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CTFA files comments on topical antimicrobials.

* The CTFA and The Soap and Detergent Association (SDA) submitted three separate comments to the Food and Drug Administration (FDA) as it develops a final monograph for Over-the-Counter (OTC) Health-Care Antiseptic Drug Products. The data and information were submitted in response to FDA's limited reopening of the docket for topical antimicrobial drug products.

In 1997, an independent review panel for the FDA reported that resistance was not an issue under current conditions of topical antimicrobial product usage. The Coalition noted that the latest research shared with the agency validates that conclusion.

The Coalition also provided additional data on the benefits of health care professional products published since the Coalition's previous submission to the FDA in 2001. Additionally, CTFA/SDA stated that FDA should be open to receiving new data on the benefits of antimicrobial products beyond the recent deadline for submitting additional comments and data.

In other news, the CTFA filed two citizen petitions with the FDA regarding updated information and data on SPF and anti-aging claims for sunscreens. The FDA is reviewing the Sunscreen Monograph adopted in May of 1999, and plans to publish proposed amendments in December. One petition supports SPF claims higher than 30 and the second petition supports anti-aging claims on sunscreens. Both were banned in 1999. More info:
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Title Annotation:Regulations
Publication:Household & Personal Products Industry
Date:Nov 1, 2003
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