More on safety concerns, fraudulent claims

WASHINGTON — The FDA announced that more than 1,500 additional manufacturers have registered with the agency to ramp up production of hand sanitizer to meet the high demand during the Covid-19 pandemic.

In addition, the FDA addressed safety concerns and reiterated concern over manufacturers whose products hawk unproven claims in regard to protection from Covid-19. The agency recently sent a warning letter to Prefense LLC for such claims.

“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,” FDA Commissioner Stephen M. Hahn, MD, said in a statement. “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.”

One issue with the manufacture of hand sanitizer is that, per FDA guidance, they need to contain denatured alcohol, which renders it “more bitter and less appealing to ingest, particularly for young children.” The agency noted that, while it may be more economical to not use denatured alcohol, “such an approach undermines the agency’s mission of helping to ensure the safety of FDA-regulated products for consumer use.”

The FDA noted that calls to poison control centers over hand sanitizer concerns increased by 79% last month, compared with March 2019. While most of the ingestion was unintentional, the FDA noted that a 13-year-old child drank hand sanitizer that came from a distillery that is making the product and bottling it in liquor bottles. The product was not denatured and apparently tasted like regular alcohol.

Candace Hoffmann, Managing Editor, BreakingMED™

Cat ID: 125

Topic ID: 79,125,728,932,730,933,125,190,520,926,192,927,151,928,925,934