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News Published: Aug 1, 2008 - 3:51:08 PM


Federal legislation that would enact sunscreen rules praised

By Attorney General's office


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Attorney General Richard Blumenthal today praised a federal bill that would force the U.S. Food and Drug Administration (FDA) to act on Blumenthal’s request and finally implement long-delayed rules that would stop dangerously misleading claims in sunscreen advertising and labeling.

The FDA last year -- in belated response to a petition by Blumenthal --issued new proposed rules to stop misleading claims by sunscreen manufacturers. Almost a year later, the FDA has still failed to implement these rule changes.

Earlier this week, Blumenthal demanded once again that the FDA act to implement these rules to make them enforceable.

Supporting Blumenthal’s efforts, U.S. Sens. Christopher Dodd and Jack Reed introduced a bill that would force the FDA to act, as Blumenthal has repeatedly requested in recent years.

“Faced with mindless inertia by our FDA, this federal legislative action is vital to immediately stop sunscreen manufacturers from making dangerously misleading claims about their products,” Blumenthal said. “The FDA has failed to implement proposed sunscreen labeling rules that would bar false claims about all-day protection, waterproof, broad spectrum UVA/UVB protection and SPF over 50. These claims -- untrue or unproven -- endanger consumers, particularly children, who may skip necessary steps to reapply sunscreen or other protection.

“The FDA has abrogated its responsibility -- making it complicit in endangering children and their parents by enabling continued false claims by sunscreen manufacturers. My office strongly supports today’s action by Senators Dodd and Reed, and will continue to fight on behalf of consumers. Implementing these draft sunscreen rules is vitally important to protect consumers against melanoma and other deadly skin cancers.”

The proposed rules would prohibit blanket sun protection promises. Based on recent scientific evidence, SPF (sun protection factor) designations could not exceed "50+"; waterproof claims would still be barred; and additional instructions would be required to warn consumers to reapply sunscreen.

The rules would also require specific rating systems for UVB and UVA protection. For UVB, the rules will require a specific SPF (sun protection factor) number and category rating of low, medium, high and highest. For UVA, the rules require a four-star rating system in which four is the greatest protection, and -- in addition -- a category of low, medium, high and highest.

Blumenthal petitioned the FDA to act in May of 2007 after the agency failed to make sunscreen standards mandatory as Blumenthal urged in a letter nearly a year earlier. The FDA's new rules, addressing issues raised by Blumenthal's criticism, came in August of 2007. At that time Blumenthal urged they be made effective this summer.

Blumenthal's action in 2007 followed the FDA's failure to adopt rules that in 1999 it updated -- but stayed. These sunscreen labeling rules would have long ago prohibited sunscreen makers from making misleading claims about their protection levels. Its failure to implement the rules has made them unenforceable and ineffective in preventing false claims by sunscreen makers.

Even after the rules are adopted -- as Blumenthal urged the FDA to do immediately -- the sunscreen makers may have as long as a year or two to actually comply with the stricter labeling requirements.




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