The cosmetic/drug dilemma: FDA regulation of alpha-hydroxy acids

Food and Drug Law Journal

Volumn 52, Issue 4, 1997, Pages 357-375

  Heymann, Laura A ^a  

^a US Ct Appeals the DC Circuit ^*

Author keywords

[No Author keywords available]

Indexed keywords

2 HYDROXYACID; CARBOXYLIC ACID; CITRIC ACID; COSMETIC; GLYCOLIC ACID; HYALURONIC ACID; HYDROXYACID; HYDROXYL GROUP; LACTIC ACID; MALIC ACID; MANDELIC ACID; SUNSCREEN; TARTARIC ACID; UNCLASSIFIED DRUG;

BURN; CLINICAL TRIAL; DRUG MANUFACTURE; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; GOVERNMENT; HUMAN; LAW; REVIEW; SKIN;

CONSUMER PRODUCT SAFETY; COSMETICS; DRUG APPROVAL; DRUGS, NON-PRESCRIPTION; HISTORY, 20TH CENTURY; HUMANS; HYDROXY ACIDS; LEGISLATION, DRUG; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0031448828     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (165)

1. MARGARET ALLEN, SELLING DREAMS: INSIDE THE BEAUTY BUSINESS 33 (1981).
2. Patricia McLaughlin, About Face, PHILADELPHIA INQUIRER, Mar. 7, 1993, at 31. The product's success inspired manufacturers to introduce more than 50 AHA products to the market in 1993. Susan Sargisson, The AHA Phenomenon, DRUG & COSM. INDUS., Jan. 1, 1994, at 24.
3. Patricia McLaughlin, About Face, PHILADELPHIA INQUIRER, Mar. 7, 1993, at 31. The product's success inspired manufacturers to introduce more than 50 AHA products to the market in 1993. Susan Sargisson, The AHA Phenomenon, DRUG & COSM. INDUS., Jan. 1, 1994, at 24.
4. Lauren Neergaard, FDA to Study Wrinkle Cream, Effect of Sensitivity to Sun, COURIER -J. (Louisville, KY), Dec. 22, 1996, at 14A.
5. Letter from John Bailey, Dir., Off. of Cosmetics and Colors, FDA, to Alan Andersen, Sci. Coordinator and Dir., Cosmetic Ingredient Review Expert Panel, CTFA (Nov. 30, 1995), quoted in F-D-C REP. ("The Rose Sheet"), Dec. 11, 1995, at 1, 3.
6. Neergaard, supra note 3, at 14A.
7. Pub. L. No. 75-717, § 201(g), (h), 52 Stat. 1040, 1041 (codified as amended 21 U.S.C. § 321(g), (h) (1994)).
8. This interpretation is now open to question after a recent federal court ruling that upheld the FDA's power to regulate tobacco. See infra text accompanying notes 82-87.
9. Of course, the possibility of suit is an incentive for manufacturers to ensure the safety of their products before marketing them. See infra text accompanying notes 123-24.
10. The first patent for AHAs was filed in 1976 by Drs. Eugene Van Scott and Ruey J. Yu, who are credited with discovery of the potential of AHAs. See Sargisson, supra note 2, at 24; Eugene J. Van Scott & Ruey J. Yu, Alpha-Hydroxy Acids: Procedures for Use in Clinical Practice, 43 CUTIS 222 (1989).
11. The first patent for AHAs was filed in 1976 by Drs. Eugene Van Scott and Ruey J. Yu, who are credited with discovery of the potential of AHAs. See Sargisson, supra note 2, at 24; Eugene J. Van Scott & Ruey J. Yu, Alpha-Hydroxy Acids: Procedures for Use in Clinical Practice, 43 CUTIS 222 (1989).
12. ZOE DIANA DRAELOS, COSMETICS IN DERMATOLOGY 241 (2d ed. 1995).
13. Id. Glycolic acid is derived from sugar cane, lactic acid is derived from fermented milk, citric acid is found in citrus fruits, malic acid is found in unripened apples, mandelic acid is an extract of bitter almonds, and tartaric acid is found in fermented grapes. Id.
14. Anita Shaw, The News in Skin Care, SOAP-COSM.-CHEM. SPECIALTIES, Oct. 1, 1996, at 72.
15. Maria Liberati, Alpha & Beta Hydroxy Adds: The Skin-Care Revolution, BETTER NUTRITION Apr. 1996, at 70.
16. Id.
17. Shelley M. Colwell, AHAs: The Reigning Ingredient, SOAP-COSM.-CHEM. SPECIALTIES, Feb. 1, 1996, at 30 (citing Dana Glazer, Dir., Pub. Relations, Guerlain).
18. Susan Brink, The Dewrinkling of America, Alpha Hydroxy Acids in Pricey Creams Are the Latest Antiaging Elixir, U.S. NEWS & WORLD REP., Jun. 6, 1994, at 79; Bernard Idson, Retinoids and AHAs, DRUG & COSM. INDUS., May 1, 1995, at 24.
19. Susan Brink, The Dewrinkling of America, Alpha Hydroxy Acids in Pricey Creams Are the Latest Antiaging Elixir, U.S. NEWS & WORLD REP., Jun. 6, 1994, at 79; Bernard Idson, Retinoids and AHAs, DRUG & COSM. INDUS., May 1, 1995, at 24.
20. See. e.g., Colwell, supra note 15, at 30 (quoting Alex Znaiden, Dir., Global Skin Innovation Center, Chesebrough-Pond's) ("If you have delivered the concentration, that's going to keep your customer with you.").
21. Alpha Hydroxy Acids (AHAs), U.S. Food & Drug Admin., Ctr. for Food Safety & Applied Nutrition, Office of Cosmetics Fact Sheet (May 3, 1995). Based on the 97 complaints received by the agency since 1989, and on the agency's assumption that one report to the agency equals approximately 50 to 100 reports received by manufacturers, FDA estimated that cosmetic companies had received about 10,000 reports of adverse reactions to AHAs. F-D-C REP. ("The Rose Sheet"), Mar. 4, 1996, at 5. Industry representatives have questioned this finding, noting that the recent publicity given to AHAs likely encouraged a higher rate of adverse reaction reports. See F-D-C REP. ("The Rose Sheet"), Mar. 11, 1996, at 1-3.
22. Alpha Hydroxy Acids (AHAs), U.S. Food & Drug Admin., Ctr. for Food Safety & Applied Nutrition, Office of Cosmetics Fact Sheet (May 3, 1995). Based on the 97 complaints received by the agency since 1989, and on the agency's assumption that one report to the agency equals approximately 50 to 100 reports received by manufacturers, FDA estimated that cosmetic companies had received about 10,000 reports of adverse reactions to AHAs. F-D-C REP. ("The Rose Sheet"), Mar. 4, 1996, at 5. Industry representatives have questioned this finding, noting that the recent publicity given to AHAs likely encouraged a higher rate of adverse reaction reports. See F-D-C REP. ("The Rose Sheet"), Mar. 11, 1996, at 1-3.
23. FDA's available data, which is reported voluntarily by the industry, indicated that glycolic acid was used in 90 products in 1996. F-D-C REP. ("The Rose Sheet"), Dec. 23, 1996, at 1-3.
24. Matthew J. Stiller et al., Topical 8% Glycolic Acid and 8% L-Lactic Acid Creams for the Treatment of Photodamaged Skin, 132 ARCHIVES OF DERMATOLOGY 631, 632 (1996). The double-blind, vehicle-controlled study was fimded in part by Unilever, parent company of Chesebrough-Pond's, the manufacturer of the products used in the study. Unilever was not, however, involved in the study's design or conduct. Doug Levy, Beauty: Age-Defying Creams Really Work but FDA Stays Cautious, DERMATOLOGY NEWS, Jun. 15, 1996, at C1.
25. Matthew J. Stiller et al., Topical 8% Glycolic Acid and 8% L-Lactic Acid Creams for the Treatment of Photodamaged Skin, 132 ARCHIVES OF DERMATOLOGY 631, 632 (1996). The double-blind, vehicle-controlled study was fimded in part by Unilever, parent company of Chesebrough-Pond's, the manufacturer of the products used in the study. Unilever was not, however, involved in the study's design or conduct. Doug Levy, Beauty: Age-Defying Creams Really Work but FDA Stays Cautious, DERMATOLOGY NEWS, Jun. 15, 1996, at C1.
26. Stiller et al., supra note 20, at 635.
27. Walter P. Smith, Epidermal and Dermal Effects of Topical Lactic Acid, 35 J. AMER. ACAD. OF DERMATOLOGY 388, 389 (1996).
28. Id.
29. Id. at 390.
30. F-D-C REP. ("The Rose Sheet"), Dec. 23, 1996, at 5. This study was conducted on hairless guinea pigs and thus has been criticized as an inappropriate model for human skirt, which has a different absorption rate. See id, at 6 (describing findings of Norman Weiner, Ph.D.).
31. F-D-C REP. ("The Rose Sheet"), Dec. 23, 1996, at 5. This study was conducted on hairless guinea pigs and thus has been criticized as an inappropriate model for human skirt, which has a different absorption rate. See id, at 6 (describing findings of Norman Weiner, Ph.D.).
32. Anita Shaw, An AHA Update, SOAP-COSM.-CHEM. SPECIALTIES, Mar. 1, 1997, at 30. See also Statement of the Cosmetic, Toiletry, and Fragrance Association on the Cosmetic Ingredient Review, Upholding the Safety of Alpha-Hydroxy Acids (Dec. 17, 1996).
33. Anita Shaw, An AHA Update, SOAP-COSM.-CHEM. SPECIALTIES, Mar. 1, 1997, at 30. See also Statement of the Cosmetic, Toiletry, and Fragrance Association on the Cosmetic Ingredient Review, Upholding the Safety of Alpha-Hydroxy Acids (Dec. 17, 1996).
34. Sensitive Feelings, COSM. INSIDERS REP., Feb. 10, 1997; see also Not Likely!, DRUG & COSM. INDUS., Feb. 1, 1997, at 20. These editorials attacked the preliminary version of the CIR study; the panel reached the same conclusions in its final report.
35. Sensitive Feelings, COSM. INSIDERS REP., Feb. 10, 1997; see also Not Likely!, DRUG & COSM. INDUS., Feb. 1, 1997, at 20. These editorials attacked the preliminary version of the CIR study; the panel reached the same conclusions in its final report.
36. Emalee G. Murphy, Cosmeceuticals - The Regulatory Environment or the Cosmetic Wars and Other Phenomena, 44 FOOD DRUG COSM. L.J. 41, 41 (1989).
37. See Estée Lauder, Inc. v. U.S. Food & Drug Admin., 727 F. Supp. 1 (D.D.C. 1989), in which the District Court for the District of Columbia rejected a challenge by the Estée Lauder company to the regulatory authority of FDA over seven of its skin creams. The company had claimed in advertisements that its "Night Repair Cellular Recovery Complex" would "accelerate the natural repair of cells" and that the cream had "changed the science of skin care to skin repair." The company also had claimed, that other products would "restructure and repair" the skin and "work inside cell layers to counteract aging forces." Id. at 3 n. 1. Avon received a warning letter regarding its product BioAdvance, for which it had claimed, "Actually helps reverse many signs of facial aging in just 6 weeks...." F-D-C REP. ("The Rose Sheet"), Mar. 18, 1996, at 12, 14.
38. See Estée Lauder, Inc. v. U.S. Food & Drug Admin., 727 F. Supp. 1 (D.D.C. 1989), in which the District Court for the District of Columbia rejected a challenge by the Estée Lauder company to the regulatory authority of FDA over seven of its skin creams. The company had claimed in advertisements that its "Night Repair Cellular Recovery Complex" would "accelerate the natural repair of cells" and that the cream had "changed the science of skin care to skin repair." The company also had claimed, that other products would "restructure and repair" the skin and "work inside cell layers to counteract aging forces." Id. at 3 n. 1. Avon received a warning letter regarding its product BioAdvance, for which it had claimed, "Actually helps reverse many signs of facial aging in just 6 weeks...." F-D-C REP. ("The Rose Sheet"), Mar. 18, 1996, at 12, 14.
39. Murphy, supra note 28, at 43-44.
40. Id. at 44.
41. Id. at 44-45 (quoting cosmetic regulatory letters from John M. Taylor, Assoc. Comm'r for Reg. Affs., to cosmetic skin care companies (Nov. 19, 1987)).
42. Id. at 45; Thomas J. Donegan, Fifty Years of Cosmetic Safety: A Government and Industry Partnership, 50 FOOD & DRUG L.J. 151, 158 (1995).
43. Id. at 45; Thomas J. Donegan, Fifty Years of Cosmetic Safety: A Government and Industry Partnership, 50 FOOD & DRUG L.J. 151, 158 (1995).
44. Skin Peelers, HHS News, U.S. Dept. of Health & Human Servs., Food & Drug Admin., P92-13 (May 21, 1992).
45. Id.
46. "Little is known about the overall safety of AHAs when they are used as chemical exfoliants because this is a relatively new application," AHAs, Office of Cosmetics Fact Sheet, supra note 18. John Bailey, Director of the agency's Office of Cosmetics and Colors, has suggested that regulation of AHAs is among the agency's current priorities. See Countercurrents, COSM. INSIDERS' REP., Mar. 24, 1997.
47. "Little is known about the overall safety of AHAs when they are used as chemical exfoliants because this is a relatively new application," AHAs, Office of Cosmetics Fact Sheet, supra note 18. John Bailey, Director of the agency's Office of Cosmetics and Colors, has suggested that regulation of AHAs is among the agency's current priorities. See Countercurrents, COSM. INSIDERS' REP., Mar. 24, 1997.
48. Pub. L. No. 59-384, 34 Stat. 768 (1906).
49. Annual Report of the Chief of the Bureau of Chemistry, Food & Drug Admin. (1917), reprinted in FEDERAL FOOD, DRUG AND COSMETIC ACT: A STATEMENT OF ITS LEGISLATIVE RECORD 24-25 (Charles Wesley Dunn ed. 1938) [hereinafter LEGISLATIVE RECORD].
50. Annual Report of the Chief of the Bureau of Chemistry, Food & Drug Admin. (1917), reprinted in FEDERAL FOOD, DRUG AND COSMETIC ACT: A STATEMENT OF ITS LEGISLATIVE RECORD 24-25 (Charles Wesley Dunn ed. 1938) [hereinafter LEGISLATIVE RECORD].
51. Annual Report of the Food & Drug Admin. for Fiscal Year Ending June 30, 1933, reprinted in LEGISLATIVE RECORD, supra note 38, at 26. The dangers of Koremlu Cream also had been well documented in ARTHUR KALLETT & F.J. SCHLINK, 100,000,000 GUINEA PIGS 80-88 (1933).
52. Annual Report of the Food & Drug Admin. for Fiscal Year Ending June 30, 1933, reprinted in LEGISLATIVE RECORD, supra note 38, at 26. The dangers of Koremlu Cream also had been well documented in ARTHUR KALLETT & F.J. SCHLINK, 100,000,000 GUINEA PIGS 80-88 (1933).
53. Annual Report of the Food & Drug Admin. for Fiscal Year Ending June 30, 1933, reprinted in LEGISLATIVE RECORD, supra note 38, at 26. The dangers of Koremlu Cream also had been well documented in ARTHUR KALLETT & F.J. SCHLINK, 100,000,000 GUINEA PIGS 80-88 (1933).
54. S. 1994, 73d Cong. § 5 (1933), reprinted in LEGISLATIVE RECORD, supra note 38, at 39.
55. As a Senate report on yet another version of the bill noted, the bill was revised "for the purpose of allaying the apprehensions of honest manufacturers without sacrificing the essential requirements for consumer protection." S. REP. NO. 361, 74th Cong. (1935), reprinted in LEGISLATIVE RECORD, supra note 38, at 238.
56. As a Senate report on yet another version of the bill noted, the bill was revised "for the purpose of allaying the apprehensions of honest manufacturers without sacrificing the essential requirements for consumer protection." S. REP. NO. 361, 74th Cong. (1935), reprinted in LEGISLATIVE RECORD, supra note 38, at 238.
57. LEGISLATIVE RECORD, supra note 38, at 54. "[The statute] would not prevent the marketing of a face powder or cream or any other cosmetic which did not contain poisonous or deleterious ingredients, even though such cosmetics might contain ingredients to which a certain class of un fortunate people are allergic." S. REP. NO. 361, 74th Cong. (1935), quoted in PETER BARTON HUTT & RICHARD A. MERRILL, FOOD AND DRUG LAW: CASES AND MATERIALS 815 (2d ed. 1991).
58. LEGISLATIVE RECORD, supra note 38, at 54. "[The statute] would not prevent the marketing of a face powder or cream or any other cosmetic which did not contain poisonous or deleterious ingredients, even though such cosmetics might contain ingredients to which a certain class of un fortunate people are allergic." S. REP. NO. 361, 74th Cong. (1935), quoted in PETER BARTON HUTT & RICHARD A. MERRILL, FOOD AND DRUG LAW: CASES AND MATERIALS 815 (2d ed. 1991).
59. LEGISLATIVE RECORD, supra note 38, at 54. "[The statute] would not prevent the marketing of a face powder or cream or any other cosmetic which did not contain poisonous or deleterious ingredients, even though such cosmetics might contain ingredients to which a certain class of un fortunate people are allergic." S. REP. NO. 361, 74th Cong. (1935), quoted in PETER BARTON HUTT & RICHARD A. MERRILL, FOOD AND DRUG LAW: CASES AND MATERIALS 815 (2d ed. 1991).
60. LEGISLATIVE RECORD, supra note 38, at 297.
61. Id. at 638. No reason appears in the legislative history for the exception's appearance or subsequent disappearance.
62. FOOD & DRUG ADMIN., CENTER FOR FOOD SAFETY & APPLIED NUTRITION, COSMETICS HANDBOOK (1992).
63. 21 U.S.C. § 361 (FDCA § 601).
64. Id. § 362 (FDCA § 602).
65. Id.
66. Id. § 361(b) (FDCA § 601 (b)).
67. Id. § 361(c) (FDCA § 601 (c)).
68. Id. § 362(a), (d) (FDCA §602 (a), (d)).
69. Id. § 362(b), (c) (FDCA § 602(b), (c)).
70. The voluntary regulations are codified at 21 C.F.R. pts. 710, 720, 730 (1996).
71. Many of the burdens of approval can be alleviated if the drug conforms to an already-existing over-the-counter (OTC) drug monograph, which provides a set of regulatory standards for various OTC drugs. Premarket approval is not required for drugs that conform to these standards. William E, Gilbertson, The Impact of the FDA's Over-the-Counter Drug Review Program on the Regulation of Cosmetics, in THE COSMETIC INDUSTRY 71, 79-80 (Norman F. Estrin ed. 1984).
72. 21 U.S.C. § 351(a)(2)(B) (FDCA § 501 (a)(2)(B)).
73. Id. § 352(a), (b), (c), (f) (FDCA § 502(a), (b), (c), (f)).
74. Id. § 352(j) (FDCA § 502 (j)).
75. Id. § 360 (FDCA § 510).
76. Id. § 355(b) (FDCA § 505(b)). Of course, the procedure is considerably more complex than the brief summary offered here.
77. Id. § 355(k) (FDCA § 505(k)).
78. Id. § 355(e) (FDCA § 505(e)).
79. See Jacqueline A. Greff, Regulation of Cosmetics That Are Also Drugs, 51 FOOD & DRUG L.J. 243, 244 n.14 (1996) (citing, e.g., H.R. 2244, 83d Cong. (1953); H.R. 4476, 84th Cong. (1955); H.R. 4015, 85th Cong. (1957); H.R. 4431, 85th Cong. (1957); H.R. 9153, 85th Cong. (1957); H.R. 1360, 86th Cong. (1959); H.R. 5661, 86th Cong. (1959); H.R. 1235, 87th Cong. (1961); H.R. 11,582, 87th Cong. (1962); H.R. 1235, 88th Cong. (1963); H.R. 5777, 88th Cong. (1963); H.R. 6788, 88th Cong. (1963); H.R. 8418, 88th Cong. (1963); H.R. 1235, 89th Cong., (1965); H.R. 1235, 90th Cong. (1967); H.R. 4486, 90th Cong. (1967)).
80. "In my view, these regulatory gaps raise serious questions about the Food and Drug Administration's ability to effectively oversee the cosmetics industiy in this country." Potential Health Hazards of Cosmetic Products: Hearings Before the Subcomm. on Reg. and Bus. Opportunities of the House Comm. on Small Bus., 100th Cong. 2 (1989) [hereinafter Hearings] (statement of Rep. Wyden, Comm. Chair).
81. 21 U.S.C. § 321(I) (FDCA § 201 (i)).
82. Id. § 321(g)(1) (FCDA § 201 (g)(1)).
83. United States v. An Article of Drug... Bacto-Unidisk..., 394 U.S. 784, 793 (1969).
84. Id. at 798. As a result, the Court held that a disc used by physicians to determine the correct antibiotic to administer to patients fell within the Act's definition of "drug." Id. at 799-800.
85. Id. at 798. As a result, the Court held that a disc used by physicians to determine the correct antibiotic to administer to patients fell within the Act's definition of "drug." Id. at 799-800.
86. See Compounder's Corner, DRUG & COSM. INDUS., Mar. 1, 1997, at 64 (noting belief that the FDCA'S definition of cosmetics is a "biological oxymoron").
87. Reclassification of Lacrisert as an Approved New Drug, 47 Fed. Reg. 46,139, 46,140 (1982). Note, however, that the statutory definition of "device," at 21 U.S.C. § 321(h), is almost identical to that of drug save that the definition of "device" contains the restriction "which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes," suggesting that "drugs," by contrast, do act in this manner.
88. Donegan, supra note 33, at 158.
89. See 21 C.F.R. §§ 201.128, 801.4 ("The words 'intended uses' ... refer to the objective intent of the persons legally responsible for the labeling of drugs.").
90. See Donegan, supra note 33, at 152 (noting that labeling or advertising claims are "usually determinative" of product classification).
91. United States v. An Article ... Consisting of 216 Individually Cartoned Bottles, More or Less, of an Article Labeled in Part: Sudden Change, 409 F.2d 734, 739 (2d Cir. 1969). This interpretation has been supported by the legislative history of the Act See S. REP. NO. 361, 74th Cong., 1st Sess. (1935), reprinted in LEGISLATIVE RECORD, supra note 38, at 240: "The use to which the product is to be put will determine the category into which it will fall.... The manufacturer of the article, through his representations in connection with its sale, can determine the use to which the article is to be put." A federal district court has rejected reliance on this statement, however, noting that "Congress' use of 'can' rather than 'will' arguably shows that Congress did not in tend for manufacturer representations to provide the only evidence of intended use." Coyne Beahm, Inc. v. U.S. Food & Drug Admin., 966 F. Supp. 1374, 1389 (M.D.N.C. 1997).
92. United States v. An Article ... Consisting of 216 Individually Cartoned Bottles, More or Less, of an Article Labeled in Part: Sudden Change, 409 F.2d 734, 739 (2d Cir. 1969). This interpretation has been supported by the legislative history of the Act See S. REP. NO. 361, 74th Cong., 1st Sess. (1935), reprinted in LEGISLATIVE RECORD, supra note 38, at 240: "The use to which the product is to be put will determine the category into which it will fall.... The manufacturer of the article, through his representations in connection with its sale, can determine the use to which the article is to be put." A federal district court has rejected reliance on this statement, however, noting that "Congress' use of 'can' rather than 'will' arguably shows that Congress did not in tend for manufacturer representations to provide the only evidence of intended use." Coyne Beahm, Inc. v. U.S. Food & Drug Admin., 966 F. Supp. 1374, 1389 (M.D.N.C. 1997).
93. United States v. An Article ... Consisting of 216 Individually Cartoned Bottles, More or Less, of an Article Labeled in Part: Sudden Change, 409 F.2d 734, 739 (2d Cir. 1969). This interpretation has been supported by the legislative history of the Act See S. REP. NO. 361, 74th Cong., 1st Sess. (1935), reprinted in LEGISLATIVE RECORD, supra note 38, at 240: "The use to which the product is to be put will determine the category into which it will fall.... The manufacturer of the article, through his representations in connection with its sale, can determine the use to which the article is to be put." A federal district court has rejected reliance on this statement, however, noting that "Congress' use of 'can' rather than 'will' arguably shows that Congress did not in tend for manufacturer representations to provide the only evidence of intended use." Coyne Beahm, Inc. v. U.S. Food & Drug Admin., 966 F. Supp. 1374, 1389 (M.D.N.C. 1997).
94. See Sudden Change, 409 F.2d at 739.
95. Manufacturers are well aware of this power. See, for example, Michele Picozzi, Discovering Cosmeceuticals (visited Jan. 14, 1997) 〈http://www.newhope.com/tradezone/library/hbc/pc/pc3.html〉, in which Rebecca James Gadberry, an industry consultant, suggests that manufactures and retailers of cosmeceuticals "be careful about making claims" and "avoid phrases that could be construed as drug-like claims." See also Compounder's Corner, supra note 68, at 64 ("In practical terms, representation that the product penetrates the skin is an instant red flag to the FDA, denoting the possibility of systemic (drug) effects.").
96. Manufacturers are well aware of this power. See, for example, Michele Picozzi, Discovering Cosmeceuticals (visited Jan. 14, 1997) 〈http://www.newhope.com/tradezone/library/hbc/pc/pc3.html〉, in which Rebecca James Gadberry, an industry consultant, suggests that manufactures and retailers of cosmeceuticals "be careful about making claims" and "avoid phrases that could be construed as drug-like claims." See also Compounder's Corner, supra note 68, at 64 ("In practical terms, representation that the product penetrates the skin is an instant red flag to the FDA, denoting the possibility of systemic (drug) effects.").
97. See, e.g., Bradley v. United States, 264 F. 79 (5th Cir. 1920) (mineral water that contained therapeutic claims on label classified as drug under 1906 Food and Drugs Act).
98. Or, as one commentator put it, "You could make a very nice eyeshadow that cures cancer [and] as long as you said this was an eyeshadow and you didn't say that it cured cancer, you could sell it as a cosmetic." F-D-C REP. ("The Rose Sheet"), Mar. 18, 1996, at 11 (quoting Gerald McEwen, Vice Pres. for Sci., CTFA).
99. Sudden Change, 409 F.2d at 734; United States v. Article Consisting of 36 Boxes, More or Less, Labeled "Line Away Temporary Wrinkle Smoother, Coty," 415 F.2d 369 (3d Cir. 1969); United States v. Article of Drug ... 47 Shipping Cartons, More or Less ... "Helene Curtis Magic Secret," 331 F. Supp. 912 (D. Md. 1971).
100. Sudden Change, 409 F.2d at 742. The court did note, however, that if the manufacturer ceased any claims that the product temporarily affected the structure of the skin, the product would not be deemed a drug under the FDCA. Id. 80 Line Away, 415 F.2d at 372.
101. Sudden Change, 409 F.2d at 742. The court did note, however, that if the manufacturer ceased any claims that the product temporarily affected the structure of the skin, the product would not be deemed a drug under the FDCA. Id. 80 Line Away, 415 F.2d at 372.
102. Magic Secret, 331 F. Supp. at 917.
103. Coyne Beahm, Inc., 966 F. Supp at 1374.
104. Id. at 1389.
105. Id.
106. Id. at 1390.
107. See Chevron v. Natural Resources Defense Council, 467 U.S. 837, 845 (1984) (when Congress has not spoken on an issue, reasonable interpretation of enforcing agency is entitled to deference). But see Action on Smoking and Health v. Harris, 655 F.2d 236, 240-41 (D.C. Cir. 1980) (noting that sufficient evidence of consumer use requires a "substantial showing" and that courts have "accorded limited discretion to the Administration in its attempt to establish the requisite intent based primarily upon consumer use").
108. See Chevron v. Natural Resources Defense Council, 467 U.S. 837, 845 (1984) (when Congress has not spoken on an issue, reasonable interpretation of enforcing agency is entitled to deference). But see Action on Smoking and Health v. Harris, 655 F.2d 236, 240-41 (D.C. Cir. 1980) (noting that sufficient evidence of consumer use requires a "substantial showing" and that courts have "accorded limited discretion to the Administration in its attempt to establish the requisite intent based primarily upon consumer use").
109. The district court's decision in Coyne Beam was appealed to the U.S. Court of Appeals for the Fourth Circuit No opinion from the appellate court has been issued as of this writing, although news reports appearing after oral argument in the case have suggested that the three-judge panel was unconvinced by the government's arguments. See Saundra Torry, Duel in a Country Courthouse, With Tobacco Regulation at Stake, WASH. POST, Aug. 18, 1997, at F7.
110. Shaw, supra note 12, at 72.
111. Cosmetic Products Containing Certain Hormone Ingredients; Notice of Proposed Rulemaking, 58 Fed. Reg. 47,611, 47,612 (1993).
112. For example, Neoteric Cosmetics' Alpha Hydrox AHA Facial Treatment, a widely available facial cream, contains the following claims on its box: "reduces the signs of aging," "[s]moothes surface imperfections caused by aging and sun damage," and "dramatically and rapidly improves surface texture, tone, firmness and elasticity of skin." FDA is likely to view an anti-aging claim as a drug claim (although this claim has been couched carefully in terms of the signs of aging rather than the aging process itself), but it seems likely that the other two claims include the word "surface" in order to avoid regulation as a drug.
113. Food & Drug Admin., Import Alert No. 66-38 (Mar. 6, 1990). Examples of possible drug claims include claims that the product "rejuvenates," "repairs," or "restructures" the skin, or that the skin molecules would "absorb and expand" to erase wrinkles. Id. Note that because drugs are defined either as "intended for use in the ... treatment or prevention of disease" or "intended to affect the structure or any function of the body," by characterizing as drugs products that claim only to control the "aging process," FDA implies that aging is a disease. The gender issues behind this characterization are too complex to be discussed here.
114. John Bailey, Dir., Off. of Cosmetics & Colors, FDA, for example, has stated with respect to AHAs that the "legal scheme that applies to cosmetics ... is clearly inadequate when applied to products that have a physiological effect beyond that which occurs with traditional cosmetic products." F-D-C REP. ("The Rose Sheet"), Dec. 11, 1995, at 1, 3. Bailey's statement also maybe interpreted as a call to Congress for amendment of the FDCA.
115. F-D-C REP. ("The Rose Sheet"), Mar. 11, 1996, at 5-6.
116. See supra text accompanying note 88.
117. Significantly, in April 1997 FDA recommended the toxicity of AHAs as a focus of study by the National Toxicology Program See Announcement of Nominated Chemicals Approved and Under Consideration for Toxicological Studies by the National Toxicology Program; Request for Comments, 62 Fed. Reg. 19, 348 (1997). Not surprisingly, industry representatives have deemed such a study "unnecessary" and a "waste of scarce testing resources." See Further Movement on Testing of AHAs, DRUG & COSM. INDUS., June 1, 1997, at 6.
118. Significantly, in April 1997 FDA recommended the toxicity of AHAs as a focus of study by the National Toxicology Program See Announcement of Nominated Chemicals Approved and Under Consideration for Toxicological Studies by the National Toxicology Program; Request for Comments, 62 Fed. Reg. 19, 348 (1997). Not surprisingly, industry representatives have deemed such a study "unnecessary" and a "waste of scarce testing resources." See Further Movement on Testing of AHAs, DRUG & COSM. INDUS., June 1, 1997, at 6.
119. See 58 Fed. Reg. at 47,611. No final rule has yet been issued.
120. Id. at 47,612.
121. Id.
122. See also United States v. Articles of Food & Drug, 444 F. Supp. 266, 271 (E.D. Wis. 1978) (finding that "representation in the labeling or in the promotion of an article ... that it is or contains amygdalin, is a representation that the article is intended for use in the cure, mitigation, treatment and prevention of cancer in man" given publicity regarding such use).
123. See, e.g., 142 CONG. REC. S8612 (daily ed. Jul. 24, 1996) (stating that FDA has been a "whipping boy" in recent times) (statement of Sen. Edward Kennedy (D-MA)); 142 CONG. REC. S 11, 129 (daily ed. Sept. 24, 1996) ("I am as angry as I can be that the FDA is being given jurisdiction over tobacco.") (statement of Sen. Wendell Ford (D-KY)). One trade publication has stated that "since the Republican landslide victory in the 1994 election [FDA] has been a mostly low profile organization, especially with regard to cosmetics." COSM. INSIDERS' REP., May 15, 1996.
124. See, e.g., 142 CONG. REC. S8612 (daily ed. Jul. 24, 1996) (stating that FDA has been a "whipping boy" in recent times) (statement of Sen. Edward Kennedy (D-MA)); 142 CONG. REC. S 11, 129 (daily ed. Sept. 24, 1996) ("I am as angry as I can be that the FDA is being given jurisdiction over tobacco.") (statement of Sen. Wendell Ford (D-KY)). One trade publication has stated that "since the Republican landslide victory in the 1994 election [FDA] has been a mostly low profile organization, especially with regard to cosmetics." COSM. INSIDERS' REP., May 15, 1996.
125. See, e.g., 142 CONG. REC. S8612 (daily ed. Jul. 24, 1996) (stating that FDA has been a "whipping boy" in recent times) (statement of Sen. Edward Kennedy (D-MA)); 142 CONG. REC. S 11, 129 (daily ed. Sept. 24, 1996) ("I am as angry as I can be that the FDA is being given jurisdiction over tobacco.") (statement of Sen. Wendell Ford (D-KY)). One trade publication has stated that "since the Republican landslide victory in the 1994 election [FDA] has been a mostly low profile organization, especially with regard to cosmetics." COSM. INSIDERS' REP., May 15, 1996.
126. In other words, the public may respond strongly to any attempt to regulate personal habits. See, e.g., JOHN W. KINGDON, AGENDAS, ALTERNATIVES, AND PUBLIC POLICIES 146 (1984) (describing public outrage over, and sub sequent abandonment of, seat belt interlocks requirement).
127. See, e.g., 142 CONG. REC. S12,053 (daily ed. Oct. 1, 1996) (statement of Sen. Orrin G. Hatch (R-UT)); 142 CONG. REC. S12,020 (daily ed. Sept. 30, 1996) (statement of Sen. Judd Gregg (R-NH)).
128. See, e.g., 142 CONG. REC. S12,053 (daily ed. Oct. 1, 1996) (statement of Sen. Orrin G. Hatch (R-UT)); 142 CONG. REC. S12,020 (daily ed. Sept. 30, 1996) (statement of Sen. Judd Gregg (R-NH)).
129. See, e.g., 143 CONG. REC. S9148 (daily ed. Sept. 11, 1997) (statement of Sen. Kennedy) ("Alpha-hydroxy acids have been linked to severe redness, burning, blistering, bleeding, rash, itching, and skin discoloration. Most troubling, there is concern that alpha-hydroxy may promote skin cancer by increasing sensitivity to sun exposure. Yet these products are in the marketplace - with no warning labels and no limits on the concentrations that may be sold."). The preemption language was part of the Food and Drug Administration Modernization and Accountability Act of 1997, S. 830, 105th Cong., 1st Sess. (1997), which was approved by the Senate on Sept. 24, 1997. A House vote is pending as of this writing.
130. "[T]here is a global trend of international harmonization for products such as cosmetics: The countries in the European Union, Latin America, and various Asian countries are working toward regulatory cooperation." 142 CONG. REC. S12,020 (daily ed. Sept. 30, 1996) (statement of Sen. Gregg).
131. Bert J. Vermeer & Barbara A. Gilchrest, Cosmeceuticals: A Proposal for Rational Definition, Evaluation, and Regulation, 132 ARCHIVES OF DERMATOLOGY 337, 338-39 (1996).
132. Bacto-Unidisk, 394 U.S. at 798.
133. Hearings, supra note 63, at 174-75 (statement of Dr. Frank E. Young, Comm'r. of Food and Drugs).
134. See, e.g., Sudden Change, 409 F. 2d at 740 ("A primary purpose of the Act is the protection of the ultimate consumer's economic interests."); S. REP. NO. 361, 74th Cong. (1935), reprinted in LEGISLATIVE RECORD, supra note 38, at 239 (stating that the expansion of the definition of "drug" was necessary to protect the consumer from products that are "worthless at best and some of which are distinctly dangerous to health").
135. See, e.g., Sudden Change, 409 F. 2d at 740 ("A primary purpose of the Act is the protection of the ultimate consumer's economic interests."); S. REP. NO. 361, 74th Cong. (1935), reprinted in LEGISLATIVE RECORD, supra note 38, at 239 (stating that the expansion of the definition of "drug" was necessary to protect the consumer from products that are "worthless at best and some of which are distinctly dangerous to health").
136. See, e.g., Sudden Change, 409 F. 2d at 740 ("A primary purpose of the Act is the protection of the ultimate consumer's economic interests."); S. REP. NO. 361, 74th Cong. (1935), reprinted in LEGISLATIVE RECORD, supra note 38, at 239 (stating that the expansion of the definition of "drug" was necessary to protect the consumer from products that are "worthless at best and some of which are distinctly dangerous to health").
137. As the Second Circuit noted in its wrinkle cream case, after holding the product to be a drug, It should be understood, however, that if the claimant ceases to employ these promotional claims and avoids any others which may fairly be interpreted as claiming to affect the structure of the skin in some physiological, though temporary, way, then assuming arguendo that no actual physical effect exists, the product will not be deemed a drug for purposes of the Act. Sudden Change, 409 F.2d at 742. It is unclear what the court's decision would have been in this scenario if an actual physical effect did exist.
138. See, e.g., NAOMI WOLF, THE BEAUTY MYTH 70 (1991) ("Women are deeply affected by what their magazines tell them (or what they believe they tell them) because they are all most women have as a window on their own mass sensibility.").
139. As Judge Mansfield noted in dissent in Sudden Change, "[I]f the claim that a product will alter the appearance of the body ... requires that the product be classified as a drug, practically all cosmetics (and indeed articles such as girdles and brassieres) would be required to be so classified." 409 F.2d at 744 (Mansfield, J., 7 dissenting). See also Naomi M. Kanof, Cosmetics: Proposal for Redefinition, 1 J. AMER. ACAD. DERMATOLOGY 67 (1979) (noting that it is not possible to "cleanse, beautify, promote the attractiveness or alter the appearance of the skin" without affecting the structure and function of the body).
140. As Judge Mansfield noted in dissent in Sudden Change, "[I]f the claim that a product will alter the appearance of the body ... requires that the product be classified as a drug, practically all cosmetics (and indeed articles such as girdles and brassieres) would be required to be so classified." 409 F.2d at 744 (Mansfield, J., 7 dissenting). See also Naomi M. Kanof, Cosmetics: Proposal for Redefinition, 1 J. AMER. ACAD. DERMATOLOGY 67 (1979) (noting that it is not possible to "cleanse, beautify, promote the attractiveness or alter the appearance of the skin" without affecting the structure and function of the body).
141. Sudden Change, 409 F. Supp. at 744 (Mansfield, J., dissenting).
142. "Manufacturers do not have to determine the safety of their products before selling them or tell the Food and Drug Administration what products they are selling and what ingredients are used in them. Many manufacturers have not voluntarily given such information to the agency. As a result, a hazardous cosmetic can be marketed until the Food and Drug Administration obtains information to prove that the product may be injurious to users." Report to the Congress of the United States by the Comptroller General, Lack of Authority Hampers Attempts to Increase Cosmetic Safety (HRD 78-139) (Aug. 8, 1978), reprinted in Hearings, supra note 63, at 605.
143. "Manufacturers do not have to determine the safety of their products before selling them or tell the Food and Drug Administration what products they are selling and what ingredients are used in them. Many manufacturers have not voluntarily given such information to the agency. As a result, a hazardous cosmetic can be marketed until the Food and Drug Administration obtains information to prove that the product may be injurious to users." Report to the Congress of the United States by the Comptroller General, Lack of Authority Hampers Attempts to Increase Cosmetic Safety (HRD 78-139) (Aug. 8, 1978), reprinted in Hearings, supra note 63, at 605.
144. 21 C.F.R. § 740, 10.
145. U.S. GEN. ACCT. OFF., LACK OF AUTHORITY HAMPERS ATTEMPTS TO INCREASE COSMETIC SAFETY (1978), reprinted in HUTT & MERRILL, supra note 42, at 820.
146. U.S. GEN. ACCT. OFF., LACK OF AUTHORITY HAMPERS ATTEMPTS TO INCREASE COSMETIC SAFETY (1978), reprinted in HUTT & MERRILL, supra note 42, at 820.
147. See, e,.g., Greff, supra note 62, at 243 ("This scheme works because cosmetics are by nature generally low risk and because of industry self-regulation.").
148. See S.L. Mayham, Chemicals in Cosmetics, 7 FOOD DRUG COSM. L.J. 184, 1990-91 (1952) (decrying the effect increased cosmetic regulation would have on small businesses).
149. See, e.g., Vermeer & Gilchrest, supra note 105, at 338.
150. "Cosmeceutical," CFSAN, FDA, Office of Cosmetics Fact Sheet (Feb. 3, 1995).
151. See, e.g., Cosmeceuticals: New Class of Products Offers Important Benefits for Aging Customers, CHAIN DRUG REV., Sept. 23 1996, at 92.
152. COSMETICS HANDBOOK, supra note 45.
153. "The law says it is prohibited for a company to produce a cosmetic product that could be injurious to the consumer under normal use .... If I am a cosmetic official, and I have that as a law, why do I need some kind of review by anybody prior to marketing? ... If you can't have happy, healthy consumers, you are going to lose a lot of money." Cosmeceuticals, supra note 122, at 92 (quoting Gerald McEwen, Vice Pres. for Sci., CTFA).
154. Joanna Rarney, Review Board Could Give Nod to Alpha-Hydroxies by June, WOMEN'S WEAR DAILY (WWD), Mar. 1, 1996, at 26, Bailey is a nonvoting member of the CIR. Id.
155. 21 U.S.C. § 321(i) (FDCA § 201(i)).
156. Of course, an exception could be made for these products; this would result in much the same system proposed below.
157. A reliance on active ingredients as the determining factor for classification as a cosmeceutical may itself require revision of FDA's regulations. For example, 21 C.F.R. § 60.3(b)(2) defines "active ingredient" as "any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or of animals." Because of the difficulties inherent in the current interpretations of "intent," see supra part IV.A, "intended to" should be read here to mean "known to or believed to." De minimis effects on the body should be deemed irrelevant to the classification.
158. Greff, supra note 62, at 257 (quoting John E. Bailey, Jr., Ph.D., then Acting Dir., Off. of Cosmetics & Colors, FDA, Skin Care - State of the Art: A Regulatory View - Alpha-Hydroxy Acid, Speech at the Annual Spring Seminar of the New York Chapter of the Society of Cosmetic Chemists, New York, NY (Apr. 6, 1994)).
159. Of course, the consumer ultimately will bear these costs; whether or not he or she decides to buy the product, and therefore absorb these costs, will depend on what value the consumer places on safety.
160. Attorney William Pendergast has advocated this option. See, e.g., David C. Steinberg, Cosmeceuticals: An Advanced Forum for Manufacturers, COSMS. & TOILETRIES, Jun. 1, 1996, at 43; F-D-C REP. ("The Rose Sheet"), Mar. 18, 1996, at 9.
161. Attorney William Pendergast has advocated this option. See, e.g., David C. Steinberg, Cosmeceuticals: An Advanced Forum for Manufacturers, COSMS. & TOILETRIES, Jun. 1, 1996, at 43; F-D-C REP. ("The Rose Sheet"), Mar. 18, 1996, at 9.
162. See 21 U.S.C. §§ 321(g)(1), 343(r)(6) (FDCA. §§ 201(g)(1), 403(r)(6)).
163. "Specifically, in 1938, cosmetics were differentiated from the agency's authority in food and drugs, and later devices, because it was judged and has continued to be judged by Congress that though these products are important, they did not quite present the risk that the other products do." Hearings, supra note 63, at 52 (statement of Dr. Frank E. Young, Comm'r of Food and Drugs).
164. GERALD MCKNIGHT, THE SKIN GAME: THE INTERNATIONAL BEAUTY BUSINESS BRUTALLY EXPOSED 185 (1989).
165. United States v. Dotterweich, 320 U.S. 277, 280 (1943).