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FARREN.DOC 12/22/2008 10:23:30 AM REMOVING THE WRINKLE IN COSMETICS
AND DRUG REGULATION: A NOTICE
RATING SYSTEM AND EDUCATION
PROPOSAL FOR ANTI-AGING
COSMECEUTICALS
Victoria Farren Anti-aging skincare products often make unrealistic anti-aging claims that mislead consumers, particularly older consumers. Because of the different premarket testing standards for cosmetics and drugs, companies often classify and market their anti-aging skincare products as cosmetics to the FDA in order to avoid more rigorous standards, yet simultaneously emphasize the drug-like qualities of the products to consumers, suggesting that these products are equivalent to drugs. The FDA allows these products, known as "cosmeceuticals," to be classified as cosmetics despite their drug-like appearances and qualities, such as high-tech anti-aging skincare products that use nanotechnology, stem cell research, or DNA. The weakness of the present classification system in handling cosmeceuticals, which fall into the gray area between clearly defined cosmetics and drugs, creates unknown health risks and confuses and misleads consumers about the actual physiological effects of these products. To resolve these two problems, the Federal Food and Drug Administration need not extensively amend its regulations of the cosmetic and drug categories. Rather, the FDA should instate a notice system paired with consumer education, as well as more carefully regulate product claims. Victoria Farren is an Associate Editor 2009, Member 2007–2008, The Elder Law Journal; J.D. 2009, University of Illinois; B.S. 2001, University of Illinois. This Note is dedicated to the author's mother and sister, "the two most beautiful women I know, with and without their cosmetics." FARREN.DOC 12/22/2008 10:23:30 AM 376 The Elder Law Journal I. Introduction
In 2005, Debra Scheufler, a forty-seven-year-old San Diego woman, filed a class action lawsuit against Estée Lauder and two department stores for false advertising in regards to anti-aging skincare cosmetics.1 Scheufler had spent an estimated $1000 on anti-aging skincare cosmetic products, including Estée Lauder's Crème de la Mer product, which retailed at $120 per ounce at the time and was "touted by the website as a ‘miracle' whose skin-enhancing ability ‘defies the laws of nature.'"2 "It didn't remove wrinkles or do anything to improve my skin," complained a disillusioned Scheufler, adding, "In fact, it clogged my pores and made my skin rougher."3 Scheufler is not alone in her confusion as an anti-aging skincare cosmetics consumer or in her decision to file suit against a cosmetics company over anti-aging skincare product claims.4 Hot on the heels of the increasing elderly population is the booming industry of anti-aging skincare products. One market re-search survey estimated sales of all skincare products in the United States racked up $5.8 billion in 2006 alone, with $7 billion projected by 2010.5 Among this growth, anti-aging skincare products lead the pack with double-digit growth rates and are hailed as "the fastest growing market segment across the globe."6 While baby boomers make up the core consumer market for anti-aging skincare products in the United 1. See NBC San Diego, Woman Sues Estée Lauder for Not Making Her Look Younger, NBCSANDIEGO.COM, Jan. 4, 2005 (on file with the Elder Law Journal at the University of Illinois); Sid Kirchheimer, Scam Alert: Anti-Aging Snake Oil, AARP BULL. TODAY, Nov. 2005, http://bulletin.aarp.org/yourmoney/scamalert/ articles/scam_alert anti-aging.html. 2. Kirchheimer, supra note 1. 4. See Simon Pitman, Israel Lobby Group Files Class Action Against Cosmetic Players, COSMETICSDESIGN.COM, June 20, 2007, http://www.cosmeticsdesign.com/ Products-Markets/Israel-lobby-group-files-class-action-against-cosmetics-players. 5. Backchannelmedia, Very Few Wrinkles in U.S. Skincare's Expected Growth to $7 Billion by 2010!, BACKCHANNELMEDIA, Jan. 3, 2007, http://news. backchannelmedia.com/articles/7662/Very-Few-Wrinkles-in-US-Skincares-Expected-Growth-to-7-Billion-by-2010 [hereinafter Very Few Wrinkles]. 6. Branna, Actives Speak Louder than Words, HAPPI, June 13, 2006, http://www.happi.com/articles/2006/06/actives-speak-louder-than-words (comment made by Tom Goode, an executive from RITA Corporation). RITA pro-vides chemical ingredients and research services to the cosmetics and personal care industries. See RITA CORP., GENERAL PRODUCT LISTING 1 (2006), available at http://www.ritacorp.com/files/Domestic_GPL.pdf. FARREN.DOC 12/22/2008 10:23:30 AM REMOVING THE WRINKLE 377 States,7 this market is also expanding globally among aging popula-tions in Japan and Western Europe.8 A trip to a department store or a browse through the Web sites of major cosmetics manufacturers reveals entire anti-aging skincare product lines.9 These cosmetics typically come with a price tag that is higher per volume than other cosmetic products by the same manu-facturer.10 For example, Clinique's Repairwear Deep Wrinkle Concen-trate for Face and Eye product can be purchased on Clinique's Web site for just over $50 for one ounce.11 In comparison to Clinique's other high-end special cosmetics, Super Defense Moisturizer, a lotion, and Redness Solutions, a cream to reduce rosacea, each retail around $40 for 1.7 ounces, while Clinique's regular moisturizer, Dramatically Different Moisturizing Lotion, is $11.50 for 1.7 ounces.12 A sampling of other anti-aging products on the market include Estée Lauder's Per-fectionist [CP+] product, advertised as a product to "dramatically re-duce[] the appearance of lines, wrinkles and age spots."13 This "tri-umph over wrinkles" retails online for just over $50 for one fluid ounce.14 Lancôme's High Resolution with Fibrelastine product, a self-proclaimed "intensive anti-wrinkle treatment," retails online at $74 for Singer, Anti-Aging Makeup: Multitasker in a Jar, N.Y. TIMES, Aug. 18, 2005, at G3. 8. See Branna, supra note 6. Extension, Tex. A&M Univ. Sys., Can Creams & Cosmetics Really Improve Aging Skin?, in HEALTH HINTS 1, 1 (Janet M. Pollard & Carol A. Rice eds., 2005) [hereinafter Creams & Cosmetics]. 10. See Clinique, Skin Care, Moisturizers, http://www.clinique.com/ templates/products/multiproduct.tmpl?category_id=category4918 (last visited Oct. 17, 2008) [hereinafter Clinique.com, Moisturizers]. 11. Clinique, Repairwear Deep Wrinkle Concentrate for Face and Eyes, http://www.clinique.com/templates/products/sp_nonshaded.tmpl?category_id=category4914&product_id=prod13047 (last visited Oct. 17, 2008). 12. Clinique.com, Moisturizers, supra note 10. Lauder, Perfectionist [CP+] with Poly-Collagen Peptides (on file with the Elder Law Journal at the University of Illinois). id. The Web site promotes the product as: [y]our triumph over wrinkles. Not a single injection necessary. Estée Lauder Research boldly advances our most comprehensive anti-wrinkle treatment ever to prove just how far a skincare formula can go. The result? An anti-aging phenomenon with patent-pending tri-ple enzyme technology and our exclusive Poly-Collagen Peptides. Perfectionist [CP+] "repairs" and corrects the look of lines, wrinkles and age spots faster than we ever have before. FARREN.DOC 12/22/2008 10:23:30 AM 378 The Elder Law Journal 1.7 fluid ounces.15 At Nordstrom's Web site, Yves Saint Laurent's "Age Expert" Age Defying Crème product, one ounce, can be pur-chased for $88.16 Beyond the so-called prestige brands,17 local drug stores and supermarkets carry mass-market brands of anti-aging skin-care products.18 Revlon has an Age Defying product line, including treatment, moisturizer, foundation, and concealer.19 Neutrogena of-fers an Anti-Oxidant Age Reverse product line including cleanser, lo-tion, eye cream, night cream, and serum.20 Across the board in all price levels, anti-aging skincare products are widely available in the mass market.21 To meet the explosive demand for anti-aging skincare products, cosmetic companies are mixing new ingredients and new technology in a race to discover the secret to a youthful face.22 According to one source, the overall number of new cosmetic ingredients has more than doubled in the past twelve years.23 Most new ingredients are referred Lancôme, High Résolution with Fibrelastine, http://www.lancome-usa. com/skincare/anti-aging/high-resolution-with-fibrelastine.htm (last visited Oct. 17, 2008). 16. Nordstrom.com, Yves Saint Laurent "Age Expert" Age Defying Crème SPF 15, http://shop.nordstrom.com/S/2822063 (last visited Oct. 17, 2008). The cosmetic alternative to DHEA, Age Expert contains the ganoderic fraction—an exclusive active ingredient with a structure similar to the famous "hormone of youthfulness," capable of providing the epider-mis with a reinvigorated look. It compensates for the signs of aging linked to hormonal imbalance, such as dull complexion, sagging skin and dehydration. Skin feels denser, softer and more radiant. The face looks visibly younger and is protected from environmental aggres-sions. Id. 17. See Navin M. Geria, Are High-Priced Cosmetics Really Worth the Price?, HAPPI, Oct. 1, 2006, at 38 ("[P]restige brands include La Mer, Natura Bisse, Ka-nebo, La Prairie and ReVive."); Creams & Cosmetics, supra note 9, at 1. 18. See, e.g., Walgreens, Skin Care, http://www.walgreens.com/beauty/ skincare.jsp?CATID=304240 (last visited Oct. 17, 2008). 19. Revlon, Age Defying, http://www.revlon.com/ProductCatalog/ ProductLine.aspx?CollectionID=1 (last visited Oct. 17, 2008). 20. Neutrogena, Anti-Aging, http://www.neutrogena.com/antiaging.asp? mainVal=antiaging&subVal=antiaging (last visited Oct. 17, 2008). 21. See Tom Branna, A New Era in Skin Care?, HAPPI, Feb. 1, 2007, http://www.happi.com/articles/2007/02/editors-page. Procter & Gamble owns brands such as Olay, for mass market shoppers, and SK-II, for so-called prestige channels. See id. 22. See Vispi Kanga, Novel Active Cosmetic Ingredient: Do Those Anti-Aging Cosmetics in Your Medicine Cabinet Do More Than Beautify the Skin?, HAPPI, June 1, 2004, http://www.happi.com/articles/2004/06/novel-active-cosmetic-ingredients. 23. Branna, supra note 21 (stating that the number of cosmetic ingredients in- creased from 6200 in 1994 to 13,500 in 2006, a twelve-year span). FARREN.DOC 12/22/2008 10:23:30 AM REMOVING THE WRINKLE 379 to by their scientific or chemical names, such as alpha-hydroxy acids (AHAs), beta-hydroxy acids, peptides, and retinoids.24 Recent anti-aging skincare products also include some exotic natural ingredients, such as fermented sea kelp with specially cultivated algae, red arctic tocol cranberry, and "rare caviar extracts found only in the waters of the Caspian Sea from the roe of the beluga sturgeon during the natu-ral birthing process."25 There is also "pietra," created by a specific type of yeast, allegedly "accidentally discovered at a sake brewery when a monk noticed exceptional skin smoothness of a worker who had excessive wrinkles elsewhere on his body."26 New technologies applied to anti-aging skincare products include nanotechnology,27 stem cell research,28 and DNA technology.29 The result of such an in-crease in ingredients with scientific names and new technology is a generation of cosmetics with an increasingly drug-like appearance and quality, often referred to as "cosmeceuticals."30 While cosmeceu-ticals may be any type of cosmetic, this Note will focus on anti-aging skincare cosmeceuticals. Behind each new anti-aging skincare product is a truckload of anti-aging product claims. More than merely hiding wrinkles, dimin-ishing age spots, and making skin appear firmer,31 products are now promising to prevent wrinkles and deliver "age-defying" results.32 One Estée Lauder advertisement for Re-Nutriv Ultimate Youth Crème suggests, "Imagine if you could postpone aging indefinitely."33 A Phi-losophy-brand face cream for preventing wrinkles is even named "Hope in a Jar."34 These marketing phrases and product claims suc- Publ., Skin Care and Repair, AARP.ORG, Apr. 6, 2007, http://www.aarp.org/health/conditions/articles/harvard skin-care-and-repair_0.html [hereinafter Skin Care and Repair]. 25. See Geria, supra note 17, at 38. 27. See Robin Fretwell Wilson, Nanotechnology: The Challenge of Regulating Known Unknowns, 34 J.L. MED. & ETHICS 704, 706 (2006). 28. Newman, Stem-Cell Creams, DNA-Based Workouts, $50,000 Check- ups, VOGUE, Jan. 2007, at 193. 29. Branna, supra note 6 (discussing DNA as a possible skin repair tool). 30. See Bryan Liang & Kurt M. Hartman, It's Only Skin Deep: FDA Regulation of Skin Care Cosmetics Claims, 8 CORNELL J.L. & PUB. POL'Y 249, 261 (1999). 31. Branna, supra note 6 (providing study figures showing the global market for cosmetics and toiletries). 32. See NBC San Diego, supra note 1. Lauder, Re-Nutriv: Ultimate Youth Crème, http://esteelauder.com/ templates/products/multiproduct.tmpl?CATEGORY_ID=CATEGORY20223 (last visited Oct. 17, 2008). 34. Dubecki, Peddling the Beauty Myth, THE AGE, Oct. 14, 2006, at 3. FARREN.DOC 12/22/2008 10:23:30 AM 380 The Elder Law Journal ceed by exploiting the fears and insecurities of aging consumers. As one writer describes, "baby boomers have both masterminded—and fallen victim to—an anti-aging epidemic far more virulent than the average case of mass hysteria."35 Selling the dream of youthfulness is not novel: products and treatments claiming anti-aging qualities have persisted throughout the ages. As far back as ancient Egypt, Cleopatra reportedly used sour milk high in lactic acid, which contained AHAs like those used in modern anti-aging skincare products, to give her skin a more youthful look.36 However, there are two major concerns arising with this new wave of anti-aging skincare cosmeceutical products: the unknown po-tential for actual health risk and the increasing consumer confusion regarding the status of these products as either cosmetics or drugs. First, current cosmetics and drug regulations keep a close watch over drugs, but leave cosmetics relatively unregulated.37 Anti-aging skincare cosmeceuticals employing new ingredients and new technol-ogy are generally still considered to be cosmetics and, accordingly, are not required to undergo extensive premarket testing or meet other re-quirements.38 As a result, relatively untested products may be sold to the mass market, leaving their unknown effects and interactions to be discovered later at the cost of unsuspecting consumers.39 Second, aggressive anti-aging skincare product claims, in com- bination with the drug-like appearance of cosmeceuticals, are causing increased consumer confusion over the status of these products as cosmetics or drugs.40 Everyone eventually faces the reality of time, but before doing so, a consumer may spend considerable amounts of money with distorted and unrealistic expectations, as was the case for Ms. Scheufler, whose cosmetic of choice was not unusually unique in its price tag.41 Some high-priced anti-aging skincare cosmetics in a 2006 study included La Mer brand Essence, which costs $2100 for a Merrell, Getting Over Getting Older, PSYCHOL. TODAY, Dec. 1996, http://psychologytoday.com/articles/pto-19961201-000026.html. 36. Heymann, The Cosmetic/Drug Dilemma: FDA Regulation of Alpha- Hydroxy Acids, 52 FOOD & DRUG L.J. 357, 359 (1997). 37. CTR. FOR FOOD SAFETY & APPLIED NUTRITION, U.S. FOOD & DRUG ADMIN., IS IT A COSMETIC, A DRUG, OR BOTH? (OR IS IT A SOAP?) (2002), http://www.cfsan. fda.gov/ dms/cos-218.html [hereinafter CFSAN, COSMETIC, DRUG, OR BOTH?]. Heymann, supra note 36, at 363. 40. See Geria, supra note 17, at 58. 41. See NBC San Diego, supra note 1. FARREN.DOC 12/22/2008 10:23:30 AM REMOVING THE WRINKLE 381 three-week supply of cream,42 and DDF brand RMX, a $1000, twenty-eight-day skincare regimen.43 Cosmeceuticals, on the whole, have been a topic of concern since their first appearance on the mass market.44 Categorized technically as cosmetics while appearing to cross into drug territory, classification of many of these new products does not conform satisfactorily with policy underlying existing cosmetic and drug regulations.45 The exist-ing cosmetic and drug system of regulation has been largely consid-ered inefficient for handling cosmeceuticals.46 In the context of anti-aging skincare cosmeceuticals, some suggested FDA reforms have in-cluded modifying existing drug and cosmetics categories, modifying tests to determine how products are classified, and adding a new cosmeceutical regulatory category.47 In response to concerns over nanotechnology cosmeceuticals, the Food and Drug Administration (FDA) created the FDA Nanotech Task Force in August 2006 to determine a regulatory approach for products with nanotechnology materials.48 However, focusing on a solution for one type of cosmeceutical at a time is merely dodging the tip of the iceberg. Nanotechnology is only one of many types of new technology being applied to cosmetics today.49 Handling each problematic new cosmeceutical only after the negative health effects become apparent is both inefficient and risky. The best approach is one that not only solves the present situation, but may also be adapted to deal with increasingly high-tech future cosme-ceuticals. In the case of anti-aging skincare cosmeceuticals, instead of modifying current regulatory categories or classification tests, the FDA should focus on a combination of alternative solutions to directly target the two concerns at hand. First, the risk of unknown side ef-fects may be better allocated by providing consumers with notice through a notice system. Second, consumer confusion is best handled Geria, supra note 17, at 38. 44. Liang & Hartman, supra note 30, at 262. 45. Id. at 262–63. id.; Heymann, supra note 36, at 371–72. 47. See Heymann, supra note 36, at 373–74. NANOTECHNOLOGY TASK FORCE, U.S. FOOD & DRUG ADMIN., NANOTECHNOLOGY 5 (2007), available at http://www.fda.gov/nanotechnology/ taskforce/report2007.pdf [hereinafter FDA, NANOTECNOLOGY]. id. at 4–6. FARREN.DOC 12/22/2008 10:23:30 AM 382 The Elder Law Journal by better education for the public and stricter policing of anti-aging product claims. This Note responds specifically to the growing industry of anti- aging skincare cosmeceuticals, but the solution may be expanded to other cosmeceuticals as well. Part II examines the current cosmetic and drug classifications and the appearance of cosmeceuticals. Part III discusses the problems of the current system in light of emerging anti-aging skincare cosmeceuticals. Part IV proposes a two-part recom-mendation that does not alter the present FDA classification system. II. Background
A. Cosmetic and Drug Regulation
Exactly what is a cosmetic and what is a drug? Either may be a product topically applied to the body.50 Either may consist of compo-sitions ranging from naturally occurring raw substances to manmade chemical compounds to any combination thereof.51 Congress defined both terms in the Federal Food, Drug, and Cosmetic Act of 1938 (FDCA).52 Section 201(i) of the FDCA defines cosmetic as a product, not including soap, "intended to be rubbed, poured, sprinkled, or sprayed on, introduced to, or otherwise applied to the human body . . for cleansing, beautifying, promoting attractiveness or alter-ing the appearance."53 In comparison, section 201(g) defines drug to include, among other things, "articles intended for use in the diagno-sis, cure, mitigation, treatment or prevention of disease in man . . and . . articles (other than food) intended to affect the structure or any function of the body of man."54 As per court decisions and legis-lative history, the legal definition of the term intended with respect to the use of a product means the desired or prescribed use as deter-mined by statements on the product's labeling.55 In short, cosmetics 50. See CFSAN, COSMETIC, DRUG, OR BOTH?, supra note 37. 51. See, e.g., Vispi Kanga, Sophisticated Cosmetic Ingredients, HAPPI, June 1, Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 321(g)(1), (i) (2000). 55. United States v. An Article, 409 F.2d 734, 739 (2d Cir. 1969) (noting that "it is well settled that the intended use of a product may be determined from its label, accompanying labeling, promotional material, advertising and any other relevant source" and listing cases); S. REP. NO. 74-361 (1935); Jacqueline A. Greff, Regulation FARREN.DOC 12/22/2008 10:23:30 AM REMOVING THE WRINKLE 383 are products intended to exert a physical effect on the body; drugs are products intended to exert a physiological effect on the body.56 A product may legally be a combination of the two if it is intended to exert both a physical and physiological effect.57 Congress designated the FDA, under the Department of Health and Human Services, as the authorized agency responsible for regu-lating cosmetics and drugs under the FDCA.58 The FDA, in turn, has created two sets of regulatory standards based on the categorization of a product as a cosmetic or a drug in the statute.59 Drug regulation is considerably more extensive than cosmetic regulation.60 Important differences between the two regimes are present in the areas of ap-proval requirements, good manufacturing practices, registration, and labeling.61 First, drugs are generally subject to premarket approval by the FDA, or they must conform to certain final regulations.62 In con-trast, the FDA does not have a premarket approval system for cosmet-ics, with an exception for color additives and certain prohibited ingre-dients.63 Second, drugs must strictly adhere to specific good manufacturing practice (GMP) requirements and certain minimum standards.64 Failure to conform to GMP requirements may cause a drug to be considered adulterated.65 No regulations set forth specific of Cosmetics That Are Also Drugs, 51 FOOD & DRUG L.J. 243, 253–54 (1996); see also Kanga, supra note 22, at 61. 56. Kanga, supra note 22, at 61. 58. Ctr. for Drug Evaluation & Research, U.S. Food & Drug Admin., Time Line, http://www.fda.gov/cder/about/history/time1.htm (last visited Oct. 17, 2008). 59. CFSAN, COSMETIC, DRUG, OR BOTH?, supra note 37. The Center for Food Safety and Applied Nutrition (CFSAN) is one of the five major centers under the FDA organization. See Compliance Home, FDA Resources, http://www. compliancehome.com/topics/FDA (last visited Oct. 17, 2008). 60. Heymann, supra note 36, at 363–64; CFSAN, COSMETIC, DRUG, OR BOTH?, supra note 37. 61. CFSAN, COSMETIC, DRUG, OR BOTH?, supra note 37. CTR. FOR FOOD SAFETY & APPLIED NUTRITION, U.S. FOOD & DRUG ADMIN., INGREDIENTS PROHIBITED AND RESTRICTED BY FDA REGULATIONS (2006), http://www.cfsan.fda.gov/ dms/cos-210.html. 64. CFSAN, COSMETIC, DRUG, OR BOTH?, supra note 37 (citing current mini- mum GMP requirements for drugs at 21 C.F.R. pts. 210–11 (2008)). A drug or device shall be deemed to be adulterated . . if it is a drug and the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the require- FARREN.DOC 12/22/2008 10:23:30 AM 384 The Elder Law Journal GMP requirements for cosmetics.66 Third, drug firms must register establishments and list drug products with the FDA.67 Cosmetic es-tablishments and formulations may be voluntarily registered through the Voluntary Cosmetic Registration Program.68 According to the FDA's Office of Cosmetics and Colors, only about 35% to 40% of cos-metics manufacturers participate in the program.69 Fourth, label re-quirements for cosmetics are found in the Cosmetic Labeling Man-ual.70 Cosmetic labels may list active and other ingredients together in order of predominance.71 Over-the-counter (OTC) nonprescription drugs are labeled according to OTC drug regulations, which require ingredient lists and specifically distinguish between "active" and "in-active" ingredients.72 If a product qualifies as both an OTC drug and a cosmetic, then it must meet the combination OTC drug and cosmetic labeling requirements.73 For example, antidandruff treatment sham-poo must comply with both requirements—it is a cosmetic, because it is used to cleanse, and also a drug, because it is used to treat dandruff by affecting the follicles where the hair is formed.74 Cosmeceuticals and Anti-Aging Products
Today, the challenge is how to reconcile the FDCA's cosmetic and drug definitions with modern cosmeceuticals. Cosmetic regula-tions have changed little since the passage of the FDCA in 1938.75 Yet ments of this chapter as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess. Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 351 (2000). 66. CFSAN, COSMETIC, DRUG, OR BOTH?, supra note 37. 67. Id. (citing Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360, and 21 C.F.R. § 207). 68. Id. (citing 21 C.F.R. §§ 710, 720). Lewis, Clearing Up Cosmetic Confusion, FDA CONSUMER, May–June 1998, http://www.fda.gov/fdac/features/1998/398_cosm.html. 70. See CFSAN, COSMETIC, DRUG, OR BOTH?, supra note 37; CTR. FOR FOOD SAFETY & APPLIED NUTRITION, U.S. FOOD & DRUG ADMIN., COSMETIC LABELING MANUAL (1991), http://www.cfsan.fda.gov/ dms/cos-lab1.html [hereinafter COSMETIC LABELING MANUAL]. 71. See COSMETIC LABELING MANUAL, supra note 70 (discussing the Declara- tion of Ingredients). 72. CFSAN, COSMETIC, DRUG, OR BOTH?, supra note 37 (OTC drug labeling includes the "Drug Facts" labeling, as described in 21 C.F.R. § 201.63). 73. Id. ("For example, the drug ingredients must be listed alphabetically as ‘Active Ingredients,' followed by cosmetic ingredients, listed in order of predomi-nance as ‘Inactive Ingredients.'"). 75. See Greff, supra note 55, at 244–45. FARREN.DOC 12/22/2008 10:23:30 AM REMOVING THE WRINKLE 385 applying new developments in science and technology to cosmetics has spawned a new generation of personal care products that appear to fall into the gray area between the cosmetics and drugs categories.76 These cosmetic products with drug-like effects have become so com-mon that they are now frequently referred to as "cosmeceuticals."77 While the market growth for skincare cosmeceuticals has been in the double and triple digits in recent years,78 the term cosmeceuticals is not officially recognized by the FDA and has no meaning under law.79 Instead, products known as cosmeceuticals fall under one or both of cosmetic and drug categories.80 For these products, often no more than a fine line exists between cosmetic and drug classification.81 For example, animal estrogen added to skin creams or lotions results in the product being classified as a drug, while the addition of phytoes-trogen, with similar effects as animal estrogen but created from plants, does not change the classification to drug.82 Tretinoin (retinoic acid), a biologically active form of vitamin A found in antiwrinkle cosmetics, is recognized as a drug when used topically to treat certain skin con-ditions.83 Anti-aging skincare products, fueled by an expanding aging population, lead the rapid growth of skincare product sales in the United States.84 These anti-aging skincare products generally claim to reduce the appearance of aging by changing the appearance of wrin-kles, particularly on the face.85 Wrinkles are the visible result of dete-rioration in fibers of the dermis, the layer of tissue beneath the epi-dermis, the outer layer of skin.86 Two important components of the skin, collagen and elastin, are affected.87 Damage may come as a re- 76. See Kanga, supra note 22. Extension, Tex. A&M Univ. Sys., Drug, Cosmetic, or Both? . . "Cosmeceuticals"?, in HEALTH HINTS, supra note 9, at 3, 3. 78. Burke, Advances in Skin Care, HAPPI, Dec. 1, 2006, http://www. CFSAN, COSMETIC, DRUG, OR BOTH?, supra note 37. 81. See Kanga, supra note 22. Rados, Science Meets Beauty: Using Medicine to Improve Appearances, FDA CONSUMER, Mar.–Apr. 2004, http://www.fda.gov/fdac/features/2004/ 204_beauty.html. Tretinoin is considered a drug when used to treat certain skin conditions because it acts deep at the skin's cellular level to increase collagen. Id. 84. See Very Few Wrinkles, supra note 5. 85. See Rados, supra note 83. 86. See id. FARREN.DOC 12/22/2008 10:23:30 AM 386 The Elder Law Journal sult of gravity, ultraviolet sun damage, pollution, exposure to smoke or chemicals, and other sources.88 One accelerator of the aging process is the presence of free radicals that cause skin damage.89 Free radicals may be removed by antioxidants, which are naturally in short supply in aging skin.90 While many anti-aging skincare products merely hide wrinkles, many new products seek to actually reduce and prevent wrinkles.91 Some function by delivering antioxidants, amino acids, proteins, and the like to the skin.92 Others function by boosting the skin's natural production of antioxidants.93 Some cosmetics focus on collagen and elastin production in the skin.94 Many new anti-aging skincare cos-metics that do more than merely cover up and hide wrinkles approach the drug regulatory lines and thus enter into cosmeceutical territory. These particular anti-aging cosmeceuticals primarily impact elderly consumers. III. The Problems of the Inadequate Current System
The emerging pool of anti-aging skincare cosmeceuticals fits awkwardly with current FDA cosmetic and drug regulations because many products fall through the cracks of the policy concerns that un-derlie the classification. This Part will examine two major concerns: unknown health risks and consumer confusion. A. Unknown
FDA regulations exist for the purpose of protecting public health.95 Congress enacted the FDCA partially in response to the 88. Id.; Tex. Coop. Extension, Tex. A&M Univ. Sys., Aging Skin 101, in HEALTH HINTS, supra note 9, at 5, 5 [hereinafter Aging Skin 101]. 89. Aging Skin 101, supra note 88, at 5. 91. See Rados, supra note 83. 92. See Geria, supra note 17, at 38. 95. U.S. Food & Drug Admin., FDA's Mission Statement, http://www.fda. gov/opacom/morechoices/mission.html (last visited Oct. 17, 2008). The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, bio-logical products, medical devices, our nation's food supply, cosmet-ics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; FARREN.DOC 12/22/2008 10:23:30 AM REMOVING THE WRINKLE 387 many horror stories of consumers who were crippled or poisoned by unregulated cosmetic products in the early 1900s.96 Such stories in-clude the famous Lash Lure case, where a woman used an eyelash dye with an ingredient, Kormelu, containing rat poison.97 After an eve-ning of itching and burning, she awoke the next morning to find "her eyes [were] gone and the flesh around them [was] a mass of tortured scars."98 Cosmetic and drug regulations protect public health by setting up requirements and monitoring for potentially dangerous products on the market.99 Drugs are assumed to be inherently risky and are thus subject to pervasive regulation to ensure safety and efficacy.100 Drug manufacturers are generally required to perform extensive test-ing and obtain premarket approval before selling products to the pub-lic.101 Simultaneously, Congress balances safety with a competing pol-icy to avoid implementing burdensome regulations unless there is clear need.102 Thus, cosmetics, which are viewed as very low risk to consumer health, receive comparatively broad freedom from regula-tion outside of specifically banned ingredients.103 In the race to meet the high demand for anti-aging skincare products, cosmetic companies are creating more and more anti-aging skincare cosmeceuticals.104 These new cosmeceuticals carry a stronger risk for unknown side effects because of the relative newness of cer-tain ingredients and technology used.105 However, despite the in-creased safety risk, they are typically classified as cosmetics and thus and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health. Id. 96. See Erika Kawalek, Artfully Made-Up, LEGAL AFFAIRS, Nov.–Dec. 2005, GWEN KAY, DYING TO BE BEAUTIFUL 5 (Susan L. Smith & Nancy Tomes eds., 2005); Kawalek, supra note 96. 98. Kawalek, supra note 96. 99. See CFSAN, COSMETIC, DRUG, OR BOTH?, supra note 37. 100. See Greff, supra note 55, at 250. 101. Heymann, supra note 36, at 363–64; CFSAN, COSMETIC, DRUG, OR BOTH?, supra note 37. 102. Greff, supra note 55, at 250. 103. Heymann, supra note 36, at 364; Kawalek, supra note 96. 104. Melissa Meisel, The Doctor's Orders: Professional Skin Treatments Comple- ment Spa Services, HAPPI, Dec. 1, 2007, http://www.happi.com/articles/2007/ 12/the-doctors-orders. 105. See Lewis, supra note 69. FARREN.DOC 12/22/2008 10:23:30 AM 388 The Elder Law Journal enjoy a low regulation standard.106 Cosmetics are not required to have expansive testing or premarket approval before being sold to the mass market.107 While cosmetics manufacturers necessarily perform some testing, many risks of new cosmeceuticals are passed on to the mass consumer.108 Many consumers purchase cosmetic products assuming they are safe to use and do not consider the possible risks and side ef-fects of those products.109 In contrast, when consumers purchase drugs, they are more likely to read the warning labels and consider the dangers of side effects and interactions.110 In this way, the unsus-pecting consumers bear the unknown health risks of new cosmeceuti-cals.111 For anti-aging skincare cosmeceuticals, an aging group of con-sumers bears the risks. This section examines the case of anti-aging skincare cosmeceuticals containing AHAs and the parallels that may be drawn to new anti-aging skincare cosmeceuticals implementing nanotechnology. 1. ALPHA-HYDROXY
The shortcomings of the current regulatory system in managing new cosmeceuticals are exemplified by the case of alpha-hydroxy ac-ids,112 considered in the 1990s to be the centerpiece of emerging cos-meceuticals.113 AHAs are a type of acid found in ingredients includ-ing glycolic, lactic, citric, malic, mandelic, and tartaric acids.114 AHAs are "basically chemical versions of facial scrubs."115 AHAs topically exfoliate the top layer of skin to expose the fresher-looking skin un-derneath.116 Essentially, the use of this ingredient allows consumers to use milder cosmetic versions of chemical peels at home.117 106. See CFSAN, COSMETIC, DRUG, OR BOTH?, supra note 37. 107. See 108. See Kawalek, supra note 96. 109. See id. "An April 2004 survey conducted by the National Consumers League revealed that 6 out of 10 adults think that the FDA tests anti-aging prod-ucts for safety and efficacy. It does no such thing." Id. 110. See Kathleen Doheny, Good Carma, L.A. TIMES, Jan. 2, 2002, at 1. 111. See Envtl. Working Group, FDA Fails to Protect Consumers, SKIN DEEP, Oct. 5, 2005, http://www.cosmeticdatabase.com/research/fdafails.php?nothanks=1. 112. Heymann, supra note 36, at 358. 113. Id. CTR. FOR FOOD SAFETY & APPLIED NUTRITION, FOOD & DRUG ADMIN., ALPHA HYDROXY ACIDS FOR SKIN CARE (1999), http://www.cfsan.fda.gov/ dms/ fdacaha.html. 114. Heymann, supra note 36, at 358. 115. Liang & Hartman, supra note 30, at 265. 116. Heymann, supra note 36, at 357. 117. Paula Kurtzweil, Alpha Hydroxy Acids for Skin Care, FDA CONSUMER, May 1998, http://www.foodsafety.gov/ dms/fdacaha.html. FARREN.DOC 12/22/2008 10:23:30 AM REMOVING THE WRINKLE 389 From 1992, AHAs began appearing in products on the mass market and quickly became popular.118 Hailed as the new "elixir of youth," AHAs took the market by storm.119 Products containing AHAs were typically categorized as cosmetics, thus avoiding premar-ket testing requirements.120 These products varied widely from cuticle softeners to shampoos, but AHAs were included most notably in skincare products such as face creams and lotions.121 The products were available everywhere from discount pharmacies to department stores in products that ranged broadly in price.122 Widespread product availability occurred before the side effects and health risks of AHAs were fully known.123 By 1998, John Bailey, the acting director of the FDA's Office of Cosmetics and Colors, esti-mated that approximately 10,000 adverse reactions were received from products containing AHAs.124 Bailey further commented that "AHAs are unlike anything else ever introduced onto the cosmetic market on such a wide scale. They are not your traditional cosmet-ics."125 Complaints received by the FDA included severe redness, swelling (especially in the area of the eyes), burning, blistering, bleed-ing, rash, itching, and skin discoloration.126 In a 1996 study conducted by the Office of Cosmetics and Colors, AHAs were found to "drasti-cally alter the structure of the skin, inducing as much as a four-fold increase in the thickness of the epidermis, the top layer of the skin."127 Another study by the Cosmetic Ingredient Review, an independent review panel established by the Cosmetic, Toiletry, and Fragrance As-sociation (CTFA), demonstrated that topically applied AHAs result in an increased skin sensitivity to ultraviolet radiation, which may re-main for a week after discontinuing application.128 The increased skin 118. See Heymann, supra note 36, at 357; Kurtzweil, supra note 117. 119. Heymann, supra note 36, at 357–58. 120. Id. at 363. 121. Kurtzweil, supra note 117. 122. Id. Some AHAs, including glycolic acid and lactic acid, can be found in face and body creams and lotions, some shampoos, and cuticle softeners. Id. 123. See, e.g., id. 124. Id. The FDA received more than 100 reports of adverse reactions; how-ever, for each adverse reaction report received by the FDA, the manufacturers re-ceive fifty to 100. Id. "This would translate into approximately 10,000 adverse re-actions being received for AHA-containing products." Id. 125. Id. 126. Id. 127. Heymann, supra note 36, at 360. 128. See CTR. FOR FOOD SAFETY & APPLIED NUTRITION, FOOD & DRUG ADMIN., LABELING FOR TOPICALLY APPLIED COSMETIC PRODUCTS CONTAINING ALPHA FARREN.DOC 12/22/2008 10:23:30 AM 390 The Elder Law Journal sensitivity also makes consumers more susceptible to sunburn.129 In 2000, the CTFA submitted a citizen petition requesting that the FDA establish label requirements for cosmetic products with AHAs to no-tify consumers of the risk of increased skin sensitivity to the sun.130 The petition further noted that products containing AHAs repre-sented a significant portion of the $6 billion domestic skincare market at the time.131 In 2005, after AHAs had been widely available on the mass mar- ket for well over a decade, the FDA finally responded by issuing a recommended "sunburn alert" warning to be added as a labeling statement for cosmetic products containing AHAs as ingredients.132 This warning is only in response to the short-term effects of AHAs; at the time of the sunburn alert issuance, the FDA's National Center for Toxicological Research was still investigating long-term exposure.133 While the risk of AHAs has now been investigated134 and rec- ommended safety concentrations and acidity levels for AHAs are now known,135 the first widespread skincare products containing AHAs were released before this knowledge was acquired.136 There is no guarantee the next new ingredient or future technology will have similar, relatively benign effects.137 If the next cosmeceutical on the HYDROXY ACIDS AS INGREDIENTS (2005), http://www.cfsan.fda.gov/ dms/ ahaguid2.html [hereinafter CFSAN, LABELING]. 129. Kurtzweil, supra note 117. 130. CFSAN, LABELING, supra note 128 (citizen petition dated June 29, 2000, assigned FDA Docket No. 2000P-1378/CP1). 131. Id. 132. Id. The FDA encourages manufacturers to use the following recom-mended labeling statement for cosmetic products containing AHAs as ingredients: "Sunburn Alert: This product contains an alpha hydroxyl acid (AHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sun-burn. Use a sunscreen, wear protective clothing, and limit sun exposure while us-ing this product and for a week afterwards." Id. 133. Id. 134. See id. The Cosmetic Ingredient Review (CIR) released an independent report regarding safe levels of AHAs for consumers. Tex. Coop. Extension, Tex. A&M Univ. Sys., Hydroxy Acids, in HEALTH HINTS, supra note 9, at 8, 8 [hereinafter Hydroxy Acids]. 135. Jane Brody, Time to Review Your Cosmetics, Under Bright Light, N.Y. TIMES, May 22, 2001, at F5. An industry review found AHAs safe to use at concen-trations of 10% or less, with a final product that has an acidity level no lower than pH 3.5. Id. 136. See CFSAN, LABELING, supra note 128. Since January 2005, the FDA has had guidelines for labeling products containing AHAs to alert consumers about sun sensitivity. See id.; Hydroxy Acids, supra note 134, at 9. 137. See CFSAN, LABELING, supra note 128 (using products with AHA can lead to skin sensitivity or sunburn). FARREN.DOC 12/22/2008 10:23:30 AM REMOVING THE WRINKLE 391 market is found to be a high health risk, the time lag in the current system effectively leaves mass consumers to be unsuspecting guinea pigs. 2. NANOTECHNOLOGY
In a parallel to AHAs, nanoscience-based anti-aging skin care is a new type of cosmeceutical growing in popularity and availability on the mass market despite unknown health risks.138 Nanotechnology involves the production and use of materials with nanosized particles (NSPs).139 One nanometer is one billionth of a meter and invisible to the naked eye.140 NSPs are increasingly being used as a way to ma-nipulate matter at a molecular level to change the characteristics of materials.141 For example, a golf club head employing nanosized car-bon allotrope resists bending significantly more than conventional clubs, thus leading to improved ball flight.142 Certain textiles have been made using nanotechnology to be allegedly "extremely resistant to wrinkles and most stains" compared to the same textiles without nanotechnology.143 In 2005, the FDA was quoted admitting "very little is known about the interaction of nano-scale particles and the skin."144 Recent hazard assessments have also determined that the "impacts of nano-materials on human health and the environment remain largely speculative."145 Despite this, the use of NSPs has been found in over thirty new anti-aging skincare cosmetics.146 For example, L'Oréal, the world's largest cosmetics company, has a product, Revitalift, contain-ing nanosomes of Pro-Retinol A.147 Lancôme Hydra Zen and some 138. See Darla Martin Tucker, Nanotech Puts New Wrinkle in Skin Care, BUS. PRESS, May 7, 2006, http://www.thebizpress.com/profiles/stories/BP_News_ Local_D_bp60508_profile.1006bd83.html. Beyond Skin Science company has been selling a full line of nanoscience-based anti-aging products since 2004. Id. 139. Wilson, supra note 27, at 704. 140. Id. 141. Id. at 705. 142. See 143. Id. 144. Lois Rogers, Safety Fears over ‘Nano' Anti-Aging Cosmetics, SUNDAY TIMES, July 17, 2005, http://www.timesonline.co.uk/tol/news/uk/article544891.ece. 145. Wilson, supra note 27, at 705. 146. Id. at 706–07. 147. Rogers, supra note 144. L'Oréal RevitaLift Double Lifting antiwrinkle cream, already available at drugstores, has a product label that includes the text, "Pro-Tensium plus nanosomes of Pro-Retinol A." Nell Greenfieldboyce, Safety of Nano-Cosmetics Questioned (National Public Radio Broadcast Mar. 13, 2006) (tran- FARREN.DOC 12/22/2008 10:23:30 AM 392 The Elder Law Journal Olay lotions also contain NSPs.148 Estée Lauder and Johnson & John-son are both developing products based on nanotechnology.149 NSPs are not limited to anti-aging products either; other cosmetics on the market, including sunscreens and exfoliating products, contain NSPs.150 The concern over the dangers of nanoscience cosmetics revolves around several issues. First, the properties of substances change at the nano size, so NSPs should be evaluated differently from their bulk counterparts.151 For example, under normal or bulk conditions, gold is yellow and inert.152 However, in a nanoscale size, gold becomes blue with low reactivity.153 Shrunk even further, it becomes reddish and catalytic.154 Therefore, in the case of cosmetics with NSPs, an ingredi-ent list may appear the same as the traditional cosmetic while the level of risk may change.155 Studies suggest nano-sized materials are "not inherently benign and that they affect biological behaviors at the cellu-lar, subcellular and protein levels."156 Second, the small size of an NSP allows the particle to penetrate barriers that the bulk-size version of the same ingredient cannot.157 The topical application of NSPs includes the risk that particles may penetrate the skin and move around the body unpredictably.158 NSPs may penetrate cells, enter the blood supply, and cross the blood-brain barrier.159 Some cosmetics use lipid nanosomes as "delivery systems for controlled release of active ingredients."160 Before selling products script available at http://www.npr.org/templates/story/story.php?storyId= 5257306). 148. See Wilson, supra note 27, at 706; Greenfieldboyce, supra note 147. 149. See Rogers, supra note 144. 150. See Consumer Groups Urge More Regulation, Testing for Nanotechnology Prod-ucts, in 11-20 MEALEY'S EMERGING DRUGS & DEVICES 21 (2006) [hereinafter MEALEY'S]; Press Release, Klein-Becker, This Year It's All About Hands! (Oct. 23, 2006), http://www.tfwa.com/duty_free/uploads/media/06_10_23_kb_.pdf (in-troducing a new nano product employing "thermo-active nanoexfoliating technol-ogy"). 151. See MEALEY'S, supra note 150. 152. Id. 153. Id. 154. Id. 155. See Envtl. Working Group, Nanotechnology, SKIN DEEP, http://www. cosmeticdatabase.com/special/sunscreens2008/report_nanotechnology.php (last visited Oct. 17, 2008). 156. Wilson, supra note 27, at 706. 157. See id. at 709. 158. See id. 159. See id; MEALEY'S, supra note 150. 160. Wilson, supra note 27, at 706. FARREN.DOC 12/22/2008 10:23:30 AM REMOVING THE WRINKLE 393 applying nanotechnology to cosmetics, researchers should examine NSP interaction with DNA, the extent to which they penetrate the skin, where they go in the body, and whether they are toxic.161 Al-though the body has mechanisms for clearing out foreign substances, NSPs are harder for the body to dispose of because of their small size.162 Despite these additional risks, new cosmetics on the market em- ploying NSPs are not required to undergo special testing or premarket screening, and the FDA has no authority to directly recall cosmetics found to be harmful to consumers.163 As stated by the FDA's Center for Drug Evaluation and Research, "currently there are no testing re-quirements that are specific to nanotechnology products."164 In 2006, eight health, environmental, and consumer groups petitioned the FDA to amend regulations to define nanotechnology and treat products with NSPs as new substances.165 Since then, the FDA Nanotech Task Force has released a report expressing concern over nanotechnology products not subject to premarket testing.166 The Royal Society, the United Kingdom's national academy of science, has also expressed concern about NSPs in anti-aging skincare cosmetics and their un-known long-term effects.167 In addition, a new generation of cosmeceuticals are on the hori- zon. One new type of cosmetic treatment under investigation, origi-nally developed to treat burn victims by scientists in Russia, involves stem-cell technology and fat injections to reduce wrinkles.168 Other 161. MEALEY'S, supra note 150 (discussing nanotechnology and cosmetics safety concerns of Dr. Philippe Martin of the European Commission and others). 162. See Wilson, supra note 27, at 709 (discussing tests done on rats exposed to NSPs and micrometer-sized particles). 163. See id. at 708. 164. Id. (citing NAKISSA SADRIEH, FDA CONSIDERATIONS FOR REGULATION OF NANOMATERIAL PRODUCTS (2006), http://www.fda.gov/ nanotechnology/NIST_meeting_Houston_01-06.ppt#38). 165. See id. (discussing the "Citizen Petition to the United States Food and Drug Administration," available at http://www.icta.org/doc/Nano%20FDA% 20petition%20final.pdf). "The petitioners want the FDA to amend its regulations to define nanotechnology, promulgate new regulations under which nano products would be treated as new substances." Id. 166. See FDA, NANOTECHNOLOGY, supra note 48, at 5. 167. See Rogers, supra note 144. 168. See Newman, supra note 28, at 193 ("In Europe, a lot of the stem-cell injec-tions for skin rejuvenation are human embryonic—from tissue from abortions, for example, or unwanted embryos—though it's not talked about."); see also Dan Childs, Stem Cells for Beauty?, ABC NEWS, Nov. 24, 2006, http://abcnews.go.com/ Health/Cosmetic/story?id=2674304&page=1 (discussing future stem cell applica-tions in cosmetics). FARREN.DOC 12/22/2008 10:23:30 AM 394 The Elder Law Journal new cosmetics focus on DNA for anti-aging serums and creams169 and the use of human growth hormone.170 Yet another new product is a gel containing a 3% extract of a neurotransmitter, a substance pro-duced in the brain, to reduce forehead frown lines and tighten sagging neck skin.171 As with nanotechnology, the health effects of these products are largely unknown.172 While nanotechnology involves a different set of risks from AHAs, the parallel remains in that new cosmetics are being sold to consumers who are largely unaware of the risks involved.173 Negative side effects will likely be discovered by the mass consumers, primarily consisting of an aging population. A more effective system should be implemented to handle new cosmeceuti-cals before adverse events occur. The AHA warning label and Nanotech Task Force are fixes that are specific to certain cosmeceuti-cals.174 Ultimately, they are a temporary Band-Aid to make up for de-ficiencies in the system until the next generation of cosmeceutical is developed.175 B. Consumer
Confusion
There is increasing consumer confusion regarding the status of anti-aging skincare cosmeceutical products as cosmetics instead of drugs, while the products themselves generally do not actually qual-ify as drugs under the FDA's regulations. A member of the NPD Group, a market research company, commented, [W]e don't necessarily see a shift in focus from traditional derma-tology to cosmeceuticals. What we've seen is that traditional der-matology and the trust that consumers hold in doctors and medi-cine has launched cosmeceutical skin care into super stardom. 169. See Burke, supra note 78 (the DNA Repair Formula is an anti-aging serum that treats photo damage and environmental stress); Simon Pitman, DNA-Tested Cosmetics Come to Europe, COSMETICSDESIGN-EUROPE.COM, July 27, 2006, http://www.cosmeticsdesign-europe.com/news/ng.asp?n=69441-genelink-dermagenetics-dna-anti-ageing. Genelink's Dermagenetics brand creates a face cream in a lab according to a DNA swab taken from the customer. Id. 170. See Vispi Kanga, Sophisticated Cosmetics Ingredients, HAPPI, June 1, 2005, http://www.happi.com/articles/2005/06/sophisticated-cosmetic-ingredients. The Nanolipo-hGH Retinol Plus product by Regeron, a Korean company, designed for enhanced antiwrinkle treatment, uses a raw material that is a bioactive human growth hormone stabilized in nano-sized liposomes for use in cosmetics. See id. 171. Skin Care and Repair, supra note 24. 172. Heymann, supra note 36, at 359–60. 173. Id. 174. See CFSAN, LABELING, supra note 128; FDA, NANOTECHNOLOGY, supra note 48. 175. See FDA, NANOTECHNOLOGY, supra note 48. FARREN.DOC 12/22/2008 10:23:30 AM REMOVING THE WRINKLE 395 Because cosmeceuticals are associated with doctors and medicine, consumers hold more belief in the efficacy and potency of these products to actually deliver on their promises.176 The results of this are disappointed consumers who believed the cos-metics would work as drugs and their subsequent lawsuits.177 The change in consumer perception is largely caused by a combination of misleading anti-aging product claims and an increasingly drug-like appearance of new products.178 New anti-aging skincare cosmeceuticals have increasingly potent product claims.179 Rather than simply hiding imperfections, products are claiming to fight them.180 The cosmetics industry sells an image and leaves the consumer to believe the claims or not, but many con-sumers do not realize this.181 Surveys have found that consumers generally believe cosmetic claims and expect products to actually pre-vent or slow the formation of wrinkles if such a claim is made on the packaging.182 A recent study by the American Academy of Dermatol-ogy estimated that 94% of women are confused by the quality and ef-fectiveness of anti-aging treatments on the market.183 The usual mechanism for preventing unsubstantiated drug-like product claims is to apply the intended-use analysis, which deter-mines a product's status as a cosmetic or a drug.184 The current regu-lation system classifies a product as a cosmetic or a drug through an analysis that places more emphasis on the manufacturer's claims and less on ingredients185 or the actual physical effects.186 To fall under ei- 176. Burke, supra note 78. Furthermore, "[i]n the last decade, the pendulum has swung and many dermatologists have embraced the cosmetics industry and formed strategic relationships . . It has proved to be a good partnership all around, as consumers demand more science in their skin care." Id. 177. See Lewis, supra note 69. In a survey, "many said they expect a product to prevent or slow the formation of wrinkles if it makes such a claim on its packag-ing." Id. 178. See id. (discussing a 1994 FDA survey about consumer perceptions about cosmetic labeling claims). 179. See Liang & Hartman, supra note 30, at 263. 180. Laurel Brown, COSMECEUTICALS OR COSMEPSEUDOCALS: EXAMINING THE FDA'S UNDER-SIGHT OF CELEBRITY DERMATOLOGISTS IN THE COSMECEUTICALS INDUSTRY (May 2005) (unpublished paper, Harvard Law School), http://leda.law. harvard.edu/leda/data/722/brown05.pdf. 181. See Lewis, supra note 69. 182. See id. 183. See Geria, supra note 17, at 41. 184. Heymann, supra note 36, at 365. 185. See Sarah E. Schaffer, Reading Our Lips, 62 FOOD & DRUG L.J. 165, 213–15 (2007). FARREN.DOC 12/22/2008 10:23:30 AM 396 The Elder Law Journal ther the "cosmetic" or "drug" regulatory schemes, the product must be "intended" for use as a "cosmetic" or a "drug," respectively.187 The intended use is determined by the objective intent of the manufac-turer, as shown by "labeling claims, advertising matter, or oral or written statements," as well as evidence of the labeler's knowledge of the product being offered or used for a particular purpose.188 How-ever, intended use may be difficult to police because the "status of a product may change according to the whims of the manufacturer, de-pending on the advertising claims the manufacturer has promulgated, the label, promotional materials, and ‘any other relevant source.'"189 A manufacturer can avoid extensive regulation and premarket testing, regardless of the product's safety, merely by drafting advertising claims in vague, unverifiable language.190 The intended-use analysis discourages cosmetic companies from making unsubstantiated drug-like product claims for anti-aging skin-care cosmetics because drug-like product claims will result in the ap-plication of drug regulation requirements.191 For cosmeceuticals, however, focusing on the intended use could lead to classification of one product as a cosmetic while another with the same ingredients is classified as a drug, which may be confusing for consumers. For ex-ample, tretinoin (retinoic acid) is an ingredient classified by the FDA as a drug for treating acne and certain other skin conditions because it increases collagen by affecting the skin at a cellular level.192 Yet treti-noin may also be found in cosmetics.193 Some cosmetic manufacturers also play with ingredient concentrations to avoid falling into the drug category.194 Certain ingredients may have only drug functions and no cosmetic functions, or cosmetic effects at low concentrations and drug effects at high concentrations.195 If the concentration of some key in-gredients is too low, the consumer may be essentially paying an exor- 186. Liang & Hartman, supra note 30, at 252–53 (labeling and promotional claims can bring a product under the definition of a drug, regardless of the actual physical effects). 187. Heymann, supra note 36, at 365. 188. Greff, supra note 55, at 254 (citing 21 C.F.R. § 210.128 (2008)). 189. Heymann, supra note 36, at 365–66. 190. Id. 191. See Greff, supra note 55, at 250. 192. See Creams & Cosmetics, supra note 9, at 1. 193. Id. 194. Liang & Hartman, supra note 30, at 266. 195. See Greff, supra note 55, at 255. FARREN.DOC 12/22/2008 10:23:30 AM REMOVING THE WRINKLE 397 bitant price for simple moisturizer.196 Consumer confusion also occurs from closely related but different compounds, such as those derived from the same vitamin.197 Drug-like names for new cosmeceuticals are also confusing to consumers.198 These days, the "cosmetics counter is looking more and more like a chemistry lab."199 Kiehl's skincare collection carries labels such as "lycopene facial moisturizing cream" and "anti-oxidant skin preserver,"200 Olay has "derma-3X," L'Oréal has "boxwelox," and Revlon has "pro-hydroxy and phyto-matrix."201 Estée Lauder's Per-fectionist [CP+] uses "triple enzyme technology" with "patent-pending triple enzyme technology and [Estée Lauder] exclusive Poly-Collagen Peptides."202 Some antiwrinkle cosmetics use medical terms, such as "serum," without specific definition.203 "Serum" is otherwise known as a part of blood in "blood serum."204 IV. Recommendation
Various proposals have been made on how to deal with cosme- ceuticals, including adjusting the existing cosmetic and drug regula-tory categories, adding a third category, or requiring premarket test-ing.205 However, many of these proposals have serious flaws. First, modifying existing categories would inevitably result in the same dif-ficult line-drawing problem as under the current system. If the drug category was expanded to include more cosmeceuticals, the emphasis on strict requirements for stronger drugs would be reduced. Drug re-quirements should not be reduced because it is better to err on the side of caution in protecting consumers from likely risks. Increasing regulations on all cosmetics would be the more reasonable choice in 196. See Liang & Hartman, supra note 30, at 266. 197. Tex. Extension, Tex. A&M Univ. Sys., Regulated? Effective? Or Not?, in HEALTH HINTS, supra note 9, at 4, 4. For example, both retinol and retinoic acid are derived from vitamin A. Id. 198. See Barbara Righton, Rip Van Wrinkle to the Rescue, BAZAAR, Jan. 23, 2006, at 54. 199. Id. 200. Dubecki, supra note 34, at 3. 201. See id. 202. See Estée Lauder, supra note 13. 203. See Navin M. Geria, Take a Closer Look at Anti-Aging Serums, HAPPI, June 1, 2006, http://www/happi/com/articles/2006/06/antiaging-cosmeceutical-corner (describing serum use and some antiwrinkle serums with their effects). 204. See 205. See Liang & Hartman, supra note 30, at 279–80. FARREN.DOC 12/22/2008 10:23:30 AM 398 The Elder Law Journal light of safety concerns, but feasibility becomes a problem. The cost of government regulation over all cosmetics might not be justified when the combined overall risk is minimal. Additionally, overly burdening cosmetics companies by simply adding drug-level requirements across the board could reduce availability of beneficial cosmetic prod-ucts at low prices due to manufacturers' costs of complying with addi-tional regulations.206 Another previously suggested alternative involves modifying existing categories by adding a new third category between drugs and cosmetics.207 In this alternative, additional regulations would be added to address more proportionately the type of product and risk involved.208 Again, this method is equally troublesome because the same line-drawing difficulties that are currently present would be doubled. What is the difference between a cosmetic and a cosmeceu-tical, and between a cosmeceutical and a drug? While a third category might provide some more protection for consumers, each category would become harder to define. Furthermore, if the wide gray band of cosmeceuticals was a separate category by itself, the sharp distinc-tion between a cosmetic and drug would be lost. Yet here again, it may be argued that a strong distinction is not necessary because the physical differences between a cosmetic and a drug are not so sharply distinct, but more like a gradient shift of gray.209 In essence, they are both substances, but one has a more potent effect on the body and is marketed as such.210 A long-term solution, more effective than the present-day tem- porary fixes that focus on specific cosmeceuticals, is to use remedies that treat the problems directly. There are two main components to this proposed solution: a notice system regarding risk and consumer education about the cosmetic-drug distinction. Additionally, overall stricter policing of product claims is desired. 206. Greff, supra note 55, at 250. 207. Heymann, supra note 36, at 373. 208. Id. 209. Id. 210. See id. at 372. FARREN.DOC 12/22/2008 10:23:30 AM REMOVING THE WRINKLE 399 A. The Notice System
Many consumers have the perception that products for sale on the mass market are thoroughly tested and safe.211 They assume that products carrying a higher health risk require a prescription or would be available only through specialists.212 These assumptions are incor-rect because products are regulated as drugs based primarily on the manufacturer's claims about the intended use of the product and less on the actual ingredients used.213 Consumers can be broken down into different types: those who want anti-aging skincare products and others who are merely looking for a general cosmetic and are drawn by the anti-aging claims to pur-chase the skincare product with the alleged anti-aging characteris-tics.214 A labeling notice system would target the unknown-health-risk problem by allocating the risk to those consumers who want the latest anti-aging product, despite its relatively untested status. These con-sumers would then also be aware of the potential for undesired side effects. Consumers who merely wanted traditional moisturizers and cosmetics would avoid these items or would at least be on notice of possible risks. The strength in using a notice system is that it would be adaptable to future cosmeceuticals, including those employing new technology, such as nanotechnology, which may not change the in-gredient list.215 Possible notice systems could include a label mark and a rating system. For example, a three-color code using red, yellow, and green would indicate corresponding levels of risk or the relatively untested status of a product. Red could identify new products in comparison with stable products that have been available on the market for forty or fifty years. Another possible notice system is a label mark present-ing a number that represents the years the product has been available. This method would require a determination of which point in time the 211. See Lewis, supra note 69. "Consumers believe that ‘if it's on the market, it can't hurt me.'" Id. (quoting John Bailey, acting director of the FDA Office of Cos-metics and Colors). 212. See 213. See CFSAN, COSMETIC, DRUG, OR BOTH?, supra note 37. 214. See Rogers, supra note 144. A skincare consultant stated, "We are seeing a generation of baby boomers who don't want to grow old or look old and, if things work, they are prepared to spend the money to pay for them." Id. 215. Andrew Bridges, FDA: No Need to Flag All Nanotechnology, USA TODAY, July 25, 2007, http://www.usatoday.com/tech/news/nano/2007-07-25-fda-nanotechnology_N.htm. FARREN.DOC 12/22/2008 10:23:30 AM 400 The Elder Law Journal years should be counted from, such as the time the particular ingredi-ent became available in products sold anywhere, the time the product became available, and the like. A taskforce would need to examine other notice systems to determine which system would fit best in this case.216 A notice system could also be a warning or disclaimer, similar to the statement used for vitamin supplements: "This statement has not been evaluated by the Food and Drug Administration. This prod-uct is not intended to diagnose, treat, cure, or prevent any diseases."217 The notice system could also be simply a symbol on certain products, functioning similarly to a biohazard symbol. Placing the notice near the ingredient list would also conveniently allow consumers to be-come familiar with substances used in the products.218 Ideally, the notice system should be facially neutral to avoid cre- ating immediate alarm or excessive negative associations with new products. The purpose would simply be to inform consumers of higher risk, but not to insinuate the product is actually unsafe. Like-wise, the notice system should not give consumers a false security that other cosmetic products are completely safe if they do not have the mark of a new product. Using systems that might imply one type of cosmetic is better than another, such as a star rating, should be avoided. Some difficulties with choosing any rating system include de- termining when to shift products from one category to the next. An-other challenge to the notice system is its implementation. The FDA would be burdened with the task of determining the best way to edu-cate the public about the notice system. This could be done through signs in sales locations or information provided from the manufactur-ers with the products. Also, a difficult problem with any notice sys-tem is enforcement of the system itself. To realistically minimize its cost, a labeling notice system would be most practical as a voluntary 216. Other rating systems include the home-energy rating, which measures energy efficiency of homes, appliances, and the like. RESNET, Frequently Asked Questions, http://www.resnet.us/ratings/overview/faq_rating.htm (last visited Oct. 17, 2008). This system uses yellow energy guide stickers to notify consumers. Energy Star, Learn More About EnergyGuide, http://www.energystar.gov/ index.cfm?c=appliances.pr_energy_guide (last visited Oct. 17, 2008). 217. CTR. FOR FOOD SAFETY & APPLIED NUTRITION, FOOD & DRUG ADMIN., OVERVIEW OF DIETARY SUPPLEMENTS (2001), http://www.cfsan.fda.gov/ dms/ qa-sup12.html. 218. Lewis, supra note 69. The ingredient list is the best place for a consumer to readily find out what they are buying. See id. FARREN.DOC 12/22/2008 10:23:30 AM REMOVING THE WRINKLE 401 program for manufacturers, as opposed to a mandatory program. Furthermore, there would need to be sufficient incentive for manufac-turers to participate. Perhaps by alerting consumers to this system, a demand could be created for products that participate in the notice system. As long as the system operated in a neutral way, it would not necessarily dissuade consumers from purchasing products with cut-ting-edge ingredients and technology. Consumers who want the lat-est anti-aging product would still create a demand for new products despite higher risks. B. Consumer
Education
While outlandish claims have always been a part of the beauty industry,219 surveys show that consumers generally believe cosmetic product claims.220 Some educated cosmetics consumers may be aware that there are no government standards on marketing phrases like "dermatologist-tested," "allergy-tested," "natural," and "hypoaller-genic," and that these are phrases employed for marketing purposes only, but many consumers do not understand this.221 Manufacturers may describe AHAs as "natural products derived from fruit," but be-ing "natural" does not necessarily make a product safer.222 Even less likely is a cosmetics consumer who understands the cosmetics with the chemical, drug-like names and terms describing nanotechnology. Ingredient lists may be the only current source of reliable govern-ment-required information,223 but with the advent of technologies like nanotechnology, where the risk changes depending on the size and not the particular ingredient, this list is no longer as reliable an indica-tor.224 Even if ingredients are not physically harmful, "at often exorbi- tant prices they could remove more cash from your wallet than wrin-kles from your skin."225 Anti-aging skincare products target aging 219. Branna, supra note 6. 220. See Lewis, supra note 69. 221. See 222. See Brody, supra note 135. 223. See Lewis, supra note 69. 224. See Philip Ross, Tiny Toxins?, TECH. REV., May 2006, http://www. technologyreview.com/nanotech/16814/pagel. 225. Skin Care and Repair, supra note 24. FARREN.DOC 12/22/2008 10:23:30 AM 402 The Elder Law Journal adults,226 including men,227 and this is the group who will ultimately pay the price for misleading claims.228 Information is already available to the consumer through some sources. Specific cosmetic ingredients can be referenced through the International Cosmetic Ingredient Dictionary and Handbook, pub-lished by the CTFA.229 Articles available in popular magazines dis-cuss cosmetics as well.230 It may not be realistic to expect to educate the majority of cosmetics consumers about the details of the many new cosmeceutical products, but consumer confusion can be mini-mized by re-educating consumers about the basic difference between cosmetic and drug classifications. Consumers today are misled into believing many anti-aging skincare cosmeceutical products are like drugs.231 In order to effec-tively protect consumers from false expectations, the presence of a bright-line difference between the categories should be reaffirmed and kept sharp and distinct: products that are drugs must undergo signifi-cant testing and products that are cosmetics are virtually unregu-lated.232 Consumers should not believe cosmetic products will func-tion like drugs. Cosmetics, regardless of their product claims, are generally limited to products that merely provide temporary im-provement of appearance and feel, whereas drugs may have an actual physiological effect.233 The FDA has consumer education information available,234 but it is not distributed widely enough to reach a large percentage of cosmetics consumers.235 If consumers understand the categories, then cosmetic claims will not be as misleading. Caridad, Forever Young, HAPPI, May 1, 2007, http://www.happi. com/articles/2006/05/forever-young. 227. See, e.g., Burke, supra note 78. 228. See Skin Care and Repair, supra note 24. 229. Lewis, supra note 69. The Handbook is available at most public libraries or at the Office of Federal Register, 1100 L St., N.W., Washington, DC 20408. Id. The FDA recognizes this association as a reliable source for which substances have been identified as cosmetic ingredients, as well as their definitions and trade names. Id. 230. See, e.g., Newman, supra note 28, at 193. 231. See Geria, supra note 17, at 38. 232. See Heymann, supra note 36, at 363. 233. Liang & Hartman, supra note 30, at 261. 234. See, e.g., Lewis, supra note 69; U.S. Food & Drug Admin., How Smart Are You About Cosmetics?, Dec. 2000, http://www.cfsan.fda.gov/ dms/costf-1.html (online quiz testing FDA regulations). 235. See U.S. Food & Drug Admin., Consumer Health Information, http://www.fda.gov/consumer. FDA consumer information is available online or by request. See id. FARREN.DOC 12/22/2008 10:23:30 AM REMOVING THE WRINKLE 403 V. Conclusion
Millions of aging consumers use anti-aging skincare cosmetic products as part of their daily routines without considering the possi-bility of health risk, trusting that the products will do what the manu-facturers have claimed.236 With the introduction of more and more anti-aging skincare cosmeceuticals into the mass market, the FDA must be prepared to handle new products that do not comfortably fit within current cosmetic and drug categories. A poor response to these new products would be to wait and react to adverse results as they appear. Anti-aging skincare cosmeceuticals are on the market now. The main problems associated with these products are unknown health risks and consumer confusion about the status of a product as a cos-metic or drug. The fix does not have to be as extensive as modifying FDA regulations of cosmetic and drug categories. Rather, a combina-tion of solutions, including a notice system and consumer education, as well as stricter policing of product claims, may drastically reduce the problems. 236. Rogers, supra note 144.

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