Hand Sanitizers Offered In Liquor Bottles Among Emerging Concerns Under US FDA's Pandemic Rule
Allowing "significant flexibility" for making OTC sanitizers has led to more than 1,500 additional manufacturers registered with FDA to produce hand sanitizer. But the agency says it "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."
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The agency clarifies in documents providing temporary guidance on preparing or compounding alcohol-based hand sanitizer products, and manufacturing alcohol for those products, that each lot of alcohol obtained from another source should be tested for methanol.
The agency’s latest in a series of increasingly strident announcements expands its its warning not to use any hand sanitizers from the firms linked to methanol contamination “even if the product or particular lot number are not listed since some manufacturers are recalling only certain – but not all – of their hand sanitizer products.”
House appropriators don’t mention the consumer health market in requesting a report on FDA’s response to COVID-19, but the agency’s frequent warnings about products marketed with unlawful claims could merit mentioning. Encouraging accelerated production of hand sanitizers while also ensuring the additional supplies are safe is another component of its COVID-19 response that could be covered in an assessment of its response to the pandemic.