On December 16, 2013, the U.S. Food and Drug Administration (FDA) issued a proposed rule to “determine safety and effectiveness of antibacterial soaps.” This proposed change applies to over-the-counter (OTC) antiseptic drug and personal products that are intended for use with water.
The proposed change has two key requirements:
- Manufacturers will have to provide FDA with evidence of their products’ safety and efficacy
- Clinical data will have to be provided to support any claims related to disease prevention or reducing infection rates (relative to soap and water alone).
Consumer groups, armed with studies suggesting that these products may not be as safe and effective as advertised, have pushed to place restrictions on the use of certain chemical agents found in consumer antibacterial washes. Much of this focus has been on triclosan and triclocarban, two of the most prevalent active ingredients used in these products. Proffered arguments against these products range from lack of effectiveness to hormone disruption, and the potential for increasing the development of bacterial resistance.
In this webinar, health scientists from Exponent, and attorneys from Bowman and Brooke, discuss the implications of the proposed FDA rule and what you need to consider when conducting safety studies, evaluating regulatory requirements, planning for future litigation trends, analyzing the potential impact on vendor and customer relationships, and addressing advertising concerns.