Spray Sunscreens Are Safe, Trade Groups Say; New Test Methods Not Needed
This article was originally published in The Rose Sheet
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New test methods are not needed to measure the SPF and broad-spectrum protective levels of sunscreens delivered in spray form, and consumers do not need to be concerned about health risks associated with inhalation of such products, the Personal Care Products Council asserts in comments to FDA. Contesting FDA’s suggestion that the products “lack a safety and efficacy record,” the Council states: “We urge the agency to reconfirm sunscreen sprays, which have been marketed for over 50 years, as eligible sunscreen dosage forms.” The Council’s comments, submitted jointly with the Consumer Healthcare Products Association, address questions and concerns raised by the agency in an advance notice of proposed rulemaking issued in June in tandem with a final rule on sunscreen labeling (Also see "FDA Questions Spray Sunscreen Safety, Efficacy & Monograph Status" - HBW Insight, 27 Jun, 2011.).
Spray sunscreens are under threat of being excluded from the final monograph for over-the-counter sunscreen products, which would require companies to take a longer and more costly route to market via a new drug application. FDA has indicated that other sunscreen delivery formats, including oils, lotions, creams, gels, butters, pastes, ointments and sticks, are better supported by data and likely will be included in the monograph as generally recognized as safe and effective. According to the Council and CHPA, barring spray sunscreens from the monograph would be a disservice to consumers for multiple reasons. First, the products’ convenience and ease of use encourage application and reapplication, increasing the likelihood that consumers are sufficiently protected for the duration of their time exposed to sun. Second, spray sunscreens can be used to coat hard-to-reach places on the body when applying without assistance, the trade groups point out. Third, the products enjoy “excellent” consumer acceptance, “especially for children and for active adults, especially men,” the organizations note. The commenters maintain that in addition to those benefits, spray sunscreens are effective and can be tested and labeled in accordance with standardized methods, contrary to what the agency has suggested. It is not necessary to modify testing protocols to account for differences in spray products versus other sunscreen dosage forms, the groups say. Testing For SPF, Broad-Spectrum Efficacy The Council and CHPA note that the efficacy of sunscreen products is gauged with respect to two metrics – the strength of protection (measured by the SPF test) and the breadth of protection (measured by the critical wavelength test). In both cases, they say, sunscreen is delivered to the test site by weight and then spread evenly across the surface to ensure consistency from one formula to the next, regardless of what form the final product takes or how it is packaged. For example, FDA specifies an exact weight of 2 mg/cm² for SPF testing, which determines how effective a formula is at preventing sunburn, or damage due largely to ultraviolet B (UVB) exposure. The agency’s new requirement that products undergo critical wavelength testing will ensure that products also provide a proportionate level of protection against ultraviolet A (UVA) radiation, which has been linked to skin cancer and premature skin aging. According to the trade organizations, “it is not necessary to modify either test [SPF or critical wavelength] to address sprays; instead, both testing methodologies can and should remain standardized and apply to all eligible sunscreen dosage forms including sprays,” they say. Lab Results Vs. Real-World Consumer Use FDA also was concerned about how the protection afforded by spray sunscreens in actual consumer use compares with levels determined in a laboratory setting. In its ANPR, the agency noted that sprays are dispensed in a sometimes cursory and “more diffuse manner ... even when applied directly to the body,” and it is unclear how much of the spray is effectively transferred to skin. According to the Council and CHPA, sunscreen testing does not take into account consumer use application levels because practices and experiences with products vary from one consumer to the next. The groups point out that there is “no agreed-upon ‘consumer use amount’” for other topical OTC products such as fluoride toothpaste or dandruff shampoo. “The amount of product used is very much a personal choice based on individual needs, preferences and experiences. Consumers have been taught through experience, education by physicians, the media and public service announcements how to use each form of sunscreen in a way that works for them to prevent sunburn, and to that end they may use different amounts on different body parts,” the groups say. They maintain that regardless of dosage form, sunscreen products should be tested via a single, standardized method “so that consumers can choose the SPF level that they know from experience works well for them when used as they would normally apply it.” The commenters add that the European Union’s sunscreen regulations, among other international regulatory regimes, use a standard testing protocol across all sunscreen forms and do not differentiate on the basis of consumer habits. Groups Address Inhalation Concerns In the ANPR, FDA also expressed concern about the potential risks of inhaling aerosolized sunscreen products. According to the Council and CHPA, particles in spray products with aerodynamic equivalent diameters of 5 µm-10 µm and smaller may be respirable – i.e., able to penetrate the deep lung, with potentially adverse health consequences. However, current sunscreen products on the market have AEDs greater than 10 µm “in order to mitigate inhalation concerns,” the groups say, pointing to FDA’s monograph for antiperspirants as a guide. That document recommends that aerosol systems be formulated “so that not less than 90% of emitted particles are greater than 10 µm in diameter.” The trade organizations hold that “the great majority of airborne formulation sprays, if inhaled, would be deposited in the upper respiratory tract where mucociliary clearance would remove them.” The groups underscore that their data on currently marketed spray sunscreens do not show the use of nano-scale metal oxide sunscreen actives, which were of particular concern to FDA. Nano-engineered titanium dioxide and zinc oxide have been widely embraced by manufacturers for inclusion in sunscreen lotions because of the performance and aesthetic advantages they offer. The Council and CHPA also point out that labeling on spray sunscreens directs consumers to use in “well-ventilated areas,” further reducing inhalation risks. Additional Labeling Recommendations FDA proposed that special warnings and directions be included in labeling for spray sunscreens, including the recommendation that consumers “hold container 4 to 6 inches from the skin to apply,” “do not spray directly into face” and “do not apply in windy conditions.” The trade groups support those proposed recommendations. However, the organizations do not agree that spray formulas should be dispensed onto skin and then “spread evenly by hand,” as FDA suggests. The groups offer data indicating that rubbing in formula after spraying it on does not translate to superior SPF protection compared with simply spraying. They note that in the same study, FDA’s prescribed application technique for SPF testing – in which the sunscreen is pipetted on and rubbed in – yielded no statistically significant difference in SPF compared with either of the two spray strategies. The Council and CHPA also argue that science does not support advising consumers to apply spray sunscreen – or any sunscreen product – 15 minutes before sun exposure (as opposed to immediately before sun exposure), for reasons outlined by the groups in comments submitted to the agency in August (Also see "Industry Needs More Time To Comply With Sunscreen Testing, Labeling Rule" - HBW Insight, 29 Aug, 2011.). The organizations also expanded their defense of powder sunscreens, which they began in their August comments, holding that such products are invaluable because “for many, in particular women, face powders ... provide a form of sunscreen that can be habitually used on a daily basis and readily reapplied throughout the day.” In fact, they say, “FDA has recognized that many consumers use facial makeup products with sunscreen ‘as their primary and only source of sunscreen protection for that area of the body.’” In addition to sprays and powders, other delivery formats that FDA is considering excluding from the monograph include sunscreen wipes, towelettes, body washes and shampoos. By Ryan Nelson |