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The use of consumer antimicrobial wash products such as antibacterial hand washes, hand soaps, and body washes has been under review with the U.S. Food and Drug Administration for both efficacy and safety. The current status has been discussed on the FDA website1-4 and is summarized briefly below.
Efficacy of Consumer Hand Washes
Consumer antimicrobial wash products are commonly used on a daily basis, but to date, they have not been shown to be more effective than non-antibacterial soaps, and both the FDA and CDC recommend using plain soap and water for home and public handwashing. In order to demonstrate efficacy, manufacturers will need clinical trial efficacy studies that clearly indicate that consumer antiseptic wash products, containing specific antimicrobial agents, are superior to non-antibacterial soap in preventing illness or reducing infection.
Safety of Consumer Hand Washes
In addition to efficacy concerns, there are concerns about the safety of long term, daily use of these products. The exposure risks for some active ingredients, such as triclosan, may be greater than anticipated because antimicrobial ingredients are now commonly present in a wide variety of consumer products. There have also been studies that suggest that triclosan may encourage bacteria to become resistant to antibiotics, which could make it harder to successfully treat patients infected with those bacteria. The FDA feels that these concerns currently outweigh the presumed benefits of consumer hand wash products.
In September 2016, the FDA published a final ruling5 that that impacts over the counter (OTC) consumer antiseptic wash products in the form of liquids, foams, gel hand soaps, bar soaps, and body washes, and amends the 1994 Tentative Final Monograph (TFM).6 The ruling conculdes that manufacturers did not provide the necessary data to validate the efficacy of 19 common active ingredients such as triclosan and triclocarban, so the FDA is calling for the removal of these ingredients from consumer antibacterial soaps and body washes on the grounds that they are not generally recognized as safe and effective (GRAS/GRAE). Three active ingredients (benzalkonium chloride, benzethonium chloride and chloroxylenol) are still under study, so this rule doesn’t apply to them at this time.
Impact on Consumer Hand Sanitizers and Health Care Antiseptic Products
This FDA ruling only applies to consumer antiseptic soaps and body washes that are used with water.
It does not impact consumer antiseptic rub products, as their use profile is much different. Alcohol-based hand rubs, hand wipes, and other leave-on formulations, are designed to be applied full strength, rubbed in until dry, and used without water rinsing. They are a convenient alternative to hand washing when a water source is not available. They do not need to demonstrate clinical effectiveness compared to soap and water, but they do require clinical simulation studies. The FDA has proposed a separate ruling for consumer waterless hand rub/hand sanitizer use.7
The ruling also does not apply to antibacterial soaps or washes that are used in health care settings, such as hospitals and nursing homes. Health care antiseptics, especially in hospital settings, are critical components for preventing the spread of pathogenic microorganisms and for reducing hospital acquired infections that can result in longer or additional hospital stays/treatment, negative clinical outcomes, and increased costs.
- Topical Antiseptic Products: Hand Sanitizers and Antibacterial Soaps http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm444681.htm
- Antibacterial Soap? You Can Skip It -- Use Plain Soap and Water http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm378393.htm
- 5 Things to Know About Triclosan http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm205999.htm
- FDA issues final rule on safety and effectiveness of antibacterial soaps http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm517478.htm
- Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use. A Rule by the Food and Drug Administration on 09/06/2016. https://www.federalregister.gov/documents/2016/09/06/2016-21337/safety-and-effectiveness-of-consumer-antiseptics-topical-antimicrobial-drug-products-for
- Federal Register Notice: Tentative Final Monograph for OTC Healthcare Antiseptic Drug Products – June 17, 1994 http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4184B1_01_16-FDA-TAB15.pdf
- Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record A Proposed Rule by the Food and Drug Administration on 06/30/2016. https://www.federalregister.gov/documents/2016/06/30/2016-15410/safety-and-effectiveness-of-consumer-antiseptics-topical-antimicrobial-drug-products-for