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ACI expects healthcare antiseptic manufacturers to lose most active ingredients
The US Food and Drug Administration (FDA) will ban some 80% of active ingredients currently allowed for use in healthcare antiseptics, the American Cleaning Institute (ACI) expects.
Plans to require manufacturers to submit data demonstrating the safety and efficacy of their antibacterial ingredients were set out in a 2015 proposed rule - and are expected to become law when the final rule is issued. The FDA will assess data submitted by industry and decide whether to classify actives as "generally recognised as safe and effective" (Gras/Grae), or ban their use in the products.
ACI expects triclosan to face a ban in healthcare products as well, along with more than 20 other ingredients, its associate vice president for environmental safety, Paul DeLeo, told CW+BiocidesHub.
Some substances will be banned due to a lack of support by industry, he said. "Companies know it won't get FDA approval so they are not willing to do the additional testing the agency is requiring."
Others will fail because the data to support them is too challenging to generate. The agency, he says, is asking for "new methods that we are not aware of anyone having successfully completed in this space", but it has been willing to give companies more time.
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