sanguine promises of “hope in a jar,” others were more specifically concerned about the safety of the suddenly ubiquitous cosmetic products. Thus, the late 1920s brought the onset of consumer and market research groups which were often particularly critical of cosmetics. One such organization established in the late 1920s was Consumers’ Research Inc., whose philosophy and goal was to “‘develop a science of consumption so that consumers can defend themselves against the aggressions of advertising and salesmanship.’”[62] In 1934, Consumers’ Research Inc. published M.C. Phillips’ expose Skin Deep . Ms. Phillips’ book “was an early expose on not merely the content of product, but the cost-to-profit ratio enjoyed by manufacturers and the dubious habit of selling illusions; ‘as deleterious’, claimed the author, ‘as some cosmetics ingredients.’”[63] Ms. Phillips’ 1934 work was a precocious harbinger of the progressively extreme product claims and the increasingly massive profits that the modern cosmetic industry would make in years to come, and Skin Deep stands as an important forerunner to modern criticisms of the industry. The federal government and the industry have historically responded to such criticisms and addressed such safety concerns by establishing a comprehensive system of self-regulation.
Industry Self-Regulation

Voluntary self-regulation by the U.S. cosmetic industry is considered by many to be both a regulatory anomaly and an exemplary success, forged from years of cooperation and experience:

No industry in the history of this country has ever made a greater commitment to self-regulation or has been more successful in achieving it than the U.S. cosmetic industry. Virtually all aspects of the cosmetic industry are subject to some form of voluntary CTFA program initiated by the industry itself to assure FDA, the medical profession, and the public that cosmetic products are safe and appropriately labeled.[64]

The primary incentives for industry self-regulation are twofold: 1) industry image, and 2) industry independence. Protecting industry image entails the maintenance of favorable consumer perceptions of safety levels in order to achieve steady retail sales. John Bailey, director of FDA’s division of color and cosmetics has noted the importance to the industry of protecting its image: “‘The cosmetic industry is sensitive to the image of an uncontrolled market where anything goes.... They counter this image with well-established self-regulation programs.’”[65] Protecting industry independence entails ensuring adequate industry safety levels in order to avoid the need for increased federal regulation which would externally impose more stringent requirements upon the industry. Bailey has commented on the industry’s utilization of self-regulation protect its independence: “‘Part of the incentive for such industry policy is to avoid increased regulatory authority.’”[66] Thus, the cosmetic industry since the 1960s or so has relied on self-regulation, particularly in times of problems, to convince Congress not to enact new, more intrusive legislation. The industry has kept federal regulation at bay by doing it themselves, often citing the industry’s record of minimal safety crises and few products liability cases as evidence of the effectiveness of this “do it yourself” industry approach. For example, when faced in the 1970s with the prospect of “onerous legislation... the industry established a broad philosophy of voluntary self-regulation and then implemented it in a truly unprecedented way.... the CTFA voluntary programs have sought to assure FDA, Congress, and the public that no further governmental effort is needed to provide safe and properly labeled products for the consumer”[67]

The Cosmetic, Toiletry, and Fragrance Association is the leading national trade association for the cosmetic, toiletry, and fragrance industry founded in 1894 by industry leaders. CTFA’s approximately 600 member companies include both active members who manufacture or distribute finished personal care products and associate members who supply raw materials, produce trade and consumer magazines, etc.[68] CTFA’s mission is as follows:

CTFA strives to ensure that the personal care products industry has the freedom to pursue creative product development and compete in a fair and responsible marketplace. CTFA represents the industry’s interests at the local, state, national, and international levels, promoting voluntary industry self-regulation and reasonable governmental requirements that support the health and safety of consumers.”[69]

This mission demonstrates the industry’s desire to protect its independence by promoting extensive self-regulation. CTFA president and CEO Pamela G. Bailey points out the collaborative nature of the industry’s internal commitment to consumer safety: “Our industry works everyday with leading medical and scientific experts to ensure the safety of our products. We start with ingredients that are thoroughly tested and shown to be safe, and then we further test the finished products to make certain they are safe.... We are ready to maintain this commitment to doing the right thing for our consumers.”[70]

The CTFA was originally founded in 1894 as the Manufacturing Perfumers’ Association of the United States (MPA), led by New York perfumer Henry Dalley. The MPA came together largely in response to pending Congressional legislation threatening to increase the tariff on imported raw materials, which would increase the cost of toilet goods production. Dalley organized his industry peers together in order to more effectively oppose the tariff, and the first ten years of the MPA’s existence were similarly spent lobbying against such tariffs and taxes. In 1922, the MPA changed its name to the American Manufacturers of Toilet Articles (AMTA). The 1938 Food, Drug and Cosmetic Act found overall support from the AMTA because it promised a uniform federal standard of regulation rather than varied state regulatory standards which would make interstate commerce more complicated for cosmetic manufacturers.[71]

The late 1960s and early 1970s brought increasing pressure on the Toilet Goods Association (TGA) in the form of consumer safety and environmental concerns, and the TGA changed its name to the Cosmetic, Toiletry and Fragrance Association in 1971 as a means of symbolizing “an organizational ‘metamorphosis’ that prepared the association, and the industry to face a new decade of challenge.”[72] During the 1970s, the CTFA began what would become “a decade-long struggle to convince regulatory agencies and consumer groups that the industry's commitment to product safety and self-regulation precluded the need to introduce new legislation.”[73] A monumentally important part of this struggle occurred in late 1970, when FDA staff declared at a meeting with CTFA that the agency would not seek Congressional legislation regarding mandatory registration and reporting if the industry would agree to voluntarily supply such information. In response, the CTFA proposed the current program, which was the first of its kind; then CTFA President Jim Merritt hailed the program a “‘desirable and innovative example of industry cooperation with government to better consumer protection.’”[74] This form of innovative cooperation has since proven itself to be enduring and effective, and “the success of this program represents a remarkable tribute to CTFA and its members and stands as a model for other industries throughout the world.”[75]

FDA reliance on CTFA voluntary cooperation and collaboration has been not only effective but also necessary given pragmatic budgetary constraints on agency resources and capabilities. For example, in 1998 FDA announced a 50% reduction in the staff of the Office of Cosmetics and Colors and the elimination of several cosmetic regulatory programs. The industry responded by successfully lobbying Congress for restoration of funding. More recently, CTFA offered a similar statement of support for adequate FDA cosmetic regulation funding, recognizing the importance of that funding to sustain even voluntary industry regulatory programs. On February 15, 2006, CTFA President Pamela G. Bailey issued a statement on the FDA budget for cosmetics:

CTFA is sensitive to the challenge of budget realities that the Administration is facing in funding existing programs at FDA while redeploying assets to high priority programs.... At the same time, CTFA wants to emphasize the importance of fully funding the existing FDA cosmetics program which helps to ensure cosmetics are among the safest products the Agency regulates. CTFA is committed to working with the cosmetics program at FDA to enhance effectiveness with existing resources. CTFA continues to strongly support voluntary industry efforts such as the Cosmetic Ingredient Review (CIR) Expert Panel and the Voluntary Cosmetic Reporting Program that support FDA’s cosmetics program.[76]

The Cosmetic Ingredient Review (CIR) is an independent nonprofit organization comprised of a group of scientists which reviews the safety of cosmetic products ingredients. Established in 1976 by CTFA after FDA declined to create a program for safety assessment of cosmetic ingredients, the CIR is financed by the cosmetic industry but is scientists are independent academics who are prohibited from working for any cosmetic company. In fact, CIR staff and consultants are kept separate from CTFA and the industry and are required to abide by the same conflicts of interest standards that apply to special federal government employees.[77] Upon establishment of CIR,

CTFA recognized that acceptance of the program and its results would depend on three major factors: (1) the safety review process had to be conducted with no cosmetic industry bias; (2) the Panel of Experts who would review the safety test data on each ingredient had to be given complete independence; and (3) the review process, the reports, and all of the data used in the safety evaluation had to be available for public and scientific scrutiny.[78]

The CIR Expert Panel consists of nine academic scientists who review both published and unpublished scientific data regarding ingredients in order to ascertain their safety as used in cosmetic products, whether additional testing on certain ingredients is required, etc. The seven CIR Expert Panel voting members are chosen via public nomination by consumer, scientific and medical groups, government agencies, and industry; the three non-voting Expert Panel members are liaisons who represent the FDA, the Consumer Federation of America, and CTFA.[79]

The configuration of the Expert Panel is designed to reflect and foster a sense of cooperation and collaboration across government, industry, and public: “By uniting industry, consumers and government, the Expert Panel creates a unique environment for discussions affecting public safety.”[80] The resultant data and all panel deliberations are open and available for public review and comment: “The Cosmetic Ingredient Review thoroughly reviews and assesses the safety of ingredients used in cosmetics in an open, unbiased, and expert manner, and publishes the results in the open, peer-reviewed scientific literature.”[81] In addition to these ingredient reports, CIR publishes a CIR Annual Report and a CIR Compendium which is updated annually.[82] The 2005 CIR Compendium summarized safety assessments for 1205 individual cosmetic ingredients.[83] CIR procedures are modeled after FDA procedures for OTC Drug Review and Biologics Review. The CIR is a paradigmatic example of cooperation across the industry and with the FDA, and is one of CTFA’s most applauded “success stories, winning praise from regulators as well as consumer groups for its efforts to ensure product safety.”[84] CIR continues to be one of CTFA's success stories, winning praise from regulators as well as consumer groups for its efforts to ensure product safety. The industry recognizes that by participating in CIR and pooling safety information on cosmetic raw materials, it can minimize the enormous expense and inefficiency of duplicate safety testing.
CTFA developed and published the International Cosmetic Ingredient Dictionary and Handbook , which provides a complete list of ingredients used in cosmetic and personal care products, along with their definitions and trade names. This dictionary is recognized by the FDA, and FDA regulations refer to it as a primary source for ingredient nomenclature in cosmetic product labeling; it is widely accepted worldwide as a resource for cosmetic ingredients. CTFA also worked with the American Academy of Dermatology to develop Cosmetic Industry on Call , an updated-yearly directory of contact information for cosmetic company employees who will respond to requests for information on cosmetic ingredients and formulations. The directory is distributed to dermatologists in order to assist them in treating allergic reactions. Another CTFA publication is the CTFA Labeling Manual: A Guide to Cosmetic and OTC Drug Labeling and Advertising , which explains FDA regulations for cosmetic labeling under the Fair Packaging and Labeling Act and the Food, Drug, and Cosmetic Act.

The Research Institute for Fragrance Materials (RIFM) reviews the safety of fragrance ingredients which are used in cosmetics and other consumer products. RIFM maintains a Database of Fragrance and Flavor Materials which is “the most comprehensive source worldwide for toxicology data, literature and information on the safety evaluation of fragrance and flavor materials.”[85] The database classifies more than 4500 materials and is operated in full cooperation with the Flavor and Extracts Manufacturing Association (FEMA). RIFM operates via a Panel of Experts (REXPAN) – an independent, international group of dermatologists, pathologists, environmental scientists and toxicologists who are not employed by the fragrance industry.[86]
Industry Example: Estee Lauder

Estee Lauder Companies is one of the world’s leading cosmetic manufacturers and one of the United States’ largest cosmetic houses: “Founded in 1946, this technologically advanced, innovative company has gained a worldwide reputation for elegant, luxurious products. Products that come with a promise to uphold the finest standards of excellence through extensive research and stringent product testing.”[87] Estee Lauder’s 2004 net sales were $5.79 billion and net earnings were $342.1 million.[88] “Through its own brands and specialist acquisitions, Estee Lauder is estimated to control 46% of America’s prestige cosmetics business, and in 2000 had a volume of $4.37 billion.”[89] As a leader in the industry, Estee Lauder constitutes an instructive example of a specific industry approach to internally managed cosmetic safety. In several places on its website, Estee Lauder invokes its 60 year record of company product safety in order to repeatedly express its commitment to internal safety regulation: “We are proud of the enviable safety record the Estee Lauder Companies Inc. has sustained since our Company was founded in 1946, and our continued commitment to producing quality products that are clean, pure and safe.”[90] Thus, not only does the cosmetic industry regulate and police itself as an industry through industry-level compliance with voluntary regulatory programs, but individual companies within that industry also pride themselves on another level of self-regulation.

Estee Lauder’s corporate website features a section entitled “Citizenship,” which delineates what it considers to be its corporate responsibilities – two of these responsibilities are “Product Safety and Testing,” and “Consumer Awareness.”[91] The Product Safety section emphasizes the company’s high internal standards and commitment to scientific testing:

Consumer safety has always been a top priority at The Estée Lauder Companies Inc. Therefore, our product safety evaluation procedures require collaboration of efforts and expertise across several biological and dermatological sciences. To ensure the greatest possible safety of all products brought to market by The Estée Lauder Companies, formulations and packaging must meet the exceedingly high Company standards for ingredient preservation and stability, product efficacy and compatibility.
Our extensive Research and Development teams use state-of-the-art laboratories to assess the safety of our product formulas against our own ongoing quality assurance and global safety evaluation standards, continuously referencing current peer-reviewed scientific research as well as international regulatory guidelines.[92]

In the “Product Safety FAQs” section of the website, the company characterizes its internal regulatory approach as extremely conservative in terms of ingredient safety: “The Estée Lauder Companies places great importance on the safety of its consumers and takes an extremely conservative view of the ingredients it uses in its products. The Company uses a stringent system of ingredient review, evaluation and testing to ensure that consumers are protected.”[93] The company also references the essentially safe nature of cosmetics in general – “among the safest of all consumer products” – and the joint efforts by the industry and the FDA to utilize voluntary industry regulation program to safeguard consumers.[94]

The Consumer Awareness section of Estee Lauder’s website features subsections entitled, “Cosmetics are Safe,” “Understanding Your Cosmetic Label,” and “Debunking Industry Rumors” – all directed specifically at consumers in order to assure them of cosmetic safety. The “Understanding Your Cosmetic Label” section urges consumers to, in addition to relying on the industry’s assurances of safety, take some responsibility themselves for understanding what the products that they are purchasing contain. In particular, consumers can utilize the product ingredients listing to avoid specific ingredients (or seek them out).[95] The company also provides ongoing, post-marketing and post-sale consumer support, indicating a desire to work with consumers to together ensure utmost cosmetic safety: “we place high value on consumer communication and awareness.  We have many systems in place to provide outstanding customer service and open dialogue on behalf of our Company and its brands. We offer state-of-the-art service and individualized attention to our customers via brand web sites, toll-free hotlines and six global Consumer Care Centers.”[96]


“In the cosmetics industry... there is one quality that counts for more than money.... Illusion, backed by entrepreneurial flair, is the essential element.”[97]

In an industry that is premised upon selling cosmetic illusions, vociferous industry proclamations of self-regulation can logically be interrogated as illusory and self-serving. Various critics have accused the industry of a range of nefarious motives and actions: from misleading consumers through marketing, to knowingly deploying products that are unsafe and even toxic to consumers’ health. However, these criticisms often fail to acknowledge both the industry’s respectable safety record and the industry’s powerful and effective incentives for conducting true forms of self-regulation. As discussed above, the cosmetic industry has historically acknowledged that both its image and its independence are dependent upon its maintenance of a real, not merely illusory, industry-wide program of self-regulation.

Safety Criticisms

The 1938 Act was the first comprehensive federal program to regulate cosmetics. In the years since then, the FDA and the industry have cooperated to build a unique regulatory regime which supplements a lack of direct FDA pre-market supervision with broad industry self-regulation. Thus, the logical conclusion arrived at and maintained by many is that the current regulatory regime is far superior in terms of consumer safety assurances than that which existed in the 1930s prior to 1938 Act enactment. However, in recent years some critics have cast doubt upon the veracity of this assumption, positing (and in the process, fostering) “a sense of public discomfort and distrust about unregulated cosmetics.”[98] For example, one historian of the cosmetic industry questions whether or not we are currently residing in a significantly safer cosmetic environment than we were in 1933:

Without any federal laws regulating cosmetics, or more specifically, their ingredients, consumers [in 1933] had little reassurance that many of their daily purchases and habits were safe. In 2005, temporary tattoos and henna / mehndi products contain PPD, despite laws specifically delineating acceptable PPD use. Has anything changed in the intervening seventy years to create a safer environment for consumers? Recent scholarship has largely ignored the devastating effect of serious accidents...[99]

This critic focuses on the federal portion of the current regulatory regime, implicitly ascribing safety uncertainties to a federal failure to regulate. In other words, one line of safety criticism in the cosmetic market emphasizes federal/FDA deficiencies. Along this line, another critic of the cosmetics market notes that sixty-five percent of consumers erroneously believe that the FDA conducts pre-market safety approvals of cosmetics, and argues that this widely-held consumer illusion has dangerous safety consequences: “In the beauty industry, appearance is everything. And one of the illusions that keeps the cosmetics industry thriving is that its products are carefully monitored by the government.... Operating under the 52-year old Food, Drug, and Cosmetic Act, cosmetic manufacturers are largely left to regulate themselves.”[100] The implication of this criticism is that the presence of a formal federal regulatory framework is arguably just as dangerous as no regulation at all, if not more so, when it is merely an illusory form of regulation. For the formal inclusion of cosmetics under the 1938 Act perhaps deceptively lulls consumers into false, unjustified confidence in the safety of cosmetic products. Thus, the illusion of regulation can be more dangerous than no regulation at all.

Safety-oriented criticisms focusing on federal regulatory deficiencies often compare cosmetic regulation to regulation of food and drugs, pointing out the disparity in FDA pre-market requirements for the two groups of regulatory objects. For example, one article criticizing the cosmetic industry notes that food and drug manufacturers must, under federal law, do pre-market safety and effectiveness testing, while cosmetic manufacturers are not required by the FDA to do such testing. While the article concedes that many cosmetic companies do in fact conduct such testing, the standards for safety are still permitted to be independently determined by each manufacturer – “a practice that critics say leaves consumers particularly vulnerable to longterm problems from hazardous substances in cosmetics.”[101] Criticisms of federal regulatory deficiencies thus eventually turn down another path – a line of more direct criticism of the industry itself and its actions in (not) maintaining consumer safety standards.

Direct criticisms of the cosmetic industry’s self-regulation programs predominantly allege insufficient safety substantiation procedures by the industry. One recent influential voice in this line of criticism is the Environmental Working Group (EWG), a Washington, D.C. based non-profit research and advocacy organization which focuses on public health and the environment. EWG has researched and lobbied for personal care product safety for the past five years, citing three major reasons for their concerns: 1) industrial chemicals constitute basic ingredient components of personal care products, 2) FDA does not require premarket safety testing, and 3) personal care products are used by everyone, every day.[102] EWG points out that the FDA does not have the authority to mandate safety studies of cosmetics, and argues that current attempts at industry self-regulation are insufficient because the cosmetic industry’s review panel has only studied and assessed about 11 percent of the 10,500 ingredients that are used in products.[103] In other words, “the industry’s self-policing safety panel falls far short of compensating for the lack of government oversight.”[104] The combination of a lack of federal regulatory power and insufficient industry self-policing is particularly dangerous in light of consumer misperceptions of regulatory reality:

‘Most of us expect that the products we find on store shelves have been tested for safety, but the government has no authority to require tests,’ said Environmental Working Group (EWG) Vice President for Science Jane Houlihan. ‘An average adult is exposed to over 100 unique chemicals in personal care products every day – these exposures add up.... Without federal oversight or standards, companies should inform consumers of their own internal studies, and how they decide if a product or ingredient is safe enough to sell.’ [105]

This criticism posits that if self-regulation is to be effective, cosmetic industry players must be more transparent and forthcoming in providing consumers with specific information as to what their safety testing entails, what standards are used, etc.

In its study and report Skin Deep, the EWG revived M.C. Phillips’ 1934 concern that the cosmetic industry is deceiving consumers and exposing them to dangerous health hazards. After an extensive survey and study of cosmetic products entitled Skin Deep, EWG declared that the current regime of self-regulation is not working and thus not sufficient for adequately protecting consumer safety. Skin Deep is an online personal care product safety guide that provides in-depth information on 14,393 products and the 6,961 ingredients that form them.[106] The Skin Deep report argues that the lack of federal regulatory power of pre-market safety substantiation of cosmetics creates dangers for consumers in the form of products that they use every day. The project provides safety ratings and brand-by-brand comparisons of cosmetic products to assist consumer decisions through use of linked databases of ingredients, products, brands, companies, hazards, and regulatory status.[107] EWG’s safety assessment rating system was methodologically based on the known and suspected hazards associated with cosmetic component ingredients, and utilized a weighted scoring system for categories of ingredients – from “known human carcinogen according to EPA” down to “skin irritant identified by the Cosmetic Ingredient Review panel.” Ingredients were scored according to the sum of the weights of these categories, and products were assigned hazard scores (safety assessment ratings) based on the sum of the hazard scores for each product’s component ingredients. Brand and company ratings were then compiled based on respective product hazard scores.[108] The Skin Deep assessment of products found that less than one percent of the 14,000+ products surveyed are made from ingredients that have all been assessed for safety. Some of the major findings are as follows: 6.6% of products surveyed contain ingredients that are unsafe for use in cosmetics; 63.5% of products surveyed contain ingredients with reproductive/developmental toxicity; 34.8% of products surveyed contain cancer hazards, and 78.6% contain ingredients with the potential for harmful impurities.[109]

The June 2004 EWG cosmetic safety petition to FDA states that the Environmental Working Group has identified serious probable safety violations of the 1938 Act by the cosmetic industry, and requests enforcement actions by the FDA such as: recalls or injunctions and seizures, clarified safety substantiation requirements, requirement of removal of any toxic impurities, requirement that internet vendors list ingredients online, and investigations of certain ingredients. The petition emphasizes the wide, nearly universal usage of a multitude of cosmetics in order to convey the importance of regulatory change: “more than a quarter of all women and one of every 100 men use at least 15 cosmetic products daily.... Despite this population-wide exposure to cosmetic chemicals, the existing law governing cosmetics has cast a disturbingly narrow safety net.”[110] In pointing out that “a self-regulating industry panel is the only existing safety screen for cosmetics,” EWG implies that the CIR Expert Panel is an insufficient safeguard because it is in the industry’s own interest to avoid being very cautious or thorough in its review. As evidence of this insufficiency, EWG argues that 89% of the 10,500 personal care product ingredients remain untested by the CIR; this deficiency in scope of ingredient testing is particularly unsettling given the FDA’s statement that “‘a cosmetic manufacturer may use almost any raw material as a cosmetic ingredient and market the product without an approval from FDA.’”[111]

The EWG is a founding member of the Campaign for Safe Cosmetics, a coalition of environmental and public health groups which works with cosmetic manufacturers to achieve safer ingredients and product formulations. Over 200 cosmetic companies had signed the “Compact for Safe Cosmetics” pledge to make safer products as of October 2005, in an effort to reformulate personal care products in ways that eliminate toxic chemicals linked to cancer, mutation, or birth defects from products.[112] Other founding groups for this campaign are: Alliance for a Healthy Tomorrow, The Breast Cancer Fund, Commonweal, Friends of the Earth, National Black Environmental Justice Network, National Environmental Trust, and Womens Voices for the Earth. A major victory for this campaign, and a defeat for the cosmetics lobby[113] , was the California Safe Cosmetics Act of 2005, which requires companies to report to the state the usage of cosmetic ingredients linked to cancer. This state law on chemicals in cosmetics represents a new approach to regulation – filling the federal regulatory gap by supplementing industry self-regulation with state oversight of the cosmetic industry. A California representative for the National Environmental Trust commented, “‘The new [California state] law has national significance.... For decades the FDA has allowed the cosmetics industry to police itself. Now, California is stepping into the breach in order to address the latest science on chemicals and health.’”[114]

Responses to Criticism

The FDA issued a final written response on September 29, 2005 to the EWG cosmetic safety petition. In this response, the FDA denied EWG’s petition, noting that enforcement action requests are not appropriate for citizen petitions, and regardless concluding that there was insufficient data and information to support EWG’s requests. The FDA stated that fulfillment of EWG’s other requests was not warranted at that time given FDA constraints and priorities.[115] The FDA noted that the cosmetic industry, largely via the CIR, conducts ingredient testing and that the FDA relies on this as well as other scientific data to determine regulatory actions and priorities.

The CTFA issued a response statement on July 14, 2004 asserting that cosmetics are safe and directing the public to a website, www.cosmeticsaresafe.org , in an effort to reassure consumers about the safety of cosmetics and the effectiveness of the current regulatory schema. This response statement opens with the following declaration: “The cosmetic industry is committed to providing the highest quality, safest personal care products possible. Constant research into new ingredients and new formulations ensures that the industry provides such products. Cost is never a consideration for safety.... The bottom line for American consumers is that they can have complete confidence that the products they use are safe.”[116] The 2005 CTFA Annual Report directly addresses the EWG report, arguing that may of EWG’s allegations are unfounded and unsupported, but using the fact that EWG has raised safety issues to point out the ways in which CTFA has worked cooperatively with FDA to ensure utmost consumer safety:

While pointing out that many of the issues raised were in error, CTFA urged FDA to act on the Environmental Working Group’s (EWG) Petition raising many issues related to claimed safety concerns for cosmetics. EWG... makes a number of unfounded allegations in the petition.... FDA reviewed and flatly denied every request in the EWG petition. FDA repeatedly noted that the petition lacked evidence or scientific data to support EWG’s points. CTFA also urged FDA to adopt a Guidance establishing criteria for cosmetic safety substantiation and for the implementations of the warning required by 21 CFR 740.10... where appropriate.[117]

The CTFA’s Cosmetics Are Safe website proclaims the safety of cosmetic products and details both FDA authority to regulate and voluntary industry safety programs. The website states the cosmetic industry’s response to EWG’s report as follows:

The ‘Skin Deep’ report was filled with mistakes and unfounded conclusions. In fact, careful review of the ‘Skin Deep’ report shows that many of the ‘ingredients’ it lists are not ingredients at all, but rather name fragments, duplicates and misspellings, which were somehow overlooked by EWG investigators.... Any statement that relies on the Environmental Working Group’s report should be automatically suspect, as the report is filled with mistakes and unfounded conclusions.[118]

The website also provides links to other internet websites which detail what it considers to be unfounded and unsubstantiated internet rumors about personal care products and safety issues.[119] Estee Lauder’s website similarly has specific sections dedicated to directly reassuring consumers of Estee Lauder’s clear commitment to cosmetics safety. One such section is entitled “Debunking Internet Rumors” – it encourages consumers to seek out factual information in order to avoid being unnecessarily frightened by internet rumors of “health scares.”[120] Estee Lauder’s website also asserts that “recent statements that cosmetics contain ingredients that may be harmful to your health are both inaccurate and misleading,” and argues that this “phantom risk” is dangerous because it distracts attention from the “known, preventable causes of cancer and birth defects.”[121]

Other Criticisms

Other criticisms of the cosmetic industry set aside consumer safety issues and focus more specifically on the ethical implications of selling illusions. One such critique of the cosmetic industry emphasizes the dynamic between ethics and consumerism. This critique entails disapproval of an exorbitantly lucrative industry utilizing misleading or even false marketing claims to trade on consumers’ gullibility[122] – in selling illusions to consumers of cosmetics, the industry deceives and arguably even defrauds their consumer base. Gerald McKnight, in analyzing the beauty industry, raises the issue of cosmetics and ethics: “In persuading us to part with billions for their products, the moguls of make-up and skin care, of anti-ageing and beautifying, genuinely believe they are doing us a service. The question is, how fair are the business practices involved? How ethical is it for the dream merchants to trade on our susceptibilities?”[123] Other critics use even stronger language to wage an ethical attack on the beauty industry for capitalizing on human insecurities and gullibility. For example, feminist critic Naomi Wolf cites McKnight but goes rhetorically further by likening cosmetics sales tactics to those deployed but cult conversion artists: “The holy oil industry is a megalith that for forty years has been selling women nothing at all. According to Gerald McKnight’s expose, the industry is ‘little more than a massive con... a sweetly disguised form of commercial robbery’ with profit margins of over 50% on a revenue of 20 billion dollars worldwide.”[124] This line of criticism focuses on the ethics of a massive profit to actual product ratio.

Wolf accuses the industry not only of unethically exploiting consumers via exorbitant profit margins, but also of making false claims that have gotten increasingly outrageous as technology and marketing capacities have evolved: “As women encountered the computerized work force of the 1908s, the ads abandoned the filmy florals of ‘hope in a bottle’ and adopted new imagery of bogus technology, graphs and statistics, to resonate with the authority of the microchip.”[125] Capitalist exploitation of consumers seems all the more nefarious when coupled with borderline fraudulent marketing ploys designed to deceive. The line between aggrandizing and deceiving along the spectrum of consumer marketing claims seems to be dissolving at the hand of the cosmetic industry. Wolf quotes one industry insider as acknowledging this phenomenon with dismay: “The professional collegial spirit that has helped keep the fraudulent nature of the industry’s claims fairly quiet was belatedly broken by Professor Albert Kligman of the University of Pennsylvania... ‘In the industry today,’ he wrote presciently to his colleagues, ‘fakery is replacing puffery.’”[126]

One industry example of the arguable disintegration of the line between puffery and fakery is Body Shop International (BSI), a company that has “long been touted as the premier socially responsible business” made successful largely through its marketing of “natural” products and a socially conscious corporate ethic.[127] However, 1994 investigative journalism and research “revealed a huge ethical gap between BSI’s marketing image and its actual practices,” including an allegedly forged company myth, misrepresentations regarding fair trade programs, and non-natural chemical and fragrances in its product formulations.[128] When confronted on the usage of non-natural ingredients in the company’s products, BSI’s chairman of the board Gordon Roddick employed “the classic ethics rationalization: ‘all [cosmetic] firms’ do it.”[129]

A more abstract line of criticism adopts an administrative standpoint and argues that self-regulation is an inherently improper form of regulation when federal legislation exists. This abstract reliance on the inherent impropriety of self-regulation ideologically underlies many of the above criticisms of both the FDA and the cosmetic industry and is explored further in the following section.


“When it comes to the clinch, the industry is always on the side of deregulation.”[130]

The Theoretical Perspective

From an administrative standpoint, the prevailing regulatory schema of voluntary industry cooperation with the FDA raises the broad theoretical question of whether or not, from a normative administrative perspective, self-regulation (in lieu of more extensive federal regulation) is a desirable regulatory approach. The current system of voluntary industry self-regulation was born out of pragmatic necessity in the 1970s, when FDA budgetary constraints necessitated industry self-regulation in order to attend to consumer safety. The cosmetic industry now argues that not only does it effectively and efficiently self-regulate, but that it does a better job at ensuring safety than direct federal regulation would be able to accomplish. Despite the professed success of cosmetic industry self-regulation, the administrative standpoint must ask whether or not this is the way that government ought to run, particularly in light of the fact that no other industry in the United States self-regulates in the way that the cosmetic industry does.[131]

Some critics disapprove of self-regulation because it represents a political model in which federal regulatory inaction occurs in conjunction with industry lobbying against more extensive regulation. This model is critically characterized as the improper “purchase” by major industry players of political inaction. For example, one article entitled “How Cosmetics Lobby Maintains Its Luster; Even Distant Threat of Regulation Spawns Industry Scurrying” links contributions to political campaigns by the cosmetics lobby to deliberate industry disregard for safety issues; the article is critical of the political process in which industry lobbying results in decreased regulation because the author implicitly reads into such a political model an industry motive which is antithetical to consumer safety interests.[132] Similarly, another article defines politicians’ decisions against regulatory legislation as the direct result of payments to such politicians in the form of industry lobbying efforts, payments tainted by undertones and implications of scams, racketeering, and threats: “private persons and firms are being shaken down and forced to pay protection money to politicians. There is no shortage of anecdotal and statistical evidence of this practice of purchasing government inaction. For example.... the cosmetics industry... maintain[s] very active lobbying offices in Washington, all pressuring not to be regulated, all pressuring not to have anything done to them.”[133] This line of criticism characterizes the system of self-regulation as tainted by the extortion-like efforts by the cosmetics lobby to minimize federal regulation; it equates self-regulation with self-interested non-regulation at the expense of consumers.

The Consumer Perspective

FDA reliance on cosmetic industry self-regulation inevitably places some of the responsibility and burden on consumers to be informed, discerning, and vigilant in order to safeguard their own health and safety. Critics of the current regulatory regime depict the FDA as wrongly abandoning consumers: “Where does this leave consumers? Public health is in the hands of an impotent agency, safety testing is voluntary, safety decisions are at the discretion of the individual companies, and the burden of choosing safe cosmetics falls squarely on the shoulders of each consumer.”[134] The three main forms of consumer responsibility are to: 1) stay informed about cosmetic ingredients, 2) exercise common sense in usage, and 3) be discerning in their expectations of cosmetics.

In order to facilitate consumer assessment and information about cosmetic ingredients, the FDA website has posted various types of information for consumers and presented this information in a straightforward, highly user-friendly style:

Consumers can check the listing to identify substances they wish to avoid. And becoming familiar with what cosmetics contain can help counter some of the alluring appeal showcased elsewhere on the product. ‘Our best friend is the ingredient label,’ says beauty consultant and 14-year veteran consumer reporter Paula Begoun. ‘And spending the time to read it may be all that is needed to protect ourselves from hurting our skin.’[135]

This information encourages consumers to take initiative in the protection of their own health and safety by familiarizing themselves with various ingredients and with their own bodies’ reactions to those ingredients. FDA efforts to increase public safety via cosmetics regulation have “also increased... the onus of individual responsibility: by listing ingredients, for example, the task of avoiding ingredients to which one is allergic rests squarely upon the individual. The right to increased knowledge and information about products means increasing responsibility as well.”[136] Thus under the current regulatory regime, the responsibility for consumer safety falls in some (arguably large) part on the consumer herself to educate herself and remain vigilant in utilizing that education. The consumer also necessarily bears the responsibility for reporting any problems or complaints to the FDA: “the FDA is aware of the problems and pressured to take action only when comments or complaints are officially registered. The onus and the responsibility for safe products and good health (still) rest, ultimately, with the consumer.”[137]

Both the FDA and the cosmetic industry argue that a crucial component of any regulatory regime is consumer common sense – consumers must be responsible for safeguarding their own safety through the exercise of common sense. For example, the FDA alludes to the fact that the few hazards and injuries that result from cosmetic usage are typically caused by a consumer’s lack of common sense: “Serious injury from makeup is a rare occurrence, according to John Bailey, director of FDA’s Office of Cosmetics and Colors. But it does happen. Good common sense and a few precautions can help consumers protect themselves against hazards associated with the misuse of cosmetics.” Bailey then goes on to list consumer safety common sense tips such as: don’t drive while applying makeup, don’t share makeup, throw away old products, et.[138] The cosmetic industry similarly emphasizes the importance of common sense on the part of consumers: “Consumers must take an active role in keeping product contamination and potential infection to a minimum once they take a product home, says Gerald McEwen, Ph.D., vice president for science for... Cosmetic, Toiletry and Fragrance Association. ‘You need [to follow] good personal hygiene – clean hands, clean face,’ he says. ‘And common sense.’”[139]

The current regulatory scheme also relies on consumers to be discerning in their consumption of personal care products. For example, the FDA’s website provides information designed to help consumers understand cosmetic labels, and encourages consumers to be discerning in their interpretations and beliefs about the claims that manufacturers make on those labels. One such article directed at consumers is entitled “Decoding the Cosmetic Lable”: “Don’t be fooled by claims made for certain cosmetic ingredients. Their presence in the products could be pure puffery because the law does not require cosmetic manufacturers to substantiate performance claims. ‘Image is what the cosmetic industry sells through its products,’ Bailey says, ‘and it’s up to the consumer to believe it or not.’”[140] The consumer thus bears a responsibility to separate useful claims from the puffery and make careful decisions about both what to purchase and what to expect from their cosmetic products.

The responsibilities assigned to consumers under the current system of cosmetic regulation – to be informed, wise, and discerning – may conflict with consumers’ expectations about FDA regulatory protection of their safety and interests. This is because many consumers assume extensive FDA protection and are unaware that the current system relies so heavily on industry self-regulation. This type of misalignment of consumer expectations and actual FDA protection was a motivating factor in the enactment of the 1938 Act; advocates of a new, more consumer-protective act were dissatisfied with the 1906 Act because its theoretical existence signaled consumer protection but its actual enforcement was hampered by lack of funding, etc. As a result, in the era between the 1906 Act and the 1938 Act, “many consumers assumed protection where none existed, unconsciously expanding the power of the law and the enforcement ability of the bureau to protect them.”[141] This assumption of protection and unconscious expansion of the law is arguably at play under today’s regulatory regime as well, to an even greater degree; for the natural implication of the existence of such a massive industry is the corresponding assumption by consumers that the FDA is heavily regulating this huge industry. Furthermore, the 1938 Act, unlike the 1906 Act, does explicitly provide for statutory regulation of the cosmetic industry by the FDA – so now that the current law does include cosmetics, consumer assumptions of federal protection are likely even higher than in the era prior to the 1938 Act. The irony of course is that the “unconscious expansion” of the perceived (by consumers) regulatory ability of the FDA has steadily increased over the years, as the actual enforcement capacities of the FDA have become increasingly limited in the face of budgetary constraints, etc.

The Pragmatic Perspective

The pragmatic perspective fills in the practical holes left open by many critiques of the cosmetic industry’s practice of self-regulation, ultimately indicating the probable wisdom and effectiveness of this system based upon the pragmatic constraints and practical realities faced by the industry and by its regulators. The primary pragmatic rationale for the current system of industry self-regulation is the practical reality of a severe misalignment between FDA funding and the sheer size of the cosmetic industry. The FDA recently cut its cosmetic regulation budget by 50%, meaning that the FDA will be forced by budgetary reality to undertake virtually no regulation of this massive industry.[142] In the face of such misalignment, voluntary self-regulation by the industry has become crucial in addressing safety concerns. Budget cuts this severe have in the past even provoked dissatisfied responses from the industry itself, prompting the industry to lobby Congress for more FDA funding. Given the reality of such limited FDA resources, the cosmetic industry points out that the effectiveness of industry self-regulation is particularly noteable in light of other FDA concerns: “The cosmetic lobby... is also arguing that the FDA is already overburdened with more pressing concerns. ‘Let’s not ask the FDA to spend more on a problem that doesn’t exist at the expense of real crises – AIDS, Alzheimer’s new drug approval, good safety,’ Kavanaugh [then CTFA president] says. ‘Why would anyone in their right mind want to direct the resources away from... safety and health?’”[143]

Another argument from a pragmatic perspective is one based on incentives – a system of self-regulation can protect consumers because it is in the industry’s best interest to create and substantiate a perception of effective self-regulation, thus pragmatically aligning the interests of consumers, the industry, and the FDA. Even those critical of the cosmetic industry’s anti-regulation stance acknowledge the industry’s natural incentive to maintain safety through self-regulation. For example, one critic writes about the Cosmetic Ingredient Review: “The CTFA, which administers the voluntary review, argues that no outside watchdog would be more vigilant. After all, who could be better motivated to keep a nice, safe status quo? If makeup did any real harm, customers would die, survivors would sue, women would stop buying, and profits would stop.”[144] In addition to the industry’s investment in maintaining the safety standards of the industry, individual cosmetic companies themselves have incentives to engage in strict internal self-regulation in order to maintain the company’s brand image and reputation among consumers. For example, Jacques Courtin Clarins, the chairman and founder of Clarins, was described as “a stickler for purity, possessed of an almost neurotic determination to keep his company and its products whiter than white.... ‘He’s never afraid to tell us that it is his name and his reputation on every bottle, every jar.’”[145] An incentives-based rationale for self-regulation is ultimately grounded in the power of consumers to “impact regulation and legislation on multiple levels,” and to demonstrate that “their real power is in the markteplace, determining the success or failure of a product.”[146]

A variant on the incentives analysis is an analogy to corporate self-governance and the industry benefits that arise out of consumers’ perceptions of efficient and effective industry self-governance. This type of rationale for self-regulation relies on the relationship between corporate accountability and company success, through which consumers can pressure the industry into aligning its incentives with consumers’ through various forms of self-regulation. “Recent financial scandals, as well as public reaction to social and environmental impacts of corporate activity, have increased pressure for corporate accountability.”[147] Current conceptions of corporate accountability include both corporate social responsibility and financial transparency; both of these forms entail individual corporations parlaying self-regulation into corporate success by way of appeal to consumers. These notions are particularly apt in the cosmetic industry context, in which brand image is of paramount importance and a clear and public commitment to internal safety standards and consumer care can be powerful marketing tools.[148]


“Beauty aspires to be all things to all women and comes close to succeeding.”[149]

The policy implications of cosmetics regulation are context dependent; a full understanding of the cosmetic industry requires analysis of the context within which cosmetics usage occurs – cultural, societal, and historical contexts contribute to the construction of cosmetics practice. More importantly, these contexts are continually changing, thus lending new importance to the issue of cosmetics regulation. Physical appearance achieves greater and greater importance in American society, usage of personal care products crosses gender lines, the line btw pharmaceuticals and cosmetics blurs, global boundaries become fluid, and women’s roles in society continue to evolve. These changes frame the evolution of the cosmetics industry in ways that impact regulation of the industry and must be accounted for by any regulatory approach.

A Massive Industry

The cosmetic industry is a massive industry, and is rapidly growing. As it expands and evolves in tandem with society, the industry creates higher and higher profit margins and gleans more and more prominence and power in American consumerism and popular culture:

By best estimates, beauty in America is a $29 billion business. Beauty departments are top earners for any store. Beauty licenses subsidize French couture and buoy the bottom lines of the American fashion houses lucky enough to land them. Beauty contracts carry the biggest paydays. offer the most publicity, and are therefore the most coveted prizes in the modeling industry. Beauty trends have replaced hemlines as the hot news from runways. Beauty advertising is a mainstay of women’s magazines. Beauty editorial always rates among the most-read pages in those same magazines.[150]

The beauty industry has not only rapidly expanded in profits and prominence over history, but also in resilience. Despite historical events such as wars and depressions, the cosmetic industry is “a business that never sees a downturn or suffers a serious setback,” for “America’s fascination with beauty seems never ending, its demand for beauty products insatiable.”[151] Sustained by a powerful ideology of intertwined physical and mental identities, cosmetics marketing and usage has shaped and been shaped by societal trends. Throughout the evolution, “the message propogated by the cosmetic industry – that if one looks good, one feels good – has sustained sales and transcended gender.”[152] This ideology of image and emotion probably in part explains why “American women spend more than half a billion dollars a year” on lipstick alone.[153] In fact, one recent US survey indicated that “the average woman owns seven lipsticks, of which only 2.6 are frequently used. The same woman will probably invest in twelve eye shadows, but only use about five of them.”[154] As capitalist consumerism continues to flourish in American society, the cosmetic industry will undoubtedly continue to grow.[155]

As discussed in the previous section, the irony of this huge industry growth is the contemporaneous decline in FDA regulatory capacity regarding the industry; it seems counterintuitive that as the industry grows and grows, the FDA becomes less and less able to directly regulate it. In fact, the growth of the industry leads the average consumer to assume that the FDA must surely have proportionally increasing regulatory power over such a massive industry. The implication of this irony is that the industry’s program of self-regulation should be made more transparent to consumers so as to avoid misleading them.

The cosmetic industry’s growth has not been limited to the domestic context. As globalization progresses and national boundaries becomes more and more fluid, the size and scope of the cosmetics industry expands instantaneously and exponentially. International regulatory efforts – by both national governments and private industry players and associations – must be coordinated in order provide uniformity of products and standards, harmonized approaches to labeling, and overall protection of consumers worldwide.[156]

A Changing Industry

The cosmetic industry is also a rapidly changing industry. As technology advances and life expectancies lengthen, consumerist quests for youth have impacted the nature, goals, and marketing of cosmetic products, and the boundary between cosmetics and drugs seems to be rapidly eroding. While currently the FDA and the 1938 Act do not recognize the term “cosmeceutical,” the term is frequently employed by the cosmetic industry to market its products as having medicinal or drug-like effects.[157] The FDA website explains that cosmetics are articles intended for application to the body for cleansing, beautifyin, promoting attractiveness, or altering appearance without affecting bodily structures or functions, while products that do affect structure or function of the body are considered drugs; drugs are subject to review and approval process by FDA prior to sale while cosmetics are not.[158] As time progresses, the current erosion of the drug/cosmetic boundary in industry marketing approaches and product formulations will likely continue. Dr. Tatsuo Ozawa, the director of research and development of Shiseido, Japan’s biggest cosmetics skincare company explains the force driving this rapid erosion:

‘The present dramatic progress in science and technology...is about to usher in a new era of human civilization. It will bring cosmetics closer to medical products.... Beauty and health... will develop in a completely separate manner, clearly distinct from pharmaceuticals. The extension of man’s lifespan is already on our scientific horizon. It will increasingly require the help of cosmetics.... If we are to live longer, the need to hold on to our youth will become essential’.... Only cosmetics, he believes, can provide the means to do so.[159]

The current precariousness of the drug/cosmetic boundary has important regulatory implications and likely will eventually necessitate the imposition of some sort of clearer definitional standard by either the FDA or the industry itself. For, “with pressure mounting on the major companies to alter their rules, to accept that some of their products are or should be listed and tested as drugs, the whole vast, enormously valuable beauty industry is at a crucial state.”[160]

The fact that these “cosmeceuticals” entail potentially more drastic risks for consumer safety indicates a need for regulatory clarification and more specific forms of consumer protection. For example, one proposed approach calls for increased FDA authority over these products:

Unfortunately for American consumers, the relative lack of attention given to cosmetics regulation by the FDA has resulted in more potent (i.e., more dangerous) materials being sold. These products have... avoided the FDA’s stringent drug approval process and have passed directly to consumers via the retail cosmetics shelf.... since these products can also cause physical in addition to economic harm, it is even more imperative that the FDA exercise some authority over assessing whether these products should be on the market.[161]

An alternative to increased FDA regulation would be increased industry regulation in area of cosmeceutical marketing claims. Thus far, CTFA has not made attempts to self-regulate in this area; the voluntary CTFA programs and the CIR address product safety and safety-related issues rather than attempting to extensively self-police advertising and labeling through self-regulation.[162]

A Gendered Industry

Cosmetics hold a special position within the realm of feminine consumerism. Beginning in the early twentieth century, they “took on a new meaning in American culture” and “became part of an ongoing discourse on femininity that made problematic women’s identity in an increasingly commercial, industrial, and urban world.” As they discursively engaged in this construction of modern femininity through consumerism, “women linked cosmetics use to an emergent notion of their own modernity, which included wage-work, athleticism, leisure, freer sexual expressiveness, and greater individual consumption. At the same time, new forms of mass culture shaped this discourse.”[163] Today, cosmetics in mass culture are situated within the context of new societal practices and cultural pressures as “employers make appearance a job requirement” and “families and peer cultures socialize girls ito the necessity of maintaining a public face.”[164] Women today utilize cosmetics in many ways to convey both personal and social meanings, and beauty culture thus exists as both a “type of commerce” and a “system of meaning” which has “helped women navigate the changing conditions of modern social experience.”[165] The central analytical dilemma which has emerged from theories of beauty culture and social theory is whether cosmetics constitute tools of liberation or oppression for women in modern society. Do they provide women with the positive means of self-expression and liberation through empowered construction of individualized feminine identity? Or, do they coerce women by embodying patriarchal ideologies of female inferiority and artifice, making women the unwitting co-conspirators of their own oppression as they accede to artificial standards of prescribed femininity? The “public debate over cosmetics today veers noisily between the poles of victimization and self-invention, between the prison of beauty and the play of makeup.”[166]

One argument for the theory of beauty culture as liberating and empowering women is that “beauty is uplifting” – it provides a way to align inner beauty with outer beauty by emphasizing cosmetics’ “underlying philosophy that women deserve time for themselves” and acknowleding “that a beauty regime, good grooming, ‘putting one’s face on’, a healthy lifestyle, vitality and above all the confidence that these things give, are essential tools for coping with life in today’s combative, competitive and often cruel world.”[167] Another argument that cosmetics represent positive elements of femininity focuses on the larger context of shared feminine identity and the social bonding that is facilitated by the shared experience of beauty culture. This line of theory argues that critics of beauty culture do make valid and important criticisms, but “have overlooked the web of intimate rituals, social relationships, and female institutions that gave form to American beauty culture.... Not only tools of deception and illusion, then, these little jars tell a rich history of women’s amibition, pleasure, and community.”[168] Furthermore, criticisms of cosmetics who characterize beauty culture as a form of oppression and cooptation of women ignore the simple fact that women often enjoy (albeit perhaps only as the result of extensive ideological coercion) their usage of cosmetics: “In truth, women knew then – as they do now – precisely what they were buying. Again and again they reported their delight in beautifying”[169]

Many critiques of the beauty industry are feminist theories condemning cosmetics as implicating women into an oppressive beauty myth. These criticisms argue that cosmetics usage and culture serve as ideological tools which maintain the subjugation of women in an already gender stratified society; women participate in and contribute to their own oppression through their acceptance of the cosmetic industry and its attendant prescribed roles for women. One leading critic of “the beauty myth,” Naomi Wolf, argues that feminine beauty ideals and pressures to conform to those ideals oppress women: “We are in the midst of a violent backlash against feminism that uses images of female beauty as a political weapon against women’s advancement: the beauty myth.”[170] More specifically, Wolf explains that beauty culture subordinates women in relation to men by “assigning value to women in a vertical hierarchy according to a culturally imposed physical standard” – this process is indicative of “power relations in which women must unnaturally compete for resources that men have appropriated for themselves.”[171] Women’s participation in this struggle via usage of cosmetics is “destroying women physicially and depleting us psychologically.”[172]

Another critic of cosmetics culture argues that the beauty industry emphasizes women’s physical appearance in society and as a result confines women’s experiences and freedom. The result of this entrapment (ultimately self-entrapment, and thus all the more insidious) is that women symbolically concede their own inferiority by signaling through cosmetics usage that they need continual improvement. For example, Una Stannard writes:

Women are not free to stop playing the beauty game, because the woman who stops would be afraid of exposing herself for what she is – not the fair sex.... Every day, in every way, the billion-dollar beauty business tells women they are monsters in disguise.... In this culture women are told they are the fair sex, but at the same time that their ‘beauty’ needs lifting, shaping, dyeing, painting, curling, padding.[173]

Along these lines, another feminist critic of the beauty industry argues that the cosmetic industry equates women’s worth with physical appearance in a way that negatively characterizes women as inherently artificial and not trustworthy: “beauty transformations maintain female deviance by associating femininity with phoniness. Props and paint undermine credibility, evoke suspicion and mistrust.... The artifice inherent in cosmetic rituals has been used as proof of female inferiority.”[174]

Other criticisms of the beauty industry focus more broadly on the role of cosmetics usage in society – in particular in relation to the rampant consumerism and societal preoccupation with physical appearance which characterize modern American society. Critics of physical appearance discrimination criticize the widespread discriminatory practice of judging people’s dispositions based on their physical appearances. These critics point out the cosmetic industry’s role in sustaining this form of discrimination: “the evolution of American commercialism and materialism surrounding the burgeoning beauty industry serves to promote physical appearance discrimination.”[175] The ability of cosmetics to alter one’s physical appearance can contribute to a difficulty in enforcement of anti-discrimination principles in the physical appearance context, for the multitude of cosmetic products available has caused people to “generally view one's attractiveness to be attributed less to fortuitous genetics than to one's desire to become more beautiful. Thus, the line between mutable and immutable characteristics becomes blurred, making it more difficult to draft and enforce laws targeted at protecting appearance traits that are immutable.”[176] Cosmetics’ omnipresence in consumerism and marketing may also be contributing to what has been criticized as American hyper-consumerism and consumer addictions. For example, one critic writes: “This... phenomenon[’s]... roots extend back almost fifty years. In 1957, Vance Packard noted the ‘triumph of the cosmetics industry in reaching the billion-dollar class by the sale of hope and making women more anxious and critical about their appearance.’”[177]


The importance of context in analyzing the cosmetic industry indicates a need for greater regulation of cosmetics. Beauty culture dramatically shapes and is shaped by American societal and cultural milieu, and thus regulation of this powerful force is important in order to protect consumers and society. This need should be continued to be met by the industry itself, through, for example, things like tighter, more transparent, and more uniform industry standards. The unavoidable reality is that the pragmatic constraints of FDA limited capacities cannot be ignored, and thus the current system voluntary self-regulation represents the most practical and effective means of utilizing aligned incentives to ensure consumer safety.



[3] Peter Barton Hutt, A History of Government Regulation of Adulteration and Misbranding of Cosmetics , in COSMETIC REGULATION IN A COMPETITIVE ENVIRONMENT 1 (Norman F. Estrin & James M. Akerson eds., 2000)

[4] CTFA President’s Message , CTFA 2005 Annual Report, available at http://www.ctfa.org/Content/NavigationMenu/About_CTFA/Annual_Report/48661a_CTFA_Lowres.pdf (last visited Feb. 23, 2006).


[6] Richard Merrill, Science for Judges II: The Practice of Epidemiology and Administrative Agencey Created Science: FDA Regulatory Requirements as Tort Standards , 12 J. L. & POL’Y 5 49, 552-53 (2004).

[7] WOODHEAD , supra note 2, at 204.

[8] MERRILL , supra note 6, at 552-53 .

[9] Hutt, supra note 3, at 5

[10] GAVENAS , supra note 5, at 59


[12] Id. at 13-14.


[14] KAY, supra note 11, at 6.

[15] Hutt, supra note 3, at 2.

[16] KAY, supra note 11, at 3.

[17] GAVENAS , supra note 5, at 60.

[18] KAY, supra note 11, at 4-5.

[19] PEISS, HOPE IN A JAR , supra note 13, at 198.

[20] Hutt, supra note 3, at 6.

[21] 21 U.S.C.S. § 361 (2006).

[22] 21 U.S.C.S. § 362 (2006).

[23] 21 U.S.C.S. § 363 (2006)

[24] Carol Lewis, Clearing Up Cosmetic Confusion , FDA CONSUMER , at http://www.cfsan.fda.gov/~dms/fdconfus.html (Aug. 2000).

[25] Hutt, supra note 3, at 7.

[26] KAY , supra note 11, at 106-118.

[27] KAY , supra note 11, at 118.

[28] KAY , supra note 11, at 119-120.

[29] FDA Authority Over Cosmetics , CFSAN/Office of Cosmetics and Colors (March 3, 2005) available at http://www.cfsan.fda.gov/~dms/cos-206.html .

[30] Emalee G. Murphy, Voluntary Self-Regulation Programs of the Cosmetic Industry , in THE COSMETIC INDUSTRY: SCIENTIFIC AND REGULATORY FOUNDATIONS 187 (Norman F. Estrin, ed. 1984).

[31] Hutt, supra note 3, at 22.

[32] Voluntary Cosmetic Registration Program , CSFAN/Office of Cosmetics and Colors (December 1, 2005), available at http://www.cfsan.fda.gov/~dms/cos-regn.html .

[33] Id .

[34] Id .

[35] Id .

[36] Judith E. Foulke, Cosmetic Ingredients: Understanding the Puffery , FDA CONSUMER (May 1992), available at http://www.fda.gov/fdac/reprints/puffery.html .

[37] Hutt, supra note 3, at 19.

[38] Hutt, supra note 3, at 19-20.

[39] Hutt, supra note 3, at 21-22.

[40] Hutt, supra note 3, at 24.

[41] Hutt, supra note 3, at 25-28.

[42] Hutt, supra note 3, at 28.

[43] CTFA History , at http://www.ctfa.org/Content/NavigationMenu/About_CTFA/History/History_5.htm (last visited Feb. 24, 2006).

[44] Hutt, supra note 3, at 28-29.

[45] The Myths and Facts Behind Cosmetic Safety, Cosmetics are Safe, at http://www.cosmeticsaresafe.org/casmythfact.htm (last visited Feb. 24, 2006).

[46] Consumer Products Sold in the United States Must Meet the Toughest Safety Standards, and Personal Care Products are Not Exempt , at http://www.cosmeticsaresafe.org./index.htm (last visited Feb. 24, 2006).

[47] Id .

[48] PEISS , HOPE IN A JAR , supra note 13, at 12.

[49] Kathy Peiss, Making Faces: The Cosmetics Industry and the Cultural Construction of Gender, 1890-1930 , in UNEQUAL SISTERS: A MULTICULTURAL READER IN U.S. WOMEN’S HISTORY 327 (Vicki L. Ruiz & Ellen Carol DuBois, eds., 2000).

[50] Id . at 326.

[51] PEISS, HOPE IN A JAR , supra note 13, at 50.

[52] A Centennial History of CTFA , at www.ctfa.org (last visited Feb. 24, 2006).

[53] KAY , supra note 11, at 32.

[54] PEISS , HOPE IN A JAR , supra note 13, at 4-5.

[55] PEISS , HOPE IN A JAR , supra note 13, at 5.


[57] PEISS , HOPE IN A JAR , supra note 13, at 5.

[58] PEISS , HOPE IN A JAR , supra note 13, at 96.

[59] PEISS , HOPE IN A JAR , supra note 13, at 97.

[60] PEISS , HOPE IN A JAR , supra note 13, at 200.

[61] PEISS , HOPE IN A JAR , supra note 13, at 238.

[62] WOODHEAD , supra note 2, at 201.

[63] WOODHEAD , supra note 2, at 201.

[64] Hutt, supra note 3, at 29.

[65] Foulke, supra note 36.

[66] Foulke, supra note 36.

[67] Hutt, supra note 3, at 31.

[68] About CTFA , at http://www.ctfa.org/Content/NavigationMenu/About_CTFA/Overview_of_CTFA/About_CTFA.htm (last visited Feb. 23, 2006).

[69] Id .

[70] CTFA President’s Message , supra note 4.

[71] A Centennial History of CTFA , at www.ctfa.org (last visited Feb. 23, 2006).

[72] Patricia A. Crosley, The CTFA Cosmetic Ingredient Dictionary , in THE COSMETIC INDUSTRY: SCIENTIFIC AND REGULATORY FOUNDATIONS 355 (Norman F. Estrin, ed., 1984).

[73] A Centennial History of CTFA , supra note 71.

[74] A Centennial History of CTFA , supra note 71.

[75] Hutt, supra note 3, at 31.

[76] Statement on FDA Budget for Cosmetics From CTFA President Pamela G. Bailey , at http://www.ctfa.org/Template.cfm?Section=CTFA_News&template=/ContentManagement/ContentDisplay.cfm&ContentID=3702 (Feb. 15, 2006).

[77] Robert Elder, The Cosmetic Ingredient Review – A Safety Evaluation Program , 11 J. AM. ACAD. DERMATOLOGY 1168 (1984).

[78] Id .

[79] CIR General Information , at http://www.cir-safety.org/info.shtml (last visited Feb. 23, 2006).

[80] Id .

[81] Cosmetic Ingredient Review , at http://www.cir-safety.org/ (last visited Feb. 23, 2006).

[82] CIR Publications , at http://www.cir-safety.org/publications.shtml (last visited Feb. 23, 2006).

[83] Cosmetic Ingredient Review Publishes New 2005 Compendium , at www.ctfa.org (March 28, 2005).

[84] A Centennial History of CTFA , supra note 71.

[85] Research Institute for Fragrance Materials , at http://www.rifm.org/index.asp (last visited Feb. 23, 2006).

[86] Id .

[87] About Estee Lauder , at http://www.esteelauder.com/customerservice/corporate_info.tmpl (last visited Feb. 23, 2006).

[88] Facts at a Glance , at http://www.elcompanies.com/the_company/company_facts_at_a_glance.asp (last visited Feb. 23, 2006).

[89] WOODHEAD , supra note 2, at 426-27.

[90] Alpha Hydroxy Acids (AHAs) , at http://www.elcompanies.com/citizenship/product_safety_testing/ahas.asp (last visited Feb. 23, 2006).

[91] Citizenship , at http://www.elcompanies.com/citizenship/citizenship.asp (last visited Feb. 23, 2006).

[92] Product Safety & Testing , at http://www.elcompanies.com/citizenship/product_safety_testing.asp (last visited Feb. 23, 2006).

[93] Product Safety FAQs , at http://www.elcompanies.com/citizenship/product_safety_testing/product_safety_faqs.asp (last visited Feb. 23, 2006).

[94] Id .

[95] Understanding Your Cosmetic Label , at http://www.elcompanies.com/citizenship/understanding_your_cosmetic_label.asp (last visited Feb. 23, 2006).

[96] Consumer Awareness , at http://www.elcompanies.com/citizenship/consumer_awareness.asp (last visited Feb. 23, 2006).


[98] KAY , supra note 11, at 2.

[99] KAY , supra note 11, at 2.

[100] Sheila Kaplan, How Cosmetics Lobby Maintains Its Luster; Even Distant Threat of Regulation Spawns Industry Scurrying , LEGAL TIMES (April 30, 1990).

[101] Id .

[102] Why This Matters – Cosmetics and Your Health , at http://www.ewg.org/reports/skindeep2/info_why.php (last visited Feb. 23, 2006).

[103] Have your personal care products been assessed for safety? , at http://www.ewg.org/reports/skindeep2/index.php (last visited Feb. 23, 2006).

[104] Why This Matters – Cosmetics and Your Health , supra note 102.

[105] New Site Gives Consumers Brand-by-Brand Safety Ratings for Over 14,000 Personal Care Products , at http://www.ewg.org/reports/skindeep2/newsrelease.php (Oct. 17, 2005).

[106] About Skin Deep , at http://www.ewg.org/reports/skindeep2/info_about.php (last visited Feb. 23, 2006).

[107] Id .

[108] Methodology , at http://www.ewg.org/reports/skindeep2/info_about.php (last visited Feb. 23, 2006).

[109] Summary of Major Findings , at http://www.ewg.org/reports/skindeep2/findings/index.php (last visited Feb. 23, 2006).

[110] Citizen Petition to Cease Unlawful Sale of Misbranded & Adulterated Cosmetics , at http://www.ewg.org/reports/skindeep/petition/petition.php (last visited Feb. 23, 2006).

[111] Id .

[112] Why This Matters – Cosmetics and Your Health , supra note 102.

[113] CTFA spent more than $600,000 in the 2003-2004 legislative session and the first quarter of 2005 to oppose this bill and other environmental health legislation in California , at http://www.safecosmetics.org/newsroom/press.cfm?pressReleaseID=13 (last visited Feb. 23, 2006).

[114] Governor Signs Safe Cosmetics Bill , at http://www.safecosmetics.org/newsroom/press.cfm?pressReleaseID=13 (Oct. 8, 2005).

[115] Letter from Margaret O’K Glavin, Associate Commissioner for Regulatory Affairs, Food and Drug Administration, to Jane Houlihan and Arianne Callendar, Environmental Working Group (Sep. 29, 2005) (on file with author).

[116] CTFA Response Statement: Cosmetics Are Safe , at http://www.ctfa.org (July 14, 2004).

[117] 2005 CTFA Annual Report , at http://www.ctfa.org/Content/NavigationMenu/About_CTFA/Annual_Report/48661a_CTFA_Lowres.pdf (last visited Feb. 23, 2006).

[118] Frequently Asked Questions Related to Cosmetics Safety , at http://www.cosmeticsaresafe.org/casqa.htm (last visited Feb. 23, 2006).

[119] Unfounded Internet Rumors , at http://www.cosmeticsaresafe.org/casrumors.htm (last visited Feb. 23, 2006).

[120] Id .

[121] Cosmetics are Safe , at http://www.elcompanies.com/citizenship/product_safety_testing/cosmetics_are_safe.asp (last visited Feb. 23, 2006).

[122] One critic notes that cosmetics companies’ “most valuable commercial asset is human gullibility.” MCKNIGHT , supra note 97, at 18.

[123] MCKNIGHT , supra note 97, at 16


[125] Id . at 109.

[126] Id . at 111

[127] Marianne M. Jennings & Jon Entine, Business with a Soul: A Reexamination of What Counts in Business Ethics , 20 HAMLINE J. PUB. L. & POL'Y 1, 52.

[128] Id . at 52-53

[129] Id . at 53.

[130] GAVENAS , supra note 5, at 63.

[131] Other industries that attempt to enact more limited forms of self-regulation are the flavor ingedients industry the fragrance ingredients industry. See Flavor and Extract Manufacturers Association, at http://www.femaflavor.org/ (last visited Feb. 23, 2006); Research Institute for Fragrance Manufacturers, at http://www.rifm.org/ (last visited Feb. 23, 2006).

[132] Kaplan, supra note 100.

[133] Fred S. McChesney, Public Choice and the Structural Constitution: Purchasing Political Inaction: How Regulators Use the Threat of Legal “Reform” to Extort Payoffs , 21 Harv. J.L. & Pub. Pol'y 211, 213-214 .

[134] Consumer Update – FDA admits inability to ensure the safety of personal care products , at http://www.ewg.org/reports/skindeep2/findings/index.php?content=FDA_fails_to_protect (Oct. 5, 2005).

[135] Lewis, Clearing Up Cosmetic Confusion , supra note 24.

[136] KAY , supra note 11, at 124.

[137] KAY , supra note 11, at 126-27.

[138] Carol Lewis, Beauty on the Safe Side , FDA CONSUMER , at http://www.cfsan.fda.gov/~dms/fdconfus.html (Aug. 2000).

[139] Dori Stehlin, Cosmetic Safety: More Complex Than at First Blush , FDA CONSUMER ,at http://www.cfsan.fda.gov/~dms/cos-safe.html (May 1995).

[140] Judith E. Foulke, Decoding the Cosmetic Label , FDA CONSUMER , at http://www.cfsan.fda.gov/~dms/cos-labl.html (May 1994).

[141] KAY, supra note 11, at 3.

[142] Telephone Interview with Peter Barton Hutt, Senior Counsel, Covington & Burling, in Cambridge, Mass. (Feb. 2006).

[143] Kaplan, supra note 100.

[144] GAVENAS, supra note 5, at 65-66.

[145] MCKNIGHT , supra note 97, at 101.

[146] KAY , supra note 11, at 8.

[147] Sonia Gioseffi, Corporate Accountability: Achieving Internal Self-Governance through Sustainability Reports, 13 CORNELL J.L. & PUB. POL’Y 503, 503 (Spring 2004).

[148] For detailed analysis of corporate accountability and internal self-governance issues, see, e.g .: Gioseffi, supra note 147; Jennings & Entine, supra note 127; David Hess, Social Reporting: A Reflexive Law Approach to Corporate Social Responsiveness , 25 IOWA J. CORP. L. 41 (Fall 1999).

[149] GAVENAS , supra note 5, at 10.

[150] GAVENAS , supra note 5, at 10.

[151] GAVENAS , supra note 5, at 11.

[152] KAY , supra note 11, at 126.

[153] MCKNIGHT , supra note 97, at 1.

[154] MCKNIGHT , supra note 97, at 2

[155] Graeme W. Austin analyzes the increasing significance of trademarks and brand imaging in the cosmetic industry, noting that consumers of cosmetics are willing to pay more for branded goods – for example, a lipstick – because of the message of prestige that such brands connote. Graeme W. Austin, Trademarks and the Burdened Imagination , 69 BROOKLYN L. REV . 827, 849-50 (Spring 2004).

[156] For more information about globalization and the cosmetics industry, see Janet Winter Blaschke, Globalization of Cosmetic Regulations , 60 FOOD DRUG L.J. 413 (2005); Cosmetics and Toiletries Trends are Taking on a Global Character , Global Cosmetic Industry, at http:;/www.gcimagazine.com/industry/1736142.html (last visited Feb. 23, 2006).

[157] Cosmeceutical , US Food and Drug Administration, Office of Cosmetics and Colors Fact Sheet, at http://ww.cfsan.fda.gov/~dms/cos-217.html (Feb. 24, 2000).

[158] Is it a Cosmetic, a Drug, or Both? (or Is It Soap?) , US Food and Drug Administration, Office of Cosmetics and Colors, at http://www.csfan.fda.gov/~dms/cos-218.html (July 8, 2002).

[159] MCKNIGHT, supra note 97, at ix-x.

[160] MCKNIGHT, supra note 97, at xi .

[161] Bryan A. Liang & Kurt M. Hartman, It’s Only Skin Deep: FDA Regulation of Skin Care Cosmetics Claims, 8 CORNELL L.J. & PUB. POL’Y 249, 258 (Winter 1999). For more information about “cosmeceuticals,” see also Laura A. Heymann,The Cosmetic/Drug Dilemma: FDA Regulation of Alpha-Hydroxy Acids , 52 FOOD DRUG L.J. 357 (1997).

[162] The current forms of industry self-regulation regarding advertising and labeling are: 1) National Advertising Division review, and 2) Lanham Act suits.

[163] Peiss, Making Faces , supra note 49, at 324.

[164] PEISS, HOPE IN A JAR , supra note 13, at 269.

[165] PEISS, HOPE IN A JAR , supra note 13, at 6.

[166] PEISS, HOPE IN A JAR , supra note 13, at 268-69.

[167] WOODHEAD , supra note 2, at 9-10.

[168] PEISS, HOPE IN A JAR , supra note 13, at 7-8.

[169] PEISS, HOPE IN A JAR , supra note 13, at 6.

[170] WOLF , supra note 124, at 10.

[171] WOLF , supra note 124, at 12.

[172] WOLF , supra note 124, at 19.

[173] Una Stannard, The Mask of Beauty , in WOMAN IN SEXIST SOCIETY 192 (Vivian Gornick & Barbara K. Moran, eds., 1971).


[175] David L. Wiley, Beauty and the Beast: Physical Appearance Discrimination in American Criminal Trials , 27 St. Mary's L. J. 193, 197-198 (1995).

[176] Karen Zakrzewski, The Prevalence of "Look"ism in Hiring Decisions: How Federal Law Should be Amended to Prevent Appearance Discrimination in the Workplace , 7 U. Pa. J. Lab. & Emp. L. 431, 460 (Winter 2005).

[177] Tamara R. Piety, “Merchants of Discontent”: An Exploration of Advertising, Addiction, and the Implications for Commercial Speech , 25 Seattle Univ. L. R. 377, 450 (Fall 2001).