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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. The 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. In a letter to FDA Commissioner Andrew C. von Eschenbach, Blumenthal urged immediate implementation of the sunscreen rules. The FDA’s inaction means that outdated rules are the only constraints on sunscreen manufacturers’ misleading claims, enabling deceptive and dangerous mislabeling. “For far too long sunscreen manufacturers have exploited the FDA’s abject failure to enact regulations that ensure truthful, accurate claims in sunscreen advertising and labeling,” Blumenthal said. “To protect consumers, I strongly urge the FDA to implement, with no continued undue delay, the 2007 Amendment to the Final Monograph for Over-the-Counter Sunscreen Products. “The proposed rule will prevent sunscreen makers from continuing false claims about their products -- improperly and falsely representing that they are waterproof or offer all-day protection or equally shield against all the sun’s dangerous rays. Implementing the rule is vitally important to protect consumers against melanoma and other deadly skin cancers. “Today and every day this summer, countless children and their families will be exposed needlessly and dangerously to life-threatening rays, often with a false sense of security created by deceptive claims from sunscreen manufacturers. The FDA’s inaction enables -- even encourages -- such false claims. Through inertia, the FDA becomes complicit, morally if not legally.” The proposed 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. © Copyright by NorwalkPlus.com. Some articles and pictures posted on our website, as indicated by their bylines, were submitted as press releases and do not necessarily reflect the position and opinion of NorwalkPlus.com, Norwalk Plus magazine, Canaiden LLC or any of its associated entities. Articles may have been edited for brevity and grammar. Related Articles: Federal legislation that would enact sunscreen rules praised - Aug 1, 2008 - 3:50 PM CURRENT HEADLINES: Top of Page
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