The U.S. Food & Drug Administration (FDA) published a final ruling last week regarding Consumer Antiseptic (antimicrobial)Washes. As a manufacturer of antiseptic hand and body washes, DermaRite would like to address this ruling and assure you that you can continue to use any of our hand and body washes as usual.
The FDA presented a Proposed Rule on Consumer Antiseptic (Antimicrobial) Washes in December of 2013. Following several years of research and consultation with manufacturers and industry leaders, the FDA has concluded that “there isn’t enough science to show that over-the-counter (OTC) antibacterial soaps are better at preventing illness than washing with plain soap and water. To date, the benefits of using antibacterial hand soap haven’t been proven. In addition, the wide use of these products over a long time has raised the question of potential negative effects on your health.”
As a result, the FDA is banning the use of 19 active ingredients commonly used as antibacterial agents in consumer hand and body washes that are used with water. Manufacturers have one year to remove these ingredients from their products.
WHAT YOU NEED TO KNOW
- This final rule applies to consumer antiseptic wash products containing one or more of 19 specific active ingredients, including the most commonly used ingredients – triclosan and triclocarban. These products are intended for use with water, and are rinsed off after use.
- This rule does not affectconsumer hand sanitizers or wipes intended to be used without water.
- This rule does not affect antibacterial products used inhealth care settings.
- DermaRite hand and body washes do not contain the active ingredients banned by the FDA.
WHAT YOU SHOULD DO
- If you are a DermaRite customer, you can continue to use any of our hand and body washes as usual as they do not contain the active ingredients banned by the FDA.
- Furthermore, if you are using handwashes in a healthcare setting, continue to follow accepted guidelines for hand hygiene, as the FDA’s ruling only applies to consumer hand and body washes.
- Hand sanitizers are also not included in the FDA’s final ruling and can be used as usual for the time being.
- In consumer settings, the FDA currently recommends practicing good hygiene by using plain soap and water.
Hand hygiene is one of the most important and most effective ways to reduce the spread of infectious diseases. It is important that healthcare facility staff maintain the highest standards for hand hygiene in order to protect the health and safety of those under their care.
DermaRite offers a full line of hand hygiene products, including alcohol-based and non-alcohol hand sanitizers, and a wide range of hand and body washes. These products are FDA approved. This wide variety of products ensures that your facility can find the products that fit your individual needs.
For the latest guidelines and information regarding proper hand hygiene, you can visit the Center for Disease Control’s website at www.cdc.gov/handhygiene.
To learn more about the FDA’s ruling you can select one of the links below:
- Federal Register – “Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use” https://www.federalregister.gov/articles/2016/09/06/2016-21337/safety-and-effectiveness-of-consumer-antiseptics-topical-antimicrobial-drug-products-for
- FDA.gov Press Release – FDA issues final rule on safety and effectiveness of antibacterial soaps http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm517478.htm
- FDA.gov for Consumers – Antibacterial Soap? You Can Skip It — Use Plain Soap and Water http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm378393.htm
 Antibacterial Soap? You Can Skip It — Use Plain Soap and Water http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm378393.htm
 FDA issues final rule on safety and effectiveness of antibacterial soaps http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm517478.htm