FDA still plugging away on sunscreen rule
This article was originally published in The Rose Sheet
Executive Summary
FDA anticipates publishing its long-awaited final sunscreen monograph in the next several months, according to an agency spokeswoman. "FDA is working on the final rule for the testing and labeling of over-the-counter (OTC) sunscreens to address protection against UVB and UVA radiation," she wrote in an e-mail to "The Rose Sheet." In Department of Health and Human Services' semi-annual regulatory agenda published in April, FDA estimated it would issue the final monograph in October (1"The Rose Sheet" May 3, 2010). The monograph has been consistently delayed since the final rule first emerged in 1999, suspended in "regulatory limbo," according to the Environmental Working Group, one activist organization anxious for its release (2"The Rose Sheet" Oct. 4, 2010). FDA has been working its way through 3,000 public comments since the draft final rule was issued in 2007
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