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Protecting the Consumer From Getting Burned: the FDA, the Administrative Process, and the Tentative Final Monograph on Over-the-Counter Sunscreens

Published online by Cambridge University Press:  24 February 2021

Patrick R. Jones
Patrick R. Jones*
Affiliation:
College of the Holy Cross, Boston University School of Law
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Extract

As consumers have become enlightened to the dangers of the sun, they have turned increasingly to sunscreens to stave off not only a sunburn but also life-threatening skin cancer. In the last decade, the incidence of skin cancer has grown a startling 500%. The increase in the number of skin cancers in adults is most likely the result of exposure to the sun as a child. Therefore, the current and continued rise in the number of skin cancers in adults is not remediable. However, as adult consumers seek to prevent further damage to their skin and protect their children from the same fate, the market for sunscreens has grown and is estimated to be worth between $170 and $650 million dollars. The increased demand for sunscreens, combined with the incorporation of sunprotection ingredients into everyday products such as makeup and skin lotions, has led the United States Food and Drug Administration (FDA) to subject sunscreens to increased regulatory scrutiny.

Type
Notes and Comments
Information
American Journal of Law & Medicine , Volume 20 , Issue 3 , 1994 , pp. 317 - 335
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 1994

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References

1 Elif Sinanoglu, Don't Get Burned When Buying Sunblock, Money, July 1994, at 121.

2 See David Cannella, Does Sunscreen Save You? Researchers Have Doubts, Ariz. Republic, July 10, 1994, at Bl. Eighty percent of the damage done to an individual's skin is caused before a person is twenty years old. M.R. Hiller, Children, Teens Especially Need Sun Protection, Chicago Sun-Times, Sept. 7, 1992, at 11; Stephen Petranek, Get Smart, Get Scared, Get Out of the Sun, Life, Aug., 1992 at 55.

3 Id.

4 Id.; Diane Debrovner, Here Comes the Sun: Sunscreen Sales Expected to Increase as Consumer Awareness Increases, Am. Druggist, June 1994, at 30; Caroline Scarborough, Sunscreen Shows Chinks in Its Armor, S.F. Chron., June 18, 1993, at B3.

5 Benson, James S., State of the Food and Drug Administration, 45 Food Drug Cosm. L.J. 301, 304 (1990)Google Scholar.

6 37 Fed. Reg. 9464 (1972).

7 Id.

8 Id.

9 58 Fed. Reg. 28,194 (1993) (to be codified at 21 C.F.R. pts. 352, 700, 701) (proposed May 12, 1993).

10 Marlene Cimons, FDA Proposes Sun Warnings on Sunscreens, L.A. Times, May 13, 1993, at Al. The rise in the number of skin cancers has been linked to the depletion of the Earth's ozone layer which normally protects the human skin from the harmful effects of ultraviolet rays. Id. See also Denise Gellene, FDA Tightening Curbs on Suncare Products, L.A. Times, July 3, 1991, at Al; Environment Helps Accelerate Consumer Demand for Sunscreens, Drug & Cosmetic Industry, Aug. 1991, at 30; Caroline Scarborough, Sunscreen Shows Chinks in Its Armor, S.F. Chron.,June 18, 1993, at B3; RJ. Ignelzi, Use Good Sun Sense, Sunscreen, San Diego Union Trib., May 28, 1993, at E-l.

11 Debrovner, supra note 4. There are three main types of skin cancer—melanoma, basal-cell carcinoma, and squamous cell carcinoma. The deadliest of these is melanoma, but squamous-cell carcinoma is also a killer and the most common form of skin cancer among African Americans. Squamous-and basal-cell carcinomas are easily treatable when detected early enough. See Alexandra Greeley, no Safe Tan, (Department of Health and Human Services, Pub. No. 92-1186, 1991).

12 See Cannella, supra note 2.

13 Id.; Greeley, supra note 11.

14 Debrovner, supra note 4.

15 Id.

16 Greeley, supra note 11.

17 Cannella, supra note 2.

18 Id.

19 Nightingale, Stuart, From the Food and Drug Administration, 270 JAMA 302, 302 (1993)Google Scholar.

20 Cannella, supra note 2; Debrovner, supra note 4.

21 Skolnick, Andrew, Revised Regulations for Sunscreen Labeling Expected Soon from FDA, 265 JAMA 3217, 3217 (1991)Google Scholar.

22 Debrovner, supra note 4.

23 Id.

24 Id

25 F-D-C Reports, the Rose Sheet, May 9, 1994, at 16.

26 Sinanoglu, supra note 1.

27 Id.

28 Debrovner, supra note 4; See also Seasonal Sales Indicate Americans Heading Outdoors Want the Protection of Sunscreens with High SPF, Pr Newswire, July 15, 1993, available in Lexis, News Library, Prnews File [hereinafter Seasonal Sales].

29 Tenerelli, Mary Jane, Sunscreen-Enhanced Makeup to Get “Drug” Status., Drug & Cosm. Indus., Aug. 1993, at 32Google Scholar; Sunscreen Market Slows Despite Improvements in Efficacy, 151 Drug & Cosm. Indus., Aug. 1992, at 21.

30 Vaughan, Christopher D. & Dulak, Michael P., Combination Sunscreen Products: A Technological Challenge, Cosm. & Toiletries, Oct. 1992, at 67Google Scholar.

31 Seasonal Sales, supra note 28.

33 Skolnick, Andrew A., Sunscreen Controversy Heats Up, 265 JAMA 3218 (1991)Google Scholar.

34 Id.

35 Id.

36 Debrovner, supra note 4; Seasonal Sales, supra note 28.

37 Seasonal Sales, supra note 28.

38 Debrovner, supra note 4.

39 Id. See also Skolnick, supra note 33.

40 See Vaughan & Dulak, supra note 30, at 67; Donald A. Davis, Anticipated Problem: FDA Regulations Affecting Toiletries Industry, Drug & Cosm. Indus., Sept. 1992, at 18 [hereinafter Anticipated Problem].

41 Regulatory Rumblings, Drug & Cosm. Indus., June 1994, at 58.

42 Davis, Donald A., Bearding the Lion, Drug & Cosm. Indus., Sept. 1993, at 22Google Scholar.

43 Id. See, e.g., Anne D'Innocenzio, FTC OKs Consent Deal by Revlon, Women's Wear Daily, Nov. 29, 1993, at 12, available in Lexis, News Library, ASAPH File (detailing recent consent agreement linked to Revlon's misleading and incomplete advertisements promising “sun protection“).

44 See Skolnick, supra note 33; Wendy Warburton, Expert's Still Out on Sunscreen's Link to Cancer, Ottawa Citizen, July 22, 1993, at B3; David Cannella, To Lower Risk of Skin Cancer, Use Sunscreen, Doctors Urge, Ariz. Republic, May 30, 1993, at B3.

45 Anticipated Problem, supra note 40.

46 43 Fed. Reg. 38,206 (1978). Section 4 of the Administrative Procedure Act requires that an agency provide notice in the Federal Register of a proposed rulemaking. 5 U.S.C. § 553(b)(3) (1993). This notice, known as an Advanced Notice of Proposed Rulemaking (ANPR), must contain “either the terms or substance of the proposed rule or a description of the subjects or the issues involved.” Id. The notice-and-comment procedure “encourages public participation in the administrative process and educates the agency, thereby helping to ensure informed agency decision making.” Chocolate Mfr. Ass'n v. Block, 755 F.2d 1098 (4th Cir. 1985). The purpose of the notice-andcomment procedure is both “to allow the agency to benefit from the experience and input of the parties who file comments … and to see to it that the agency maintains a flexible and open minded attitude towards its own rules.” National Tour Brokers Ass'n v. United States, 591 F.2d 896, 902 (D.C. Cir. 1978).

47 Brady, Robert P., A Lawyer's View—Sunscreen TFM: Legal Implications Present and Future, Cosm. and Toiletries, July 1993, at 43Google Scholar. Prior to the publication of a final monograph, the FDA will not pursue regulatory action against manufacturers that are not in compliance with the TFM unless “failure to do so poses a potential health hazard to the consumer.” Id. (citing Food & Drug Administration, Fda Compliance Policy Guide, § 7132(b)(15)).

48 58 Fed. Reg. 28,205. Recently, Dr. John Bailey, Jr., an upper level director within the FDA, defined the difference between a cosmetic and a drug:

A cosmetic is intended to alter the appearance, or attractiveness, to beautify, or cleanse, and is meant to perform in a temporary or superficial way …. [D]rugs are intended to treat disease or in some way alter the structure or function of the body. Drugs must be shown to be safe and efficacious.

Shaw, Anita H., Sunscreen Symposium, 69 Soap-Cosm.-Chem. Specialties 52, 53 (1993)Google Scholar available in Lexis News Library, ASAPH File.

49 The American Academy of Dermatology (AAD) has criticized the use of the terms “beach” and “non-beach” in association with sunscreen products. The AAD suggests that using “beach nomenclature” for sunscreen products erroneously implies that the product should be used only at the beach. Herman E. Jass, Regulatory Review: New Regulations at the Federal, State and International Levels, Cosm. & Toiletries, July 1994, at 31.

50 58 Fed. Reg. 28,195.

51 Id Melanogenisis is the physiological process triggered by sunburn and various dermatoses which results in the production of melanin, a black pigment of the skin. In common terms, melangenisis is the natural tanning process of the skin. See the American Heritage Dictionary of the English Lancuace 817 (9th ed. 1980).

52 58 Fed. Reg. 28,195.

53 58 Fed. Reg. 28,205.

54 Id.

55 Klein, Kenneth, A Cosmetic Chemist's View: A Look at the Sunscreen TFM, Cosm. & Toiletries, July 1993, at 39Google Scholar.

56 58 Fed. Reg. 28,295.

57 59 Fed. Reg. 29,706 (1994) (to be codified at 21 C.F.R. pt. 352) (proposed June 8, 1994).

58 Id.

59 58 Fed. Reg. 28,231. The proposed rules include phraseology such as the following which might be chosen by manufacturers for use on the label: (Select one of the following: “Filters” or “Screens“) “out the sun ‘s” (select one of the following:

ldquo;burning” or “harsh and often harmful“) “rays to prevent sunburn“; “Allows you to stay in the sun up to (insert SPF of product up to 30) times longer than without sunscreen protection“; or (Select one of the following: “Filters” or “Screens“) “out the” (select one of the following: “sun's rays,” “sun's harsh rays,” or “sun's harmful rays“) “to help prevent” (select one or more of the following: “lip damage,” “skin damage,” “freckling,” or “uneven coloration“).

Id.

60 Id.

61 58 Fed. Reg. 28,285-86.

62 Id.

63 58 Fed. Reg. 28,217.

64 Id.

65 Id.

66 F-D-C Reports, the Rose Sheet, May 17, 1993, at 11.

67 58 Fed. Reg. 28,206.

68 58 Fed. Reg. 28,286.

69 58 Fed. Reg. 28,228.

70 Id.

71 Id.

72 F-D-C Reports, the Rose Sheet, May 17, 1993, at 12-13 (quoting an unidentified FDA official).

73 58 Fed. Reg. 28,287.

74 The TFM lists the following examples of unacceptable language pertaining to premature aging of the skin:

(1) Statements that include only the term “anti-aging“; (2) “Helps prevent lines and wrinkles by guarding against UV damage” because “premature aging of the skin” cannot be defined as “wrinkling” and “lines” since they are only part of the aging process; (3) Statements including terms such as stops, reverses, or reduces the signs of aging because the agency is not aware of any data showing that the use of a sunscreen stops, reverses, or reduces the signs of aging; (4) “Helps to minimize the visible signs of aging” when used in conjunction with a sunscreen ingredient; (5) “Prevent (or reduce) skin aging caused by exposure to ultraviolet rays” because the use of absolute terms such as “prevent” is not justified in the labeling of sunscreen drug products; and (6) “Reverses aging of the skin caused by exposure to the sun.”

58 Fed. Reg. 28,287.

75 Id.

76 Other examples of acceptable language regarding premature aging of the skin include:

(1) “Sunscreen may reduce the chance of skin aging caused by exposure to the sun“; (2) “Skin can age prematurely from exposure to the sun. Sunscreen may help reduce the chance of this type of aging“; and (3) “May help inhibit the signs of skin aging caused by exposure to ultraviolet rays from the sun's rays.”

Id,

77 The FDA asserts that “premature aging” of the skin should not be denned as “wrinkling” because wrinkling is only part of the aging process. Id.

78 Id.

79 58 Fed. Reg. 28,288.

80 Id.

81 Id. FDA representatives considered Eclipse Labs’ Skin Cancer Garde sunscreen product labeling misleading because “consumers may be led to believe that use of the product will absolutely prevent cancer, when such is not the case.” F-D-C Reports, the Rose Sheet, May 17, 1993, at 14.

83 58 Fed. Reg. 28,205.

84 58 Fed. Reg. 28,223.

85 See supra notes 31-37 and accompanying text.

86 FDA Releases Sunscreen Rulings, Cosm. Int'l, June 10, 1993, at 1, available in Lexis, News Library, Csmint File; F-D-C Reports, the Rose Sheet, May 17, 1993, at 5-6.

87 FDA Releases Sunscreen Rulings, Cosm. Int'l, June 10, 1993, at 1, available in Lexis, News Library, CSMINT File.

88 58 Fed. Reg. 28,298.

89 F-D-C Reports, the Rose Sheet, May 17, 1993, at 6.

90 See, e.g., Ignelzi, supra note 10, at E-l (discussing the variables which affect the level of protection offered by sunscreens).

91 See F-D-C Reports, the Rose Sheet, May 17, 1993, at 12-13.

92 Id.

93 See Vaughan & Dulak, supra note 30, at 67.

94 See, e.g., 58 Fed. Reg. 28,232, 28,250 (indicating the need for further regulation relating to UVA protection).

95 Id

96 See Skolnick, supra note 33, at 3218; Ignelzi, supra note 10.

97 Anticipated Problem, supra note 40, at 18.

98 Id

99 Skolnick, supra note 33; Warburton, supra note 44, at B3; Canella, supra note 44, at B3.

100 F-D-C Reports, the Rose Sheet.June 13,1994, at 18. See also Vaughan & Dulak, supra, note 30, at 67.

101 F-D-C Reports, the Rose Sheet, Aug. 30, 1993, at 5.

102 Id.

103 See, e.g., F-D-C Reports, the Rose Sheet, Sept. 6, 1993, at 3-4 (describing critiques of the the UVA protectant list in the TFM, suggesting the list contains “serious errors“).

104 Seasonal Sales, supra note 28.

105 Id. See also T im Cavanaugh, The Numbers Game, Chem. Mktg. Rep., Aug. 9, 1993, at SR18.

106 F-D-C Reports, the Rose Sheet, July 19, 1993, at 2.

107 F-D-C Reports, the Rose Sheet, Jan. 24, 1994, at 18.

108 F-D-C Reports, the Rose Sheet, NOV. 22, 1993, at 9.

109 Letter from Catherine R. Otto-Rieke, Proctor & Gamble, Inc., to FDA (Oct. 29,1993) (commenting on the TFM) (on file with author).

110 Sun Worshippers, We've Got Your Number, Courier Journal (Lousiville, KY), May 18, 1993, at 1C.

111 Id.

112 Id.

113 F-D-C Reports, the Tan Sheet, Oct. 11, 1993, at 12; Sunscreen Symposium, Cosm. Insider's Rep., Oct. 18, 1993, available in Lexis, News Library, ZCPG1 File.

114 F-D-C Reports, the Tan Sheet, Oct. 11, 1993, at 1.

115 Telephone Interview with Nancy Wellcheck, Public Relations Representative, Schering Plough, Hill & Knowlton (November 1, 1993).

116 Comments have focused primarily on the need for a longer period of implementation due to the seasonal nature of the sunscreen market. It has also been suggested that the increased cost of packaging necessitated by the additional required labeling copy is unwarranted. See Letter from James H. Skiles, Cosmetic, Toiletry, and Fragrance Association, to FDA (Mar. 21,1994); Letter from Irwin Butensky, Sun Pharmaceuticals Corp., to FDA (Feb. 1, 1994); Letter from Thomas W. Robinson, Tanning Research Laboratories, Inc., to FDA (Jan. 18, 1994) (on file with author).

117 See generally notes 29-32 and accompanying text.

118 Robert L. Goldemberg, Free Radicals: Efforts to Reduce Skin Aging Process by Fighting Free Radicals, Drug & Cosm. Indus., Nov. 1993, at 48, available in LEXIS, NEWS Library, ASAPII File.

119 Id.

120 Tenerelli, supra note 29, at 32.

121 Id.

122 58 Fed. Reg. 28,294 (1993).

123 21 C.F.R. §211.22 (1994).

124 Id.§ 211.25.

125 Id.§ 211.28.

126 Id.§ 211.34.

127 Id. §211.80.

128 58 Fed. Reg. 28,294.

129 Id.

130 Florida Sunscreen Seminar Assays Monograph, Drug & Cosm. Indus., Nov. 1993, at 34 (indicating that the chief author of the TFM recognizes the existence of “ ‘economic consequences’ to the marketer“).

131 Tenerelli, supra note 29, at 32.

132 58 Fed. Reg. 28,294.

133 Id

134 Id.

135 Letter from Thomas W. Robinson, Tanning Research Laboratories, Inc., to FDA (Jan. 18, 1994) (commenting on the TFM) (on file with author).

136 Letter from James H. Skiles, Cosmetic, Toiletry and Fragrance Assoc, to FDA (Mar. 21, 1994) (commenting on the TFM) (on file with author).

137 Debrovner, supra note 4.

138 See also Cindy LaFavre Yorks, Don't Leave Home Without It: Sunscreen Makeup Not Only Makes You Look Good—It's Good For You, Chicago Sun Times, May 31, 1992, at 39 (responding to efficacy concerns by suggesting that “anything is better than nothing” when it comes to the benefits of makeup containing sunscreen).

139 See supra notes 3-5 and accompanying text.

140 43 Fed. Reg. 38,206 (1978).

141 Edward Jackson, A Toxicologist's View—UVA Sunscreens Left As Is in 1993 Sunscreen TFM, Cosm. & Toiletries, July 1993, at 41.

142 21 C.F.R. § 330.10 (1994).

143 58 Fed. Reg. 53,460 (1993).

144 59 Fed. Reg. 6,606 (1994); see also F-D-C Reports, the Rose Sheet, Feb. 7,1994, at 5 (outlining reasons for extension).

145 F-D-C Reports, the Tan Sheet, Oct. 11, 1993, at 12.

146 Brady, Robert P., A Lawyer's View—Sunscreen TFM: Legal Implications Present and Future, Cosm. and Toiletries, July 1993, at 43.Google Scholar

147 Perlman, David, Labels on Sunscreen Lotions to Face First FDA Regulations, S.F. Chron., Dec. 8, 1992, at A5Google Scholar.

148 F-D-C Reports, the Rose Sheet, Oct. 11, 1993, at 1.

149 Cavanaugh, supra note 105, a t SR18.

150 See 21 U.S.C. § 355(a) (1988) (mandating manufacturers’ use of NDAs to introduce any new drugs into interstate commerce).

151 Kurt Topfer, Sunscreens to Benefit as Health Trends Emerge, Chem. Mktg. Rep., Apr. 27, 1992, at 33, available in LEXIS News Library, ASAPH File.

152 Klein, Ken, U.S. Regulation of Cosmetic Product Labeling: A Brief Overview, Cosm. & Toiletries, Aug. 1994, at 51Google Scholar.

153 Jackson, Gregory C., Pharmaceutical Product Liability May Be Hazardous To Your Health: A No- Fault Alternative to Concurrent Regulation, 42 Am. U.L. Rev. 199, 209 (1992)Google Scholar.

154 FDA Issues Final Report on Over-the-Counter Drugs, Pub. Health Rep., Jan. 1984, at 102.

155 Food and Drug Administration, U.S. Dep't of Health and Human Services, 1979 Fda Annual Report 11 (1979).

156 See Annabel Hecht, Slashing Away at Red Tape in the New Drug Approval Process, FDA Consumer, Feb. 1983, a t 10, 11 (outlining t h e workload facing a n attempt to gain approval of a n NDA).

157 47 Fed. Reg. 46,622, 46,624 (1982).

158 Nelson, Richard J., Regulation of Investigational New Drugs: “Giant Step for the Sick and Dying“?, 77 Geo. L.J. 463, 463 (1989)Google Scholar.

159 Jackson, Edward M., Reviewing a Three-Dimensional In-Vitro Human Cell Test, Cosm. & Toiletries, Dec. 1993, at 41Google Scholar.

160 Nelson, supra note 158, at 481.

161 Cavanaugh, supra note 105, a t SR18.

162 Wheaton, James J., Generic Competition and Pharmaceutical Innovation: The DrugPrice Competition and Patent Term Restoration Act of 1984, 35 Cath. U.L. Rev. 433, 473 (1986)Google Scholar.

163 Tindall, Margaret W., Breast Implant Information as Trade Secrets: Another Look at FOIA's Fourth Exemption, 7 Admin. Lj. Am. U. 213, 216 (1993)Google Scholar.

164 See U.S. Dep't of Health & Human Servs. Advisory Comm., Final Report on the Food and Drug Administration 39 (1991).

l65 Jackson, supra note 141, at 41.

166 Id.

167 See Perlman, supra note 147.

168 58 Fed. Reg. 28,195.

169 Id. The ability of this phase-in period to effectively reduce the drain on administrative resources is also in doubt. At least three comments have indicated the need for a two- to three-year phase-in period so that manufacturers will not be forced to absorb the cost of unsold stock in an industry that makes most of its sales in a three month span. See, e.g. Letter from James H. Skiles, Cosmetic, Toiletry, and Fragrance Association, to FDA (Mar. 21, 1994) (on file with author); Letter from Irwin Butensky, Sun Pharmaceuticals Corp., to FDA (Feb. 1, 1994) (on file with author). 170 F-D-C Reports, the Rose Sheet, Dec. 20, 1993, at 4.

171 Debrovner, supra note 4.

172 See Id. See also F-D-C Reports, the Rose Sheet, May 16, 1994, at 9.

173 See supra notes 95 to 99.

174 Debrovner, supra note 4.

175 Sunstein, Cass R., Paradoxes of the Regulatory State, 57 U. CHI. L. REV. 407, 418 (1990)Google Scholar.

176 Id

177 Nelson, supra note 158, at 485-87.

178 Id. at 487.

179 Janet McCue, What's Hot, What's Not, Cleveland Plain Dealer, July 1, 1993, at 2D.

180 Id

181 Id.

182 Id.

183 See Sunstein, supra note 175; F-D-C Reports, the Rose Sheet, Oct. 11, 1993, at 2.

184 Id

185 See supra notes 9-19 and accompanying text.

186 Dr. Gilbertson, the primary author of the document, has indicated that this type of statement is unique for the agency. “The FDA rarely, if ever, promotes the use of a drug. We treat symptoms that are already there. We don't necessarily promote preventing something,” he stated. See Shaw, supra note 48, at 53.