Showing posts with label FDA antibacterial soap rule. Show all posts
Showing posts with label FDA antibacterial soap rule. Show all posts

Friday, March 28, 2014

FDA Warning: Think Twice Before Using Antibacterial Soaps

You may assume that you’re doing your family a favor by buying antibacterial soaps. But the U.S. Food and Drug Administration (FDA) surprised consumers with its recent pronouncement that antibacterial soaps are no more effective at preventing illness or spreading targeted infections than plain ol’ soap and water. Worse, the FDA added a caution with their announcement: that some of the most common antibacterial soap additives may even be dangerous to humans.

The new antibacterial soap rule


In December, the FDA proposed a rule that would require manufacturers of hand soaps and body washes with active antibacterial ingredients added to prove that their products are safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections. And, if companies cannot demonstrate this, then manufactures must reformulate or re-label their antibacterial  soaps and washes to keep them on the market. 


FDA research contradicts long-held assumptions


Today, millions of us use antibacterial hand soap and body washes. And why not? – We’ve been assured by manufacturers that they are effective in preventing the spread of germs. However, the FDA studies found no evidence that these products did more for preventing illness than washing with plain soap and water.

Their data also suggests that some of the active ingredients used in antibacterial products, such as the triclosan and the triclocarban, can generate health risks with long-term exposure. Those antibacterial soap risks include your body developing bacterial resistance or experiencing hormonal effects.

According to the FDA’s Center for Drug Evaluation and Research (CDER), one of the concerns is the fact that antibacterial soaps and body washes are frequently and widely used by consumers in nearly every environment – home, work, school, and public settings. Consequently, it collectively amounts to 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,” said Janet Woodcock, M.D., director of the CDER.


The big soap question: Is it “GRASE” enough?


The widespread consumer use of antibacterial products, combined with the growing volume of both scientific data and the concerns of health care/consumer groups prompted the FDA to reevaluate what data are needed to classify the active ingredients in consumer antibacterial products as “generally recognized as safe and effective” or GRASE. 

Under the new rule, if it goes into effect, manufacturers may be required to provide the FDA with more data on the efficacy and safety of their antibacterial soaps and body washes, such as clinical study results that demonstrate that these products are not dangerous and are better than non-antibacterial soaps in preventing human illness or reducing infection.

“While the FDA continues to collect additional information on antibacterial hand soaps and body washes, we encourage consumers to make an educated choice about what products they choose to use,” said Sandra Kweder, M.D., deputy director, Office of New Drugs at CDER. 


What you can do NOW to protect your family


Until further research validates the FDA's case, your best bet is to avoid antibacterial soaps and lotions, or at least those containing the antibacterial active ingredients currently under scrutiny. These include:
  • Triclosan (used in liquid soaps)
  • Triclocarban (commonly used in bar soaps)
One of these two ingredients can be found in nearly all soaps labeled antibacterial or antimicrobial.  As well, the FDA cautions that some soaps labeled "deodorant" may also have one of these ingredients.
So what should you use instead? According to Kweder, “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.”
When soap and water are not available, alcohol-based hand sanitizers are a smart second-best choice, especially those that contain at least 60 percent alcohol. 


What is not included in the antibacterial soap ban


The proposed FDA rule does not demand the banning of any antibacterial soap products yet. It just requires adequate testing to confirm safety and effectiveness in order to keep using the same labeling or reformulate the product, removing both the antibacterial active ingredients and the antibacterial labeling.
Also, the proposed rule covers only those consumer antibacterial soaps and body washes that are used with water. The rule does not apply to hand sanitizers, hand wipes or antibacterial soaps that are used in health care settings such as hospitals.


Learn more about proper hand washing and antibacterial soaps 


For more information, check out these resources.

Ric Moxley
Contributing Writer