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FDA Final Rule Calls for Removal of Antiseptic-Containing Consumer Hand and Body Washes from the Market for Lack of Demonstrated Safety and Effectiveness

September 07, 2016 On September 2, 2016, the U.S. Food and Drug Administration (FDA) issued a final rule calling for the removal of antiseptic-containing consumer hand and body washes from the market for lack of demonstrated long-term safety and effectiveness as compared with plain soap and water washes.1 This final rule applies to over-the-counter (OTC) antiseptic wash products containing one or more of 19 specific active ingredients, including the most commonly used ingredients, triclosan (liquid soaps) and triclocarban (bar soaps). These OTC products are intended for use with water and are rinsed off after use; the rule does not affect consumer hand sanitizers or wipes, or antibacterial products used in health-care settings. In a personal communication to the ADA, FDA staff clarified that this final rule also does not affect the marketing of triclosan-containing toothpaste, i.e., Colgate Total®, which was approved by FDA in 1997 following review of safety and efficacy data submitted as part of a specific new drug application.2

FDA had issued a proposed rule1 in 2013 after data suggested that long-term exposure to certain active ingredients used in OTC antibacterial hand and body washes could pose health risks, such as bacterial resistance or effects on human hormone systems. As part of the proposed rule, manufacturers were required to provide FDA with additional data on the safety and effectiveness of antiseptic ingredients used in OTC consumer antibacterial washes in order to continue marketing products containing those ingredients. The Agency was seeking data from clinical studies demonstrating that hand or body wash products containing antibacterial ingredients were superior to non-antibacterial (i.e., “plain”) washes in preventing illness or reducing infection.1  According the FDA press release, “Antibacterial hand and body wash manufacturers did not provide the necessary data to establish safety and effectiveness for the 19 active ingredients addressed in this final rulemaking. For these ingredients, either no additional data were submitted or the data and information that were submitted were not sufficient for the agency to find that these ingredients are Generally Recognized as Safe and Effective (GRAS/GRAE).”

In a follow-on news item from the September 7, 2016, New York Times,3 FDA spokesperson Andrea Fischer is quoted as follows, “Toothpastes that contain triclosan have ‘demonstrated to be effective at reducing plaque and gingivitis,’” and “Based on scientific evidence, the balance of benefit and risk is favorable for these products.”  The Times report3 also cites a 2013 Cochrane systematic review,4, 5 which reviewed 30 randomized, controlled trials and concluded that there was moderate-quality evidence showing that triclosan/fluoride-containing toothpastes reduced plaque, gingival inflammation and gingival bleeding when compared with fluoride-only toothpastes; however, the clinical importance of these changes was not clear.

References

  1. U.S. Food and Drug Administration. FDA News Release: FDA issues final rule on safety and effectiveness of antibacterial soaps. Accessed September 7, 2016.
  2. Hyman F. Personal email communication: Triclosan status - final FDA rule issued today.  September 2, 2016.
  3. Saint Louis C. Why your toothpaste still has triclosan. New York Times. September 7, 2016. Accessed September 7, 2016.
  4. Riley P, Lamont T. Triclosan/copolymer containing toothpastes for oral health. Cochrane Database Syst Rev 2013;12(12):CD010514.
  5. Kraglund F. Triclosan produces statistically significant reduction in plaque, gingivitis and caries but not clinically important benefit. Evid Based Dent 2014;15(1):6-7.

Prepared by: Center for Scientific Information, ADA Science Institute


About Science in the News

Science in the News is a service by the American Dental Association (ADA) to its members to present current information about science topics in the news. The ADA is a professional association of dentists committed to the public's oral health, ethics, science and professional advancement; leading a unified profession through initiatives in advocacy, education, research and the development of standards. As a science-based organization, the ADA's evaluation of the scientific evidence may change as more information becomes available. Your thoughts would be greatly appreciated.