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ACI & PCPC responds to FDA's proposed rule on antibacterial soaps and washes
The American Cleaning Institute and the Personal Care Products Council have issued a statement in response to the US Food and Drug Administration's proposed rule governing antibacterial soaps and washes.
For readers unfamiliar with the FDA's proposals, its scientists - warning that antibacterial products may pose health risks by creating resistance to antibiotics in humans - have called for a safety review of such products. Further, they have proposed a rule requiring manufacturers to prove that such soaps are safe and that they are more effective against infection than plain soap and water.
Recent studies indicate that an ingredient in such products could disrupt hormones and boost drug-resistant bacteria.The proposal rule does not apply to alcohol-based hand sanitisers and products used in healthcare settings.Under the proposals, manufacturers would have until the end of 2014 to submit the results of clinical trials on their products and the new regulations would be finalised in 2016.
"New data suggest that the risks associated with long-term, daily use of antibacterial soaps may outweigh the benefits," says the report. "Certain ingredients in such products - such as triclosan in liquid soaps and triclocarban in bar soaps - may contribute to bacterial resistance to antibiotics and such products may also have unanticipated hormonal effects that are of concern.
Because so many consumers use them, FDA believes that there should be clearly demonstrated benefits to balance any potential risks."
The American Cleaning Institute and Personal Care Products Council have responded thus:"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 healthcare providers in the US and worldwide.
Today's proposed rule is a next step towards FDA finalising 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 analysing 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 centres, food facilities, and other commercial settings."
More information on the safety and benefits of antibacterial soaps can be found at
19th December 2013