Today, 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. As a result of the agency’s significant flexibility, more than 1,500 additional manufacturers have registered with the agency to produce hand sanitizer. At the same time, the agency is addressing safety concerns related to products being sold that are not in line with the FDA’s policy and others being marketed with unproven claims.
Following the FDA’s guidance aimed at increasing availability of alcohol-based hand sanitizers, the agency has received feedback and questions over the past few weeks from industry and congressional members, particularly regarding the need to use denatured alcohol for these products. Adding these denaturants to the alcohol renders the product more bitter and less appealing to ingest, particularly for young children. While the agency understands the economic and business reasons behind foregoing this step in the manufacturing process, such an approach undermines the agency’s mission of helping to ensure the safety of FDA-regulated products for consumer use, which is the FDA’s top priority. This approach is consistent with the FDA’s policies prior to the COVID-19 pandemic on including denatured alcohol in hand sanitizer and is even more important now as more consumers rely on its use as a mitigation tool against the deadly virus.
To illustrate the importance of using denatured alcohol and, according to an FDA analysis of data provided by the U.S. Centers for Disease Control and Prevention and the American Association of Poison Control Centers surveillance team, calls to the National Poison Data System last month related to hand sanitizer increased by 79% compared to March 2019. The majority of these calls were for unintentional exposures in children 5 years of age and younger. Every year, there are hundreds of calls to poison control centers regarding exposure to hand sanitizer, many of which result in adverse events, including death. Unfortunately, ingestion of only a small amount of hand sanitizer may be potentially lethal in a young child.
This month, the agency received an adverse event report of a 13-year-old child drinking hand sanitizer packaged in a liquor bottle from a distiller. The sanitizer was not denatured and was reported to taste like normal drinking alcohol. To protect consumers, especially children, it is important to make hand sanitizer unpalatable.
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