Sunscreen products are everywhere. And consumers assume they work. Consumers rely on them to prevent not only sunburn but also skin cancer, sun damage, sun spots, and leathery, wrinkled faces. Consumers rely on them regardless of what the product labels say and regardless of whether their expectations are reasonable.
And skin cancer is serious business, not just for Americans of Northern European descent. The Department of Health and Human Services recently issued a webcast entitled: “Anyone Can Get Skin Cancer,” alerting Americans of all skin tones about the risk of skin cancer. Irene Ekwede, a dermatological nurse at the National Institutes of Health, noted: “When minority Americans are diagnosed with melanoma, the most severe form of skin cancer, it is usually at a later stage, when the disease is harder to treat.”
FDA has recognized the importance of regulating sunscreen since at least 1993, when it proposed a rule for OTC sunscreen products dealing with certain active ingredients and associated labeling and testing requirements for UVB radiation. FDA proposed a new rule in 2007 that dealt with both UVB and UVA rays. Still, it had not taken final action to make either of these proposed rules official.
Last month, FDA issued its long-awaited final rule, titled “Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use,” The rule takes effect June 18, 2012 and, among other things, outlines standards for testing the effectiveness of sunscreen products and requires labeling that accurately reflects test results.
What does the new rule require?