On September 2, 2016, the Food and Drug Administration (FDA) issued a press release on the safety and effectiveness of antibacterial soaps, calling for the removal of 19 active ingredients, including the much used triclosan and triclocarban, from over-the-counter antibacterial hand and body washes, determining that the risks of using these products outweigh their benefits. This is perhaps one of the Agency’s boldest steps yet toward fighting the phenomenon of antimicrobial resistant superbugs, an issue of increasing global frustration.
In its official final rule, issued in the Federal Register on September 6, the FDA noted that the investigation into the risk-benefit analysis of antiseptic began in 2013. “New information on potential risks posed by the use of certain consumer antiseptic washes prompted us to reevaluate the data needed for classifying consumer antiseptic wash active ingredients as generally recognized as effective (GRAE). As a result, we proposed that the risk from the use of a consumer antiseptic wash drug product must be balanced by a demonstration—through studies that demonstrate a direct clinical benefit (i.e., a reduction of infection)—that the product is superior to washing with [non-antibacterial] soap and water in reducing infection .” As a result of considering recommendations from the public, evaluating available literature, data and comments, the FDA determined that “the data and information submitted for these active ingredients are insufficient to demonstrate that there is any additional benefit from the use of these active ingredients in consumer antiseptic wash products compared to [non-antibacterial] soap and water. Consequently, the available data do not support a GRAE determination for these consumer antiseptic wash active ingredients.” Likewise, with regard to safety, the FDA declared that “the available information and published data for the 19 active ingredients . . . are insufficient to establish the safety of long-term, daily repeated exposure to these active ingredients used in consumer wash products,” and thus could not be considered generally recognized as safe (GRAS).
“[W]e have no scientific evidence that [antibacterial washes] are any better than plain soap and water…In fact, some data suggests that antibacterial ingredients may do more harm than good over the long-term,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER).
This announcement comes at a time when the spread of antibiotic-resistant strains of bacteria, or superbugs, have proliferated, causing international concern. Antibiotic resistance occurs when bacteria evolve, becoming immune to what was used to treat the infections they cause. While a nature occurrence, it is believed that the widespread use of antibacterials, including soaps, exacerbate the problem.
Some bacterial infections once thought to be relatively benign, or at the very least curable, are having much more dire consequences. On July 26, 2016, professional football player Daniel Fells ended a short career with the NFL after contracting an antibiotic resistant strain of MRSA from a cortisone shot for an ankle injury. Further, in earlier this month, gonorrhea patients in Hawaii made up the first known US case cluster in which the sexually transmitted infection showed reduced susceptibility to the only available effective treatment option, the Centers for Disease Control and Prevention said, though their conditions were ultimately positively resolved.
On September 21, heads of state from across the globe convened at the United Nations General Assembly in New York, alongside experts in the field, for a one-day, high-level meeting to address the issue of antibacterial resistance. A rare occurrence, the UN has only met for public health issues three times before for reasons which included the HIV and Ebola pandemics. In a historic agreement, the U.N.’s declaration required nations to develop a two-year plan to protect themselves against antibiotics. After two years, the U.N.’s secretary-general would evaluate each country’s plan and monitor progress.
At this time, hand sanitizers, antibacterial wipes, and antiseptic products used in healthcare settings are not subject to the new regulation, though the FDA has called for additional research.
The effective date of this rule is September 06, 2017.