The FDA issued a proposed rule yesterday requesting additional scientific data to support the safety and effectiveness of ingredients used in hand sanitizers that are marketed over the counter. The agency wants to make sure that regular use of these products doesn’t present unknown safety and efficacy concerns. This does not mean the FDA thinks these products are unsafe or ineffective.
Antiseptic rubs are products used when soap and water are not available. They are left on and not rinsed off with water.
Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research said in a statement, “today, consumers are using antiseptic rubs more frequently at home, work, school, and in other public settings where the risk of infection is relatively low. These products provide a convenient alternative when hand washing with plain soap and water is unavailable, but it’s our responsibility to determine whether these products are safe and effective so consumers can be confident when using them on themselves and their families multiple times a day. To do that, we must fill the gaps in scientific data on certain active ingredients.”
The CDC says that washing hands with plain soap and running water is one of the most important ways consumers can avoid getting sick. This action also prevents spreading infections to others. If soap and water aren’t available, the CDC recommends using an alcohol-based hand sanitizer that has at least 60% alcohol.
Based on new scientific information and input of outside scientific and medical experts on an independent advisory committee, the agency wants more data to demonstrate that the active ingredients used in these sanitizers are safe and effective to reduce bacteria. The three ingredients the FDA is interested in are alcohol (ethanol or ethyl alcohol), isopropyl alcohol, and benzalkonium chloride.
A doctor at Rush University Medical Center was interviewed about hand sanitizers. Dr. Gordon Trenholme, director of the Section of Infectious Diseases at the hospital, says that hand sanitizers are useful in the hospital. He added that hand sanitizers are more convenience, so they make it more likely that people will clean their hands.
If a hand sanitizer contains triclosan, also called triclocarban, it could be unnecessarily risky. Triclosan does contribute to antibiotic resistance, it can weaken the immune system, and it may disrupt hormones. A 2011 study by the Epidemic Intelligence Service at the CDC found that health care employees who used hand sanitizers over soap and water were almost six times more at risk for norovirus infections. Alcohol poisoning is another concern about these sanitizers, especially for teenagers and young children.
The rule requires manufacturers who want to continue selling these products under the OTC Drug Review to give the FDA more data on these ingredients, including data to evaluate absorption.
The FDA began reviewing topical antiseptics in the 1970s. Many things have changed since then, including the frequency of use of these products, new technology that can detect low levels of antiseptics in the body, and FDA’s safety standards. The FDA is especially interested in getting more data on the long-term safety of daily, repeated exposure to these ingredients, especially by pregnant women and children.
Emerging science suggests that for some antiseptic active ingredients, systemic exposure is higher than previously thought, and more information is needed about the effects of repeated daily human exposure.
The proposed rule will be available for public comment for 180 days. Companies will have one year to submit new data and information concurrently.