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With Summer In Sight, FDA Pushes Final Sunscreen Rule To Fall

This article was originally published in The Rose Sheet

Executive Summary

FDA aims to issue a final OTC monograph for sunscreens in October, according to the Department of Health and Human Services' semi-annual regulatory agenda published April 26

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FDA still plugging away on sunscreen rule

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

FDA still plugging away on sunscreen rule

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

Environmental Group Assesses Availability Of UVA Protection, Warns Public

With summer over, the Environmental Working Group is warning consumers to remain cognizant of sun exposure, as UVA radiation is still a factor in the fall and just one-third of sunscreens tested provide adequate UVA protection, the group says

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