The US FDA should re-evaluate all data relevant to the safety and efficacy of antibacterial healthcare ingredients, before asking industry for additional information, says the American Cleaning Institute (ACI).
Earlier this year, the FDA proposed that manufacturers of biocidal active substances, used in healthcare products, should be required to provide additional data on the substances' safety and effectiveness if they want them to stay on the market (BiocidesHub 13 May 2015).
In its response to the consultation on the proposals, the ACI said the FDA should first re-evaluate all existing data and mark substances that are generally recognised as safe and effective (Grase). It should then indicate where, if any, specific data gaps exist for each active ingredient.
The trade body says there is no evidence of adverse health effects in humans because of the use of healthcare antiseptic products, which have “very favourable benefit/risk ratios demonstrated over many years of extensive use”.
“For the agency to suggest that previous tests of the same or similar strains are no longer valid is arbitrary and the requirement for new repeated tests is unduly burdensome,” the institute's associate vice president for environmental safety, Paul DeLeo, said this week.
The ACI has also asked the FDA not to change safety classifications of several key biocidal ingredients, stating that the “FDA has provided no data to indicate that there is any safety issue, associated with the use of products containing these actives, or that they are ineffective in their use.”
It also wants the agency to consider the level of human exposure to each of the actives and assess the potential for harm from this, prior to determining the need for additional safety data.
The proposed rule is based on information gathered by an FDA advisory committee, last year (CW 3 September 2014).
The consultation ended on 27 October, and is followed by a 60-day comment period.
The FDA will then evaluate all the data and comments, before determining Grase status for each active ingredient.