The U.S. Food and Drug Administration (FDA) proposed a rule in December that will make it tougher for companies that manufacture antibacterial soaps and body washes used with water to sell their products – without providing proof that they are effective at preventing illness.
The FDA wants companies to provide evidence that their antibacterial products for washing hands and body are safe for daily use. In addition, the FDA wants proof that shows that these antibacterial products are more effective than regular soap and water at preventing bacterial infection and at preventing the spread of infection.
Manufacturers will have to conduct clinical studies to test and demonstrate products’ clinical benefit. They also will be required to provide data on the safety of their products before they can be recognized as safe for use.
If companies are unable to show evidence of product efficacy, they will have to either reformulate or change the labelling on their products, removing the antibacterial claims to continue selling them in the marketplace.
The rule does not concern the bottles of hand-cleansing gel that you might carry in your car or pocket.
“Washing with plain soap and running water is one of the most important steps consumers can take to avoid getting sick and to prevent spreading germs to others,” said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research (CDER).
“Due to consumers’ extensive exposure to the ingredients in antibacterial soaps, we believe there should be a clearly demonstrated benefit from using antibacterial soap to balance any potential risk.”
Each day, millions of Americans use antibacterial soaps and washes at home, school, work and public places. A lot of the time, these products are used in places where the risk of bacterial infection is relatively low.
Many people reach for the soap labelled “antibacterial” because they think that the product will prevent them from getting sick. However, the FDA has not been given any data to date that demonstrates that these antibacterial products are any more effective than plain soap and water for bacterial infection prevention.
Furthermore, these antibacterial products contain chemicals that plain soaps do not: Chemicals include triclosan and triclocarban which both carry potential risks. Dr. Colleen Rogers, lead microbiologist at the FDA, states that new data has shown that the risks associated with long-term use of antibacterial soaps may outweigh the benefits.
There is some evidence that has shown that certain ingredients in these products may contribute to bacterial resistance to antibiotics which may have a detrimental impact on some medical treatments. Also, long-term exposure to these chemicals may have hormonal side effects.
Clear benefits of these products need to be clinically demonstrated in order to balance the potential risk of using these products on a daily basis.
The proposed rule does not mean that antibacterial products need to be removed from the marketplace now. The FDA hopes to finalize its rule by September 2016. For now, the FDA is encouraging consumers, clinicians, environmentalists, scientists and industry representatives to discuss the proposed new rule over the 180-day comment period.
In the meantime, we should continue to be diligent about washing our hands – especially in cold and flu season. If soap and water are not available, the FDA recommends an alcohol-based hand sanitizer that contains at least 60 percent alcohol.