On December 16, 2013, the U.S. Food & Drug Administration (FDA) issued a proposed rule, “Safety and Effectiveness of Consumer Antiseptics,” that would require manufacturers of over-the-counter (OTC) antibacterial soaps and body washes to provide the FDA with data demonstrating that the products are safe for long-term use and effective in preventing illness and infection. You can read the FDA’s announcement here.
The proposed rule is part of the FDA’s ongoing review of the safety and effectiveness of the active ingredients in antibacterial soaps and related products, which are not found in non-antibacterial, or plain, soap. Further, as noted above, these products are regulated as OTC drugs, etc., as opposed to soaps generally, which are typically regulated as cosmetics by the FDA. As far as the ingredients found in these antibacterial products, the FDA notes that new data suggests that long-term exposure to certain active ingredients—primarily triclosan and triclocarban–in antibacterial products poses health risks such as hormonal effects and resistance to antibiotics. Also, according to the FDA, there is no evidence that antibacterial soaps and hand washes are more effective at preventing illness and reducing infection than plain soap and water.
If finalized, the rule would require manufacturers to submit additional evidence that the active ingredients in antibacterial soap and other products are safe for repeated daily use and provide a clinical benefit as compared to non-antibacterial soap and water. Specifically, the risk must be balanced by the clinical benefit to establish that the OTC antibacterial active ingredients are generally recognized as safe and effective (GRASE) for their intended use. Otherwise, to continue marketing the products, manufacturers would need to remove the antibacterial active ingredients from the product and the antibacterial claims from the product’s labeling. Accordingly, if finalized, the rule would require both formulation and labeling changes for those companies marketing these products.
In sum, the proposed rule will be available for comment for 180 days, until June 16, 2014, with a concurrent one-year period for companies to submit new data and information. If you have any questions about this announcement, GRASE status, or compliance with any FDA regulations pertaining to cosmetics or OTC drugs and need a food and drug (FDA) lawyer, please contact us at: contact@sglawfl.com.