FDA seeks more data about Antiseptic Sanitizers used in Health Care Settings
The Food and Drug Administration (FDA) has called for more data about antiseptic sanitizers used in health care settings, including hospitals. The request is applicable on products, including antibacterial soaps and hand washes.
The federal agency wants to find out if the products are as safe and effective as they were the last time, when the organization thoroughly investigated the subject, 40 years ago.
Antiseptic manufacturers have been asked to supply the FDA with information on how their products may be affective in the rise of antibiotic-resistant microorganisms, and absorption into the bodies of users, and about its possible hormonal effects.
In many professional antibacterial products, alcohol and iodine are generally used as active ingredients, and the agency is concerned that the exposure to such chemicals is higher than previously believed.
Brian Sansoni, spokesperson for the American Cleaning Institute (ACI), said, "We're going to try to answer their questions in great detail as called for, but we believe the FDA already has sufficient data on these products". ACI represents manufacturers of products, including Dial soap and Purell hand sanitizer.
The FDA has stated that its current review is not going to affect home use of antibacterial soaps and lotions and also mentioned that it does not intend, at this time, to pull any products from store shelves.
The request is applicable only on the products that have been created following the monograph, a type of recipe book outlining certain chemical combinations, doses and labeling etiquette.
Once a final version of the monograph completes, the companies will be able to market products without FDA approval.
Antiseptics used in the workplace are generally used in nursing homes, doctor's offices, clinics and hospitals, and FDA is trying to know whether these products are still safe and effective when used as directed or not.