The Food and Drug Administration said on Monday that 1,500 manufacturers have registered to produce hand sanitizer to help fill a shortage amid the spread of COVID-19.
While the FDA said it is being flexible with the registration process, the FDA expressed some concern over some of the manufacturing of hand sanitizer.
The FDA said that it has received feedback on the use of denatured alcohol for these products. Denatured alcohol makes hand sanitizer less appealing for children to ingest. Foregoing denatured alcohol undermines the FDA’s mission of producing safe products, the FDA said.
Calls to the National Poison Data System last month related to hand sanitizer increased by 79% compared to March 2019, the FDA said, with the majority of the calls involving children under age 5 ingesting alcohol-based hand sanitizer.
Meanwhile, the FDA warns consumers that some hand sanitizers are being sold with unproven claims. The FDA said that one company falsely claimed that hand sanitizer provided protection for 24 hours. The FDA is not aware of any evidence that hand sanitizer products can protect consumers for 24 hours or after multiple hand-washings, the FDA said.
"We appreciate industry's willingness to help supply alcohol-based hand sanitizer to the market to meet the increasing demand for these products and are grateful for their efforts," said FDA Commissioner Stephen M. Hahn, M.D. "With this increased supply comes our continued mission to ensure safety of these products. It is important that hand sanitizer be manufactured in a way that makes them unpalatable to people, especially young children, and that they are appropriately labeled to discourage accidental or intentional ingestion. Additionally, hand sanitizers are not proven to treat COVID-19, and like other products meant for external use, are not for ingestion, inhalation, or intravenous use."