Proposed FDA Rule Would Require New Data or Relabeling of Antibacterial Soaps


  • December 18, 2013

Millions of Americans use antibacterial hand soap and body wash products, many under the assumption that these products are more effective at preventing germs and illness than regular soap and water. Due to the widespread use of these products, FDA is investigating their safety and effectiveness.

As a part of this ongoing review, on December 16, 2013 FDA issued a proposed rule requiring manufacturers of antibacterial hand soaps and body washes to demonstrate that their products are more effective than plain soap and safe for prolonged periods of daily use. If the rule is finalized, manufacturers will need to submit data that supports their antibacterial claims, otherwise they will need to reformulate or relabel their products to remain on the market.

The proposed rule asserts that there is little conclusive data to demonstrate that there is any benefit to using antibacterial soaps vs. nonantibacterial soap and water. Past studies have concluded that antibacterial products are not more effective than ordinary soaps, whereas others have concluded that such products are key to preventing foodborne illnesses and other readily transmitted infections. Similarly, past studies have also indicated that antibacterial products are safe, whereas other studies have concluded that these products can act as endocrine disruptors and may contribute to antimicrobial resistance, as well as contributing to important environmental contamination. What is clear, however, is that human exposures to these products are nearly ubiquitous, at least at trace levels.

FDA action on this topic has long been in the works. At the center of this debate is triclosan, an antibacterial agent which has long been under investigation by FDA. Over three decades ago, FDA reviewed evidence and concluded that triclosan was not proven either safe or effective, although years later toothpaste containing triclosan was approved. Subsequently, considerable debate has ensued regarding both the safety and efficacy of antibacterial products containing active ingredients such as triclosan.

Manufacturers of products such as antibacterial hand soap and body wash products are not likely to have proprietary efficacy and safety data that will satisfy FDA. The usual approach to claim verification, assessment of published literature, will not suffice in this instance given that FDA has already concluded that the existing scientific data are not adequate to support safe and effective use of these products. Shorter-term animal studies might be undertaken to satisfy the Agency’s requirements for data, although sponsors are unlikely to volunteer more expensive animal investigations. It is inconceivable that manufacturers would incur the high expense of clinical trials in order to obtain prospective human data. The remaining option, that of relabeling of marketed antibacterial soaps and body wash products, is the big unknown. Ingredients such as triclosan are already recognized as Category 3 (containing ingredients for which FDA has concluded there is insufficient evidence to determine whether they are safe and effective). Would label language of this sort allow the products to remain on the market? Such an outcome wouldn’t seem to do much to resolve all the scientific and medical issues, and would have dubious value in providing consumers with sufficient information to make informed judgments regarding available products.

Posted by Bob Roth, M.D., Ph.D., Vice President and Worldwide Medical Director. For more information, please contact Bob at bob.roth@weinberggroup.com.