Manufacturers of antibacterial soap will have to prove their products are more effective than regular soap and water for washing hands and safe for long-term use, according to a new proposal by the Food and Drug Administration.
The proposed rule -- which does not effect hand sanitizers, wipes, or antibacterial products used in health care settings -- will be applicable to products using antibacterial ingredients such as triclosan and triclocarban.
While these products are marketed as being effective in killing bacteria, there is no actual evidence to suggest their long-term safety or increased effectiveness as compared to plain soap and water.
“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,” said Janet Woodcock of the FDA.
Recent data has suggested that excessive and long-term use of such products can lead to bacterial resistance and hormonal effects. The FDA is asking companies to provide clinical data and evidence to support their claims, if they want to continue marketing these products and retain them under the “generally recognized as safe and effective” category of products.
Monday's proposal does not require companies to pull products off the shelves, but if finalized, manufactures that fail to provide the required data will have to reformulate or relabel these products.
The FDA will accept public comment for the next 180 days and companies will have one year to submit the data to the agency.
