Benzoyl peroxide is one of the most popular over-the-counter acne products and is often combined with other ingredients in various acne treatments. It works by providing oxygen to the skin’s pores and killing the type of bacteria that require an oxygen-free environment to survive. Benzoyl peroxide also helps clear excess dead skin to keep pores clear, which reduces blackheads and other potential blockages. (1)
In June, 2011, the Food and Drug Administration (FDA) released guidelines specifying how manufacturers should provide safety warnings on the labeling of their products containing benzoyl peroxide. These instructions were released to further clarify what had been recommended in March of 2010 after research of the safety of benzoly peroxide use had been completed. (4)
New labeling must include:
· Benzoyl peroxide products must state that they should be used with sunscreen as well as outline new warnings (i.e., the products should not be used on broken skin or warnings about potential skin irritation)
· Benzoyl peroxide generally is recognized as safe and effective as an OTC topical acne drug product or GRASE (Generally Recognized As Safe and Effective).
· Consistency with the standardized Drug Facts formatting requirements of permitted single and combination of ingredients in benzoyl peroxide formulations.
Benzoyl peroxide was first approved by the FDA in 1985. It was originally labeled as Category I, or GRASE (Generally Recognized As Safe and Effective). In 1991, the FDA changed it to Category III, which means “more data needed”, based on the results of studies on mice that indicated benzoyl peroxide might be carcinogenic, mutogenic, and possibly photocarcinogenic. After examining the data, the FDA returned benzoly peroxide to Category I GRASE (Generally Recognized As Safe and Effective) in concentrations of 2.5 to 10%. (2)
It was during this testing period it was determined that benzoyl peroxide can decrease the skin’s tolerance to UV radiation. According to Bion, an acne product manufacturer, on Feb 17, 1995, the FDA proposed “additional labeling (warning and directions) for all topically-applied acne treatment drug products containing benzoyl peroxide. The warning advises consumers to avoid unnecessary sun exposure and to use a sunscreen when using a benzoyl peroxide product to treat acne..." (3)
In March of 2010, the FDA gave manufacturers one year to add warning alert labels to their products that “If going outside, apply sunscreen after using this product.”
The current 2011 update is an attempt to clarify and reinforce what manufacturers have been asked to do, otherwise manufacturers risk regulatory enforcement action by the FDA if they are not in compliance.
Before using benzoyl peroxide products, make sure you read the safety label or talk with a doctor or pharmacist if you are concerned about side effects.
sources:
1. Benzoyl Peroxide
http://acne.about.com/od/acnetreatments/a/benzoylperoxide.htm
2. FDA reclassifies benzoyl peroxide as Safe and Effective
http://www.acne.org/blog/2010/04/22/fda-reclassifies-benzoyl-peroxide-as-safe-and-effective/
3. http://www.bion-research.com/benzoyl_peroxide_skin_damage.htm
4. Guidance for Industry on Topical Acne Drug Products for Over-the-Counter Human Use-Revision of Labeling and Classification of Benzoyl Peroxide as Safe and Effective; Small Entity Compliance Guide; Availability
A Rule by the Food and Drug Administration on 06/22/2011
http://www.federalregister.gov/articles/2011/06/22/2011-15560/guidance-for-industry-on-topical-acne-drug-products-for-over-the-counter-human-use-revision-of
To view actual document, cut and paste into browser window:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM259744.pdf
Michele is an R.N. freelance writer with a special interest in woman’s healthcare and quality of care issues. Other articles by Michele are at www.helium.com/users/487540/show_articles
Edited by Shannon Koehle