FDA’s Proposed Rule on Antibacterial Soaps

By EAS Senior Consultant Norma Skolnik

In 2010 the Natural Resources Defense Council (NRDC) sued FDA to force the agency to issue a final rule on antibacterial soaps. As part of a settlement signed last month, the agency issued a proposed rule Dec. 16, 2013 and committed to taking final action by 2016. Well before this lawsuit, however, FDA was investigating this area and considering action on this topic.

FDA’s focus centers on triclosan, an antibacterial agent that’s long been under agency scrutiny. More than 30 years ago, FDA reviewed evidence and concluded that triclosan wasn’t proven either safe or effective (category III), although years later toothpaste containing triclosan was approved. Nonetheless, antibacterial products have been widely marketed for years. Widespread use of these products and related public health and environmental concerns provided a backdrop for the NRDC lawsuit that was the ultimate catalyst for FDA’s regulatory action. As Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, stated: “Due to consumers’ extensive exposure to the ingredients in antibacterial soaps, we believe there should be a clearly demonstrated benefit from using antibacterial soap to balance any potential risk.”

FDA Action and Rationale

On Dec. 16, 2013 the FDA released a proposed regulation to ban certain ingredients in anti-bacterial soaps if manufacturers cannot prove that these products are safe to use and more effective than plain soap and water for preventing the spread of infections. Such a move could potentially force makers of antibacterial products to reformulate all bar soaps, liquid soaps, body washes, and dishwashing liquids labeled as “anti-bacterial” and “antimicrobial” to keep them on store shelves.

According to Colleen Rogers, a lead microbiologist at FDA, “there’s currently no evi­dence that OTC antibacterial soap products are more effective at preventing illness than washing with plain soap and water”. Moreover, antibacterial soap prod­ucts contain ingredients, such as triclosan and triclocarban, which according to FDA, may pose risks associated with long-term, daily use that may outweigh the benefits. Active ingredients in these soaps may contribute to bacte­rial resistance to antibiotics, and may also have unanticipated hormonal effects that are an FDA concern based on animal study data.

Because of these concerns, FDA’s proposed rule requires manufac­turers to provide more substantial data to demonstrate the safety and effectiveness of antibacterial soaps. The proposed rule covers only consumer antibacterial soaps and body washes that are used with water. It doesn’t apply to hand sanitizers, hand wipes or antibacterial soaps that are used in health care settings such as hospitals.

Most soaps labeled “antibacterial” or “antimicrobial” contain at least one of the antibacterial ingredients that FDA has targeted in this proposed rule. Certain household cleaning products and some toothpastes may also contain them.

Laboratory tests that have historically been used to evaluate the effectiveness of anti­bacterial soaps don’t directly test the effect of a product on infection rates. That would change with FDA’s cur­rent proposal, which would require studies that directly test the ability of an antibacterial soap to provide a clinical benefit over washing with non-antibacterial soap and water.

Environmental concerns also brought the Environmental Protection Agency (EPA) into the picture and the two agencies have been collaborating on scientific and regulatory issues regarding triclosan. EPA is updating its assessment of triclosan’s use in pesticides and its overall environmental impact, while FDA has focused on the antimicrobial’s widespread use by consumers in soaps and body washes. In sharing information, the two agencies are assessing exposure risks.

Next Steps

FDA’s proposed rule doesn’t require the antibacterial soap products to be removed from the market at this time. When the proposed rule is finalized, either companies will have provided adequate data to support an antibacterial claim, or if not, they must reformulate to remove the active ingredients or relabel to remove the antibacterial claim from the product’s labeling in order to continue marketing these products. The proposed rule is available for public comment for 180 days, with a concurrent one year period for companies to submit new data and information, followed by a 60 day rebuttal comment period.

Manufacturers of antibacterial soap and body wash products and trade associations are sure to respond with comments. Two industry trade groups, the Personal Care Products Council and the American Cleaning Institute, already cited a review of two dozen studies they say showed washing hands with antimicrobial soaps produces “statistically greater reductions in bacteria on the skin” than plain soap.” They may also offer legal arguments about the absence of serious adverse event data resulting from antibacterial soap use as well as study data and scientific literature support. Results of animal studies will likely be submitted as well as clinical studies using standardized microbe doses to try to satisfy the agency’s data requirements. However, it’s not likely that manufacturers would incur the enormous cost of full scale clinical trials to obtain prospective human data.

Industry groups intend to file comments reaffirming that use of antibacterial soap products does not contribute to antibiotic resistance. However, the question is whether they can provide sufficient efficacy and safety data to convince FDA that the benefits outweigh the risks. The assessment of published scientific literature alone won’t persuade FDA, since they’ve already concluded that existing scientific data aren’t adequate to support safe and effective product use.

If FDA determines an antibacterial claim is not supported, companies must reformulate to remove or replace a category III ingredient or relabel their products. How one would relabel such a marketed antibacterial soap product is a big unknown. Would FDA permit a disclaimer stating an ingredient like triclosan lacks evidence of safety and efficacy and allow such products to remain on the market? Would consumers continue to use these products without an antibacterial claim? We suspect it will be a while before these issues are resolved.

Posted in 2014, 2014 January, Issue of the Month.