American beauty: An analytical view of the past and current effectiveness of cosmetic safety regulations and future direction

Food and Drug Law Journal

Volumn 63, Issue 1, 2008, Pages 257-274

  Termini, Roseann B ^a   Tressler, Leah ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

COSMETIC;

DRUG EFFICACY; DRUG FORMULATION; DRUG INDUSTRY; DRUG SAFETY; ESTHETICS; ETHICS; FOOD AND DRUG ADMINISTRATION; REVIEW;

CONSUMER PRODUCT SAFETY; COSMETICS; ETHICS, MEDICAL; HISTORY, 20TH CENTURY; HUMANS; INTERNATIONAL COOPERATION; LEGISLATION, DRUG; PRODUCT LABELING; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 40549111042     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (144)

1. Federal Food, Drug, and Cosmetic Act of 1938 ch. 675, 52 Stat. 1040 (1938) codified at 21 U.S.C. § 301 et seq.
2. Gwen Kay, Dying to be Beautiful: The Fight for Safe Cosmetics, 10-12 (The Ohio State University Press, 2005).
3. Id. at 10.
4. Id. at 11.
5. This may beg the question as to the true effectiveness of warnings and labels; however, Americans seem to demand an informed consumer market where the consumer decides whether he or she is willing to accept potential hazards.
6. On February 6, 2007, Congress enacted a concurrent resolution expressing the opinion that Madame C.J. Walker, who invented a hair relaxing treatment in 1905 and was one of the first American women to amass a personal net worth exceeding one million dollars, should be recognized as one of history's greatest female business women and role models. H.R.J. Res. 58, 110th Cong. (2007).
7. Flappers began changing the popularity and use of visible makeup. See Kay, supra note 2, at 39.
8. Smith v. Denholm & McKay Co., 192 N.E. 631, 632 (Mass. 1934).
9. The American Medical Association created The Propaganda Department in 1906. The Department was later re-named the Bureau of Investigation in 1925. The purpose of the Bureau was to collect and disseminate information about health quackery and fraud. Kay, supra note 2, at 70-71; see also American Medical Association, Chronology of AMA History, http://www.ama-assn.org/ ama/pub/category/1922.html (last visited Nov. 19, 2007).
10. The product manufacturer eventually went bankrupt and ceased selling Koremlu Cream. Id.
11. Bundy v. Ey-Teb, Inc., 160 Misc. 325, 326 (N.Y. Misc. 1935) (finding the manufacturer liable for personal injuries suffered by a customer who used a lash tint according to instructions and relied on the label stating that the preparation contained no poisonous metals).
12. Id.
13. See Kay, supra note 2, at 97 citing "Cosmetics labeled with therapeutic claims subject to action under food and drug laws," May 13, 1932, Press Notices, PR Manuscripts (021.1); General Correspondence 1932, NACP 88.
14. This concern continues to be a debated issue today.
15. S.B. Forbes & W.C. Blake, Fatality Resulting from the Use of Lash-Lure on the Eyebrow and Eyelashes, 103 JAMA 1441-42 (1934).
16. While an 1897 version of the 1906 Act included cosmetics within the drug definition, this was dropped from the 1906 version, apparently due to an interest in increasing political support. Gary L. Yingling & Suzan Onel, Cosmetic Regulation Revisited, FUNDAMENTALS OF LAW AND REGULATION VOL. I, 316 (Robert P. Brady ed., FDLI 1997),
17. citing Anderson, Pioneer Statutes: The Pure Food and Drugs Act of 1906, 13 J. PUB. LAW 189 (1964).
18. See Yingling, supra note 16, at 316-317 citing Federal Food, Drug and Cosmetic Act: A Statement of Its Legislative Record 24-25 (Charles Wesley Dunn ed. 1938).
19. S. 1944, 73d Cong., 1st Sess., reprinted in 77 Cong. Rec. 5721-23 (1933).
20. 1933 USDA, FDA Annual Report 1, 13-16 (1934).
21. See Yingling, supra note 16, at 317.
22. Id. at 319.
23. Id. at 319-320.
24. Additional changes to the bill included the definition of what would constitute an adulterated cosmetic. The original language that included a product as being adulterated "if it was or could be injurious to the user under usual or prescribed conditions" was rejected, with the substitute bill limiting an adulterated product to one that "bears or contains any poisonous or deleterious substance that may render it injurious to the user under the usual or prescribed conditions of use." Laura A. Heymann, The Cosmetic/Drug Dilemma: FDA Regulation of Alpha-Hydroxy Acids, 52 FOOD DRUG L.J. 357, 362 (1997).
25. See Yingling, supra note 16, at 320 citing 83 Cong. Rec. 13,183 (1938).
26. 21 U.S.C. § 321(i) (2006).
27. Roseann B. Termini, LIFE SCIENCES LAW: FEDERAL REGULATIONS OF DRUGS, BIOLOGICS, MEDICAL DEVICES, FOOD AND DIETARY SUPPLEMENTS 3rd Ed., 415 (Forti Publications 2007).
28. 21 U.S.C. § 361 (2006).
29. Products containing coal tar dyes must include: "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." The label must bear adequate directions for preliminary testing. The term "hair dye" in subsections (a) and (e) shall not include eyelash dyes or eyebrow dyes. 21 U.S.C. § 361(a) (2006).
30. 21 U.S.C. § 362 (2006).
31. Ctr. for Food Safety & Applied Nutrition Office of Compliance, Final Guidance for Industry Cosmetics Processors and Transporters: Cosmetics Security Preventative Measures Guidance, Dec. 17, 2003, 2003 WL 24014301 (FDA).
32. 21 C.F.R. § 710.1 (2007).
33. 21 C.F.R. § 710, § 720.1 (2007). According to Stanley R. Milstein, Ph.D. of FDA's Office of Cosmetics and Colors, the total number of cosmetics manufacturers and/or distributors who have formulations registered with the FDA e-VCRP as of February 1, 2008 is 1,066. Author conducted interview.
34. FDA, Voluntary Cosmetic Registration Program, June 6, 2000, http://www.cfsan.fda.gov/~dms/cos-regn.html (last visited Oct.24, 2007).
35. 21 U.S.C. § 379e (2006).
36. 21 U.S.C. § 379e (2006); 21 C.F.R. 70.50 (2007); Public Citizen, et al. v. Dept. of Health & Human Servs., et al., 831 F.2d 1108, 1110-13 (D.C. Cir. 1987) (describing the history and implications of the Delaney Clause.)
37. U.S. v. Eight Unlabeled Cases, 888 F.2d 945, 947-48 (2d. Cir. 1989) (finding that although the color additive canthaxanthin was approved for use in foods or drugs, this did not automatically render it safe for use in cosmetics).
38. Public Citizen, et al., 831 F.2d at 1110-13.
39. Id.
40. 21 C.F.R. § 70.50; § 81.10 (2007).
41. Scott v. FDA, 728 F.2d 322, 324-25 (6th Cir. 1984).
42. Id.
43. In addition to FDA approval, numerous color additives derived primarily from petroleum must be batch certified by FDA prior to being used in cosmetic formulations. Certification is granted after the additives have passed composition and purity testing. CFSAN, Color Additives and Cosmetics, April 2007, http://www.cfsan.fda.gov/~dms/cos-col.html (last visited Jan. 28, 2008).
44. 21 C.F.R. 70.3 (2007); CFSAN, Hair Dye Products, Nov. 1997, http://www.cfsan.fda.gov/~dms/cos-hdye.html (last visited Oct. 24, 2007).
45. Id.
46. In the 1970s, FDA requested that Congress repeal the exemption. Industry representatives and lobbyists vigorously opposed a repeal of the exemption. No changes came to pass. James T. O'Reilly, Food and Drug Administration, 2d. Ed., 17:3 (Thomson/West 2005), citing Letter of FDA Director of the Office of the Commissioner on Human Resources, at 4 (Dec. 12, 1977) (re: S. 1681) and 37 F-D-C Reports at TG-1 (Mar. 24, 1975).
47. Fact Sheet, Cosmetic Labeling, March 26, 2003; see also FDA, Fair Package and Label Act, www.fda.gov/opacom/laws/fplact.htm.
48. 21 C.F.R. § 701.10 (2007).
49. 21 C.F.R. § 701.10; § 701.12 (2007).
50. 21 C.F.R. § 20.61 (2007).
51. 21 C.F.R. § 701.3; 720.8 (2007).
52. CFSAN; Office of Cosmetics & Colors, Cosmetic Labeling Manual, Oct. 1991, available at 1991 WL 11250880 (FDA)
53. 21 C.F.R. § 701.3(d) (2007).
54. 21 C.F.R. § 740.10 (2007).
55. F. Alan Andersen, Approaching 30 Years The Cosmetic Ingredient Review Program, FDLI UPDATE, 13 (Nov./Dec. 2005).
56. Id.
57. See CFSAN, supra 51.
58. 42 Am. Jur. Proof of Facts 2d. 97 § 22 (2007).
59. 63A Am. Jur. 2d. Products Liability § 1108; 1244 (2007).
60. Whitehurst v. Revlon, Inc., 307 F. Supp. 918, 919-21 (E.D.Va. 1969), citing Daniel v. Ben E. Keith Co., 97 F.3d 1329 (10th Cir. 1996).
61. Id.
62. Jack v. Alberto-Culver USA, Inc., 949 So. 2d 1256, 1257 (La. 2007).
63. The court noted that the product warning did satisfy the Louisiana statute requirements for an adequate warning. Id. at 1259.
64. Cosmetic, Toiletry & Fragrance Ass'n v. Schmidt, 409 F. Supp. 57, 59-60, 64 (D.D.C. 1976).
65. Id. at 64 (finding this requirement following a suit in which a child punctured a hairspray can and was subsequently burned when a fire erupted).
66. Office of Cosmetics & Colors, Draft Guidance for Industry Labeling for Topically Applied Cosmetic Products Containing Alpha Hydroxy Acids as Ingredients, Dec. 2, 2002, available at www.cfsan.fda.gov/~dms/ ahaguide.html.
67. Id.
68. Id.
69. See Andersen, supra note 54, at 13.
70. Id.
71. Id.
72. Id.
73. Id.
74. Id.
75. Report Criticizes Lack of Regulation for Cosmetics: 89 Percent of Ingredients Not Evaluated, Impurities High, Warning Letter Bulletin Vol. 12 Issue 12, June 14, 2004, available at 2004 WLNR 6598802.
76. Id.
77. Out of the 2,395,582 human exposure calls made to poison centers during 2003, 223,189 were associated with personal care products. Of these 223,189 calls, 2,356 were judged moderate, 120 were judged major and eight resulted in death. Phillip L. Casterton, Benefits From the Scientific Side of Cosmetics, FDLI UPDATE, 21 (Nov./Dec. 2005),
78. citing W.A. Watson et al., 2003 Annual Report of the Am. Ass'n of Poison Control Ctrs. Toxic Effects Surveillance System, 22 AM. J. EMERGENCY MED., 335-392 (2003).
79. Id.
80. Because these state acts do not impose requirements on labeling and packaging of cosmetics, the acts do not violate the federal preemption of state labeling under 21 U.S.C. § 379s (2006). Natasha Singer, Should You Trust Your Makeup?, N.Y. TIMES, Feb. 15, 2007, at G1, available at 2007 WLNR 2956300.
81. Lisa Stiffler, State Mulls Cosmetic Safety Bill Based on California Measure, SEATTLE POST INTELLIGENCER (WA), Feb. 20, 2007, at B1, available at 2007 WLNR 3389055.
82. Id.
83. The test group linking this plasticizer to developmental defects included only 85 participants. Janet Raloff & Ben Harder, Gender Measure: Pollutant Appears to Alter Boys' Genitals, 167 SCIENCE NEWS, No. 23, 355 (2005).
84. Coratti v. Wella Corp., 14 Misc. 3d 1204(A) (N.Y.S. 2d 2006).
85. Id.
86. Smallwood v. Clairol, Inc., 2005 U.S. Dist. LEXIS 2726, *1 (S.D.N.Y. 2005).
87. Id. at 1-2.
88. Id. at 8.
89. Id. at 3-7.
90. While the press often cites scientific findings that arguably show links between physical injury and cosmetic ingredients, there are many scientific studies disproving these causal links. See Hair Straightening Chemicals Not Linked to Breast Cancer Risk in African-Americans, WOMEN'S HEALTH WEEKLY, May 31, 2007, available at 2007 WLNR 9759057.
91. See Termini, supra note 26 at 422.
92. Robert G. Pinco, Implications of FDA's Proposal to Include Foreign Marketing Experience in the Over-the-Counter Drug Review Process, 53 FOOD DRUG L.J. 105, 109 (1998).
93. 21 C.F.R. § 701.3(d) (2007).
94. Many bleaching creams contain hydroquinone, a bleaching chemical. Hormonal skin creams contain estrogens that can penetrate the epidermis and cause plumping of the skin. FDA has voiced concern over the safety and effectiveness of these products and has stated that labeling such as cosmetics constitutes misbranding. 42 Am. Jur. Proof of Facts 2d. 97, § 8 (2006); see also Straus, Hormones in Cosmetics, 186 JAMA 759 (1963).
95. See Heymann, supra note 23, at 361, citing Skin Peelers, U.S. Dept. of Health & Human Servs., Food and Drug Admin., P92-13 (May 21, 1992).
96. Id.
97. Id.
98. Letter from Dept. of Health & Human Servs. to BioForm Medical Inc. (Feb. 15, 2007), available at http://www.fda.gov/foi/warning_letters/ g6265d.htm.
99. Id.; see also Letter from Dept. of Health & Human Servs. to Fusion Brands International SRL (Apr. 24, 2007), available at http://www.fda.gov/foi/warning_letters/s6371c.htm (finding the company was advertising Lift-Fusion brand products as cosmetics although the associated claims placed the products within the definition of a drug).
100. 641 F. Supp. 1209 (D. Del. 1986). This claim involved a patent infringement suit pertaining to a compound, minoxidil, found to promote hair growth. Defendants sold a product that contained minoxidil as a cosmetic without receiving pre-approval by FDA. Although the defendants claimed that the product did not cause hair growth, no testing had been done to support the contention that the product was a cosmetic rather than a drug. In addition to potential dangers of an untested drug, the court noted potential misleading as a problem since promotional materials implied hair growth. Upjohn Co. v. Riahom Corp. et al., 641 F. Supp. 1209, 1225-26 (D. Del. 1986).
101. Cosmetics Introduction, European Commission (Jan. 23, 2006), http://ec.europa.eu/enterprise/cosmetics/index_en.htm (last visited Oct. 24, 2007).
102. Id.
103. Id.
104. Id.
105. See Pinco, supra note 90, at 109.
106. Janet Winter Blaschke, Globalization of Cosmetic Regulations, 60 FOOD DRUG L.J. 413, 415-17 (2005).
107. Id.
108. Id. at 417-18.
109. Cosmetic Industry Filed FDA Comments on Use of Nanoparticles in Personal Care Products, GLOBAL NEWS WIRE - PR NEWS WIRE, Sept. 19, 2006.
110. Id.
111. Id.
112. Id.
113. FDA Warns Consumers About Use of "Litargirio," FDA TALK PAPER, Oct. 2, 2003, http://www.fda.gov/bbs/topics/ ANSWERS/2003/ANS01253.html (last visited Oct. 24, 2007).
114. Id.
115. Id.
116. For example, a shipment of toothpaste made in China was found to contain an antifreeze ingredient, diethylene glycol, which can be poisonous. Although a shipment was found at the U.S. border before the product reached United States stores, two retail stores within the United States were found to be selling the contaminated product. FDA Says to Avoid Chinese Toothpaste, ST. LOUIS POST-DISPATCH (MO), June 2, 2007, at A18, available at 2007 WLNR 10333402.
117. The European Union has taken a very different approach from the United States and recently considered a directive amendment that would effectively ban the sale of products if animal testing was used to ensure the safety of the product. Azalea O. Rosholt, The Seventh Amendment Directive- An Unnecessary Measure to a Necessary End, 60 FOOD DRUG L.J. 421, 422 (2005);
118. see also Kate Phillips, New Methods to Eliminate Animal Testing, CHEMICAL WEEK, May 16, 2007, available at 2007 WLNR 9299075 (stating that five new in-vitro tests have been endorsed and may eliminate the practice of using rabbits in skin and eye irritancy testing for cosmetics).
119. Delcianna J. Winders, Combining Reflexive Law and False Advertising Law to Standardize "Cruelty-Free" Labeling of Cosmetics, 81 N.Y.U.L. REV. 454, 454-57 (2006).
120. Id. at 455.
121. L'Oreal USA, http://www.lorealusa.com/_en/_us/index.aspx?from=ww- dispatch-loreal-corporate (last visited Oct. 24, 2007).
122. Dr. Diane Madfes of Mount Sinai School of Medicine states that a counter argument to the issue of high prices is that expensive product purchases may cause customers to use cleansers and creams more often, thereby potentially benefiting their skin. The Skinny on Skin: It Might Make You Smile but the Efficacy of That Cosmetic is Doubtful, FINANCIAL POST, Global News Wire - Europe Intelligence Wire, Jan. 5, 2007.
123. Id.
124. Natasha Singer, The Cosmetics Restriction Diet, N.Y. TIMES, Jan. 4, 2007, at G1, available at 2007 WLNR 134283.
125. A secondary concern raised by high cosmetic prices is the presence, particularly within international countries, of counterfeit cosmetics that may expose the public to products potentially containing hazardous ingredients such as mercury. See Counterfeit Cosmetics Still Widely Available, JAKARTA POST (Indonesia), May 26, 2007, available at 2007 WLNR 9873979.
126. 21 C.F.R. § 7.53 (2007).
127. Palmer's Baby Butter Massage Lotion was found contaminated with Enterobacter Gergoviae, a pathogen that may cause several infections including, but not limited to, lower respiratory tract infections, skin and soft tissue infections and urinary tract infections. 46 FDA ENF. REP. 4 (2006), available at 2006 WL 3309388 (FDA).
128. This same bacteria was found by manufacturers of Alpine Extreme Evergreen Forest Body Wash. Vi-Jon Issues Nationwide Consumer Recall, Apr. 19, 2007, http://www.fda.gov/oc/po/firmrecalls/vijon04_07.html (last visited Oct. 24, 2007);
129. see also Susan L. Fraser, Enterobacter Infections, Wed MD, January 8, 2007, http://www.emedicine.com/med/topic678.htm (last visited Oct. 24, 2007).
130. 01 FDA ENF. REP. 2 (2001), available at 2007 WL 29841 (FDA.).
131. Id.
132. FDA, Woodridge Labs Recalls Certain Dermafreeze365 Products Because of Possible Health Risk, Mar. 23, 2007, http://www.fda.gov/oc/po/firmrecalls/ woodridge03_07.html (last visited Oct. 24, 2007).
133. Id.
134. O'Reilly, supra note 45, at 17:1-17:2, citing Letter of FDA Comm'r F. Young to Congressman R. Wyden (July 5, 1989).
135. Annual Meeting Speech by Pamela Bailey, CEO of Cosmetic, Toiletries & Fragrance Association, Mar. 1, 2007, http://www.ctfa.org/Content/ NavigationMenu/CTFA_News/Speeches/ Pamela_Bailey_Speech_at_the_CTFA_2007_Annual_Meeting.htm (last visited Oct. 24, 2007).
136. Id.
137. Id.
138. Id.
139. Id.
140. The purpose of the Campaign for Safe Cosmetics is a coalition aimed at educating consumers on cosmetic products containing potentially harmful ingredients as well as working with manufacturers in an attempt to decrease these ingredients. Judy Foreman, Scrutinizing the Safety of Cosmetic Ingredients, BALT. SUN, April 13, 2007, at 3D, available at 2007 WLNR 7123742;
141. see also Robert Cohen, Cosmetics Safety Comes Under Fire, OLYMPIAN, June 3, 2007, available at 2007 WLNR 10360041 (citing a quote made by an Estee Lauder representative who stated that the company removed dibutyl phthalate from its nail polishes in order to meet European Union marketing requirements, not because of activist groups who "do not rely on sound, peer-reviewed science in their reports").
142. See Annual Meeting Speech by Pamela Bailey, supra note 130; see also Melissa Suggit, Global Cosmetics and Toiletries Sales Reach Five Year High in 2006, EUROMONITOR INTERNATIONAL, Apr. 16, 2007, http://www.euromonitor.com/ Global_cosmetics_and_toiletries_sales_reach_five_year_high_in_2006 (finding that overall cosmetic sales in the United States increased three percent in 2006) (last visited Oct. 24, 2007).
143. Id.
144. Dori Stehlin, Cosmetic Safety: More Complex Than at First Blush, FDA CONSUMER, Nov. 1991, rev. May 1995, http://www.cfsan.fda.gov/~dms/ cos-safe.html (last visited Oct. 24, 2007).