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


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#1 real maverick

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Posted 12 September 2013 - 07:51 AM

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.

 

Additional points of interest: -They did not find BPO to be a genotoxic substance, which basically means they do not believe that it damages DNA. They go on to add that even though BPO has been shown in research to create oxidative damage, that in humans, there are oxidative repair mechanisms that would likely prevent benzoyl peroxide from causing DNA damage. -They did not find BPO to be carcinogenic. They state: "We have reviewed a number of animal studies examining the carcinogenic potential of benzoyl peroxide and conclude that benzoyl peroxide is not a carcinogen." They also determined that there was no evidence to indicate that BPO is a photocarcinogen. 

 

They are requiring an update to the warning labels on BPO products as well. Any OTC products that contain BPO will need to have the following warnings on the label: - Avoiding unnecessary sun exposure - Not using on very sensitive skin - Keeping away from the eyes, lips, and mouth - Cautioning that benzoyl peroxide may bleach hair or dye fabric They will also require a direction for drug products containing benzoyl peroxide to use a sunscreen when going outside.






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