In Brief

In a letter to FDA, Johnson & Johnson and Energizer propose a study exploring questions FDA has raised about previous studies on sun-protection products with SPF values greater than 50. Separately, Reckitt Benckiser divests Indian personal-care brands and Revlon and Givaudan report sales and earnings for fiscal 2011. More news in brief.

Johnson & Johnson Consumer Products and Energizer Personal Care propose a new study of sunscreens with sun protection factor 85, focusing on consumer use. The firms explain in a letter to FDA, published Feb. 17, that the study will address the agency’s concerns about previous studies that demonstrated superior efficacy of sunscreens with SPF values higher than 50, but did not show that lab results translate to real-world use scenarios. FDA has proposed capping sunscreen SPFs at 50 so as not to mislead consumers or instill an inflated sense of security so that consumers are more negligent than usual about reapplying Also see "FDA Considers Capping SPF Values At 50+ Despite Efficacy Data" - HBW Insight, 27 June, 2011.. The new study will instruct subjects to use the sunscreen “as they normally would” to determine if they sufficiently reapply, among other endpoints, the firms explain.

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