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FDA Delays Sunscreen Rule by 6 Months


 

The Food and Drug Administration announced in May that it was giving sunscreen manufacturers 6 additional months to comply with the final ruling on product labeling and effectiveness testing.

That final rule was published in June 2011; soon after, the Personal Care Products Council (PCPC) and the Consumer Healthcare Products Association (CHPA) sought a 6-month delay in the deadline, saying that manufacturers needed more time.

The agency agreed and has pushed back compliance dates. Now, products that have sales of less than $25,000 will have until Dec. 17, 2013, to comply; all other products must comply by Dec. 17, 2012. However, the agency is encouraging manufacturers to "introduce individual products bearing the new labeling as it becomes available, even in advance of the revised compliance date."

The American Academy of Dermatology also urged sunscreen makers to comply sooner, rather than later, but said in a statement that the extension "allows manufacturers the necessary time to test their products for broad-spectrum protection and properly label them."

The Environmental Working Group, which publishes a database of sunscreen effectiveness, chided the FDA, saying in a statement that it "has caved to industry pressure every step of the way," of getting the rules finalized – a 30-year process. The group estimates that 90% of sunscreens are already in compliance with what it calls the FDA’s "low-bar regulations on efficacy and safety."

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