Dermatologists Expect FDA Sunscreen Rule "Soon," End Product Seal Program
This article was originally published in The Rose Sheet
Executive Summary
The American Academy of Dermatology says its seal of approval for products offering sun protection is no longer necessary with FDA's final sunscreen rule imminent
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The American Academy of Dermatology says its seal of approval for products offering sun protection is no longer necessary with FDA's final sunscreen rule imminent. "With the expectation that the FDA will soon be issuing a sunscreen monograph that will likely be aligned with the stringent criteria of the AAD Seal of Recognition program, the Board of Directors determined that the need for the program would be diminished," explains AAD President David M. Pariser in a Dec. 3 release. New applications for AAD's seal are no longer being taken, and the organization will phase out the program altogether by 2012. Products accepted into the program prior to Nov. 15 are free to wear the seal until their two-year terms expire. AAD notes that it launched its certification program in 2007 to "help decrease the incidence of skin cancer by giving the public a reliable method to make an informed decision when choosing sun-protection products." Why the academy is suddenly confident that FDA's monograph will be released "soon" is not apparent; the organization could not be reached immediately for comment. Is Two-Year Phase-Out Enough Time For FDA? FDA's final action on sunscreens has been expected for quite some time. A final monograph for sunscreens emerged in 1999, but its publication has been consistently stayed due to industry pressure. In August 2007 the agency issued a draft rule amending its final sunscreen monograph, which also drew criticism from manufacturers (1 (Also see "Industry Groups Burned About Proposed Sunscreen Labeling Requirements" - HBW Insight, 14 Jan, 2008.)). In its semi-annual regulatory agenda published over summer 2009, FDA indicated that it planned to issue the final word on sunscreens in September - another deadline that has come and gone. The delay has persisted despite pressure from consumer advocacy groups and Capitol Hill (2 'The Rose Sheet' June 1, 2009). In early November, the Personal Care Products Council requested a meeting with FDA to reopen discussion around proposed changes to the monograph; as of the end of the month, the trade group had not heard back (3 'The Rose Sheet' Nov. 30, 2009, In Brief). AAD seems confident that the public shortly will be able to trust in FDA to ensure that sun-protection products on the market are effective and safe. It states: "The FDA sunscreen monograph is expected to provide additional guidance to manufacturers regarding sunscreen product development and testing, and require new labeling which is expected to help consumers choose effective sun-protection products." To date, consumers seeking guidance in selecting such products could look for AAD's seal. In a March 2008 interview with "The Rose Sheet," dermatologist James Spencer, then chair of the Application Review Work Group under the academy's Seal of Recognition program, championed the program as a valuable service to consumers. He maintained that with terms like "dermatologist-recommended" and "broad-spectrum protection" being used freely by marketers regardless of the quality of their products, and with substandard SPF 4 formulas still widely available on the market, consumers could use some help in making purchasing decisions so they were not unsafely exposing themselves to sun. AAD's seal "recognized products for their sun-protection benefits based on review of independent testing results which demonstrate that the products meet stringent, evidence-based sun-protection criteria as verified by a panel of dermatologists and an independent scientist." Will Monograph Give Same Level Of Protection? In 2008, AAD's Spencer claimed the academy's standards for its Seal of Recognition program were higher than those proposed by FDA, particularly with regard to UVA protection requirements. The 4-star UVA rating system outlined in the agency's draft rule was one component frequently cited as problematic in industry comments. Whether FDA has taken industry's recommendations and modified its UVA protection criteria - and whether the level of protection it affords will compare now with AAD's - remains to be seen. With the dissolution of its Seal of Recognition program, AAD's "resources now should be focused on enhancing its other public education efforts to increase awareness of the dangers of excessive sun exposure and to encourage positive behavior change with respect to sun protection," according to the Dec. 3 release. AAD's Seal of Recognition program may not have enjoyed the level of participation the academy had initially hoped for. Its membership includes just three companies with topical products - AminoGenesis, Johnson & Johnson/ Aveeno and Mertz Pharmaceuticals - and Coolibar, which markets sun-protective garments. The product faced some resistance in the past from members who believed it posed a conflict of interest (4 (Also see "AAD Defends Seal Of Recognition Against “Conflict Of Interest” Claims" - HBW Insight, 24 Mar, 2008.)). The faction argued that requiring companies to pay a $5,000 application fee and $10,000 annually after receiving AAD's seal was contrary to the academy's mission. Spencer rejected that view, noting that all funds remaining after covering the program's administrative costs were funneled back into the academy's skin cancer public awareness initiative. - Ryan Nelson ( 5 [email protected] ) |