FDA to require proof antibacterial soaps actually work, are safe


Many consumers opt for antibacterial soap products because they believe it will keep them healthier and protected against disease. However, the Food and Drug Administration (FDA) announced Monday that some antibacterial products may not be that great at killing germs and may pose more health risks.

The agency said it is proposing a new rule to further regulate antibacterial hand soaps and body washes. In the near future, manufacturers of these products will be required to prove that their items are generally safe for long-term use and are effective at preventing disease before being allowed on the market.

“Because of consumers' high exposure to these products, we at the FDA believe there should be clear benefits to using antibacterial soups to balance out any risks,” Dr. Sandra Kweder, deputy director of the Office of New Drugs in FDA's Center for Drug Evaluation and Research, said during a press conference.

The ruling refers to antibacterial products that need to be combined with water to work, and they usually contain the compounds triclosan and triclocarban.

It does not encompass hand sanitizers or wipes that do not require water, because those are usually alcohol based. It will also not include antibiotic sanitizing products that are used in the medical or food preparation industries. Those will be addressed at a different time.  

The FDA grew concerned that antibacterial products were causing more harm than good because of animal studies that showed that overuse of the products -- especially those that contained tricoclan – caused hormonal problems, including infertility and early puberty.  

The agency had announced in May that it was reviewing antibacterial soaps and body washes. Even at that time, the FDA’s website stated that "the agency does not have evidence that triclosan in antibacterial soaps and body washes provides any benefit over washing with regular soap and water."

Kweder reiterated that sentiment today.

“We have not been provided with data to demonstrate these products prevent people from getting sick better than washing with plain soap and water,” she said.

Dr. Brian Koll, an infectious disease expert at Beth Israel Medical Center in New York, added to CBS News that triclosan contains small amounts of known carcinogens. While using them once in a while probably won't hurt, it’s repeated use that is worrisome.

“When you look at products in the market where we buy our soup, where we buy our laundry detergent, everything is antibacterial -- it’s very difficult to avoid product with antibacterial action… Every time we got reach for a product and it has an antibacterial, that’s what's concerning,” he said.

Koll also pointed out that by using antibacterial products all the time, we may be creating super bacteria that is immune to anything we have on the market.

“The concern is development of drug resistance so that makes our bacteria stronger,” he added.

Companies will have to submit additional data showing their products are better at preventing illness than soap and water, as well as additional safety data. Products currently for sale will not be removed from shelves.

The FDA encouraged people that if they want to kill dangerous germs, they probably are better off washing their hands with soap and water.

“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,” Dr. Sandra Kweder, deputy director, Office of New Drugs at the FDA’s Center for Drug Evaluation and Research, said in a press release. “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.”

To properly wash your hands, use clean cold or warm water and apply soap to both hands before rubbing them together to create a lather. Scrub the entire hand, including between the fingers and the back of the hands, for at least 20 seconds, or until you’ve hummed the “Happy Birthday” song twice. Rinse thoroughly with water and dry completely.  

“For the majority of us at home, old fashioned soap and water that’s used effectively are just as effective. There’s no benefits to an antibacterial product at home,” Koll stated.