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Journal of the Dermatology Nurses' Association:
doi: 10.1097/JDN.0b013e318234faea
DEPARTMENTS: Guest Editorial

Food and Drug Administration's Final Ruling on Sunscreens: Have We Simply Rearranged the Deck Chairs on the Titanic?

Maguire-Eisen, Maryellen

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Maryellen Maguire-Eisen, RN, MSN, Boston University School of Medicine, Boston, Massachusetts.

There was no financial compensation involved in the preparation of this manuscript.

Correspondence concerning this article should be addressed to Maryellen Maguire-Eisen, RN, MSN, Children's Melanoma Prevention Foundation, 10 Tupelo Drive, Hingham, MA 02043. E-mail: maryellen@melanomaprevention.org

The long-awaited, recently announced Food and Drug Administration's (FDA) ruling on sunscreens is a cause of both relief and concern-relief for what has finally been included, labeling and ultraviolet (UV) testing requirements, and concern for what has not been included, specifically, proper usage. Although I believe that these new regulations may make it simpler for our patients and the public to select a sunscreen to prevent sun damage and reduce skin cancer risk, I am concerned that these new regulations do not adequately address its proper use in terms of sunscreen dosing and application. I fear that this may result in further confusion and, potentially, greater danger from UV radiation exposure.

First, I think that it is important to understand the role of the FDA in regulating over-the-counter (OTC) drug products. The FDA's stated mission is "to protect consumers and enhance public health by maximizing compliance of FDA regulated products and minimize risk associated with those products" (FDA, 2006). One of the ways the FDA does this is through a three-phase "public-ruling-making process," which results in the establishment of standards (monographs) for an OTC therapeutic drug category. The FDA oversees 80 classes of OTC drug products. In the sunscreen category, there are 17 approved agents formulated into thousands of products. The FDA began their rule-making process for sunscreens over 30 years ago.

The first phase of the public-ruling-making process determines which drug products are "generally recognized as safe and effective." An advisory panel "reviews claims and recommends appropriate labeling including therapeutic indications, dosage instructions, and warnings about side effects and preventing misuse." The second phase is to review ingredients in each category and publish its findings in a "tentative final monograph." The third phase is to establish conditions under which sunscreen products may be used to meet the requirements for "safe and effective" (FDA, 2011c).

Previously considered as "cosmetics," sunscreens were reclassified as OTC medications by the FDA in 1972. In the FDA's sunscreen monograph in 1978, Americans were warned that "overexposure to the sun may lead to premature aging of the skin and skin cancer." In 1999, the FDA published its "final ruling" on OTC sunscreen products with the proviso that a final ruling on UVA testing and labeling requirements would be released at a later date. It was not until 2007, however, that the FDA released their "proposed rulings" on these two very important guidelines. Some of the proposed rulings included a tiered system for rating both UVA and UVB protection, capping Sun Protection Factor (SPF) values at 50+, eliminating erroneous terminology, and simplifying labeling. There were over 2,900 public submissions in response to the proposed ruling (FDA, 2011b).

Four years later, on June 18, 2011, the FDA completed its "final ruling" with the release of the regulations governing UVA testing and labeling. The document is filed with the Office of the Federal Register and is titled, "Labeling and Effectiveness Testing: Sunscreen Drug Products for Over-the-Counter Human Use" (FDA, 2011b). The FDA's "final ruling" on sunscreen labeling will require manufacturers to follow strict guidelines in displaying product information on the principal display panel (PDP) and to include a new Drug Facts box. The FDA stated that the new ruling would "ensure that currently marketed sunscreen products are appropriately labeled and tested for both UVA and UVB protection." In addition, they made it very clear that the "final ruling does not address issues related to sunscreen active ingredients" or certain other issues regarding the "generally recognized as safe and effective determination for sunscreen products" (see Figure 1).

Figure 1
Figure 1
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In the final ruling, the FDA has officially capped sunscreens at an SPF value of 50+. However, they did issue guidelines for manufacturers to submit additional research to substantiate higher SPF rating claims for added protection (FDA, 2011a). Conceivably, at some point, the SPF cap may be higher than 50+ for certain products.

In addition, the FDA eliminated the misnomers "sunblock," "sweatproof," and "waterproof." Contrary to expectation, they did not change the term for SPF from "sun protection factor" to "sunburn protection factor," as previously proposed. Their justification for the retention of the term was that UVA rays can account for as much as 20% of the sunburn reaction (Sayre, Dowdy, Lott, & Marlowe, 2008).

The FDA calls the most prominent part of the drug product label as the "principal display panel" (PDP). They believe that the approved changes to the PDP on the sunscreen label should "simplify the purchase decision for consumers by allowing them to easily find information." The regulations governing the PDP in the final ruling address three factors: effectiveness, water resistance, and an educational statement.

The effectiveness rating is the degree of protection from UVA and UVB radiation. The final ruling has eliminated the proposed separate tiered system for UVA and UVB. The numerical SPF value for a sunscreen will continue to be calculated via in vivo methods (human testing) according to FDA testing guidelines. Rather than having a separate UVA testing indicator, the new ruling has introduced a simpler broad spectrum SPF statement that will address protection for both UVA and UVB wavelengths.

This simpler pass/fail test will require that sunscreens provide protection against a critical wavelength equal to or greater than 370 nm2. The UVA testing criteria in this final ruling is therefore pass/fail, with a product either qualifying or not for a broad spectrum statement. The use of this statement will also require the UVA protection to be proportional to the UVB protection. Therefore, increasing SPF values will carry with it a higher degree of UVA protection. The new ruling requires manufacturers to demonstrate broad spectrum protection using an in vitro test (laboratory) only.

For products that meet the criteria for a broad spectrum statement, the term "Broad Spectrum SPF" will appear on the PDP, along with the numerical SPF value. The FDA ruling for labeling will mandate that the broad spectrum statement appear in continuous text with the same font style, size, and color. For products that do not qualify for a broad spectrum statement, the numerical SPF value will appear on the PDP with only the numerical value achieved in testing but with no statement indicating a lack of UVA protection. In this sense, I believe that the four-star UVA rating system previously proposed would have served consumers better.

The proposed labeling changes regarding the degree of water protection have been accepted in this ruling and will be prominently featured on the PDP. Manufacturers must now include clear time frames for which the labeled SPF maintains its value, that is, "water resistant" (40 minutes) and "very water resistant" (80 minutes).

Although the FDA acknowledges, in this ruling, that sunscreen alone will not prevent skin cancer and might actually increase incidence, they have not included an educational statement to this point on the PDP. Instead, they have relegated educational statements (Sun Protection Measures) concerning the limitations of sunscreen to the Directions section of the back label. In the final ruling, the FDA acknowledges the shortcomings of sunscreen while explaining their rationale for requiring educational messages or statements on products. To paraphrase, if a consumer relies on the use of a sunscreen with a broad spectrum SPF value of 15 or higher alone, they may not obtain a meaningful net decrease in skin cancer risk or early skin aging because he or she may spend more time in the sun and/or wear less protective clothing.

The new Drug Facts box will include these sections: Active Ingredients, Uses, Warnings, Directions, Inactive Ingredients, Other, and Questions and Comments. The FDA ruled that active ingredients should be listed first, in alphabetical order, followed by the word "sunscreen" under the heading, Purpose.

Under Uses, all sunscreens may use the statement "helps prevent sunburn." An optional statement under Uses may be included in the sunscreen products with a broad spectrum SPF value of 15 or higher, which states that "if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."

The Warning section was designed to ensure that consumers do not mistakenly conclude that all sunscreens tested have been shown to provide the same benefits. The FDA believes that it is important that the consumer is able to differentiate between sunscreens that prevent sunburn and those that have been shown to reduce the risk of skin cancer and early skin aging. The FDA has achieved this by mandating that sunscreens that are not broad spectrum or have an SPF value of <15 must include a Skin Cancer/Skin Aging Alert statement. This warning alert states, "spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging."

The familiar warnings "for external use only," "when using this product keep out of eyes," "stop use and ask a doctor if rash occurs," and "keep out of reach of children" have all been retained in the final ruling but have been positioned more prominently in the Drug Facts box. A new and very important warning advisory has also been included. It advises consumers: "do not use on damaged or broken skin." This warning is very timely, given the concerns that nanoparticle technology used in zinc oxide and titanium dioxide products to make them more cosmetically appealing may penetrate the skin barrier through cuts and abrasions (Loden et al., 2011). This is a very important issue for dermatology nurses, because so many of our patients have altered skin integrity. Patients with eczema, psoriasis, fresh surgical wounds or status post cryotherapy, and so forth should all be counseled to use sun protective clothing instead of sunscreens to avoid this problem.

There were six submissions requesting that the FDA warn consumers that frequent use of sunscreen may cause vitamin D deficiency. The FDA has chosen not to include this warning for many reasons, including the recent report of the Institute of Medicine (2010), which eliminates sun exposure as a source of vitamin D for daily requirements.

Under Directions, the FDA has required manufacturers to continue to direct consumers to apply "liberally" or "generously" but has reduced the time frame for application from 20 to 15 minutes prior to sun exposure. The Directions section will specify to reapply sunscreen after 40 minutes (water resistant) or 80 minutes (very water resistant) of swimming or sweating, immediately after towel drying, and at least every 2 hours. For non-water-resistant sunscreens, a recommendation to use a water-resistant sunscreen if swimming or sweating has been added. The Directions will also include the recommendation to "ask a doctor regarding use on children under 6 months of age."

In the Directions section, the FDA has specified that all sunscreens with a broad spectrum SPF value of 15 or higher must include an educational statement, "spending time in the sun increases your risk of skin cancer and early aging. To decrease this risk, regularly use a broad spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 am to 2 pm and wear long-sleeved shirts, pants, hats and sunglasses."

The items in Inactive Ingredients will be listed in alphabetical order in the Drug Facts box. As for Active Ingredients, these new guidelines will list ingredients alphabetically rather than in quantitative percentages. This may make it easier for the consumer to locate a specific ingredient on the one hand but may make it more difficult for the consumer to determine relative concentrations on the other.

The Other section will include a statement to "protect this product from excessive heat and direct sun." More specifically, we need to advise our patients not to leave sunscreen in the car and to place it in a cooler area while at the beach. The manufacturer's toll-free number will be provided for questions and comments (see Table 1).

Table 1
Table 1
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The FDA has set a compliance date of 1 year (June 2012) for all companies whose sunscreen sales are greater than $25,000. Smaller companies have a deadline of 2 years for compliance. To prevent a shortage of sunscreen, the FDA has agreed that products already distributed by the effective date would not have to be retested or relabeled.

Some submissions to the FDA suggested that consumer comprehension testing be performed before the proposed labeling changes are mandated. As the FDA stated in their final ruling, "we agree with the submission that consumer comprehension data can be very helpful in formulating label changes; however, we believe that this much simpler labeling statement, along with recommendations for additional sun protection actions, will not require consumer comprehension testing."

As a dermatology nurse who has been involved in skin cancer prevention education for many years, I am very concerned that eliminating consumer comprehension studies may be dangerously shortsighted. Sunscreen is the preferred method of sun protection for Americans despite the availability of more effective modes of sun protection (Balk, 2011). Researchers indicate that compliance by the sunscreen user is the most important factor in achieving good UV protection (Osterwalder & Herzog, 2009). I believe that we need more consumer comprehension efforts, especially regarding the selection and proper use of sunscreen.

When the Dermatology Nurses' Association endorsed the five action steps in the SunAWARE acronym, they did so because sunscreen use was appropriately positioned as a third step in this skin cancer prevention program (Barrow, 2010). We know that our patients must, first, avoid unprotected UV exposure and, second, wear sun protective clothing, including sunglasses, to protect themselves. Now it is time for us to determine if our patients understand that sunscreen is only one small part of a sun protection plan. We must also ensure that patients know how to properly use sunscreen.

Consumer comprehension in the area of appropriate application or dosing is extremely important. Dermatology nurses know that sunscreen is often ineffective simply because patients and consumers use too little and do not reapply as indicated. The decision to maintain vague terminology in the Directions section is most disappointing to me as a nurse and an educator. The FDA indicated that some submissions requested that they include specific application instructions regarding the dose rather than the imprecise terms "generously" and "liberally." One submission suggested that the statement should read "apply 2 tablespoonfuls." In this submission, it was argued that more specific directions would lead consumers to apply more sunscreen product, better reflecting the 2 mg/cm2 dose used in SPF testing. The FDA disagreed stating that specifying a certain amount in the Directions section was misleading because the amount of sunscreen needed to achieve dosing varies depending on the product and the amount of skin surface area to be covered.

Because we know that dosing affects the absolute SPF value achieved on the skin, I believe that failure to better define dosage directions is a fatal flaw in the FDA's overall consumer protection plan. Research shows that most subjects only apply 25% of the recommended sunscreen dose (Thieden, Philipsen, Sandby-Moller, & Wulf, 2005). This limited application would result in a reduction of actual SPF by 75%. For example, in the case of an SPF 15 rating, the actual protection would be equivalent to approximately SPF 4 if the individual applied 25% of the recommended dose. I cannot understand the rationale for using ambiguous directions given the fact that the FDA has demanded a Skin Cancer/Skin Early Aging Alert for sunscreens with an SPF of less than 15. Because sunscreen products have been capped at SPF 50+, then, theoretically, all sunscreen products, if applied in this typical manner, will fall short of the SPF 15 level that the FDA requires to qualify for the indication, "prevents skin cancer and early aging."

In the Children's Melanoma Prevention Foundation's SunAWARE School Curriculum (CMPF, 2011), we advise children to apply a "handful" of sunscreen to cover their entire skin surface when wearing a bathing suit. We believe that this advice is both practical and easy to understand. A handful is proportional to the size of the individual and is easily visualized even by a young child. When we hold up an 8-oz bottle of sunscreen and tell children that this is how much a family of four should apply in a half day at the beach, they are astounded. We often hear from parents that this was their child's "biggest" take-home message with regards to proper sunscreen use.

Marianne Berwick, PhD, an epidemiologist specializing in skin cancer, warned us that sunscreen alone does not provide protection against basal cell carcinoma or melanoma (Berwick, 2011). She claimed that the real problem with sunscreen is that "individuals use sunscreen to stay out longer in the sun." I believe that the rising incidence of all types of skin cancer, despite the increased use of sunscreen, proves Dr. Berwick's admonition to be correct.

I applaud the FDA for improving sunscreen testing and labeling rules. However, I question if the average American will really read the Drug Facts box to learn that a three-pronged method of sun protection is necessary to reduce skin cancer risk and early skin aging. I believe that our role as nurses to educate our patients in skin cancer prevention is more important than ever. We must perform our own consumer comprehension studies and work with our friends in the industry to create educational campaigns that reinforce the helpful rulings and correct the ones that fall short of the mark.

The SunAWARE acronym, endorsed by the Dermatology Nurses' Association in 2007, provides both primary and secondary prevention steps for an effective skin cancer prevention program. The five easy action steps for skin cancer prevention and early detection are listed in Figure 2. I encourage you to use this acronym "liberally" and "generously" with every patient you see.

Figure 2
Figure 2
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Be safe. Be SunAWARE!▪

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REFERENCES

Balk, S. J. (2011). Ultraviolet radiation: A hazard to children and adolescent. Pediatrics, 127(3), 791-817. Retrieved from www.pediatrics.aappublications.org.

Barrow, M. (2010). Approaching skin cancer education with a clear message: 'Be safe. Be SunAWARE'. Journal of the Dermatology Nurses' Association, 2(5), 209-213.

Berwick, M. (2011). The good, the bad, and the ugly of sunscreens. Clinical Pharmacology Therapeutics. 89(1), 31-33.

Children's Melanoma Prevention Foundation. (2011). SunAWARE program curriculum. Retrieved from www.melanomaprevention.org/resource_center.html

Food and Drug Administration. (2006). Foreword 2006 enforcement story: Mission. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/EnforcementStory/EnforcementStoryArchive/ucm090984.htm

Food and Drug Administration. (2011a). Guidance for industry. Enforcement policy - OTC sunscreen drug products marketed without a new drug application. Retrieved from http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM259001.pdf

Food and Drug Administration. (2011b). Labeling and effectiveness testing: Sunscreen drug products for over-the-counter human use. Retrieved from http://www.mlmlaw.com/2011-FDA-suncreeen-regulations.pdf

Food and Drug Administration. (2011c). Rulemaking history for over-the-counter sunscreen drug products. Retrieved from http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Over-the-CounterOTCDrugs/StatusofOTCRulemakings/ucm072134.htm

Institute of Medicine. (2010). Dietary reference intakes for calcium and vitamin D. A.C. Ross et al. (Eds.). Washington, DC: The National Academies Press.

Loden, M., Beitner, H., Gonzalez, H., Edstrom, D. W., Akerstrom, U., Austad, J., et al. (2011). Sunscreen use: Controversies, challenges and regulatory aspects. British Journal of Dermatology. 165(2), 255-262.

Osterwalder, U., & Herzog, B. (2009). Sun protection factors: World wide confusion. British Journal of Dermatology, 161(Suppl. 3), 13-24.

Sayre, R. M., Dowdy, J. C., Lott, D. L., & Marlowe, E. (2008). Commentary on "UVB-SPF": The SPF labels of sunscreen products convey more than just UVB protection. Photodermatology, Photoimmunology & Photomedicine, 24(4), 218-220.

Thieden, E., Philipsen, P. A., Sandby-Moller, J., & Wulf, H.C. (2005). Sunscreen use related to UV exposure, age, sex, and occupation based on personal dosimeter readings and sun-exposure behavior diaries. Archives of Dermatology. 141(8), 967-973.

© 2011 Lippincott Williams & Wilkins, Inc.

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