By Kim Smiley

The Federal Drug Agency (FDA) has formally questioned the safety and effectiveness of antibacterial soaps with a ruling on December 16, 2013.   Manufacturers of antibacterial soaps have one year to provide data that proves that anti-bacterial soaps are both safe and more effective than regular soap and water. Any antibacterial products that have not provided sufficient data to satisfy regulators by late 2016 would have to be reformulated, relabeled or removed from the market.

This issue can be analyzed by building a Cause Map, or visual root cause analysis.  A Cause Map visually lays out the many causes that contribute to an incident to intuitively show the cause-and-effect relationships.  When starting the Cause Mapping process, the first step is to fill in an Outline. The Outline documents the basic background information as well as lists how the issue impacts the goals.

In this example, there are a number of impacts to the goals worth considering.  The potential financial impacts are certainly significant.   It is estimated that it will cost companies between $112 million and $368 million to comply with the new regulations.  The safety goal is also a key component of this issue since safety concerns are one of the driving factors for the new push for additional data.

The FDA is concerned about the safety of antibacterial soaps because many contain triclosan and other similar chemicals.  Studies using lab animals have found that triclosan can disrupt hormones, such as sex hormones and thyroid hormones.  Interference with the body’s natural hormone levels can have a huge impact on how the body functions, especially in children who are still growing.  Use of antibacterial agents has also been associated with an increase in allergies, although more data would be needed before a definitive link could be established.  Use of antibacterial products may also lead to increased resistance to antibiotics which is an issue generating increasing concern.

In addition to questions about safety, there are also questions about the effectiveness of the products.  Microbiologists at the FDA have stated that there is currently no evidence that use of over-the-counter antibacterial soap is any more effective at illness prevention than simply washing with soap and water.  Consumers buying the products assume that they are getting some sort of additional protection against illness, but that doesn’t appear to be the case.  It is also worth noting that viruses are the most common cause of infection in the United States and antibacterial products are powerless against them.

The bottom line appears to be that antibacterial soaps are more expensive, have potential risks associated with them and aren’t better at preventing illness.   Manufacturers will have the opportunities to present data about their products to the FDA, but I expect that there will be some significant changes to antibacterial products in the future.

The current ruling does not apply to hand sanitizers which are typically alcohol based so don’t be afraid of using sanitizer if hand washing is unavailable.  Also, studies have proven triclosan is effective at fighting gingivitis in toothpaste.  This current ruling only applies to personal hygiene products (like hand soap), but I suspect this is just the first of many hard questions for the billion dollar anti-bacterial product industry.

To view the Outline and Cause Map, please click “Download PDF” above.