FDA Urged to Preserve Critical Healthcare Antibacterial Products, Ingredients

Washington, DC, November 3, 2015 – The American Cleaning Institute® (ACI) urged the Food and Drug Administration to re-evaluate all data relevant to the safety and efficacy of antibacterial health care ingredients and make affirmative findings that they are generally recognized as safe and effective.

ACI submitted detailed comments to FDA on the agency’s proposed rules governing over-the-counter antiseptic healthcare products.

“The active ingredients used in healthcare antiseptic drug products have very favorable benefit/risk ratios demonstrated over many years of extensive use,” wrote Dr. Paul DeLeo, ACI Associate Vice President, Environmental Safety. “These products clearly save lives by reducing bacterial transmission which can cause infections in healthcare settings.

“By reducing Healthcare-Associated Infections, these products also reduce health care costs. There is no evidence of adverse health effects in humans as a result of the use of health care topical antiseptic products. In addition, a robust body of research supports the safety of active ingredients used in healthcare topical antiseptic products.”

ACI also said FDA should consider all existing data relevant to the efficacy of health care antiseptic active ingredients and indicate where specific data gaps exist, if any, for each active ingredient. Read more…


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