The U.S. Food and Drug Administration provided an update on its efforts to ensure the availability of alcohol-based sanitizer to help meet the demand for hand sanitizer during the COVID-19 pandemic.
The FDA also found that the product ingested by the 13-year-old child was not consistent with the labeling component of the agency’s temporary policy— underscoring the importance that these products include a Drug Facts Label, warnings to keep the product out of reach of children, information to get medical help or call a poison control center right away if swallowed and to supervise use in children under 6 years of age to prevent accidental swallowing. These safety measures apply regardless of where the product is intended to be used, as it can easily be distributed beyond the original intended setting.
The FDA is also concerned about hand sanitizer products being sold by some manufacturers during the COVID-19 pandemic with unproven claims. Last week, the agency issued its first warning letter for a hand sanitizer product marketed with unproven COVID-19-related claims, in violation of federal law.