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2011 Food and Drug Administration's Final Rule on Labeling COMMENTARY Current status of the sunscreen regulation in the United States: 2011 Food and Drug Administration’s final rule on labeling and effectiveness testing Steven Q. Wang, MD,a and Henry W. Lim, MDb New York, New York, and Detroit, Michigan Key words: broad-spectrum SPF; critical wavelength; FDA sunscreen monograph; sunscreen. INTRODUCTION Abbreviations used: On June 17, 2011, the US Food and Drug Administration (FDA) issued its long awaited final ANPR: Advance Notice of Proposed Rulemaking CW: critical wavelength ruling on labeling and effectiveness testing of sun- FDA: Food and Drug Administration screen products in the United States.1 At the same MED: minimal erythema dose time, the FDA published 3 other documents: (1) a PPD: persistent pigment darkening SPF: sun protection factor Draft Enforcement Guidance for Industry document, TEA: Time and Extent Application further explaining the final rule,2 (2) a Proposed Rule on sunscreens with sun protection factors (SPFs) greater than 50, seeking additional comments on its 3 In this review, we report the highlights that are proposal to cap SPF at 501, and (3) an Advance relevant to dermatologists and medical professionals Notice of Proposed Rulemaking (ANPR), requesting and provide the rationales underpinning these deci- information about alternative dosage forms of sun- sions by the FDA. screen products (ie, sprays), and proposing that certain dosage forms (wipes, towelettes, powders, body washes, and shampoos) to be considered not HISTORY eligible for review under the sunscreen monograph Sunscreen is deemed as an over-the-counter drug process.4 in the United States. As a result, rules relating to the Only the final rule regarding labeling and testing safety and efficacy of sunscreens are created and of sunscreens1 has been approved, whereas the enforced by the FDA. In modifying or adding new regulations and suggestions in the other 3 docu- items, a ‘‘proposed rule’’ is released by the FDA, ments, hence the sunscreen monograph itself, have seeking comments by the public. The FDA would not been finalized. This announcement signals a then need to address all the public comments recognition by the FDA of the clinical benefits of received. Once done, a ‘‘final rule’’ is released, which photoprotection, with sunscreens as one of the becomes a legally binding document. measures. Furthermore, it provides a much antici- The first set of rules was proposed in 1978, and the pated standard for testing and labeling UVA protec- last rule revision that was approved by the FDA and tion in sunscreens. adopted in the monograph occurred on May 21, 1999.5 On that occasion, the FDA specified the list of acceptable active ingredients, SPF testing require- ments, and related labeling on the product display From Memorial Sloan-Kettering Cancer Center, New York City,a panel. The 1999 ruling, however, did not provide and Department of Dermatology, Henry Ford Hospital, Detroit.b clear directions in testing and labeling of UVA pro- Funding sources: None. tection requirements. Instead, this particular task was Conflicts of interest: None declared. Reprints not available from the authors. postponed to a future date. In August 2007, the FDA 6 Correspondence to: Steven Q. Wang, MD, Dermatology Service, published a proposed rule with an aim to accom- Memorial Sloan-Kettering Cancer Center, 136 Mountain View plish this particular task. In the ensuing months, the Blvd, Basking Ridge, NJ 07920. E-mail: [email protected]. FDA received nearly 2900 comments and sugges- Published online August 5, 2011. tions from the industry, nonprofit groups, and health J Am Acad Dermatol 2011;jj:j-j. 0190-9622/$36.00 organizations. Four years later, in June 2011, the FDA Ó 2011 by the American Academy of Dermatology, Inc. finalized its decision and published a more compre- doi:10.1016/j.jaad.2011.07.025 hensive and updated guideline largely addressing 1 2 Wang and Lim JAM ACAD DERMATOL the testing and labeling of sunscreens for both UVB and UVA; this is referred to as ‘‘Final Rule: Labeling and Effectiveness Testing’’.1 Although this final rule has now been approved and published, because of other unresolved issues (SPF501, dosage forms), at this time the FDA sunscreen monograph is not yet considered to be finalized. HIGHLIGHTS OF THE 2011 FINAL RULE TITLED ‘‘LABELING AND EFFECTIVENESS TESTING’’ Fig 1. Critical wavelength method. Absorption spectra of SPF abbreviation two sunscreens (products #1 and #2). The SPF values were The abbreviation SPF has long been designated as 30 and 15 for product #1 and #2, respectively. Critical ‘‘sun protection factor.’’ wavelength (CW) represents the wavelength below which In the 2007 proposed rule, in recognition that the 90% of absorbance curve resides. Sunscreens #1 and #2 end-point of SPF testing is erythema, there was a have a CW of 357 nm and 378 nm, respectively. According suggestion to change the abbreviation from ‘‘sun to the 2011 final rule, only product 2 can claim the ‘‘broad spectrum’’ status. protection factor’’ to ‘‘UVB sunburn protection fac- tor.’’ However, in the 2011 Final Rule, the SPF abbreviation remains as ‘‘sun protection factor.’’ measures across the UV spectrum from 290 to 400 This decision stems from the acknowledgement nm (Fig 1). Specific criteria for conducting the CW that both UVB and UVA can induce sunburn reaction, test have also been defined in the current rule. and that sunscreen products protect against a variety Briefly, a specific amount (ie, 0.75 mg/cm2)of of harmful effects associated with sun exposure, sunscreen product should be applied to polymethyl- such as early skin aging and skin cancer, in addition methacrylate plates. Before the UV transmittance to protecting against sunburn. through the product is measured, a fixed effective dose of 800 J/m2 (ie, 4 times the minimal erythema Broad-spectrum statement and testing dose of skin phototype II) is delivered to the test methodology product as a pre-irradiation dose. This fixed expo- For more than 20 years, sunscreen manufacturers sure was incorporated in the test to take account of have labeled some products as ‘‘broad spectrum’’; the photostability of the sunscreen formulations. this term has been used if the product contains one Products that are not photostable can potentially be or more UVA filters. Before this current 2011 ruling, degraded with the pre-irradiation, resulting in low there were limited requirements or guidelines on the CW measurement. Based on the UV transmittance testing and labeling of UVA protection. As a result, data, the CW is then calculated. the ‘‘broad spectrum’’ claim is never verified. As shown in Fig 1, as the UVB absorbance Therefore, until the 2011 final rule is implemented increases, reflected as increased SPF, in order to in June 2012, products that contain a short UVA filter, maintain the CWof 370 nm, the UVA absorbance also a long UVA filter, or combination of both, can all be must proportionally increase. Therefore CW is a labeled as ‘‘broad spectrum.’’ Clearly, the protection measurement of the breadth of the UV absorbance against UVA of these products varies. of the sunscreen product. Because a product con- In the 2007 proposed rule, the FDA proposed a taining excellent UVA filters and poor UVB filters can 4-star rating system to designate UVA protection. In have high CW but low SPF, it is essential that CW is the current 2011 rule, the star rating system was always used in combination with appropriate SPF abandoned because it is considered to be potentially values. confusing to consumers. For example, under the star The CW method was chosen because the FDA system, consumers may have to choose between a noted that it is ‘‘simple, reproducible and inexpen- product with an SPF of 50 and 2 UVA stars versus a sive.’’ It should be noted that the European product with an SPF of 30 and 3 stars. Commission recommends both a CW greater than In this current final rule, the FDA has adopted a 370 nm and UVA protection factor (UVA PF) at least pass/fail test using the in vitro critical wavelength one third of the labeled SPF as the criterion to pass (CW) as the only method in assessing UVA or broad- the UVA or broad spectrum test. Lastly, it is important spectrum protection. CW is defined as the wave- to mention that the in vivo persistent pigment dark- length at which 90% of the total area under the ening (PPD) test is not required according to the new absorbance curve resides, with the absorption ruling. The FDA was concerned about the unknown JAM ACAD DERMATOL Wang and Lim 3 Fig. 2. Sunscreen labeling. Note that ‘‘Broad Spectrum’’ and ‘‘SPF’’ labels are of the same font; they appear next to each other. ‘‘Water resistant’’ claim is to appear on the front of the package, whereas ‘‘Drug Facts,’’ are to be listed on the back. (From the U.S. Food and Drug Administration: www.fda.gov/Drugs/ResourcesForYou. Accessed June 19, 2011). health consequence of exposing human subjects to public is more familiar with this term and its associ- high levels of UVA exposure alone during the PPD ated benefits. Again, the labeling format is consistent tests. Furthermore, the FDA agreed that the PPD test with that of the European Commission, where broad is ‘‘expensive, time consuming, and labor intensive,’’ spectrum protection is indicated by a symbol—the and the test results may not be reproducible between acronym ‘‘UVA’’ enclosed within a circle. To empha- the different testing labs. size the importance of broad spectrum coverage, and The FDA specified that only products with CW to minimize confusion to the consumer, FDA re- $ 370 nm can be labeled as ‘‘broad spectrum.’’ quires that the ‘‘Broad Spectrum’’ and the ‘‘SPF’’ label When enforced in June 2012, this will be the only be of the same font and color and to appear in the labeling format permissible for manufacturers to same line, or immediately next to each other (Fig 2).
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