Opponents Want Antimicrobial Soap Choice Left Up To Consumers

The rule change ultimately comes down to consumer choice, and the ACI is fighting for the choice of whether to use antibacterial soaps to be up to consumers and institutions, not the FDA.

“This could eliminate consumer access to antibacterial soaps, could substantially hinder choices not just for consumers in their homes but in institutions of every kind that want to use antibacterial soap,” says Sansoni.

The ACI is also concerned that the elimination of antibacterial soap could lead to more cases of foodborne illnesses in homes. The association estimates these rules could be responsible for up to 7.5 million new cases of foodborne illness and $38 billion in additional healthcare costs.

The public comment period for this rule has closed, but the period for submission of new data and information for the tentative final monograph will continue until Dec. 16, 2014. The rebuttal period ends in February of 2015. The FDA review of comments, data and information; drafting of the final monograph; and final review and approval by the FDA, Department of Health and Human Services, and Office of Management and Budget ends August 31, 2016, with the publication of the final monograph slated for Sept. 15, 2016.

Since the FDA’s announcement last December, the ACI has been mobilizing its members to lobby in defense of antibacterials.

“We have urged our affected members to bring all their data to the table. The ACI has tried to summarize all the existing and new data on the safety and effectiveness of the products and on the specific antibacterial ingredients,” says Sansoni. “We believe that antibacterial soap and body wash manufacturers need to have a palate of ingredients to choose from to make the most effective products.”

Triclosan is the one antibacterial that actually has the most data available relative to other antimicrobials. In fact, there are decades worth of data showing it is a safe and effective antibacterial chemical, says Sansoni.

The ACI, along with the Personal Care Products Council, has summarized and submitted a large amount of material to the FDA about antibacterial safety and effectiveness. It has also submitted separate sets of comments about the safety profiles of individual active ingredients.

While some members of the cleaning product industry have put in an immense amount of effort into this cause, there may be others — the smaller users, producers or private label producers of antibacterial soaps or ingredients, specifically in the commercial sector — who may not be fully engaged or aware what’s happening, says Sansoni.

“This is something companies small and large in that sector need to be worried about,” he says.