Citing a lack of efficacy data, the FDA has banned marketing of over-the-counter consumer antiseptic and antibacterial hand and body wash products in a final rule that will not affect healthcare settings.
In a final rule issued Sept. 6, 2016, the FDA closed a prolonged comment and analysis period by concluding that “manufacturers did not demonstrate that the ingredients are both safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections.”1
The rule applies to 19 specific ingredients, including the commonly used triclosan and triclocarban.
“These products are intended for use with water, and are rinsed off after use,” the FDA stated. “This rule does not affect consumer hand ‘sanitizers’ or wipes, or antibacterial products used in healthcare settings.”
Last year, the FDA issued a proposed rule2 to address data gaps in active ingredients in healthcare antiseptics, but said the products should continue to be used for infection control while additional data are collected.
The final rule on the consumer antibacterial soaps follows a proposed rule in 2013 that raised the issue of whether the products were no better than traditional soaps and may even pose health risks and increased bacterial resistance.
In response to comments submitted by industry, the FDA has deferred rulemaking for one year on three ingredients used in consumer wash products: benzalkonium chloride, benzethonium chloride and chloroxylenol (PCMX). The grace period will give manufacturers using those ingredients more time to submit new safety and effectiveness data. Thus, products containing those three ingredients will continue to be marketed to consumers in the interim.
In comments submitted on the proposed rule in 2014, the Society for Healthcare Epidemiology of America said it agreed that there are insufficient data to show the antibacterial consumer products are any better than soap and water. However, SHEA noted that triclosan has demonstrated some efficacy in healthcare facilities, particularly in the reduction of surgical site infections. Again, those products would not be affected by the FDA rule.
For its part, APIC expressed concern to the FDA about industry marketing efforts that suggest an “unproven effect” of consumer antiseptics on preventing infections. APIC called for “clear data to demonstrate clinical benefit,” and apparently finding none, the FDA issued the final rule banning marketing of the products. The FDA rule is effective Sept. 6, 2017.
- FDA. Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use. Fed Reg 2016;81 FR:61106 -61130.
- FDA. Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record. Fed Reg 2015; 80 FR:25165 -25205