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real maverick

Benzoyl Peroxide Considered By Fda To Be "safe And Effective"

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The safety of Benzoyl Peroxide is periodically brought up by board members as an area of concern. Questions about whether it may increase skin cancer risk or cause DNA damage (and thus damage or accelarate the aging the skin) are the most common concerns. Given those concerns, I thought this information from the FDA was important to share with the messageboard members.

The FDA has updated its safety classification of Benzoyl Peroxide to a Category I (Safe and Effective). In 1991, the classification was listed as a type III, which meant that more data was needed before the FDA could determine the actual safety classification (it was never considered to be "unsafe" though). The body of the research conducted since that time has lead the FDA to change the classification to a safe and effective. I have the full article from the Federal Registry, for those who are interested in reading more details. I plan to post it in another thread. The abstract is below, and I highlighted a few points from the article as well.

Classification of Benzoyl Peroxide as Safe and Effective and Revision of Labeling to Drug Facts Format; Topical Acne Drug Products for Over-The-Counter Human Use; Final Rule AGENCY: Food and Drug Administration,HHS. ACTION: Final rule. SUMMARY: We, the Food and Drug Administration (FDA), are issuing this final rule to include benzoyl peroxide as a generally recognized as safe and effective (GRASE) active ingredient in over-the-counter (OTC) topical acne drug products. In addition, this final rule includes new warnings and directions required for OTC acne drug products containing benzoyl peroxide. We are also revising labeling for OTC topical acne drug products containing resorcinol, resorcinol monoacetate, salicylic acid and/or sulfur to meet OTC drug labeling content and format requirements in a certain FDA regulation. This final rule is part of our ongoing review of OTC drug products and represents our conclusions on benzoyl peroxide in OTC acne drug products.

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