FDA Calls for Effectiveness and Stronger Safety Data on Antibacterial Soaps
On December 16, 2013, the U.S. Food and Drug Administration (FDA) issued a proposed rule1 that would require manufacturers of antibacterial hand soaps and body washes to provide stronger data that their products are safe. The proposed rule will also require that these products be more effective than regular soap and water in preventing illness. The proposed rule was widely reported by the New York Times,2 National Public Radio,3 and other media outlets.
The proposed FDA rule only calls for additional safety and effectiveness data from manufacturers of antibacterial hand soaps and body washes. The proposed rule does not apply to hand sanitizers, wipes and antibacterial hand washes used in health care settings, nor to oral hygiene products such as triclosan-containing toothpaste. Rather, the FDA announcement aims to address the routine use of triclosan, triclocarban and other antimicrobial agents in certain consumer products. The FDA notes that there is some limited research indicating that triclosan can alter hormone regulation in animals, and that triclosan may contribute to making bacteria resistant to antibiotics.
When providing the public with information about triclosan-containing toothpaste, dentists can reference the FDA’s Consumer Update on triclosan,4 which includes information on triclosan’s effectiveness in reducing gingivitis. The ADA closely monitors emerging research and proposed rules from federal agencies addressing the safety and effectiveness of antibacterial ingredients in oral hygiene products. For more information, visit the Federal Register for a full-text copy of the proposed FDA rule.
1. FDA issues proposed rule to determine safety and effectiveness of antibacterial soaps (news release). U.S. Food and Drug Administration. December 16, 2013. Available at: “http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm378542.htm”. Accessed December 17, 2013.
2. Tavernise S. F.D.A. Questions Safety of Antibacterial Soaps. The New York Times. December 16, 2013. Available at: “http://www.nytimes.com/2013/12/17/health/fda-to-require-proof-that-antibacterial-soaps-are-safe.html?_r=0”. Accessed December 17, 2013.
3. Shute N. FDA Asks for Proof That Antibacterial Soaps Protect Health. National Public Radio. December 16, 2013. Available at: “http://www.npr.org/blogs/health/2013/12/16/251632461/fda-asks-for-proof-that-antibacterial-soaps-protect-health ”. Accessed December 17, 2013.
4. U.S. Food and Drug Administration. Triclosan: What Consumers Should Know (consumer update). Updated Nov. 25, 2013. Available at: “http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm205999.htm”. Accessed December 17, 2013.
- MouthHealthy: ADA Seal of Acceptance Program
- Triclosan Facts (Environmental Protection Agency)
- Handwashing: Clean Hands Save Lives (CDC)