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PCPC and ACI continue defense of antibac soap safety following FDA ruling

By Andrew McDougall+

06-Jan-2014
Last updated on 06-Jan-2014 at 16:11 GMT

PCPC and ACI continue defense of antibac soap safety following FDA ruling

The American Cleaning Institute and the Personal Care Products Council have responded to the U.S. Food and Drug Administration's (FDA) proposed rule governing antibacterial soaps and washes, reaffirming its safety and efficacy and applauding the agency for finally making the move.

After 35 years the Agency signed a new court agreement with the Natural Resources Defence Council to govern the use of triclosan in the industry.

In recent years lobby groups claimed the chemical to be an endocrine system disruptor, and criticised the FDA's 'lengthy approval process' on the matter.

Industry backing

However, 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 applaud FDA for moving this rulemaking forward, and industry will continue to operate in good faith to submit any new data that is available,” says the joint statement from ACI and PCPC.

"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.”

These soaps and washes in-question 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 U.S. and worldwide.

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.

Staunch defence

PCPC and ACI says that industry's Topical Antimicrobial Coalition submitted in-depth data showing that antibacterial soaps are more effective in killing germs when compared with non-antibacterial soap, to the FDA.

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,” concludes the statement.

“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."

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