References And Notes

1. a) Jackson EM. Consumer products: cosmetics and topical over-the-counter drug products. In: Chengelis CP, Holson JF, Gad SC, eds. Regulatory Toxicology. New York: Raven Press, 1995:117-119; b) McEwen GN, Murphy EG. The Federal Food, Drug, and Cosmetic Act and the Regulation of Cosmetics. In: Schlossman, ML, ed., The Chemistry and Manufacture of Cosmetics, Volume I, Basic Science, Carol Stream, IL: Allured Publishing Corporation, 2000, p. 82.

2. Hobbs CO. Advertising for foods, veterinary products, and cosmetics. In: Brady RP, Cooper RM, Silverman RS, eds. Fundamentals of Law and Regulation. Vol. 1. Washington, D.C.: Food and Drug Law Institute (FDLI), 1997:347-379.

3. a) Working Agreement Between FTC and FDA, FTC Press Release, Federal Trade Commission, Washington, D.C. June 9, 1954. b) Memorandum of Understanding (MOU) Between the Federal Trade Commission and the Food and Drug Administration Concerning Exchange of Information (FDA-225-71-8003), FDA Compliance Policy Guide 7155m.01, April 27, 1971 (FDA); Approved and Accepted for the FTC May 14, 1971.

4. a) Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 n, Public Law 91-601, 84 Stat. 1670, December 30, 1970, as amended). b) Household Products Containing Petroleum Distillates and Other Hydrocarbons; Advance Notice of Proposed Rulemaking, 62 FR 8659, February 26, 1997. c) Requirements for Child-Resistant Packaging; Household Products Containing Methacrylic Acid; Proposed Rule, 63 FR 71800, December 30, 1998. d) Requirements for Child-Resistant Packaging; Requirements for Household Glue Removers Containing Acetoni-trile and Home Cold Wave Permanent Neutralizers Containing Sodium Bromate or Potassium Bromate, 55 FR 51897, December 18, 1990; e) T.E. Wood, ''Regulatory Considerations for Soap Products in the U.S.A.,'' Cosmetics and Toiletries, 104(12), 75-76, 78-79 (1989); f) Consumer Product Safety Act, 15 U.S.C. Sec. 2051 et. seq. (Pub. L. No. 92-573, October 27, 1972); g) Federal Hazardous Substances Act, 15 U.S.C., Sec. 1261 et. seq. (Pub. L. No. 86613, July 12, 1960, as amended); codified regulations at 16 CFR 1500.

5. Federal Insecticide, Fungicide, and Rodenticide Act of 1972 (FIFRA, 7 U.S.C. Sec. 136-136 | y); codified regulations at 40 CFR 162-180. |

6. FD&C Act, Section 201 (p) (definitions, ''new drug'').

7. a) Liquid soap category will reach $250 million by 1985. In: The Rose Sheet (June 29, 1981), 'c p. 3. b) SoftSoap expected to add $65 million to Colgate-Palmolive's, ibid, August 17, 1987:

8. a) Antiseptic wash monograph directions with manufacturer reference suggested. In: The Rose

Sheet. February 10, 1997, p. 6-7. b) Fischler G., Shaffer M. Healthcare continuum: a model q for the classification and regulation of topical antimicrobial wash products. The Healthcare

Continuum Model Symposium, Washington, D.C., June 2-3, 1997. S

9. (a) FD&C Act, Section 601 (a). (b) Hair-dye products. In: FDA's Cosmetics Handbook. Wash- 2

ington, D.C.: U.S. Government Printing Office, 1992, pp. 11-12; (c) 21 CFR 70.3 (u); (d) 21 CFR 73.2150; (e) 21 CFR 70.5(a).

10. a) Nitrosamine-contaminated cosmetics; call for industry action; request for data; notice, 44 FR 21365-21367, April 10, 1979. b) FDA's Cosmetics Handbook. Washington, D.C.: U.S. Government Printing Office, 1992, p. 8-9. c) Greif M, Wenninger JA, Yess N. Cosmetic regulation: an overview of FDA's role. Cosmetic Technology, 1980:43-44. d) Chou HJ. Determination of diethanolamine and N-nitrosodiethanolamine in fatty acid diethanolamines. J. of AOAC International. 1998:81(5), 943-947. e) Havery DC, Chou HJ. N-nitrosamines in cosmetic products: an overview. Cosmetics and Toiletries 1994:109(5), 53-58, 61-62.

12. a) Ref. 10, p. 9, loc cit.; b) RE Black, FJ Hurley, and DC Havery, ''Determination of 1,4-Dioxane in Ethoxylated Cosmetic Raw Materials and in Cosmetic Finished Products,'' J of AOAC International, 84 (2001), accepted for publication (in press).

13. a) 21 CFR 110.3-110.93. b) Cosmetic good manufacturing practice guidelines. In: FDA's Cosmetics Handbook. Washington, D.C.: U.S. Government Printing Office, 1992, p. 4-6.

14. a) Halper AR to Milstein SR, personal communication, February 1, 2000. b) Food and Drug Administration Recall Policies. Informational flier. U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Food Safety and Applied Nutrition, Washington, D.C.

15. Calogero C. Regulatory review, Cosmetics and Toiletries, 2000; 115(7):26.

16. a) Duffy DT. Classification and regulation of cosmetics and drugs: a legal overview and alternatives for legislative change,'' American Law Division, Congressional Research Service, The Library of Congress, Washington, D.C., May 4, 1990, p. CRS-16. b) Yingling GL, Onel S. Cosmetic regulation revisited. In: Brady RP, Cooper RM, Silverman RS, eds. Fundamentals of Law and Regulation. Vol. 1. Washington, D.C.: Food and Drug Law Institute (FDLI), 1997: 315-346. c) Bass IS. Enforcement powers of the Food and Drug Administration: foods, dietary supplements, and cosmetics'', ibid, 55-90; d) E.G. Murphy and P.J. Wilson, Regulation of cosmetic products. In Williams DF and Schmitt WH, eds., Chemistry and Technology of the Cosmetics and Toiletries Industry, 2nd Edition, London: Blackie Academic & Professional, 1996:344-361.

17. Rumore MM, Strauss S, Kothari AB. Regulatory aspects of color additives. Pharmaceutical Technology. 68, 70, 72, 74, 76, 78, 80, 82. March 1992.

18. FDA's Cosmetics Handbook. Washington, D.C.: U.S. Government Printing Office, 1992, p. 2.

19. Wenninger JA, Canterbery RC, McEwen GN. International Cosmetic Ingredient Dictionary and Handbook, 8th Edition. Washington, D.C.: The Cosmetic, Toiletry, and Fragrance Association, (CTFA), 1999.

20. Permanent Listing of Color Additive Lakes; Proposed Rule, 61 FR 8372-8417, March 4, 1996.

24. a) The Federal Fair Packaging and Labeling Act, 15 U.S.C. Sec. 1451 et. seq. b) 15 U.S.C. Sec. 1459 a (definitions).

25. Cosmetic Ingredient Labeling and Voluntary Filing of Cosmetic Product Experiences. Regulations for the Enforcement of the Federal Food, Drug and Cosmetic Act and the Fair Packaging Labeling Act. Cosmetic Ingredient Labeling. 38 FR 28912-28917 @28912, October 17, 1973.

26. a) The American Technology Preeminence Act of 1991 [Pub. L. 102-245, Section 107], February 14, 1992. b) Pub. L. 102-329, August 3, 1992. c) Metric Labeling; Quantity of Contents Labeling Requirements for Foods, Human and Animal Drugs, Animal Foods, Cosmetics, and Medical Devices; Proposed Rule. 58 FR 67444-67464, December 21, 1993.

27. Council Directive 76/768/EEC on the Approximation of the Member States Relating to Cos-

metic Products, OJECNI, 169, 262 (July 27, 1976) (hereinafter referred to as the Cosmetic Directive).

28. Council Directive 93/35/EEC (June 14, 1993) (hereinafter, referred to as the Sixth Amendment to the Cosmetic Directive).

29. Bailey JE to McEwen GN, personal communication June 1, 1995. b) Citizen Petition [Docket No. 96P-0347], September 20, 1996; c) ibid, personal communication, January 17, 1996.

30. Tamper-Resistant Packaging Requirements; Certain Over-the-Counter Human Drugs and Cosmetic Products; Contact Lens Solutions and Tablets; Final Rules. 47 FR 50442-50456 @ 50447, November 5, 1982.

31. a) FDA Office of Regulatory Affairs. FDA Investigations Operations Manual. Washington, D.C., January 2000, Chapter 10—reference materials, subchapter 1020—guidelines and other guidance materials, Section 1023—cosmetics. b) Guide to Inspections of Cosmetic Product Manufacturers. FDA/ORA Web site address: http://www.fda.gpv/ora/inspect_ref/igs/cos-met.html.

32. a) Beyond approval: drug manufacturer regulatory responsibilities. In: Mathieu M. New Drug Development: A Regulatory Overivew, 4th Ed. Waltham, MA: PAREXEL International Corporation, 1997:272-279. b) 21 CFR. 211 (Current Good Manufacturing Practice for Finished Pharmaceuticals), April 1, 2000.

33. a) Subchapter G—Cosmetics. Reorganization and Republication. 39 FR 10054-10064 @ 1059-10062, March 15, 1974. b) Modification in Voluntary Registration of Cosmetic Industry Data. Final Rule. 46 FR 38073-38074, July 24, 1981. c) Modification of Voluntary Filing of Cosmetic Product Experiences. Final Rule. 51 FR 25687, July 16, 1986.

34. Modification in Voluntary Filing of Cosmetic Product Ingredient and Cosmetic Raw Material Composition Statements. Final Rule, 57 FR 3128-3130, January 28, 1992.

35. Food and Cosmetic Labeling; Revocation of Certain Regulations. Final Rule. 62 FR 4307143075 @ 43073, August 12, 1997.

36. a) Voluntary Cosmetics Registration Program: Suspension of Activity—March 30, 1998. (Letter to Industry Participants, Department of Health and Human Services, Public Health Service, Food and Drug Administration). b) FDA Cosmetics Office registration program suspended. The Rose Sheet, April 6, 1998, p. 1.

37. Voluntary cosmetics registration program reinstated with no changes. The Rose Sheet, January 11, 1999, p. 3.

38. VCRP reporting incentives to boost industry participation considered. The Rose Sheet, November 15, 1999, pp. 8-9.

39. Bergfeld WF, Elder RL, Schroeter AL. The cosmetic ingredient review self-regulatory safety program. Dermatologic Clinics 1991; 9(1):105-122.

40. Ford RA. The toxicology and safety of fragrances. In: Muller PM, Lamparsky D, eds. Perfumes, Art, Science, and Technology, London and New York: Elsevier Applied Science, 1991: 441-463.

41. a) Morrison T. Using the Lanham Act to achieve truth in advertising. Drug & Cosmetic Industry (DCI), 24, 26, 28, 30, 32, 81-83, April 1989. b) Donegan TJ. Section 43 (a) of the Lanham Trademark Act as a private remedy for false advertising. Food Drug Cosmetic Law Journal 1982; 37:264-288.

42. a) Government regulation of competition and pricing. In: Anderson RA, Fox I, Twomey DP. Business Law & The Legal Environment. Comprehensive Volume (16th Edition). Cincinnati, OH: South-Western College Publishing, 1996, pp. 60-68. b) Antitrust issues and pricing strategy (discriminatory pricing). In: Stern LW, Eovaldi TL. Legal Aspects of Marketing Strategy: Antitrust and Consumer Protection Issues. Englewood Cliffs, NJ: Prentice-Hall, 1984, pp. 263-279.

43. a) National Advertising Division, Children's Advertising Review Unit, & National Advertising Review Board Procedures (June 10, 1993). New York: Council of Better Business Bureaus, 1996. b) Smithies RH. Substantiating performance claims. Cosmetics and Toiletries 1984; 99(3):79-81, 84.

44. a) The social and legal impact of advertising. In: Bovee CL, Arens WF. Contemporary Advertising. Homewood, IL: Richard D. Irwin, 1982, pp. 60-86. b) Handler J. The self-regulatory system—an advertiser's viewpoint. Food Drug Cosmetic Law Journal 1982; 37:257-263.

45. McNamara SH. The 'C' in the FDC Act. FDA CONSUMER 1981; 15(5):62-63.

46. a) Steinberg DC. Compliance with self-regulation. Cosmetics and Toiletries, 2000; 115(4): 37-40.

47. Hendrick BS, Horton LR. International harmonization of cosmetic regulation. In: Brady RP, Cooper RM, Silverman RS, eds. Fundamentals of Law and Regulation. Vol. 1. Washington, D.C. Food, Drug, and Law Institute (FDLI), 1997:485-505.

49. a) Sunscreen Drug Products for Over-the-Counter Human Use; Final Monograph. Final Rule. 64 FR 27666-27693, May 21, 1999. b) Skin Bleaching Drug Products for Over-the-Counter Human Use; Tentative Final Monograph; Notice of Proposed Rulemaking. 47 FR 3910839117, September 3, 1982. c) Antiperspirant Drug Products for Over-the-Counter Human Use; Tentative Final Monograph; Proposed Rule. 47 FR 36492-36505, August 20, 1982. d) Dandruff, Sebborheic Dermatitis, and Psoriasis Drug Products for Over-the-Counter Human Use; Final Rule. 56 FR 63554-63569, December 4, 1991 (as amended as 59 FR 4000, January 28, 1994).

50. a) Santucci LG, Rempe JM. Legislation and safety regulations for cosmetics in the United States, Europe, and Japan. In: Butler H, ed. Poucher's Perfumes, Cosmetics, and Soaps, 9th Edition. Vol. 3. London: Chapman & Hall, 1993:566-571. b) Steinberg DC. Global understanding 2000. Toward global harmonization of cosmetic regulation. Cosmetics and Toiletries, 2000; 115 (8):27. c) Ref. 47, op. cit., p. 496-498. d) Anon., Minutes of the Third Summit of the Public Health Authorities of the Americas, Lima, Peru, June 15-16, 2000. e) Ref. 47, op. cit., p. 498-501.

52. a) International Harmonization; Draft Policy on Standards; Availability; Notice. 59 FR 6087060874 (November 28, 1994). b) International Harmonization; Policy on Standards; Notice. 60 FR 53078-53084 (October 11, 1995); c) Food and Drug Administration Modernization Act of 1997 (Pub. L. No. 105-115, November 15, 1997).

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