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FDA Updates Warnings for Benzoyl Peroxide

By HERWriter
 
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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

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Michele Blacksberg RN
Empowered
HERWriter

Benzoyl Peroxide acts to control one of the main types of bacteria that causes acne. This is from my source listed:
"Propionibacteria acnes, or P. acnes, are the bacteria responsible for acne breakouts. They cannot live in an aerobic (oxygen-rich) environment. Benzoyl peroxide works by introducing oxygen into the pore, thereby killing P. acnes. When the bacteria population is reduced, the number of breakouts on the skin is reduced as well."

You can also read here on EmpowHer about other ways to treat your acne by searching acne in the search box. It may require some trial and error to come up with what works for you and you might consider seeing a dermatologist to come up with a plan specifically for you. Good luck.

July 23, 2011 - 11:48am

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Anonymous

How does Benzoyl Peroxide effected to acne..I had acne am 27 yrs old but can't treat this..what medicine can take to prevent acne?

July 23, 2011 - 7:44am

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Michele Blacksberg RN
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We value and respect our HERWriters' experiences, but everyone is different. Many of our writers are speaking from personal experience, and what's worked for them may not work for you. Their articles are not a substitute for medical advice, although we hope you can gain knowledge from their insight.