FDA Hand Sanitizer
On June 29, 2016, The U.S. Food and Drug Administration (FDA) requested more scientific data be collected to support the safety and effectiveness of certain active ingredients used in over-the-counter hand sanitizers.
Janet Woodcock Explains Need for Further FDA Hand Sanitizer Data
According to Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research,
“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 that 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.”
“Emerging Science” Contributes to FDA’s Concern Over Hand Sanitizer Effects
The FDA’s concern was prompted by emerging science which suggests that in some of the antiseptic active ingredients in hand sanitizers full body exposure (as shown by detection of antiseptic ingredients in the blood or urine) is higher than previously thought.
To obtain more information about the effects of hand sanitizers, more scientific data is needed.
As stated in the FDA’s News Release, the FDA is particularly interested in gathering additional data on the long-term safety of daily, repeated exposure to these ingredients by consumers, and on the use of these products by certain populations, including pregnant women and children, for which topical absorption of the active ingredients may be important.
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At this Point, The FDA Does Not Believe Hand Sanitizer is Unsafe or Ineffective
“The FDA’s request for more data is intended to help the agency ensure that regular use of these products does not present unknown safety and efficacy concerns. However, this does not mean the FDA believes these products are ineffective or unsafe,” the news release asserted.
