2011 OCT 1 P 1 : 1 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 CITIZEN PETITION In reference to: Docket No. PDA-1978 N-0018, RIN 0910 ZA40 Bare Escentuals Beauty, Inc. ("Bare Escentuals") is a manufacturer and marketer of personal care products including powder-based makeup products that are intended for use as both cosmetics and over-the-counter (OTC) sunscreen drug products. All Bare Escentuals cosmeticsunscreen products have been tested and provide effective levels of UVA and UVB protection. These products meet a significant consumer need: they are beauty products that are also skin care products, and women use them to obtain daily sun protection with the convenience of their daily makeup application. Thus, these products provide a meaningful contribution to the public health. In June 2011, when FDA promulgated its final sunscreen labeling rule (21 CFR 201.327), it stated (for the first time in the 30-year history of the sunscreen monograph) that it does not consider a powder sunscreen dosage form to be eligible for review under the OTC monograph process. We respectfully request that FDA reconsider this position. Accordingly, Bare Escentuals submits this petition to request that FDA consider makeup powder dosage forms of OTC sunscreen drug products to be eligible for inclusion in the sunscreen monograph, and to consider such products to be generally recognized as safe and effective (GRASE) when they comply with the sunscreen testing and other applicable requirements of the monograph (and the final sunscreen labeling rule). The basis for this request is that: frz,4.00tff BARE ESCENTUALS 71 Stevenson Street San Francisco, California 94105 BAREESCENTUALS.COM
Page 2 1. Powder dosage forms of sunscreens (including makeup powders) were marketed in the United States before the beginning of the OTC Drug Review in 1972, and powder dosage forms were reviewed by FDA's Advisory Review Panel on OTC Topical Analgesic, Antirheumatic, Otic, Burn, and Sunburn Prevention and Treatment Products ("Advisory Panel") as part of its assessment of the safety and effectiveness of sunscreens covered by the OTC Drug Review; 2. A makeup powder dosage form is "suitable for topical administration" within the meaning of the sunscreen monograph and meets all legal conditions for inclusion in the monograph; 3. A conclusion that a makeup powder dosage form is covered by the sunscreen monograph is consistent with FDA's historical approach to the monograph; and 4. Excluding makeup powder dosage forms from the sunscreen monograph would reduce the number of sunscreens available to consumers for daily use and would eliminate a sunscreen option for persons who prefer this dosage form. This would be detrimental to the public health. A. Action Requested FDA's June 2011 statements on sunscreen powder dosage forms appear in two documents. In an advance notice of proposed rulemaking (ANPR), FDA stated: In response to the August 27, 2007 proposed rule for OTC sunscreen products..., several submissions recommended that we include the following dosage forms in the final sunscreen monograph...: Wipes Towelettes Powders Body washes Shampoos We currently do not consider these dosage forms eligible for review under the OTC monograph process. We were unable to identify any sunscreen products in wipe, towelette, powder, body wash, or shampoo dosage forms that were marketed OTC before the OTC Drug Review began. * * * We also have not received any time and extent applications for OTC sunscreen products formulated as wipes, towelettes, powders, body washes or shampoos. Therefore, sunscreens formulated as wipes, towelettes, powders, body washes, or shampoos are not currently eligible for review under the OTC sunscreen monograph. 76 FR 35669, 35671 (June 17, 2011).
I 1 Petition to Revise Sunscreen Guidance Documents Page 3 In its Draft Guidance for Industry: Enforcement Policy OTC Sunscreen Drug Products Marketed Without an Approved Application (June 2011) ("Draft Guidance"), FDA referred to the above ANPR, stating: The 2011 ANPR also listed those dosage forms that we did not consider currently eligible for review for potential inclusion in the OTC sunscreen monograph: wipes 1 towelettes 1 powders I body washes shampoos. Draft Guidance at 8. We respectfully request that FDA consider makeup powder dosage forms of OTC sunscreen drug products to be eligible for inclusion in the OTC sunscreen monograph and revise the abovecited documents to refer to "Powders (other than makeup powders)." 1 The factual and legal basis for this request is provided in section B, below. In the Draft Guidance, FDA stated Manufacturers of OTC sunscreen products in dosage forms that are not currently considered eligible for the OTC Drug Review may submit the information needed to support the eligibility of these products. In the 2011 ANPR, we invite submitters to identify any additional sunscreen dosage forms that may be eligible for potential inclusion in the OTC sunscreen monograph based on marketing prior to the commencement of the OTC Drug Review in 1972.2 This petition both provides information about the marketing of sunscreens in makeup powder dosage form prior to 1972 (section B.1 below) and explains why, even if there were no powder dosage forms marketed prior to 1972, makeup powder dosage forms meet all legal conditions for inclusion in the monograph (section B.2 below).3 1 Although Bare Escentual's products are limited to makeup powders, the conclusions in this petition apply to powder dosage forms in general. Therefore, FDA could respond to this petition by excluding "Powders" from the list of dosage forms that it does not consider currently eligible for review under the OTC sunscreen monograph. 2 The comment period for the ANPR was extended to. 76 FR 56682 (Sept. 14, 2011). 3 This petition does not request a change in the wording of the sunscreen monograph, 21 CFR Part 352, because no such change is needed, but this petition is analogous to a petition to amend the monograph under 21 CFR 330.10(a)(12)(i), and is consistent with section III B of FDA's Guidance for Industry Time and Extent Applications for Nonprescription Drug Products (Sept. 2011).
Page 4 B. Statement of Grounds We request that FDA consider makeup powder dosage forms of OTC sunscreen drug products to be eligible for inclusion in the OTC sunscreen monograph for the following reasons: 1. Powder dosage forms of sunscreens (including makeup powders) were marketed in the United States before the beginning of the OTC Drug Review in 1972, and powder dosage forms were reviewed by the Advisory Panel as part of its assessment of the safety and effectiveness of sunscreens covered by the OTC Drug Review PDA has focused on May 1972 as the date on or before which sunscreen powder dosage forms had to be marketed in the United States in order to be eligible for the OTC Drug Review. In its Draft Guidance, FDA said that OTC sunscreen products in powder dosage form "are not currently eligible for review under the OTC sunscreen monograph, because we lack the evidence that such products existed in the OTC drug marketplace on or before May, 1972." Draft Guidance at 8. However, we have identified several powder products intended for use as sunscreens that were marketed in the United States prior to May 1972. These include the following: Lablache Face Powder: Advertisements depicting claims for this product were published in at least five U.S. magazines from 1898 to 1906. The product was described as a tinted powder that "prevents and cures sunburn." Claims for the product included, "Lablache Face Powder not only cures sunburn..., but it prevents such disagreeable conditions if applied before exposure to the sun..." (Appendix A.) This product contained zinc oxide, among other ingredients, according to the Pharmaceutical Record of November 3, 1892 (Appendix E) and according to Harvey W. Wiley's 1916 publication 1001 Tests of Foods, Beverages and Toilet Accessories, Good and Otherwise ("Wiley") (Appendix F). Mennen's Borated Talcum Toilet Powder: Advertisements depicting labeling and claims for this product were published in at least nine U.S. magazines during 1908. Claims stated that, "When used daily, Mennen's keeps the skin smooth and healthy, relieves and prevents Sunburn,... and all skin troubles of summer. Makes possible the attractive, evenly browned complexion without burning." (Appendix B.) This product contained talc and boric acid, among other ingredients, according to Wiley (Appendix F). Nadine Face Powder: Advertisements depicting labeling and claims for this product were published in at least twelve U.S. magazines and newspapers from 1911 to 1920. The product was described as a tinted powder that "prevents sunburn." (Appendix C.) It contained zinc oxide, among other ingredients, according to Wiley (Appendix F).
Page 5 Nvsis Talcum: Advertisements depicting labeling and claims for this product were published in at least two U.S. magazines during 1920. It is described as a talcum powder that "produc[es] a scarcely visible veil against the light-rays which, acting upon the inner, or true skin, cause sunburn." (Appendix D.) In 1946, in their book Cosmetics and Dermatitis, Drs. Schwartz and Peck described a variety of sunscreen preparations, including powders ("Schwartz & Peck") (Appendix G). 4 They stated, in the Chapter "Suntan Preparations": Heavily pigmented preparations (liquids, creams, or powders) will prevent or reduce the passage of the ultraviolet radiation, i.e., cast a shadow upon the portion of the skin to which they are applied. Of course, while preventing sunburn, such preparations will prevent also suntan. Zinc oxide, calamine, and titanium dioxide are most effective in this regard. * * * Powders to prevent sunburn can be prepared by mixing zinc or titanium oxides with magnesium or zinc stearates. The stearates cause the titanium oxide to adhere better to the skin. Magnesium oxide and precipitated chalk may also be used as extenders for sunburn-preventive powders." The 1973 United States Dispensatory, which described drugs found in the scientific literature prior to that date, notes that titanium dioxide was formulated "as a protective against sunburn... in ointments or lotions, * * * in other protective preparations, and in dusting powders and face powders." (Appendix H.)5 The records described above include both literature disseminated to lay consumers as well as medical and scientific literature. These records corroborate each other and consistently demonstrate that sunscreens were on the U.S. market in powder dosage form prior to 1972. This fact was known to the Advisory Panel. In the 1978 proposed monograph on sunscreen OTC drug products, which consisted of the unaltered conclusions and recommendations of the Panel, the Panel reviewed each of the sunscreen active ingredients that it deemed to be safe and effective. In particular, the Panel reviewed effectiveness data on titanium dioxide in powder form. Quoting Schwartz & Peck and the United States Dispensatory, the Panel stated It [titanium dioxide] is used in ointments and lotions at a concentration of 15 to 25 percent as a protective against sunburn. It is also used in other protective preparations and in dusting powders and face powders... * * * Schwartz and Peck reported that 4 Schwartz, L. and S. M. Peck, "Cosmetics and Dermatitis," Paul B. Hoeber, Inc., New York (1946), pp. 142-146. 5 The United States Dispensatory, 27th Ed., Edited by A. Osol and R. Pratt, J. B. Lippincott and Co., Philadelphia (1973), p. 1198.
Page 6 "Heavily pigmented preparations (liquids, creams or powders) will prevent or reduce the passage of the UV radiation" but, "while preventing sunburn, such preparations will prevent also suntan. Zinc oxide, calamine, and titanium dioxide are most effective in this regard"... 43 FR 38206, 38251 (August 25, 1978). This and other information enabled the Panel to conclude that, "[biased on the available data,... titanium dioxide is an effective sunscreen ingredient for OTC use." Id. Thus, it is clear from the language of the proposed monograph that both the Panel and FDA were aware in 1978 of powder dosage forms that were effective sunscreens. Further, both the Panel and FDA relied on information about those dosage forms when reaching their overall conclusions about the safety and effectiveness of sunscreens in the proposed monograph. Accordingly, notwithstanding FDA's statement that it "lack[s] the evidence that such products existed in the OTC drug marketplace on or before May, 1972" (Draft Guidance at 8), in fact powder dosage forms of sunscreens (including makeup powders) were marketed in the United States before the beginning of the OTC Drug Review in 1972, and powder dosage forms were reviewed by the Advisory Panel as part of its assessment of the safety and effectiveness of sunscreens covered by the OTC Drug Review. Therefore, makeup powder dosage forms are covered by the OTC Drug Review and the sunscreen monograph.' 2. A makeup powder dosage form is "suitable for topical administration" within the meaning of the sunscreen monograph and meets all legal conditions for inclusion in the monograph Even if (notwithstanding the discussion in section B.1 above) FDA concludes that powder dosage forms of sunscreens were not available prior to 1972, makeup powder dosage forms nevertheless meet all legal conditions for inclusion in the monograph. 6 In the ANPR, FDA states, "To determine eligibility for the OTC Drug Review, we must have actual product labeling or a facsimile of labeling that documents the conditions of marketing of the product prior to May 1972 (21 CFR 330.10(a)(2))." 76 FR 35669, 35671 (June 17, 2011). However, the regulation cited by FDA is a procedural regulation that governed only submissions for review by an advisory panel after publication of the original Federal Register notice calling for data to establish a monograph and prior to the publication of a proposed monograph. Neither this nor any other regulation requires the submission of labeling (or any other specific evidence) to support a determination made after the publication of a proposed monograph that a dosage form (such as makeup powders) is properly covered by that monograph. The information provided in this petition about pre-1972 powder sunscreens is sufficiently specific to document the conditions of marketing of such products in the United States prior to May 1972.
Page 7 a. The monograph covers any condition for use that is consistent with the terms of the monograph and is substantially indistinguishable from the conditions reviewed by the Advisory Panel The fundamental principle of the OTC Drug Review is that a manufacturer may launch a newly marketed OTC drug product without the need for an approved new drug application (NDA), so long as the product is consistent with the terms of an OTC drug monograph with respect to active ingredients and conditions of use. Under 201(p) of the Federal Food, Drug, and Cosmetic Act, the active ingredients and conditions of use that may be marketed under an OTC drug monograph are not "new drugs" that require an approved NDA because: An advisory panel and/or FDA have concluded that they are "generally recognized... as safe and effective," and Active ingredients and conditions of use reviewed by an advisory panel and included in a proposed monograyh are considered to have "been used to a material extent [and] for a material time..."/ If a newly marketed OTC drug product varies significantly from the conditions of use on which the monograph is based, the product can be considered a "new drug" that is not covered by the monograph. 21 CFR 310.3(h). However, insignificant variations do not cause a product to become a "new drug." In determining whether a product is a "new drug," FDA has applied a "substantially indistinguishable" standard. This standard was first articulated in a September 23, 1977 letter from FDA to a drug manufacturer. In that letter, FDA stated:... an ingredient may legally meet the criterion [that an ingredient be used to a material extent and for a material time under its labeled conditions of use] without having been marketed under the precise conditions of use sought to [be] included in an OTC monograph if it has been marketed to a material extent and for a material time under other conditions of use that, although different, are substantially indistinguishable in all respects relevant to the drug's safety and effectiveness. By "substantially indistinguishable" conditions of use, I mean conditions of use that are similar enough to each other that experts can reliably conclude that knowledge about the safety and effectiveness of a drug derived from experience with its use under one set of conditions is applicable to the evaluation of the safety and effectiveness of its use under the conditions for which approval is sought. 7 FDA regulations specify that active ingredients limited to prescription use as of May 11, 1972, or active ingredients at a dosage level higher than that available OTC on December 4, 1975, may be considered "new drugs" that may not be marketed unless they are the subject of a determination that they are generally recognized as safe and effective. 21 CFR 330.13. However, these dates were not considered by advisory panels for purposes of the review of active ingredients and conditions of use. See e.g., 21 CFR 330.10.
Page 8 FDA letter to Richardson-Merrell, Inc. (September 23, 1977) (Appendix I). As FDA explained, the "substantially indistinguishable" standard reflects that the law "... may be applied in the special circumstances of the OTC Drug Review with a degree of flexibility commensurate with the objective of establishing conditions of use under which classes of drugs, rather than individual products, are considered generally recognized as safe and effective." Id. FDA reaffirmed the applicability of the "substantially indistinguishable" standard in 1996, stating that In applying the material extent and material time provision of section 201(p)(2) of the act to determine whether certain conditions were eligible for consideration in the OTC drug monograph system, FDA has... applied a "substantially indistinguishable" standard. 61 FR 51625, 51627 (October 3, 1996). This standard has been in effect throughout the period during which the sunscreen monograph, and all other OTC monographs, have been promulgated and implemented by FDA and the regulated industry. The industry has relied on this standard throughout this period for purposes of formulating OTC drug products that are consistent with FDA's interpretation of the law.8 Thus, this standard constitutes a "settled course" of administrative agency behavior. As the Supreme Court has stated (in a case involving the Interstate Commerce Commission) A settled course of behavior embodies the agency's informed judgment that, by pursuing that course, it will carry out the policies committed to it by Congress. There is, then, at least a presumption that those policies will be carried out best if the settled rule is adhered to. Atchison, T. & S. F. R. Co. v. Wichita Bd. of Trade, 412 U. S. 800, 807-808 (1973). For these reasons, the sunscreen monograph covers any condition for use that is consistent with the terms of the monograph and is substantially indistinguishable from the conditions reviewed by the Advisory Panel. 8 See e.g., T. 0. Henteleff and S. M. Lassman, "Innovating Within the OTC Monograph System," Regulatory Affairs Focus at 23-26 (March 2000), in which the authors discuss the "substantially indistinguishable" standard as the legal basis for marketing an OTC drug that is not identical to an OTC dmg marketed at the time the monograph was created.
Page 9 b. Makeup powder dosage forms are covered by the terms of the sunscreen monograph and are substantially indistinguishable from other topical dosage forms reviewed by the Advisory Panel A makeup powder dosage form is covered by the sunscreen monograph because The terms of the monograph are not dosage-form specific and permit the use of a makeup powder dosage form, and Such a dosage form is substantially indistinguishable from other dosage forms that are accepted by FDA as being covered by the monograph. (1) Makeup powder dosage forms comply with the terms of the sunscreen monograph The monograph's definition of "sunscreen" does not distinguish among dosage forms. It says only that an OTC sunscreen must be "in a form suitable for topical administration." 21 CFR 352.1(a) (stayed). It does not define a "suitable" form or specify permitted inactive ingredients but recognizes that finished dosage forms may vary. The monograph's directions for use also do not distinguish among dosage forms but accommodate variability in dosage forms by stating that, "[m]ore detailed directions applicable to a particular product formulation (e.g, cream, gel, lotion, oil, spray, etc.) may also be included." 21 CFR 352.52(d) (stayed). As FDA has said, the monograph "provide[s] that manufacturers can voluntarily expand and supplement these required directions with more detailed instructions applicable to a particular product formulation and dosage form." 58 FR 28194, 28244 (May 12, 1993). Most importantly, the monograph does not distinguish among dosage forms in terms of effectiveness but permits the use of any topical dosage form that meets the testing requirements for effectiveness. As FDA has stated, [T]he influence of the vehicle on the effectiveness of a sunscreen drug product is accounted for in the SPF testing procedure because the test is done on the final formulation of a sunscreen product. As provided in Sec. 352.10, a final sunscreen drug product must have an SPF value of not less than 2. Any product that can demonstrate that it meets the labeled SPF value is considered to be effective. 58 FR 28194, 28215 (May 12, 1993). The testing procedures specified by FDA (in its 1999 Final Monograph, its 2007 proposed amendments to the Final Monograph, and its 2011 final sunscreen labeling tule) can be used for many topical dosage forms, including makeup powders.
Page 10 In fact, all Bare Escentuals sunscreens in makeup powder dosage form are effective at a level of at least SPF 15. Testing data also demonstrate effectiveness in reducing skin's exposure to UVA radiation. Copies of test reports are provided at Appendix J.9 Therefore, makeup powder dosage forms comply with the terms of the monograph so long as they pass the monograph's efficacy test. 21 CFR Part 352 (stayed). In the same way, makeup powder dosage forms comply with the terms of FDA's new sunscreen labeling rule, 21 CFR 201.327. (2) Makeup powder dosage forms are substantially indistinguishable from other topical dosage forms reviewed by the Advisory Panel A conclusion that makeup powder dosage forms are substantially indistinguishable from other topical dosage forms reviewed by the Advisory Panel is fully consistent with FDA's articulation of the "substantially indistinguishable" standard in its 1977 letter. In fact, makeup powder dosage forms are more like other topical sunscreen dosage forms than were the products that FDA deemed to be substantially indistinguishable in 1977. 41) FDA's 1977 letter dealt with potassium nitrite for use as a tooth desensitizer in OTC toothpaste at a concentration of 5 percent. The question was whether this proposed use of potassium nitrite was sufficiently similar to a previously marketed product that it could, as a matter of law, be deemed to have been "used to a material extent [and] for a material time" under 201(p) of the Act. The previously marketed product was "Albion D," a prescription device in the form of a dental tray containing a paste with 8.5 percent potassium nitrite intended for use by dentists or other dental health professionals and not by consumers. FDA stated that, "Mresumably, [Albion D] is intended for occasional use... and not for repeated use." FDA letter to Richardson-Merrell, Inc. (September 23, 1977) (Appendix I). The differences between a makeup powder dosage form and the other topical dosage forms covered by the sunscreen monograph are relatively minor when compared with the differences between OTC potassium nitrite toothpaste and Albion D. In particular, unlike Albion D, all of the relevant sunscreen dosage forms are topically applied to the skin (rather than involving use of a device), use OTC (rather than prescription) levels of active ingredients, and are for regular consumer use (rather than occasional professional use). Indeed, in all material respects, makeup powders are like the lotions, creams, pastes and other dosage forms deemed by FDA to be covered by the sunscreen monograph in that they are rubbed onto the skin, adhere to the skin's surface for a period of time, and are effective at reducing skin's exposure to UVA and UVB radiation. They are particularly similar to water-based lotions 9 All SPF tests were conducted by an independent laboratory using validated procedures in accordance with the test method specified in FDA's 1999 Final Monograph.
Page 11 and pastes, which can have the characteristics of powders after the water vehicle evaporates. Based on the standard articulated by FDA, makeup powder dosage forms are substantially indistinguishable from other topical dosage forms reviewed by the Advisory Panel. We are providing with this petition two letters from prominent dermatologists who have considered the question of whether knowledge about the safety and effectiveness of sunscreens in forms accepted by FDA (lotions, creams, gels, etc.) is applicable to the evaluation of sunscreens in powder dosage form. These experts are: Mark G. Lebwohl, M.D., professor and chairman of the Department of Dermatology at The Mount Sinai School of Medicine in New York City. Dr. Lebwohl is a practicing dermatologist and has conducted extensive research on dermatological diseases. He is very familiar with the effects of sunscreens and their importance in reducing the risk of skin cancer and premature aging from exposure to ultraviolet radiation. His letter and curriculum vitae are provided at Appendix K. Howard I. Maibach, M.D., professor in the Department of Dermatology at the University of California, San Francisco. Dr. Maibach has written and conducted extensive research on sunscreen issues. He has been involved in the development of the sunscreen monograph over its more than 30-year history. His letter and curriculum vitae are provided at Appendix L. Dr. Lebwohl states: There is no question that sunscreens in makeup powder dosage form are effective. I have reviewed testing data on UVA and UVB testing conducted by Bare Escentuals and agree that these tests establish that makeup powders can meet the same broad spectrum SPF criteria as all other sunscreens that are acceptable under the monograph. Furthermore, the conditions of use of sunscreen in makeup powder form are similar to those of sunscreens in other dosage forms such as lotions or creams. Specifically, they are intended for short-term topical use in a form that can be readily reapplied to the skin. (In fact, makeup powders have an advantage over other dosage forms because consumers can see color changes that indicate when the sunscreen-containing makeup needs to be reapplied. With other sunscreen dosage forms, consumers do not know when their coverage has been diminished.) Dr. Maibach's views are consistent and he concludes that... makeup powders are not materially different from other sunscreen dosage forms that FDA considers to be covered by the monogyaph (e.g., lotions, creams, gels, etc). The conclusions that the advisory panel and FDA have reached about sunscreens in the course of the development of the monograph are relevant to sunscreens in makeup powder form.
Page 12 Accordingly, the use of a makeup powder dosage form does not by itself cause a product to be a "new drug" under 201(p) of the Act and there is no legal basis for concluding that makeup powder dosage forms cannot be covered by the sunscreen monograph. c. Conclusion For the reasons discussed above, although makeup powders are different in form than creams, lotions, pastes, and other topical dosage forms, they are "substantially indistinguishable" from those other dosage forms within the meaning of FDA's 1977 letter. A makeup powder dosage form is "suitable for topical administration" within the meaning of the sunscreen monograph and meets all legal conditions for inclusion in the monograph.10 3. A conclusion that a makeup powder dosage form is covered by the sunscreen monograph is consistent with FDA's historical approach to the monograph FDA's historical approach to the sunscreen monograph is consistent with a conclusion that a makeup powder dosage form is covered by the terms of the monograph, for the following reasons: In over 30 years of administering the sunscreen monograph, FDA has never previously suggested that makeup powder dosage forms might not be eligible to be covered by the monograph. As discussed in section B.1 above, the 1978 proposed monograph stated that the Advisory Panel considered "... powders... [that] prevent or reduce the passage of the UV radiation" and that "prevent[] sunburn." 43 FR 38206, 38251 (August 25, 1978). Further, FDA repeatedly acknowledged that the monograph would cover "make-up products" containing sunscreens. 64 FR 27666, 27678 (May 21, 1999). It is common knowledge that many makeup products consist of powders. Thus, FDA has long known that sunscreens in makeup powder form have been marketed to a material extent and for a material time. 11 Until now, FDA has (correctly) never advised manufacturers that makeup powder dosage forms might not be covered by the monograph. Because makeup powder dosage forms fall within the conditions of the original sunscreen monograph, the procedures in 21 CFR 330.14, including a time-and-extent application (TEA), are not applicable. As FDA explained when it proposed this regulation, "The agency will continue to use the existing OTC drug review procedures for conditions subject to the original OTC drug review." 64 FR 71062, 71065 (December 20, 1999). This conclusion is consistent with the conditions eligible for TEAs as described in section III.0 of FDA's Guidance for Industry Time and Extent Applications for Nonprescription Drug Products (Sept. 2011). 11 See 21 CFR 720.4(c)(7), which defines "makeup preparations" as including "face powders." In 2007, FDA referred to a comment stating that makeup includes foundations, tints, blushes and rouges. 72 FR 49070, 49076 (August 27, 2007). These references further indicate that FDA was aware of the presence in the marketplace of sunscreens formulated as makeup powders.
Page 13 FDA has encouraged the formulation of sunscreens in makeup form. Because makeup powders are a subset of traditional makeup, FDA has also encouraged the formulation of sunscreens in makeup powder form. FDA has done this by adopting special labeling rules in 21 CFR 352.52(f) (stayed) for sunscreens in small packages that are labeled for use on small areas of the face. In the preamble to this Final Monograph, FDA acknowledged the importance of makeup formulations of sunscreen including powder formulations saying, "FDA believes that sunscreen products labeled for use only on small areas of the face... serve an important public health need and FDA does not want to discourage manufacturers from marketing these products..." 72 FR 49070, 49075 (August 27, 2007). Thus, until now, FDA has sought to encourage, not discourage, the marketing of sunscreen in makeup form including makeup powders. Based on this history, manufacturers have been justified in concluding that sunscreens in makeup powder dosage form are covered by the monograph. FDA's statements and actions over the last 30 years have supported such a conclusion. FDA' s June 2011 ANPR and Draft Guidance do not set forth an adequate legal or scientific basis for revising this history and reaching a different conclusion. 4. Excluding powder dosage forms from the sunscreen monograph would reduce the number of sunscreens available to consumers for daily use, and would therefore be detrimental to the public health If FDA concludes that powder dosage forms of sunscreens are not eligible for review under the OTC monograph process, this will, as a practical matter, force such products off the market. This result would be detrimental to the public health because it would reduce the number of sunscreens available to consumers for daily use and would eliminate a sunscreen option for persons who prefer this dosage form. According to 2010 data, products formulated as powder sunscreens comprised about 23% of the U.S. market for pressed and loose foundation and powder makeup, and about 9% of the total U.S. market for foundation and powder makeups in all formats. 12 Thus, there are a significant number of these sunscreen products in the marketplace and their loss would mean the loss of a significant sunscreen protection option for consumers. As Dr. Lebwohl states in his letter, it would be "very unfortunate" from a medical and public health perspective if FDA were to remove from the market all OTC sunscreens that are formulated as makeup powders: Effective sun protection requires repeated, combined use of different sunscreen measures. To protect the face, women who wear makeup should be encouraged to combine a variety 12 NPD Market Research Data 2010.
Page 14 of measures that will help increase their effective protection. This might include, for example, use of a sunscreen-containing foundation, use of sunscreen-containing makeup powders, use of sun-protective clothing, and remaining indoors when the sun's rays are strongest. Thus, sunscreens in makeup powder form can and do play an important role. Dr. Maibach urges FDA to... encourage, rather than discourage, the marketing of sunscreens in makeup powder dosage forms. This will have a long-term benefit, because just as the applying of makeup is a daily habit these products can help make sunscreen use a daily habit. Both of these experts are concerned that it would be detrimental to the public health if sunscreens were to become unavailable in makeup powder forms. As Dr. Lebwohl states, "In light of the current and projected increased incidence of skin cancer,... manufacturers should be encouraged to formulate more, not fewer, products as sunscreens." 5. Conclusion 111 This petition provides information to support that Powder dosage forms of sunscreens (including makeup powders) were marketed in the United States before the beginning of the OTC Drug Review in 1972, and powder dosage forms were reviewed by the Advisory Panel as part of its assessment of the safety and effectiveness of sunscreens covered by the OTC Drug Review; A makeup powder dosage form is "suitable for topical administration" within the meaning of the sunscreen monograph and meets all legal conditions for inclusion in the monograph; and Considering makeup powder dosage forms to be covered by the monograph would be fully consistent with the history of FDA's implementation of the monograph, and would contribute to protection of the public health. We therefore respectfully request that FDA consider makeup powder dosage forms of OTC sunscreen drug products to be eligible for inclusion in the sunscreen monograph, and to consider such products to be generally recognized as safe and effective when they comply with the sunscreen testing and other applicable requirements of the monograph (and the final sunscreen labeling rule). We appreciate FDA's consideration of this issue and are prepared to meet with the agency and/or respond to any questions the agency may have that would facilitate review of this matter.
Page 15 C. Environmental Impact A categorical exclusion from the requirement to prepare an Environmental Assessment or Environmental Impact Statement is claimed under 21 CFR 25.30. D. Certification The undersigned certifies that, to the best knowledge and belief of the undersigned, this petition includes all information and views on which the petition relies, and that it includes representative data and information known to the petitioner which are unfavorable to the petition. Sincerely, 0,2 (Lk /149, Deanna Chechile Senior Vice President and General Counsel
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