FDA has taken additional action to help ensure widespread access to alcohol-based hand sanitizers that are free of contamination. The agency issued updated guidances to provide additional clarification on testing of alcohol used in hand sanitizers manufactured under FDA’s temporary policies to help ensure that harmful levels of methanol are not present in these products.
FDA is advising importers, consignees, distributors, retailers and others not to distribute or sell certain hand sanitizers, even if the manufacturer of the product has not recalled it, due to the dangers of methanol contamination, including death. The agency is maintaining a list of dangerous hand sanitizers, and recommends entities involved in distributing and selling hand sanitizers continuously check this list as it is being updated regularly. FDA considers all of the hand sanitizers on the list to be adulterated, and it is prohibited under federal law to distribute or sell these products interstate.
FDA is sending a voluntary request for information to firms that have registered and listed hand sanitizers, ethanol for use in hand sanitizers, or both with FDA after March 1, 2020. The information will help FDA assess the state of the market for these products and ensure that quality hand sanitizers, are available to the American public during the COVID-19 public health emergency. The firms’ responses to this information request will enable FDA to better monitor the quality of alcohol-based hand sanitizers, understand the drug supply chain for these products, and provide firms with appropriate outreach and Guidance.