Cosmeceuticals: myths and misconceptions

References 

1. Prestige beauty industry reaches record $8 billion high. NPD press release. April 13, 2006. Available at: www.NPD.com/press/releases/press_060413.htmlAccessed January 21, 2007
2. Reed R. The definition of “cosmeceutical”. J Soc Cosmet Chem. 1962;13:103–106
3. Riordan T. In: Inventing beauty. New York: Broadway Books; 2004;p. 19–24
4. Swann J. History of the FDA. In:  Kurian G editors. A historical guide to the US government. New York: Oxford University Press; 1998;
5. Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. Sec. 301 et seq.
6. Milestones in U.S. food and drug law history. FDA Web site. Available at: www.fda.gov/AboutFDA/WhatWeDo/History/Milestones/ucm128305.htmAccessed June 16, 2009
7. Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. §379e.
8. Fair Packaging and Labeling Act (FPLA), 15 U.S.C. Sec. 1451 et seq. FDA Web site. Available at: www.fda.gov/RegulatoryInformation/Legislation/ucm148722.htmAccessed June 16, 2009
9. Federal Food, Drug, and Cosmetic Act (FDCA), a. 21 U.S.C. §321(g); b. 21 U.S.C. §201(g)(1)(c); c. 21 U.S.C. §321(i).
10. Code of Federal Regulations. 21 C.F.R. §740.1.
11. a. Schmidt A. food drug and cosmetic products, warning statements. Federal Register, 40(42):8912-8929 (1975); b. 21 C.F.R. §740.10.
12. Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. §361.
13. Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. §362. Cosmetic Ingredient Review. Available at: www.cir-safety.orgAccessed June 16, 2009
14. Cruelty free–not tested on animals. FDA Web site. Available at: www.fda.gov/cosmetics/CosmeticLabelingLabelClaims/LabelClaimsandExpirationDating/ucm2005202.htmAccessed June 16, 2009
15. Code of Federal Regulations. 21 C.F.R. §250.250; 21 C.F.R. §§700.11-700.35.
16. Berdick M. Coping with the color additive regulations. In:  Estrin N editors. The cosmetic industry, scientific and regulatory foundations. New York (NY): Marcel Dekker Inc.; 1984;p. 385–414
17. FDA. Tattoos and permanent makeup. Available at: www.fda.gov/Cosmetics/ProductandIngredientSafety/ProductInformation/ucm108530.htmAccessed: June 16, 2009
18. Fair Packaging and Labeling Act (FPLA), 15 U.S.C. §1454(c)(3); 21 C.F.R. §701.3.
19. Federal Trade Commission Act, 15 U.S.C. §§45 and 55.
20. Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. §362(a-(f)).
21. 21 C.F.R. §§710-730.
22. Milstein S, Halper A, Katz L. Regulatory requirements for the marketing of cosmetics in the United States. In:  Paye M,  Barel A,  Maibach H editor. Handbook of cosmetic science and technology. New York: CRC Press; 2006;p. 838–839
23. 21 C.F.R. §§7.40-7.59.
24. Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. §§331-334.
25. Kurtzweil, Paula. Hair relaxers destroyed after consumers complain - products sold by World Rio Corp. FDA Consumer Magazine March 1994
26. Meadows M. Heading off hair care disasters. FDA Consumer Magazine 2001;35. Available at: vm.cfsan.fda.gov/~dms/fdahdye.html. Accessed June 16, 2009.
27. FDA News: approximately $2 million of potentially harmful “cosmetic” eye product seized. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm109028.htmAccessed June 16, 2009
28. Greff J. Regulation of cosmetics that are also drugs. Food Drug Law J. 1996;51:243–272
    • MEDLINE
29. Jacobellis V. Ohio. 378 U.S. 184, 197. 1964.
30. Drugs approved by the FDA. Available at: www.centerwatch.com/patient/drugs/dru31.htmlAccessed June 16, 2009
31. DiMasi J, Hansen R, Grabowski H. The price of innovation: new estimates of drug development costs. J Health Econ. 2003;22:151–185
    • MEDLINE
    • CrossRef
32. FDA authority over cosmetics. FDA Web site. Available at: www.cfsan.fda.gov/~dms/cos-206.htmlAccessed June 16, 2009
33. Paye M, Barel A. Introduction to the “proof of claims”. In:  Paye M,  Barel A,  Maibach H editor. Handbook of cosmetic science and technology. New York: CRC Press; 2006;p. 880–886
34. Wentz R. Substantiating skin care cosmetic claims. Soap Cosmet Chem Spec. 1986;36-42:54–56
35. Hypoallergenic cosmetics. FDA Web site. Available at: www.fda.gov/Cosmetics/CosmeticLabelingLabelClaims/LabelClaimsandExpirationDating/ucm2005203.htmAccessed June 16, 2009
36. Weichers J. Mind over matter: cosmetic claim substantiation issues facing the future. Cosmet Toilet. 2005;120:57–64
37. Foulke J. Cosmetic ingredients: understanding the puffery. FDA Consumer Magazine, May 1992.
38. FTC Policy Statement on Deception, Appended to Cliffdale Associates, Ind. 103 F.T.C. 110, 174(1984). Available at: www.ftc.gov/bcp/policystmt/ad-decept.htm. Accessed June 16, 2009.
39. Smithles R. Substantiating performance claims. Cosmet Toilet. 1984;99:79–84