FDA Questions Use of Antibacterial Soap

According to reports in the Wall Street Journal and MSNBC, the U.S. Food and Drug Administration (FDA) is taking a hard look at the use of anti-bacterial soaps.

In preparation for an October 20th meeting on the topic, the FDA’s Nonprescription Drugs Advisory Committee issued a number of documents on Monday detailing the safety concerns of those who argue that antibacterial products do more harm than good, creating resistant bacteria.  A committee of experts will meet on Thursday to examine whether the FDA needs to limit the use of antibacterial products by consumers.

The committee will be looking at the use of these products by healthy consumers, as opposed to people in the healthcare and food service industries.  In their briefing documents, the FDA said that they had not found any medical studies that definitively linked antibacterial products to reduced infection rates.  The committee will consider if there is evidence that antibacterial products pose long-term hazards, and whether they should recommend that the FDA issue restrictions or warnings on the sales and labeling of these products.

According to the Journal, any moves by the FDA could affect hundreds of products that are on store shelves.  Manufacturers have introduced 253 antibacterial products in the United States so far this year, and over 300 new products hit American shelves in 2004.

Manufacturers of these products disagree that their products cause health risks, and they point to studies that back up their view.  Other studies, however, point in the opposite direction.

A recent study done by the Centers for Disease Control (CDC) takes both sides of the argument.  Scientists recorded the development of bacteria in 224 households for a year.  No significant increase in resistant bacteria was found, nor did it find that antibacterial soap led to healthier homes than regular soap.  In its briefing papers, the FDA says “current data are conflicting and unclear.”

In addition to looking at the issue of resistant bacteria, the committee will also consider whether the synthetic materials in some soap poses an environmental hazard when they go down the drain, and whether the use of antibacterial soaps may leave homes too clean for children, who need some exposure to bacteria to develop a healthy immune system.

This entry was posted in Legal News. Bookmark the permalink.

© 2005-2019 Parker Waichman LLP ®. All Rights Reserved.