On September 6, 2016, the U.S. Food and Drug Administration (FDA) issued a final rule on the effectiveness and safety of over-the-counter (OTC) antibacterial soaps. This final rule affects consumer antiseptic wash products for both hands and body which contain the frequently used ingredients triclosan and triclocarban as well as 17 other active ingredients (See 81 FR 61110 for a full list of eligible ingredients). Beginning September 6, 2017, companies that manufacture and market affected antibacterial soaps may not legally introduce or deliver for introduction their products into interstate commerce unless approved under a new drug application.
FDA first proposed this rule in 2013 after research suggested that long-term use and exposure to specific active ingredients used in antibacterial soaps may cause a health risk to consumers. Examples of these health risks include hormonal effects and bacterial resistance. According to Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER), “Consumers may think antibacterial washes are more effective at preventing the spread of germs, but we have no scientific evidence that they are any better than plain soap and water.”
FDA has postponed a rule making decision for consumer antiseptic soaps and washes that contain the ingredients- benzalkonium chloride, benzethonium chloride, and cloroxylenol (PCMX) for one year to allow industry to provide additional safety information. FDA will take regulatory action at that time, dependent upon whether the data provided by industry supports the conclusion that those active ingredients are generally recognized as safe and effective for this intended use.
FDA’s final rule only applies to consumer rinse-off antibacterial soaps. This final rule does not affect consumer no-rinse handnitizers or antibacterial products used in hospital or health care settings.
Registrar Corp can help manufacturers determine whether their product is affected by FDA’s final rule. For questions or assistance with the compliance of the final rule on antibacterial soaps, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.come/livehelp.