FDA Releases Consumer Update on Antibacterials

FDA and the Environmental Protection Agency (EPA) have been closely collaborating on science and regulatory issues related to triclosan. This joint effort will help to ensure government-wide consistency in the regulation of the chemical, noted the FDA in a consumer update released on its website. Manufacturers of antibacterial hand soap and body wash will be required to prove their products are more effective than plain soap and water in preventing illness and the spread of infection, under a new proposed rule. Companies also will be required to prove their products are safe for long-term use.

According to the FDA, the two agencies are reviewing the effects of triclosan from two different perspectives. EPA regulates the use of triclosan as a pesticide, and is in the process of updating its assessment of the effects of triclosan when it is used in pesticides. FDA's focus is on the effects of triclosan when it is used by consumers on a regular basis in hand soaps and body washes. By sharing information, the two agencies will be better able to measure the exposure and effects of triclosan and how these differing uses of triclosan may affect human health.

For more information on EPA's most recent assessment of triclosan, see: www.epa.gov/pesticides/reregistration/triclosan/triclosan-questions.htm

EPA re-evaluates each pesticide active ingredient every 15 years. EPA's Preliminary Work Plan for the triclosan risk assessment, can be found in docket EPA-HQ-OPP-2012-0811 at www.regulations.gov.

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

The American Cleaning Institute and the Personal Care Products Council issued the following statement in response to the proposed rule governing antibacterial soaps and washes:

“These products are over-the-counter drugs (OTC) and as such, go through rigorous review by FDA, including review of data and information submitted by industry and health care providers in the US and worldwide.  Today’s proposed rule is a next step towards FDA finalizing the safety and efficacy of this OTC product category.

“Over the past two decades, manufacturers of these products have provided significant data and information to the Agency about the safety and efficacy of this product category.

“We are perplexed that the Agency would suggest there is no evidence that antibacterial soaps are beneficial as industry has long provided data and information about the safety and efficacy of these products.  In fact, in 2008, at industry’s request, FDA held a public meeting to discuss the data and industry asked FDA if the Agency required any further information.  Our industry’s Topical Antimicrobial Coalition has submitted to the FDA in-depth data showing that antibacterial soaps are more effective in killing germs when compared with non-antibacterial soap.

“Additionally, a review of two dozen relevant published studies analyzing the effectiveness of antibacterial soaps showed that hand washing with these products produces statistically greater reductions in bacteria on the skin than when using non-antibacterial soap.

“We intend to file comments to FDA reaffirming that the use of antibacterial wash products in the home environment does not contribute to antibiotic or antibacterial resistance.  The ingredients used in antibacterial soap and washes have been evaluated and regulated by agencies and scientific bodies around the world.  In some instances, these products have been found to be critical in the reduction of infection and disease.

“We applaud FDA for moving this rulemaking forward, and industry will continue to operate in good faith to submit any new data that is available. Consumers should continue to have access to antibacterial products that are used safely and effectively every day, in homes, offices, schools, child care centers, food facilities and other commercial settings.”