Approximately 90% of “antibacterial” or “antimicrobial” soaps currently on the market are made with the active ingredient triclosan, a chemical known to kill bacteria. For obvious reasons, consumers generally consider these soaps more effective than plain soap and water. However, recent scientific evidence is causing FDA to rethink its position on this controversial ingredient. FDA is now giving manufacturers one year (with the intent of publishing a Final Rule in August 2016) to submit evidence proving that triclosan is both safe for general use and effective in reducing infection rates.
FDA’s original review of triclosan, and the original methods of determining safety for products using triclosan as an antibacterial agent, did not uncover any evidence of triclosan being hazardous to humans. However, since these regulations were originally created in 1978, new studies have surfaced indicating that prolonged or daily exposure to triclosan can disrupt hormone regulation in animals. These results have caused consumer groups and environmental groups to request that FDA reconsider its ruling in the 1978 Tentative Final Monograph.
Amid growing public concern about the effectiveness and future of antibacterial products in general, this new regulation will be well-received by consumers and environmental groups. Manufacturers, though, are a different story. The market for antibacterial products is large and profitable, and being required to prove effectiveness as well as safety for these products will be a difficult and costly move. Some groups have already come forward to affirm the safety and effectiveness of triclosan, but FDA will consider all evidence presented at the end of the comment period. To learn more about how this new regulation will affect your business, or to discuss how to effectively comment on these regulations, contact us today.
