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FDA delays new rules for sunscreen makers

5/14/2012

WASHINGTON  — Manufacturers of sunscreen now will have six additional months to meet the new labeling and testing requirements as imposed by the Food and Drug Administration, according to an announcement from the Federal Register.



The FDA ordered the changes last summer but gave manufacturers one year — until this June — to get the revised bottles on the shelf.



The FDA now is delaying the compliance dates of the 2011 final rule by six months, to Dec. 17, 2012, for products with sales of $25,000 or more, and until Dec. 17, 2013, for products with annual sales of less than $25,000.



“The 2011 final rule requirements are intended to ensure that [over-the-counter] sunscreen products are used safely and effectively. Therefore, allowing adequate time for the 2011 final rule requirements to be fully implemented is in the interest of public health. Our reassessment of the time needed for full implementation of the 2011 final rule requirements supports delaying the compliance dates by six months,” according to the announcement from the Federal Register.

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